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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

language: English

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

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