June 20, 2016
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Drug-Eluting Scaffold Yields Favorable Safety Results in Patients With PAD

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A bioresorbable drug-eluting scaffold for treatment of peripheral artery disease appears to be safe, with no procedure- or device-related deaths or amputations up to 2 years, according to results from a first-in-human clinical investigation.

In the prospective, single-arm, open-label, multicenter trial, researchers evaluated the bioresorbable vascular scaffold (Esprit BVS, Abbott Vascular) in 35 patients (mean age, 65 years; 77% men).

All patients had recurrent, symptomatic claudication due to PAD of the superficial femoral artery (88.6%) or external iliac artery (11.4%). Patients eligible for inclusion had a single de novo lesion of the superficial femoral artery or external iliac artery, with lesion length of up to 50 mm (mean, 35.7 mm) and vessel diameter of 5 mm to 6.5 mm.

All patients underwent placement of the scaffold and were assessed by duplex ultrasonography after the procedure and at 1, 6, 12 and 24 months, according to the researchers. Angiography was performed before the procedure, in-scaffold after the procedure and at 12 months.

The primary endpoints were acute procedural success, death and amputation of the ipsilateral extremity, scaffold thrombosis, binary restenosis rate, target lesion revascularization, ankle-brachial index and Rutherford classification.

Acute procedural success was attained in all cases, according to the results. There were three procedure-related adverse events: one flow-limiting dissection, which was treated by bare-metal stent implantation, and two groin hematomas, which receded without treatment.

One death occurred due to unrelated stroke in year 2, and one MI occurred in year 1 in a patient with established CAD. There were no amputations. Duplex ultrasonography results revealed a mean peak systolic velocity ratio of 1.27 after the procedure, a mean peak systolic velocity ratio of 1.66 at 1-year follow-up and a mean peak systolic velocity ratio of 1.56 at 2 years, the data showed.

At 1 year, the rate of binary restenosis was 12.1%, and at 2 years, the rate was 16.1%.

At 1 year, three of 34 patients had TLR (8.8%), and at 2 years, TLR occurred in four of 32 patients (11.8%), the researchers wrote. Three TLRs were clinically driven, whereas one was conducted during the 1-year control angiogram in a patient with no symptoms. At 1-year follow-up, freedom from TLR was 91.2%, and at 2-year follow-up, freedom from TLR was 88.2%.

An improvement in ankle-brachial index was observed with the scaffold, going from 0.75 before the procedure to 0.96 at 2 years, according to the researchers.
At 2 years, 71% percent of the patients had symptom-free Rutherford classification 0 and 93.5% were able to walk the maximum distance of 1,500 feet.

“This is the first-in-human study of an everolimus-eluting BVS for treatment of symptomatic claudication. In comparison to non-drug-eluting BVS, a high 2-year patency rate and low 2-year TLR rate have been demonstrated,” the researchers wrote. “The BVS needs to be tested in [TransAtlantic Inter-Society Consensus] B-C lesions and should be compared to other drug-eluting technologies such as DES and [drug-eluting balloons] in patients with PAD.” – by Jennifer Byrne

Disclosure: Some of the researchers report financial ties with Abbott Vascular. Please see the full study for a list of the researchers’ relevant financial disclosures.