High-Bleeding Risk Analysis of the BIO-RESORT Randomized Trial, Comparing 12-Month Clinical Outcome of Allcomer Patients Treated with Very Thin-Strut Biodegradable Polymer Versus Thin-strut Durable Polymer Drug-Eluting Stents - Clemens von Birgelen

Written by Katrina Mountford, Medical Editor.
19th March 2018

Abstract

At least 15 % of all patients who require percutaneous intervention (PCI) have a high bleeding risk (HBR). In populations comprising only patients with acute coronary syndromes (ACS), the HBR can exceed 40 %.1 Patients with HBR also have an increased risk of ischaemic events.2 Therefore, HBR patients represent a population with an overall high risk of adverse clinical outcomes. Most patients who require PCI, including patients with HBR, are currently treated with metallic drug-eluting stents (DES). Biodegradable polymer-coated metallic DES (BP-DES) were developed to overcome vessel wall inflammation and delayed vessel healing, related to the permanent presence of polymers on durable polymer-coated metallic DES (DP-DES) in the coronary artery.3 While no clear benefit of contemporary BP-DES over DP-DES has been demonstrated,4,5 there might be an advantage in high-risk populations such as HBR patients. Nevertheless, it is unclear whether potential advantages of BP-DES may be seen as early as at 1-year follow-up.5

Dr von Birgelen presented data from the randomised, prospective multicentre BIO-RESORT trial, which aimed to evaluate the 1-year safety and efficacy of treatment with contemporary very thin-strut BP-DES compared with thin-strut DP-DES in patients with HBR who require PCI. Patients were classified at HBR if they met the following criteria: age ≥ 75 years; current use of oral anticoagulation therapy; anaemia; thrombocytopenia; gastro-intestinal bleeding within the last 12 months; stroke within the last 12 months; previous intracranial haemorrhage; severe renal insufficiency and current use of non-steroidal anti-inflammatory drug (NSAIDs), which was consistent with previous trials.1 According to these criteria, almost 29 % of the 3,514 allcomers patients in the study had HBR. Participants were randomised (1:1:1) to receive a Synergy® (Boston Scientific) everolimus-eluting stent (BP-DES), Orsiro sirolimus-eluting stent (BP-DES), or Resolute™ Integrity (Medtronic Inc.) zotarolimus-eluting stent (DP-DES). The primary endpoint was a composite of safety (cardiac death or target vessel-related myocardial infarction) and efficacy (target vessel revascularisation) at 12 months. Results showed that both BP-DES (eluting either everolimus or sirolimus) were non-inferior to the DP-DES (eluting zotarolimus) in treating allcomers with a high proportion of patients with ACS (6.5 % of patients treated with BP-DES [pooled two devices] experienced TVF compared to 7.3 % of patients treated with DP-DES).6

Primary Endpoint TVF at 1 Year

Long-term follow up of this high-risk patient group is required to assess the long-term benefits (if any) of BP-DES over DP-DES. While the study was limited by low overall event rates, these data provide an interesting reference to compare the findings of future and ongoing stent studies in patients with HBR and in patients treated with short term dual antiplatelet therapy.

References

1. Urban P, Meredith IT, Abizaid A, et al., Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk, N Engl J Med, 2015;373:2038-47.

2. Matteau A, Yeh RW, Camenzind E, et al., Balancing Long-Term Risks of Ischemic and Bleeding Complications After Percutaneous Coronary Intervention With Drug-Eluting Stents, Am J Cardiol, 2015;116:686-93.

3. Joner M, Finn AV, Farb A, et al., Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk, J Am Coll Cardiol, 2006;48:193-202.

4. El-Hayek G, Bangalore S, Casso Dominguez A, et al., Meta-Analysis of Randomized Clinical Trials Comparing Biodegradable Polymer Drug-Eluting Stent to Second-Generation Durable Polymer Drug-Eluting Stents, JACC Cardiovasc Interv, 2017;10:462-73.

5. Lu P, Lu S, Li Y, et al., A comparison of the main outcomes from BP-BES and DP-DES at five years of follow-up: A systematic review and meta-analysis, Sci Rep, 2017;7:14997.

6. von Birgelen C, Kok MM, van der Heijden LC, et al., Very thin strut biodegradable polymer everolimus-eluting and sirolimus-eluting stents versus durable polymer zotarolimus-eluting stents in allcomers with coronary artery disease (BIO-RESORT): a three-arm, randomised, non-inferiority trial, Lancet, 2016;388:2607-17.