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ESPRIT I: BVS for PAD safe, linked to low event rate at 3 years
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LAS VEGAS — Three-year results in a first-in-human clinical evaluation confirm earlier data that demonstrated safety and feasibility of an everolimus-eluting bioresorbable vascular scaffold for treatment of peripheral artery disease of the superficial femoral and iliac arteries.
The prospective, single-arm, open-label, multicenter ESPRIT I study was conducted in 35 patients with symptomatic claudication from PAD involving the superficial femoral (89%) and common or external iliac arteries (11%) at seven centers in Europe. Each patient had one target lesion treated with a single 6 x 58-mm bioresorbable vascular scaffold (Esprit BVS, Abbott Vascular). Vessel diameter was ≥ 5.5 mm to ≤ 6.5 mm and lesion length was ≤ 50 mm. Patients completed follow-up through 3 years.
Results at 3 years confirm earlier data that showed safety and feasibility of treatment with the BVS. “No new events occurred between 2 and 3 years,” Michael R. Jaff, DO, FSCAI, professor of medicine at Harvard Medical School and President of Newton-Wellesley Hospital, said during a late-breaking clinical trial presentation at VIVA 16.
At 3 years:
- the rate of all-cause death was 3.4%;
- ·no patients required amputation of the treated limb (0%);
- ·no patients required bypass surgery of the treated limb (0%);
- freedom from restenosis on duplex ultrasound was 90%;
- the rate of target lesion revascularization was 13.8%; and
- the rate of scaffold thrombosis was 3.4%.
Importantly, according to Jaff, “there was no decrement in TLR” during follow-up and there was “no need for further TLRs between 2 and 3 years.” Kaplan-Meier freedom from TLR was 91.2% at 1 year, 88.2% at 2 years and 88.2% at 3 years.
The ESPRIT I researchers also analyzed outcomes after adjustment for oversized vessels. There were four cases in which the BVS was not sized optimally. Among cases within the upper limit of the maximal vessel diameter of < 6.5 mm, the rate of all-cause death was 4%; amputation of the treated limb, 0%; bypass surgery of the treated limb, 0; TLR, 8%; and scaffold thrombosis, 0%.
“When you remove those in whom sizing was not done appropriately, the TLR rate improves to below 10% out to 3 years,” Jaff said.
In other results, 88% of patients were in Rutherford category 0-1 at 3 years, according to the data presented. All patients were in Rutherford category 1-3 at baseline. – by Katie Kalvaitis
Reference:
Jaff MR, et al. Late-Breaking Clinical Trials. Presented at: VIVA 16; Sept. 18-22, 2016; Las Vegas.
Disclosure: The ESPRIT I trial was sponsored and funded by Abbott Vascular. Jaff reports no relevant financial disclosures.
Perspective
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Michael D. Dake, MD
The results of ESPRIT I, albeit in a small number of patients, are incredibly good and encouraging. It opens the door to moving to the next step of evaluation of these bioresorbable technologies, studying them in more patients and in patients with longer lesions. The biggest benefit is likely to be in patients with longer lesions, but if it works in the shorter lesions presented in this study, and it is financially reasonable to consider, why not take advantage of its benefits in short- or moderate-length lesions. This is the natural extension of the paradigm of leave nothing behind.
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