Trial Outcomes & Findings for Comparison of a Rivaroxaban-based Strategy With an Antiplatelet-based Strategy Following Successful TAVR for the Prevention of Leaflet Thickening and Reduced Leaflet Motion as Evaluated by Four-dimensional, Volume-rendered Computed Tomography (4DCT) (NCT NCT02833948)
NCT ID: NCT02833948
Last Updated: 2020-01-18
Results Overview
Reduced systolic leaflet excursion is classified as: (I) normal, (II) mildly reduced (\<50%), (III) moderate to severely reduced (\>50%), and (IV) immobile. Reduced systolic leaflet excursion is considered significant when it is \> 50% or immobile. Quantitative assessment of leaflet motion is performed with a blood pool inversion volume rendered cine reconstruction throughout the cardiac cycle evaluating the bioprosthetic leaflets.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
231 participants
Primary outcome timeframe
3 months
Results posted on
2020-01-18
Participant Flow
Participant milestones
| Measure |
ASA + Clopidogrel
ASA (Acetylsalicylic acid) 75-100mg + Clopidogrel 75mg for 90 days, followed by ASA 75-100mg monotherapy
Acetylsalicylic acid: Drug: Acetylsalicylic acid:
75 - 100 mg OD (for first 90 days only in arm 1)
Clopidogrel: Drug: Clopidogrel 75 mg OD for first 90 days
If new-onset atrial fibrillation occurred within three months, clopidogrel was replaced by vitamin K antagonist targeting an international normalized ratio of 2 to 3 and combined with acetylsalicyclic acid 75mg to 100mg once-daily (which was discontinued at three month post-TAVR); however, if new-onset atrial fibrillation occurred after three months, acetylsalicyclic acid 75mg to 100mg once-daily was replaced by vitamin K antagonist targeting an international normalized ratio of 2 to 3.
|
Rivaroxaban + ASA
Rivaroxaban 10mg + ASA 75-100mg for 90 days, followed by rivaroxaban 10mg monotherapy
Acetylsalicylic acid: Drug: Acetylsalicylic acid:
75 - 100 mg OD (for first 90 days only in arm 1)
Rivaroxaban: Drug: Rivaroxaban (Xarelto):
10 mg OD (once-daily)
If new-onset atrial fibrillation occurred within this group, the rivaroxaban drug dose was increased from 10mg once-daily to 20mg once-daily (or 15mg once-daily in patients with moderate renal dysfunction as per drug label) plus acetylsalicyclic acid 75mg to 100mg once-daily; acetylsalicyclic acid was discontinued at three months post-TAVR.
|
|---|---|---|
|
Overall Study
STARTED
|
116
|
115
|
|
Overall Study
COMPLETED
|
101
|
97
|
|
Overall Study
NOT COMPLETED
|
15
|
18
|
Reasons for withdrawal
| Measure |
ASA + Clopidogrel
ASA (Acetylsalicylic acid) 75-100mg + Clopidogrel 75mg for 90 days, followed by ASA 75-100mg monotherapy
Acetylsalicylic acid: Drug: Acetylsalicylic acid:
75 - 100 mg OD (for first 90 days only in arm 1)
Clopidogrel: Drug: Clopidogrel 75 mg OD for first 90 days
If new-onset atrial fibrillation occurred within three months, clopidogrel was replaced by vitamin K antagonist targeting an international normalized ratio of 2 to 3 and combined with acetylsalicyclic acid 75mg to 100mg once-daily (which was discontinued at three month post-TAVR); however, if new-onset atrial fibrillation occurred after three months, acetylsalicyclic acid 75mg to 100mg once-daily was replaced by vitamin K antagonist targeting an international normalized ratio of 2 to 3.
|
Rivaroxaban + ASA
Rivaroxaban 10mg + ASA 75-100mg for 90 days, followed by rivaroxaban 10mg monotherapy
Acetylsalicylic acid: Drug: Acetylsalicylic acid:
75 - 100 mg OD (for first 90 days only in arm 1)
Rivaroxaban: Drug: Rivaroxaban (Xarelto):
10 mg OD (once-daily)
If new-onset atrial fibrillation occurred within this group, the rivaroxaban drug dose was increased from 10mg once-daily to 20mg once-daily (or 15mg once-daily in patients with moderate renal dysfunction as per drug label) plus acetylsalicyclic acid 75mg to 100mg once-daily; acetylsalicyclic acid was discontinued at three months post-TAVR.
|
|---|---|---|
|
Overall Study
Death
|
2
|
3
|
|
Overall Study
were not scanned
|
8
|
13
|
|
Overall Study
scans could not be evaluated
|
5
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
ASA + Clopidogrel
n=116 Participants
ASA (Acetylsalicylic acid) 75-100mg + Clopidogrel 75mg for 90 days, followed by ASA 75-100mg monotherapy
Acetylsalicylic acid: Drug: Acetylsalicylic acid:
75 - 100 mg OD (for first 90 days only in arm 1)
Clopidogrel: Drug: Clopidogrel 75 mg OD for first 90 days
If new-onset atrial fibrillation occurred within three months, clopidogrel was replaced by vitamin K antagonist targeting an international normalized ratio of 2 to 3 and combined with acetylsalicyclic acid 75mg to 100mg once-daily (which was discontinued at three month post-TAVR); however, if new-onset atrial fibrillation occurred after three months, acetylsalicyclic acid 75mg to 100mg once-daily was replaced by vitamin K antagonist targeting an international normalized ratio of 2 to 3.
|
Rivaroxaban + ASA
n=115 Participants
Rivaroxaban 10mg + ASA 75-100mg for 90 days, followed by rivaroxaban 10mg monotherapy
Acetylsalicylic acid: Drug: Acetylsalicylic acid:
75 - 100 mg OD (for first 90 days only in arm 1)
Rivaroxaban: Drug: Rivaroxaban (Xarelto):
10 mg OD (once-daily)
If new-onset atrial fibrillation occurred within this group, the rivaroxaban drug dose was increased from 10mg once-daily to 20mg once-daily (or 15mg once-daily in patients with moderate renal dysfunction as per drug label) plus acetylsalicyclic acid 75mg to 100mg once-daily; acetylsalicyclic acid was discontinued at three months post-TAVR.
|
Total
n=231 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
80.5 years
STANDARD_DEVIATION 6.2 • n=116 Participants
|
79.7 years
STANDARD_DEVIATION 7.3 • n=115 Participants
|
80.1 years
STANDARD_DEVIATION 6.7 • n=231 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=116 Participants
|
41 Participants
n=115 Participants
|
83 Participants
n=231 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=116 Participants
|
74 Participants
n=115 Participants
|
148 Participants
n=231 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body-mass index
|
27.8 kg/m^2
STANDARD_DEVIATION 5.1 • n=116 Participants
|
27.7 kg/m^2
STANDARD_DEVIATION 6.5 • n=115 Participants
|
27.8 kg/m^2
STANDARD_DEVIATION 5.8 • n=231 Participants
|
|
Hypertension
|
95 Participants
n=116 Participants
|
98 Participants
n=115 Participants
|
193 Participants
n=231 Participants
|
|
Diabetes Mellitus
|
27 Participants
n=116 Participants
|
21 Participants
n=115 Participants
|
48 Participants
n=231 Participants
|
|
STS risk score
|
3.0 %
STANDARD_DEVIATION 2.1 • n=116 Participants
|
2.8 %
STANDARD_DEVIATION 1.5 • n=115 Participants
|
2.9 %
STANDARD_DEVIATION 1.8 • n=231 Participants
|
|
STS risk category - High
|
3 Participants
n=116 Participants
|
1 Participants
n=115 Participants
|
4 Participants
n=231 Participants
|
|
STS risk category - Intemediate
|
35 Participants
n=116 Participants
|
37 Participants
n=115 Participants
|
72 Participants
n=231 Participants
|
|
STS risk category - low
|
78 Participants
n=116 Participants
|
77 Participants
n=115 Participants
|
155 Participants
n=231 Participants
|
|
Congestive Heart Failure
|
52 Participants
n=116 Participants
|
52 Participants
n=115 Participants
|
104 Participants
n=231 Participants
|
|
Coronary Artery Disease
|
36 Participants
n=116 Participants
|
42 Participants
n=115 Participants
|
78 Participants
n=231 Participants
|
|
Previous stroke
|
6 Participants
n=116 Participants
|
11 Participants
n=115 Participants
|
17 Participants
n=231 Participants
|
|
Peripheral Artery disease
|
10 Participants
n=116 Participants
|
10 Participants
n=115 Participants
|
20 Participants
n=231 Participants
|
|
Previous venous thromboembolism
|
1 Participants
n=116 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=231 Participants
|
|
Permanent Pacemaker
|
14 Participants
n=116 Participants
|
14 Participants
n=115 Participants
|
28 Participants
n=231 Participants
|
|
Chronic obstructive pulmonary disease
|
16 Participants
n=116 Participants
|
19 Participants
n=115 Participants
|
35 Participants
n=231 Participants
|
|
Glomerular filtration rate
|
76.6 ml/min/1.73m2
STANDARD_DEVIATION 19.4 • n=116 Participants
|
73.6 ml/min/1.73m2
STANDARD_DEVIATION 19.2 • n=115 Participants
|
75.1 ml/min/1.73m2
STANDARD_DEVIATION 19.3 • n=231 Participants
|
|
Valve type - balloon-expandable
|
54 Participants
n=116 Participants
|
52 Participants
n=115 Participants
|
106 Participants
n=231 Participants
|
|
Valve type - Self-expandable
|
62 Participants
n=116 Participants
|
63 Participants
n=115 Participants
|
125 Participants
n=231 Participants
|
|
Valve type - Supra-annular leaflet position
|
46 Participants
n=116 Participants
|
37 Participants
n=115 Participants
|
83 Participants
n=231 Participants
|
|
Valve-in-valve
|
1 Participants
n=116 Participants
|
3 Participants
n=115 Participants
|
4 Participants
n=231 Participants
|
|
Post TAVR Echo - Aortic-valve-area
|
1.8 cm2
STANDARD_DEVIATION 0.5 • n=116 Participants
|
1.8 cm2
STANDARD_DEVIATION 0.5 • n=115 Participants
|
1.8 cm2
STANDARD_DEVIATION 0.5 • n=231 Participants
|
|
Post TAVR Echo - mean aortic-valve gradient
|
11 mm Hg
STANDARD_DEVIATION 4 • n=116 Participants
|
11 mm Hg
STANDARD_DEVIATION 5 • n=115 Participants
|
11 mm Hg
STANDARD_DEVIATION 4 • n=231 Participants
|
|
Post TAVR Echo - Left Ventricular ejection fraction
|
56 %
STANDARD_DEVIATION 10 • n=116 Participants
|
55 %
STANDARD_DEVIATION 11 • n=115 Participants
|
56 %
STANDARD_DEVIATION 11 • n=231 Participants
|
|
Paravalvular aortic regurgitation - none or trace
|
96 Participants
n=116 Participants
|
94 Participants
n=115 Participants
|
190 Participants
n=231 Participants
|
|
Paravalvular aortic regurgitation - Mild
|
19 Participants
n=116 Participants
|
19 Participants
n=115 Participants
|
38 Participants
n=231 Participants
|
|
Paravalvular aortic regurgitation - moderate or severe
|
1 Participants
n=116 Participants
|
2 Participants
n=115 Participants
|
3 Participants
n=231 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Intention-to-treat (ITT) study population
Reduced systolic leaflet excursion is classified as: (I) normal, (II) mildly reduced (\<50%), (III) moderate to severely reduced (\>50%), and (IV) immobile. Reduced systolic leaflet excursion is considered significant when it is \> 50% or immobile. Quantitative assessment of leaflet motion is performed with a blood pool inversion volume rendered cine reconstruction throughout the cardiac cycle evaluating the bioprosthetic leaflets.
Outcome measures
| Measure |
ASA + Clopidogrel
n=101 Participants
ASA (Acetylsalicylic acid) 75-100mg + Clopidogrel 75mg for 90 days, followed by ASA 75-100mg monotherapy
Acetylsalicylic acid: Drug: Acetylsalicylic acid:
75 - 100 mg OD (for first 90 days only in arm 1)
Clopidogrel: Drug: Clopidogrel 75 mg OD for first 90 days
If new-onset atrial fibrillation occurred within three months, clopidogrel was replaced by vitamin K antagonist targeting an international normalized ratio of 2 to 3 and combined with acetylsalicyclic acid 75mg to 100mg once-daily (which was discontinued at three month post-TAVR); however, if new-onset atrial fibrillation occurred after three months, acetylsalicyclic acid 75mg to 100mg once-daily was replaced by vitamin K antagonist targeting an international normalized ratio of 2 to 3.
|
Rivaroxaban + ASA
n=97 Participants
Rivaroxaban 10mg + ASA 75-100mg for 90 days, followed by rivaroxaban 10mg monotherapy
Acetylsalicylic acid: Drug: Acetylsalicylic acid:
75 - 100 mg OD (for first 90 days only in arm 1)
Rivaroxaban: Drug: Rivaroxaban (Xarelto):
10 mg OD (once-daily)
If new-onset atrial fibrillation occurred within this group, the rivaroxaban drug dose was increased from 10mg once-daily to 20mg once-daily (or 15mg once-daily in patients with moderate renal dysfunction as per drug label) plus acetylsalicyclic acid 75mg to 100mg once-daily; acetylsalicyclic acid was discontinued at three months post-TAVR.
|
|---|---|---|
|
Rate of Patients With at Least One Prosthetic Leaflet With >50% Motion Reduction as Assessed by Cardiac 4DCT-scan
|
11 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Intention-to-treat (ITT) study population
The rate of prosthetic leaflets with RLM\> grade 3 as assessed by cardiac 4DCT
Outcome measures
| Measure |
ASA + Clopidogrel
n=303 leaflets
ASA (Acetylsalicylic acid) 75-100mg + Clopidogrel 75mg for 90 days, followed by ASA 75-100mg monotherapy
Acetylsalicylic acid: Drug: Acetylsalicylic acid:
75 - 100 mg OD (for first 90 days only in arm 1)
Clopidogrel: Drug: Clopidogrel 75 mg OD for first 90 days
If new-onset atrial fibrillation occurred within three months, clopidogrel was replaced by vitamin K antagonist targeting an international normalized ratio of 2 to 3 and combined with acetylsalicyclic acid 75mg to 100mg once-daily (which was discontinued at three month post-TAVR); however, if new-onset atrial fibrillation occurred after three months, acetylsalicyclic acid 75mg to 100mg once-daily was replaced by vitamin K antagonist targeting an international normalized ratio of 2 to 3.
|
Rivaroxaban + ASA
n=291 leaflets
Rivaroxaban 10mg + ASA 75-100mg for 90 days, followed by rivaroxaban 10mg monotherapy
Acetylsalicylic acid: Drug: Acetylsalicylic acid:
75 - 100 mg OD (for first 90 days only in arm 1)
Rivaroxaban: Drug: Rivaroxaban (Xarelto):
10 mg OD (once-daily)
If new-onset atrial fibrillation occurred within this group, the rivaroxaban drug dose was increased from 10mg once-daily to 20mg once-daily (or 15mg once-daily in patients with moderate renal dysfunction as per drug label) plus acetylsalicyclic acid 75mg to 100mg once-daily; acetylsalicyclic acid was discontinued at three months post-TAVR.
|
|---|---|---|
|
The Rate of Prosthetic Leaflets With > 50% Motion Reduction as Assessed by Cardiac 4DCT-scan
|
14 leaflets
|
3 leaflets
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Intention-to-treat (ITT) study population
The rate of patients with at least one prosthetic leaflet with hypoattenuated leaflet thickening (HALT) as assessed by cardiac 4DCT.
Outcome measures
| Measure |
ASA + Clopidogrel
n=102 Participants
ASA (Acetylsalicylic acid) 75-100mg + Clopidogrel 75mg for 90 days, followed by ASA 75-100mg monotherapy
Acetylsalicylic acid: Drug: Acetylsalicylic acid:
75 - 100 mg OD (for first 90 days only in arm 1)
Clopidogrel: Drug: Clopidogrel 75 mg OD for first 90 days
If new-onset atrial fibrillation occurred within three months, clopidogrel was replaced by vitamin K antagonist targeting an international normalized ratio of 2 to 3 and combined with acetylsalicyclic acid 75mg to 100mg once-daily (which was discontinued at three month post-TAVR); however, if new-onset atrial fibrillation occurred after three months, acetylsalicyclic acid 75mg to 100mg once-daily was replaced by vitamin K antagonist targeting an international normalized ratio of 2 to 3.
|
Rivaroxaban + ASA
n=97 Participants
Rivaroxaban 10mg + ASA 75-100mg for 90 days, followed by rivaroxaban 10mg monotherapy
Acetylsalicylic acid: Drug: Acetylsalicylic acid:
75 - 100 mg OD (for first 90 days only in arm 1)
Rivaroxaban: Drug: Rivaroxaban (Xarelto):
10 mg OD (once-daily)
If new-onset atrial fibrillation occurred within this group, the rivaroxaban drug dose was increased from 10mg once-daily to 20mg once-daily (or 15mg once-daily in patients with moderate renal dysfunction as per drug label) plus acetylsalicyclic acid 75mg to 100mg once-daily; acetylsalicyclic acid was discontinued at three months post-TAVR.
|
|---|---|---|
|
The Rate of Patients With at Least One Prosthetic Leaflet With Thickening as Assessed by Cardiac 4DCT-scan
|
33 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Intention-to-treat (ITT) study population
The rate of prosthetic leaflet with HALT as assessed by cardiac 4DCT-scan
Outcome measures
| Measure |
ASA + Clopidogrel
n=102 Participants
ASA (Acetylsalicylic acid) 75-100mg + Clopidogrel 75mg for 90 days, followed by ASA 75-100mg monotherapy
Acetylsalicylic acid: Drug: Acetylsalicylic acid:
75 - 100 mg OD (for first 90 days only in arm 1)
Clopidogrel: Drug: Clopidogrel 75 mg OD for first 90 days
If new-onset atrial fibrillation occurred within three months, clopidogrel was replaced by vitamin K antagonist targeting an international normalized ratio of 2 to 3 and combined with acetylsalicyclic acid 75mg to 100mg once-daily (which was discontinued at three month post-TAVR); however, if new-onset atrial fibrillation occurred after three months, acetylsalicyclic acid 75mg to 100mg once-daily was replaced by vitamin K antagonist targeting an international normalized ratio of 2 to 3.
|
Rivaroxaban + ASA
n=291 Leaflets
Rivaroxaban 10mg + ASA 75-100mg for 90 days, followed by rivaroxaban 10mg monotherapy
Acetylsalicylic acid: Drug: Acetylsalicylic acid:
75 - 100 mg OD (for first 90 days only in arm 1)
Rivaroxaban: Drug: Rivaroxaban (Xarelto):
10 mg OD (once-daily)
If new-onset atrial fibrillation occurred within this group, the rivaroxaban drug dose was increased from 10mg once-daily to 20mg once-daily (or 15mg once-daily in patients with moderate renal dysfunction as per drug label) plus acetylsalicyclic acid 75mg to 100mg once-daily; acetylsalicyclic acid was discontinued at three months post-TAVR.
|
|---|---|---|
|
The Rate of Prosthetic Leaflets With Thickening as Assessed by Cardiac 4DCT-scan
|
53 Leaflets
|
16 Leaflets
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Intention-to-treat (ITT) study population
Transprosthetic mean pressure gradiënt as determined by transthoracic echocardiography at three months after randomization. scale \[0-100\]
Outcome measures
| Measure |
ASA + Clopidogrel
n=105 Participants
ASA (Acetylsalicylic acid) 75-100mg + Clopidogrel 75mg for 90 days, followed by ASA 75-100mg monotherapy
Acetylsalicylic acid: Drug: Acetylsalicylic acid:
75 - 100 mg OD (for first 90 days only in arm 1)
Clopidogrel: Drug: Clopidogrel 75 mg OD for first 90 days
If new-onset atrial fibrillation occurred within three months, clopidogrel was replaced by vitamin K antagonist targeting an international normalized ratio of 2 to 3 and combined with acetylsalicyclic acid 75mg to 100mg once-daily (which was discontinued at three month post-TAVR); however, if new-onset atrial fibrillation occurred after three months, acetylsalicyclic acid 75mg to 100mg once-daily was replaced by vitamin K antagonist targeting an international normalized ratio of 2 to 3.
|
Rivaroxaban + ASA
n=102 Participants
Rivaroxaban 10mg + ASA 75-100mg for 90 days, followed by rivaroxaban 10mg monotherapy
Acetylsalicylic acid: Drug: Acetylsalicylic acid:
75 - 100 mg OD (for first 90 days only in arm 1)
Rivaroxaban: Drug: Rivaroxaban (Xarelto):
10 mg OD (once-daily)
If new-onset atrial fibrillation occurred within this group, the rivaroxaban drug dose was increased from 10mg once-daily to 20mg once-daily (or 15mg once-daily in patients with moderate renal dysfunction as per drug label) plus acetylsalicyclic acid 75mg to 100mg once-daily; acetylsalicyclic acid was discontinued at three months post-TAVR.
|
|---|---|---|
|
Aortic Transvalvular Mean Pressure Gradient (mmHg) as Determined by Transthoracic Echocardiography.
|
10 mm Hg
Standard Deviation 5
|
10 mm Hg
Standard Deviation 5
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Intention-to-treat (ITT) study population
Effective orifice area (cm2) as determined by transthoracic echocardiography at three months after randomization. scale \[0.1-4.0\]
Outcome measures
| Measure |
ASA + Clopidogrel
n=105 Participants
ASA (Acetylsalicylic acid) 75-100mg + Clopidogrel 75mg for 90 days, followed by ASA 75-100mg monotherapy
Acetylsalicylic acid: Drug: Acetylsalicylic acid:
75 - 100 mg OD (for first 90 days only in arm 1)
Clopidogrel: Drug: Clopidogrel 75 mg OD for first 90 days
If new-onset atrial fibrillation occurred within three months, clopidogrel was replaced by vitamin K antagonist targeting an international normalized ratio of 2 to 3 and combined with acetylsalicyclic acid 75mg to 100mg once-daily (which was discontinued at three month post-TAVR); however, if new-onset atrial fibrillation occurred after three months, acetylsalicyclic acid 75mg to 100mg once-daily was replaced by vitamin K antagonist targeting an international normalized ratio of 2 to 3.
|
Rivaroxaban + ASA
n=102 Participants
Rivaroxaban 10mg + ASA 75-100mg for 90 days, followed by rivaroxaban 10mg monotherapy
Acetylsalicylic acid: Drug: Acetylsalicylic acid:
75 - 100 mg OD (for first 90 days only in arm 1)
Rivaroxaban: Drug: Rivaroxaban (Xarelto):
10 mg OD (once-daily)
If new-onset atrial fibrillation occurred within this group, the rivaroxaban drug dose was increased from 10mg once-daily to 20mg once-daily (or 15mg once-daily in patients with moderate renal dysfunction as per drug label) plus acetylsalicyclic acid 75mg to 100mg once-daily; acetylsalicyclic acid was discontinued at three months post-TAVR.
|
|---|---|---|
|
Effective Orifice Area (cm^2) as Determined by Transthoracic Echocardiography.
|
1.8 cm2
Standard Deviation 0.4
|
1.8 cm2
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Intention-to-treat (ITT) study population, subgroup of patients with analysable scans
Death, Dichotomization by HALT
Outcome measures
| Measure |
ASA + Clopidogrel
n=151 Participants
ASA (Acetylsalicylic acid) 75-100mg + Clopidogrel 75mg for 90 days, followed by ASA 75-100mg monotherapy
Acetylsalicylic acid: Drug: Acetylsalicylic acid:
75 - 100 mg OD (for first 90 days only in arm 1)
Clopidogrel: Drug: Clopidogrel 75 mg OD for first 90 days
If new-onset atrial fibrillation occurred within three months, clopidogrel was replaced by vitamin K antagonist targeting an international normalized ratio of 2 to 3 and combined with acetylsalicyclic acid 75mg to 100mg once-daily (which was discontinued at three month post-TAVR); however, if new-onset atrial fibrillation occurred after three months, acetylsalicyclic acid 75mg to 100mg once-daily was replaced by vitamin K antagonist targeting an international normalized ratio of 2 to 3.
|
Rivaroxaban + ASA
n=44 Participants
Rivaroxaban 10mg + ASA 75-100mg for 90 days, followed by rivaroxaban 10mg monotherapy
Acetylsalicylic acid: Drug: Acetylsalicylic acid:
75 - 100 mg OD (for first 90 days only in arm 1)
Rivaroxaban: Drug: Rivaroxaban (Xarelto):
10 mg OD (once-daily)
If new-onset atrial fibrillation occurred within this group, the rivaroxaban drug dose was increased from 10mg once-daily to 20mg once-daily (or 15mg once-daily in patients with moderate renal dysfunction as per drug label) plus acetylsalicyclic acid 75mg to 100mg once-daily; acetylsalicyclic acid was discontinued at three months post-TAVR.
|
|---|---|---|
|
Death Assessed in the Main GALILEO Study and Analyzed in the GALILEO-4D Substudy With Regards to Occurence of the Leaflet Abnormalities (HALT) - as Exploratory Analysis.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Intention-to-treat (ITT) study population, subgroup of patients with analysable scans
Death, Dichotomization by RLM
Outcome measures
| Measure |
ASA + Clopidogrel
n=169 Participants
ASA (Acetylsalicylic acid) 75-100mg + Clopidogrel 75mg for 90 days, followed by ASA 75-100mg monotherapy
Acetylsalicylic acid: Drug: Acetylsalicylic acid:
75 - 100 mg OD (for first 90 days only in arm 1)
Clopidogrel: Drug: Clopidogrel 75 mg OD for first 90 days
If new-onset atrial fibrillation occurred within three months, clopidogrel was replaced by vitamin K antagonist targeting an international normalized ratio of 2 to 3 and combined with acetylsalicyclic acid 75mg to 100mg once-daily (which was discontinued at three month post-TAVR); however, if new-onset atrial fibrillation occurred after three months, acetylsalicyclic acid 75mg to 100mg once-daily was replaced by vitamin K antagonist targeting an international normalized ratio of 2 to 3.
|
Rivaroxaban + ASA
n=25 Participants
Rivaroxaban 10mg + ASA 75-100mg for 90 days, followed by rivaroxaban 10mg monotherapy
Acetylsalicylic acid: Drug: Acetylsalicylic acid:
75 - 100 mg OD (for first 90 days only in arm 1)
Rivaroxaban: Drug: Rivaroxaban (Xarelto):
10 mg OD (once-daily)
If new-onset atrial fibrillation occurred within this group, the rivaroxaban drug dose was increased from 10mg once-daily to 20mg once-daily (or 15mg once-daily in patients with moderate renal dysfunction as per drug label) plus acetylsalicyclic acid 75mg to 100mg once-daily; acetylsalicyclic acid was discontinued at three months post-TAVR.
|
|---|---|---|
|
Death Assessed in the Main GALILEO Study and Analyzed in the GALILEO-4D Substudy With Regards to Occurence of the Leaflet Abnormalities (RLM)- as Exploratory Analysis.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Intention-to-treat (ITT) study population, subgroup of patients with analysable scans
Thromboembolic event, Dichotomization by HALT
Outcome measures
| Measure |
ASA + Clopidogrel
n=151 Participants
ASA (Acetylsalicylic acid) 75-100mg + Clopidogrel 75mg for 90 days, followed by ASA 75-100mg monotherapy
Acetylsalicylic acid: Drug: Acetylsalicylic acid:
75 - 100 mg OD (for first 90 days only in arm 1)
Clopidogrel: Drug: Clopidogrel 75 mg OD for first 90 days
If new-onset atrial fibrillation occurred within three months, clopidogrel was replaced by vitamin K antagonist targeting an international normalized ratio of 2 to 3 and combined with acetylsalicyclic acid 75mg to 100mg once-daily (which was discontinued at three month post-TAVR); however, if new-onset atrial fibrillation occurred after three months, acetylsalicyclic acid 75mg to 100mg once-daily was replaced by vitamin K antagonist targeting an international normalized ratio of 2 to 3.
|
Rivaroxaban + ASA
n=44 Participants
Rivaroxaban 10mg + ASA 75-100mg for 90 days, followed by rivaroxaban 10mg monotherapy
Acetylsalicylic acid: Drug: Acetylsalicylic acid:
75 - 100 mg OD (for first 90 days only in arm 1)
Rivaroxaban: Drug: Rivaroxaban (Xarelto):
10 mg OD (once-daily)
If new-onset atrial fibrillation occurred within this group, the rivaroxaban drug dose was increased from 10mg once-daily to 20mg once-daily (or 15mg once-daily in patients with moderate renal dysfunction as per drug label) plus acetylsalicyclic acid 75mg to 100mg once-daily; acetylsalicyclic acid was discontinued at three months post-TAVR.
|
|---|---|---|
|
Thromboembolic Event Assessed in the Main GALILEO Study and Analyzed in the GALILEO-4D Substudy With Regards to Occurence of the Leaflet Abnormalities (HALT)- as Exploratory Analysis.
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Intention-to-treat (ITT) study population, subgroup of patients with analysable scans
Thromboembolic event, Dichotomization by RLM
Outcome measures
| Measure |
ASA + Clopidogrel
n=169 Participants
ASA (Acetylsalicylic acid) 75-100mg + Clopidogrel 75mg for 90 days, followed by ASA 75-100mg monotherapy
Acetylsalicylic acid: Drug: Acetylsalicylic acid:
75 - 100 mg OD (for first 90 days only in arm 1)
Clopidogrel: Drug: Clopidogrel 75 mg OD for first 90 days
If new-onset atrial fibrillation occurred within three months, clopidogrel was replaced by vitamin K antagonist targeting an international normalized ratio of 2 to 3 and combined with acetylsalicyclic acid 75mg to 100mg once-daily (which was discontinued at three month post-TAVR); however, if new-onset atrial fibrillation occurred after three months, acetylsalicyclic acid 75mg to 100mg once-daily was replaced by vitamin K antagonist targeting an international normalized ratio of 2 to 3.
|
Rivaroxaban + ASA
n=25 Participants
Rivaroxaban 10mg + ASA 75-100mg for 90 days, followed by rivaroxaban 10mg monotherapy
Acetylsalicylic acid: Drug: Acetylsalicylic acid:
75 - 100 mg OD (for first 90 days only in arm 1)
Rivaroxaban: Drug: Rivaroxaban (Xarelto):
10 mg OD (once-daily)
If new-onset atrial fibrillation occurred within this group, the rivaroxaban drug dose was increased from 10mg once-daily to 20mg once-daily (or 15mg once-daily in patients with moderate renal dysfunction as per drug label) plus acetylsalicyclic acid 75mg to 100mg once-daily; acetylsalicyclic acid was discontinued at three months post-TAVR.
|
|---|---|---|
|
Thromboembolic Event Assessed in the Main GALILEO Study and Analyzed in the GALILEO-4D Substudy With Regards to Occurence of the Leaflet Abnormalities (RLM) - as Exploratory Analysis.
|
2 Participants
|
0 Participants
|
Adverse Events
ASA + Clopidogrel
Serious events: 3 serious events
Other events: 17 other events
Deaths: 2 deaths
Rivaroxaban + ASA
Serious events: 7 serious events
Other events: 16 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
ASA + Clopidogrel
n=116 participants at risk
ASA (Acetylsalicylic acid) 75-100mg + Clopidogrel 75mg for 90 days, followed by ASA 75-100mg monotherapy
Acetylsalicylic acid: Drug: Acetylsalicylic acid:
75 - 100 mg OD (for first 90 days only in arm 1)
Clopidogrel: Drug: Clopidogrel 75 mg OD for first 90 days
If new-onset atrial fibrillation occurred within three months, clopidogrel was replaced by vitamin K antagonist targeting an international normalized ratio of 2 to 3 and combined with acetylsalicyclic acid 75mg to 100mg once-daily (which was discontinued at three month post-TAVR); however, if new-onset atrial fibrillation occurred after three months, acetylsalicyclic acid 75mg to 100mg once-daily was replaced by vitamin K antagonist targeting an international normalized ratio of 2 to 3.
|
Rivaroxaban + ASA
n=115 participants at risk
Rivaroxaban 10mg + ASA 75-100mg for 90 days, followed by rivaroxaban 10mg monotherapy
Acetylsalicylic acid: Drug: Acetylsalicylic acid:
75 - 100 mg OD (for first 90 days only in arm 1)
Rivaroxaban: Drug: Rivaroxaban (Xarelto):
10 mg OD (once-daily)
If new-onset atrial fibrillation occurred within this group, the rivaroxaban drug dose was increased from 10mg once-daily to 20mg once-daily (or 15mg once-daily in patients with moderate renal dysfunction as per drug label) plus acetylsalicyclic acid 75mg to 100mg once-daily; acetylsalicyclic acid was discontinued at three months post-TAVR.
|
|---|---|---|
|
Blood and lymphatic system disorders
Major bleeding event
|
0.86%
1/116 • Number of events 1 • 90 days
Adverse event reporting was captured via the Main Galileo trial (Global Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement to Optimize Clinical Outcomes) NCT02556203
|
3.5%
4/115 • Number of events 4 • 90 days
Adverse event reporting was captured via the Main Galileo trial (Global Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement to Optimize Clinical Outcomes) NCT02556203
|
|
Cardiac disorders
Thromboembolic event
|
1.7%
2/116 • Number of events 2 • 90 days
Adverse event reporting was captured via the Main Galileo trial (Global Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement to Optimize Clinical Outcomes) NCT02556203
|
3.5%
4/115 • Number of events 4 • 90 days
Adverse event reporting was captured via the Main Galileo trial (Global Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement to Optimize Clinical Outcomes) NCT02556203
|
Other adverse events
| Measure |
ASA + Clopidogrel
n=116 participants at risk
ASA (Acetylsalicylic acid) 75-100mg + Clopidogrel 75mg for 90 days, followed by ASA 75-100mg monotherapy
Acetylsalicylic acid: Drug: Acetylsalicylic acid:
75 - 100 mg OD (for first 90 days only in arm 1)
Clopidogrel: Drug: Clopidogrel 75 mg OD for first 90 days
If new-onset atrial fibrillation occurred within three months, clopidogrel was replaced by vitamin K antagonist targeting an international normalized ratio of 2 to 3 and combined with acetylsalicyclic acid 75mg to 100mg once-daily (which was discontinued at three month post-TAVR); however, if new-onset atrial fibrillation occurred after three months, acetylsalicyclic acid 75mg to 100mg once-daily was replaced by vitamin K antagonist targeting an international normalized ratio of 2 to 3.
|
Rivaroxaban + ASA
n=115 participants at risk
Rivaroxaban 10mg + ASA 75-100mg for 90 days, followed by rivaroxaban 10mg monotherapy
Acetylsalicylic acid: Drug: Acetylsalicylic acid:
75 - 100 mg OD (for first 90 days only in arm 1)
Rivaroxaban: Drug: Rivaroxaban (Xarelto):
10 mg OD (once-daily)
If new-onset atrial fibrillation occurred within this group, the rivaroxaban drug dose was increased from 10mg once-daily to 20mg once-daily (or 15mg once-daily in patients with moderate renal dysfunction as per drug label) plus acetylsalicyclic acid 75mg to 100mg once-daily; acetylsalicyclic acid was discontinued at three months post-TAVR.
|
|---|---|---|
|
Blood and lymphatic system disorders
minor bleeding
|
14.7%
17/116 • Number of events 17 • 90 days
Adverse event reporting was captured via the Main Galileo trial (Global Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement to Optimize Clinical Outcomes) NCT02556203
|
13.9%
16/115 • Number of events 16 • 90 days
Adverse event reporting was captured via the Main Galileo trial (Global Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement to Optimize Clinical Outcomes) NCT02556203
|
Additional Information
Ole De Backer, MD, PhD
The Heart Center - Rigshospitalet, Copenhagen, Denmark
Phone: +45-35457086
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place