Trial Outcomes & Findings for Efficacy of Everolimus-Eluting Versus Zotarolimus-Eluting Sten for Coronary Lesions in Acute Myocardial Infarction (NCT NCT01347554)

Results Overview

defined as a composite of cardiac death, Myocardial infarction not clearly attributable to a nontarget vessel and target lesion revascularization

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

461 participants

Primary outcome timeframe

Two year

Results posted on

2014-09-29

Participant Flow

Between January 2009 and December 2010, we undertook a multicenter, prospective, randomized trial in 4 tertiary university hospitals.

Patients with acute myocardial infarction were eligible if they had at least one lesion with a diameter stenosis of 50%or more. Before randomization, 3 patients withdrew consent and 18 patients did not meet inclusion criteria among 500 patients.

Participant milestones

Participant milestones
Measure	Xience V Stent Group Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction	Endeavor Resolute Group Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
Overall Study STARTED	237	242
Overall Study COMPLETED	230	231
Overall Study NOT COMPLETED	7	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Xience V Stent Group Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction	Endeavor Resolute Group Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
Overall Study Lack of Efficacy	7	11

Baseline Characteristics

Efficacy of Everolimus-Eluting Versus Zotarolimus-Eluting Sten for Coronary Lesions in Acute Myocardial Infarction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Xience V Stent Group n=230 Participants Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction	Endeavor Resolute Group n=231 Participants Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction	Total n=461 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	106 Participants n=93 Participants	106 Participants n=4 Participants	212 Participants n=27 Participants
Age, Categorical >=65 years	124 Participants n=93 Participants	125 Participants n=4 Participants	249 Participants n=27 Participants
Age, Continuous	64.5 years STANDARD_DEVIATION 12.8 • n=93 Participants	64.5 years STANDARD_DEVIATION 11.8 • n=4 Participants	64.5 years STANDARD_DEVIATION 12.3 • n=27 Participants
Sex: Female, Male Female	63 Participants n=93 Participants	62 Participants n=4 Participants	125 Participants n=27 Participants
Sex: Female, Male Male	167 Participants n=93 Participants	169 Participants n=4 Participants	336 Participants n=27 Participants
Region of Enrollment Korea, Republic of	230 participants n=93 Participants	231 participants n=4 Participants	461 participants n=27 Participants

PRIMARY outcome

Timeframe: Two year

defined as a composite of cardiac death, Myocardial infarction not clearly attributable to a nontarget vessel and target lesion revascularization

Outcome measures

Outcome measures
Measure	Xience V Stent Group n=230 Participants Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction	Endeavor Resolute Group n=231 Participants Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
Device-oriented Composite Outcome	12 participants	13 participants

SECONDARY outcome

Timeframe: Two years

defined as a composite of all-cause mortality, any MI (includes non-target vessel territory) and repeat revascularization (includes all target and non-target vessel)

Outcome measures

Outcome measures
Measure	Xience V Stent Group n=230 Participants Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction	Endeavor Resolute Group n=231 Participants Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
Device-oriented Composite Outcome	20 participants	24 participants

SECONDARY outcome

Timeframe: Two years

Definite and probable stent thrombosis

Outcome measures

Outcome measures
Measure	Xience V Stent Group n=230 Participants Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction	Endeavor Resolute Group n=231 Participants Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
Stent Thrombosis	0 participants	7 participants

SECONDARY outcome

Timeframe: Two year

Outcome measures

Outcome measures
Measure	Xience V Stent Group n=230 Participants Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction	Endeavor Resolute Group n=231 Participants Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
Any Bleeding	7 participants	11 participants

Adverse Events

Xience V Stent Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Endeavor Resolute Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Seung-Hwan Lee

Yonsei University Wonju College of Medicine

Phone: +82-33-741-0920

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place