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Extended DAPT benefited patients receiving PES
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CHICAGO — Among patients treated with a paclitaxel-eluting stent, 30 months of dual antiplatelet therapy consisting of prasugrel and aspirin decreased rates of MACCE and stent thrombosis when compared with 12 months of the same regimen.
Furthermore, rates of moderate or severe bleeding were not significantly increased in the group that received the longer duration.
For the study, Kirk N. Garratt, MD, of the Lennox Hill Hospital, New York, and colleagues randomly assigned 2,191 patients who had received a paclitaxel-eluting stent (PES; Taxus Liberté, Boston Scientific) to 12 months of prasugrel (Effient, Daiichi Sankyo/Eli Lilly) plus aspirin (n=1,093) or 30 months of that regimen (n=1,098).
Kirk N. Garratt
According to Garratt, the baseline characteristics of the patients were “remarkable, chiefly for the relative paucity of patients who were over the age of 75 or who had very low body mass … those are concerns with prasugrel therapy,” he said during a presentation. “In addition, it is notable that about two-thirds of the patients enrolled had initially presented with an acute coronary syndrome, either unstable angina or myocardial infarction.”
The two co-primary efficacy endpoints were MACCE — all-cause mortality, MI or stroke — and definite or probable stent thrombosis occurring between 12 and 30 months after the procedure. The primary safety endpoint was major bleeding, which was defined as GUSTO moderate or severe bleeding, also between 12 and 30 months.
Garratt reported that rates of MACCE at 540 days after randomization were 8.8% in the 12-month group vs. 3.7% in the 30-month group (P<.001). Similarly, definite or probable stent thrombosis was also higher in the 12-month DAPT group (2.9% vs. 0.2%; P<.001).
Differences in GUSTO moderate or severe bleeding did not reach statistical significance at 540 days after randomization (30-month group, 2.4% vs. 6-month group, 1.7%; P=0.234). Also at this time point, the 30-month group demonstrated lower rates of ARC-defined MI related to (0% vs. 2.6%; P<.001) and not related to (1.9% vs. 4.5%; P<.001) stent thrombosis.
Importantly, Garratt said, “withdrawal of prasugrel was associated with an … increase in the risk of ischemic events early after drug discontinuation. The principal risk was MI and the impact of this was evident within 90 days of drug cessation.”
Because of the early increase in events after withdrawal of prasugrel, the data monitoring committee recommended that randomized treatment in the study be unblinded for patients who had not yet completed 30-month follow-up, allowing discussion of continuing open-label prasugrel. The unblinding affected a very few number of patients (n=27), Garratt said. – by Brian Ellis
For more information:
Garratt KN. LBCT.01: Risk and Benefit of Dual Antiplatelet Therapy. Presented at: American Heart Association Scientific Sessions; Nov. 15-19, 2014; Chicago.
Disclosure: Garratt reports consulting agreements with Boston Scientific and The Medicines Company, and research support from Boston Scientific, CeloNova, Daiichi Sankyo/Eli Lilly and Mayo Foundation.