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NEW DATA SHOW EVIDENCE FOR SHORTER DURATION OF CLOT-PREVENTING DRUGS WITH COATED STENTS
EXCELLENT Study Shows Length of Therapy Could be Shorter than Guidelines Suggest, Larger Study Needed
New Orleans, LA – Patients with drug-releasing stents – tubes inserted to keep heart arteries clear after angioplasty – take antiplatelet drugs to reduce the risk of clotting, but questions exist about how long the therapy should last. New data from the EXCELLENT study provide the first evidence from a randomized controlled trial that show six-month antiplatelet therapy is equivalent to the 12-month regimen prescribed by current guidelines, 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.
Coronary arteries opened with angioplasty often close up again in a process known as restenosis. In this natural response to angioplasty, the body overproduces cells, which line the artery like a layer of scar tissue and narrow the blood flow channel. Placing wire mesh stents in those arteries reduces the restenosis rate from 40 percent to about 25 percent six months after angioplasty. This rate can be lowered even more by coating stents with a slow-release drug that inhibits cell buildup.
Although these drug-eluting stents (DES) outperform bare metal stents, data suggest they have a slightly higher risk of late stent thrombosis – blockage by a blood clot – a common cause of heart attack and sudden death. The most important risk factor for late thrombosis has been stopping dual antiplatelet therapy (DAPT) too soon, but alternatively, long durations of DAPT can increase the risk of bleeding.
“The recommended duration of DAPT was three to six months in the early introduction period of drug-eluting stents,” said Hyeon-Cheol Gwon, M.D., Ph.D., Department of Cardiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea. “Current American College of Cardiology/American Heart Association guidelines recommend 12 months or longer without solid scientific evidence.”
In this 19-center trial, 1,443 patients were randomly assigned to six or 12 months of DAPT with a stent that released either everolimus or sirolimus; 12-month data are available for 1,428 patients and results of the stent trial have been presented. This is the first presentation of findings for a comparison of six-month and 12-month DAPT with the standard combination of aspirin and clopidogrel. Patients will be followed for at least two more years.
Results for target vessel failure – defined as cardiac death, myocardial infarction and target vessel revascularization − were 34 of 716 patients (4.7 percent) in the six-month group and 31 of 712 patients (4.4 percent) in the 12-month group. For this primary endpoint, the six-month group was non-inferior to the 12-month group, with a pre-specified non-inferiority margin of 40 percent (p=0.0031). For the safety endpoint – a composite of death, myocardial infarction, cerebrovascular accident, stent thrombosis and a
type of major bleeding (TIMI) – results were 24 (3.4 percent) in the six-month group and 22 (3.1 percent) in the 12-month group. Major adverse cerebro-cardiovascular events for these groups were 54 (7.5 percent) and 60 (8.4 percent), respectively. The subgroup analysis by stent type showed very even numbers by outcome for the everolimus stent at six and 12 months, but the study was underpowered to compare the two regimens reliably for death, myocardial infarction and stent thrombosis.
“Our results may be very reassuring for many physicians who may need to discontinue clopidogrel before the routinely recommended 12-month duration for various reasons,” Gwon said. “However, we need to remember that this study was underpowered to test the non-inferiority of the shorter duration for hard endpoints. A larger-scale randomized controlled trial is needed.”
The study was funded by the Ministry of Health, Welfare, and Family Affairs of Korea, Abbott Vascular Korea and Boston Scientific Korea. Gwon has no financial relationship with either company.
Dr. Gwon will be available to the media on Tuesday, April 5, at 9:45 a.m. CDT, in Room 338/339.
Dr. Gwon will present the study, “The Randomized Comparison of Six-month vs. 12-month Duration of Dual Antiplatelet Therapy After Implantation of Drug-Eluting Stent: From Comparison of Everolimus- vs. Sirolimus-Eluting Stents for Coronary Revascularization Therapy (EXCELLENT) Trial,” on Tuesday, April 5, 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.