12-month High-Bleeding Risk (HBR) subgroup analysis of the BIO-RESORT trial, RCT Orsiro and Synergy vs. Resolute Integrity

BIO-RESORT HBR subgroup analysis at 12 months


• Almost 29% of the BIO-RESORT all-comers had a High-Bleeding Risk (HBR)

• In this subanalysis (n = 1,009), the Bioabsorbable Polymer DES (BP-DES) arm, including Orsiro®, showed numerically lower event rates of the primary composite endpoint Target Vessel Failure (TVF) compared to Durable Polymer DES (DP-DES)

• On a product level, Orsiro alone demonstrated a numerically lower TVF rate (6.0%) than Synergy* (6.9%), and Resolute Integrity** (7.3%) in HBR patients, respectively. The differences did not reach statistical significance

Study design

HBR patient stratification of an all-comers, multi-center, assessor and patient-blinded, randomized, non-inferiority trial according to defined established HBR criteria


Primary endpoint
• TVF at 12 months defined as the composite of cardiac death,TV-MI or TVR

Secondary endpoints
• Individual components of the primary endpoint
• All-cause mortality
• Any MI
• Target Lesion Failure (TLF)
• Clinically indicated Target Lesion Revascularization (TLR)
• ST

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12-month clinical endpoints in HBR patients1

INTEGRITY n = 1,172
TVF¤ 6.0% 6.9% 7.3%
   Cardiac death 1.5% 2.1% 2.1%
   TV-MI 2.4% 3.0% 3.3%
   TVR 2.4% 2.2% 3.0%
TLF 5.7% 6.6% 5.7%
Major adverse cardiac events 6.8% 8.4% 8.1%
Patient-oriented composite
10.1% 9.3% 10.5%
Definite or probable ST 0.3% 0.6% 0.6%
Major bleeding 3.0% 3.7% 3.1%

BP-DES showed numerically lower event rates in HBR patients

Primary endpoint TVF – at 12 months1

Orsiro demonstrated a numerically lower TVF1

Product level comparison

Differences did not reach statistical significance (Orsiro vs. Synergy p = 0.60, Orsiro vs. Resolute Integrity p = 0.49, Synergy vs. Resolute Integrity p = 0.87)

Principal investigators

Prof. Clemens von Birgelen, Enschede, the Netherlands

* Synergy is a registered trademark of Boston Scientific
**Resolute and Integrity are registered trademarks of Medtronic Vascular Inc.
¤ Primary endpoint; Myocardial infarction and stent thrombosis classified according to Academic Research Consortium (ARC) criteria; Major bleeding = BARC 3 or 5 bleeding, or TIMI major bleeding. Values are n (%).
§ A composite of any death, any MI, or any revascularization.
1. von Birgelen C et al. High-Bleeding Risk Analysis of the BIO-RESORT Randomized Trial, Comparing 12-Month Clinical Outcome of All comer Patients Treated With Very Thin-Strut Biodegradable Polymer Versus Thin-strut Durable Polymer Drug-Eluting Stents; Presented at: CRT18; March 03, 2018 Washington DC, USA; : NCT01674803; 2. Zocca P, Kok MM, von Birgelen C, et al. High Bleeding Risk Patients Treated with Very Thin-Strut Biodegradable Polymer or Thin-Strut Durable Polymer Drug-Eluting Stents in the BIO-RESORT Trial. Cardiovascular drugs and therapy. 2018 Aug 24:1-0.

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