Two-year follow-up data the BIOSTEMI trial, presented during a late-breaking trial session at the 2021 Cardiovascular Research Technologies meeting (CRT 21 Virtual, 13 February–24 April) demonstrate the superiority of the ultrathin-strut Orsiro stent (Biotronik) over Xience DES (Abbott) for target lesion failure (TLF).
The results were presented by Thomas Pilgrim, Inselspital Bern, University Hospital, Bern, Switzerland, and were published simultaneously in JACC Cardiovascular Interventions.
BIOSTEMI is an investigator-initiated, multicentre, superiority trial, using a Bayesian design, to compare biodegradable-polymer, sirolimus-eluting stents to durable-polymer, everolimus-eluting stents in 1,300 patients with acute myocardial infarction. The ultrathin-strut Orsiro DES demonstrated superiority in the clinical primary endpoint of TLF5 at 12 months, which was further confirmed at 24 months with an incidence of 5.1%. In comparison, the Xience DES, showed an incidence of 8.1% at 24 months (Rate Ratio 0.58, 95% Bayesian credible interval, 0.40-0.84; posterior probability of superiority, 99.8%).
The difference remained significant after the exclusion of historical data from the BIOSCIENCE trial with only the BIOSTEMI patients being analyzed (Rate Ratio 0.62, 95% Bayesian credible interval, 0.40-0.96; posterior probability of superiority, 98.5%). The difference was driven by a lower incidence of clinically indicated, target lesion revascularization (TLR). No significant difference was observed between the two treatment arms for safety endpoints.
Most drug eluting stent trials are powered only to demonstrate non-inferiority. BIOSTEMI is a rare trial that demonstrates the superiority between two contemporary DES in patients presenting with acute ST-segment elevation myocardial infarction (STEMI), Biotronik said in a press release.
Caused by a complete thrombotic occlusion in a coronary vessel, STEMI is the most acute manifestation of coronary artery disease, with substantial rates of morbidity and mortality—STEMI patients represent about 30% of all primary percutaneous coronary intervention (PCI) cases.
“In contrast to the primary endpoint data at one-year, two-year data show a significant difference between the two treatment arms, not only using Bayesian statistics incorporating a historical prior from the BIOSCIENCE trial, but also when analysed as an independent clinical trial,” explained Pilgrim.
“The BIOSTEMI outcomes at 24 months demonstrate the unequivocal superiority of ultrathin strut Orsiro DES over Xience DES,” commented Alexander Uhl, President Vascular Intervention at Biotronik. “In my opinion this data should define a new standard of care in the treatment of STEMI patients, what would you choose for your heart?”