BACKGROUND: The clinical benefit of percutaneous transluminal coronary angioplasty (PTCA) as compared with coronary-artery bypass grafting (CABG) for patients with multivessel coronary artery disease has not been established. To determine the outcomes of these treatments in patients referred for the first time for coronary revascularization, we conducted a three-year prospective, randomized trial comparing the two procedures. METHODS: Revascularization was performed by accepted methods. Follow-up clinical information was collected every six months, and coronary arteriography and thallium stress scanning were performed at one and three years. The primary end point was a composite of death, Q-wave myocardial infarction, and a large ischemic defect identified on thallium scanning at three years. Secondary end points included clinical and angiographic status and the need for additional revascularization procedures. Data were analyzed according to the intention-to-treat principle. RESULTS: Of the 5118 patients screened for the trial, 842 (16.5 percent) were eligible for enrollment, and 392 (7.7 percent) agreed to participate. A total of 194 patients were randomly assigned to the CABG group, and 198 to the PTCA group. The primary end point occurred in 27.3 percent of the CABG group and 28.8 percent of the PTCA group (P = 0.81). Death occurred in 6.2 percent of the CABG group and 7.1 percent of the PTCA group (P = 0.73 by log-rank test). At three years, the proportions of patients in the CABG group who required repeated bypass surgery (1 percent) or angioplasty (13 percent) were significantly lower than the proportions in the PTCA group (22 and 41 percent, respectively; P < 0.001). Angiographic studies at three years showed a greater degree of revascularization in the CABG group. Angina was more frequent in the PTCA group (20 percent) than in the CABG group (12 percent). CONCLUSIONS: We found that CABG and PTCA did not differ significantly with respect to the occurrence of the composite primary end point. Consequently, the selection of one procedure over the other should be guided by patients' preferences regarding the quality of life and the possible need for subsequent procedures.
RCT Entities:
BACKGROUND: The clinical benefit of percutaneous transluminal coronary angioplasty (PTCA) as compared with coronary-artery bypass grafting (CABG) for patients with multivessel coronary artery disease has not been established. To determine the outcomes of these treatments in patients referred for the first time for coronary revascularization, we conducted a three-year prospective, randomized trial comparing the two procedures. METHODS: Revascularization was performed by accepted methods. Follow-up clinical information was collected every six months, and coronary arteriography and thallium stress scanning were performed at one and three years. The primary end point was a composite of death, Q-wave myocardial infarction, and a large ischemic defect identified on thallium scanning at three years. Secondary end points included clinical and angiographic status and the need for additional revascularization procedures. Data were analyzed according to the intention-to-treat principle. RESULTS: Of the 5118 patients screened for the trial, 842 (16.5 percent) were eligible for enrollment, and 392 (7.7 percent) agreed to participate. A total of 194 patients were randomly assigned to the CABG group, and 198 to the PTCA group. The primary end point occurred in 27.3 percent of the CABG group and 28.8 percent of the PTCA group (P = 0.81). Death occurred in 6.2 percent of the CABG group and 7.1 percent of the PTCA group (P = 0.73 by log-rank test). At three years, the proportions of patients in the CABG group who required repeated bypass surgery (1 percent) or angioplasty (13 percent) were significantly lower than the proportions in the PTCA group (22 and 41 percent, respectively; P < 0.001). Angiographic studies at three years showed a greater degree of revascularization in the CABG group. Angina was more frequent in the PTCA group (20 percent) than in the CABG group (12 percent). CONCLUSIONS: We found that CABG and PTCA did not differ significantly with respect to the occurrence of the composite primary end point. Consequently, the selection of one procedure over the other should be guided by patients' preferences regarding the quality of life and the possible need for subsequent procedures.
Authors: J P Pell; D Walsh; J Norrie; G Berg; A D Colquhoun; K Davidson; H Eteiba; A Faichney; A Flapan; K J Hogg; R R Jeffrey; K Jennings; J McArthur; P Mankad; K Oldroyd; A C Pell; I R Starkey Journal: Heart Date: 2001-06 Impact factor: 5.994