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

Elvin Kedhi* (Corresponding Author), Enrico Fabris, Martin Van Der Ent, Pawel Buszman, Clemens Von Birgelen, Vincent Roolvink, Alexander Zurakowski, Carl E. Schotborgh, Jan C.A. Hoorntje, Christian Hasbø Eek, Stéphane Cook, Marco Togni, Martijn Meuwissen, Niels Van Royen, Ria Van Vliet, Hans Wedel, Ronak Delewi, Felix Zijlstra

*Corresponding author for this work

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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.

Original languageEnglish
Article numberk3793
JournalBMJ (Online)
Volume363
DOIs
Publication statusPublished - 2 Oct 2018

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Drug-Eluting Stents
Percutaneous Coronary Intervention
Therapeutics
ST Elevation Myocardial Infarction
Myocardial Infarction
Confidence Intervals
Random Allocation
Aspirin
Stents
Stroke
Outcome Assessment (Health Care)
Hemorrhage

Cite this

Kedhi, Elvin ; Fabris, Enrico ; Van Der Ent, Martin ; Buszman, Pawel ; Von Birgelen, Clemens ; Roolvink, Vincent ; Zurakowski, Alexander ; Schotborgh, Carl E. ; Hoorntje, Jan C.A. ; Eek, Christian Hasbø ; Cook, Stéphane ; Togni, Marco ; Meuwissen, Martijn ; Van Royen, Niels ; Van Vliet, Ria ; Wedel, Hans ; Delewi, Ronak ; Zijlstra, Felix. / 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. In: BMJ (Online). 2018 ; Vol. 363.
@article{2df04f7b6acc479f862458ce283c1271,
title = "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",
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.",
author = "Elvin Kedhi and Enrico Fabris and {Van Der Ent}, Martin and Pawel Buszman and {Von Birgelen}, Clemens and Vincent Roolvink and Alexander Zurakowski and Schotborgh, {Carl E.} and Hoorntje, {Jan C.A.} and Eek, {Christian Hasb{\o}} and St{\'e}phane Cook and Marco Togni and Martijn Meuwissen and {Van Royen}, Niels and {Van Vliet}, Ria and Hans Wedel and Ronak Delewi and Felix Zijlstra",
year = "2018",
month = "10",
day = "2",
doi = "10.1136/bmj.k3793",
language = "English",
volume = "363",
journal = "British Medical Journal",
issn = "0959-8146",
publisher = "BMJ Publishing Group",

}

Kedhi, E, Fabris, E, Van Der Ent, M, Buszman, P, Von Birgelen, C, Roolvink, V, Zurakowski, A, Schotborgh, CE, Hoorntje, JCA, Eek, CH, Cook, S, Togni, M, Meuwissen, M, Van Royen, N, Van Vliet, R, Wedel, H, Delewi, R & Zijlstra, F 2018, '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 (Online), vol. 363, k3793. https://doi.org/10.1136/bmj.k3793

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. / Kedhi, Elvin (Corresponding Author); Fabris, Enrico; Van Der Ent, Martin; Buszman, Pawel; Von Birgelen, Clemens; Roolvink, Vincent; Zurakowski, Alexander; Schotborgh, Carl E.; Hoorntje, Jan C.A.; Eek, Christian Hasbø; Cook, Stéphane; Togni, Marco; Meuwissen, Martijn; Van Royen, Niels; Van Vliet, Ria; Wedel, Hans; Delewi, Ronak; Zijlstra, Felix.

In: BMJ (Online), Vol. 363, k3793, 02.10.2018.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Six months versus 12 months dual antiplatelet therapy after drug-eluting stent implantation in ST-elevation myocardial infarction (DAPT-STEMI)

T2 - Randomised, multicentre, non-inferiority trial

AU - Kedhi, Elvin

AU - Fabris, Enrico

AU - Van Der Ent, Martin

AU - Buszman, Pawel

AU - Von Birgelen, Clemens

AU - Roolvink, Vincent

AU - Zurakowski, Alexander

AU - Schotborgh, Carl E.

AU - Hoorntje, Jan C.A.

AU - Eek, Christian Hasbø

AU - Cook, Stéphane

AU - Togni, Marco

AU - Meuwissen, Martijn

AU - Van Royen, Niels

AU - Van Vliet, Ria

AU - Wedel, Hans

AU - Delewi, Ronak

AU - Zijlstra, Felix

PY - 2018/10/2

Y1 - 2018/10/2

N2 - 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.

AB - 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.

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U2 - 10.1136/bmj.k3793

DO - 10.1136/bmj.k3793

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JO - British Medical Journal

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