Single arm retrospective study of bioresorbable vascular scaffolds to treat patients with severe infrapopliteal arterial disease

Abstract

Objectives To assess the safety and efficacy of the Absorb bioresorbable vascular scaffold (BVS) in complex, infrapopliteal lesions for the management of chronic limb ischemia. Background The interventional management of infrapopliteal PAD remains challenging due to high restenosis rates with metallic drug‐eluting stents and balloon angioplasty. Metallic stents are associated with impaired vessel vasomotor tone, remodeling, autoregulation, and long‐term inflammation. BVSs are biodegradable scaffolds that provide short‐term vascular support before degrading to allow restoration of vasomotor tone and endothelial function. A recent trial reported excellent 12‐month vessel patency rates in simple infrapopliteal arterial lesions treated with Absorb BVS. Methods This single‐center, retrospective study evaluated the use of the Absorb BVS (everolimus impregnated poly‐L‐lactic scaffold) in patients with infrapopliteal PAD with respect to safety (thrombosis and TIMI bleeding), technical success, and clinically driven target vessel failure (CD‐TVF) at 12 months. Results Thirty‐one patients (51.6% male) with a median age of 67 years with advanced infrapopliteal disease were treated with 49 BVS in 41 vessels. The mean stenosis was 94% (80–100), with 49% of lesions being CTOs. No scaffold thrombosis or periprocedural bleeding was observed. Procedural success was achieved in all patients. Freedom from CD‐TVF was 95.1% at 12 months driven by one revascularization and one amputation. Primary patency was 96.7% at 12 months. All patients were alive at 12 months, and 96.8% of patients improved their Rutherford–Becker classification. Conclusions At 12 months, our study found that patients with advanced infrapopliteal PAD who were treated with Absorb BVS reported improved clinical status and a low rate of CD‐TVF.

Early and Midterm Experience With the Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold in Asian Patients With Chronic Limb-Threatening Ischemia: One-Year Clinical and Imaging Outcomes From the DISAPEAR Registry

“…The limb salvage rates were also numerically lower in the AMS vs PTA groups (87.6% vs 92.4%, respectively; p=0.434). 22 On the contrary, the findings from our study and others 14–16 collectively suggest that the Absorb BVS may be an effective and safe option for the treatment of infrapopliteal disease, even in high-risk CLTI patients.…”

Two-year follow-up of bioresorbable vascular scaffolds in severe infra-popliteal arterial disease

“…Figure 1 demonstrates a long severely diseased peroneal artery lesion that was successfully treated with three overlapping Absorb vascular scaffolds. 17 Each patient was required to be on DAPT therapy for at least three months, the remainder of the duration of therapy was left up to the discretion of the operator.…”

Commentary: Bioresorbable Drug-Eluting Scaffold for Peripheral Artery Disease: The Best of Two Worlds or Unnecessary?

“…Including the current report, 4 the results of 165 patients with infrapopliteal artery disease treated with BVS have been published. [3][4][5][6][7] In 60 patients treated with a magnesium stent, 3 the 6-month patency rate of 32% was lower compared with the angioplasty-only control group. In the other 105 patients, an everolimus-eluting PLLA scaffold was used; the 12-month patency rate ranged from 86% to 97%.…”

“…In the other 105 patients, an everolimus-eluting PLLA scaffold was used; the 12-month patency rate ranged from 86% to 97%. [4][5][6][7] BVS have thus far been tested in 160 patients with symptomatic PAD due to external iliac, common femoral, and femoropopliteal arterial obstructions. [8][9][10][11][12] The 1-year primary patency rates ranged widely between 88% (PLLA with drug elution) 8 and 32% (PLLA without drug elution).…”

“…In the other 105 patients, an everolimus-eluting PLLA scaffold was used; the 12-month patency rate ranged from 86% to 97%. 4–7…”