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 CLTI patients.2 The 3-year data presented at TCT 2025 demonstrated sustained efficacy & safety.1
Clinical Follow-Up
LIFE-BTK Study Results
Superior Efficacy at 1 Year2, Sustained Benefits through 3 Years1
Esprit™ BTK offers continued long-term benefits vs PTA, particularly in terms of limb salvage and primary patency through 3 years. A clear advantage over PTA in terms of sustained vascular patency and limb preservation.1
Low Reintervention Rate in CLTI Patients through 3 years1
Esprit™ BTK reduces binary restenosis and total occlusion, due to its biological efficacy and resorbable mechanical support. Esprit™ BTK demonstrates long-term durability, effectively reducing restenosis and promoting long-term vessel patency.1,2
Esprit™ BTK demonstrated to be as safe as balloon angioplasty, maintained at 3 years.1
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, multicenter trial across 50 Global Sites
- 261 patients randomized (2:1 Esprit™ BTK System vs. PTA†)
- Esprit™ BTK System (n=173)
- PTA† (n=88)
* clinicaltrials.gov/study/NCT04227899
** Follow up focused on index wound assessment
† defined as Percutaneous Transluminal Angioplasty
Sites and Enrollment
Total Enrolled Sites: 50 | Total Randomized Patients: 261
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
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 treatment4,5
The LIFE-BTK trial was designed and conducted to include a diverse patient population representative of those most affected by the disease6
Race, Gender, and Ethnicity Distribution
Gender
LIFE-BTK U.S. Sites
LIFE-BTK Global Sites
LIFE-BTK U.S. Sites
LIFE-BTK Global Sites
Race and Ethnicity
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
Proven Efficacy and Durability Across Diverse Races and Ethnicities
Composite Primary Effectiveness Endpoint at 1 Year
The primary and secondary endpoint results for different race and ethnicity subgroups were consistent with the overall population, demonstrating the Esprit™ BTK device’s biological efficacy, durability, and robust performance across diverse patient populations5.
Race and Ethnicity Subgroup Analysis
LIFE-BTK 1Y Endpoints2
| 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 a of 0.0249 | Non-inferiority of Esprit™ BTK against PTA with a 1-sided a 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 a of 0.025 | Superiority of Esprit™ BTK against PTA with a 1-sided a of 0.025. |
Implanted Vessel Sites
Baseline Lesion & Patient Characteristics
| Lesion Characteristics | Esprit BTK | PTA |
|---|---|---|
| Lesion length (mm) | 43.78 ± 31.84 | 44.75 ± 29.07 |
| RVD pre-intervention (mm) | 2.94 ± 0.77 | 2.82 ± 0.74 |
| Site-Reported Calcification (Moderate/Severe) | 30.8% | 30.5% |
| %DS pre-intervention | 72.6 ± 18.9 | 73.7 ± 21.0 |
| Patient Demographics* | Esprit BTK | PTA |
|---|---|---|
| Hypertension | 94.2% | 90.9% |
| Hyperlipidemia | 80.9% | 81.8% |
| Tobacco Use | 52.6% | 53.4% |
| Diabetes | 71.7% | 69.3% |
| Rutherford Becker 4 | 52.0% | 51.1% |
| Rutherford Becker 5 | 48.0% | 48.9% |
| Prior PAD | Esprit 82.7% | PTA 77.3% |
*All patients in the LIFE-BTK trial presented with CLTI with either ischemic rest pain (Rutherford-Becker class 4) or minor tissue loss (Rutherford-Becker class 5) along with multiple risk factors.
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.
Abbott continues to study Esprit BTK in real-world patient populations. Learn more about the Esprit BTK Post-Approval Study.
References:
*Re-intervention defined as CD-TLR.
- Parikh, S., Three-Year Outcomes of the LIFE-BTK Randomized Controlled Trial Evaluating the Esprit™ BTK Drug-Eluting Resorbable Scaffold for Treatment of Infrapopliteal Lesions, Presented at TCT 2025.
- Varcoe, RL., et al. Drug-Eluting Resorbable Scaffold versus Angioplasty for Infrapopliteal Artery Disease. N Eng J Med 2024;390:9-19.
- Brian G. DeRubertis et al., Drug-Eluting Resorbable Scaffold Versus Balloon Angioplasty for Below-the-Knee Peripheral Artery Disease: 2-Year Results From the LIFE-BTK . Circulation 2025.
- Eid MA, et al. Semin Vasc Surg. 2021;34(1):38-46.
- Chen L, et al. Front Cardiovasc Med. 2021;8:692236.
- Garcia, LA, 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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