Long-term outcomes after coronary intervention with biodegradable polymer stents in patients with acute coronary syndromes

Catheter Cardiovasc Interv. 2024 Feb;103(2):276-285. doi: 10.1002/ccd.30937. Epub 2023 Dec 13.

Abstract

Background: Patients with acute coronary syndromes (ACS) may have worse outcomes after percutaneous coronary intervention compared to patients without ACS.

Aims: To compare 5-year efficacy and safety outcomes in patients with and without ACS treated with biodegradable polymers, the ultrathin strut sirolimus-eluting Orsiro stent (O-SES) or the biolimus-eluting Nobori stent (N-BES).

Methods: The Scandinavian Organisation for Randomized Trials with Clinical Outcome VII is a randomized trial comparing O-SES and N-BES in an all-comer setting. Of 2525 patients, 1329 (53%) patients had ACS and 1196 (47%) patients were without ACS. Endpoints were target lesion failure (TLF) (a composite of cardiac death, target lesion myocardial infarction, or target lesion revascularization) and definite stent thrombosis within 5 years.

Results: At 5-year follow-up, TLF did not differ significantly between patients with and without ACS (12.3% vs. 13.2%; rate ratio (RR) 1.00; 95% confidence interval (CI): 0.70-1.44), whereas the risk of definite stent thrombosis was increased in patients with ACS (2.3% vs. 1.3; RR: 2.01 [95% CI: 1.01-3.98]). In patients with ACS, the rate of TLF was similar between O-SES and N-BES (12.4% vs. 12.3%; RR: 1.02; 95% CI: 0.74-1.40). The reduced risk of definite stent thrombosis in O-SES treated ACS patients within the first year (0.2% vs. 1.6%; RR: 0.12; 95% CI: 0.02-0.93) was not maintained after 5 years (1.8% vs. 2.7%; RR: 0.77; 95% CI: 0.37-1.63).

Conclusion: Patients with ACS had an increased risk of stent thrombosis regardless of the stent type used. Long-term outcomes were similar for ACS patients treated with O-SES or N-BES at 5 years.

Keywords: biodegradable polymers; biolimus; coronary stents; myocardial infarction; sirolimus; stent thrombosis; target lesion failure; target lesion revascularization.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Absorbable Implants
  • Acute Coronary Syndrome* / complications
  • Acute Coronary Syndrome* / diagnostic imaging
  • Acute Coronary Syndrome* / therapy
  • Alkanesulfonic Acids*
  • Cardiovascular Agents* / adverse effects
  • Coronary Artery Disease* / complications
  • Coronary Artery Disease* / diagnostic imaging
  • Coronary Artery Disease* / therapy
  • Coronary Thrombosis* / etiology
  • Drug-Eluting Stents* / adverse effects
  • Humans
  • Percutaneous Coronary Intervention* / adverse effects
  • Polymers
  • Prosthesis Design
  • Risk Factors
  • Stents / adverse effects
  • Treatment Outcome

Substances

  • BES
  • Cardiovascular Agents
  • Polymers
  • Alkanesulfonic Acids