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Randomized trial of stents versus bypass surgery for left main coronary artery disease
- Source :
- The New England journal of medicine. 364(18)
- Publication Year :
- 2011
-
Abstract
- Percutaneous coronary intervention (PCI) is increasingly used to treat unprotected left main coronary artery stenosis, although coronary-artery bypass grafting (CABG) has been considered to be the treatment of choice.We randomly assigned patients with unprotected left main coronary artery stenosis to undergo CABG (300 patients) or PCI with sirolimus-eluting stents (300 patients). Using a wide margin for noninferiority, we compared the groups with respect to the primary composite end point of major adverse cardiac or cerebrovascular events (death from any cause, myocardial infarction, stroke, or ischemia-driven target-vessel revascularization) at 1 year. Event rates at 2 years were also compared between the two groups.The primary end point occurred in 26 patients assigned to PCI as compared with 20 patients assigned to CABG (cumulative event rate, 8.7% vs. 6.7%; absolute risk difference, 2.0 percentage points; 95% confidence interval [CI], -1.6 to 5.6; P=0.01 for noninferiority). By 2 years, the primary end point had occurred in 36 patients in the PCI group as compared with 24 in the CABG group (cumulative event rate, 12.2% vs. 8.1%; hazard ratio with PCI, 1.50; 95% CI, 0.90 to 2.52; P=0.12). The composite rate of death, myocardial infarction, or stroke at 2 years occurred in 13 and 14 patients in the two groups, respectively (cumulative event rate, 4.4% and 4.7%, respectively; hazard ratio, 0.92; 95% CI, 0.43 to 1.96; P=0.83). Ischemia-driven target-vessel revascularization occurred in 26 patients in the PCI group as compared with 12 patients in the CABG group (cumulative event rate, 9.0% vs. 4.2%; hazard ratio, 2.18; 95% CI, 1.10 to 4.32; P=0.02).In this randomized trial involving patients with unprotected left main coronary artery stenosis, PCI with sirolimus-eluting stents was shown to be noninferior to CABG with respect to major adverse cardiac or cerebrovascular events. However, the noninferiority margin was wide, and the results cannot be considered clinically directive. (Funded by the Cardiovascular Research Foundation, Seoul, Korea, and others; PRECOMBAT ClinicalTrials.gov number, NCT00422968.).
- Subjects :
- Male
medicine.medical_specialty
medicine.medical_treatment
Myocardial Ischemia
Left Main Coronary Artery Stenosis
Kaplan-Meier Estimate
Left coronary artery
Internal medicine
Angioplasty
medicine.artery
medicine
Humans
cardiovascular diseases
Myocardial infarction
Prospective Studies
Angioplasty, Balloon, Coronary
Coronary Artery Bypass
Aged
Sirolimus
business.industry
Coronary Stenosis
Percutaneous coronary intervention
Stent
Drug-Eluting Stents
General Medicine
Middle Aged
medicine.disease
Surgery
surgical procedures, operative
Bypass surgery
Cardiovascular Diseases
Conventional PCI
Cardiology
Female
business
Follow-Up Studies
Subjects
Details
- ISSN :
- 15334406
- Volume :
- 364
- Issue :
- 18
- Database :
- OpenAIRE
- Journal :
- The New England journal of medicine
- Accession number :
- edsair.doi.dedup.....b0400de506eedf52f6d75ec7e5d08840