Angioplasty of Left Main - lAriboisiere Registry

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT01725373
• Lead Sponsor: Hopital Lariboisière

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 Timeline

• Study Start: 2007-01
• Primary Completion: 2012-05
• Study First Submitted: 2012-11-08
• Study First Submitted QC: 2012-11-09
• Study First Posted: 2012-11-12
• Study Completion: 2013-11
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-12
• Last Update Posted: 2014-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major cardiovascular events (MACCE)	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.

Trial Locations

Locations (1)

Departement of Cardiology, Laribosiere Hospital, APHP; 🇫🇷 Paris, France