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DRUG-ELUTING STENTS IMPROVE OUTCOMES COMPARED TO BARE-METAL STENTS IN SAPHENOUS VEIN GRAFT LESIONS
ISAR-CABG Trial Shows Drug-Eluting Stents Lead to a Lower Combined Rate of Death, Heart Attack, and Target-Lesion Revascularization
New Orleans, LA – In the largest randomized, multicenter trial to compare drug-eluting stents (DES) and bare-metal stents (BMS) placed in saphenous vein graft lesions, researchers found that DES led to a lower combined rate of death, heart attack, and repeat revascularization, 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.
While saphenous vein grafts (SVGs) have been used extensively in coronary artery bypass graft (CABG) surgery, these conduits develop atherosclerotic disease that results in vessel narrowing or closure in a high percentage of patients. Conducting a second CABG surgery to fix the graft is a possibility but can result in higher mortality and morbidity rates than the first operation. Performing angioplasty with a stent is an alternative to repeat CABG surgery; research is still being conducted to optimize this procedure.
“DES have proven superior to BMS in all coronary artery lesion subsets examined, but their performance has been insufficiently evaluated in SVG lesions,” said Julinda Mehilli, M.D., director of clinical research and data coordinating in the Intracoronary Stenting and Antithrombosis Research (ISAR) Center at the German Heart Center Munich, Germany. “The only two very small randomized trials comparing DES with BMS in SVG lesions provided conflicting results. Thus, the aim of the ISAR-CABG trial was to investigate this question in a larger population sufficiently powered to provide information on clinical endpoints.”
For the study, German researchers enrolled 610 patients who had previously undergone CABG surgery. All study patients had subsequently developed at least one lesion in their saphenous vein graft and were randomized to receive either a DES (n = 303) or a BMS (n = 307) in the study angioplasty procedure.
The study’s primary endpoint was a composite of major adverse cardiac events [death, heart attack, and target-lesion revascularization (TLR)] at the one-year follow-up point. The secondary endpoints were the individual rates of death, heart attack, ARC- definite stent thrombosis (ARC – Academic Research Consortium), and the need for TLR over one year.
The researchers found that the incidence of major adverse cardiac events was reduced by 35 percent in the DES cohort compared to the BMS group. Specifically, 16.5 percent of patients in the DES group experienced the primary endpoint compared with 22.1 percent of patients in the BMS group (hazard ratio [HR] 0.65; 95 percent confidence interval [CI] 0.45 – 0.96; p = 0.028). The reduction in the DES group was primarily due to a significantly lower rate of TLR, which occurred in 7.2 percent of patients in the
DES group and in 12.9 percent of patients in the BMS group (hazard ratio [HR] 0.52; 95 percent confidence interval [CI] 0.30 – 0.90; p = 0.020).
The research team found no significant differences in the individual rates of death or heart attack. Additionally, only one patient in the DES cohort experienced ARC-definite stent thrombosis. None of the patients in the BMS group experienced this outcome.
“Saphenous vein graft lesions remain a challenging disease subset for angioplasty. The ISAR-CABG trial, however, demonstrates that DES can safely be used to reduce adverse events in this high-risk subset of patients,” Mehilli said.
The study was funded by the German Heart Center Munich and by Cordis. Mehilli had no disclosures to report.
Dr. Mehilli will be available to the media on Monday, April 4 at 12:30 p.m. CDT in Room 338/339.
Dr. Mehilli will present the study “Long-term Outcomes After Use of Drug-Eluting Stents and Bare-Metal Stents for the Treatment of Saphenous Vein Graft Lesions: Results of the Randomized ISAR-CABG Trial” on Monday, April 4 at 10:45 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.