Trial Outcomes & Findings for E-Five Registry: A World-Wide Registry With The Endeavor Zotarolimus Eluting Coronary Stent (NCT NCT00623441)

Last Updated: 2015-11-23

Results Overview

MACE is defined as death, myocardial infarction (Q-wave and non-Q wave), emergent cardiac bypass surgery, or target lesion revascularization (repeat PTCA (Percutaneous Transluminal Coronary Angioplasty) or CABG (Coronary Artery Bypass Graft surgery))

Recruitment status

COMPLETED

Target enrollment

8314 participants

Primary outcome timeframe

12 Months

Results posted on

2015-11-23

Participant Flow

Consecutive patients with an indication for coronary stent implantation according to the Instructions For Use of the Endeavor Coronary Stent, in whom it is an intent to implant one or more Endeavor Coronary Stents should be included (provided patient consent).

All enrolled subjects were followed for 12 months. An extended 2-year follow-up was performed in 2116 subjects from 26 centers.

Participant milestones

Participant milestones
Measure	Endeavor Coronary Stent Patients with an indication for a percutaneous coronary intervention with implantation with a drug eluting stent
Overall Study STARTED	8314
Overall Study COMPLETED	8314
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

E-Five Registry: A World-Wide Registry With The Endeavor Zotarolimus Eluting Coronary Stent

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Endeavor Coronary Stent n=8314 Participants Patients with an indication for a percutaneous coronary intervention with implantation with a drug eluting stent
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4266 Participants n=5 Participants
Age, Categorical >=65 years	4048 Participants n=5 Participants
Age, Continuous	63.29 years STANDARD_DEVIATION 11.06 • n=5 Participants
Sex: Female, Male Female	1940 Participants n=5 Participants
Sex: Female, Male Male	6374 Participants n=5 Participants
Region of Enrollment Europe	6566 participants n=5 Participants
Region of Enrollment Southeast Asia	879 participants n=5 Participants
Region of Enrollment Pacifica	57 participants n=5 Participants
Region of Enrollment South America	220 participants n=5 Participants
Region of Enrollment Africa	6 participants n=5 Participants
Region of Enrollment India	586 participants n=5 Participants
Diabetes Mellitus IDDM (Insulin Dependent Diabetes Mellitus)	682 Participants n=5 Participants
Diabetes Mellitus Non-IDDM (Non-Insulin Dependent Diabetes Mellitus)	2039 Participants n=5 Participants
Diabetes Mellitus No Diabetes Mellitus	5593 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 Months

Population: Intention to Treat (ITT)

Outcome measures

Outcome measures
Measure	Endeavor Coronary Stent n=8314 Participants Patients with an indication for a percutaneous coronary intervention with implantation with a drug eluting stent
MACE (Major Adverse Cardiac Events)	7.5 Percentage of participants

Adverse Events

Endeavor Coronary Stent

Serious events: 135 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Endeavor Coronary Stent n=7832 participants at risk Patients with an indication for a percutaneous coronary intervention with implantation with a drug eluting stent
Cardiac disorders Cardiac Death	1.7% 135/7832 • Number of events 135

Other adverse events

Adverse event data not reported

Additional Information

Sofia Pateraki, MSc - Sr. Clinical Research Specialist

Medtronic Bakken Research Center

Phone: +31 43 3566785

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction on the PI is that results communications are provided to the sponsor at least 90 days prior to submittal for publication or presentation. The sponsor shall not require changes beyond the extent necessary to allow the sponsor to protect its rights in copyrightable material, and to check for technical correctness.
Publication restrictions are in place

Restriction type: OTHER