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ADAPT-DES: Low responsiveness to clopidogrel after DES predicted stent thrombosis, MI
MIAMI — One-year results from the ADAPT-DES registry suggest that clopidogrel hyporesponsiveness after implantation of a drug-eluting stent is an independent predictor of stent thrombosis and MI at 1 year.
The large, multicenter registry included 8,583 patients undergoing PCI with at least one DES at 11 sites between January 2008 and September 2010. Gregg W. Stone, MD, professor of medicine at Columbia University College of Physicians and Surgeons and director of cardiovascular research and education at the Center for Interventional Vascular Therapy at New York-Presbyterian/Columbia University Medical Center, and colleagues assessed platelet reactivity with the VerifyNow Aspirin, P2Y12 and IIb/IIIa tests. Patients were followed for 1 year to determine the relationship between platelet hyporesponsiveness and subsequent events, according to a press release.
Gregg W. Stone
Clopidogrel hyporesponsiveness (platelet reactivity unit >208) was significantly associated with stent thrombosis (1.3% vs. 0.5%; P=.0001) and MI (3.9% vs. 2.7%; P=.002), but was also protective against major bleeding (5.6% vs. 6.7%; P=.04), when compared with patients with a PRU <208.
“As a result, on-treatment clopidogrel hyporesponsiveness was not independently predictive of 1-year mortality,” Thomas Stuckey, MD, interventional cardiologist at Lebauer Healthcare and clinical professor of medicine at University of North Carolina School of Medicine, said at the conference. Because clopidogrel hyporesponsiveness is associated with other patient risk factors and baseline characteristics, multivariate modeling was also performed, which demonstrated no independent association between clopidogrel hyporesponsiveness and mortality (adjusted HR=1.2; 95% CI, 0.85-1.7).
At 1 year, stent thrombosis occurred in 70 patients (0.84%), MI in 224 (2.7%), major bleeding in 531 (6.2%) and death in 161 (1.9%), according to the release.
More than 42% of patients demonstrated clopidogrel hyporesponsiveness.
Hyporesponsiveness to aspirin was unrelated to stent thrombosis, MI or death. However, it “may be related to bleeding, questioning the utility of aspirin in patients treated with DES,” according to Stuckey.
At TCT 2011, ADAPT-DES researchers reported a strong relationship between platelet hyporesponsiveness to clopidogrel and subsequent stent thrombosis up to 30 days after stent implantation.
“Overcoming clopidogrel hyporesponsiveness with more potent antiplatelet agents is therefore unlikely to improve survival unless the beneficial effects of reducing stent thrombosis and MI can be uncoupled from the likely increase in bleeding with greater platelet inhibition,” Stuckey said.
For more information:
Stone GW. Plenary session XVII. First report investigations II. Presented at: TCT 2012; Oct. 22-26, 2012; Miami.
Disclosure: The ADAPT-DES trial was sponsored by the Cardiovascular Research Foundation with research support from Abbott Vascular, Accumetrics, Biosensors, Boston Scientific, Cordis, Daiichi Sankyo, Eli Lilly, Medtronic, The Medicines Company and Volcano. Stone reports consulting fees from Abbott Vascular, AstraZeneca, Boston Scientific, Daiichi Sankyo, Eli Lilly, Medtronic, The Medicines Company and Volcano. Stuckey reports consulting fees/honoraria from Daiichi Sankyo and Eli Lilly.