Drug coated balloon supported Supera stent versus Supera stent in intermediate and long-segment lesions of the superficial femoral artery: 2-year results of the RAPID Trial

Sanne W. de Boer*, Jean Paul P. M. de Vries, Debora A. Werson, Bram Fioole, Dammis Vroegindeweij, Jan A. Vos, Daniel van den Heuvel, Gerlof P. Bosma, Lee H. Bouwman, Dittmar Boeckler, Dmitriy Dovzhanskiy, Otto E. Elgersma, Jan M. Heyligers, Rutger J. Hissink, Pieter Hooijboer, Bernart L. de Leeuw, Rudolf P. Tutein Nolthenius, Ted W. Vink, Floris A. Vos, RAPID trial investigators

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

BACKGROUND: Endovascular treatment of occlusive disease of the superficial femoral artery (SFA) has evolved from plain old balloon angioplasty (MBA) through primary stenting strategy to drug eluting technology-based approach. The RAPID Trial investigates the added value of drug coated balloons (DCB, Legflow) in a primary stenting strategy (Supera stent) for intermediate (5-15 cm) and long segment (>15 cm) SFA lesions.

METHODS: In this multicenter, patient-blinded trial, 160 patients with intermittent claudication, ischemic rest pain, or tissue loss due to intermediate or long SFA lesions were randomized (1:1) between Supera + DCB and Supera. Primary endpoint was primary patency at 2 years, defined as freedom from restenosis on duplex ultrasound (peak systolic velocity ratio

RESULTS: At 2 years, primary patency was 55.1% (95% CI: 43.1-67.1%) in the Supera + DCB group versus 48.3% (95% CI: 35.6-61.0%) in the Supera group (P=0.957). Per protocol analysis showed a primary patency rate of 60.9% (95% CI: 48.6-73.2%) in the Supera + DCB group versus 49.8% (95% CI: 36.9-62.7%) in the Supera group (P=0.469). The overall mortality rate was 5% in both groups (P=0.975). Sustained functional improvement was similar in both groups.

CONCLUSIONS: The 2-year results in the current trial of a primary Supera stenting strategy are consistent with other trials reporting on treatment of intermediate and long SFA lesions. A DCB supported Supera stent strategy did not improve patency rate compared to a Supera stent only strategy.

Original languageEnglish
Pages (from-to)679-685
Number of pages7
JournalJournal of Cardiovascular Surgery
Volume60
Issue number6
DOIs
Publication statusPublished - Dec 2019

Keywords

  • ANGIOPLASTY
  • Angioplasty
  • DISEASE
  • FEMOROPOPLITEAL LESIONS
  • FOLLOW-UP
  • Femoral artery
  • INTERWOVEN NITINOL STENT
  • LOWER-EXTREMITY
  • PACLITAXEL-ELUTING STENTS
  • Peripheral arterial disease
  • RANDOMIZED-TRIAL
  • RESTENOSIS
  • Stents
  • TASK-FORCE
  • UNCOATED BALLOON
  • balloon
  • REVASCULARIZATION

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