학술논문
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.
Document Type
Academic Journal
Author
de Boer SW; Department of Radiology, St. Antonius Hospital, Nieuwegein, the Netherlands - s.deboer@mumc.nl.; Department of Radiology, Maastricht University Medical Center, Maastricht, the Netherlands - s.deboer@mumc.nl.; CARIM School for Cardiovascular Diseases, University of Maastricht, Maastricht, the Netherlands - s.deboer@mumc.nl.; de Vries JPPM; Department of Vascular Surgery, St. Antonius Hospital, Nieuwegein, the Netherlands.; Department of Vascular Surgery, University Medical Center Groningen, Groningen, the Netherlands.; Werson DA; Department of Vascular Surgery, St. Antonius Hospital, Nieuwegein, the Netherlands.; Fioole B; Department of Vascular Surgery, Maasstad Hospital, Rotterdam, the Netherlands.; Vroegindeweij D; Department of Radiology, Maasstad Hospital, Rotterdam, the Netherlands.; Vos JA; Department of Radiology, St. Antonius Hospital, Nieuwegein, the Netherlands.; van den Heuvel D; Department of Radiology, St. Antonius Hospital, Nieuwegein, the Netherlands.
Source
Publisher: Edizioni Minerva Medica Country of Publication: Italy NLM ID: 0066127 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1827-191X (Electronic) Linking ISSN: 00219509 NLM ISO Abbreviation: J Cardiovasc Surg (Torino) Subsets: MEDLINE
Subject
Language
English
Abstract
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.
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.