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BIO-RESORT

36-month clinical follow-up results of the Small Vessel subgroup

Orsiro® DES - Extensive Clinical Program

Conclusions

• At 36 months in the small vessel subgroup, Orsiro® shows a trend towards lower rates of Target Lesion Failure (TLF) and Stent Thrombosis (ST) compared to both Resolute Integrity* and Synergy**.

• Orsiro demonstrates significantly lower rates in Target Lesion Revascularization (TLR) compared to Resolute Integrity and numerically lower rates compared to Synergy.

• Orsiro’s ultrathin struts may contribute to a lower repeat revascularization risk in patients with small target vessels.

Study design

Small vessel, defined as Reference Vessel Diameter (RVD) <2.5 mm, subgroup analysis of a large-scale, all-comers, multi-center, assessor and patient-blinded, randomized, non-inferiority trial.

Endpoints

Clinical endpoints
• TLF defined as the composite of: Cardiac Death, Target Vessel-related Myocardial Infarction (TV-MI), and TLR
• ST

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PATIENT CHARACTERISTICS1 ORSIRO n = 525 SYNERGY n = 496 RESOLUTE
INTEGRITY n = 485
Age, yrs‡ 64.9 ± 10.2 64.0 ± 10.6 64.0 ± 10.3
Diabetes mellitus 19.2% 21.4% 21.0%
Hypertension 47.6% 46.4% 51.3%
Previous MI 18.1% 17.5% 22.5%
Clinical indication      
   STEMI 27.2% 27.2% 23.3%
   NSTEMI 22.5% 21.0% 22.9%
   Unstable angina 19.4% 17.3% 19.2%
   Stable angina 30.9% 34.5% 34.6%
   Multivessel treatment 29.3% 28.4% 32.4%

LESION CHARACTERISTICS1 ORSIRO n = 636¤ SYNERGY n = 581¤ RESOLUTE
INTEGRITY n = 602¤
B2/C 71.4% 68.7% 68.3%
Bifurcated lesion 34.9% 35.5% 34.1%
Severe calcification 17.8% 19.1% 20.9%
Reference vessel diameter (mm)‡ 2.11 ± 0.28 2.12 ± 0.28 2.11 ± 0.28
Acute lumen gain‡ 1.04 ± 0.49 1.08 ± 0.48 1.02 ± 0.48
Postdilation 67.3% 74.5% 69.4%

Small vessel lesions in the Orsiro group were significantly more often complex (pSynergy vs. Resolute Integrity = 0.002), and stent postdilation was more often performed in lesions treated with Synergy (pOrsiro vs. Resolute Integrity = 0.05).

Small vessel subgroup TLF rates at 3 years1

Small vessel subgroup clinical endpoints at 3 years1

TLF COMPONENTS ORSIRO n = 525 RESOLUTE
INTEGRITY n = 485		 Synergy n = 496 p-VALUE ORSIRO
VS. RESOLUTE
INTEGRITY
TLF 7.0% 10.0% 9.5% 0.08
   TLR 2.1% 5.3% 4.0% 0.009
   Cardiac Death 2.4% 2.5% 2.5% 0.85
TV-MI 3.3% 4.2% 3.9% 0.46
ST        
   Definite ST 0.4% 1.1% 0.8% 0.21
   Def./prob. ST 0.6% 1.5% 1.5% 0.16

Small vessel subgroup TLR rates at 3 year1

TLR landmark analyses 1 – 3 years1

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
‡ Data shown as mean ± SD
¤ Number of lesions

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

1. Buiten R et al. Outcomes in patients treated with thin-strut, very thin-strut, or ultrathin-strut drug-eluting stents in small coronary vessels - A prespecified analysis of the randomized BIO-RESORT trial; JAMA Cardiol. Published online May 21, 2019. doi:10.1001/jamacardio.2019.1776; ClinicalTrials. gov: NCT01674803.

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