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WOEST: Less bleeding risk with dual therapy
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MUNICH — A strategy of adding clopidogrel only to oral anticoagulants and omitting aspirin was associated with less bleeding and appears to be safe with respect to preventing thrombotic and thromboembolic complications for patients on oral anticoagulants undergoing coronary stenting.
Results from the 573-patient WOEST study revealed a lower cumulative rate of bleeding at 1 year with clopidogrel only (75 mg) added to oral anticoagulants when compared with clopidogrel and aspirin (80 mg) added to oral anticoagulants (19.5% vs. 44.9%; HR=0.39; 95% CI, 0.26-0.5). When researchers examined location of bleeding, the rate of intracranial hemorrhage was identical for both groups (n=3), but patients randomly assigned triple therapy had lower rates of access site, gastrointestinal, skin and other bleeding.
Willem Dewilde
“The primary endpoint was met. As expected, oral anticoagulants plus clopidogrel causes less bleeding than triple antithrombotic therapy, but this is now shown in a randomized fashion,” Willem Dewilde, MD, of TweeSteden Hospital, Tilburg, the Netherlands, said during a press conference at the European Society of Cardiology Congress.
Dual therapy was also associated with a lower cumulative all-cause mortality rate compared with triple therapy (2.6% vs. 6.4%; HR=0.39; 95% CI, 0.16-0.93). Further, researchers found no excess risk for the occurrence of MI (dual, 3.3% vs. triple, 4.7%; P=.382), stent thrombosis (1.5% vs. 3.2%; P=.128), target vessel revascularization (7.3% vs. 6.8%; P=.876) or stroke (1.1% vs. 2.9%; P=.128) with dual therapy compared with triple therapy.
The study was conducted from November 2008 to November 2011. Patients enrolled were already treated with oral anticoagulants for AF or mechanical valves and underwent coronary stenting. The multicenter study involved 15 hospitals in the Netherlands and Belgium.
“This is the first randomized trial to address the optimal antiplatelet therapy in patients on oral anticoagulants undergoing coronary stenting,” Dewilde said at the conference. “We propose that a strategy of oral anticoagulants plus clopidogrel — but without aspirin — could be applied in this group of high-risk patients on oral anticoagulants when undergoing PCI.” – by Katie Kalvaitis
For more information:
Dewilde W. Hot line III: Late breaking trials on arrhythmias and CAD. Presented at: the European Society of Cardiology Congress; Aug. 25-29, 2012; Munich.
Disclosure: Dr. Dewilde reports no relevant financial disclosures.
Perspective
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David R. Holmes Jr., MD
This is an incredibly important issue. We are faced with a huge clinical problem, with the number of patients with AF who undergo stent procedures. From a clinical standpoint, [these data have] a huge implication. I think studies such as these randomized trials which are appropriately powered for the primary endpoint of bleeding wind up having the chance to make it to the guidelines and provide new evidence that then change the way we practice medicine. Is it going to change the guidelines overnight? It is hard to be sure because guidelines change on a year-to-year basis. Will it change practice overnight? Clearly, people are going to look at this and say, ‘Bleeding is such a huge issue; we now have some scientific data.’ From a patient standpoint, this is a huge deal.
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