Predictors of outcome in diabetic patients undergoing infrapopliteal endovascular revascularization for chronic limb-threatening ischemia.

OBJECTIVE: The incidence of chronic limb-threatening ischemia in diabetic patients is increasing. The factors influencing outcome after infrapopliteal revascularization in these patients are largely unknown. Therefore, this study aims to identify the impact of perioperative glucose control on the long-term outcomes in this patient cohort, and furthermore to identify other factors independently associated with outcome. METHODS: Consecutive diabetic patients undergoing infrapopliteal endovascular revascularization for chronic limb-threatening ischemia were identified. Patients' demographics, procedural details, daily capillary blood glucose, and hemoglobin A1C levels were collected and analyzed against the study end points using Kaplan-Meier and Cox regression analysis. RESULTS: A total of 437 infrapopliteal target vessels were successfully crossed in 203 patients. Amputation-free survival by Kaplan-Meier (estimate (standard error)%) was 74 (3.3)% and 63 (3.7)%, primary patency was 61 (4.2)% and 50 (4.9)%, assisted primary patency was 69 (5.2)% and 55 (6.1)%, and secondary patency was 71 (3.8)% and 59 (4.1)% at 1 year and 2 years, respectively. Cox regression analysis showed high perioperative capillary blood glucose levels to be an independent predictor of binary restenosis (hazard ratio [HR], 1.49; 95% confidence interval [CI], 1.31-1.1.78; P = .015). Postprocedural dual-antiplatelet therapy was found to be an independent predictor of amputation-free survival (HR, 1.69; 95% CI, 1.04-2.75; P = .033), and freedom from major adverse limb events (HR: 1.96; 95% CI, 1.16-3.27; P = .023) and baseline estimated glomerular filtration rate was significantly associated with better amputation-free survival (HR, 0.52; 95% CI, 0.31-0.87; P = .014). CONCLUSIONS: Poor perioperative glycemic control is associated with a higher incidence of restenosis after infrapopliteal revascularization in diabetic patients. Dual antiplatelet therapy is associated with better outcomes in this group.

Paclitaxel and Mortality Following Peripheral Angioplasty: An Adjusted and Case Matched Multicentre Analysis.

OBJECTIVE: Paclitaxel based drug coated balloons (DCBs) and drug eluting stents (DESs) may be associated with increased mortality in patients with peripheral arterial occlusive disease (PAOD), based on a recent meta-analysis. This study, however, had a number of limitations, which have been discussed at great length among the vascular community. The aim of this research was to assess the association between paclitaxel based endovascular treatment (PTX) in the femoropopliteal (F-P) segment and mortality, adjusting for relevant risk factors and including patients with chronic limb threatening ischaemia (CLTI). METHODS: This was a retrospective cohort study of a prospectively maintained multicentre (three sites) database of patients with claudication or CLTI. Patients having F-P angioplasty between 1 January 2014 and 30 May 2019 with or without PTX were included. Survival was compared in Cox regression analyses adjusted for parameters of the Charlson comorbidity index. A separate nested case matched (based on each individual's Charlson index) analysis was performed to compare mortality rates between those who received PTX and those who did not. RESULTS: A total of 2 071 patients were analysed: 966 patients (46.6%) were treated with PTX (952 [46%] had CLTI and 1 119 [54%] severe claudication [Rutherford stage 3]). Over a 24 month median follow up, 456 (22.1%) patients died. Using multivariable Cox regression, PTX was not associated with mortality (HR 0.94, p = .46), even when assessed separately for those with intermittent claudication (HR 1.30, p = .15) or CLTI (HR 0.81, p = .060). In the case matched analysis (885 matched pairs of patients), PTX was not associated with mortality (HR 0.89, p = .17). Paclitaxel dose and use of a DCB or DES were not associated with mortality in any subanalysis. CONCLUSION: When relevant risk factors were taken into account, there were no associations between PTX and mid term mortality in patients with PAOD.

Interwoven Nitinol Stents versus Drug Eluting Stents in the Femoro-Popliteal Segment: A Propensity Matched Analysis.

BACKGROUND: Percutaneous transluminal angioplasty (PTA) is a common procedure in patients with peripheral arterial disease (PAD) affecting the femoropopliteal segment (F-P). Biomimetic nitinol stents (Supera peripheral stent, SPS) and drug eluting stents (DES) were designed to improve the longevity of F-P PTA; however, their performance has not been compared in a pragmatic setting, taking atherosclerotic plaque characteristics into account. METHODS: Overall, 296 consecutive patients (mean age: 73 y, SD: 11 y, 65% male, 68% with chronic limb threatening ischaemia) who underwent F-P PTA using SPS or DES between 2013 and 2018 were identified from a prospectively maintained institutional database. Patient and plaque characteristics, including F-P plaque characterisation based on computed tomography, were collected; 121 case matched pairs were created using a propensity score based on patient and plaque data. RESULTS: During the median two year follow up, 28% of the cohort (32% SPS vs. 24% DES, p = .07) developed target lesion restenosis (TLR) > 50%. Among the 121 case matched pairs of patients, those with SPS vs. DES were not significantly more likely to develop TLR >50% (31% vs. 27%, p = .34), or stent occlusion (13% vs. 12%, p = .85 - secondary patency rate 87% vs. 88%), have a major amputation (10% vs. 6%, p = .16), require re-intervention (14% vs. 9%, p = .12), or die (7% vs.4%, p = .31). Plaque calcification did not predict restenosis or occlusion in either stent group, both in the matched and non matched populations. Multivariable analysis adjusted for patient and plaque characteristics revealed that the main predictors of restenosis >50% at two years were female sex [odds ratio (OR): 2.05, p = .01], hypertension (OR: 2.10, p = .04) and previous F-P occlusion (OR: 1.35, p = .04). CONCLUSION: Medium term results following F-P PTA with either SPS or DES are comparable, regardless of plaque calcification and patient characteristics.

Complex infrapopliteal revascularization in elderly patients with critical limb ischemia: impact of multidisciplinary integrated care on mid-term outcome.

BACKGROUND: The incidence of critical limb ischemia (CLI) is exponentially rising among our aging population. There is a paucity of scientific evidence on best management and clinical outcome of infra-popliteal (IP) revascularizations in elderly CLI patients. METHODS: A prospectively collected database was analyzed to identify consecutive octogenarian and nonagenarian patients who underwent IP revascularizations (bypass or angioplasty) for CLI (Rutherford 4-6) in a single center between 2010-2014. The primary end points were overall amputation-free-survival (AFS) and overall survival (OS) at 1 and 2 years. Secondary endpoints were primary, assisted-primary, secondary patency and limb-salvage (LS) rates by Kaplan-Meier analysis. Univariate and multivariate analysis was performed to find factors predicting outcome. RESULTS: A total of 129 limbs in 120 patients were treated with IP bypass (N.=42) and endovascular (N.=87) revascularizations with a mean age of 85(±5) years. The overall primary patency, assisted-primary patency and secondary patency were 58%, 65% and 70%, respectively at 12 months and 34%, 48% and 59% at 24 months. Primary, assisted-primary and secondary patency analyzed by treatment method (endovascular vs. bypass) was 54% vs. 52%, 61% vs. 70%, 69% vs. 75% at 1 year and 21% vs. 36%, 24% vs. 62%, 31% vs. 72% at 2 years. The overall AFS at 12 and 24 months was 62% and 46% respectively; AFS was 71%-68% in the bypass group and 53-21% in the Endovascular group (P<0.001). LS was 89% at 12 months and 84% at 24 months, with no significant difference between the bypass and endovascular groups (P=0.24). The overall perioperative mortality rate was 2%. OS by Kaplan-Meier was 68% and 54% at 1 and 2 years respectively. Diabetes (P=0.046) and low eGFR (P=0.041) were predictors of worse AFS and OS, respectively. CONCLUSIONS: IP revascularizations (either endovascular or surgical) is feasible and effective in octogenarians and nonagenarians with CLI. By adopting a patient-tailored approach, both revascularizations strategies have satisfactory technical and clinical outcomes in this high-risk group. Subgroup analysis suggests that bypass surgery may have better mid-term secondary patency and AFS rates.

The efficacy of salvage interventions on threatened distal bypass grafts.

OBJECTIVE: Infrapopliteal bypass is an established and effective method for limb salvage in patients with critical limb ischemia. Secondary interventions maybe required to maintain graft patency. The aim of this study was to look at the frequency and outcomes of such interventions. METHODS: Consecutive patients undergoing bypasses onto the infrapopliteal vessels for critical limb ischemia (Rutherford 4-6) at a single institution were analyzed between 2009 and 2013. The primary end points were graft patency, amputation-free survival (AFS), and freedom from reintervention at 12 months by Kaplan-Meier analysis. RESULTS: A total of 114 infrapopliteal bypasses were performed in 102 patients. Distal anastomosis was on to the anterior tibial (n = 31), posterior tibial (n = 27), peroneal (n = 24), tibioperoneal trunk (n = 23), or dorsalis pedis artery (n = 9). Primary patency, assisted primary patency, and secondary patency was 57%, 76%, and 82%, respectively, at 12 months and 44%, 70%, and 80%, respectively, at 36 months. AFS was 80% at 12 months and 65% at 36 months. Endovascular salvage interventions were performed on 58 grafts (51%) including angioplasty of inflow/proximal anastomosis (33%), outflow/distal anastomosis (46%), and graft stenosis (20%), with a further 12 grafts (11%) undergoing thrombolysis for occlusion. Surgical salvage interventions included jump grafts (n = 7), revision of anastomotic stenosis (n = 3), and thrombectomy (n = 2). AFS was similar in salvaged threatened and acutely occluded grafts compared with nonthreatened grafts (P = .064) and better in grafts requiring reintervention later (>6 months from bypass) compared with those requiring early reintervention (<6 months; P = .047). CONCLUSIONS: Secondary interventions in threatened distal bypass grafts are successful at maintaining graft patency and AFS when compared with nonthreatened grafts, and are associated with a low morbidity rate.