Thin strut CoCr biodegradable polymer biolimus A9-eluting stents versus thickerstrut stainless steel biodegradable polymer biolimus A9-eluting stents: two-year clinical outcomes.

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Authors
Cotton, James Matthew
Issue Date
2021-04-01
Journal
Type
Article
Peer-Reviewed Publication
Keywords
Absorbable implants
Acute coronary syndrome
Adverse effects
Aged
Anti-inflammatory agents
Bare-metal stents (BMS)
Biodegradable polymer
Cardiac surgical procedures
Chromium alloys
Cobalt-Chromium
Comparative study
Coronary artery disease
Coronary thrombosis
Drug-eluting stents
Female
Follow-up studies
Male
Middle aged
Multicentre study
Myocardial infarction
Patient outcomes
Percutaneous coronary intervention
Peer-reviewed article
Polymers
Prospective study
Registries
Retrospective study
Sirolimus
Stainless steel
Stainless steel biodegradable polymer biolimus A9-eluting stents (SS-BP-BES)
Struts
Treatment outcome
Umirolimus
Journal Title
Journal of Interventional Cardiology
Volume
Issue
Begin page
End page
Abstract
Background: While thinner struts are associated with improved clinical outcomes in bare-metal stents (BMS), reducing strut thickness may affect drug delivery from drug-eluting stents (DES) and there are limited data comparing otherwise similar thin and thick strut DES. We assessed 2-year outcomes of patients treated with a thin strut (84-88um) cobalt-chromium, biodegradable polymer, Biolimus A9-eluting stent (CoCr-BP-BES) and compared these to patients treated with a stainless steel, biodegradable polymer, Biolimus A9-eluting stent (SS-BP-BES). Methods: In total, 1257 patients were studied: 400 patients from 12 centres receiving ≥1 CoCr-BP-BES in the prospective Biomatrix Alpha registry underwent prespecified comparison with 857 patients who received ≥1 Biomatrix Flex SS-BP-BES in the LEADERS study (historical control). The primary outcome was major adverse cardiac events (MACE)-cardiac death, myocardial infarction (MI), or clinically driven target vessel revascularization (cd-TVR). Propensity analysis was used to adjust for differences in baseline variables and a landmark analysis at day-3 to account for differences in periprocedural MI definitions. Results: MACE at 2 years occurred in 6.65% CoCr-BP-BES versus 13.23% SS-BP-BES groups (unadjusted HR 0.48 [0.31-0.73]; P=0.0005). Following propensity analysis, 2-year adjusted MACE rates were 7.4% versus 13.3% (HR 0.53 [0.35-0.79]; P=0.004). Definite or probable stent thrombosis, adjudicated using identical criteria in both studies, occurred less frequently with CoCr-BP-BES (1.12% vs. 3.22%; adjusted HR 0.32 [0.11-0.9]; P=0.034). In day-3 landmark analysis, the difference in 2-year MACE was no longer significant but there was a lower patient-orientated composite endpoint (11.7% vs. 18.4%; HR 0.6 [0.43-0.83]; P=0.006) and a trend to lower target vessel failure (5.8% vs. 9.1%; HR 0.63 [0.4-1.00]; P=0.078). Conclusion: At 2-year follow-up, propensity-adjusted analysis showed the thin strut (84-88um) Biomatrix Alpha CoCr-BP-BES was associated with improved clinical outcomes compared with the thicker strut (114-120um) Biomatrix Flex SS-BP-BES.
Citation
Menown IBA, Mamas MA, Cotton JM, Hildick-Smith D, Eberli FR, Leibundgut G, Tresukosol D, Macaya C, Copt S, Slama SS, Oldroyd KG. Thin Strut CoCr Biodegradable Polymer Biolimus A9-Eluting Stents versus Thicker Strut Stainless Steel Biodegradable Polymer Biolimus A9-Eluting Stents: Two-Year Clinical Outcomes. J Interv Cardiol. 2021 Apr 1;2021:6654515. doi: 10.1155/2021/6654515. PMID: 33880087; PMCID: PMC8032541.