BIO-RESORT

36-month primary endpoint results RCT Orsiro and Synergy vs. Resolute Integrity

ORSIRO'S EXTENSIVE CLINICAL PROGRAM

including BIO-RESORT

Conclusions

• In this 3,514 patient large, randomized, investigator-initiated, all-comers trial, Orsiro® demonstrated non-inferiority to Resolute Integrity* while performing equally well as Synergy** (primary endpoint Target Vessel Failure (TVF) at 12 months: Orsiro 4.7%, Synergy 4.7%, Resolute Integrity 5.4%, pnon-inferiority < 0.0001).

• At 36 months, in this highly complex patient population, Orsiro has shown favorable outcomes with numerically lower event rates in TVF compared to both Synergy and Resolute Integrity.

• Additionally, there were no differences observed between Orsiro and Synergy when compared to Resolute Integrity for safety endpoints

Study design

All-comers, multi-center, assessor and patient-blinded, randomized, non-inferiority trial

Endpoints

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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Patient characteristics2 ORSIRO n = 1,169 Synergy n = 1,172 Resolute Integrity n = 1,172
Age, yrs** 64.2 ± 10.7 100 ± 10.2 100 ± 10.2
Male 73% 72% 72%
Smoking 30% 30% 31%
Diabetes mellitus 18% 17% 18%
Previous MI 17% 16% 21%
Previous PCI 18% 18% 17%
Previous CABG 7% 8% 8%
Clinical indication      
ST-elevation MI (STEMI) 32% 32% 28%
Non-ST-elevation MI (NSTEMI) 20% 21% 23%
Unstable angina 18% 16% 19%

Lesion characteristics2 ORSIRO n = 1,551¤ Synergy n = 1,532¤ Resolute Integrity n = 1,580​​​​​​​¤
De novo lesion 96.8% 97.1% 96.8%
Bifurcated lesion 28.6% 29.1% 27.7%
Severe calcification 20.4% 19.3% 20.7%
ACC-AHA lesion class (n) 1,545 1,527 1,573
   A/B1 26.3% 29.0% 27.8%
   B2/C 73.7% 71.0% 72.2%
Median lesion length (mm) 14.63 14.59 14.74
Minimum lumen diameter (mm) 0.71 0.71 0.70
Reference vessel diameter (mm)‡ 2.75 ± 0.56 2.76 ± 0.56 2.76 ± 0.59
Stenosis (lumen diameter %) 72.8% 73.8% 72.5%

TVF at 3 years1,3

Selected clinical results up to 3 years1,3

Cumulative incidence (%) represent Kaplan-Meier failure estimates at 36 months; p>0.05 for all comparisons

Definite or probable ST at 3 years3

◊ Logrank statistical method

Principal investigators

Prof. Clemens von Birgelen, Enschede, the Netherlands

* Resolute and Integrity are registered trademarks of Medtronic Vascular Inc.
**Synergy is a registered trademark of Boston Scientific
¤ Number of lesions
‡ Data shown as mean ± SD
1. von Birgelen C et al. The Lancet. 2016;388(10060):2607-17; 2. von Birgelen C et al. BIO-RESORT (TWENTE III). A Prospective, Randomized Three-Arm Trial Comparing Orsiro, Synergy and Resolute Integrity in an All-Comers Population; Presented at: TCT 2016; October 30, 2016; Washington DC, USA; ClinicalTrials.gov: NCT01674803; 3. von Birgelen C et al. 3-Years BIO-RESORT: Results of the 3-Arm randomized study in all-comers, treated with contemporary biodegradable or durable polymer-coated drug-eluting stents. Presented at CRT 2019, March, 2019; Washington DC, USA; ClinicalTrials.gov: NCT016748

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