Optimized drug-coated balloon angioplasty of the superficial femoral and proximal popliteal arteries using the Tack Endovascular System: TOBA III 12-month results

J Vasc Surg. 2020 Nov;72(5):1636-1647.e1. doi: 10.1016/j.jvs.2020.01.078. Epub 2020 May 12.

Abstract

Objective: The Tack Endovascular System (Intact Vascular, Wayne, Pa) combines low-metallic content with focal delivery to seal areas of dissection associated with balloon angioplasty. The device system is designed to treat vascular dissections in the superficial femoral and proximal popliteal arteries. Tack implants exert low radial force and are associated with minimal metal burden, which reduces the mechanical stress on the arterial wall in treating dissections after balloon angioplasty. This study investigated the safety and effectiveness of the Tack Endovascular System in patients with dissections after drug-coated balloon (DCB) angioplasty.

Methods: The Tack Optimized Balloon Angioplasty III (TOBA III) study is a prospective, multicenter, single-arm study in which patients who underwent percutaneous transluminal angioplasty with the Medtronic IN.PACT Admiral DCB (Medtronic, Dublin, Ireland) and experienced dissection after angioplasty were treated with Tack implants. The primary end points were freedom from major adverse events at 30 days and primary patency at 12 months.

Results: A total of 201 patients were enrolled in the trial, 169 with standard-length lesions (≥20 mm and ≤150 mm) and 32 with long-length lesions (>150 mm and ≤250 mm). Safety and effectiveness results were favorable compared with historical benchmarks at 12 months in the standard-lesion cohort. Notably, patients in the standard-lesion cohort experienced 95.0% primary patency, 97.5% freedom from clinically driven target lesion revascularization, 100% freedom from amputation, and 100% survival at 12 months (P < .0001). Primary patency in long-lesion patients was 89.3%, freedom from clinically driven target lesion revascularization was 96.8%, and freedom from amputation was 100% at 12 months. Device success was achieved in 95.8% (182/190) and 97.7% (43/44) of devices deployed into standard-lesion and long-lesion patients, respectively. Procedural success was 99.4% (168/169) and 100% (44/44) in the standard-lesion and long-lesion cohorts, respectively, with only one bailout stent placed in the entire population.

Conclusions: The Tack Endovascular System is a safe and effective treatment option for patients with dissections after angioplasty in the superficial femoral and proximal popliteal arteries, with high patency, low rates of secondary intervention, and low incidence of bailout stenting when it is used in combination with DCB.

Trial registration: ClinicalTrials.gov NCT02802306.

Keywords: Angioplasty; Dissection; Peripheral artery disease; Proximal popliteal artery; Superficial femoral artery; Tack.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aneurysm, Dissecting / etiology
  • Aneurysm, Dissecting / surgery*
  • Angioplasty, Balloon / adverse effects
  • Angioplasty, Balloon / instrumentation*
  • Angioplasty, Balloon / statistics & numerical data
  • Coated Materials, Biocompatible / adverse effects
  • Female
  • Femoral Artery / surgery
  • Humans
  • Male
  • Middle Aged
  • Peripheral Arterial Disease / surgery*
  • Popliteal Artery / surgery
  • Postoperative Complications / etiology
  • Postoperative Complications / surgery*
  • Prospective Studies
  • Reoperation / statistics & numerical data
  • Stents / adverse effects*
  • Treatment Outcome
  • Vascular Patency

Substances

  • Coated Materials, Biocompatible

Associated data

  • ClinicalTrials.gov/NCT02802306