ADAPT-DES: Results at 1 year of the clinical impact of hypo-responders to aspirin and clopidogrel.

Background: The ADAPT-DES registry showed a strong correlation between hypo-responders to clopidogrel and the likelihood of stent thrombosis at 30 days, while the impact of aspirin response has not been evaluated so far. This presentation focuses on the aspirin response impact in the clinical course of one year.

Methods and Results: A total of 8,583 patients in 11 centers in the United States and Germany who underwent angioplasty with eluting stent implantation. The study population is representative of the real world: 32.4% diabetics, chronic renal 7.7%, acute coronary syndromes 50% and pan-arterial 28%. After one year, 95% of patients were taking aspirin and 83.9% clopidogrel. The hypo-responder to aspirin rate was 5.6% and 42.7% to clopidogrel (with cutoff> 208 PRU) and 35% (with cutoff> 230 PRU). The probable or definite stent thrombosis rate at one year was 0.84% (n = 70), (57% in the first month). The hypo-response to clopidogrel, (> 208 PRU), was a conclusive predictor of stent thrombosis, (p = 0.0006), and myocardial infarction, (p = 0.01). Similarly, the absence of adequate response to clopidogrel was a “protective” factor against major bleeding, (p = 0.002), and had no independent impact on mortality, (p = 0.30). Stent thrombosis, stroke and bleeding were independent predictors of mortality, (p <0.0001). The presence of hypo-response to aspirin, (ARU> 550), meanwhile, was not associated with a higher rate of thrombosis or infarction, (p = 0.42 and 0.46, respectively), but constituted a protective factor against bleeding, (p = 0.04).

Conclusions: Hypo-response to clopidogrel was an independent predictor of stent thrombosis and infarction at one year but less of a bleeding predictor. The presence of hypo-response only predicted a lower rate of bleeding and had no impact on the thrombosis rate. Ischemic events and bleeding were closely associated with increased mortality.

Editorial comment: Editorial comment: Net clinical benefit of a drug includes reducing events such as stroke and thrombosis and a lower occurrence of complications such as bleeding. Combined analysis shows that the hypo-responders to clopidogrel modified those three variables. 

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Gregg Stone.

Original title: ADAPT-DES One Year: A Large-Scale, Multicenter, Prospective, Observational Study of the Impact of Clopidogrel and Aspirin Hyporesponsiveness on Patient Outcomes