Paolo Zocca1, Marlies M Kok1, Liefke C van der Heijden1, K Gert van Houwelingen1, Marc Hartmann1, Frits H A F de Man1, Martin G Stoel1, J Hans W Louwerenburg1, Iris L Knottnerus2, Gerard C M Linssen3, Carine J M Doggen4, Clemens von Birgelen5. 1. Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, Netherlands. 2. Department of Neurology, Medisch Spectrum Twente, Enschede, Netherlands. 3. Department of Cardiology, Ziekenhuisgroep Twente, Almelo, and Hengelo, Netherlands. 4. Department Health Technology and Services Research, MIRA Institute for Biomedical Technology and Technical Medicine, University of Twente, Enschede, Netherlands. 5. Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, Netherlands; Department Health Technology and Services Research, MIRA Institute for Biomedical Technology and Technical Medicine, University of Twente, Enschede, Netherlands. Electronic address: c.vonbirgelen@mst.nl.
Abstract
BACKGROUND: The prospective observational CHANGE DAPT study compared clopidogrel versus ticagrelor-based dual antiplatelet (DAPT) regimens in consecutive patients with acute coronary syndrome (ACS), treated with percutaneous coronary intervention (PCI) with contemporary drug-eluting stents (DES). During the ticagrelor period (TP, May 2014-August 2015) there were more major bleedings than during the clopidogrel period (CP, December 2012-April 2014). METHODS AND RESULTS: To evaluate whether the excess of major bleedings during TP may be limited to high bleeding risk (HBR) patients, we performed an explorative analysis of all 2062 CHANGE DAPT participants, of whom 547(26.5%) were classified as HBR (CP, n = 245; TP, n = 302). In HBR and non-HBR patients, we assessed the impact of CP versus TP on propensity score-adjusted rates of major bleeding and a pre-defined ischemic endpoint (composite of cardiac death, myocardial infarction, or stroke) at 1-year follow-up. Among HBR patients, the rate of major bleeding was significantly higher during TP (1.7% vs. 5.0%; HRadjusted 3.70 [95% CI 1.18-11.67], p = 0.03), while there was no significant difference in the ischemic endpoint (6.6% vs. 8.0%, HRadjusted 1.23 [95% CI 0.63-2.42], p = 0.54). In non-HBR patients, the rates of major bleeding (1.1% vs. 1.7%; HRadjusted 2.13 [95% CI 0.84-5.43], p = 0.11) and the ischemic endpoint (2.8% vs. 3.4%, HRadjusted 1.38 [95% CI 0.74-2.57], p = 0.32) were similar between both periods. CONCLUSIONS: Among consecutive ACS patients, the increased risk of major bleeding during ticagrelor-based DAPT was limited to HBR patients. In both HBR and non-HBR patients, ticagrelor-based DAPT did not reduce ischemic outcomes following treatment with contemporary DES implantation.
BACKGROUND: The prospective observational CHANGE DAPT study compared clopidogrel versus ticagrelor-based dual antiplatelet (DAPT) regimens in consecutive patients with acute coronary syndrome (ACS), treated with percutaneous coronary intervention (PCI) with contemporary drug-eluting stents (DES). During the ticagrelor period (TP, May 2014-August 2015) there were more major bleedings than during the clopidogrel period (CP, December 2012-April 2014). METHODS AND RESULTS: To evaluate whether the excess of major bleedings during TP may be limited to high bleeding risk (HBR) patients, we performed an explorative analysis of all 2062 CHANGE DAPTparticipants, of whom 547(26.5%) were classified as HBR (CP, n = 245; TP, n = 302). In HBR and non-HBRpatients, we assessed the impact of CP versus TP on propensity score-adjusted rates of major bleeding and a pre-defined ischemic endpoint (composite of cardiac death, myocardial infarction, or stroke) at 1-year follow-up. Among HBRpatients, the rate of major bleeding was significantly higher during TP (1.7% vs. 5.0%; HRadjusted 3.70 [95% CI 1.18-11.67], p = 0.03), while there was no significant difference in the ischemic endpoint (6.6% vs. 8.0%, HRadjusted 1.23 [95% CI 0.63-2.42], p = 0.54). In non-HBRpatients, the rates of major bleeding (1.1% vs. 1.7%; HRadjusted 2.13 [95% CI 0.84-5.43], p = 0.11) and the ischemic endpoint (2.8% vs. 3.4%, HRadjusted 1.38 [95% CI 0.74-2.57], p = 0.32) were similar between both periods. CONCLUSIONS: Among consecutive ACS patients, the increased risk of major bleeding during ticagrelor-based DAPT was limited to HBRpatients. In both HBR and non-HBRpatients, ticagrelor-based DAPT did not reduce ischemic outcomes following treatment with contemporary DES implantation.
Authors: Seng Chan You; Yeunsook Rho; Behnood Bikdeli; Jiwoo Kim; Anastasios Siapos; James Weaver; Ajit Londhe; Jaehyeong Cho; Jimyung Park; Martijn Schuemie; Marc A Suchard; David Madigan; George Hripcsak; Aakriti Gupta; Christian G Reich; Patrick B Ryan; Rae Woong Park; Harlan M Krumholz Journal: JAMA Date: 2020-10-27 Impact factor: 56.272
Authors: Paolo Zocca; Marlies M Kok; Liefke C van der Heijden; Peter W Danse; Carl E Schotborgh; Martijn Scholte; Marc Hartmann; Gerard C M Linssen; Carine J M Doggen; Clemens von Birgelen Journal: Cardiovasc Drugs Ther Date: 2018-12 Impact factor: 3.727