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…
How strong is the evidence?
Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 5,780 participants or records.
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