Rodrigo B Biagioni1, Luisa C Biagioni2, Felipe Nasser3, Marcelo C Burihan2, José C Ingrund2, Adnan Neser2, Fausto Miranda4. 1. Santa Marcelina Hospital, São Paulo, Brazil. Electronic address: rbbiagioni@gmail.com. 2. Santa Marcelina Hospital, São Paulo, Brazil. 3. Santa Marcelina Hospital, São Paulo, Brazil; HIAE (Hospital Israelita Albert Einstein), São Paulo, Brazil. 4. UNIFESP - Federal University of Sao Paulo, São Paulo, Brazil.
Abstract
OBJECTIVE: The aim was to analyse the effect of the treatment of more than one infrapopliteal artery with respect to wound healing and limb salvage. METHODS:Seventy-eight patients were enrolled prospectively for 80 procedures (80 limbs) that were randomly divided into two groups: 40 in the single vessel (SV) group and 40 in the multiple vessel group (MV). All patients had tissue loss. The choice of the first artery to treat was based on an analysis of two factors: the ease of the required endovascular technique and the presence of adequate distal outflow. The randomisation point was after the first successful distal artery angioplasty. The primary endpoints were the wound healing rate and limb salvage. RESULTS:The mean age of the patients was 69.1 ± 4.3 years, and 56% were male. Concomitant treatment of the femoral and popliteal arteries was performed in 38.8% of patients. All demographic characteristics and technical aspects were statistically comparable for both groups. Successful recanalisation was achieved in 95.8%, 86.2%, 86.9%, and 92.5% for the tibio-fibular trunk, anterior tibial, posterior tibial, and fibular artery, respectively. In the MV group, a higher contrast volume (29 mL more; p = .049), longer procedure time (p = .01), and higher radiation exposure (p = .04) were noted. There was no difference in renal function between the groups either before or 30 days after the procedure (p = .165). The limb salvage rates after 1 and 3 years, respectively, were 75.9% and 67% for the SV group and 91.1% and 91.1% for the MV group (log rank p = .052). The wound healing rates after 1 and 3 years, respectively, were 33.6% and 70.9% for the SV and 63.9% and 78.4% for MV group (log rank p = .006). Wound healing was faster in MV (2.11 cm2/month) than SV group (0.62 cm2/month; p = .004). CONCLUSION: Endovascular treatment of more than one artery was associated with better wound healing rates but not with better limb salvage.
RCT Entities:
OBJECTIVE: The aim was to analyse the effect of the treatment of more than one infrapopliteal artery with respect to wound healing and limb salvage. METHODS: Seventy-eight patients were enrolled prospectively for 80 procedures (80 limbs) that were randomly divided into two groups: 40 in the single vessel (SV) group and 40 in the multiple vessel group (MV). All patients had tissue loss. The choice of the first artery to treat was based on an analysis of two factors: the ease of the required endovascular technique and the presence of adequate distal outflow. The randomisation point was after the first successful distal artery angioplasty. The primary endpoints were the wound healing rate and limb salvage. RESULTS: The mean age of the patients was 69.1 ± 4.3 years, and 56% were male. Concomitant treatment of the femoral and popliteal arteries was performed in 38.8% of patients. All demographic characteristics and technical aspects were statistically comparable for both groups. Successful recanalisation was achieved in 95.8%, 86.2%, 86.9%, and 92.5% for the tibio-fibular trunk, anterior tibial, posterior tibial, and fibular artery, respectively. In the MV group, a higher contrast volume (29 mL more; p = .049), longer procedure time (p = .01), and higher radiation exposure (p = .04) were noted. There was no difference in renal function between the groups either before or 30 days after the procedure (p = .165). The limb salvage rates after 1 and 3 years, respectively, were 75.9% and 67% for the SV group and 91.1% and 91.1% for the MV group (log rank p = .052). The wound healing rates after 1 and 3 years, respectively, were 33.6% and 70.9% for the SV and 63.9% and 78.4% for MV group (log rank p = .006). Wound healing was faster in MV (2.11 cm2/month) than SV group (0.62 cm2/month; p = .004). CONCLUSION: Endovascular treatment of more than one artery was associated with better wound healing rates but not with better limb salvage.