Pilgrim, Thomas; Rothenbühler, Martina; Siontis, George Cm; Kandzari, David E; Iglesias, Juan F; Asami, Masahiko; Lefèvre, Thierry; Piccolo, Raffaele; Koolen, Jacques; Saito, Shigeru; Slagboom, Ton; Muller, Olivier; Waksman, Ron; Windecker, Stephan (2021). Biodegradable polymer sirolimus-eluting stents vs durable polymer everolimus-eluting stents in patients undergoing percutaneous coronary intervention: A meta-analysis of individual patient data from 5 randomized trials. American Heart Journal, 235, pp. 140-148. Elsevier 10.1016/j.ahj.2021.02.009
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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 5 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 365-1,806 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 = .16). There were no significant differences between BP SES and DP EES with regards to cardiac death (111 (3.4%) vs 102 (4.1%); HR 1.05, 95%CI 0.80-1.37, P = .73), target-vessel myocardial infarction (136 (4.1%) vs 126 (5.0%), HR 0.79, 95%CI 0.62-1.01, P = .061), and clinically-driven target-lesion revascularization (163 (5.0%) vs 147 (5.9%); HR 0.94, 95%CI 0.75-1.18, P = .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 5 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 registry (CRD42018109098).
Item Type: |
Journal Article (Original Article) |
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Division/Institute: |
04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology |
UniBE Contributor: |
Pilgrim, Thomas, Asami, Masahiko, Windecker, Stephan |
Subjects: |
600 Technology > 610 Medicine & health |
ISSN: |
0002-8703 |
Publisher: |
Elsevier |
Language: |
English |
Submitter: |
Nadia Biscozzo |
Date Deposited: |
04 Jan 2022 14:42 |
Last Modified: |
05 Dec 2022 15:59 |
Publisher DOI: |
10.1016/j.ahj.2021.02.009 |
PubMed ID: |
33609498 |
BORIS DOI: |
10.48350/163220 |
URI: |
https://boris.unibe.ch/id/eprint/163220 |
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