Ascertainment of Silent Myocardial Infarction in Patients Undergoing Percutaneous Coronary Intervention (from the GLOBAL LEADERS Trial)
Section snippets
Methods
The details of the GLOBAL LEADERS trial have been reported previously.8,9 In the investigator-initiated, multicenter, prospective randomized GLOBAL LEADERS trial, 15,991 patients who underwent PCI with Biolimus A9 eluting stents were randomly assigned to 2 antiplatelet treatment strategies. In the experimental treatment strategy, patients received aspirin 75 to 100 mg once daily in combination with ticagrelor 90 mg twice daily for 1 month; followed by ticagrelor 90 mg twice daily monotherapy
Results
The GLOBAL LEADERS trial enrolled 15,991 patients, of whom 23 subsequently withdrew consent and requested deletion of their data from the database, leaving 15,968 patients for the final analysis. Vital status was obtained in all but 8 patients (99.95%). The study flow chart is shown in Figure 1. At 2-year follow-up, the ECG information was complete in 93.3% (7,446 of 7,980) patients in the experimental group and 92.4% (7,383 of 7,985) in the reference group.
During the 2-year follow-up, new
Discussion
In the GLOBAL LEADERS trial, we documented the prevalence of new QWMI including silent MI in an all-comers population with coronary artery disease undergoing PCI, by serial ECG assessment with central adjudication. Silent MI accounted for 78.5% of new QWMI and 22.1% of total MI events. Patients with silent MI had similar baseline characteristics as those with clinical MI. At 2-year follow-up, the experimental antiplatelet treatment did not result in significant differences in rates of clinical
Disclosures
Dr. Chang received grants from Taipei Veterans General Hospital-National Yang-Ming University Excellent Physician Scientists Cultivation Program (No.107-V-A-002).
Dr. Spitzer received institutional grants from European Cardiovascular Research Institute, during the conduct of the study.
Dr. Gori received speaker´s fees from Abbott Vascular.
Dr. Zaman received lecture and consulting fees from sanofi, astra, daiichi-sankyo.
Dr. Steg received grants and personal fees from Bayer/Janssen, grants and
Acknowledgment
The authors would like to acknowledge the major contribution of Eugene McFadden to this scientific document and specifically acknowledge for his intellectual input in manuscript editing.
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Cited by (0)
Funding: This study was sponsored by the European Cardiovascular Research Institute (ECRI, Rotterdam, the Netherlands) that received funding from one device (Biosensors International Ltd, Europe) and two drug manufacturers (Astra Zeneca, Cambridge United Kingdom; The Medicines Company, Parsippany; United States of America).