Prospective Registry in Patients With Unprotected Left Main Disease Treated by Percutaneous Coronary Intervention: The ALMA (Angioplasty of Left Main - lAriboisiere) Registry
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 125
- Locations
- 1
- Primary Endpoint
- Major cardiovascular events (MACCE)
Study Overview
Brief Summary
In patients with unprotected left main disease (ULMD), angioplasty is emerging as an alternative technique. The investigators aimed to determine the rate of major cardiovascular events in patients treated by angioplasty for ULMD in a "real world" registry.
Detailed Description
Current guidelines recommend coronary artery bypass graft surgery as the "gold standard" treatment in patients with unprotected left main disease. However, patients with ULMD and high surgical risk score or favourable anatomy are still referred for angioplasty. Recently, several studies and registries comparing surgery and percutaneous intervention with drug eluting stents report similar results regarding cardiovascular death and myocardial infarction in patients with multivessel coronary artery disease including unprotected left main disease.
The aim of the study is to evaluate major cardiovascular events in a "real world" registry.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •stable or unstable angina and/or documented ischemia
- •50% de novo ULMD referred for angioplasty
Exclusion Criteria
- •acute coronary syndrome with ST elevation,
- •cardiogenic shock or out of hospital cardiac arrest
Outcomes
Primary Outcomes
Major cardiovascular events (MACCE)
Time Frame: One year
Major cardiovascular events (MACCE)were measured after 1 year follow-up. MACCE included all-cause of death, stroke, myocardial infarction, and repeat revascularizations. Non-Q-wave myocardial infarction was defined using universal definition with troponin I. Stent thrombosis was defined according to the Academic Research Consortium definition as definite, probable, or possible and as early or late after the index procedure. Repeat revascularization was composed of any repeat percutaneous intervention or surgical bypass.
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Jean-Guillaume DILLINGER
Principal investigator - Medical Doctor in the Departement of Cardiology
Hopital Lariboisière