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Objective: To compare short- and mid-term outcomes of patients with femoropopliteal (FP) occlusive disease treated with a retrograde vs antegrade crossing strategy., Background: Few studies have directly compared procedural details and outcomes after retrograde vs antegrade crossing of FP lesions., Methods: Patients undergoing retrograde approaches to FP lesions were identified from the multicenter Excellence in Peripheral Artery Disease (XLPAD) registry between 2007 and 2015. These patients were matched 1:1 to patients treated with antegrade crossing strategies based on age, gender, comorbidities, indication for procedure, and lesion characteristics. Technical success, major adverse limb events (MALEs), and overall device cost were compared between retrograde and antegrade-only crossing., Results: A total of 116 patients (58 antegrade and 58 retrograde) were included. The retrograde group had higher prevalence of coronary artery disease and presence of chronic total occlusions. The retrograde approach was associated with significantly longer procedural time (186 ± 70 minutes vs 124.4 ± 60 minutes; P<.001), but similar technical success (91.4% vs 96.6%; P=.24). There was no significant difference in perioperative morbidity. Patients treated with a retrograde approach had a lower total amputation rate (8.6% vs 22.4%; P=.04) and no difference in overall mortality (8.6% vs 5.2%; P=.47). Mean procedural costs were similar in the antegrade and retrograde groups., Conclusion: In patients with similar disease characteristics, a retrograde approach to FP occlusive disease was associated with longer procedural time, but improved limb salvage, without significant difference in procedural cost.

Objective: The optimal antiplatelet regimen after lower extremity revascularization in patients with chronic limb-threatening ischemia (CLTI) is unknown because current recommendations are based on extrapolation of data from trials in coronary artery disease and stroke., Methods: We identified all patients undergoing an elective lower extremity revascularization for CLTI in the Vascular Quality Initiative registry discharged on a mono antiplatelet agent (MAPT) or dual antiplatelet therapy (DAPT)., Results: From 2003 to 2018, 50,890 patients underwent revascularization procedures for CLTI, and were discharged on MAPT or DAPT. Of these, 33,781 patients underwent endovascular therapy (EVT), and 17,109 patients underwent open surgery (OS) procedures. The rate of major amputation at 30 days in the target limb in the EVT group was 0.3% and 0.4% in the OS group (P = .22). On Kaplan-Meier analyses, patients on MAPT at discharge had a higher risk of 1-year major amputation compared with DAPT after EVT but not after OS procedures. Patients on MAPT had lower overall survival and amputation-free survival at 30 days and 1 year compared with DAPT after both EVT and OS. At 1 year, the MAPT group was at higher risk for target lesion reintervention after EVT compared with the DAPT group (15.9% vs 13%; P = .0012). There was no significant difference in thrombosis at 1 year between the MAPT and DAPT groups either after EVT (3.9% vs 3.7%; P = .3048) or OS (3.1% vs 3.2%; P = .2893). On Cox regression analysis, DAPT was associated with improved survival but not major amputation after both EVT and OS., Conclusions: In patients with CLTI, DAPT at the time of discharge has a positive impact on amputation-free survival and overall survival after both EVT and OS as well as target lesion reintervention after EVT. DAPT was not associated with a positive impact on major amputation after either EVT or OS., (Published by Elsevier Inc.)

Purpose: To report a propensity score analysis comparing outcomes of the Supera interwoven nitinol stent to bare nitinol stents (BNS) in the femoropopliteal segment. Materials and Methods: A retrospective study was conducted utilizing data extracted from the Excellence in Peripheral Artery Disease (XLPAD) registry ( ClinicalTrials.gov identifier NCT01904851) on 871 patients (mean age 65.1 years; 713 men) who underwent femoropopliteal balloon angioplasty with either Supera stent implantation in 118 limbs or other contemporary BNS in 753 limbs between January 2006 and December 2016. All patients in both groups were matched for baseline demographic and clinical characteristics in a 1:1 propensity score matching using the nearest neighbor method to create the 118-patient matched BNS cohort. One-year outcomes included all-cause mortality, target vessel revascularization (TVR), and target limb revascularization (TLR). An additional core laboratory analysis was conducted to measure the deployed length of Supera stents. Results: In unmatched data, the Supera stent group had a numerically lower rate of TVR (7.6% vs 13.4%, p=0.08) and a significantly lower 1-year TLR rate (7.6% vs 16.2%, p=0.02) compared to the BNS group. Both groups had similar 1-year mortality (2.5% vs 2.7%, p=0.9). Kaplan-Meier analysis demonstrated that the Supera group had a significantly lower risk of TVR (p=0.02) and TLR (p=0.002) than the BNS group. After propensity matching, the 1-year TVR estimate was lower for Supera stents (7.6% vs 12.7%, p=0.08) and significantly lower for TLR (7.6% vs 13.6%, p=0.04) than the BNS group. There was no statistically significant association between Supera stent elongation (>10% of the labeled stent length) and 1-year risk of TLR (p=0.6). Conclusion: Supera stent usage in femoropopliteal intervention was associated with reduced risk of 1-year repeat target limb revascularization compared with BNS treatment in both unmatched and matched cohorts.

Objective: Peripheral artery disease is a common comorbidity in patients with end-stage renal disease (ESRD), but there is a paucity of data comparing outcomes of different interventions in this group of patients. In this study, we examined perioperative outcomes of lower extremity endovascular revascularization (ER) and open revascularization (OR) in dialysis patients with critical limb ischemia (CLI)., Methods: Patients on dialysis and undergoing ER and OR for CLI from 2011 to 2015 were identified in the American College of Surgeons National Surgical Quality Improvement Program dataset. Patient demographics, comorbidities, anatomic features, and perioperative outcomes were compared between ER and OR procedures., Results: From 2011 to 2015, 1021 lower extremity revascularizations were performed in dialysis patients with CLI. In this group, 535 were ER (53%) and 486 were OR (47%) procedures. Although demographic characteristics such as age and gender were similar between the two groups, there was a higher proportion of Caucasians and African Americans in the OR group. Patients undergoing open and endovascular procedures had similar rates of hypertension, congestive heart failure, diabetes, chronic obstructive pulmonary disease, and bleeding disorders. A minority of procedures (4%) were emergencies, which were distributed equally between the two groups. Preoperative aspirin usage was higher in the ER group (84% vs 78%; P = .024), beta-blocker use was higher in the OR group (79% vs 74%; P = .08), and statin use was similar between the two groups (72% in OR and 70% in ER; P = .54). On risk-adjusted multivariate analysis, OR was associated with a lower rate of major amputation (5.97% vs 11.78%; odds ratio, 0.48; 95% confidence interval [CI], 0.26-0.85), but a higher rate of postoperative bleeding (29.6% vs 8.97%; odds ratio, 2.86; 95% CI, 1.8-4.35) and wound complications (15% vs 3%; odds ratio, 4.5; 95% CI, 2.38-8.3). The 30-day mortality and cardiovascular morbidity were similar between the two groups., Conclusions: In patients with ESRD with CLI, OR is associated with a lower risk of major limb amputation but a higher rate of postoperative wound complications and bleeding, compared with ER. Cardiovascular complications, 30-day mortality, reinterventions and readmissions were similar between the two groups. In patients with ESRD with CLI, OR should be considered as an option for limb salvage if feasible. Long-term outcomes comparing the two types of procedures are needed., (Published by Elsevier Inc.)

Background: Use of atherectomy for the treatment of peripheral arterial disease (PAD) is increasing as an adjunctive treatment to either conventional or drug-coated balloon angioplasty. There is limited data on atherectomy outcomes in below-the-knee (BTK) endovascular interventions., Methods: Data from the multicenter Excellence in Peripheral Artery Disease (XLPAD) registry (NCT01904851) were analyzed to examine predictors of atherectomy use and its associated 1-year patency rate. We analyzed 518 BTK procedures performed between January 2005 and December 2016., Results: Overall a total of 518 BTK procedures were treated in 430 patients, and 43% of interventions used atherectomy. African American patients were less likely (13% vs 25%; |standard residual| = 3.41) to be treated with atherectomy. Use of atherectomy was lower in chronic total occlusive (CTO) lesions (48% vs 58%; P = 0.02). There were no significant associations of baseline comorbidities, critical limb ischemia (CLI), ankle-brachial index, number of BTK vessel run-off, or vessel location with atherectomy use. Compared with patients without atherectomy, use of atherectomy was associated with lower incidence of repeat target limb intervention at 1 year after adjusting for age, CLI, in-stent restenosis, heavy calcification, presence of diffuse disease, and CTO lesion traits (Hazard Ratio 0.41, 95% confidence interval 0.23-0.72; P < 0.01)., Conclusions: Compared with no atherectomy, use of atherectomy in BTK interventions is associated with lower rates of 1-year repeat target limb revascularization. These findings require confirmation in prospective, randomized clinical studies., (© 2018 Wiley Periodicals, Inc.)

Background: The contemporary limb outcomes and costs of stent-based vs non-stent based strategies in endovascular revascularization of femoropopliteal (FP) peripheral artery disease (PAD) are not well understood., Methods and Results: We present data from the ongoing United States multicenter Excellence in Peripheral Artery Disease Registry between 2006-2016 to compare stent vs non-stent treatment outcomes and associated costs in FP interventions. A total of 2910 FP interventions were performed in 2162 patients (mean age, 66 years), comprising 1339 stent based (superficial femoral artery, 93%) in 1007 patients and 1571 non-stent interventions (superficial femoral artery, 85%) in 1155 patients. A growing trend for non-stent based interventions and a declining trend in repeat revascularization rate at 1 year were observed across years of registry enrollment. Stent implantation was the prevailing strategy in treating longer FP lesions (mean length, 152 mm vs 105 mm; P<.001) and chronic total occlusions (65% vs 40%; P<.001), while stent implantation was employed less frequently when treating in-stent restenotic lesions (14% vs 20%; P<.001). Stent and non-stent interventions had similar 1-year limb outcomes in all-cause death, target-limb revascularization, target-vessel revascularization, and major or minor amputation. The average procedure costs for the stent group were significantly higher than the non-stent group ($6215 vs $4790; P<.001)., Conclusion: There is a growing trend for non-stent FP artery interventions, with a significant decline in 1-year target-limb revascularization rates over time. One-year limb outcomes in stent-based compared to non-stent interventions are similar; however, at a significantly higher procedural cost.

With growing use of drug-coated balloons (DCB) for femoropopliteal (FP) artery interventions, there is limited information on rates of real-world adjunctive stent use and its association with short and long-term outcomes. We report on 225 DCB treated FP lesions in 224 patients from the Excellence in Peripheral Artery Disease (XLPAD) registry (NCT01904851) between 2014 and 2016. Cochran-Mantel-Haenszel and Wilcoxon rank sum statistics were used to compare stented (planned or 'bail-out') versus non-stented DCB treated lesions. Stents were implanted in 31% of FP DCB interventions. Among the 70 stents implanted, 46% were for 'bail-out' indications and 54% were planned. Lesions treated with stents were longer (mean 150 mm vs 100 mm; p < 0.001) and less likely to be in-stent restenosis lesions (10% vs 28%; p=0.003). Stenting was significantly more frequent in complex FP lesions, including chronic total occlusions (66% vs 34%; p < 0.001). For bail-out stenting, interwoven nitinol stents were the most common type (50%) followed by drug-eluting stents (34%) and bare-metal stents (22%). There were no differences in peri-procedural complication rates or 12-month target limb revascularization rates (18.6% vs 11.6%; p=0.162) or 12-month amputation rates (11.4% vs 11%; p=0.92) between lesions where adjunctive stenting was used versus lesions without adjunctive stenting, respectively. In conclusion, in a contemporary 'real-world' adjudicated multicenter US registry, adjunctive stenting was necessary in nearly a third of the lesions, primarily for the treatment of more complex FP lesions, with similar short and intermediate-term clinical outcomes compared with non-stented lesions. ClinicalTrials.gov Identifier: NCT01904851.

This study compares procedural complications and clinical outcomes between subintimal crossing versus intraluminal crossing during endovascular treatment of infrainguinal peripheral artery chronic total occlusions (CTO). We identified 1335 CTO interventions in 1001 patients from the multicenter Excellence in Peripheral Artery Disease (XLPAD) registry from January 2005 to October 2015. Outcomes included 30-day and 12-month all-cause death, non-fatal myocardial infarction or stroke, peripheral artery stent, or vessel, thrombosis (ST), need for any target limb endovascular or surgical revascularization, target limb major amputation and procedural complications. A subintimal crossing technique was necessary in 388 lesions (27% overall in 1335 lesions; 34% ( n=351) in 1023 femoropopliteal lesions, and 12% ( n=37) in 312 infrapopliteal lesions, p<0.01) with a lower procedural ( p<0.01) and technical ( p<0.01) success than the intraluminal in both femoropopliteal and infrapopliteal interventions. There were no significant differences in procedural complications, major adverse cardiac events, or clinically driven target limb revascularization at 1 year between the two groups, except a higher residual dissection rate in the subintimal crossing group than the intraluminal group in femoropopliteal target vessels ( p = 0.04).

Purpose: To determine whether diabetes mellitus has an independent impact on major limb outcomes at 1 year after endovascular treatment of lower extremity peripheral artery disease (PAD)., Methods: The study involved 1906 consecutive patients (mean age 66 years; 1469 men) enrolled in the observational Excellence in Peripheral Artery Disease (XLPAD) registry ( ClinicalTrials.gov identifier NCT01904851) between January 2005 and October 2015 after undergoing index endovascular procedures in 2426 limbs for arterial occlusive disease. Patient outcomes included 12-month target limb amputation (above ankle) and target limb revascularization as well as all-cause death. Kaplan-Meier analysis and adjusted Cox proportional hazard models were used for time-to-event analysis of outcomes for the entire study sample as well as for the critical limb ischemia (CLI) and claudication subgroups. Results of the Cox regression models are reported as the hazard ratio (HR) and 95% confidence interval (CI)., Results: Diabetics undergoing endovascular procedures had higher rates of comorbid conditions (p<0.001), CLI (p<0.001), heavily calcified lesions (p=0.002), multivessel disease (p=0.030), and fewer infrapopliteal runoff vessels (p<0.001). Regression analysis after adjusting for confounders revealed significantly higher target limb major amputation in diabetics compared with nondiabetics (HR 5.02, 95% CI 1.44 to 17.56, p=0.011). However, repeat revascularization rates were similar. When considering CLI and claudication subgroups, diabetes was associated with a nonsignificant increased risk of 12-month major amputation only for patients presenting with CLI (HR 3.48, 95% CI 0.97 to 12.51, p=0.056). Diabetes was also associated with an increased risk of 12-month all-cause mortality in the overall study sample (HR 4.64, 95% CI 2.01 to 10.70, p<0.001) and in the CLI subgroup (HR 14.15, 95% CI 3.16 to 63.32, p<0.001) but not in the claudication subgroup (HR 1.42, 95% CI 0.45 to 4.54, p=0.552)., Conclusion: Diabetes increases the risk of major amputation and all-cause death at 12 months following endovascular revascularization in patients with symptomatic PAD. These risks are especially heightened in patients presenting with CLI.

Paclitaxel-coated drug-coated balloons have significantly improved short-term and mid-term clinical outcomes in patients with symptomatic femoropopliteal peripheral artery disease. However, long-term results are awaited. Furthermore, the clinical success of drug-coated balloons in the infrapopliteal peripheral arteries has been more modest and overall similar to traditional balloon angioplasty, and remains an area of unmet clinical need. This article provides an overview of the clinical evidence for paclitaxel-coated balloons in the femoropopliteal and infrapopliteal peripheral artery distributions and future directions in this area., (Published by Elsevier Inc.)

This study examined a gender difference in 12-month patient outcomes after endovascular intervention for symptomatic peripheral artery disease (PAD) utilizing propensity score-matched Excellence in Peripheral Artery Disease registry data. Mortality and repeat intervention outcomes after endovascular treatment in women compared with men in the existing literature are inconsistent and confounded by other risk factors. The study included 1,084 patients who underwent 1,702 endovascular procedures, at 8 non-Veterans Administration hospitals from January 2005 to October 2015. Frailty hazard ratios by gender for time-to-event analysis were estimated. Women made up about 40% of the study population. After propensity score matching, 449 women and 449 men were included in the analysis, in which women had similar baseline patient and lesion characteristics, laboratory data, procedural characteristics, and medical therapy as men. Within 12-month postintervention, women were at a lower risk of mortality than men (p = 0.05); however, they underwent significantly more frequent repeat revascularization procedures (p = 0.04). In subgroup analysis, women with superficial femoral artery disease were also at higher risk of 12-month repeat intervention than men (p <0.01) and had a higher mortality risk, albeit with an attenuated significance (p = 0.07). Women with PAD are at a higher risk of 12-month repeat intervention than men., (Published by Elsevier Inc.)

Objectives: The aim of this study was to assess actual procedural costs and outcomes comparing wire-catheter and dedicated chronic total occlusion (CTO) device strategies to cross peripheral artery CTOs., Background: Peripheral artery CTO interventions are frequently performed, but there are limited data on actual procedural costs and outcomes comparing wire-catheter and dedicated CTO devices., Methods: The XLPAD (Excellence in Peripheral Artery Disease Intervention) registry (NCT01904851) was accessed to retrospectively compare cost and 30-day and 12-month outcomes of wire-catheter and crossing device strategies for treatment of infrainguinal peripheral artery CTO., Results: Of all 3,234 treated lesions, 42% (n = 1,362) were CTOs in 1,006 unique patients. Wire-catheter approaches were used in 82% of CTOs, whereas dedicated CTO devices were used in 18% (p < 0.0001). CTO crossing device use was associated with significantly higher technical success (74% vs. 65%; p < 0.0001) and mean procedure cost ($7,800.09 vs. $4,973.24; p < 0.0001). Because 12-month repeat revascularization (11.3% vs. 17.2%; p = 0.02) and amputation rates (2.8% vs. 8.5%; p = 0.002) in the CTO crossing device arm were lower compared with the wire-catheter group, the net cost for an initial CTO crossing device strategy was $423.80 per procedure., Conclusions: An initial wire-catheter approach to cross a peripheral artery CTO is most frequently adopted. The use of dedicated CTO crossing devices provides significantly higher technical success and lower reintervention and amputation rates, at a net cost of $423.80 per procedure at 12 months., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)