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  3. Six months versus 12 months dual antiplatelet therapy after drug-eluting stent implantation in ST-elevation myocardial infarction (DAPT-STEMI): randomised, multicentre, non-inferiority trial
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Research

Six months versus 12 months dual antiplatelet therapy after drug-eluting stent implantation in ST-elevation myocardial infarction (DAPT-STEMI): randomised, multicentre, non-inferiority trial

BMJ 2018; 363 doi: https://doi.org/10.1136/bmj.k3793 (Published 02 October 2018) Cite this as: BMJ 2018;363:k3793

Linked BMJ opinion

Dual antiplatelet therapy in patients with STEMI—is longer treatment needed?
  1. Elvin Kedhi, cardiologist1,
  2. Enrico Fabris, cardiologist1 2,
  3. Martin van der Ent, cardiologist3,
  4. Pawel Buszman, professor and cardiologist4 5,
  5. Clemens von Birgelen, professor and cardiologist6 7,
  6. Vincent Roolvink, cardiologist1,
  7. Alexander Zurakowski, cardiologist8,
  8. Carl E Schotborgh, cardiologist9,
  9. Jan C A Hoorntje, professor10,
  10. Christian Hasbø Eek, cardiologist11,
  11. Stéphane Cook, professor12,
  12. Marco Togni, cardiologist12,
  13. Martijn Meuwissen, cardiologist13,
  14. Niels van Royen, professor14,
  15. Ria van Vliet, research program coordinator3,
  16. Hans Wedel, professor15,
  17. Ronak Delewi, cardiology fellow16,
  18. Felix Zijlstra, professor6
  1. 1Isala Hartcentrum, Isala Klinieken, Zwolle, Netherlands
  2. 2Cardiovascular Department, University of Trieste, Trieste, Italy
  3. 3Maasstad Ziekenhuis, Rotterdam, Netherlands
  4. 4American Heart of Poland, Ustroń, Poland
  5. 5Medical University of Silesia, Katowice, Poland
  6. 6Thoraxcenter, Erasmus Medisch Centrum, Rotterdam, Netherlands
  7. 7University of Twente, Enschede, Netherlands
  8. 8American Heart of Poland, Chrzanów, Poland
  9. 9Haga Hospital, The Hague, Netherlands
  10. 10Zuyderland Medical Centre, Heerlen, Netherlands
  11. 11Department of Cardiology, Oslo Academic University, Oslo, Norway
  12. 12Department of Cardiology, University & Hospital, Fribourg, Switzerland
  13. 13Department of Cardiology, Amphia Hospital, Breda, Netherlands
  14. 14Department of Cardiology, Radboud University Medical Centre, Nijmegen, Netherlands
  15. 15Sahlgrenska Academy, University of Gothenburg, and Nordic School of Public Health, Gothenburg, Sweden
  16. 16Heart Centre, Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands
  1. Correspondence to: E Kedhi e.kedhi{at}isala.nl
  • Accepted 22 August 2018

Abstract

Objective To show that limiting dual antiplatelet therapy (DAPT) to six months in patients with event-free ST-elevation myocardial infarction (STEMI) results in a non-inferior clinical outcome versus DAPT for 12 months.

Design Prospective, randomised, multicentre, non-inferiority trial.

Setting Patients with STEMI treated with primary percutaneous coronary intervention (PCI) and second generation zotarolimus-eluting stent.

Participants Patients with STEMI aged 18 to 85 that underwent a primary PCI with the implantation of second generation drug-eluting stents were enrolled in the trial. Patients that were event-free at six months after primary PCI were randomised at this time point.

Interventions Patients that were taking DAPT and were event-free at six months were randomised 1:1 to single antiplatelet therapy (SAPT) (ie, aspirin only) or to DAPT for an additional six months. All patients that were randomised were then followed for another 18 months (ie, 24 months after the primary PCI).

Main outcome measures The primary endpoint was a composite of all cause mortality, any myocardial infarction, any revascularisation, stroke, and thrombolysis in myocardial infarction major bleeding at 18 months after randomisation.

Results A total of 1100 patients were enrolled in the trial between 19 December 2011 and 30 June 2015. 870 were randomised: 432 to SAPT versus 438 to DAPT. The primary endpoint occurred in 4.8% of patients receiving SAPT versus 6.6% of patients receiving DAPT (hazard ratio 0.73, 95% confidence interval 0.41 to 1.27, P=0.26). Non-inferiority was met (P=0.004 for non-inferiority), as the upper 95% confidence interval of 1.27 was smaller than the prespecified non-inferiority margin of 1.66.

Conclusions DAPT to six months was non-inferior to DAPT for 12 months in patients with event-free STEMI at six months after primary PCI with second generation drug-eluting stents.

Trial registration Clinicaltrials.gov NCT01459627.

Footnotes

  • Contributors: EK conceived and designed the study. HW performed the power calculation. RD performed the statistical analysis. EK and EF prepared the first draft of the manuscript. All other authors acquired the data, critically revised the manuscript, and approved the final manuscript. All authors had full access to the data in the study and can take responsibility for the integrity of the data and the accuracy of the data analysis. EK is the guarantor.

  • Funding: The trial was sponsored form the Maasstad Cardiovascular Research Rotterdam, The Netherlands and from an unrestricted research grant from Medtronic.

  • Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: no support from any organisation for the submitted work other than those listed above; no other financial relationships with organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

  • Ethical approval: This study was conducted in accordance with the Declaration of Helsinki and was approved by the local research ethics committee.

  • Data sharing: The dataset is available on written request to the corresponding author.

  • Transparency: The manuscript’s guarantor (EK) affirms that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned and registered have been explained.

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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