Long-term outcomes after coronary intervention with biodegradable polymer stents in patients with acute coronary syndromes
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.
CONFLICT OF INTEREST STATEMENT
Evald Høj Christiansen has received research grants from Biosensors and Biotronik to his institution. Martin Kirk Christensen has received an educational grant from Biotronik and Terumo, and a research grant from Biotronik to his institution. Michael Maeng has received an institutional research grant from Bayer and lecture fees from Novo Nordisk and is on the advisory board at Novo Nordisk. Christian Juhl Terkelsen has received a proctor fee from Meril Life. Steen Dalby Kristensen is the national coordinator of the SOS-AMI trial (Selatogrel, Idorsia): departmental grant. Lisette Okkels Jensen has received research grants from Biotronik, OrbusNeich, Biosensors, and Terumo to her institution and honoraria from Biotronik. The remaining authors declare no conflicts of interest.
Open Research
DATA AVAILABILITY STATEMENT
The data that support the findings of this study are available from the corresponding author upon reasonable request.
