Biodegradable polymer scores over durable-polymer stent for STEMI setting, BIOSTEMI study.
BIOSTEMI study results
Percutaneous coronary intervention (PCI) is an effective strategy to restore myocardial perfusion in patients with acute myocardial infarction. Long-term are determined by the safety and efficacy profile of the newest generation drug-eluting stents. In the latest issue of JACC, Pilgrim et al have shown that in patients with STEMI undergoing primary PCI, biodegradable polymer sirolimus eluting stent (BP-SES) were superior to durable polymer (DP-EES) with respect to target lesion failure (TLF) at 2 years.
Drug-eluting stents (DES) mitigate the need for repeat revascularizations compared with bare-metal stents and represent the current standard of care. Recent refinements of newer generation DES involve the reduction of strut thickness of the metallic stent platform and the use of biodegradable polymers as a carrier for the antiproliferative substance. These improvements in stent design mitigate arterial injury, inflammation, and thrombogenicity, facilitate endothelialization, and reduce neointimal hyperplasia.
BP-SES have evolved from being claimed as non-inferior to DP-EES to now being superior according to some recent literature with regard to device-oriented clinical outcomes in patients with chronic and acute coronary syndromes.Acute myocardial infarction confers an increased risk for stent-related adverse events due to an exacerbated inflammatory response resulting in delayed arterial healing. The BIOSTEMI study aimed to investigate the safety and efficacy of BP-SES compared with DP-EES in patients with STEMI.
This was an investigator-initiated, multicenter, assessor-blind, randomized superiority trial. Patients with STEMI undergoing primary PCI within 24 h of symptom onset were randomized in a 1:1 ratio to receive BP-SES (n = 649) or DP-EES (n = 651). The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial reinfarction, and clinically indicated target lesion revascularization (TLR) at 2 years.
The study showed that:
- At 2 years, TLF occurred in 5.1% treated with BP-SES and in 8.1% treated with DP-EES (Figure).
- The difference was driven by a lower incidence of clinically indicated TLR in patients treated with BP-SES compared with DP-EES (2.5% vs. 5.1%).
- There were no significant differences in rates of cardiac death, target vessel myocardial reinfarction, and definite stent thrombosis between the 2 treatment arms.
These findings are consistent with the 3-year data of the BIOFLOW-V trial, which showed a lower rate of target lesion failure in patients with chronic or acute coronary syndromes treated with BP-SES compared with DP-EES.
Acute STEMI is the flagship indication for PCI. The BIOSTEMI trial is the first head-to-head comparison of 2 newer generation DES in patients undergoing primary PCI for acute myocardial infarction. In a field of stent comparisons dominated by noninferiority trials, the BIOSTEMI trial stands out by its superiority design, demonstrating a significant difference between 2 contemporary DES.
To conclude, BP-SES are superior to DP-EES with respect to target lesion failure at 2-year follow-up among patients undergoing primary for STEMI. The difference is driven by lower rates of ischemia-driven target lesion revascularization.
Source: JACC: Cardiovascular Interventions, 2021-03-22, Volume 14, Issue 6, Pages 639-648
