Differences Between Patients With Intermittent Claudication and Critical Limb Ischemia Undergoing Endovascular Intervention: Insights From the Excellence in Peripheral Artery Disease Registry.

BACKGROUND: There are limited data on differences in angiographic distribution of peripheral artery disease and endovascular revascularization strategies in patients presenting with intermittent claudication (IC) and critical limb ischemia (CLI). We aimed to compare anatomic features, treatment strategies, and clinical outcomes between patients with IC and CLI undergoing endovascular revascularization. METHODS: We examined 3326 patients enrolled in the Excellence in Peripheral Artery Disease registry from 2006 to 2019 who were referred for endovascular intervention for IC (n=1983) or CLI (n=1343). The primary outcome was 1-year major adverse limb events, which included death, repeat target limb revascularization, or target limb amputation. RESULTS: Patients with CLI were older and more likely to have diabetes and chronic kidney disease and less likely to receive optimal medical therapy compared with IC. Patients with IC had higher femoropopliteal artery interventions (IC 87% versus CLI 65%; P<0.001), while below the knee interventions were more frequent in CLI (CLI 47% versus IC 12%; P<0.001). Patients with CLI were more likely to have multilevel peripheral artery disease (CLI 32% versus IC 15%, P<0.001). Patients with IC were predominantly revascularized with stents (IC 48% versus CLI 37%; P<0.001) while balloon angioplasty was more frequent in CLI (CLI 37% versus IC 25%; P<0.001). All-cause mortality was higher in patients with CLI (CLI 4% versus IC 2%; P=0.014). Major adverse limb event rates for patients with IC and CLI were 16% and 26%, respectively (P<0.001) and remained higher in CLI after multivariable adjustment of baseline risk factors. CONCLUSIONS: Patients with IC and CLI have significant anatomic, lesion, and treatment differences with significantly higher mortality and adverse limb outcomes in CLI. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01904851. Graphic Abstract: A graphic abstract is available for this article.

Clinical outcomes of patients with and without chronic kidney disease undergoing endovascular revascularization of infrainguinal peripheral artery disease: Insights from the XLPAD registry.

OBJECTIVES: The purpose of the present study was to define clinical outcomes of chronic kidney disease (CKD) patients undergoing endovascular revascularization of infrainguinal peripheral artery disease (PAD). BACKGROUND: CKD is an established predictor of advanced PAD. However, clinical outcomes for these patients following endovascular revascularization remain inadequately defined. METHODS: Using the ongoing multicenter Excellence in Peripheral Artery Disease (XLPAD) registry (NCT01904851), we analyzed all-cause death, target limb amputation, and need for repeat revascularization for patients with and without CKD undergoing infrainguinal endovascular revascularization between the years 2005 and 2018. RESULTS: Of 3,699 patients, 15.1% (n = 559) had baseline CKD. CKD patients had significantly higher incidence of heavily calcified lesions (48.4% vs. 38.1%, p < .001) and diffuse disease (66.9% vs. 61.5%, p = .007). Kaplan-Meier analysis showed significant differences between CKD and non-CKD patient outcomes at 12 months for freedom from target limb amputation (79.9% vs. 92.7%, p < .001) and all-cause death (90.1% vs. 97.6%, p < .001). However, freedom from target vessel revascularization was similar between the groups. After adjusting for baseline comorbidities in the CKD and non-CKD groups, the hazard ratios for target limb amputation and death at 12 months were 2.28 (95% confidence interval or CI 1.25-4.17, p < .001) and 4.38 (95% CI 2.58-7.45, p < .001), respectively. CONCLUSIONS: Following endovascular revascularization for infrainguinal PAD, CKD was an independent predictor of all-cause death and target limb amputation at 12 months.

Comparative 12-Month Outcomes of Drug-Coated Balloon Versus Non-Drug-Coated Balloon Revascularization Strategy in Chronic Limb-Threatening Ischemia: Results From the XLPAD Registry.

BACKGROUND: Endovascular therapy is often the preferred first treatment option for chronic limb threatening ischemia (CLTI) patients. Drug coated balloons (DCB) reduce restenosis rates compared to percutaneous transluminal angioplasty (PTA), however DCB use has not been studied systematically in patients with CLTI. Thus, the optimal treatment option for these complex lesions remains controversial. METHODS: We report on 327 patients with CLTI treated either with DCB (n = 105) or non-DCB (n = 222) for femoropopliteal disease. Data were retrieved from the Excellence in Peripheral Artery Disease (XLPAD) registry (NCT01904851). Two DCB types were used at the discretion of the operator: Lutonix® (BARD Peripheral Vascular, Inc., Tempe, AZ, USA) and IN.PACT AdmiralTM (Medtronic, Santa Rosa, CA, USA). Odds ratios and the respective 95% confidence interval were synthesized to examine the association between the two groups in terms of all-cause mortality, target limb repeat endovascular or surgical revascularization, target vessel revascularization (TVR), major and minor amputation at 12 months of follow up. RESULTS: The mean lesion length was 150.0 mm (SD:123.2) and 151.2 mm (SD:108.3) for the DCB and non-DCB group respectively. No difference between the two groups was detected in terms of all-cause mortality (2.86%vs2.7%,p = .94), target limb repeat endovascular or surgical revascularization (16.19%vs12.61%,p = .25), TVR (16.19%vs.11.71%,p = .26) or minor amputation (15.24%vs10.81%,p = .25) at 12 months of follow up. Although a higher incidence of 12 months major amputation was observed in the DCB group (11%vs.4%,p = .01), after adjusting for several risk factors the odds of major amputation were not statistically different between the DCB and non-DCB groups (OR:1.54;95%CI:0.53-4.51;p = .43). CONCLUSIONS: Both DCB and non-DCB strategies are effective modalities for revascularization of patients with CLTI. No differences were identified between the DCB and non-DCB group in terms of late outcomes during 12 months of follow up.

Atherectomy in below-the-knee endovascular interventions: One-year outcomes from the XLPAD registry.

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.

Intravenous Antiplatelet Therapy Bridging in Patients Undergoing Cardiac or Non-Cardiac Surgery Following Percutaneous Coronary Intervention.

BACKGROUND: The effect of perioperative bridging therapy on risks of ischemic cardiac events and major bleeding complications in patients on dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI) remains undefined. METHODS: We report on 60 consecutive patients between 2010 and 2017 who required cardiac (CS; n = 15) or non-cardiac (NCS; n = 45) surgeries following PCI at our institution. Short-acting intravenous (IV) antiplatelet (APT) bridging with eptifibatide, tirofiban and cangrelor were instituted after DAPT interruption. RESULTS: All patients were men with multiple atherosclerosis risk factors. An acute coronary syndrome indication (56.7%) was the most common PCI indication in the CS and NCS groups. Drug-eluting stents were used in 93.33% and 95.56% of the above groups, respectively. The median duration from PCI to CS and NCS were 11.17 and 18.25 months, respectively and 38.33% of all surgeries were performed within 6 months of the index PCI. Most patients were on background aspirin (83.33%) and clopidogrel (81.67%) and median duration of DAPT interruption was 7 days. Median duration of perioperative IV APT bridging was 3 days for CS and 5 days for NCS groups. In the CS group, two patients (13.33%) had non-fata myocardial infarction (MI), and four (26.67%) had clinically significant bleeding. No patients had perioperative stent thrombosis. In the NCS group, one patient (2.22%) had stent thrombosis; four (6.67%) had myocardial infarction, and five (11.11%) clinically significant bleeding. CONCLUSIONS: Despite using IV APT as bridging therapy during perioperative DAPT interruption in post-PCI patients, postoperative cardiac events and bleeding complications can still occur.