Rationale and design of the comparison between a P2Y12 inhibitor monotherapy versus dual antiplatelet therapy in patients undergoing implantation of coronary drug-eluting stents (SMART-CHOICE): A prospective multicenter randomized trial.

Abstract

BACKGROUND AND RATIONALE:

Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor reduces thrombotic events in patients undergoing percutaneous coronary intervention (PCI), but these benefits come at the expense of increased risk of bleeding when compared with aspirin monotherapy. It is unclear whether P2Y12 inhibitor monotherapy might maintain anti-ischemic efficacy while reducing the bleeding risk compared with DAPT after implantation of the current generation of drug-eluting stents (DES).

STUDY DESIGN:

The SMART-CHOICE trial is a prospective, open-label, multi-center, and randomized study designed to test the non-inferiority of P2Y12 inhibitor monotherapy compared with aspirin plus a P2Y12 inhibitor after mandatory 3-month DAPT in patients undergoing PCI with current-generation DES. A total of 3000 patients will be randomized to 1 of the 2 antiplatelet treatment strategy groups. Randomization will be stratified by stent type (cobalt-chromium everolimus-eluting stents, platinum-chromium everolimus-eluting stents, and sirolimus-eluting stents with bioresorbable polymer), P2Y12 inhibitors (clopidogrel, prasugrel, and ticagrelor), clinical presentation (acute coronary syndrome and stable ischemic heart disease), and investigational centers. The primary end point is a composite of all-cause death, myocardial infarction, and cerebrovascular events at 12 months after the index procedure. The key secondary end points are definite/probable stent thrombosis defined by the Academic Research Consortium, and bleeding defined by Bleeding Academic Research Consortium type 2-5.

CONCLUSIONS:

The SMART-CHOICE trial aims to examine the non-inferiority of monotherapy with one of any available oral P2Y12 inhibitors versus conventional DAPT of an identical P2Y12 inhibitor plus aspirin in a broad spectrum of patients receiving representative current-generation DES.

• Authors: Young Bin Song, Seok Kyu Oh, Ju-Hyeon Oh, Eul-Soon Im, Deok-Kyu Cho, Byung Ryul Cho, Jong-Young Lee, Joo Myung Lee, Taek Kyu Park, Jeong Hoon Yang, Jin-Ho Choi, Seung-Hyuck Choi, Sang Hoon Lee, Hyeon-Cheol Gwon, Joo-Yong Hahn
• Journal: American heart journal (Am Heart J) Vol. 197 Pg. 77-84 (03 2018) ISSN: 1097-6744 [Electronic] United States
• PMID: 29447787 (Publication Type: Clinical Trial Protocol, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2017 Elsevier Inc. All rights reserved.

Chemical References

• Aspirin
• Platelet Aggregation Inhibitors
• Purinergic P2Y Receptor Antagonists

Topics

• Adult
• Female
• Humans
• Male
• Aspirin (administration & dosage, adverse effects)
• Coronary Restenosis (etiology, prevention & control)
• Drug Therapy, Combination (adverse effects, methods)
• Drug-Eluting Stents (adverse effects)
• Hemorrhage (chemically induced, prevention & control)
• Myocardial Ischemia (surgery)
• Outcome Assessment, Health Care
• Percutaneous Coronary Intervention (adverse effects, instrumentation, methods)
• Platelet Aggregation Inhibitors (administration & dosage, adverse effects)
• Purinergic P2Y Receptor Antagonists (administration & dosage, adverse effects, classification)
• Republic of Korea
• Multicenter Studies as Topic
• Randomized Controlled Trials as Topic
• Prospective Studies