LIFE-BTK

Randomized Controlled Trial

LIFE-BTK Randomized Controlled Trial

LIFE-BTK Study Design*

The LIFE-BTK Study is a prospective, multicenter, randomized controlled trial to evaluate the safety and efficacy of the investigational 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)


Clinical Follow-Up

Clinical Follow-Up

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
* clinicaltrials.gov/study/NCT04227899
** Follow up focused on index wound assessment
† defined as Percutaneous Transluminal Angioplasty

LIFE-BTK Study:
Sites and Enrollment

Total Enrolled Sites: 50  |  Total Randomized Patients: 261

Sites and Enrollment Map

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

Gender

LIFE-BTK U.S. Sites
Life-BTK U.S. Sites
LIFE-BTK Global Sites
Life-BTK Global Sites

Race and Ethnicity

LIFE-BTK U.S. Sites
Life-BTK U.S. Sites
LIFE-BTK Global Sites
Life-BTK Global Sites

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

LIFE-BTK Study Results

Superior Efficacy vs PTA Without Compromising Safety

Primary Efficacy Endpoint

Composite of Limb Salvage and Primary Patency at 1 Year
Primary Efficacy Endpoint Esprit BTK vs PTA

Results driven by reduced binary restenosis, total occlusion and CD-TLR as part of the composite endpoint.

Primary Safety Endpoint

Freedom from Major Adverse Limb Event (6mo) and Peri-operative Death (30 days)
Primary Safety Endpoint - Esprit BTK vs PTA

The primary safety endpoint was met.

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


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

Primary Efficacy Endpoint Esprit BTK vs PTA

NOTE: Post-hoc subgroup analysis by lesion length terciles was conducted where no pre-specified hypothesis testing was completed to provide a p-value.

Varco, 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.

Esprit™ BTK System

CAUTION: Investigational Device. Limited by Federal (or US) law to investigational use only.
 

Resorbable scaffold backbone comprised of 100% poly (L-lactide) (PLLA) and strut thickness of 99µm**

1

Coating comprised of the active pharmaceutical ingredient everolimus and resorbable poly (D,L- lactide) (PDLLA)

2

Four platinum markers of the same mass, two each embedded at the proximal and distal ends of the scaffold for radiopacity

3
Esprit Scaffold Diagram

Delivery System

Delivery System Diagram

** ≤ 3.0 mm size; 3.5-3.75 mm sizes have 120 µm strut thickness.
† Platinum markers at proximal and distal ends remain for angiographic visualization
Data on file at Abbott.

MAT-2401524 v1.0