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
| Autor: | Ria van Vliet, Martijn Meuwissen, Elvin Kedhi, Vincent Roolvink, Jan C.A. Hoorntje, Stéphane Cook, Alexander Zurakowski, Marco Togni, Christian Eek, Paweł Buszman, Martin van der Ent, Hans Wedel, Carl E. Schotborgh, Ronak Delewi, Clemens von Birgelen, Felix Zijlstra, Enrico Fabris, Niels van Royen |
|---|---|
| Přispěvatelé: | ACS - Atherosclerosis & ischemic syndromes, ACS - Pulmonary hypertension & thrombosis, Cardiology, ACS - Microcirculation, Kedhi, E., Fabris, E., Van Der Ent, M., Buszman, P., Von Birgelen, C., Roolvink, V., Zurakowski, A., Schotborgh, C. E., Hoorntje, J. C. A., Eek, C. H., Cook, S., Togni, M., Meuwissen, M., Van Royen, N., Van Vliet, R., Wedel, H., Delewi, R., Zijlstra, F., Health Technology & Services Research |
| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Male
medicine.medical_treatment 030204 cardiovascular system & hematology law.invention 0302 clinical medicine Randomized controlled trial law Adolescent Adult Aged Aged 80 and over Combined Modality Therapy Drug Administration Schedule Female Humans Middle Aged Platelet Aggregation Inhibitors ST Elevation Myocardial Infarction Sirolimus Treatment Outcome Young Adult Drug-Eluting Stents Clinical endpoint 80 and over Sirolimu 030212 general & internal medicine Myocardial infarction Vascular damage Radboud Institute for Molecular Life Sciences [Radboudumc 16] General Medicine Thrombolysis Drug-eluting stent Human medicine.medical_specialty Ticlopidine 03 medical and health sciences All institutes and research themes of the Radboud University Medical Center Percutaneous Coronary Intervention medicine cardiovascular diseases business.industry Platelet Aggregation Inhibitor Research Stent Percutaneous coronary intervention medicine.disease Surgery Conventional PCI business |
| Zdroj: | The BMJ BMJ (Clinical research ed.), 363:k3793. British Medical Association BMJ-British medical journal, 363:k3793. BMJ Publishing Group BMJ. British Medical Journal (Online), 363, k3793 BMJ, 363:k3793. BMJ BMJ. British Medical Journal (Online), 363, pp. k3793 |
| ISSN: | 1756-1833 0959-8138 0145-9627 0959-8146 0959-535X |
| Popis: | 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 . |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|