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.

 

Are you interested in specific study data?

CONTACT US