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Paolo Zocca, Marlies M. Kok, Liefke C. van der Heijden, Peter W. Danse, Carl E. Schotborgh, Martijn Scholte, Marc Hartmann, Gerard C.M. Linssen, Carine J.M. Doggen, Clemens von Birgelen* (Corresponding Author)
Research output: Contribution to journal › Article › Academic › peer-review
Purpose: Patients 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.
Methods: Participants 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.
Results: Of 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.
Conclusions: At 1-year follow-up, very thin-strut BP-DES showed similar safety and efficacy for treating HBR patients as thin-strut DP-DES.
Original language | English |
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Pages (from-to) | 567–576 |
Number of pages | 10 |
Journal | Cardiovascular Drugs and Therapy |
Volume | 32 |
Issue number | 6 |
Early online date | 24 Aug 2018 |
DOIs | |
Publication status | Published - 1 Dec 2018 |
Research output: Thesis › PhD Thesis - Research UT, graduation UT