Trial Outcomes & Findings for PROMUS PREMIER™ China Post-Approval Study (NCT NCT03273023)

Last Updated: 2026-07-22

Results Overview

12-month Major Adverse Cardiac Event (MACE) rate, defined as cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR).

Recruitment status

COMPLETED

Target enrollment

2059 participants

Primary outcome timeframe

12 months

Results posted on

2026-07-22

Participant Flow

Participant milestones

Participant milestones
Measure	PROMUS PREMIER Group Participants received PROMUS PREMIER DES
Overall Study STARTED	2059
Overall Study COMPLETED	2059
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ITT analysis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PROMUS PREMIER Group n=2059 Participants Participants received PROMUS PREMIER DES
Age, Continuous	62.2 years STANDARD_DEVIATION 11.0 • n=9 Participants • ITT analysis
Sex: Female, Male Female	588 Participants n=9 Participants • ITT analysis
Sex: Female, Male Male	1471 Participants n=9 Participants • ITT analysis
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants • ITT analysis
Race (NIH/OMB) Asian	2059 Participants n=9 Participants • ITT analysis
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants • ITT analysis
Race (NIH/OMB) Black or African American	0 Participants n=9 Participants • ITT analysis
Race (NIH/OMB) White	0 Participants n=9 Participants • ITT analysis
Race (NIH/OMB) More than one race	0 Participants n=9 Participants • ITT analysis
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants • ITT analysis
Region of Enrollment China	2059 participants n=9 Participants • ITT analysis

PRIMARY outcome

Timeframe: 12 months

Population: For the ITT analysis, all subjects who sign the written ICF and are enrolled in the study will be included in the analysis sample, regardless of whether the study stent was implanted.

12-month Major Adverse Cardiac Event (MACE) rate, defined as cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR).

Outcome measures

Outcome measures
Measure	PROMUS PREMIER Group n=2059 Participants Participants received PROMUS PREMIER DES
12-month Major Adverse Cardiac Event (MACE) Rate	41 Participants

SECONDARY outcome

Timeframe: 12 months

Population: For the ITT analysis, all subjects who sign the written ICF and are enrolled in the study will be included in the analysis sample, regardless of whether the study stent was implanted.

Participants occurred cardiac death event in 12 months

Outcome measures

Outcome measures
Measure	PROMUS PREMIER Group n=2059 Participants Participants received PROMUS PREMIER DES
12-month Cardiac Death	21 Participants

SECONDARY outcome

Timeframe: 12 months

Population: For the ITT analysis, all subjects who sign the written ICF and are enrolled in the study will be included in the analysis sample, regardless of whether the study stent was implanted.

Participants occurred myocardial infarction event in 12 months

Outcome measures

Outcome measures
Measure	PROMUS PREMIER Group n=2059 Participants Participants received PROMUS PREMIER DES
12-month Myocardial Infarction	10 Participants

SECONDARY outcome

Timeframe: 12 months

Population: For the ITT analysis, all subjects who sign the written ICF and are enrolled in the study will be included in the analysis sample, regardless of whether the study stent was implanted.

Participants occurred TVR event in 12 months

Outcome measures

Outcome measures
Measure	PROMUS PREMIER Group n=2059 Participants Participants received PROMUS PREMIER DES
12-month TVR	13 Participants

Adverse Events

PROMUS PREMIER Group

Serious events: 48 serious events

Other events: 58 other events

Deaths: 30 deaths

Serious adverse events

Serious adverse events
Measure	PROMUS PREMIER Group n=2059 participants at risk Participants received PROMUS PREMIER DES
Cardiac disorders Cardiac disorders	1.9% 39/2059 • Number of events 45 • 1 years Adverse Event
General disorders General disorders	0.34% 7/2059 • Number of events 7 • 1 years Adverse Event
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	0.05% 1/2059 • Number of events 1 • 1 years Adverse Event
Nervous system disorders Nervous system disorders	0.05% 1/2059 • Number of events 1 • 1 years Adverse Event

Other adverse events

Other adverse events
Measure	PROMUS PREMIER Group n=2059 participants at risk Participants received PROMUS PREMIER DES
Gastrointestinal disorders Gastrointestinal disorders	2.8% 58/2059 • Number of events 78 • 1 years Adverse Event

Additional Information

Chunlong Feng, Senior Medical Affairs Manager

BSC China

Phone: 13636498543

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place