Purpose: We sought to investigate the effect of 1-month DAPT followed by 23-month ticagrelor monotherapy (ticagrelor monotherapy) compared with the reference arm, 12-month DAPT followed by 12-month aspirin monotherapy (standard DAPT), on clinical outcomes in patients with hypertension undergoing PCI.
Methods: This is a post-hoc analysis of the prospective, multi-center, open-label, all-comers, randomized controlled trial Global Leaders, that tested ticagrelor monotherapy versus standard DAPT in patients receiving PCI with biolimus A9-eluting stent. Patients were stratified by the hypertension status. The primary endpoint for the present analysis was the patient oriented composite endpoint (POCE - defined as composite of all-cause death, any stroke, any MI, or all revascularization) and safety endpoint of BARC type 3 or 5 bleeding, both at 2 years. Event rates are presented as Kaplan-Meier estimates (%).
Results: In Global Leaders 15,991 patients were randomized, 23 (0.14%) requested complete deletion of their data from the database and 54 (0.34%) had no information on hypertension status. Of the 15,914 (99.52%) included in the analysis 11,715 were hypertensive. In the non-hypertensive patients, comparing ticagrelor monotherapy with standard DAPT, no difference was found regarding POCE (12.17% vs. 12.13%, HR 1.004, 95% CI 0.843 to 1.195, p=0.965) nor bleeding (1.71% vs. 1.72%, HR 1.0, 95% CI 0.628 to 1.592, p=1.0, respectively). In hypertensive patients the experimental treatment of ticagrelor monotherapy resulted in less POCE (13.62% vs. 15.04%, HR 0.898, 95% CI 0.816 to 0.988, p=0.028, p for interaction=0.271) with similar bleeding (2.21% vs. 2.26%, HR 0.976, 95% CI 0.765 to 1.246, p=0.846), compared with the standard DAPT at 2 years.
Conclusion: In this sub-group analysis of Global Leaders, in patients with hypertension undergoing PCI the experimental treatment of 1-month DAPT followed by 23-month ticagrelor monotherapy may offer ischemic protection without increasing bleeding. The results must be interpreted cautiously as there was no interaction between treatment strategy and the status of hypertension. Thus, the present results are hypothesis generating.