Lower extremity arterial disease vs. coronary artery disease: mortality differences after revascularization.

BACKGROUND AND AIMS: Patients undergoing revascularization for lower extremity arterial disease (LEAD) may face a higher risk of mortality than those with coronary artery disease (CAD). This study aimed to characterize the difference in mortality risk between patients undergoing revascularization for LEAD and CAD and identify associated factors. METHODS: The 1-year database of 10 754 patients undergoing revascularization for CAD (n = 6349) and LEAD (n = 4405) was analysed. Poisson regression models were used to characterize interpopulation differences in mortality, adjusting for baseline clinical features, including age, sex, polyvascular disease, comorbidities, medications, and vulnerabilities. RESULTS: Individuals with LEAD were older, were more likely to have polyvascular disease, had more comorbidities, and received fewer cardioprotective drugs than those with CAD. Vulnerabilities remained more common in the LEAD group even after adjusting for these clinical features. The crude risk ratio of mortality incidence for LEAD vs. CAD was 2.91 (95% confidence interval, 2.54-3.34), attenuated to 2.14 (1.83-2.50) after controlling for age, sex, and polyvascular disease. The percentage attenuation in the excessive mortality associated with LEAD was 29%. The stepwise addition of comorbidities, medications, and vulnerabilities as adjusting factors attenuated the incidence risk ratio to 1.48 (1.26-1.72), 1.33 (1.12-1.58), and 1.17 (0.98-1.39), respectively, and increased the percentage attenuation to 64%, 73%, and 86%, respectively. CONCLUSIONS: Mortality risk was almost three-fold higher in patients undergoing revascularization for LEAD than in those with CAD. The excessive mortality was considerably attributable to inter-group differences in baseline characteristics, including potentially clinically or socially modifiable factors.

Impact of a Less Than 50% Residual Stenosis Following Vessel Preparation in Femoropopliteal Drug-Coated Balloon Angioplasty.

PURPOSE: Drug-coated balloon (DCB) has been established as first-line therapy in femoropopliteal (FP) intervention, and successful vessel preparation (VP) is considered a key element. However, the clinical impact of successful VP remains unknown. This retrospective study examined the clinical impact of successful VP in DCB FP intervention. METHODS: In total, 268 patients (308 limbs) who underwent successful FP intervention using DCB without atherectomy devices for symptomatic lower extremity artery disease between March 2018 and December 2019 were included in this study (high-dose DCB: 69.8%; low-dose DCB: 30.2%). Successful VP was defined as <50% residual stenosis and

Pulmonary Vein Intervention for Severe Pulmonary Vein Stenosis After Atrial Fibrillation Ablation　- A Retrospective Cohort Study.

BACKGROUND: Pulmonary vein (PV) stenosis (PVS) is a serious complication of atrial fibrillation (AF) ablation. The objective of this study was to describe interventional treatments for PVS after AF ablation and long-term outcomes in Japanese patients.Methods and Results: This multicenter retrospective observational study enrolled 30 patients (26 [87%] male; median age 55 years) with 56 severe PVS lesions from 43 PV interventional procedures. Twenty-seven (90%) patients had symptomatic PVS and 19 (63%) had a history of a single AF ablation. Of the 56 lesions, 41 (73%) were de novo lesions and 15 (27%) were retreated. Thirty-three (59%) lesions were treated with bare metal stents, 14 (25%) were treated with plain balloons, and 9 (16%) were treated with drug-coated balloons. All lesions were successfully treated without any systemic embolic event. Over a median follow-up of 584 days (interquartile range 265-1,165 days), restenosis rates at 1 and 2 years were 35% and 47%, respectively. Multivariate Cox regression analysis revealed devices <7 mm in diameter (hazard ratio [HR] 2.52; 95% confidence interval [CI] 1.04-6.0; P=0.040) and totally occluded lesions (HR 3.33; 95% CI 1.21-9.15; P=0.020) were independent risk factors for restenosis. CONCLUSIONS: All PVS lesions were successfully enlarged by the PV intervention; however, restenosis developed in approximately half the lesions within 2 years.

Five-year outcomes of the GORE VIABAHN Endoprosthesis for the treatment of complex femoropopliteal lesions from a Japanese postmarket surveillance study.

Introduction: The safety and effectiveness of the GORE VIABAHN Endoprosthesis for treatment of symptomatic patients with peripheral artery disease (PAD) and complex femoropopliteal (FP) lesions was assessed in a real-world Japanese practice setting. Methods: A prospective, multicenter, postmarket surveillance study was conducted from 2016 to 2017 at 64 sites in Japan. Symptomatic patients with PAD and FP lesions ⩾ 10 cm and reference vessel diameters ranging from 4.0 to 7.5 mm were eligible for enrollment. Outcome measures evaluated at 5 years were primary patency (PP), primary-assisted patency (PAP), secondary patency (SP), freedom from target lesion revascularization (fTLR), occurrence of device- or procedure-related serious adverse events (SAEs), and stent fractures. Results: A total of 321 patients were enrolled and were a mean age of 73.9 ± 8.7 years; 77.3% were men and 26.5% had chronic limb-threatening ischemia (CLTI). The mean lesion length was 23.6 ± 6.6 cm and the frequency with TASC II C/D lesions and chronic total occlusions was 86.6% and 70.4%, respectively. The Kaplan-Meier estimated PP, PAP, SP, and fTLR at 5 years was 62.4%, 74.1%, 82.3%, and 75.9%, respectively. The mean ankle-brachial index was 0.92 ± 0.15 and the mean improvement in Rutherford class was 2.3 ± 1.4, which was maintained through 5 years. The rate of cumulative device- or procedure-related SAEs through 5 years was 19.9% with only 9.3% of those occurring after the first year. No stent fractures were observed through 5 years by x-ray evaluation. Conclusion: The 5-year safety and efficacy outcomes of the endoprosthesis were clinically acceptable for treating complex FP lesions in a real-world cohort of Japanese patients with PAD. (ClinicalTrials.gov Identifier: NCT04706273).

Three-year clinical course after fluoropolymer-based drug-eluting stent implantation for femoropopliteal lesions.

BACKGROUND: Although the 1-year clinical outcomes of fluoropolymer-based drug-eluting stents (FP-DES) were favorable for the treatment of real-world femoropopliteal lesions in symptomatic peripheral artery disease (PAD), their performance beyond 1 year remained unknown. The current study determined the 3-year clinical course of FP-DES implantation for real-world femoropopliteal lesions. METHODS: This multicenter, prospective, observational study evaluated 1204 limbs (chronic limb-threatening ischemia, 34.8%; mean lesion length, 18.6 ± 9.9 cm, chronic total occlusion: 53.2%) of 1097 patients with PAD (age, 75 ± 9 years; diabetes mellitus, 60.8%) undergoing FP-DES implantation for femoropopliteal lesions. The primary outcome measure was 3-year restenosis. The secondary outcome measures included 3-year occlusive restenosis, stent thrombosis, target lesion revascularization (TLR), and aneurysmal degeneration. RESULTS: The 3-year cumulative occurrence of restenosis was 27.3%, whereas that of occlusive restenosis, stent thrombosis, and TLR was 16.1%, 7.3%, and 19.6%, respectively. The annual occurrence of restenosis decreased by 12.0%, 9.5%, and 5.8% in the first, second, and third year, respectively (p < 0.001). Similarly, the rates of occlusive restenosis and stent thrombosis decreased (p < 0.001 and p = 0.007, respectively), whereas the rate of TLR remained unchanged for 3 years (p = 0.15). The incidence of aneurysmal degeneration at 3 years (15.7%) did not significantly differ from that at 1 and 2 years (p = 0.69 and 0.20, respectively). CONCLUSIONS: This study highlights the favorable long-term clinical course of FP-DES in real-world practice, emphasizing the importance of monitoring for occlusive restenosis and stent thrombosis while considering the potential onset of aneurysmal degeneration.

Difference in one-year late lumen loss between high- and low-dose paclitaxel-coated balloons for femoropopliteal disease.

The objective of the study is to investigate the difference in 1-year late lumen loss (LLL) between the high- (IN.PACT Admiral) and low-dose (Lutonix) paclitaxel-coated balloon (PCB). Although a recent randomized clinical trial demonstrated no difference in efficacy endpoint between high- and low-dose PCB, it remains unclear whether high-dose PCB was superior to low-dose PCB in actual clinical practice. We enrolled 64 patients with 67 de novo femoropopliteal lesions who underwent PCB angioplasty at Kokura Memorial Hospital from May 2014 to March 2020 and subsequent follow-up angiography after 1 year. The primary endpoint was 1-year LLL, whereas the secondary endpoints were binary restenosis and clinically driven target lesion revascularization (CD-TLR) after 1 year. The high- and low-dose PCB groups had 45 and 22 lesions, respectively. Although the low-dose PCB group had higher rates of coronary artery disease, hemodialysis, and chronic limb-threatening ischemia than the high-dose PCB group, the latter had a longer lesion length and more lesions with a TASC classification C or D than the former. The high-dose PCB group had a significantly lower LLL than the low-dose PCB group (0.40 ± 1.05 vs. 1.19 ± 1.03 mm; P = 0.003, respectively). Moreover, the high-dose PCB group had significantly lower rates of binary restenosis at 1 year than the low-dose PCB group (22.2% vs. 50.0%; P = 0.02, respectively). Moreover, negative LLL was only observed in the high-dose PCB group (33.3% vs. 0%, P = 0.005). The high-dose PCB group had a significantly lower LLL than the low-dose PCB group.

Sodium-glucose co-transporter 2 inhibitor use in patients with diabetes mellitus undergoing endovascular therapy for symptomatic peripheral artery disease.

BACKGROUND: This study aimed to reveal the prevalence of sodium-glucose co-transporter 2 (SGLT2) inhibitor treatment and its association with restenosis risk in patients with diabetes mellitus undergoing endovascular therapy for symptomatic peripheral artery disease. METHODS: We used the database of a multicenter prospective study registering patients with symptomatic peripheral artery disease undergoing femoropopliteal drug-coated balloon treatment in Japan. The current analysis included 1058 patients with diabetes mellitus free from end-stage renal disease. The association of clinical characteristics with SGLT2 inhibitor use was investigated using the logistic regression model. The propensity score matching was adopted to compare the primary patency, i.e., freedom from restenosis, after endovascular therapy between patients treated with and without a SGLT2 inhibitor. RESULTS: The proportion of SGLT2 inhibitor treatment at revascularization was 14.8% (95% confidence interval, 12.8-17.1%). Younger age, increased body mass index, and increased hemoglobin A1c levels were independently associated with SGLT2 inhibitor use (all P < 0.05). The proportion of SGLT2 inhibitor reached 38.2% (95% confidence interval, 25.4-52.3%) in patients with the three associated factors. The propensity score-matching analysis demonstrated that primary patency was not different between patients treated with a SGLT2 inhibitor and those without it (72.0% [95% confidence interval, 64.1-80.9%] versus 67.8% [62.7-73.3%] at 2 years; P = 0.45). CONCLUSIONS: SGLT2 inhibitors were not rarely used in patients with diabetes mellitus who underwent femoropopliteal endovascular therapy using a drug coated balloon for symptomatic peripheral artery disease in real-world settings. SGLT2 inhibitor treatment was not associated with an increased risk of restenosis.

Intravascular Ultrasound Guidance During Peripheral Vascular Interventions: Long-term Clinical Outcomes and Costs From the Japanese Perspective.

PURPOSE: The value of intravascular ultrasound (IVUS) guidance during peripheral vascular revascularization procedures is incompletely understood. Moreover, data on long-term clinical outcomes and costs are limited. The objective of this study was to compare outcomes and costs between IVUS and contrast angiography alone in patients undergoing peripheral revascularization procedures in Japan. MATERIALS AND METHODS: This retrospective comparative analysis was performed using the Japanese Medical Data Vision insurance claims database. All patients undergoing revascularization for peripheral artery disease (PAD) between April 2009 and July 2019 were included. Patients were followed until July 2020, death, or a subsequent revascularization procedure for PAD. Two patient groups were compared: one undergoing IVUS imaging or the other contrast angiography alone. The primary end point was major adverse cardiac and limb events, including all-cause-mortality, endovascular thrombolysis, subsequent revascularization procedures for PAD, stroke, acute myocardial infarction, and major amputations. Total health care costs were documented over the follow-up and compared between groups, using a bootstrap method. RESULTS: The study included 3956 patients in the IVUS group and 5889 in the angiography alone group. Intravascular ultrasound was significantly associated with reduced risk of a subsequent revascularization procedure (adjusted hazard ratio: 0.25 [0.22-0.28]) and major adverse cardiac and limb events (0.69 [0.65-0.73]). The total costs were significantly lower in the IVUS group, with a mean cost saving over follow-up of $18 173 [$7 695-$28 595] per patient. CONCLUSION: The use of IVUS during peripheral revascularization provides superior long-term clinical outcomes at lower costs compared with contrast angiography alone, warranting wider adoption and fewer barriers to IVUS reimbursement for patients with PAD undergoing routine revascularization. CLINICAL IMPACT: Intravascular ultrasound (IVUS) guidance during peripheral vascular revascularization has been introduced to improve the precision of the procedure. However, questions over the benefit of IVUS in terms of long-term clinical outcome and over cost have limited its use in everyday clinical practice. This study, performed in a Japanese health insurance claims database, demonstrates that use of IVUS provides a superior clinical outcome over the long term at a lower cost compared to angiography alone. These findings should encourage clinicians to use IVUS in routine peripheral vascular revascularization procedures and encourage providers to reduce barriers to use.

Effect of High-Dose Drug-Coated Balloon Repetition After Drug-Coated Balloon Failure.

PURPOSE: Although the optimal treatment for femoropopliteal (FP) drug-coated balloon (DCB) restenosis lesions remains debatable, the effectiveness of DCB repetition for DCB restenosis has been reported. However, the optimal DCB repetition strategy is not yet established. Thus, this study aimed to compare the clinical outcomes of high-dose DCB repetition with those of low-dose DCB repetition for FP DCB restenosis lesions. MATERIALS AND METHODS: This single-center, observational study used a clinical database of 677 consecutive patients undergoing FP endovascular intervention for symptomatic peripheral artery disease between December 2018 and December 2021. Of these patients, 89 cases treated with DCB repetition for FP DCB restenosis lesions were analyzed. The primary endpoint was recurrent restenosis (re-restenosis) and the secondary endpoints were recurrent target-lesion revascularization (TLR), re-occlusion, and major adverse limb events (MALE) obtained using propensity score matching. Interaction analysis was also performed to explore the effects of the baseline characteristics on the association between high- and low-dose DCB with restenosis risk. RESULTS: After propensity score matching, high-dose DCB demonstrated a significantly higher freedom from re-restenosis compared with low-dose DCB repetition at 1 year (90.4% vs 40.9%, p=0.034). In addition, freedom from re-TLR and MALE at 1 year was significantly higher in the high-dose DCB group (95.0% vs 53.3%, p=0.025; 95.0% vs 54.7%, p=0.025, respectively). Conversely, freedom rates from re-occlusion were not significantly different between the 2 groups (100.0% vs 84.0%, p=0.99). No baseline characteristics or perioperative outcomes had any significant interaction effect on the association of high-dose DCB versus low-dose DCB with restenosis risk. CONCLUSION: For FP DCB restenosis lesions, high-dose DCB repetition offered more favorable outcomes than low-dose DCB repetition. CLINICAL IMPACT: This study revealed that for femoropopliteal drug-coated balloon (DCB) restenosis lesions, high-dose DCB repetition obtained more favorable outcomes than low-dose DCB repetition. In addition, there was no significant interaction effect on the association of high- versus low-dose DCB with re-restenosis risk for the baseline characteristics and perioperative outcomes. This finding might be also a reason for choosing high-dose DCB repetition for FP DCB restenosis lesions in daily clinical practice.

Institutional Volume and Initial Results for Endovascular Treatment for Chronic Occlusive Lower-Extremity Artery Disease: A Report From the Japanese Nationwide Registry.

PURPOSE: Chronic total occlusion (CTO) remains as a major target for endovascular treatment (EVT) in improving symptomatic lower-extremity artery disease (LEAD). However, despite the technical demand and learning curve for the procedure, volume-outcome relationship of EVT targeted for CTO in symptomatic LEAD remains unclear. MATERIALS AND METHODS: Data were obtained from a nationwide registry for EVT procedures limited to the Japanese Association of Cardiovascular Intervention and Therapeutics between January 2018 and December 2020 from 660 cardiovascular centers in Japan. In total, 96 099 patients underwent EVT for symptomatic LEAD, and 41 900 (43.6%) underwent CTO-targeted EVTs during the study period. Institutional volume was classified into quartiles. The association of institutional volumes with short-term outcomes was explored using the generalized linear mixed model using a logit link function, in which, interinstitution variability was used as a random effect. RESULTS: The median institutional volume for all EVT cases per quartile was 29, 68, 125, and 299 cases/year for the first, second, third, and fourth quartiles, respectively. With each model analysis, the adjusted odds ratios (ORs) for technical success were significantly lower in patients who underwent EVT in institutions within the first quartile (<52 cases/year) than in the other quartiles (P < .01, respectively). On the contrary, the adjusted ORs for procedural complications were significantly higher in the first and second quartiles than in the third and fourth quartiles (P < .01, respectively). CONCLUSION: In contemporary Japanese EVT practice, a higher institutional volume but not operator volume was associated with a higher technical success rate and a lower procedural complication rate in patients with symptomatic LEAD involving CTO lesions. CLINICAL IMPACT: EVT for CTO lesions is still challenging for clinicians because of difficulties of wire/devise crossing or high procedural complications rate. Our study demonstrated that a higher institutional volume but not operator volume was associated with a higher technical success rate and a lower procedural complication rate in patients with symptomatic LEAD involving CTO lesions. In contemporary Japanese practice, a higher institutional experience has better impacts on short-term clinical outcomes. Future research should determine the relationship between institutional volume and long-term clinical outcomes.

Endovascular Therapy with Interwoven Nitinol Stent Placement after Predilation for Heavily Calcified Femoropopliteal Artery Disease: Results of the BURDOCK Study.

PURPOSE: To investigate the 1-year and 2-year clinical outcomes of interwoven stent (IWS) implantation for symptomatic femoropopliteal arterial disease with calcification. MATERIAL AND METHODS: This prospective multicenter study evaluated 308 limbs (63% with the peripheral arterial calcium scoring system 3 and 4 severe calcification and 87% with ≥180° calcification on intravascular ultrasound) of 299 patients (diabetes in 66.9%, chronic renal failure in 52.8%, and dialysis in 49.2%) who underwent IWS (Supera; Abbott, Abbott Park, Illinois) implantation after sufficient predilation (residual stenosis < 30%) for calcified femoropopliteal lesions. The primary outcome measure was primary patency (freedom from restenosis) at 1 and 2 years, whereas the secondary outcome measure included freedom from clinically driven target lesion revascularization (CD-TLR). Clinical parameters associated with loss of patency were explored. RESULTS: Kaplan-Meier analysis showed that primary patency was 88.2% (95% confidence interval [CI], 84.5%-92.1%) at 1 year and 80.8% (95% CI, 76.1%-85.8%) at 2 years. The CD-TLR-free rate was 96.5% and 94.8% at 1 and 2 years, respectively. The characteristics associated with loss of patency were restenotic lesion with and without stent implantation (adjusted hazard ratio, 1.96 and 2.40; P = .047 and .041, respectively), chronic total occlusion (adjusted hazard ratio, 1.88; P = .022), and popliteal involvement (adjusted hazard ratio, 2.60; P = .002). CONCLUSIONS: The implantation of IWS after sufficient predilation for calcified femoropopliteal atherosclerotic disease demonstrated clinically acceptable primary patency.

Clinical outcomes of chronic limb-threatening ischemia due to inflammatory nonatherosclerotic versus atherosclerotic etiologies undergoing revascularization.

BACKGROUND: The scope of clinical guidelines for the management of chronic limb-threatening ischemia (CLTI) is limited to atherosclerotic disease of the lower-extremity arteries. This study aimed to reveal the clinical features and prognoses of CLTI due to inflammatory nonatherosclerotic etiologies undergoing revascularization. METHODS: DECOPON (DatabasE of ChrOnic limb-threatening ischemia Presenting ischemic ulcer and gangrene due to nON-atherosclerotic disease) is a multicenter retrospective study that evaluated 465 limbs of 414 patients with CLTI undergoing revascularization for ischemic tissue loss with inflammatory nonatherosclerotic etiologies between 2010 and 2020. Clinical features and prognoses were compared with 930 limbs of 809 patients with atherosclerotic CLTI during the same period. RESULTS: The frequency of conventional atherosclerotic risk factors was significantly lower in the inflammatory nonatherosclerotic group. The inflammatory nonatherosclerotic group had more severe WIfI (wound, ischemia, and foot infection) W and fI grades, and more frequent infrapopliteal and inframalleolar artery diseases with a rarer presence of arterial calcification (all p < 0.05). Adjunctive therapy was more frequently performed in the inflammatory nonatherosclerotic group (p < 0.05). The inflammatory nonatherosclerotic group had a lower incidence rate of wound healing (0.64-fold, p < 0.001) and a higher incidence rate of major reintervention (2.30-fold, p = 0.006), whereas the risk ratio of all-cause mortality was 0.83-fold (p = 0.067). The association of inflammatory nonatherosclerotic disease with the delayed wound healing and the susceptibility to major reintervention remained significant even after adjustment for covariates (both p < 0.001). CONCLUSIONS: Patient, limb, and lesion characteristics of inflammatory nonatherosclerotic CLTI were considerably different from those of atherosclerotic CLTI. Inflammatory nonatherosclerotic CLTI was less likely to heal than atherosclerotic CLTI.

Impact of postprocedural minimum lumen area on clinical outcome after femoropopliteal drug-eluting stent implantation.

INTRODUCTION: Although favorable results of fluoropolymer-based drug-eluting stent (FP-DES) treatment for femoropopliteal lesions have been reported, it is unclear whether minimal lumen area (MLA) after FP-DES implantation affects clinical outcomes. This study aimed to reveal the association between intravascular ultrasound (IVUS)-evaluated MLA and the 1-year risk of restenosis and aneurysmal degeneration after FP-DES implantation for femoropopliteal lesions. METHODS: A subanalysis of the CAPSICUM (Contemporary outcomes After Paclitaxel-eluting peripheral Stent implantation for symptomatic lower limb IsChemia with sUperficial feMoral or proximal popliteal lesion) study analyzed 718 limbs in 686 patients with available IVUS-evaluated MLA data. The association of MLA with the 1-year risk of restenosis and aneurysmal degeneration was analyzed using the generalized propensity score method. RESULTS: The 1-year incidence rate of restenosis was estimated to be 8.8% (95% CI, 6.1% to 12.5%) for the upper quartile of MLA (21.1 mm2) versus 14.3% (95% CI, 10.7% to 18.7%) for the lower quartile of MLA (15.2 mm2), with an odds ratio of 0.58 (95% CI, 0.36 to 0.93; p = 0.024), whereas the 1-year incidence rate of aneurysmal degeneration was 23.8% (95% CI, 19.5% to 28.8%) for the upper quartile versus 16.8% (95% CI, 12.6% to 22.0%) for the lower quartile, with an odds ratio of 1.55 (95% CI, 1.04 to 2.32; p = 0.031). CONCLUSION: A large MLA after FP-DES implantation for femoropopliteal lesions was associated with decreased restenosis risk but increased aneurysmal degeneration risk. These findings suggest that MLA is a valuable predictor of clinical outcomes.

Primary results of the SAVAL randomized trial of a paclitaxel-eluting nitinol stent versus percutaneous transluminal angioplasty in infrapopliteal arteries.

BACKGROUND: Effective and durable options for infrapopliteal artery revascularization for patients with chronic limb-threatening ischemia (CLTI) are limited. METHODS: The SAVAL trial is a prospective, multicenter, randomized trial of patients with CLTI and infrapopliteal artery lesions with total lesion length ⩽ 140 mm, stenosis ⩾ 70%, and Rutherford category 4-5 assigned 2:1 to treatment with the SAVAL self-expandable paclitaxel drug-eluting stent (DES) or percutaneous transluminal angioplasty (PTA) with an uncoated balloon. The primary effectiveness endpoint was primary vessel patency (i.e., core lab-adjudicated duplex ultrasound-based flow at 12 months in the absence of clinically driven target lesion revascularization or surgical bypass of the target lesion). The primary safety endpoint was the 12-month major adverse event (MAE)-free rate; MAEs were defined as a composite of above-ankle index limb amputation, major reintervention, and 30-day mortality. The endpoints were prespecified for superiority (effectiveness) and noninferiority (safety) at a one-sided significance level of 2.5%. RESULTS: A total of 201 patients were enrolled and randomly assigned to treatment (N = 130 DES, N = 71 PTA). Target lesion length was 68.1 ± 35.2 mm for the DES group and 68.7 ± 49.2 mm for the PTA group, and 31.0% and 27.6% of patients, respectively, had occlusions. The 12-month primary patency rates were 68.0% for the DES group and 76.0% for the PTA group (Psuperiority = 0.8552). The MAE-free rates were 91.6% and 95.3%, respectively (Pnoninferiority = 0.0433). CONCLUSION: The SAVAL trial did not show benefit related to effectiveness and safety with the nitinol DES compared with PTA in infrapopliteal artery lesions up to 140 mm in length. Continued innovation to provide optimal treatments for CLTI is needed. (ClinicalTrials.gov Identifier: NCT03551496).

Clinical outcome of endovascular therapy using a VIABAHN VBX-covered stent for complex aortoiliac artery disease: the AVOCADO II study.

Clinical trials have demonstrated the efficacy of a balloon-expandable covered stent (CS) for aortoiliac occlusive disease (AIOD). However, the real-world clinical outcomes and the underlying factors remain unclear. We assessed the clinical outcomes and factors associated with primary patency after implantation of a balloon-expandable CS for patients with complex AIOD. This prospective multicenter observational study enrolled 149 consecutive patients undergoing VIABAHN® VBX-CS (W.L. Gore & Associates, Flagstaff, AZ) implantation for complex AIOD (age, 74 ± 9 years; male, 74%; diabetes mellitus, 46%; renal failure on dialysis, 23%; chronic limb-threatening ischemia, 26%). The primary study endpoint was 1-year primary patency, and the secondary endpoints were procedural complications, freedom from occlusion, clinical-driven target lesion revascularization (CD-TLR), and surgical revision at 1 year. Risk factors for restenosis were explored using random survival forest analysis. The median follow-up period was 13.1 months (interquartile range 9.7-14.0 months). Procedural complications were observed in 6.7% of the patients. The 1-year primary patency was 94.8% (95% confidence interval 91.0-98.6%), while the 1-year freedom rate from occlusion, CD-TLR, and surgical revision rates were 96.5% (93.5-99.5%), 94.7% (90.9-98.6%), and 97.8% (95.4-100%), respectively. The presence of chronic total occlusion, aortic bifurcation lesion, the number of disease regions, and TASC-II classification was significantly associated with the restenosis risk. In contrast, the calcification severity, IVUS use, IVUS parameters were not associated with restenosis risk. We observed excellent 1-year real-world outcomes after implantation of a balloon-expandable CS for complex AIOD; only a few perioperative complications occurred.

Twelve-month safety and effectiveness of TCD-17187 drug-coated balloon for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal artery.

PURPOSE: The aim of this preapproval trial was to evaluate the 12-month safety and effectiveness of the TCD-17187 drug-coated balloon (DCB) for the treatment of atherosclerotic lesions in the superficial femoral artery (SFA) and/or proximal popliteal artery (PA). METHODS: This was a prospective, multicenter, core laboratory adjudicated, single-arm trial. From October 2019 to November 2020, a total of 121 symptomatic peripheral artery disease patients with SFA and/or proximal PA lesions were enrolled. The primary effectiveness endpoint was 12-month primary patency defined as freedom from restenosis as determined by duplex ultrasonography in the absence of clinically driven target lesion revascularization (CD-TLR). The safety endpoint was the major adverse event (MAE) rate defined as freedom from a composite of device- and procedure-related death within 30 days, and index limb major amputation and/or CD-TLR through follow-up. RESULTS: Average age was 74.5 ± 7.3 years and the frequency of diabetes mellitus was 67.5%. Average lesion length and vessel diameter were 106.0 ± 52.6 and 5.2 ± 0.8 mm, respectively. The frequency of chronic total occlusion and bilateral calcification was 17.5% and 50.8% of patients, respectively. The 12-month primary patency rate calculated by Kaplan-Meier analysis was 81.1%, while 12-month freedom from CD-TLR was 95.8%. The MAE rate at 30 days was 1.7% and all events comprised CD-TLR. There were no instances of device- or procedure-related deaths, major amputations, or thrombosis throughout the 12-month evaluation period. CONCLUSION: This preapproval trial confirmed the safety and effectiveness of TCD-17187 DCB in the treatment of atherosclerotic lesions in the SFA and/or proximal PA.

Vessel Diameter Evaluated by Intravascular Ultrasound Versus Angiography.

PURPOSE: Although reference vessel diameter (RVD) is conveniently measured by angiography during femoropopliteal (FP) endovascular therapy (EVT) in clinical practice, angiography will potentially underestimate RVD. On the other hand, intravascular ultrasound (IVUS) can measure RVD precisely. The aim of this study was to reveal the difference between angiography- and IVUS-assessed RVD in patients undergoing FP-EVT for symptomatic peripheral artery disease (PAD). METHODS: We analyzed a prospective and multicenter database including 1967 limbs of 1725 patients with symptomatic PAD undergoing IVUS-supported FP-EVT. The study outcome measure was the difference between IVUS- and angiography-assessed distal RVD (ΔRVD), calculated as angiography-assessed RVD subtracted from IVUS-assessed RVD. The clinically important difference was defined as 1 mm or larger. RESULTS: IVUS-assessed RVD was significantly larger than angiography-assessed RVD (6.0±1.0 mm vs 5.0±1.0 mm; p<0.001). Mean ΔRVD (IVUS- minus angiography-assessed RVD) was 0.98 mm (95% CI, 0.94-1.03 mm). ΔRVD was 1 mm or larger in 48.8% (46.5%-51.0%) of the whole population. Multivariate analysis demonstrated that small angiography-assessed RVD, angiography-assessed bilateral calcification, and history of stent implantation were significantly associated with an increasing risk of ΔRVD ≥1mm, whereas presence of chronic total occlusion (CTO) was significantly associated with a decreasing risk of ΔRVD ≥1 mm. CONCLUSION: The current study revealed the difference between angiography-assessed reference lumen diameter and IVUS-assessed reference EEM diameter of FP lesions. About half of population had ΔRVD ≥1 mm. IVUS-assessed RVD was more likely to be different by angiography in cases with small vessels, CTO, bilateral calcification, and history of stent implantation.

Twelve-Month Outcomes From the Japanese Post-Market Surveillance Study of the Viabahn Endoprosthesis as Treatment for Symptomatic Peripheral Arterial Disease in the Superficial Femoral Arteries.

PURPOSE: To assess the midterm safety and effectiveness of the Gore® Viabahn® Endoprosthesis as treatment for symptomatic peripheral arterial disease (PAD) in the superficial femoral arteries (SFA). MATERIALS AND METHODS: A prospective, multicenter, post-market surveillance study was conducted in Japan. Patients with symptomatic SFA lesions ≥ 10 cm and reference vessel diameters ranging from 4.0 to 7.5 mm were eligible for enrollment; patients with traumatic or iatrogenic vessel injury in the thoracic, abdominal, or pelvic arteries were excluded. Outcomes evaluated at 12 months were primary patency (PP), primary-assisted patency (PAP), secondary patency (SP), freedom from target lesion revascularization (fTLR), occurrence of device- or procedure-related serious adverse events (SAEs), and stent fractures. RESULTS: From August 2016 to May 2017, 321 patients were enrolled at 64 Japanese sites (mean age, 73.9±8.7 years; 77.3% male). Hypertension, diabetes, and end stage renal disease were present in 84.4%, 54.8%, and 23.1% of patients, respectively. Mean lesion length was 23.6 cm±6.6 cm, with lesions ≥ 15 cm in 271 patients (84.4%). TASC C/D lesions accounted for 86.6% (39.1% TASC C, 47.5% TASC D); 26.5% had critical limb ischemia. Baseline ABI was 0.60±0.16. A total of 562 devices were implanted in 324 limbs, with a majority of patients (68.8%) receiving 2 stents. Through 12 months, 92.1% of patients were evaluable. Kaplan-Meier-estimated PP, PAP, and SP at 12 months was 85.6%, 91.7%, and 94.8%, respectively. Twelve-month fTLR was 92.3%. Mean change in ABI at 12 months was 0.343±0.21; mean improvement in Rutherford class was 2.5. Device- or procedure-related SAEs occurred in 3.1% through 30 days, with a majority of early SAEs consisting of access complications. Through 12 months, a cumulative 10.6% had device- or procedure-related SAEs, with the most common being device occlusions in 4.0%. Lower limb amputation occurred in 0.9% and was related to pre-existing ulceration or gangrene in all 3 cases. No stent fractures were observed at 12-month x-ray evaluation. CONCLUSION: In a real-world Japanese patient population characterized by long SFA lesions and complex PAD, the Viabahn endoprosthesis was associated with excellent patency rates through 12 months and an acceptable safety profile.

Clinical Safety and Efficacy of Rotational Atherectomy in Japanese Patients with Peripheral Arterial Disease Presenting Femoropopliteal Lesions: The J-SUPREME and J-SUPREME II Trials.

PURPOSE: The purpose of the J-SUPREME (J-S) and J-SUPREME II (J-SII) trials was to evaluate the performance of the Jetstream Atherectomy System for the treatment of Japanese patients with symptomatic occlusive atherosclerotic lesions in the superficial femoral and popliteal arteries. MATERIALS AND METHODS: The J-S and J-SII trials were both prospective, multicenter, single-arm clinical trials. Patients in J-S underwent Jetstream atherectomy followed by percutaneous transluminal angioplasty (PTA), whereas those in J-SII had adjunctive drug-coated balloon (DCB) treatment following atherectomy. Patients were adults with Rutherford category 2, 3, or 4 and had stenotic, restenotic, or occlusive lesion(s) with a degree of stenosis ≥70 in the superficial femoral artery and/or proximal popliteal artery. In J-S, lesions were required to be calcified, and in J-SII lesions were required to be severely calcified. RESULTS: A total of 50 patients were enrolled in J-S (mean age 72.3±8.7 years, lesion length 82.0±41.5 mm, 36% calcification PACSS Grade 3, 22% Grade 4) and 31 patients in J-SII (mean age 72.5±7.7 years, lesion length 122.6±55.6 mm, 19.4% calcification PACSS Grade 3, 77.4% Grade 4). No bailout stenting or bypass conversions were required. No major adverse events (MAEs) were reported for either trial through 1 month. The 6-month primary patency for J-S, with PTA alone following atherectomy, was 40.4% (19/47). The 6-month primary patency for J-SII, with DCB treatment following atherectomy, was 96.7% (29/30). At 6-month post-procedure, 79.2% (38/48) of patients in J-S, and 100% (30/30) of patients in J-SII had improved by at least 1 Rutherford category. CONCLUSION: J-SUPREME trial results demonstrate procedural safety and efficacy of the Jetstream Atherectomy System and J-SII showed sustained patency through 6 months following combination treatment with Jetstream atherectomy and DCB.

Vascular Pathology and Impact of Stent Eccentricity for Stent Restenosis in Femoropopliteal Endovascular Therapy.

PURPOSE: To explore the clinical features associated with stent eccentricity and reveal the impact of stent eccentricity on the risk of 1-year restenosis after femoropopliteal stent implantation for symptomatic atherosclerotic peripheral artery disease (PAD). MATERIALS AND METHODS: The clinical database of a multicenter prospective study was used. It registered 2,018 limbs of 1,766 patients in whom intravascular ultrasound (IVUS)-supported femoropopliteal endovascular therapy (EVT) for symptomatic atherosclerotic PAD was planned from November 2015 to June 2017. The study included 1,233 limbs of 1,088 patients implanted with a bare nitinol stent, drug-eluting stent (DES), or stent graft and administered ≥2 antithrombotic drugs. The stent eccentricity was evaluated using IVUS, calculated as [(maximum diameter) / (minimum diameter) - 1] at the cross-sectional segment with the lowest lumen area after stent implantation. RESULTS: Chronic total occlusion and bilateral arterial calcification (peripheral artery calcification scoring system Grades 3 and 4) were positively associated with stent eccentricity, whereas renal failure while receiving dialysis, DES use, and stent graft use were negatively associated with stent eccentricity (all P < .05). Stent eccentricity was associated with an increased risk of 1-year restenosis (odds ratio [OR], 1.18; 95% CI, 1.01-1.37; P = .034). However, after adjustment for lesion severity and implanted stent types, the association was no longer significant (OR, 1.07; 95% CI, 0.91-1.24; P = .43). CONCLUSIONS: Stent eccentricity was not significantly associated with the risk of 1-year restenosis after femoropopliteal EVT.