1 research outputs found
Ticagrelor Monotherapy or Dual Antiplatelet Therapy After DrugâEluting Stent Implantation: PerâProtocol Analysis of the GLOBAL LEADERS Trial
International audienceBackground In the GLOBAL LEADERS trial, ticagrelor monotherapy beyond 1Â month compared with standard antiplatelet regimens after coronary stent implantation did not improve outcomes at intentionâtoâtreat analysis. Considerable differences in treatment adherence between the experimental and control groups may have affected the intentionâtoâtreat results. In this reanalysis of the GLOBAL LEADERS trial, we compared the experimental and control treatment strategies in a perâprotocol analysis of patients who did not deviate from the study protocol. Methods and Results Baseline and postrandomization information were used to classify whether and when patients were deviating from the study protocol. With logistic regressions, we derived timeâvarying inverse probabilities of nondeviation from protocol to reconstruct the trial population without protocol deviation. The primary end point was a composite of allâcause mortality or nonfatal Qâwave myocardial infarction at 2Â years. At 2âyear followâup, 1103 (13.8%) of 7980 patients in the experimental group and 785 (9.8%) of 7988 patients in the control group qualified as protocol deviators. At perâprotocol analysis, the rate ratio for the primary end point was 0.88 (95% CI, 0.75â1.03; P =0.10) on the basis of 274 versus 325 events in the experimental versus control group. The rate ratio for the key safety end point of major bleeding was 1.00 (95% CI, 0.79â1.26; P =0.99). The perâprotocol and intentionâtoâtreat effect estimates were overall consistent. Conclusions Among patients who complied with the study protocol in the GLOBAL LEADERS trial, ticagrelor plus aspirin for 1Â month followed by ticagrelor monotherapy was not superior to 1âyear standard dual antiplatelet therapy followed by aspirin alone at 2Â years after coronary stenting. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01813435