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Clinical Trial2020 May 14. [Epub ahead of print]

JOURNAL：Catheter Cardiovasc Interv. Article Link

Safety and efficacy of the bioabsorbable polymer everolimus-eluting stent versus durable polymer drug-eluting stents in high-risk patients undergoing PCI: TWILIGHT-SYNERGY

U Baber, R Chandiramani, R Mehran et al. Keywords: stent comparation; DES; bioabsorbable; durable polymer; high-risk patients

ABSTRACT

BACKGROUND - Data examining the safety and efficacy of the bioabsorbable polymer (BP) drug‐eluting stent (DES) as compared with durable polymer (DP) DES in high‐risk patients undergoing percutaneous coronary intervention (PCI) remain limited.

 

METHODS - We conducted a pre‐specified analysis among patients enrolled in the TWILIGHT trial treated with the SYNERGY BP‐DES or a DP‐DES. Following successful PCI and 3 months of ticagrelor plus aspirin, patients were randomized to aspirin or placebo for 1 year; DES choice was at physician discretion. The primary endpoint was target lesion failure (TLF) [composite of cardiac death, target vessel myocardial infarction (MI), clinically driven target lesion revascularization (TLR) or definite/probable stent thrombosis (ST)].

 

RESULTS - Among enrolled participants (N = 9006), 653 were treated exclusively with the SYNERGY BP‐DES and 6404 with a comparator DP‐DES. Over 15 months, TLF rates were 6.4% and 6.1% among those receiving a SYNERGY BP‐DES and a DP‐DES, respectively (adjusted HR 0.93; 95% CI 0.64 – 1.35; p = 0.72). The effect of ticagrelor monotherapy on Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding and the composite of all‐cause death, MI or stroke was uniform across DES groups (both pint >0.10).

 

CONCLUSIONS - The safety and efficacy profile of the SYNERGY BP‐DES is comparable to that of contemporary DP‐DES in high‐risk patients undergoing PCI. Compared to ticagrelor plus aspirin, the effect of ticagrelor monotherapy is consistent among patients receiving SYNERGY BP‐DES or DP‐DES.

 

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