Abstract
PurposePatients with high bleeding risk (HBR) who undergo percutaneous coronary intervention also have an increased risk of ischemic events and represent an overall high-risk population. The coating of durable polymer drug-eluting stents (DP-DES) may induce inflammation and delay arterial healing, which might be reduced by novel biodegradable polymer DES (BP-DES). We aimed to evaluate the safety and efficacy of treating HBR patients with very thin-strut BP-DES versus thin-strut DP-DES.MethodsParticipants in BIO-RESORT (NCT01674803), an investigator-initiated multicenter, randomized all-comers trial, were treated with very thin-strut BP-DES (Synergy or Orsiro) or thin-strut DP-DES (Resolute Integrity). For the present analysis, patients were classified following HBR criteria based on previous trials. The primary endpoint was target vessel failure: a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization at 1 year.ResultsOf all 3514 patients, 1009 (28.7%) had HBR. HBR patients were older (p < 0.001) and had more co-morbidities than non-HBR patients (p < 0.001). At 1-year follow-up, HBR patients had significantly higher rates of target vessel failure (6.7 vs. 4.2%, p = 0.003), cardiac death (1.9 vs. 0.4%, p < 0.001), and major bleeding (3.3 vs. 1.5%, p = 0.001). Of all 1009 HBR patients, 673 (66.7%) received BP-DES and 336 (33.3%) had DP-DES. The primary endpoint was met by 43/673 (6.5%) patients treated with BP-DES and 24/336 (7.3%) treated with DP-DES (HR 0.88 [95%CI 0.54–1.46], p = 0.63). There were no significant between-group differences in the most global patient-oriented clinical endpoint (9.7 vs. 10.5%, HR 0.92 [95%CI 0.61–1.39], p = 0.69) and other secondary endpoints.ConclusionsAt 1-year follow-up, very thin-strut BP-DES showed similar safety and efficacy for treating HBR patients as thin-strut DP-DES.
Highlights
Most patients undergoing percutaneous coronary intervention (PCI) are currently treated with drug-eluting stents (DES) that elute an antiproliferative drug from their coating [1, 2]
Despite the theoretical advantage of biodegradable polymer DES (BPDES), meta-analyses of clinical trials showed no unequivocal benefit of biodegradable polymer DES (BP-DES) over contemporary durable polymer drug-eluting stents (DP-DES) [5,6,7,8], but there might still be an advantage for BP-DES in high-risk subgroups
The present study is an explorative analysis of the BIORESORT trial (Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents in an AllComers Population) [TWENTE III]) [12]
Summary
Most patients undergoing percutaneous coronary intervention (PCI) are currently treated with drug-eluting stents (DES) that elute an antiproliferative drug from their coating [1, 2]. Novel very thin-strut biodegradable polymer DES (BPDES) were designed to overcome these limitations of DPDES and merely leave a bare metal stent in place after the polymer has been absorbed [1, 2]. International guidelines recommend the use of contemporary DES over firstgeneration DES and bare metal stents in all patients undergoing PCI [4]. There is no preference for newer-generation BPDES over DP-DES, as both DES groups have shown to improve clinical outcome as compared to first-generation DES and bare metal stents. Despite the theoretical advantage of BPDES, meta-analyses of clinical trials showed no unequivocal benefit of BP-DES over contemporary DP-DES [5,6,7,8], but there might still be an advantage for BP-DES in high-risk subgroups. Patients who are at high bleeding risk (HBR) may represent such a patient population
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