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PARIS: Nonadherence to DAPT associated with ischemic, bleeding events
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TCT 2011
SAN FRANCISCO — Ischemic and bleeding events at 30 days were associated with nonadherence to antiplatelet therapy, according to results presented at the 2011 Transcatheter Cardiovascular Therapeutics scientific symposium.
The PARIS registry, a multicenter, multinational, observational study with an “all comers” design, enrolled 5,033 patients who underwent bare metal or drug-eluting stent implantation. Primary objectives included examination of modes of nonadherence to dual antiplatelet therapy (DAPT) after stenting and evaluation of subsequent clinical outcomes and the relationship to DAPT nonadherence.
Modes of nonadherence included discontinuation of DAPT, interruption of DAPT because of need for surgery and disruption of DAPT because of bleeding or noncompliance.
“Importantly, any nonadherence was associated with higher rate of both ischemic and bleeding events at 30 days, including death, MI, definite or probable stent thrombosis, target vessel revascularization and bleeding,” Roxana Mehran, MD, professor of medicine at Mount Sinai School of Medicine and director of Interventional Cardiovascular Research and Clinical Trials at the Zena and Michael A. Wiener Cardiovascular Institute, said in a press release.
At 30-day follow-up, researchers found incidence of nonadherence to DAPT was 2%; 69% of patients had disruption of therapy (61% to noncompliance and 32% to bleeding event), 19% had interruption of DAPT (67% due to surgery or medical procedures) and 12% were recommended by their physician to discontinue therapy. For patients on aspirin or thienopyridines, nonadherence was equally distributed.
“There was a sixfold increase in odds for definite or probable stent thrombosis associated with nonadherence compared to adherence to [DAPT] at 30 days,” Mehran said. “The 2-year data will be more definitive and should be able to link the patterns of nonadherence with important clinical events.”
Disclosure: Dr. Mehran reports receiving grant and research support from Sanofi-Aventis, Bristol-Myers Squibb and TMC. Consulting fees and honoraria were provided by AstraZeneca, Abbott Vascular, Ortho McNeil and Regado Biosciences.
For more information:
- Mehran R. Plenary session V. Late-breaking clinical trials and first report investigations I. Presented at: the 2011 Transcatheter Cardiovascular Therapeutics Scientific Symposium; Nov. 7-11; San Francisco.
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