Durable-polymer versus biodegradable-polymer drug-eluting stents in acute coronary syndromes: three-year outcomes of the HOST REDUCE POLYTECH RCT Trial

초록

BACKGROUND: Long-term follow-up is essential to evaluate the impact of polymer degradation in drug -eluting stents (DES). AIMS: We aimed to compare durable -polymer DES (DP -DES) and biodegradable -polymer DES (BP -DES) during a 3 -year follow-up to evaluate the entire period of polymer resolution (before, during, and after degradation). METHODS: The HOST REDUCE POLYTECH RCT Trial was a randomised clinical trial enrolling patients with acute coronary syndrome (ACS) and comparing the efficacy and safety of DP -DES and BP -DES. The primary outcome was a patient -oriented composite outcome (POCO), and the key secondary outcome was a device -oriented composite outcome (DOCO). RESULTS: A total of 3,413 ACS patients were randomised to either the DP -DES (1,713 patients) or BP -DES (1,700 patients) group. During the 3 -year follow-up, the risk of the POCO was similar between the DP -DES and BP -DES groups (14.8% vs 15.4%, hazard ratio [HR] 0.96, 95% confidence interval [CI]: 0.80-1.14; p=0.613). However, the risk of the DOCO was lower in the DP -DES group (6.0% vs 8.0%, HR 0.73, 95% CI: 0.57-0.95; p=0.020). In a landmark analysis, the lower risk of the DOCO for the DP -DES group was evident during the transition from the early to the late period after percutaneous coronary intervention (PCI) (from 8 to 16 months post-PCI; 1.8% vs 3.3%, HR 0.54, 95% CI: 0.34-0.84; p=0.007), which was mainly driven by a risk reduction of target lesion revascularisation. CONCLUSIONS: In ACS patients, DP -DES showed similar results to BP -DES regarding the POCO up to 3 years. For the DOCO, DP -DES were superior to BP -DES; this was due to the higher event rate during the period of polymer degradation.

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