ORIGINAL ARTICLE  RECENT DEVELOPMENTS IN THE MANAGEMENT OF CRITICAL LIMB ISCHEMIA 

The Journal of Cardiovascular Surgery 2019 December;60(6):679-85

DOI: 10.23736/S0021-9509.19.11109-3

Copyright © 2019 EDIZIONI MINERVA MEDICA

lingua: Inglese

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 ^{1, 2, 3} ✉, Jean Paul P. M. de VRIES ^{4, 5}, Debora A. WERSON ⁴, Bram FIOOLE ⁶, Dammis VROEGINDEWEIJ ⁷, Jan A. VOS ¹, Daniel van den HEUVEL, on behalf of the RAPID trial investigators 

¹ Department of Radiology, St. Antonius Hospital, Nieuwegein, the Netherlands; ² Department of Radiology, Maastricht University Medical Center, Maastricht, the Netherlands; ³ CARIM School for Cardiovascular Diseases, University of Maastricht, Maastricht, the Netherlands; ⁴ Department of Vascular Surgery, St. Antonius Hospital, Nieuwegein, the Netherlands; ⁵ Department of Vascular Surgery, University Medical Center Groningen, Groningen, the Netherlands; ⁶ Department of Vascular Surgery, Maasstad Hospital, Rotterdam, the Netherlands; ⁷ Department of Radiology, Maasstad Hospital, Rotterdam, the Netherlands

BACKGROUND: Endovascular treatment of occlusive disease of the superficial femoral artery (SFA) has evolved from plain old balloon angioplasty (POBA) 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 <2.4).
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.

KEY WORDS: Femoral artery; Peripheral arterial disease; Angioplasty, balloon; Stents