Roles of Angioplasty With Drug-Coated Balloon for Chronic Ischemia in Wound Healing

2021 ◽  
pp. 152660282110250
Author(s):  
Yosuke Hata ◽  
Osamu Iida ◽  
Nobuhiro Ito ◽  
Yoshimitsu Soga ◽  
Masashi Fukunaga ◽  
...  
Keyword(s):  
Overall Survival ◽  
Wound Healing ◽  
Propensity Score ◽  
Limb Salvage ◽  
Outcome Measure ◽  
Primary Patency ◽  
Intergroup Difference ◽  
Chronic Ischemia ◽  
Artery Disease ◽  
Drug Coated Balloon

Purpose: Clinical trials have demonstrated sustained benefits of drug-coated balloon (DCB) angioplasty compared with noncoated balloon angioplasty in symptomatic peripheral artery disease (PAD) presenting with femoropopliteal (FP) artery disease. However, there is still controversy whether particulate embolization caused by crystalline paclitaxel, the so-called “downstream effect,” is adversely associated with clinical outcomes after use of FP DCB among chronic limb-threatening ischemia (CLTI) patients. The current RADISH (Roles of Angioplasty with Drug-coated balloon for chronic ISchemia in wound Healing) study investigated wound healing following DCB therapy vs non-DCB therapy for real-world CLTI patients presenting with FP lesions. Materials and Methods: This multicenter, retrospective study analyzed 927 patients with CLTI (mean age, 76±10 years; male, 57.8%; diabetes mellitus, 64.5%; dialysis, 50.7%) presenting with FP lesions and treated endovascularly via DCB (138 patients) vs non-DCB therapy (789 patients) between April 2014 and March 2019. The primary outcome measure was 1-year wound healing, while the secondary outcome measure was 1-year primary patency. Clinically-driven target lesion revascularization (CD-TLR), limb salvage and overall survival were also analyzed by using propensity score matching analysis. Results: The propensity score matching extracted 111 pairs (as many patients in the DCB group and 629 patients in the non-DCB group). The 1-year cumulative incidence of wound healing (95% CI) was 74.4% (62.6% to 82.5%) in the DCB group and 71.9% (60.4% to 80.1%) in the non-DCB group, with no significant intergroup difference (p=0.93). The DCB group had a higher rate of primary patency (p=0.002) and freedom from CD-TLR (p=0.010) than the non-DCB group, whereas there was no significant intergroup difference in limb salvage (p=0.21) or overall survival (p=0.93). Conclusion: The current analysis of data from the RADISH study demonstrated that DCB therapy did not lead to delayed wound healing and reduced restenosis rate in CLTI patients presenting FP lesions. From this results, DCB therapy would be a reasonable treatment option for CLTI patients.

Influence of pedal arch quality on 5-year survival and limb salvage in patients with diabetic foot ulcers undergoing peripheral angiography

Vascular ◽  
2021 ◽  
pp. 170853812110320
Author(s):  
Nicola Troisi ◽  
Azzurra Guidotti ◽  
Filippo Turini ◽  
Renzo Lombardi ◽  
Francesca Falciani ◽  
...  
Keyword(s):  
Coronary Artery Disease ◽  
Overall Survival ◽  
Renal Failure ◽  
Limb Salvage ◽  
Foot Ulcers ◽  
Diabetic Patients ◽  
Diabetic Foot Ulcers ◽  
Peripheral Angiography ◽  
Kaplan Meier ◽  
Artery Disease

Introduction The aim of this study was to evaluate the influence of pedal arch quality on 5-year survival and limb salvage in diabetic patients with foot wounds undergoing peripheral angiography. Methods Between January 2014 and December 2014, 153 diabetic patients with foot wounds underwent peripheral angiography. Final foot angiograms were used to allocate patients according to pedal arch: complete pedal arch (CPA), incomplete pedal arch (IPA), and absent pedal arch (APA). Five-year survival and limb salvage rates were analyzed with Kaplan–Meier curves and compared by means of Gehan–Breslow–Wilcoxon test. Associations of patient and procedure variables with overall survival and limb salvage outcomes were sought with univariate and multivariate analyses. Results A below-the-knee (BTK) artery was the target vessel in 80 cases (52.3%). Five-year Kaplan–Meier rates of survival were similar in all groups ( p = 0.1): CPA 30%, IPA 27.5%, and APA 26.4%. Five-year limb salvage rates were significantly better in patients with CPA/IPA ( p < 0.001): CPA 95.1%, IPA 94.3%, and APA 67.3%. In the whole population study, multivariate analysis showed significant association of smoking ( p = 0.01), chronic renal failure ( p = 0.02), and severity of foot wounds ( p < 0.001) with survival. Coronary artery disease ( p = 0.03), severity of foot wounds ( p = 0.001), and pedal arch status ( p = 0.05) showed strong association with limb salvage. Conclusions Pedal arch quality significantly affected limb salvage but not survival at 5 years in patients with diabetic foot ulcers. Smoking, chronic renal failure, and severity of foot wounds affected overall survival, whilst coronary artery disease, and severity of foot wounds limb salvage.

Abstract 3312: Cilostazol Improves Long-term Patency after Percutaneous Transluminal Angioplasty in Hemodialysis Patients with Peripheral Artery Disease

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Yoshitaka Kumada ◽  
Hideki Ishii ◽  
Toru Aoyama ◽  
Miho Tanaka ◽  
Takanobu Toriyama ◽  
...  
Keyword(s):  
Propensity Score ◽  
Peripheral Artery Disease ◽  
Percutaneous Transluminal Angioplasty ◽  
Transluminal Angioplasty ◽  
Primary Patency ◽  
Control Group ◽  
Peripheral Artery ◽  
Artery Disease ◽  
Percutaneous Transluminal

Background: Percutaneous transluminal angioplasty (PTA) has become common therapeutic standard for peripheral artery disease (PAD). Although initial success rate of PTA is high, higher restenosis rate is a limitation in hemidialysis (HD) patients. Cilostazol is a PDE3 inhibitor with anti-platelet and vasodilatory effects, and also inhibits the proliferation of the smooth muscle cells, and has been reported to reduce target lesion revascularization (TLR) in PAD patients. The aim of this study was to clarify the effects of cilostazol administration for long-term patency after PTA in HD patients. Methods: Consecutive 372 lesions of 193 HD patients undergoing successfully PTA were enrolled. They were divided into two groups; patients administered cilostazol (130 lesions of 71 patients) and those without cilostazol as a control (242 lesions of 122 patients). They were followed-up using Doppler ultrasound and/or angiography for 5 years. To minimize the selection bias for cilostazol administration, a propensity-matched analysis using the model including male, age, diabetes, critical limb ischemia (CLI), TASC C+D type, femoropopoliteal (FPA) lesion and stenting was performed. The propensity score was matched 1:1 with two-digit (AUC=0.69 using ROC analysis). Results: Mean follow-up period was 28±24months. Primary patency rate for 5 years was significantly higher in the cilostazol group than in the control group (53% vs 33%, p = 0.0003). Also, rates for freedom from TLR and for limb salvage were higher in cilostazol group than in control group (67% vs. 50%, p=0.011 and 88% vs. 72%, p =0.031, respectively). In 102 lesions matched after propensity score analysis, the primary patency for 5-year was significantly higher in the cilostazol group (58%) than in the control group (35%) (HR 0.48, 95%CI 0.30 – 0.76, p = 0.0017). Upon multivariate Cox analysis, Cilostazol (HR 0.50, 95%CI 0.26 – 0.87, p = 0.014), age (HR 1.03, 95%CI 1.01–1.07, p = 0.041), FPA lesion (HR 2.62, 95%CI 1.22–5.62, p = 0.013), TASC C+D type (HR 2.85, 95%CI 1.56 –5.20, p = 0.0006) and CLI (HR 4.09, 95%CI 2.10 –7.94, p <0.0001) were independent predictors of restenosis after PTA. Conclusion: These data suggest that cilostazol administration improves long-term patency after PTA in HD Patients with PAD.

Effectiveness of combined superficial femoral artery endovascular therapy with popliteal-to-distal bypass: A paradigm shift in surgical open bypass for chronic limb-threatening ischemia

Vascular ◽  
2020 ◽  
pp. 170853812098122
Author(s):  
Taira Kobayashi ◽  
Masaki Hamamoto ◽  
Takanobu Okazaki ◽  
Misa Hasegawa ◽  
Takashi Fujiwara ◽  
...  
Keyword(s):  
Wound Healing ◽  
Limb Salvage ◽  
Endovascular Therapy ◽  
Femoral Artery ◽  
Superficial Femoral Artery ◽  
Popliteal Artery ◽  
Primary Patency ◽  
Drug Eluting Stent ◽  
Secondary Patency ◽  
Nitinol Stent

Objectives The purpose of this study was to evaluate the results of combining superficial femoral artery endovascular therapy with distal bypass originating from the popliteal artery as a method of lower extremity revascularization in patients with chronic limb-threatening ischemia. Methods The records of patients undergoing combined superficial femoral artery endovascular therapy with popliteal-to-distal bypass for chronic limb-threatening ischemia from January 2014 to April 2020 at a single institution were retrospectively reviewed. The patients’ background, operative details, and long-term outcomes were analyzed. Results Fifty-two popliteal-to-distal bypasses with superficial femoral artery endovascular therapy were performed in 49 patients (33 men; mean age, 76 ± 9 years; diabetes mellitus, 80%; end-stage renal disease with hemodialysis, 47%). The Trans-Atlantic Inter-Society Consensus II classification of superficial femoral artery–popliteal lesion was “A” in 8 (15%) patients, “B” in 14 (27%) patients, “C” in 24 (46%) patients, and “D” in 6 (12%) patients. The intervention for superficial femoral artery lesions was plain old balloon angioplasty in 4 patients, self-expandable nitinol stent in 15 patients, drug-coated balloon in 18 patients, drug-eluting stent in 4 patients, stent graft in 10 patients, and interwoven nitinol stent in 1 patient. Distal bypass originated from the above-knee popliteal artery in 9 (17%) limbs and the below-knee popliteal artery in 43 (83%) limbs. The most common outflow artery was the posterior tibial artery (44%). The mean follow-up period was 17 ± 17 months. The primary and secondary patency of the graft was 44% and 72%, respectively, at 1 year and 39% and 72%, respectively, at 3 years. Primary patency and freedom from clinical-driven target lesion revascularization of superficial femoral artery endovascular therapy lesions were 85% and 90%, respectively, at 1 year and 63% and 75%, respectively, at 3 years. Limb salvage was 97% at 1 year and 92% at 3 years. Wound healing was 67% at 6 months and 83% at 12 months. Conclusions Combined superficial femoral artery endovascular therapy with popliteal-to-distal bypass may be a promising approach for patients with chronic limb-threatening ischemia because of durable patency, acceptable wound healing, and good limb salvage.

Inframalleolar bypass for chronic limb-threatening ischemia

2021 ◽  
pp. 1358863X2097846
Author(s):  
Filippo Benedetto ◽  
Domenico Spinelli ◽  
Narayana Pipitò ◽  
David Barillà ◽  
Francesco Stilo ◽  
...  
Keyword(s):  
Overall Survival ◽  
Limb Salvage ◽  
Popliteal Artery ◽  
Survival Rates ◽  
Primary Patency ◽  
Secondary Patency ◽  
Predicting Factors ◽  
Dorsalis Pedis Artery ◽  
Single Center Study ◽  
Good Patency

The aims of this study were to analyze the results of inframalleolar bypass for chronic limb-threatening ischemia (CLTI) and to identify outcome-predicting factors. All consecutive patients undergoing inframalleolar bypass for CLTI between 2015 and 2018 were included in this retrospective, single-center study. Outflow artery was the most proximal patent vessel segment in continuity with inframalleolar arteries. Bypasses originating from the popliteal artery were defined as ‘short bypasses’. Sixty patients underwent inframalleolar bypass, with four patients undergoing bilateral procedures, making a total of 64 limbs included. The mean age was 73 ± 14 and 52 (81%) were male. The great saphenous vein was the preferred conduit ( n = 58, 91%), in a devalvulated fashion ( n = 56, 88%). Superficial femoral artery was the most common inflow artery for ‘long’ grafts ( n = 22, 34%), while popliteal artery was the inflow artery for all ‘short’ grafts ( n = 25, 39%). Dorsalis pedis artery was chosen as an outflow artery in 41 patients (63%). Median follow-up was 21 months. Two-year primary and secondary patency, limb salvage, amputation-free survival, and overall survival rates were 67 ± 6%, 88 ± 4%, 84 ± 4%, 72 ± 6%, and 85 ± 4%, respectively. At multivariate analysis, dialysis was an independent predictor for poor primary patency (HR, 4.6; 95% CI, 1.62–13.05; p = 0.004), whereas a short bypass was independently associated with an increased primary patency (HR, 0.3; 95% CI, 0.10–0.89; p = 0.03). In conclusion, bypass grafting to the inframalleolar arteries resulted in good patency rates, limb salvage and overall survival. Dialysis patients had lower primary patency but still had good limb salvage and survival. Short bypass was a predictor of improved primary patency.

Orchid drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of femoropopliteal artery disease: 12-month result of the randomized controlled trial

Vascular ◽  
2021 ◽  
pp. 170853812110139
Author(s):  
Chuan-Jun Liao ◽  
Sheng-Han Song ◽  
Tan Li ◽  
Yang Zhang and Wang-de Zhang
Keyword(s):  
Randomized Controlled Trial ◽  
Percutaneous Transluminal Angioplasty ◽  
Controlled Trial ◽  
Transluminal Angioplasty ◽  
Primary Patency ◽  
Femoropopliteal Artery ◽  
Randomized Controlled ◽  
Artery Disease ◽  
Percutaneous Transluminal ◽  
Drug Coated Balloon

Purpose To assess the efficacy and safety of the Orchid drug-coated balloon (coated with paclitaxel) for the treatment of femoropopliteal artery disease versus percutaneous transluminal angioplasty in Chinese population. Methods This is a prospective, single center, single-blinded, randomized controlled trial that randomized (1:1) 60 patients (38 men; mean age 68.7 ± 8.8) to drug-coated balloon group ( n = 30) or percutaneous transluminal angioplasty group ( n = 30). The primary efficacy endpoint was primary patency of the target lesion and clinically driven target lesion revascularization (CD-TLR) at 12 months. The primary safety end point was freedom from perioperative death at 30 days and freedom from limb-related death and major amputation at 12 months. Results Baseline characteristics were similar between the two groups. Drug-coated balloon group resulted in higher primary patency (82.8% vs. 48.3%, p = 0.005) and lower CD-TLR rates (3.5% vs. 27.6%; p = 0.001) versus percutaneous transluminal angioplasty group at 12 months. The ABI was significantly higher in drug-coated balloon group than percutaneous transluminal angioplasty group (0.86 ± 0.13 vs. 0.72 ± 0.18, p = 0.025). There were no perioperative death at 30 days, no limb-related death and no major amputation at 12 months in either group. Conclusions The randomized controlled trial showed superior treatment effect with drug-coated balloon versus percutaneous transluminal angioplasty, with remarkably higher patency and lower CD-TLR rates. The result is consistent with other study and demonstrates the safety and efficacy of the Orchid drug-coated balloon for the treatment of femoropopliteal artery disease.

scholarly journals Systematic review of inframalleolar endovascular interventions and rates of limb salvage, wound healing, restenosis, rest pain, reintervention and complications

Vascular ◽  
2021 ◽  
pp. 170853812110042
Author(s):  
M Machin ◽  
HC Younan ◽  
AM Guéroult ◽  
S Onida ◽  
J Shalhoub ◽  
...  
Keyword(s):  
Systematic Review ◽  
Wound Healing ◽  
Limb Salvage ◽  
Peripheral Artery Disease ◽  
Critical Limb Ischaemia ◽  
Rest Pain ◽  
Peripheral Artery ◽  
Single Study ◽  
Artery Disease

Objectives Peripheral artery disease is estimated to affect 237 million individuals worldwide. Critical limb ischaemia, also known as chronic limb threatening ischaemia is a consequence of the progression of peripheral artery disease which occurs in ∼21% of patients over a five-year period. The aim of this systematic review is to assess the use of additional below-the-ankle angioplasty in comparison to the use of above-the-ankle angioplasty alone, and the subsequent rates of amputation, wound healing, restenosis, rest pain, reintervention and complications. Methods This systematic review was undertaken in accordance with PRISMA guidelines following a registered protocol (CRD42019154893). Online databases were searched using a search strategy of 20 keywords. Included articles reported the outcome for inframalleolar (pedal artery, pedal arch, plantar arteries) angioplasty with additional proximal angioplasty in comparison to proximal angioplasty alone. GRADE assessment was applied to assess the quality of the evidence. Results After screening 1089 articles, 10 articles met the inclusion criteria. Comparative performance assessment of below-the-ankle with above-the-ankle versus above-the-ankle angioplasty alone was undertaken in 3 articles, with the remaining 7 articles reporting outcomes of below-the-ankle with above-the-ankle angioplasty with no distinct comparator group. Significant decrease in major lower limb amputation at the last follow-up in the below-the-ankle group when compared with the above-the-ankle angioplasty alone group was observed in a single study (3.45% vs. 14.9%, p < 0.05). Improved wound healing rate at follow-up in the below-the-ankle group versus above-the-ankle angioplasty alone group was also reported in a single study (59.3% vs. 38.1%, p < 0.05). Subsequent rate of amputation after below-the-ankle angioplasty has been estimated as 23.5%. Conclusion To date, there is a lack of studies assessing inframalleolar interventions and their use in improving limb salvage, wound healing and symptomatology. Prospective RCTs should be undertaken with adequate participant numbers to be sufficiently powered and report clinically important end-points.

Outcomes of Pedal Artery Angioplasty Are Independent of the Severity of Inframalleolar Disease: A Subanalysis of the Multicenter RENDEZVOUS Registry

2020 ◽  
Vol 27 (2) ◽  
pp. 186-193 ◽  
Author(s):  
Yoshinori Tsubakimoto ◽  
Tatsuya Nakama ◽  
Daisuke Kamoi ◽  
Hiroshi Andoh ◽  
Kazushi Urasawa
Keyword(s):  
Wound Healing ◽  
Limb Salvage ◽  
Healing Rate ◽  
De Novo ◽  
Severe Disease ◽  
Success Rates ◽  
Moderate Disease ◽  
Artery Disease ◽  
Type 3 ◽  
Wound Healing Rate

Purpose: To examine the efficacy of pedal artery angioplasty (PAA) for chronic limb-threatening ischemia (CLTI) according to the severity of inframalleolar disease. Methods: In total, 257 consecutive CLTI patients (mean age 73.2 years; 175 men) with de novo infrapopliteal and inframalleolar artery disease were enrolled from the retrospective RENDEZVOUS registry. Inframalleolar artery disease was classified as moderate (Kawarada type 2, 144 patients) or severe (Kawarada type 3, 113 patients). PAA was performed in 140 patients: 66 (45.8%) with moderate disease and 74 (65.5%) with severe disease. The remaining 117 patients (78 with moderate disease and 39 with severe disease) underwent interventions that did not include PAA. The primary outcomes were the wound healing and limb salvage rates at 12 months after the initial treatment. The outcomes of the PAA and no-PAA groups were examined to determine any correlation between treatment efficacy and baseline disease severity. Results: The success rates of PAA among the patients with moderate and severe inframalleolar disease were 89.4% and 87.8%, respectively (p=0.683). The wound healing rate at 12 months was significantly higher in the PAA group than in the no-PAA group regardless of the severity of inframalleolar disease [moderate: 58.8% vs 40.0% (p=0.049); severe: 59.6% vs 33.2% (p=0.021), respectively]. The worst limb salvage rate (76.9%) was seen among patients in the no-PAA group with severe inframalleolar disease (no-PAA/moderate: 94.8%; PAA/moderate: 90.9%; and PAA/severe: 87.8%, p=0.028). Conclusion: PAA improves the wound healing rate of patients with CLTI regardless of the severity of inframalleolar disease. This treatment modality also might improve limb salvage rates in patients with severe inframalleolar disease affecting both the anterior and posterior pedal circulations.

Outcomes of the paclitaxel-eluting Eluvia stent for long femoropopliteal lesions in Asian patients with predominantly chronic limb-threatening ischemia

2021 ◽  
pp. 1358863X2098789
Author(s):  
Steven Kum ◽  
Jetty Ipema ◽  
Eline Huizing ◽  
Yih K Tan ◽  
Darryl Lim ◽  
...  
Keyword(s):  
Wound Healing ◽  
Clinical Improvement ◽  
Limb Salvage ◽  
Clinical Results ◽  
Target Lesion ◽  
Primary Patency ◽  
Lesion Length ◽  
Technical Success ◽  
Asian Patients ◽  
Run Off

The fluoropolymer-coated, paclitaxel-eluting Eluvia stent has shown promising results for the endovascular treatment of femoropopliteal artery lesions in patients with claudication. The aim of the current study was to evaluate efficacy and safety outcomes of the Eluvia stent for the treatment of long femoropopliteal lesions in Asian patients. This is a single-center, retrospective study. The primary endpoint was primary patency at 1 year. Secondary outcomes were 30-days complication rate, technical success, 1-year freedom from clinically driven target lesion revascularization (CD-TLR), limb salvage, survival, amputation-free survival (AFS), wound healing, and clinical improvement. A total of 64 patients with 67 femoropopliteal lesions were included; 78% suffered from diabetes and 84% had chronic limb-threatening ischemia (CLTI). Of those with ischemic wounds, 79% did not have run-off to the foot. Mean lesion length was 193 ± 128 mm and 52% were severely calcified. Primary patency at 1 year was 84% in the overall cohort and 91% in patients with complete lesion coverage with the Eluvia stent. Technical success was achieved in 100% of the cases and 30-day complications occurred in six patients. Twelve-month freedom from CD-TLR, limb salvage, survival, and AFS were 92%, 93%, 85%, and 80%, respectively. In 80% of patients, complete wound healing was experienced and 84% had clinical improvement after 1 year. The Eluvia stent showed promising 12-month patency and clinical results for femoropopliteal treatment in this CLTI-dominant patient population with severely calcified, long lesions. Patient numbers were, however, small; larger trials are required to validate these findings. Aneurysmal change seen in some cases also needs further investigation.

One-Year Clinical Outcome and Risk Factor Analysis of Directional Atherectomy Followed With Drug-Coated Balloon for Femoropopliteal Artery Disease

2021 ◽  
pp. 152660282110305
Author(s):  
Zibo Feng ◽  
Shuofei Yang ◽  
Hongfei Sang ◽  
Guanhua Xue ◽  
Qihong Ni ◽  
...  
Keyword(s):  
Risk Factor ◽  
Real World ◽  
Patency Rate ◽  
Primary Patency ◽  
Primary Patency Rate ◽  
Femoropopliteal Artery ◽  
Directional Atherectomy ◽  
The Mean ◽  
Artery Disease ◽  
Drug Coated Balloon

Purpose: This study investigated the 1-year clinical outcomes of directional atherectomy combined with drug-coated balloon (DA + DCB) in femoropopliteal artery disease (FPAD) from real-world experience. Materials and Methods: A retrospective study was conducted of patients treated between July 2016 and June 2019 using DA + DCB for FPAD. Patients’ demographics, comorbidities, clinical characteristics and outcomes, and angiography and duplex ultrasound findings were analyzed. The 6-month and 1-year primary patency, primary assisted patency, secondary patency, and freedom from clinically-driven target lesion revascularization (CD-TLR) were evaluated. Univariate and multivariate analyses were performed to identify risk factors of primary patency loss or CD-TLR. Results: Seventy-nine consecutive patients (83 lesions, mean age 70.9 years, 52 men) were included. Twenty-seven limbs had lifestyle-limiting claudication and 56 limbs had critical limb ischemia. There were 73 and 10 limbs with de novo lesion and in-stent restenosis, respectively. The mean lesion length of all the patients was 22.1 cm. The mean length of chronic total occlusions (CTOs) was 8.3 cm. Severe calcification was found in 32.5% cases. The 1-year primary patency rate was 80.8% and freedom from CD-TLR was 92.2%. The bailout stenting rate was 2.4%. Patients with CTO >10 cm had significantly lower 1-year primary patency rate and freedom from CD-TLR than did patients with CTO ≤10 cm. Total length of CTO (stratified as ≤5 cm, 5–10 cm, >10 cm) was identified as an independent risk factor of 1-year primary patency loss and CD-TLR. Conclusion: DA + DCB appears to be a safe and effective endovascular therapy to treat FPAD in real-world clinical practice, with a promising 1-year patency rate with a low rate of bailout stenting.

P4704The efficacy of intravascular ultrasound for patients with peripheral artery diseases presenting aorto-iliac artery disease

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
T Tsujimura ◽  
O Iida ◽  
M Takahara ◽  
Y Yamauchi ◽  
Y Shintani ◽  
...  
Keyword(s):  
Propensity Score ◽  
Propensity Score Matching ◽  
Clinical Outcomes ◽  
Intravascular Ultrasound ◽  
Stent Implantation ◽  
Primary Patency ◽  
Peripheral Artery ◽  
Baseline Characteristics ◽  
Artery Disease ◽  
The Impact

Abstract Background The use of intravascular ultrasound (IVUS) promotes better clinical outcomes for intervention in complex lesions. However, the data demonstrating whether use of IVUS improves primary patency following stenting for aorto-iliac lesions in patients with peripheral artery disease (PAD) are limited. Purpose The purpose of the current study was to investigate the impact of IVUS use on primary patency 12 months after stent implantation for aorto-iliac lesions. Methods We analyzed a clinical database of the OMOTENASHI registry (Observational prospective Multicenter registry study on Outcomes of peripheral arTErial disease patieNts treated by AngioplaSty tHerapy in aortoIliac artery), registering symptomatic PAD patients (Rutherford category 2, 3, or 4) undergoing endovascular therapy for aorto-iliac lesions between January 2014 and April 2016 in Japan. The current study analyzed 803 patients who underwent self-expandable stent implantation at 61 centers with the institutional volume known. The primary endpoint was 12-month restenosis, defined as ≥50% stenosis on computed tomography or angiography, or a peak systolic velocity ratio ≥2.5 on duplex ultrasound. When treatment strategies, endovascular procedures and clinical outcomes were compared between the patients treated with IVUS use and those treated without IVUS use, the propensity score matching was performed to minimize the inter-group difference in baseline characteristics. Results A total of 545 patients (67.9%) underwent IVUS-supported stent implantation. Patients treated with IVUS use had a lower prevalence of regular dialysis, whereas they had a higher prevalence of TASC II class D and chronic total occlusion. In patients treated with IVUS use, carbon dioxide contrast agent were more often used, and 0.035-inch guidewire was less frequently selected. Implanted stents in these patients were longer and smaller in diameter. The propensity score matching extracted 138 pairs, with no remarkable intergroup difference in baseline characteristics. Procedure time ≤1 hour was less frequent in patients treated with IVUS use; their radiation time was longer. Endovascular strategies, as well as postoperative medication were not significantly different between patients with and without IVUS use. The 12-month restenosis risk was not significantly different between patients with and without IVUS use (10.2% [6.9 to 14.9%] versus 10.3% [5.4 to 18.6%], P=0.99). Conclusion IVUS use in aorto-iliac stenting for patients with PAD was not associated with primary patency at 12 months. Acknowledgement/Funding None

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