Long-term outcomes with biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents in ST-segment elevation myocardial infarction: 5-year follow-up of the BIOSTEMI randomised superiority trial.

BACKGROUND

Biodegradable polymer sirolimus-eluting stents improve early stent-related clinical outcomes compared to durable polymer everolimus-eluting stents in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention. The long-term advantages of biodegradable polymer sirolimus-eluting stents after complete degradation of its polymer coating in patients with STEMI remains however uncertain.

METHODS

BIOSTEMI Extended Survival (BIOSTEMI ES) was an investigator-initiated, follow-up extension study of the BIOSTEMI prospective, multicentre, single-blind, randomised superiority trial that compared biodegradable polymer sirolimus-eluting stents with durable polymer everolimus-eluting stents in patients with STEMI undergoing primary percutaneous coronary intervention at ten hospitals in Switzerland. All individuals who had provided written informed consent for participation in the BIOSTEMI trial were eligible for this follow-up study. The primary endpoint was target lesion failure, defined as a composite of cardiac death, target vessel myocardial re-infarction, or clinically indicated target lesion revascularisation, at 5 years. Superiority of biodegradable polymer sirolimus-eluting stents over durable polymer everolimus-eluting stents was declared if the Bayesian posterior probability for a rate ratio (RR) of less than 1 was greater than 0·975. Analyses were performed according to the intention-to-treat principle. The study was registered with ClinicalTrials.gov, NCT05484310.

FINDINGS

Between April 26, 2016, and March 9, 2018, 1300 patients with STEMI (1622 lesions) were randomly allocated in a 1:1 ratio to treatment with biodegradable polymer sirolimus-eluting stents (649 patients, 816 lesions) or durable polymer everolimus-eluting stents (651 patients, 806 lesions). At 5 years, the primary composite endpoint of target lesion failure occurred in 50 (8%) patients treated with biodegradable polymer sirolimus-eluting stents and in 72 (11%) patients treated with durable polymer everolimus-eluting stents (difference of -3%; RR 0·70, 95% Bayesian credible interval 0·51-0·95; Bayesian posterior probability for superiority 0·988).

INTERPRETATION

In patients undergoing primary percutaneous coronary intervention for STEMI, biodegradable polymer sirolimus-eluting stents were superior to durable polymer everolimus-eluting stents with respect to target lesion failure at 5 years of follow-up. The difference was driven by a numerically lower risk for ischaemia-driven target lesion revascularisation.

FUNDING

Biotronik.

Informations de copyright

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Déclaration de conflit d'intérêts

Declaration of interests JFI reports a research grant to their institution, speaker fees, and support for attending meetings from Biotronik; research grants to their institution from Abbott Vascular, Astra Zeneca, Biosensors, Concept Medical, Philips, and Terumo Corporation, outside the submitted work; and speaker fees from AstraZeneca, Biosensors, Biotronik, Bristol Myers Squibb, Cordis, Concept Medical, Medalliance, Medtronic, Novartis, Terumo Corporation, Pfizer, and Philips, outside the submitted work. MR reports research grants to the institution from Biotronik, Boston Scientific, Cordis, Medtronic, and Terumo Corporation, outside the submitted work. SL and DH are employed by the CTU Bern, University of Bern, which has a staff policy of not accepting honoraria or consultancy fees. However, CTU Bern is involved in design, conduct, or analysis of clinical studies funded by not-for-profit and for-profit organisations. In particular, pharmaceutical and medical device companies provide direct funding to some of these studies. An up-to-date list of CTU Bern's conflicts of interest can be found online. OM reports a research grant to their institution, and speaker and personal fees from Edwards Lifesciences, outside the submitted work; and speaker fees from Abbott Vascular, outside the submitted work. SD reports research grants to their institution from Abbott Vascular and Biotronik, outside the submitted work; and speaker fees from Biotronik, Medalliance, and Medtronic, outside the submitted work. LH reports research grants to their institution from Abbott Vascular, Abiomed, Amarin, Amgen, AstraZeneca, Bayer, Biosense Webster, Biotronik, Boston Scientific, Bracco, Bristol Myers Squibb, B-Braun, Daiichi-Sankyo, Edwards Lifesciences, GE HealthCare, Medtronic, Microport, Novartis, Pfizer, Vascular Medical, and Zoll, outside the submitted work; speaker fees from Medtronic, outside the submitted work; and support for attending meetings from Daiichi-Sankyo and Biotronik. CK reports consulting fees to the institution from Unimedtec Switzerland; and support for attending meetings from Medtronic, outside the submitted work. SW reports research, travel, or educational grants to their institution from Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Bbraun, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, CardioValve, Cordis Medical, Corflow Therapeutics, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Farapulse, Fumedica, Guerbet, Idorsia, Inari Medical, InfraRedx, Janssen-Cilag, Johnson & Johnson, Medalliance, Medicure, Medtronic, Merck Sharp & Dohme, Miracor Medical, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pharming Tech, Pfizer, Polares, Regeneron, Sanofi-Aventis, Servier, Sinomed, Terumo Corporation, Vifor, and V-Wave; and served as an advisory board member or member of the steering or executive group of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo Corporation, and V-Wave, with payments to the institution but no personal payments. He is also a member of the steering or executive committee group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration. TP reports a research grant to their institution from Biotronik; research, travel, or educational grants to their institution without personal remuneration from Biotronik, Boston Scientific, Edwards Lifesciences, and ATSens, outside the submitted work; and speaker fees and consultancy fees to their institution from Abbott Vascular, Biotronik, Biosensors, Boston Scientific, Edwards Lifesciences, Highlife, and Medtronic, outside the submitted work. All other authors declare no competing interests.