Patrick Björkman1, Tommi Auvinen2, Harri Hakovirta3, Pekka Romsi4, Johanna Turtiainen5, Hannu Manninen6, Maarit Venermo7. 1. Department of Vascular Surgery and University of Helsinki, Helsinki University Hospital, Helsinki, Finland. Electronic address: patrick.bjorkman@hus.fi. 2. Department of Vascular Surgery, Kuopio University Hospital, Kuopio, Finland. 3. Department of Vascular Surgery, Turku University Hospital, Turku, Finland. 4. Department of Vascular Surgery, Oulu University Hospital, Oulu, Finland. 5. Department of Surgery, Joensuu Central Hospital, Joensuu, Finland. 6. Department of Radiology, Kuopio University Hospital, Kuopio, Finland. 7. Department of Vascular Surgery and University of Helsinki, Helsinki University Hospital, Helsinki, Finland.
Abstract
BACKGROUND: Claudication and critical limb threatening ischemia are significant causes of mortality in the elderly. The gold standard of superficial femoral artery (SFA) revascularization is thus far considered to be the femoropopliteal bypass. The aim of this study was to compare mid-term patency between drug-eluting stents (DESs) and prosthetic bypass grafts (BSX). Studies have reported comparable results for both the methods. METHODS:Forty-six patients with claudication or rest pain due to a 5-25 cm SFA occlusion were randomized between DES and BSX groups. The follow-up period was 24 months, and the primary outcome measure was overall patency. Secondary outcome measures were primary and primary assisted patency, change in ankle-brachial index (ABI), and amputation-free survival. RESULTS: Forty-one patients were eventually analyzed. Six-month secondary patency was 91% (DES) versus 83% (BSX) (P = 0.450). The corresponding numbers at 12 months in the DES and BSX groups were 74% and 80% (P = 0.750), respectively. At 24 months, the respective numbers were 56% and 71% (P = 0.830). There were no statistically significant differences in primary or assisted primary patency at 1, 6, or 12 months. CONCLUSION: There were no demonstrable differences in patency rates or clinical outcomes such as ABI or major amputations between DES and BSX. Although underpowered, the results suggest noninferiority of the DES compared with prosthetic bypass surgery. TRIAL REGISTRATION: The trial was preregistered at ClinicalTrials.org (NCT01450722).
RCT Entities:
BACKGROUND:Claudication and critical limb threatening ischemia are significant causes of mortality in the elderly. The gold standard of superficial femoral artery (SFA) revascularization is thus far considered to be the femoropopliteal bypass. The aim of this study was to compare mid-term patency between drug-eluting stents (DESs) and prosthetic bypass grafts (BSX). Studies have reported comparable results for both the methods. METHODS: Forty-six patients with claudication or rest pain due to a 5-25 cm SFA occlusion were randomized between DES and BSX groups. The follow-up period was 24 months, and the primary outcome measure was overall patency. Secondary outcome measures were primary and primary assisted patency, change in ankle-brachial index (ABI), and amputation-free survival. RESULTS: Forty-one patients were eventually analyzed. Six-month secondary patency was 91% (DES) versus 83% (BSX) (P = 0.450). The corresponding numbers at 12 months in the DES and BSX groups were 74% and 80% (P = 0.750), respectively. At 24 months, the respective numbers were 56% and 71% (P = 0.830). There were no statistically significant differences in primary or assisted primary patency at 1, 6, or 12 months. CONCLUSION: There were no demonstrable differences in patency rates or clinical outcomes such as ABI or major amputations between DES and BSX. Although underpowered, the results suggest noninferiority of the DES compared with prosthetic bypass surgery. TRIAL REGISTRATION: The trial was preregistered at ClinicalTrials.org (NCT01450722).