The Scaffold is Gone, But the Benefit Remains
The LIFE-BTK Study, published in the New England Journal of Medicine, is the first successful RCT to demonstrate superiority of an investigational device over standard of care for treatment of BTK disease in patients with CLTI.1 The 3-year data, published in the Journal of the American College of Cardiology, demonstrated sustained efficacy & safety.2
Clinical Follow-Up
LIFE-BTK Study Results
Low Reintervention Rate in CLTI Patients through 3 years2
Clinically-Driven Target Lesion
Revascularization at 3 Years
Superior Efficacy at 1 Year1, Sustained Benefits through 3 Years2
Composite of Limb Salvage and
Primary Patency through 3 years
Consistently Higher Observed Rate of Limb Salvage and Primary Patency With
Esprit™ BTK Across a Range of Lesion Lengths Up to 148 mm
Primary Efficacy Endpoint
Composite of Limb Salvage and Primary Patency at 1 Year
NOTE: Post-hoc subgroup analysis by lesion length terciles was conducted where no pre-specified hypothesis testing was completed to provide a p-value.
Varcoe, Ramon L., et. al. "Supplementary Appendix." In "Drug-eluting resorbable scaffold versus angioplasty for infrapopliteal artery disease." New England Journal of Medicine. 390 (2024): 9-19.
LIFE-BTK Study Design*
The LIFE-BTK Study is a prospective, multicenter, randomized controlled trial to evaluate the safety and efficacy of the Esprit™ BTK Everolimus Eluting Resorbable Scaffold System vs percutaneous transluminal angioplasty (PTA) for the treatment of infrapopliteal arterial disease in patients with chronic limb-threatening ischemia (CLTI).
Prospective
Randomized RCT
261
Patients
50
Global Sites
* clinicaltrials.gov/study/NCT04227899
† defined as Percutaneous Transluminal Angioplasty
LIFE-BTK 1Y Endpoints1
| PRIMARY EFFICACY ENDPOINT | PRIMARY SAFETY ENDPOINT | |
|---|---|---|
| Endpoint | Limb Salvage + Primary Patency | Freedom from MALE + POD |
| Definition | Freedom from above ankle amputation in index limb, 100% total occlusion of target vessel, binary restenosis of target lesion, and CD-TLR at 12 months | MALE = Above ankle amputation in index limb, major re-intervention at 6 months POD = Perioperative mortality at 30 days |
| Test | Superiority of Esprit™ BTK against PTA with a 1-sided α of 0.0249 | Non-inferiority of Esprit™ BTK against PTA with a 1-sided α of 0.025. |
| 1st SECONDARY ENDPOINT | 2nd SECONDARY ENDPOINT | |
|---|---|---|
| Endpoint | Binary restenosis of the target lesion at 1 year | Freedom from above ankle amputation in index limb, 100% total occlusion of target vessel and CD-TLR at 1 year |
| Test | Superiority of Esprit™ BTK against PTA with a 1-sided α of 0.025 | Superiority of Esprit™ BTK against PTA with a 1-sided α of 0.025. |
Key Baseline and History Risk Factors
Target Lesion Characteristics
| Esprit BTK | PTA | |
|---|---|---|
| Lesion length (mm) | 43.78 ± 31.84 (172) | 44.75 ± 29.07 (89) |
| RVD pre-intervention (mm) | 2.94 ± 0.77 (147) | 2.82 ± 0.74 (80) |
| Site-Reported Calcification | ||
| None/Mild | 69.3% (124/179) | 69.6% (64/92) |
| Moderate | 27.4% (49/179) | 28.3% (26/92) |
| Severe | 3.4% (6/179) | 2.2% (2/92) |
| TASC II classification | ||
| A | 48.3% (83/172) | 52.8% (47/89) |
| B | 35.5% (61/172) | 25.8% (23/89) |
| C | 16.3% (28/172) | 21.3% (19/89) |
| D | 0.0% (0/172) | 0.0% (0/89) |
| % DS pre-intervention | 72.6 ± 18.9 (172) | 73.7 ± 21.0 (89) |
Implanted Vessel Sites
Race, Gender, and Ethnicity Distribution
Multiple studies have shown racial and ethnic disparities in the prevalence of PAD and CLTI, as well as in access to and outcomes of treatment3,4
The LIFE-BTK trial was designed and conducted to include a diverse patient population representative of those most affected by the disease5
Race/Ethnicity (%)
Gender (%)
AA: African American | NH: Native Hawaiian | PI: Pacific Islander | NA: North American Native/American Indian | AN: Alaska Native
Varcoe, R. Primary Outcomes of the Esprit™ BTK Drug-Eluting Resorbable Scaffold for the Treatment of Infrapopliteal Lesions: The LIFE-BTK Trial. Presented at TCT 2023
Publications
Drug-Eluting Resorbable Scaffold versus Angioplasty for Infrapopliteal Artery Disease
The New England Journal of Medicine
2024
5-Year Outcomes After Bioresorbable Coronary Scaffolds Implanted With Improved Technique
Journal of the American College of Cardiology
2023
Journal of Endovascular Therapy
2025
Circulation
2025
Journal of the American College of Cardiology
2026
Journal of the Society for Cardiovascular Angiography & Interventions
2025
Drug-Eluting Resorbable Scaffolds: Design Considerations and Clinical Data
Interventional Cardiology Clinics
2026
JVS – Vascular Insights
2023
Journal of Endovascular Therapy
2025
Abbott continues to study Esprit BTK in real-world patient populations. Learn more about the Esprit BTK Post-Approval Study.
References:
- Ramon L., Varcoe et al. Drug-Eluting Resorbable Scaffold versus Angioplasty for Infrapopliteal Artery Disease. N Eng J Med 2024;390:9-19.
- Sahil A. Parikh et al., Long-Term Outcomes of the Esprit BTK Scaffold Versus Angioplasty in Infrapopliteal Chronic Limb-Threatening Ischemia: 3-Year Results from the LIFE-BTK Trial, J Am Coll Cardiol. 2026 May 13:S0735-1097(26)06208-X. doi: 10.1016/j.jacc.2026.04.008.
- Mark A. Eid et al. Epidemiology of peripheral artery disease, Semin Vac Surg. 2021; 34(1):38-46
- LaiTe Chen et al. Disparities in Peripheral Artery Disease Hospitalizations Identified Among Understudied Race-Ethnicity Groups. Front Cardiovasc Med. 2021;8:692236.
- Lawrence A. Garcia et al. Diversity, Equity, and Inclusion in the LIFE-BTK Trial Evaluating the Esprit™ BTK Drug-Eluting Resorbable Scaffold for the Treatment of Infrapopliteal Lesions in Patients with Chronic Limb-Threatening Ischemia, VIVA 2024.
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