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ANGIOPLASTY FOUND NON-INFERIOR TO CABG IN PATIENTS WITH UNPROTECTED LEFT MAIN CORONARY ARTERY DISEASE
PRECOMBAT Trial Shows the Procedures Have Similar Rates of Major Adverse Events
New Orleans, LA – A study from a South Korean research team found that angioplasty with a sirolimus-eluting stent was non-inferior to coronary artery bypass surgery (CABG) in patients with unprotected left main coronary artery disease for rates of death, heart attack, stroke, and ischemia-driven target vessel revascularization (TVR), according to research presented today at the American College of Cardiology’s 60th Annual Scientific Session. ACC.11 is the premier cardiovascular medical meeting, bringing together cardiologists and cardiovascular specialists to further advances in cardiovascular medicine.
The trial follows decades of questioning among cardiovascular specialists about which procedure – CABG or angioplasty – yields better outcomes. While angioplasty is less invasive and requires a shorter recovery time, it is also associated with a greater need for repeat procedures and a reduced ability to fully revascularize patients with multivessel disease. Although numerous trials have been conducted comparing the two procedures, a lack of randomized clinical trials has left the question open to debate.
“In spite of higher revascularization after angioplasty, it can be a potential alternative if the two treatments have a similar risk of hard endpoints, such as death, heart attack, or stroke,” said Seung-Jung Park, M.D., Ph.D., lead study author and professor of medicine at the University of Ulsan College of Medicine in Seoul, South Korea. “At the time this study was initiated, there was great enthusiasm about the outcomes of angioplasty, and as a result, off-label use rapidly spread without enough evidence. Therefore, initiation of a randomized study was urgent.”
For the study, the researchers randomized 600 patients to receive either CABG (n = 300) or angioplasty with the sirolimus-eluting Cypher® stent (manufactured by Cordis; n = 300). After the procedure, clinical follow-up was conducted at 30 days and six, nine, and 12 months; angiographic follow-up was conducted from eight to 10 months for the angioplasty cohort.
The study’s primary outcome measure was a composite of major adverse cardiac or cerebrovascular events (MACCE) at 12 months that included: death from any cause, heart attack, stroke, and ischemia-driven TVR.
The researchers found that angioplasty was not inferior to CABG for the primary outcome measure, with MACCE rates of 8.7 percent and 6.7 percent, respectively (p = 0.001; HR 1.29, 95 percent CI, 0.72 – 2.32). The rates of MACCE at 24 months were also comparable between the two groups, at 12.2 percent for angioplasty and 8.1 percent for CABG. A different composite of death, heart attack, and stroke (which was used as a safety indicator), also showed similar outcomes at 24 months, at 4.4 percent for the angioplasty cohort and 4.7 percent in the CABG cohort (p = 0.83).
The research team did find a significant difference, however, in the rates of ischemia-driven TVR at 24 months. Specifically, 9.0 percent of patients in the angioplasty group experienced this individual outcome, compared with 4.2 percent in the CABG group (p = 0.022).
“Our study endpoints included safety and efficacy outcomes. The incidences of death, heart attack, and stroke – which are indicators of safety and have a significant impact on mortality – were comparable,” Park said. “Although angioplasty did have a higher risk of TVR, this efficacy endpoint does not have a direct association with mortality and thus has a less significant implication than the safety outcomes. Therefore, we can conclude that angioplasty can be a feasible alternative to CABG surgery.”
The study was supported by funds from the Cardiovascular Research Foundation (Seoul), Cordis, and the Health 21 Research and Development Project (Ministry of Health & Welfare, South Korea). Park had no disclosures.
This study will be simultaneously published in the New England Journal of Medicine (NEJM).
Dr. Park will be available to the media on Monday, April 4 at 9:45 a.m. CDT in Room 338/339.
Dr. Park will present the study “Premier of Randomized Comparison of Bypass Surgery Versus Angioplasty Using Sirolimus-eluting Stent in Patients with Left Main Coronary Artery Disease (PRECOMBAT) Trial” on Monday, April 4 at 8:00 a.m. CDT in the Joint Main Tent: La Nouvelle.
The American College of Cardiology (www.cardiosource.org) represents the majority of board certified cardiovascular care professionals through education, research, promotion, development and application of standards and guidelines – and to influence health care policy. ACC.11 is the largest cardiovascular meeting, bringing together cardiologists and cardiovascular specialists to share the newest discoveries in treatment and prevention, while helping the ACC achieve its mission to address and improve issues in cardiovascular medicine.