Biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents in patients undergoing percutaneous coronary intervention: a meta-analysis of individual patient data from five randomized trials.

ABSTRACT Background: Newest generation drug-eluting stents combine biodegradable polymers with ultrathin stent platforms in order to minimize vessel injury and inflammatory response. Evidence from randomized controlled trials suggested that differences in stent design translate into differences in clinical outcome. The aim of the present study was to evaluate the safety and efficacy of ultrathin strut, biodegradable polymer sirolimus eluting stents (BP SES) compared with thin strut, durable polymer everolimus-eluting stents (DP EES) among patients undergoing percutaneous coronary intervention (PCI). Methods: We pooled individual participant data from five randomized trials (NCT01356888, NCT01939249, NCT02389946, NCT01443104, NCT02579031) including a total of 5,780 patients, and performed a one-stage meta-analysis using a mixed effects Cox regression model. Results: At a median duration of follow-up of 739 days (interquartile range 365-1806 days), target-lesion failure occurred in 337 (10.3%) and 304 (12.2%) patients treated with BP SES and DP EES (HR 0.86, 95%CI 0.71-1.06, p=0.16). There were no significant differences between BP SES and DP EES with regards to cardiac death (111 (3.4%) versus 102 (4.1%); HR 1.05, 95%CI 0.80-1.37, p=0.73), target-vessel myocardial infarction (136 (4.1%) versus 126 (5.0%), HR 0.79, 95%CI 0.62-1.01, p=0.061), and clinically-driven target-lesion revascularization (163 (5.0%) versus 147 (5.9%); HR 0.94, 95% CI 0.75-1.18, p=0.61). The effect was consistent across major subgroups. In a landmark analysis, there was no significant interaction between treatment effect and timing of events. Conclusions: In this patient-level meta-analysis of five randomized controlled trials, BP SES were associated with a similar risk of target-lesion failure compared with DP EES among patients undergoing PCI. Study Registration: PROSPERO identifier CRD42018109098