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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.
Perspective
Back to TopRajesh Gupta, MD
Lammer and colleagues have reported first-in-human findings of a BVS for treatment of external iliac artery and superficial femoral artery (SFA) stenosis. This study leverages Abbott’s existing technology of poly-L-lactide BVS, which has been tested in the coronary setting in the ABSORB clinical trials and is now tested in the peripheral setting. The device is deployed on a balloon-expandable platform and has everolimus drug elution.
Whether in the coronary or peripheral vasculature, there remains an intuitive appeal to the use of a “disappearing” stent. The BVS could provide excellent acute technical results and then its bioabsorption could prevent chronic irritation or inflammation in the arterial wall that may be responsible for late failures. Late failure remains a critical problem in the SFA territory. The SFA is a long artery and is subject to many external forces including torsion, flexion and external compression. Furthermore, chronic outward force from nitinol stents has been implicated in late restenosis and target lesion failure.
Lammer et al. have reported very high acute technical success rates and good durability with a freedom from TLR of 88.2% at two years. The study is small in size and included very focal lesions, with a mean lesion length of only 3.6 cm. Regardless of these limitations, the findings are innovative. We will await future trials with larger patient populations and more complex lesion characteristics to determine if BVS represents a breakthrough technology for peripheral interventions. The field of peripheral vascular interventions is undergoing robust innovation with multiple drug-coated balloons (DCB) and multiple drug-eluting stents currently available or in development. The DCB trials have been very successful, although late failures and more difficult real-world lesion characteristics remain a problem. There is a lot of movement and innovation in this field. It is an exciting time for peripheral interventions.
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