ACS | Orsiro

BIOFLOW-V

36-month clinical follow-up of the Acute Coronary Syndrome (ACS) Subgroup analysis of BIOFLOW-V trial.

BIOFLOW-V ACS subgroup analysis at 36 months

Conclusions

  • At 36 months, in the ACS population of the BIOFLOW-V trial, Orsiro® shows significantly lower rate of Target Lesion Failure (TLF) compared to Xience (8.5% vs. 16.5%, p = 0.004).
  • The difference in TLF at 36-months was driven by significantly lower peri-procedural MI and spontaneous MI favoring Orsiro.
  • The findings of the BIOFLOW-V ACS subgroup analysis support the treatment with the ultrathin strut Orsiro DES in patients with acute coronary syndrome undergoing PCI.

Study design

ACS subgroup analysis of a prospective, multicenter, 2:1 randomized controlled IDE (Investigational Device Exemption) trial.

Endpoints

Primary Endpoints
Target Lesion Failure (TLF) at 12 months follow-up
defined as the composite of:

• Cardiac Death
• Target Vessel-Myocardial Infarction (TV-MI)
• Ischemia-driven Target Lesion Revascularization (TLR)

Secondary Endpoints

• Components of the primary endpoint
• MACE as a composite of all-cause death, MI or ischemia-driven TLR
• Target Vessel Failure (TVF) and individual TVF components
• Definite/Probable Stent Thrombosis

Flowchart
Patient chracteristics1​​​​​​​ 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%
   Prior MI 28.7% 26.2%
   Prior PCI 29.0% 25.8%
   Prior CABG 6.9% 5.0%

Lesion chracteristics​​​​​​​1 Orsiro n = 539 Xience n = 283
Bifurcation lesion 14.5% 14.1%
Moderate/severe calcification 21.0% 24.0%
Moderate/severe tortuosity 59.2% 59.4%
ACC/AHA lesion class B2/C 72.5% 74.6%
Lesion length (mm)* 13.8 ± 7.8 13.2 ± 7.0
Reference vessel diameter (mm)* 2.7 ± 0.6 2.6 ± 0.6
No. target lesions/patient* 1.3 ± 0.5 1.3 ± 0.6
No. stents/patient** 1.4 ± 0.7 1.5 ± 0.9
Total study stent lengths (mm)* 27.2 ± 14.9 30.0 ± 18.0

Primary Endpoint - TLF at 36 months1

Secondary Endpoint - TV-MI at 36 months1

Selected Secondary Endpoints at 36 months1

  Orsiro n = 454 Xience n = 223 p-value​​​​​​​
Cardiac Death 0.98% 1.96% 0.451
TV-MI 4.68% 12.44% <0.001
Ischemia-driven TLR 4.40% 7.46% 0.129
Definite ST 0.50% 2.00% 0.096
Definite/Probable Stent Thrombosis)      
   Very late (>1 year and ≤3 years) 0.00% 1.50% 0.036
   Late/Very Late (>30 days ≤3 years) 0.00% 1.90% 0.012

Principal investigators

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

* Data shown as mean ± SD
** p<0.05 for comparison

1. Kandzari DE et al. Ultrathin Bioresorbable Polymer Sirolimus-Eluting Stents versus Thin Durable Polymer Everolimus-Eluting Stents in Patients Undergoing Coronary
Revascularization (BIOFLOW V): 3-year Results of the Acute Coronary Syndrome Subgroup Analysis. Presented at TCT Connect 2020.


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


Clinical data conducted with Orsiro, Orsiro Mission’s predecessor device can be used to illustrate Orsiro Mission clinical outcomes.

 

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