Author + information
- Thomas Pilgrim1,
- Martina Rothenbühler1,
- George C.M. Siontis1,
- David E. Kandzari2,
- Masahiko Asami1,
- Thierry Lefèvre3,
- Raffaele Piccolo4,
- Lukas Hunziker1,
- Jacques Koolen5,
- Shigeru Saito6,
- Ton Slagboom7,
- Ron Waksman8 and
- Stephan Windecker1
- 1Bern University Hospital, Bern, Switzerland
- 2Piedmont Heart Institute, Atlanta, GA
- 3Hopital Jacques Cartier, Massy, France
- 4Department of Advanced Biomedical Sciences, Federico II University, Naples, Italy
- 5Catharina Hospital, Eindhoven, Netherlands
- 6Shonan Kamakura General Hospital and Sapporo Higashi Tokushukai Hospital, Sapporo, Japan
- 7OLVG, Amsterdam, Netherlands
- 8MedStar Cardiovascular Research Network, MedStar Washington Hospital Center, Washington, DC
Newer-generation drug-eluting stents combining biodegradable polymers with ultrathin-strut cobalt-chromium stent platforms minimize coronary vessel injury and inflammatory response. The objective 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).
We pooled individual patient data of four randomized trials (BIOFLOW-II [NCT01356888], BIOFLOW-IV [NCT01939249], BIOFLOW-V [NCT02389946] and BIOSCIENCE [NCT01443104]). The primary outcome of interest was target-lesion failure, defined as the composite of cardiac death, target-vessel myocardial infarction, and clinically-driven target-lesion revascularization. We performed a one-stage meta-analysis by using a mixed-effects Cox regression model, which took into account the variation between and within trials. Risk estimates were expressed as hazard ratios (HRs) with 95% confidence intervals (CI). The protocol of the meta-analysis is registered with PROSPERO (CRD42018109098).
A total of 4,480 patients undergoing PCI were randomly allocated to treatment with BP SES (n=2,630) or DP EES (n=1,850). The median duration of follow-up was 1,328 days (interquartile range 750-1816 days). At maximum duration of follow-up, target-lesion failure occurred in 312 (11.9%) and 268 (14.5%) patients treated with BP SES and DP EES (HR 0.90, 95%CI 0.73-1.11, p=0.32), respectively. There were no significant differences between BP SES and DP EES with regard to cardiac death (93 (3.5%) versus 83 (4.5%); HR 1.07, 95%CI 0.79-1.44, p=0.66), target-vessel myocardial infarction (131 (5.0%) versus 120 (6.5%), HR 0.79, 95%CI 0.61-1.01, p=0.064), and clinically-driven target-lesion revascularization (154 (5.9%) versus 130 (7.0%); HR 1.00, 95% CI 0.79-1.26, p=0.97). The risk of myocardial infarction was lower in patients randomized to BP SES compared with DP EES (186 (7.1%) versus 178 (9.6%; HR 0.79, 95%CI 0.64-0.98, p=0.030). The effect for the primary endpoint was consistent across major subgroups. In a landmark analysis, there was no significant interaction in timing of events.
In this patient-level meta-analysis of four randomized controlled trials, BP SES were associated with a similar risk of target-lesion failure but lower risk of myocardial infarction compared with DP EES.