A randomized comparison of two paclitaxel-coated balloons for the treatment of in-stent restenosis: The LONGTY ISR China randomized trial (LONGTY DCB vs. SeQuent Please DCB)

Catheter Cardiovasc Interv. 2021 May 1:97 Suppl 2:988-995. doi: 10.1002/ccd.29589. Epub 2021 Mar 18.

Abstract

Objectives: This study sought to compare the efficacy and clinical safety of the LONGTY drug-coated balloon (DCB) with those of SeQuent Please DCB in patients with in-stent restenosis (ISR).

Background: Although DCB technologies have evolved, little is known about the clinical efficacy of the new-generation LONGTY DCB.

Methods: This was a prospective, multicenter, randomized, noninferiority trial comparing LONGTY DCB with SeQuent Please DCB in patients with ISR. The primary endpoint was target lesion late lumen loss at 9 months' follow-up.

Results: A total of 211 patients with ISR from 13 Chinese sites were included (LONGTY DCB, n = 105; SeQuent Please DCB, n = 106). Device success was achieved in all patients. At the 9 month angiographic follow-up, target lesion late lumen loss was 0.35 ± 0.42 mm with LONGTY and 0.38 ± 0.45 mm with SeQuent Please (p for noninferiority <.001). The target lesion revascularization rates at 1 year were similar in both DCB groups (15.24 vs. 13.21%; p = .673). Over an extended follow-up of 2 years, the clinical endpoints, including cardiac death, myocardial infarction, and thrombus rate, were extremely low and similar in both groups.

Conclusions: In this multicenter, head-to-head, randomized trial, the new-generation LONGTY DCB was noninferior to the SeQuent Please DCB for the primary endpoint of target lesion late lumen loss at 9 months.

Keywords: clinical outcomes; coronary artery disease; drug-coated balloon; stent restenosis.

Publication types

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

MeSH terms

  • Angioplasty, Balloon, Coronary* / adverse effects
  • Cardiovascular Agents* / adverse effects
  • China
  • Coated Materials, Biocompatible
  • Coronary Restenosis* / diagnostic imaging
  • Coronary Restenosis* / etiology
  • Coronary Restenosis* / therapy
  • Drug-Eluting Stents*
  • Humans
  • Paclitaxel / adverse effects
  • Prospective Studies
  • Time Factors
  • Treatment Outcome

Substances

  • Cardiovascular Agents
  • Coated Materials, Biocompatible
  • Paclitaxel