Cache Test Div

BIOFLOW-V

Comparison of Ultrathin strut Orsiro® Bioresorbable Polymer DES to Xience* Durable Polymer DES at 36 Months

BIOFLOW-V: FDA pivotal trial at 36 months

Conclusions

Significant differences in TLF observed at year 1 and 2 were maintained and further increased at year 3 (8.6% vs. 14.4%, p = 0.003), driven by significant differences in TV-MI (5.5% vs. 10.1%, p = 0.004) and Ischemia-driven TLR (3.4% vs. 6.9%, p = 0.008) that favor Orsiro over Xience.

• 40% lower TLF rate (p = 0.003)

• 46% lower TV-MI rate (p = 0.004)

• 52% lower ischemia-driven TLR rate (p = 0.008)

​​​​​​​• 90% lower late/very late definite/probable ST rate (p = 0.018)

Study design

Prospective, multi-center, 2:1 randomized controlled IDE 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)

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

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
• Stent Thrombosis (all, definite, definite/probable, probable, possible ST)¹
• Success rates (device, lesion and procedure)

study design
Patient characteristics2,3 Orsiro n = 884 Xience n = 450
Age, yrs** 64.5 ± 10.3 64.6 ± 10.7
Female 25.3% 27.1%
Hypertension 79.7% 80.5%
Diabetes 34.0% 37.0%
Stable Angina 48.4% 47.4%
Unstable Angina 39.3% 39.0%
Acute Coronary Syndrome​​​​​​​◊ 51.4% 49.6%
Previous PCI 36.8% 33.0%
Previous CABG 7.1% 5.2%

Lesion characteristic2,3 Orsiro n = 1,051 Xience n = 561
Lesion length (mm) 13.3 ± 7.6 13.2 ± 7.7
Bifurcation lesion 14.8% 15.0%
Calcification, moderate/severe 24.0% 26.7%
Lesion Class B2/C 72.6% 75.9%
Number of target lesion/patient**§ 1.2 ± 0.4 1.3 ± 0.5
Number of stents/patient**§ 1.3 ± 0.7 1.5 ± 0.9
Total stent length (mm)**§ 26.8 ± 14.7 29.5 ± 17.5
Reference vessel diameter (mm)** 2.59 ± 0.54 2.60 ± 0.58

TLF and components at 12, 24 and 36 Months2,3,4,6

TV-MI Landmark Analysis5

Ischemia-driven TLR Landmark Analysis5

Stent Thrombosis at 36 Months5

Secondary Clinical Endpoints at 36 Months6

  Orsiro Xience p-value
Cardiac Death or any MI 8.1% 12.4% 0.018
MACE 11.9% 18% 0.004
TVF 10.2% 17% <0.001

Principal investigators

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

Target-lesion characteristics as assessed by an independent angiographic core laboratory.

* Xience is a trademark of Abbott Cardiovascular Systems Inc.
** Data shown as mean ± SD
◊ Acute coronary syndrome defined as subjects with unstable angina or any elevated cardiac enzymes at baseline (any pre-procedure CK, CK-MB or troponin out of normal range).
§ There were no statistically significant differences between groups except for variable denoted by (§). Multivariable analysis of TLF, TV-MI and TLR confirmed no clinical, angiographic or procedural characteristic that differed between group was identified as a predictor of adverse outcome.

1. According to Academic Research Consortium (ARC) criteria for acute, subacute, late, very late and cumulative stent thrombosis; 2. 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; 3. Kandzari D, et al. BIOFLOW-V: A Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the Treatment Of Subjects With up to Three De Novo or Restenotic Coronary Artery Lesions Science. Presentation at ESC 2017; 4. Kandzari D et al. Ultrathin bioresorbable polymer sirolimus-eluting stents versus thin durable polymer everolimus-eluting stents. Journal of the American College of Cardiology. 2018 Dec 17;72(25):3287-97; 5. Kandzari D et al. J Am Coll Cardiol. Cardiovasc Interven. 2020, doi: 10.1016/j. jcin.2020.02.019; 6. Kandzari D et al. J Am Coll Cardiol. Cardiovasc Interven. 2020. Supplemental Material.

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

Do you want to further explore Orsiro's extensive clinical program?

CONTACT US