Ischaemic and bleeding outcomes in elderly patients undergoing a prolonged versus shortened duration of dual antiplatelet therapy after percutaneous coronary intervention: insights from the PRODIGY randomised trial.

Piccolo, Raffaele; Magnani, Giulia; Ariotti, Sara; Gargiulo, Giuseppe; Marino, Marcello; Santucci, Andrea; Franzone, Anna; Tebaldi, Matteo; Heg, Dik; Windecker, Stephan; Valgimigli, Marco (2017). Ischaemic and bleeding outcomes in elderly patients undergoing a prolonged versus shortened duration of dual antiplatelet therapy after percutaneous coronary intervention: insights from the PRODIGY randomised trial. EuroIntervention, 13(1), pp. 78-86. Europa Digital & Publishing 10.4244/EIJ-D-16-00497

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AIMS The aim of this study was to evaluate the efficacy and safety of 24-month vs. six-month dual antiplatelet therapy (DAPT) among elderly (≥75 years) and non-elderly patients (<75 years) undergoing percutaneous coronary intervention. METHODS AND RESULTS The primary efficacy endpoint of the PRODIGY trial was the composite of death, myocardial infarction, or cerebrovascular accident at 24-month follow-up. The key safety endpoint was type 2, 3 or 5 bleeding according to the BARC criteria. Of 1,970 participants, 587 (29.8%) were elderly and had a higher risk of adverse events compared with younger patients. The risk of the primary endpoint was not significantly reduced with 24-month compared to six-month DAPT among both elderly (HR 0.80, 95% CI: 0.55-1.16, p=0.24) and non-elderly patients (HR 1.48, 95% CI: 0.95-2.30, p=0.08), although interaction testing was significant (p=0.036). A 24-month versus six-month DAPT significantly increased the risk of BARC type 2, 3 or 5 bleeding in both older (HR 1.90, 95% CI: 1.06-3.38, p=0.03) and younger patients (HR 2.54, 95% CI: 1.43-4.53, p=0.002, p-interaction=0.48). However, measures of absolute risk difference indicated a less favourable safety profile of prolonged DAPT for older rather than younger patients. CONCLUSIONS In the PRODIGY trial, prolonging clopidogrel-based DAPT beyond six months in elderly patients increased the risk of bleeding, without affording a significant prevention of ischaemic events.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology
04 Faculty of Medicine > Pre-clinic Human Medicine > Institute of Social and Preventive Medicine
04 Faculty of Medicine > Pre-clinic Human Medicine > CTU Bern

UniBE Contributor:

Piccolo, Raffaele; Magnani, Giulia; Ariotti, Sara; Gargiulo, Giuseppe; Franzone, Anna; Heg, Dierik Hans; Windecker, Stephan and Valgimigli, Marco

Subjects:

600 Technology > 610 Medicine & health
300 Social sciences, sociology & anthropology > 360 Social problems & social services

ISSN:

1774-024X

Publisher:

Europa Digital & Publishing

Language:

English

Submitter:

Tanya Karrer

Date Deposited:

05 Sep 2017 13:28

Last Modified:

18 Oct 2017 13:36

Publisher DOI:

10.4244/EIJ-D-16-00497

PubMed ID:

28044986

BORIS DOI:

10.7892/boris.102373

URI:

https://boris.unibe.ch/id/eprint/102373

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