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Eur Heart J. 2015 May 21;36(20):1242-51. doi: 10.1093/eurheartj/ehv038. Epub 2015 Feb 25.

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.

Author information

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.

KEYWORDS:

Bleeding; Clopidogrel; Drug-eluting stents; Dual-antiplatelet therapy

PMID:
25718355
DOI:
10.1093/eurheartj/ehv038
[Indexed for MEDLINE]

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