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BIO-RESORT

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

Orsiro® DES - Extensive Clinical Program

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 of Target Vessel-related Myocardial Infarction (TV-MI), Stent Thrombosis (ST) or Cardiac Death.    

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

Bioresort Flow
Patient characteristics1 ORSIRO n = 1,169 Synergy n = 1,172 Resolute Integrity n = 1,173
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

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
◊ Logrank statistical method

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: NCT01674803.
 

Synergy is a trademark or registered trademark of the Boston Scientific Group of Companies. Resolute, Integrity, Resolute Integrity and Resolute Onyx are trademarks or registered trademarks of the Medtronic Group of Companies.

Orsiro is a trademark or registered trademark of the BIOTRONIK Group of Companies.

 

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