Ascertainment of Silent Myocardial Infarction in Patients Undergoing Percutaneous Coronary Intervention (from the GLOBAL LEADERS Trial)

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Q-wave myocardial infarction (QWMI) comprises 2 entities. First, a clinically evident MI, which can occur spontaneously or be related to a coronary procedure. Second, silent MI which is incidentally detected on serial electrocardiographic (ECG) assessment. The prevalence of silent MI after percutaneous coronary intervention (PCI) in the drug-eluting stent era has not been fully investigated. The GLOBAL LEADERS is an all-comers multicenter trial which randomized 15,991 patients who underwent PCI to 2 antiplatelet treatment strategies. The primary end point was a composite of all-cause death or nonfatal new QWMI at 2-years follow-up. ECGs were collected at discharge, 3-month and 2-year visits, and analyzed by an independent ECG core laboratory following the Minnesota code. All new QWMI were further reviewed by a blinded independent cardiologist to identify a potential clinical correlate by reviewing clinical information. Of 15,968 participants, ECG information was complete in 14,829 (92.9%) at 2 years. A new QWMI was confirmed in 186 (1.16%) patients. Transient new Q-waves were observed in 28.5% (53 of 186) of them during the follow-up. The majority of new QWMI (78%, 146 of 186) were classified as silent MI due to the absence of a clinical correlate. Silent MI accounted for 22.1% (146 of 660) of all MI events. The prevalence of silent MI did not differ significantly between treatment strategies (experimental vs reference: 0.88% vs 0.98%, p = 0.5027). In conclusion, we document the prevalence of silent MI in an all-comers population undergoing PCI in this large-scale randomized trial.

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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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    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).

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