OBJECTIVES: This study was done to identify the best treatment for an isolated high-grade stenosis of the proximal left anterior descending coronary artery (LAD). BACKGROUND:Percutaneous transluminal coronary angioplasty with stenting (PCI) and off-pump coronary artery bypass grafting (surgery) are used to treat single-vessel disease of a high-grade stenosis of the proximal LAD. Midterm results of both treatments are compared in this prospective randomized study. METHODS: In a single-center prospective trial, we randomly assigned 102 patients with a high-grade stenosis of the proximal LAD (American College of Cardiology/American Heart Association classification type B2 or C) to PCI (n = 51) or surgery (n = 51). Primary composite end point was freedom from Major Adverse Cardiac and Cerebrovascular Events (MACCE) at follow-up, including death, myocardial infarction, cerebrovascular accident, and repeat target vessel revascularization (TVR). Secondary end points were angina pectoris class and need for antianginal medication at follow-up. Analysis was by intention-to-treat (ITT) and received treatment (RT). RESULTS: Mean follow-up time was three years (90% midrange, two to four years). Incidence of MACCE was 23.5% after PCI and 9.8% after surgery; p = 0.07 ITT (24.1% vs. 8.3%; p = 0.04 RT). After surgery a significantly lower angina pectoris class (p = 0.02) and need for antianginal medication (p = 0.01) was found compared to PCI. Target vessel revascularization was 15.7% after PCI and 4.1% after surgery (p = 0.09). CONCLUSIONS: At three-year follow-up (range, two to four years), a trend in favor of surgery is observed in regard to MACCE-free survival with a significantly lower angina pectoris status and significantly lower need for antianginal medication.
RCT Entities:
OBJECTIVES: This study was done to identify the best treatment for an isolated high-grade stenosis of the proximal left anterior descending coronary artery (LAD). BACKGROUND: Percutaneous transluminal coronary angioplasty with stenting (PCI) and off-pump coronary artery bypass grafting (surgery) are used to treat single-vessel disease of a high-grade stenosis of the proximal LAD. Midterm results of both treatments are compared in this prospective randomized study. METHODS: In a single-center prospective trial, we randomly assigned 102 patients with a high-grade stenosis of the proximal LAD (American College of Cardiology/American Heart Association classification type B2 or C) to PCI (n = 51) or surgery (n = 51). Primary composite end point was freedom from Major Adverse Cardiac and Cerebrovascular Events (MACCE) at follow-up, including death, myocardial infarction, cerebrovascular accident, and repeat target vessel revascularization (TVR). Secondary end points were angina pectoris class and need for antianginal medication at follow-up. Analysis was by intention-to-treat (ITT) and received treatment (RT). RESULTS: Mean follow-up time was three years (90% midrange, two to four years). Incidence of MACCE was 23.5% after PCI and 9.8% after surgery; p = 0.07 ITT (24.1% vs. 8.3%; p = 0.04 RT). After surgery a significantly lower angina pectoris class (p = 0.02) and need for antianginal medication (p = 0.01) was found compared to PCI. Target vessel revascularization was 15.7% after PCI and 4.1% after surgery (p = 0.09). CONCLUSIONS: At three-year follow-up (range, two to four years), a trend in favor of surgery is observed in regard to MACCE-free survival with a significantly lower angina pectoris status and significantly lower need for antianginal medication.
Authors: Sandra Eifert; Helmut Mair; Anne-Laure Boulesteix; Eckehard Kilian; Martin Adamczak; Bruno Reichart; Peter Lamm Journal: Vasc Health Risk Manag Date: 2010-08-09