Trial Outcomes & Findings for Apixaban Drug Utilization Study In Stroke Prevention In Atrial Fibrillation (Spaf) (NCT NCT03441633)

Results Overview

Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included smoking habit.

Recruitment status

COMPLETED

Target enrollment

51690 participants

Primary outcome timeframe

Day 1

Results posted on

2023-06-09

Participant Flow

Participant milestones

Participant milestones
Measure	Apixaban: Naive Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician.	Apixaban: Non Naive Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Acenocoumarol: Naive Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Acenocoumarol: Non-Naive Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Warfarin: Naive Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Warfarin: Non-Naive Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Dabigatran: Naive Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Dabigatran: Non-Naive Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Rivaroxaban: Naive Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Rivaroxaban: Non-Naive Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Overall Study STARTED	4712	1423	32212	192	2286	363	2855	953	5132	1562
Overall Study COMPLETED	4712	1423	32212	192	2286	363	2855	953	5132	1562
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Apixaban: Naive n=4712 Participants Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician.	Apixaban: Non Naive n=1423 Participants Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Acenocoumarol: Naive n=32212 Participants Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Acenocoumarol: Non-Naive n=192 Participants Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Warfarin: Naive n=2286 Participants Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Warfarin: Non Naive n=363 Participants Participants who were treated with warfarin with prior prescription of different VKA, apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Dabigatran: Naive n=2855 Participants Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Dabigatran: Non-Naive n=953 Participants Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Rivaroxaban: Naive n=5132 Participants Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Rivaroxaban: Non-Naive n=1562 Participants Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Total n=51690 Participants Total of all reporting groups
Age, Continuous	71.8 years STANDARD_DEVIATION 11.1 • n=4712 Participants	78.1 years STANDARD_DEVIATION 8.7 • n=1423 Participants	73.5 years STANDARD_DEVIATION 12.3 • n=32212 Participants	74.6 years STANDARD_DEVIATION 10.7 • n=192 Participants	69.7 years STANDARD_DEVIATION 13.4 • n=2286 Participants	74.9 years STANDARD_DEVIATION 12.9 • n=363 Participants	69.9 years STANDARD_DEVIATION 12.3 • n=2855 Participants	76.5 years STANDARD_DEVIATION 9.5 • n=953 Participants	69.3 years STANDARD_DEVIATION 13.2 • n=5132 Participants	76.4 years STANDARD_DEVIATION 10.5 • n=1562 Participants	72.8 years STANDARD_DEVIATION 12.3 • n=51690 Participants
Sex: Female, Male Female	2661 Participants n=4712 Participants	751 Participants n=1423 Participants	15531 Participants n=32212 Participants	94 Participants n=192 Participants	979 Participants n=2286 Participants	205 Participants n=363 Participants	1399 Participants n=2855 Participants	479 Participants n=953 Participants	2649 Participants n=5132 Participants	811 Participants n=1562 Participants	25559 Participants n=51690 Participants
Sex: Female, Male Male	2051 Participants n=4712 Participants	672 Participants n=1423 Participants	16681 Participants n=32212 Participants	98 Participants n=192 Participants	1307 Participants n=2286 Participants	158 Participants n=363 Participants	1456 Participants n=2855 Participants	474 Participants n=953 Participants	2483 Participants n=5132 Participants	751 Participants n=1562 Participants	26131 Participants n=51690 Participants
Race and Ethnicity Not Collected	—	—	—	—	—	—	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Day 1

Population: Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.

Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included smoking habit.

Outcome measures

Outcome measures
Measure	Apixaban: Naive n=4712 Participants Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician.	Apixaban: Non Naive n=1423 Participants Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Acenocoumarol: Naive n=32212 Participants Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Acenocoumarol: Non-Naive n=192 Participants Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Warfarin: Naive n=2286 Participants Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Warfarin: Non-Naive n=363 Participants Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Dabigatran: Naive n=2855 Participants Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Dabigatran: Non-Naive n=953 Participants Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Rivaroxaban: Naive n=5132 Participants Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Rivaroxaban: Non-Naive n=1562 Participants Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Number of Participants by Their Sociodemographic Characteristics: Smoking Habit Missing	207 Participants	23 Participants	1844 Participants	7 Participants	112 Participants	14 Participants	225 Participants	23 Participants	354 Participants	38 Participants
Number of Participants by Their Sociodemographic Characteristics: Smoking Habit Non-smoker	3104 Participants	946 Participants	19440 Participants	119 Participants	1166 Participants	234 Participants	1684 Participants	623 Participants	3079 Participants	1030 Participants
Number of Participants by Their Sociodemographic Characteristics: Smoking Habit Ex-smoker	459 Participants	83 Participants	3676 Participants	16 Participants	320 Participants	26 Participants	355 Participants	72 Participants	608 Participants	102 Participants
Number of Participants by Their Sociodemographic Characteristics: Smoking Habit Smoker	942 Participants	371 Participants	7252 Participants	50 Participants	688 Participants	89 Participants	591 Participants	235 Participants	1091 Participants	392 Participants

PRIMARY outcome

Timeframe: Day 1

Population: Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.

Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included alcoholic habit.

Outcome measures

Outcome measures
Measure	Apixaban: Naive n=4712 Participants Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician.	Apixaban: Non Naive n=1423 Participants Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Acenocoumarol: Naive n=32212 Participants Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Acenocoumarol: Non-Naive n=192 Participants Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Warfarin: Naive n=2286 Participants Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Warfarin: Non-Naive n=363 Participants Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Dabigatran: Naive n=2855 Participants Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Dabigatran: Non-Naive n=953 Participants Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Rivaroxaban: Naive n=5132 Participants Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Rivaroxaban: Non-Naive n=1562 Participants Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit Missing	2162 Participants	353 Participants	11299 Participants	40 Participants	839 Participants	91 Participants	1263 Participants	211 Participants	2475 Participants	366 Participants
Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit No intake	1749 Participants	810 Participants	14337 Participants	111 Participants	984 Participants	212 Participants	1054 Participants	550 Participants	1696 Participants	923 Participants
Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit Moderate intake	765 Participants	247 Participants	6241 Participants	39 Participants	447 Participants	58 Participants	505 Participants	187 Participants	915 Participants	255 Participants
Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit Risk consumption	36 Participants	13 Participants	335 Participants	2 Participants	16 Participants	2 Participants	33 Participants	5 Participants	46 Participants	18 Participants

PRIMARY outcome

Timeframe: Day 1

Population: Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF. Here, "Overall Number of Participants Analyzed (N)" signifies participants who were evaluable for this outcome measure.

Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included MEDEA. MEDEA was a deprivation index that was associated with overall mortality in urban areas. It included factors like job, education, housing conditions and single parent homes. The MEDEA index was categorized in quintiles for urban areas, with quintile 1 corresponding to the least deprived population and quintile 5, the most deprived.

Outcome measures

Outcome measures
Measure	Apixaban: Naive n=4027 Participants Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician.	Apixaban: Non Naive n=1210 Participants Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Acenocoumarol: Naive n=25477 Participants Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Acenocoumarol: Non-Naive n=154 Participants Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Warfarin: Naive n=2163 Participants Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Warfarin: Non-Naive n=322 Participants Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Dabigatran: Naive n=2393 Participants Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Dabigatran: Non-Naive n=789 Participants Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Rivaroxaban: Naive n=4430 Participants Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Rivaroxaban: Non-Naive n=1389 Participants Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Number of Participants by Their Sociodemographic Characteristics: MEDEA Missing - Urban area	190 Participants	90 Participants	1754 Participants	16 Participants	120 Participants	28 Participants	110 Participants	57 Participants	230 Participants	145 Participants
Number of Participants by Their Sociodemographic Characteristics: MEDEA Quintile 1 - Urban area	716 Participants	224 Participants	4735 Participants	31 Participants	149 Participants	73 Participants	558 Participants	156 Participants	973 Participants	230 Participants
Number of Participants by Their Sociodemographic Characteristics: MEDEA Quintile 2 - Urban area	754 Participants	216 Participants	4753 Participants	25 Participants	315 Participants	73 Participants	461 Participants	148 Participants	803 Participants	234 Participants
Number of Participants by Their Sociodemographic Characteristics: MEDEA Quintile 3 - Urban area	825 Participants	256 Participants	4801 Participants	27 Participants	606 Participants	52 Participants	447 Participants	137 Participants	904 Participants	230 Participants
Number of Participants by Their Sociodemographic Characteristics: MEDEA Quintile 4 - Urban area	807 Participants	231 Participants	4744 Participants	28 Participants	635 Participants	55 Participants	429 Participants	152 Participants	837 Participants	300 Participants
Number of Participants by Their Sociodemographic Characteristics: MEDEA Quintile 5 - Urban area	735 Participants	193 Participants	4690 Participants	27 Participants	338 Participants	41 Participants	388 Participants	139 Participants	683 Participants	250 Participants

PRIMARY outcome

Timeframe: Day 1

Population: Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.

Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included BMI. BMI was defined as an index for assessing overweight and underweight and was obtained by dividing body weight in kilograms (kg) by height in meters squared (m\^2).

Outcome measures

Outcome measures
Measure	Apixaban: Naive n=4712 Participants Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician.	Apixaban: Non Naive n=1423 Participants Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Acenocoumarol: Naive n=32212 Participants Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Acenocoumarol: Non-Naive n=192 Participants Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Warfarin: Naive n=2286 Participants Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Warfarin: Non-Naive n=363 Participants Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Dabigatran: Naive n=2855 Participants Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Dabigatran: Non-Naive n=953 Participants Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Rivaroxaban: Naive n=5132 Participants Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Rivaroxaban: Non-Naive n=1562 Participants Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) Missing	1424 Participants	261 Participants	6898 Participants	34 Participants	509 Participants	87 Participants	960 Participants	178 Participants	1746 Participants	311 Participants
Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) 18.5 - 25 kg per m^2 (Normal)	423 Participants	253 Participants	4471 Participants	30 Participants	295 Participants	78 Participants	272 Participants	144 Participants	464 Participants	271 Participants
Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) Less than (<) 18.5 kg per m^2 (Underweight)	12 Participants	6 Participants	141 Participants	0 Participants	6 Participants	2 Participants	10 Participants	8 Participants	16 Participants	0 Participants
Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) 25 - 30 kg per m^2 (Overweight)	1229 Participants	493 Participants	10074 Participants	68 Participants	712 Participants	119 Participants	735 Participants	306 Participants	1289 Participants	482 Participants
Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) Greater than (>) 30 kg per m^2 (Obese)	1624 Participants	410 Participants	10628 Participants	60 Participants	764 Participants	77 Participants	878 Participants	317 Participants	1617 Participants	498 Participants

PRIMARY outcome

Timeframe: Up to 12 months after date of first prescription

Population: Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.

Comorbidity was defined as the presence of one or more additional diseases or disorders co-occurring with (that is, concomitant or concurrent with) a primary disease or disorder.

Outcome measures

Outcome measures
Measure	Apixaban: Naive n=4712 Participants Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician.	Apixaban: Non Naive n=1423 Participants Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Acenocoumarol: Naive n=32212 Participants Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Acenocoumarol: Non-Naive n=192 Participants Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Warfarin: Naive n=2286 Participants Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Warfarin: Non-Naive n=363 Participants Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Dabigatran: Naive n=2855 Participants Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Dabigatran: Non-Naive n=953 Participants Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Rivaroxaban: Naive n=5132 Participants Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Rivaroxaban: Non-Naive n=1562 Participants Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Number of Participants by Comorbidity	3695 Participants	1316 Participants	26450 Participants	173 Participants	1819 Participants	318 Participants	2030 Participants	870 Participants	3731 Participants	1417 Participants

PRIMARY outcome

Timeframe: Up to 12 months prior to enrollment

Population: Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.

Risk of bleeding events was assessed by using HAS-BLED score. HAS-BLED was a scoring system that was developed to assess 1 year risk of occurrence of major hemorrhage. HAS-BLED score was assessed by combining score of 9 risk factors: hypertension history, renal disease, liver disease, stroke history, prior major bleeding or predisposition to bleeding, labile international normalized ratio (INR), age \>65 years, medication usage predisposing to bleeding and alcohol or drug usage history. The total score ranged from 0 to 9 where 0 = low risk of bleed per 100 participants-year and \>3 = high risk of bleed per 100 participants-year.

Outcome measures

Outcome measures
Measure	Apixaban: Naive n=4712 Participants Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician.	Apixaban: Non Naive n=1423 Participants Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Acenocoumarol: Naive n=32212 Participants Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Acenocoumarol: Non-Naive n=192 Participants Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Warfarin: Naive n=2286 Participants Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Warfarin: Non-Naive n=363 Participants Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Dabigatran: Naive n=2855 Participants Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Dabigatran: Non-Naive n=953 Participants Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Rivaroxaban: Naive n=5132 Participants Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Rivaroxaban: Non-Naive n=1562 Participants Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Risk of Bleeding Events: HAS-BLED Score	1.7 bleed per 100 participants-year Standard Deviation 1.0	2.7 bleed per 100 participants-year Standard Deviation 1.1	2.2 bleed per 100 participants-year Standard Deviation 1.1	2.5 bleed per 100 participants-year Standard Deviation 1.0	1.9 bleed per 100 participants-year Standard Deviation 1.1	2.4 bleed per 100 participants-year Standard Deviation 1.2	1.5 bleed per 100 participants-year Standard Deviation 1.0	2.6 bleed per 100 participants-year Standard Deviation 1.0	1.6 bleed per 100 participants-year Standard Deviation 1.0	2.6 bleed per 100 participants-year Standard Deviation 1.1

PRIMARY outcome

Timeframe: Up to 12 months prior to enrollment

Population: Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.

Thromboembolic events were defined as an embolic stroke that occurred when a blood clot that formed elsewhere in the body breaks loose and travels to the brain via bloodstream. Risk of thromboembolic events was calculated using CHADS2 score. CHADS2 score was assessed by combining score of 5 risk factors (congestive heart failure history, hypertension history, age \>=75 years, diabetes mellitus history and stroke/transient ischemic attack symptoms previously). Total CHADS2 score ranged from 0-6 where 0 =low risk and 6 =high risk of stroke.

Outcome measures

Outcome measures
Measure	Apixaban: Naive n=4712 Participants Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician.	Apixaban: Non Naive n=1423 Participants Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Acenocoumarol: Naive n=32212 Participants Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Acenocoumarol: Non-Naive n=192 Participants Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Warfarin: Naive n=2286 Participants Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Warfarin: Non-Naive n=363 Participants Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Dabigatran: Naive n=2855 Participants Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Dabigatran: Non-Naive n=953 Participants Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Rivaroxaban: Naive n=5132 Participants Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Rivaroxaban: Non-Naive n=1562 Participants Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Risk of Thromboembolic Events: CHADS2 Score	1.7 stroke risk per year Standard Deviation 1.3	2.8 stroke risk per year Standard Deviation 1.4	1.9 stroke risk per year Standard Deviation 1.3	2.3 stroke risk per year Standard Deviation 1.3	1.8 stroke risk per year Standard Deviation 1.3	2.5 stroke risk per year Standard Deviation 1.5	1.5 stroke risk per year Standard Deviation 1.3	2.6 stroke risk per year Standard Deviation 1.4	1.5 stroke risk per year Standard Deviation 1.2	2.6 stroke risk per year Standard Deviation 1.4

PRIMARY outcome

Timeframe: Up to 12 months prior to enrollment

Population: Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.

Thromboembolic events were defined as an embolic stroke that occurred when a blood clot that formed elsewhere in the body breaks loose and travels to the brain via bloodstream. Risk of thromboembolic events was calculated using CHA2DS2Vasc score. CHA2DS2Vasc score was assessed by combining score of 8 risk factors (female, \>=65 and \<75 years, congestive heart failure history, hypertension history, diabetes mellitus history, vascular disease history, age \>=75 years and stroke/TIA symptoms previously). Total CHA2DS2Vasc score ranged from 0-9 where 0=low risk and 9=high risk of stroke.

Outcome measures

Outcome measures
Measure	Apixaban: Naive n=4712 Participants Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician.	Apixaban: Non Naive n=1423 Participants Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Acenocoumarol: Naive n=32212 Participants Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Acenocoumarol: Non-Naive n=192 Participants Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Warfarin: Naive n=2286 Participants Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Warfarin: Non-Naive n=363 Participants Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Dabigatran: Naive n=2855 Participants Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Dabigatran: Non-Naive n=953 Participants Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Rivaroxaban: Naive n=5132 Participants Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Rivaroxaban: Non-Naive n=1562 Participants Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Risk of Thromboembolic Events: CHA2DS2Vasc Score	3.0 stroke risk per year Standard Deviation 1.7	4.4 stroke risk per year Standard Deviation 1.6	3.2 stroke risk per year Standard Deviation 1.7	3.7 stroke risk per year Standard Deviation 1.6	2.9 stroke risk per year Standard Deviation 1.8	3.9 stroke risk per year Standard Deviation 1.9	2.7 stroke risk per year Standard Deviation 1.8	4.0 stroke risk per year Standard Deviation 1.7	2.7 stroke risk per year Standard Deviation 1.7	4.1 stroke risk per year Standard Deviation 1.7

PRIMARY outcome

Timeframe: Up to 30 days after date of first prescription

Population: Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.

Comedication was defined as the second or alternative medication used to relieve the side-effects of another medicine.

Outcome measures

Outcome measures
Measure	Apixaban: Naive n=4712 Participants Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician.	Apixaban: Non Naive n=1423 Participants Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Acenocoumarol: Naive n=32212 Participants Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Acenocoumarol: Non-Naive n=192 Participants Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Warfarin: Naive n=2286 Participants Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Warfarin: Non-Naive n=363 Participants Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Dabigatran: Naive n=2855 Participants Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Dabigatran: Non-Naive n=953 Participants Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Rivaroxaban: Naive n=5132 Participants Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Rivaroxaban: Non-Naive n=1562 Participants Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Number of Participants by Comedications	4712 Participants	1406 Participants	32212 Participants	188 Participants	2286 Participants	352 Participants	2855 Participants	947 Participants	5132 Participants	1532 Participants

PRIMARY outcome

Timeframe: Up to 12 months after date of first prescription

Population: Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF. Here "N" signifies number of participants evaluable for the specified outcome measure.

MPR was one of the methods of measuring adherence and was defined as the ratio of all days supply to elapsed days, during the 12-month observation period. All days supply defined as sum of number of days supply between the start date and last prescription dispensed. Elapsed days defined as number of days between the start date and the last prescription dispensed. There were three categories of adherence: poor defined as \<80% of MPR, good defined as between 80% and 120% of MPR and over adherence defined as \>120% of MPR.

Outcome measures

Outcome measures
Measure	Apixaban: Naive n=424 Participants Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician.	Apixaban: Non Naive n=430 Participants Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Acenocoumarol: Naive n=6108 Participants Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Acenocoumarol: Non-Naive n=32 Participants Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Warfarin: Naive n=344 Participants Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Warfarin: Non-Naive n=79 Participants Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Dabigatran: Naive n=447 Participants Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Dabigatran: Non-Naive n=311 Participants Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Rivaroxaban: Naive n=527 Participants Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Rivaroxaban: Non-Naive n=495 Participants Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR) MPR: Poor adherence	162 Participants	151 Participants	5634 Participants	31 Participants	103 Participants	57 Participants	241 Participants	177 Participants	147 Participants	131 Participants
Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR) MPR: Good adherence	259 Participants	276 Participants	460 Participants	0 Participants	151 Participants	13 Participants	206 Participants	133 Participants	378 Participants	360 Participants
Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR) MPR: Over adherence	3 Participants	3 Participants	14 Participants	1 Participants	90 Participants	9 Participants	0 Participants	1 Participants	2 Participants	4 Participants

PRIMARY outcome

Timeframe: Up to 12 months after date of first prescription

Population: Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF. Here "N" signifies number of participants evaluable for the specified outcome measure.

Discontinuation rate was defined as the lack of subsequent prescription of the index drugs within 2 months after last supply day of the last prescription. It was analyzed by calculating the treatment withdrawal or switch rate.

Outcome measures

Outcome measures
Measure	Apixaban: Naive n=1305 Participants Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician.	Apixaban: Non Naive n=666 Participants Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Acenocoumarol: Naive n=17434 Participants Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Acenocoumarol: Non-Naive n=117 Participants Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Warfarin: Naive n=1353 Participants Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Warfarin: Non-Naive n=206 Participants Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Dabigatran: Naive n=1449 Participants Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Dabigatran: Non-Naive n=559 Participants Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Rivaroxaban: Naive n=1718 Participants Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Rivaroxaban: Non-Naive n=817 Participants Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Discontinuation Throughout the Year	881 Participants	236 Participants	11326 Participants	85 Participants	1009 Participants	127 Participants	1002 Participants	248 Participants	1191 Participants	322 Participants

PRIMARY outcome

Timeframe: Up to 12 months after date of first prescription

Population: Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF. Here "N" signifies number of participants evaluable for the specified outcome measure.

NDDD was a measure that represented the average daily maintenance dose for the main indication of a drug.

Outcome measures

Outcome measures
Measure	Apixaban: Naive n=1305 Participants Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician.	Apixaban: Non Naive n=666 Participants Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Acenocoumarol: Naive n=17434 Participants Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Acenocoumarol: Non-Naive n=117 Participants Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Warfarin: Naive n=1353 Participants Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Warfarin: Non-Naive n=206 Participants Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Dabigatran: Naive n=1449 Participants Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Dabigatran: Non-Naive n=559 Participants Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Rivaroxaban: Naive n=1718 Participants Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Rivaroxaban: Non-Naive n=817 Participants Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Apixaban Adherence With VKA, Dabigatran and Rivaroxaban by Number of Defined Daily Dose (NDDD)	15.0 milligrams per day Interval 15.0 to 30.0	30.0 milligrams per day Interval 15.0 to 30.0	16.0 milligrams per day Interval 16.0 to 32.0	16.0 milligrams per day Interval 16.0 to 32.0	53.0 milligrams per day Interval 53.0 to 53.0	16.0 milligrams per day Interval 5.0 to 53.0	22.0 milligrams per day Interval 22.0 to 29.0	22.0 milligrams per day Interval 22.0 to 29.0	21.0 milligrams per day Interval 15.0 to 28.0	28.0 milligrams per day Interval 21.0 to 28.0

PRIMARY outcome

Timeframe: Up to 12 months after date of first prescription

Population: Study population included all participants with a first-recorded prescription of VKA for SPAF registered in SIDIAP database during the study and diagnosed with NVAF. Here "N" signifies number of participants evaluable for the specified outcome measure.

INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. INR was categorized according to the risk level: risk for coagulation (INR\<2); optimal range (2\<INR\<3); and risk of hemorrhages (INR\>3).

Outcome measures

Outcome measures
Measure	Apixaban: Naive n=19192 Participants Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician.	Apixaban: Non Naive n=113 Participants Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Acenocoumarol: Naive n=872 Participants Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Acenocoumarol: Non-Naive n=158 Participants Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Warfarin: Naive Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Warfarin: Non-Naive Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Dabigatran: Naive Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Dabigatran: Non-Naive Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Rivaroxaban: Naive Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Rivaroxaban: Non-Naive Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.
International Normalized Ratio (INR) Values During the Last 12 Months Values in Participants Previously Treated With VKA	2.5 ratio Standard Deviation 0.4	2.5 ratio Standard Deviation 0.4	2.5 ratio Standard Deviation 0.3	2.6 ratio Standard Deviation 0.4	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to 12 months after date of first prescription

Population: Study population included all participants with a first-recorded prescription of VKA for SPAF registered in SIDIAP database during the study and diagnosed with NVAF. Here "N" signifies number of participants evaluable for the specified outcome measure.

TTR was defined as the duration of time in which the participant's INR values were within a desired range (2 to 3). INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. INR was categorized according to the risk level: risk for coagulation (INR\<2); optimal range (2\<INR\<3); and risk of hemorrhages (INR\>3).

Outcome measures

Outcome measures
Measure	Apixaban: Naive n=19192 Participants Participants who were treated with apixaban without prior prescription of vitamin K antagonists (VKA) (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date (when the participant took the drug for the first time). The dose and frequency of drug was as per treating physician.	Apixaban: Non Naive n=113 Participants Participants who were treated with apixaban with prior prescription of VKA (warfarin or acenocoumarol), dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Acenocoumarol: Naive n=872 Participants Participants who were treated with acenocoumarol without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Acenocoumarol: Non-Naive n=158 Participants Participants who were treated with acenocoumarol with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Warfarin: Naive Participants who were treated with warfarin without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Warfarin: Non-Naive Participants who were treated with warfarin with prior prescription of different VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Dabigatran: Naive Participants who were treated with dabigatran without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Dabigatran: Non-Naive Participants who were treated with dabigatran with prior prescription of VKA (warfarin or acenocoumarol), apixaban or rivaroxaban in the 12 months before start date. The dose and frequency of drug was as per treating physician.	Rivaroxaban: Naive Participants who were treated with rivaroxaban without prior prescription of VKA (warfarin or acenocoumarol), apixaban, dabigatran or rivaroxaban during 12 months before start date. The dose and frequency of drug was as per treating physician.	Rivaroxaban: Non-Naive Participants who were treated with rivaroxaban with prior prescription of VKA (warfarin or acenocoumarol), apixaban and dabigatran in the 12 months before start date. The dose and frequency of drug was as per treating physician.
Time in Therapeutic Range (TTR) Values During the Last 12 Months Values in Participants Previously Treated With VKA	60.2 days Interval 47.2 to 71.8	59.6 days Interval 47.7 to 68.4	66.2 days Interval 52.2 to 77.4	58.9 days Interval 43.2 to 68.2	—	—	—	—	—	—

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER