Key result
Target lesion failure was similar between biodegradable and durable polymer DES before (8.0% vs 7.7%, p>0.99) and after (2.9% vs 3.8%, p=0.16) DAPT discontinuation.
Why the study?
Whether DAPT duration differentially affects outcomes after treating ischemic coronary disease with durable versus biodegradable drug-eluting stents remains poorly defined.
Does a biodegradable-polymer sirolimus-eluting stent reduce target lesion failure compared to a durable-polymer everolimus-eluting stent on and off dual antiplatelet therapy in patients with ischemic coronary artery disease?
RCT (n=1,296)
randomized
Does a biodegradable-polymer sirolimus-eluting stent reduce target lesion failure compared to a durable-polymer everolimus-eluting stent on and off dual antiplatelet therapy in patients with ischemic coronary artery disease?
Absolute Event Rate: 8% vs 7.7%
p-value: p=>.99
Biodegradable-polymer and durable-polymer stents show comparable target lesion failure rates regardless of DAPT discontinuation, though biodegradable stents showed a trend toward lower myocardial infarction and revascularization after DAPT cessation.
Supports the interchangeable use of biodegradable and durable polymer stents in routine practice; leaves open whether biodegradable platforms offer.
BACKGROUND: Current guidelines recommend dual antiplatelet therapy (DAPT) following percutaneous coronary intervention for 6-12 months in patients with acute coronary syndrome (ACS) and 3-6 months in those with chronic coronary syndromes (CCS). Whether DAPT duration has a differential effect on outcomes following treatment of ischemic coronary disease with durable versus biodegradable drug-eluting stent (DES) is poorly defined. METHODS: The TARGET All Comer study was a randomized trial of patients with ischemic coronary artery disease assigned to treatment with either a biodegradable polymer DES (Firehawk) or a durable polymer DES (XIENCE). This pre-specified TARGET AC sub-analysis sought to evaluate the 2-year clinical outcomes before and after DAPT discontinuation. The primary endpoint was target lesion failure (TLF). RESULTS: A total of 1,296 (78.4%) of 1,653 randomized patients were included in this substudy, of which 1,210 (93.4%) remained on DAPT at 6 months, 863 (66.6%) at 12 months, and 409 (31.6%) at 2 years. There was no difference in TLF between patients treated with Firehawk and XIENCE stents from index procedure to DAPT discontinuation (8.0 and 7.7%, p > .99) or after DAPT discontinuation (2.9 vs. 3.8%, p = .16). After DAPT discontinuation, target vessel myocardial infarction (1.3 vs. 3.3%, p = .07), and ischemia-driven target lesion revascularization (0.5 vs. 1.9%, p = .06) favored treatment with Firehawk. CONCLUSIONS: Although TLF was comparable for both Firehawk and XIENCE stent groups before and after DAPT discontinuation, after DAPT discontinuation, there was a trend for less target vessel myocardial infarction and ischemia-driven revascularization with the biodegradable polymer DES.
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Saito et al. (2021) conducted an RCT in Ischemic coronary artery disease (n=1,296). Biodegradable polymer DES (Firehawk) vs. Durable polymer DES (XIENCE) was evaluated on Target lesion failure (TLF) (p=>.99). Target lesion failure was similar between biodegradable and durable polymer DES before (8.0% vs 7.7%, p>0.99) and after (2.9% vs 3.8%, p=0.16) DAPT discontinuation.
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