Elvin Kedhi1, Enrico Fabris2, Martin van der Ent3, Mark W Kennedy4, Pawel Buszman5, Clemens von Birgelen6, Stéphane Cook7, Hans Wedel8, Felix Zijlstra9. 1. Isala Hartcentrum, Zwolle, the Netherlands. Electronic address: e.kedhi@isala.nl. 2. Isala Hartcentrum, Zwolle, the Netherlands; Cardiovascular Department, University of Trieste, Trieste, Italy. 3. Maasstad Ziekenhuis, Rotterdam, the Netherlands. 4. Isala Hartcentrum, Zwolle, the Netherlands. 5. American Heart of Poland, Ustroń, Poland. 6. University of Twente, Enschede, the Netherlands. 7. Department of Cardiology, University & Hospital, Fribourg, Switzerland. 8. Sahlgrenska Academy, University of Gothenburg, and Nordic School of Public Health, Gothenburg, Sweden. 9. Erasmus Medisch Centrum, Rotterdam, the Netherlands.
Abstract
BACKGROUND: The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention with second-generation drug eluting stents (DESs) is unclear. Because prolonged DAPT is associated with higher bleeding risk and health care costs, establishing optimal DAPT duration is of paramount importance. No other randomized controlled trials have evaluated the safety of shorter DAPT duration in ST-elevation myocardial infarction (STEMI) patients treated with second-generation DESs and latest P2Y12 platelet receptor inhibitors. HYPOTHESIS: Six months of DAPT after Resolute Integrity stent implantation in STEMI patients is not inferior to 12 months of DAPT in clinical outcomes. STUDY DESIGN: The Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation In ST-elevation Myocardial Infarction (DAPT-STEMI) trial is a randomized, multicenter, international, open-label trial designed to examine the safety (noninferiority) of 6-month DAPT after Resolute Integrity stent implantation in STEMI patients compared with 12-month DAPT. Event-free patients on DAPT at 6month will be randomized (1:1 fashion) between single (aspirin only) versus DAPT for an additional 6 months and followed until 2 years after primary percutaneous coronary intervention. The primary end point is a patient-oriented composite endpoint of all-cause mortality, any myocardial infarction, any revascularization, stroke, and major bleeding (net adverse clinical events [NACE]) at 18 months after randomization. To achieve a power of 85% for a noninferiority limit of 1.66, a total of 1100 enrolled patients are required. SUMMARY: The DAPT-STEMI trial aims to assess in STEMI patients treated with second-generation DESs whether discontinuation of DAPT after 6 months of event-free survival is noninferior to routine 12-month DAPT.
BACKGROUND: The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention with second-generation drug eluting stents (DESs) is unclear. Because prolonged DAPT is associated with higher bleeding risk and health care costs, establishing optimal DAPT duration is of paramount importance. No other randomized controlled trials have evaluated the safety of shorter DAPT duration in ST-elevation myocardial infarction (STEMI) patients treated with second-generation DESs and latest P2Y12 platelet receptor inhibitors. HYPOTHESIS: Six months of DAPT after Resolute Integrity stent implantation in STEMI patients is not inferior to 12 months of DAPT in clinical outcomes. STUDY DESIGN: The Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation In ST-elevation Myocardial Infarction (DAPT-STEMI) trial is a randomized, multicenter, international, open-label trial designed to examine the safety (noninferiority) of 6-month DAPT after Resolute Integrity stent implantation in STEMI patients compared with 12-month DAPT. Event-free patients on DAPT at 6month will be randomized (1:1 fashion) between single (aspirin only) versus DAPT for an additional 6 months and followed until 2 years after primary percutaneous coronary intervention. The primary end point is a patient-oriented composite endpoint of all-cause mortality, any myocardial infarction, any revascularization, stroke, and major bleeding (net adverse clinical events [NACE]) at 18 months after randomization. To achieve a power of 85% for a noninferiority limit of 1.66, a total of 1100 enrolled patients are required. SUMMARY: The DAPT-STEMI trial aims to assess in STEMI patients treated with second-generation DESs whether discontinuation of DAPT after 6 months of event-free survival is noninferior to routine 12-month DAPT.
Authors: Elvin Kedhi; 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 Journal: BMJ Date: 2018-10-02