Francesco Costa1, Pascal Vranckx2, Sergio Leonardi3, Elisabetta Moscarella4, Giuseppe Ando5, Paolo Calabro4, Giuseppe Oreto5, Felix Zijlstra6, Marco Valgimigli7. 1. Thoraxcenter, Erasmus Medical Center, 3015 CE Rotterdam, The Netherlands Department of Clinical and Experimental Medicine, Policlinico 'G. Martino', University of Messina, Italy. 2. Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium. 3. Fondazione I.R.C.C.S. Policlinico San Matteo, Pavia, Italy. 4. Division of Cardiology, Department of Cardiothoracic Sciences, Second University of Naples, Naples, Italy. 5. Department of Clinical and Experimental Medicine, Policlinico 'G. Martino', University of Messina, Italy. 6. Thoraxcenter, Erasmus Medical Center, 3015 CE Rotterdam, The Netherlands. 7. Thoraxcenter, Erasmus Medical Center, 3015 CE Rotterdam, The Netherlands m.valgimigli@erasmusmc.nl vlgmrc@unife.it.
Abstract
AIMS: We investigated if acute coronary syndrome (ACS) rather than stable coronary artery disease (SCAD) presentation is an outcome modifier with respect to the duration of dual-antiplatelet therapy (DAPT) in patients undergoing coronary stenting. METHODS AND RESULTS: In the Prolonging Dual-Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia (PRODIGY) trial, a total of 1465 (74.3%) patients presented ACS whereas 505 (25.7%) had SCAD and were randomized to 6- or 24-month DAPT. At 24 months, the composite of death, myocardial infarction (MI), or cerebrovascular accident (CVA) did not differ between the long- and short-term DAPT arms in both ACS (11.1 vs. 11.7%; P = 0.67) and SCAD (7.5 vs. 4.8%; P = 0.21) patients, respectively. Long-term DAPT was associated with a 75% increase of Bleeding Academic Research Consortium (BARC)-class 2, 3, or 5 bleeding in ACS [7.1 vs. 4.1%; hazard ratio (HR) 1.75, 95% confidence interval (CI) 1.11-2.74, P = 0.015; number needed to treat for harm (NNTH): 33.3] and a five-fold increase in SCAD (8.2 vs. 1.6%; HR 5.37, 95% CI 1.84-15.74, P = 0.002; NNTH: 15.1) patients, with a borderline quantitative interaction (PINT = 0.056). As a result, net adverse cardiovascular events (death, MI, CVA, BARC class 2, 3, or 5 bleeding) were more than doubled in SCAD patients receiving 24-month DAPT, whereas they did not differ in ACS patients (PINT = 0.024). CONCLUSIONS: This analysis suggests that clinical presentation may be a treatment modifier with respect to DAPT duration after stenting consistent with the hypothesis that SCAD-but not ACS-patients are exposed to a significant increase in bleeding and net adverse clinical events when treated with 24-month compared with 6-month therapy. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00611286. http://clinicaltrials.gov/ct2/show/NCT00611286?term=prodigy&rank=2. Published on behalf of the European Society of Cardiology. All rights reserved.
RCT Entities:
AIMS: We investigated if acute coronary syndrome (ACS) rather than stable coronary artery disease (SCAD) presentation is an outcome modifier with respect to the duration of dual-antiplatelet therapy (DAPT) in patients undergoing coronary stenting. METHODS AND RESULTS: In the Prolonging Dual-Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia (PRODIGY) trial, a total of 1465 (74.3%) patients presented ACS whereas 505 (25.7%) had SCAD and were randomized to 6- or 24-month DAPT. At 24 months, the composite of death, myocardial infarction (MI), or cerebrovascular accident (CVA) did not differ between the long- and short-term DAPT arms in both ACS (11.1 vs. 11.7%; P = 0.67) and SCAD (7.5 vs. 4.8%; P = 0.21) patients, respectively. Long-term DAPT was associated with a 75% increase of Bleeding Academic Research Consortium (BARC)-class 2, 3, or 5 bleeding in ACS [7.1 vs. 4.1%; hazard ratio (HR) 1.75, 95% confidence interval (CI) 1.11-2.74, P = 0.015; number needed to treat for harm (NNTH): 33.3] and a five-fold increase in SCAD (8.2 vs. 1.6%; HR 5.37, 95% CI 1.84-15.74, P = 0.002; NNTH: 15.1) patients, with a borderline quantitative interaction (PINT = 0.056). As a result, net adverse cardiovascular events (death, MI, CVA, BARC class 2, 3, or 5 bleeding) were more than doubled in SCAD patients receiving 24-month DAPT, whereas they did not differ in ACS patients (PINT = 0.024). CONCLUSIONS: This analysis suggests that clinical presentation may be a treatment modifier with respect to DAPT duration after stenting consistent with the hypothesis that SCAD-but not ACS-patients are exposed to a significant increase in bleeding and net adverse clinical events when treated with 24-month compared with 6-month therapy. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00611286. http://clinicaltrials.gov/ct2/show/NCT00611286?term=prodigy&rank=2. Published on behalf of the European Society of Cardiology. All rights reserved.
Authors: Neil J Wimmer; Alyssa B Dufour; Kelly Cho; David R Gagnon; Lien Quach; Samantha Ly; Jacquelyn-My Do; Simon Ostrowski; J Michael Gaziano; David P Faxon; Scott Kinlay Journal: Catheter Cardiovasc Interv Date: 2016-11-10 Impact factor: 2.692
Authors: Marco Valgimigli; Francesco Costa; Yuliya Lokhnygina; Robert M Clare; Lars Wallentin; David J Moliterno; Paul W Armstrong; Harvey D White; Claes Held; Philip E Aylward; Frans Van de Werf; Robert A Harrington; Kenneth W Mahaffey; Pierluigi Tricoci Journal: Eur Heart J Date: 2017-03-14 Impact factor: 29.983