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Eur Heart J. 2016 Jan 21;37(4):378-85. doi: 10.1093/eurheartj/ehv614. Epub 2015 Nov 18.

Causes of late mortality with dual antiplatelet therapy after coronary stents.

Author information

1
Harvard Clinical Research Institute, Boston, USA Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA Harvard Medical School , Boston, USA lmauri1@partners.org.
2
Harvard Clinical Research Institute, Boston, USA Harvard Medical School , Boston, USA Massachusetts General Hospital, Boston, USA.
3
Harvard Clinical Research Institute, Boston, USA Harvard Medical School , Boston, USA Beth Israel Deaconess Medical Center, Boston, USA.
4
Département Hospitalo-Universitaire Fibrosis, Inflammation, and Remodeling, Assistance Publique - Hôpitaux de Paris, Paris, France National Heart and Lung Institute, Imperial College, Royal Brompton Hospital, London, UK.
5
Bern University Hospital, Bern, Switzerland.
6
Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA Harvard Medical School , Boston, USA.
7
Saint Luke's Mid America Heart Institute, Kansas City, MO, USA University of Missouri-Kansas City School of Medicine, Kansas City, MO, USA.
8
Harvard Clinical Research Institute, Boston, USA Boston University School of Public Health, Boston, USA Université Paris-Diderot, INSERM U-1148, Hôpital Bichat, Paris, France.
9
Harvard Clinical Research Institute, Boston, USA Boston University School of Public Health, Boston, USA.
10
The Christ Hospital Heart and Vascular Center, The Lindner Center for Research and Education, Cincinnati, OH, USA.

Abstract

AIMS:

In the dual antiplatelet therapy (DAPT) study, continued thienopyridine beyond 12 months after drug-eluting stent placement was associated with increased mortality compared with placebo. We sought to evaluate factors related to mortality in randomized patients receiving either drug-eluting or bare metal stents in the DAPT study.

METHODS AND RESULTS:

Patients were enrolled after coronary stenting, given thienopyridine and aspirin for 12 months, randomly assigned to continued thienopyridine or placebo for an additional 18 months (while taking aspirin), and subsequently treated with aspirin alone for another 3 months. A blinded independent adjudication committee evaluated deaths. Among 11 648 randomized patients, rates of all-cause mortality rates were 1.9 vs. 1.5% (continued thienopyridine vs. placebo, P = 0.07), cardiovascular mortality, 1.0 vs. 1.0% (P = 0.97), and non-cardiovascular mortality, 0.9 vs. 0.5% (P = 0.01) over the randomized period (Months 12-30). Rates of fatal bleeding were 0.2 vs. 0.1% (P = 0.81), and deaths related to any prior bleeding were 0.3 vs. 0.2% (P = 0.36), Months 12-33). Cancer incidence did not differ (2.0 vs. 1.6%, P = 0.12). Cancer-related deaths occurred in 0.6 vs. 0.3% (P = 0.02) and were rarely related to bleeding (0.1 vs. 0, P = 0.25). After excluding those occurring in patients with cancer diagnosed before enrolment, rates were 0.4 vs. 0.3% (P = 0.16).

CONCLUSION:

Bleeding accounted for a minority of deaths among patients treated with continued thienopyridine. Cancer-related death in association with thienopyridine therapy was mainly not related to bleeding and may be a chance finding. Caution is warranted when considering extended thienopyridine in patients with advanced cancer.

TRIAL REGISTRATION:

clinicaltrials.gov Identifier: NCT00977938.

KEYWORDS:

Cancer; Dual antiplatelet therapy; Mortality; Thienopyridine

PMID:
26586780
PMCID:
PMC4751218
DOI:
10.1093/eurheartj/ehv614
[Indexed for MEDLINE]
Free PMC Article

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