Impact of clinical presentation on ischaemic and bleeding outcomes in patients receiving 6- or 24-month duration of dual-antiplatelet therapy after stent implantation: a pre-specified analysis from the PRODIGY (Prolonging Dual-Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia) trial.

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.

• Authors: Francesco Costa, Pascal Vranckx, Sergio Leonardi, Elisabetta Moscarella, Giuseppe Ando, Paolo Calabro, Giuseppe Oreto, Felix Zijlstra, Marco Valgimigli
• Journal: European heart journal (Eur Heart J) Vol. 36 Issue 20 Pg. 1242-51 (May 21 2015) ISSN: 1522-9645 [Electronic] England
• PMID: 25718355 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: [email protected].

Chemical References

• Platelet Aggregation Inhibitors
• Clopidogrel
• Ticlopidine
• Aspirin

Topics

• Acute Coronary Syndrome (mortality, therapy)
• Aged
• Aspirin (administration & dosage)
• Clopidogrel
• Coronary Artery Disease (mortality, therapy)
• Drug Therapy, Combination
• Female
• Hemorrhage (chemically induced)
• Humans
• Hyperplasia (etiology)
• Male
• Myocardial Infarction (etiology, mortality)
• Percutaneous Coronary Intervention (methods, mortality)
• Platelet Aggregation Inhibitors (administration & dosage)
• Prognosis
• Stents
• Stroke (etiology, mortality)
• Ticlopidine (administration & dosage, analogs & derivatives)
• Tunica Intima (pathology)