EXCELLENT: Guidelines may have overestimated length of DAPT after DES

American College of Cardiology 60th Annual Scientific Sessions

NEW ORLEANS — Instead of the 12 months currently recommended by guidelines for dual antiplatelet therapy following drug-eluting stent insertion, new data from the EXCELLENT trial have suggested that 6 months of therapy may be all that is necessary to produce equivalent results.

In order to generate these findings, researchers conducted a 19-center trial in which 1,443 patients were randomly assigned to 6 or 12 months of dual-antiplatelet therapy (DAPT) in addition to aspirin following insertion of a drug-eluting stent. Inclusion criteria of the prospective, open-label trial included >50% stenosis by visual estimation, evidence of myocardial ischemia and location of target lesion in a native coronary artery. The patients were then followed for at least 2 additional years.

Among the 1,428 patients in which 12-month data was available for, target vessel failure – cardiac death, MI and target vessel revascularization – occurred in 4.7% of patients in the 6-month group and 4.4% in the 12-month group. This primary endpoint, according to analysis, showed non-inferiority between 6-month and 12-month groups with a pre-specified non-inferiority margin of 40 percent (P=0.0031).

Additionally, the safety endpoint, which was a composite of death, MI, cerebrovascular accident, stent thrombosis and thrombolysis in MI bleeding, was 3.4% in the 6-month group vs. 3.1% in the 12-month group (P=.678).

“At least in low-risk patients, [those] non-diabetic and treated with second generation DES, we may safely discontinue clopidogrel [Plavix, Sanofi-Aventis] at about 6 months, especially in patients that are at high-risk of bleeding,” concluded Hyeon-Cheol Gwon, MD, PhD, with the department of cardiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea, and study researcher, in a press conference. - by Brian Ellis

For more information:

Gwon H. LBCT IV, Session 3015. Presented at: ACC 60th Annual Scientific Sessions; April 2-5, 2011; New Orleans.

This adds confidence in taking people off of Plavix early against the current guidelines if we need to. If they are going to get surgery, if they have a higher bleeding risk or if they’ve shown some minor bleeding and we’re nervous about the Plavix and aspirin combination then we have confidence that it is probably okay at least in the short-term. We don’t have the long-term data yet — that is, data at 2 and 3 years — but at least in the short-term, it looks fine.

– Byron Lee, MD
Associate Professor of Medicine, University of California, San Francisco

Disclosures: Dr. Gwon reports that either he or his spouse or partner have received consulting fees/honoraria from Cordis and Medtronic Asia Pacific, as well as research grants from Abbott Korea and Medtronic Korea. Dr. Lee reports no relevant financial disclosures.

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