LIFE-BTK trial: Bioresorbable scaffold did not disrupt wound healing in patients with CLTI
Click Here to Manage Email Alerts
Key takeaways:
- In patients with CLTI, there was no difference in wound healing parameters between a drug-eluting scaffold and angioplasty.
- The treatment effect was more pronounced in those with wounds of arterial etiology.
An everolimus-eluting bioresorbable scaffold did not affect wound healing compared with angioplasty in patients with chronic limb-threatening ischemia, according to new data from the LIFE-BTK trial.
As Healio previously reported, in the main results of LIFE-BTK, the scaffold (Esprit BTK everolimus-eluting resorbable scaffold system, Abbott) was superior to balloon angioplasty for the primary efficacy endpoint of freedom from amputation above the ankle of the target limb, occlusion of the target vessel, clinically driven revascularization of the target lesion and binary restenosis of the target lesion at 1 year and noninferior for the primary safety endpoint of freedom from perioperative death and from major adverse limb events at 6 months in 261 patients with chronic limb-threatening ischemia (CLTI).
Image: Adobe Stock
Raghu Kolluri, MD, MS, RVT, system medical director of vascular medicine and system medical director of the noninvasive vascular labs for OhioHealth System and Riverside Methodist Hospital, president of Syntropic Core Lab and clinical professor of medicine at Ohio University, presented wound-related outcomes from LIFE-BTK at VIVA 23.
The wound analysis included 184 wounds from 130 patients. All patients had their wounds assessed at 14, 30, 42, 90 and 180 days (if necessary) and 1 year (if necessary), Kolluri said during a presentation.
“This is the first time ever that this many wounds have been evaluated in a CLTI trial,” he said. “We were able to go into a lot of fine details.”
Wound treatments were not specified and varied by site, he said.
The percentage of wounds healed at 1 year did not differ between the scaffold group and the angioplasty group for all index wounds (scaffold, 76.1%; angioplasty, 80%; difference, –3.94 percentage points; 95% CI, –18.08 to 11.58), ischemic wounds (scaffold, 77.8%; angioplasty, 81.4%, difference, –3.62 percentage points; 95% CI, –20.23 to 13.41) and mixed etiology wounds (scaffold, 73.1%; angioplasty, 71.4%; difference, 1.65 percentage points; 95% CI, –26.3 to 39.56), Kolluri said, noting there were no differences at the per-patient level or at the per-wound level.
There was no difference between the groups in risk for failure to heal wounds (HR = 0.79; 95% CI, 0.53-1.19; log-rank P = .26), ischemic wounds (HR = 0.71; 95% CI, 0.44-1.13; log-rank P = .14) or mixed etiology wounds (HR = 1.19; 95% CI, 0.64-3.21; log-rank P = .73), he said.
The groups were also similar in average time to heal, percentage area reduction, average wound area over time and occurrence of new wounds, Kolluri said.
Kolluri also provided additional analyses of the clinical endpoints. The treatment effect of the scaffold for primary efficacy endpoint of freedom from amputation above the ankle of the target limb, occlusion of the target vessel, clinically driven revascularization of the target lesion and binary restenosis of the target lesion at 1 year was more pronounced in patients with Rutherford class 4 (RR = 0.25; 95% CI, 0.14-0.46) than in those with Rutherford class 5 (RR = 0.71; 95% CI, 0.46-1.1), and in those whose wound etiology was arterial insufficiency only (RR = 0.55; 95% CI, 0.33-0.93) than in those whose wound etiology was mixed (RR = 1.12; 95% CI, 0.43-2.9).
The same pattern was true for the first powered secondary endpoint of binary restenosis of the target lesion at 1 year, Kolluri said, noting that for the second powered secondary endpoint of freedom from amputation above the ankle of the target limb, occlusion of the target vessel and clinically driven revascularization of the target lesion, the treatment effect favoring the scaffold was more pronounced in patients with Rutherford class 4 than in those with Rutherford class 5, but there was no difference in treatment effect by wound etiology.
“Wound healing is a complex process, and establishing inline flow is only one part of it,” Kolluri said during the presentation. “We now have data for angiosomal healing potentially, because we have the locations of the ulcers and how the lesions were treated. Esprit BTK was not associated with any disruption in wound healing over a period of time.”
Collapse
Kolluri R, et al. Late-breaking clinical trials. Presented at: VIVA 23; Oct. 30-Nov. 2, 2023; Las Vegas (hybrid meeting).
Click Here to Manage Email Alerts