A prospective, randomized, open-label trial of 6-month versus 12-month dual antiplatelet therapy after drug-eluting stent implantation in ST-elevation myocardial infarction: Rationale and design of the "DAPT-STEMI trial".

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.

• Authors: Elvin Kedhi, Enrico Fabris, Martin van der Ent, Mark W Kennedy, Pawel Buszman, Clemens von Birgelen, Stéphane Cook, Hans Wedel, Felix Zijlstra
• Journal: American heart journal (Am Heart J) Vol. 188 Pg. 11-17 (Jun 2017) ISSN: 1097-6744 [Electronic] United States
• PMID: 28577666 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2017 Elsevier Inc. All rights reserved.

Chemical References

• Antithrombins
• Hirudins
• Peptide Fragments
• Platelet Aggregation Inhibitors
• Purinergic P2Y Receptor Antagonists
• Recombinant Proteins
• Prasugrel Hydrochloride
• Ticagrelor
• Adenosine
• bivalirudin

Topics

• Adenosine (administration & dosage, analogs & derivatives)
• Antithrombins (administration & dosage)
• Cause of Death (trends)
• Disease-Free Survival
• Dose-Response Relationship, Drug
• Drug Therapy, Combination
• Drug-Eluting Stents
• Europe (epidemiology)
• Follow-Up Studies
• Hirudins (administration & dosage)
• Peptide Fragments (administration & dosage)
• Percutaneous Coronary Intervention
• Platelet Aggregation Inhibitors (administration & dosage)
• Postoperative Period
• Prasugrel Hydrochloride (administration & dosage)
• Prospective Studies
• Purinergic P2Y Receptor Antagonists (administration & dosage)
• Recombinant Proteins (administration & dosage)
• ST Elevation Myocardial Infarction (diagnosis, mortality, therapy)
• Survival Rate (trends)
• Ticagrelor
• Time Factors
• Treatment Outcome