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Bioresorbable Stent Promising for PAD First-in-human results good at 2 years with Esprit stent
Nicole Lou Reporter, MedPage Today/CRTonline.org
The Esprit bioresorbable vascular scaffold (BVS) appears to be safe and effective in treating peripheral artery disease (PAD), according to 2-year data from the ESPRIT I trial.
The everolimus-coated stent was successfully deployed in all cases with no recoil, reported Johannes Lammer, MD, of Austria's Medical University of Vienna, and colleagues in the study appearing online in JACC: Cardiovascular Interventions.
The binary restenosis rate was 12.1% at 1 year, which grew to 16.1% by the second year. Target lesion revascularization (TLR) was recorded for 8.8% of patients in year 1 and 11.8% by year 2.
The ankle brachial index rose from 0.75 before stenting to 0.96 at the second year. Also at 2 years, 71.0% of patients were Rutherford-Becker class 0, while 93.5% could walk 1,500 feet.
"The Esprit drug-eluting BVS did not cause safety concerns and 2-year patency rates were encouraging," the investigators wrote.
John R. Laird, MD, and Gagan D. Singh, MD, both of the University of California Davis, agreed, writing in an accompanying editorial that "the data from ESPRIT I are intriguing, especially when comparing against 2-year TLR rates of 22% with bare metal stents and 17% with drug-eluting stents in patients with similar lesion characteristics."
"The investigators are to be congratulated on successfully demonstrating the safety and efficacy of the everolimus-eluting BVS with impressive 2-year angiographic and clinical outcomes," they concluded.
This is in contrast to other bioabsorbable devices — namely, the Igaki-Tamai PLLA stent and the Remedy BVS — that had been felled by high TLR and restenosis rates, according to Laird and Singh. "The initial theoretical promise of BVS for femoropopliteal disease fell short of expectations, likely because of the platform design and non-drug-eluting property of these particular scaffolds."
The Esprit is a bioabsorbable stent coated with a mixture of a polymer and everolimus.
The prospective ESPRIT I trial study included 35 patients who got peripheral artery stenting with the device at seven participating centers. These patients had focal, mild-to-moderately calcified TASC A external iliac arteries (11.4%) and superficial femoral arteries (88.6%).
Procedure-related complications occurred in 8.6% of patients, comprised of two groin hematomas and one flow-limiting dissection.
At 1 year, a patient with known coronary artery disease had a myocardial infarction. By 2 years, there was 1 death unrelated to the Esprit implantation and no amputations yet.
Despite the positive preliminary findings, Lammer and colleagues noted their small sample size as a major limitation. "The scaffold needs to be tested in TASC B and C lesions as well and should be compared to other drug-eluting technologies," the authors added.
To those caveats Laird and Singh added the narrow inclusion criteria that limit the generalizability of ESPRIT I, which included "the treatment of only short lesions (mean lesion length 36 mm), limited device diameter and length (6 x 58 mm), inclusion of lesions in the external iliac artery (11%), and exclusion of lesions in the popliteal artery."
Yet the editorialists reasoned that bioresorbable vascular scaffold stents might be here to stay for the treatment of PAD. The benefits of a device like Esprit, they listed, include a dissipated scaffold that can limit long-term inflammation; the facilitation of positive vascular remodeling and the preservation of vasomotion; potentially improved patency rates from the addition of drugs such as everolimus; the ability to conduct subsequent imaging with CT or MR angiography; and the option to perform future endovascular or surgical procedures in the target vessel.
"Unfortunately, the pathway to U.S. Food and Drug Administration approval for this first-generation platform or subsequent iterations of this device will be long and arduous," the duo noted.
"Until approval, when a scaffold is needed during endovascular treatment of complex femoropopliteal disease, we will be relegated to 'leaving metal behind.'"
ESPRIT I was sponsored by Abbott Vascular.
Lammer reported serving on the scientific advisory board for and receiving an honorarium from Abbott Vascular.
Laird disclosed relationships with Bard Peripheral Vascular, Boston Scientific, Cordis, Medtronic, Abbott Vascular, and W. L. Gore.
Singh declared no relevant conflicts of interest.
JACC: Cardiovascular Interventions
http://interventions.onlinejacc.org/article.aspx?articleid=2526797
Lammer J, et al "Bioresorbable everolimus-eluting vascular scaffold for patients with peripheral artery disease (ESPRIT I): 2-year clinical and imaging results" JACC Cardiovasc Interv 2016; DOI: 10.1016/j.jcin.2016.02.51.
Laird JR, et al "Leaving nothing behind: bioresorbable vascular scaffolds for femoropopliteal disease" JACC Cardiovasc Interv 2016; DOI: 10.1016/j.jcin.2016.04.002.