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Comparison of Ultrathin Orsiro® Bioresorbable Polymer DES to Xience* Durable Polymer DES Acute Coronary Syndrome (ACS) Subgroup Analysis at 12 months



• More than 50% of the patients treated in the BIOFLOW-V study presented with ACSΔ

• In the ACS subgroup analysis, Orsiro® demonstrated statistically significantly lower Target Lesion Failure (TLF) rates compared to Xience at 12 months (Orsiro 5.6%, Xience 11.0%, p-value = 0.023)

• Procedure success was significantly higher with Orsiro (Orsiro 94.7%, Xience 89.7%, p-value = 0.023), mainly driven by significantly lower peri-procedural Myocardial Infarction (MI)

Study design

ACS subgroup analysis of a prospective, multi-center, 2:1 randomized controlled IDE (Investigational Device Exemption) trial to assess the safety and effectiveness of Orsiro in the treatment of patients with up to three de novo or restenotic lesions (standard PTCA only)


Primary Endpoints
• TLF at 12 months defined as a composite of Cardiac Death, Target Vessel Myocardial Infarction (TV-MI) or any ischemia driven Target Lesion Revascularization (TLR) Secondary Endpoints
• Components of the primary endpoint
• Target Vessel Failure (TVF) and individual TVF components
• Death
• Myocardial Infarction (MI) and/or Cardiac Death
• Stent Thrombosis (ST) (all, definite, definite/probable, probable, possible ST)1
• Success rates (device, lesion and procedure)

Patient chracteristics2 Orsiro n = 454 Xience n = 223
Age, yrs** 63.1 ± 10.8 63.2 ± 11.2
Female 25.8% 29.6%
Hypertension 76.7% 79.8%
Diabetes 34.0% 36.9%
Previous PCI 29.0% 25.8%
Previous CABG 6.9% 5.0%

Lesion chracteristics2 Orsiro n = 539 Xience n = 283
Bifurcation lesion** 14.5% 14.1%
Calcification, moderate/severe 21.0% 24.0%
Lesion Class B2/C 72.5% 74.6%

12-month clinical endpoints in ACS patients2

Analysis of interaction by ACS subgroups and treatment subgroups TLF at 12 months3

Principal investigators

Dr. David Kandzari, Piedmont Heart Institute, Atlanta, US Dr. Jacques Koolen, Catharina Ziekenhuis, Eindhoven, the Netherlands

* Xience is a trademark of Abbott Cardiovascular Systems Inc.
** Data shown as mean ± SD
Δ ACS defined as unstable angina or any elevated cardiac enzymes at baseline (any pre-procedure CK, CK-MB or troponin above upper normal limit)

1. According to Academic Research Consortium (ARC) criteria for acute, subacute, late, very late and cumulative stent thrombosis; 2. Roguin A et al. Subgroup Analysis Comparing Ultrathin, Bioresorbable Polymer Sirolimus-Eluting Stents Versus Thin, Durable Polymer Everolimus-Eluting Stents in Acute Coronary Syndrome Patients, Circulation: Cardiovascular Interventions. 2018; 11:e007331; doi: CIRCINTERVENTIONS.118.007331; 3.Kandzari D et al. Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimus-eluting stents in patients undergoing coronary revascularisation (BIOFLOW V): a randomised trial. Lancet. 2017 Oct 21; 390(10105):1843-1852.

Xience is a trademark or registered trademark of Abbott Cardiovascular Systems.
Orsiro is a trademark or registered trademark of the BIOTRONIK Group of Companies.

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