Coronary Artery Disease, Autosomal Dominant, 1 Clinical Trial
Official title:
Patient Related OuTcomes With Endeavor Versus Cypher Stenting Trial: PROTECT Continued Access Post Marketing Surveillance Trial
In order to expand safety information in patients treated with the Endeavor Drug Eluting Stent System, or next generation model, a Continued Access (CA) study is added to the PROTECT Trial. The amended study is "PROTECT CONTINUED ACCESS" ("PROTECT CA").
This was a prospective, multicenter, non-randomized, single-arm, open-label post market
surveillance study designed to expand safety information in patients treated with the
Endeavor® Zotarolimus Eluting Coronary Stent System.
Since their introduction, Drug Eluting Stents (DES) have markedly decreased stent restenosis
and the clinical need for repeat revascularization frequently observed with bare metal
stents (BMS)1-10. However, the widespread use of DES has raised concerns regarding the
occurrence of late stent thrombosis (> 30 days after stent implantation)12-14. Although the
incidence might seem low (0.2-0.7%)13,15-18 the high mortality and morbidity associated with
stent thrombosis, and the soaring number of stents implanted annually, make it a significant
medical problem.
The purpose of this trial was to investigate the long-term clinical safety and efficacy of
the Endeavor drug eluting stent in a large and higher risk patient population, which more
closely reflects clinical practice today. Both unstable and stable patients with single or
multivessel disease and complex lesions were eligible for enrollment.
The selected primary endpoint was stent thrombosis, defined as definite and probable stent
thrombosis according to the ARC definition, at 3 years. The main secondary endpoints were
the composite of death or cardiac death combined with large or all non-fatal myocardial
infarction, which are the typical clinical manifestations of stent thrombosis. These events
are adjudicated by a clinical events committee.
1.2 Study Endpoints 1.2.1 Primary Endpoint: The overall stent thrombosis rate defined as
definite and probable stent thrombosis according to the ARC definition at 3 years 1.2.2
Secondary Endpoints:
Main Secondary Endpoints include:
- Composite endpoint of total death and number of patients with all non-fatal myocardial
infarction at 3 years
- Composite endpoint of cardiac death and number of patients with all non-fatal
myocardial infarction at 3 years
- Composite endpoint of total death and number of patients with large non-fatal
myocardial infarction at 3 years
- Composite endpoint of cardiac death and number of patients with large non-fatal
myocardial infarction at 3 years
Additional secondary endpoints include:
- Total Death and subcategories of Death
- Large and all Myocardial Infarction (MI)
- Stent thrombosis defined as definite, probable and possible
- Composite score of clinical outcomes (death, myocardial infarction, stroke and
revascularization) *
- Major Adverse Cardiac and Cerebral Events (MACCE)
- Stroke (hemorrhagic in nature while on clopidogrel)
- Bleeding complications in general
- Target lesion revascularization (TLR)
- Target vessel revascularization (TVR)
- Non target vessel revascularization (non TVR)
- Procedural success
- Device success
- Lesion success
- Endpoints will be calculated at the follow-up time points and for the mean follow-up
period.
- The composite score of clinical outcomes (death, myocardial infarction, stroke and
revascularization) constructed from a patient population according to the Delphi
method.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment