Effect of Stenting Plus Medical Therapy vs Medical Therapy Alone on Risk of Stroke and Death in Patients With Symptomatic Intracranial Stenosis: The CASSISS Randomized Clinical Trial.

Importance: Prior randomized trials have generally shown harm or no benefit of stenting added to medical therapy for patients with symptomatic severe intracranial atherosclerotic stenosis, but it remains uncertain as to whether refined patient selection and more experienced surgeons might result in improved outcomes. Objective: To compare stenting plus medical therapy vs medical therapy alone in patients with symptomatic severe intracranial atherosclerotic stenosis. Design, Setting, and Participants: Multicenter, open-label, randomized, outcome assessor-blinded trial conducted at 8 centers in China. A total of 380 patients with transient ischemic attack or nondisabling, nonperforator (defined as nonbrainstem or non-basal ganglia end artery) territory ischemic stroke attributed to severe intracranial stenosis (70%-99%) and beyond a duration of 3 weeks from the latest ischemic symptom onset were recruited between March 5, 2014, and November 10, 2016, and followed up for 3 years (final follow-up: November 10, 2019). Interventions: Medical therapy plus stenting (n = 176) or medical therapy alone (n = 182). Medical therapy included dual-antiplatelet therapy for 90 days (single antiplatelet therapy thereafter) and stroke risk factor control. Main Outcomes and Measures: The primary outcome was a composite of stroke or death within 30 days or stroke in the qualifying artery territory beyond 30 days through 1 year. There were 5 secondary outcomes, including stroke in the qualifying artery territory at 2 years and 3 years as well as mortality at 3 years. Results: Among 380 patients who were randomized, 358 were confirmed eligible (mean age, 56.3 years; 263 male [73.5%]) and 343 (95.8%) completed the trial. For the stenting plus medical therapy group vs medical therapy alone, no significant difference was found for the primary outcome of risk of stroke or death (8.0% [14/176] vs 7.2% [13/181]; difference, 0.4% [95% CI, -5.0% to 5.9%]; hazard ratio, 1.10 [95% CI, 0.52-2.35]; P = .82). Of the 5 prespecified secondary end points, none showed a significant difference including stroke in the qualifying artery territory at 2 years (9.9% [17/171] vs 9.0% [16/178]; difference, 0.7% [95% CI, -5.4% to 6.7%]; hazard ratio, 1.10 [95% CI, 0.56-2.16]; P = .80) and 3 years (11.3% [19/168] vs 11.2% [19/170]; difference, -0.2% [95% CI, -7.0% to 6.5%]; hazard ratio, 1.00 [95% CI, 0.53-1.90]; P > .99). Mortality at 3 years was 4.4% (7/160) in the stenting plus medical therapy group vs 1.3% (2/159) in the medical therapy alone group (difference, 3.2% [95% CI, -0.5% to 6.9%]; hazard ratio, 3.75 [95% CI, 0.77-18.13]; P = .08). Conclusions and Relevance: Among patients with transient ischemic attack or ischemic stroke due to symptomatic severe intracranial atherosclerotic stenosis, the addition of percutaneous transluminal angioplasty and stenting to medical therapy, compared with medical therapy alone, resulted in no significant difference in the risk of stroke or death within 30 days or stroke in the qualifying artery territory beyond 30 days through 1 year. The findings do not support the addition of percutaneous transluminal angioplasty and stenting to medical therapy for the treatment of patients with symptomatic severe intracranial atherosclerotic stenosis. Trial Registration: ClinicalTrials.gov Identifier: NCT01763320.

Choice of antithrombotic therapy for patients with atrial fibrillation undergoing carotid angioplasty and stenting: a nationwide population-based study.

Nonvalvular atrial fibrillation (NVAF) and carotid stenosis are important risk factors for stroke. Carotid angioplasty and stent placement (CAS) is recommended for patients with symptomatic high-grade carotid stenosis. The optimal medical management for patients with NVAF after CAS remains unclear. We aimed to clarify this issue using real-world data from the Taiwanese National Health Insurance Research Database (NHIRD). In total, 2116 consecutive NVAF patients who received CAS between January 1, 2010, and December 31, 2016, from NHIRD were divided into groups based on post-procedure medication as follows: only antiplatelet agent (OAP, n = 587); only anticoagulation agent (OAC, n = 477); dual antiplatelet agents (DAP, n = 49); and a combination of antiplatelet and anticoagulation agents (CAPAC, n = 304). Mortality, vascular events, and major bleeding episodes were compared after matching with the Charlson comorbidity index and CHA2DS2-VASc score. The CAPAC and the OAC groups had lower mortality rates than the OAP group (P = 0.0219), with no statistical differences in major bleeding, ischemic stroke, or vascular events. Conclusively, OAC therapy after CAS appears suitable for NVAF patients. CAPAC therapy might be considered as initial therapy or when there is concern about vascular events.

Intracranial Angioplasty with Enterprise Stent for Intracranial Atherosclerotic Stenosis: A Single-Center Experience and a Systematic Review.

BACKGROUND: The high rate of periprocedural complications for the endovascular stent procedure in the Stenting Versus Aggressive Medical Management Therapy for Intracranial Arterial Stenosis (SAMMPRIS) trial resulted in it being less recommended than medical therapy to treat intracranial atherosclerotic stenosis (ICAS). Because Enterprise stent use might reduce the incidence of complications in ICAS treatment compared to other frequently used stents, this paper evaluated the safety and effectiveness of the Enterprise stent for the treatment of ICAS. METHODS: We performed a comprehensive literature search for reports on intracranial angioplasty using the Enterprise stent for ICAS treatment from the earliest date available from each database to May 2020 for PubMed, EMBASE, Web of Science, Cochrane, and Clinical Trials databases. We also reviewed the single-center experience of the First Affiliated Hospital of Harbin Medical University. We extracted information regarding periprocedural complications, procedure-related morbidity, mortality, immediate angiographic outcome, and long-term clinical and angiographic outcomes, among others. Event rates were pooled across studies using random-effects or fixed-effects models depending on the heterogeneity. RESULTS: Five hundred fifty-seven patients with 588 lesions from seven studies, including the institutional series, were included in the analysis. The incidence of stroke or death within 30 days was 7.4% (95% confidence interval (CI), 5.5%-10.1%). The incidence of ischemic stroke or TIA in the territory of the qualifying artery beyond 30 days and during follow-up was 3.2% (95% CI, 1.1%-9.5%). The incidence of in-stent restenosis was 10.1% (95% CI, 4.6%-22.2%), and the incidence of symptomatic restenosis was 4.1% (95% CI, 1.7%-9.9%). CONCLUSIONS: Intracranial angioplasty utilizing the Enterprise stent for ICAS treatment was relatively safe and effective but required further verification using additional sources for evidence.

Endovascular Treatment of Chronic and Acute on Chronic Mesenteric Ischaemia: Results From a National Cohort of 245 Cases.

OBJECTIVE: Endovascular treatment of chronic mesenteric ischaemia (CMI) is linked to low early morbidity and mortality but a higher risk of recurrence than open repair. Mid and long term outcomes after endovascular treatment remain to be proven in larger series. The aim of this study was to assess short and mid term outcome after first line endovascular revascularisation of CMI and acute on chronic mesenteric ischaemia (AoCMI). METHODS: This was a prospective population and registry based cohort study supplemented by a retrospective review of medical records and imaging files. A national cohort was created based on data extracted from the Danish National Registry for Vascular Surgery (Karbase) for all patients treated endovascularly for CMI or AoCMI between 2011 and 2015 in Denmark. Survival data, bowel resection, complications, re-intervention rate, and improvement of clinical symptoms were analysed, as were potential risk factors. RESULTS: In total, 245 patients had an endovascular intervention for CMI (n = 178; 72.6%) and AoCMI (n = 67; 27.3%). One and three year survival estimates were 85% (95% confidence interval [CI] 79 - 90) and 74% (95% CI 67 - 80) in the CMI-group, and 67% (95% CI 54 - 77) and 54% (95% CI 41 - 65) in the AoCMI group. The hazard ratio for death was 1.89 (95% CI 1.23 - 2.9) for AoCMI, relative to patients with CMI. Superior mesenteric artery (SMA) stenosis, rather then occlusion, significantly increased the success of SMA recanalisation: OR 19.4 (95% CI 6.2 - 61.4) and 9.3 (95% CI 1.6 - 53.6) in the CMI and AoCMI groups, respectively. The proportion of patients reporting clinical improvement was 71% (n = 127) in the CMI group and 59% (n = 39) in the AoCMI group. Five patients (3%) in the CMI and 30 (45%) in the AoCMI groups underwent bowel resection (p < .001), and the overall length of hospital stay (LoS) was a median of two days (interquartile range [IQR] 1 - 3 days) in the CMI group and seven days (IQR 3 - 23 days) in the AoCMI group. Within the first year, re-intervention was performed in 14 patients (5.7%). CONCLUSION: First line endovascular treatment of CMI carries a three year mortality rate of 25%, and low risk of re-occurrence of symptomatic ischaemia. Relative to CMI, patients suffering AoCMI have significantly higher morbidity and mortality, more bowel resections, and longer LoS.

Evaluating the Impact of Medial Arterial Calcification on Outcomes of Infrageniculate Endovascular Interventions for Treatment of Diabetic Foot Ulcers.

BACKGROUND: Medial arterial calcification (MAC) of the tibial and pedal arteries has been associated with an increased risk of amputation among people with diabetes. Endovascular interventions on infrageniculate vessels are frequently performed with the intent of treating peripheral artery disease (PAD) and decreasing the risk of amputation in those with diabetes. This study aimed to investigate how the extent of MAC impacts outcomes of endovascular procedures in people with diabetic foot ulcers (DFU). METHODS: We identified all patients who had undergone infrageniculate angioplasty in the setting of DFU at our institution between 2009 and 2019. Subjects were assigned a MAC score based on the severity of MAC in each vessel visualized on plain radiographs of the ankle and foot. We evaluated the relationship between MAC and the primary outcome, major adverse limb event (MALE), using stratified Cox proportional modeling. RESULTS: Among 99 subjects with DFU who had undergone infrageniculate angioplasty, MALE occurred in 50% (95% confidence interval [CI] 38%-61%) of patients within 1 year of intervention. On univariate Cox regression analysis, each 1 point increment in MAC score (hazard ratio [HR], 1.09; 95% CI 1.01-1.18), the third tertile of MAC score (HR, 2.27; 95% CI 1.01-5.11), age (HR 0.96; 95% CI 0.93-0.99), and wound grade (HR, 5.34; 95% CI 2.17-13.14), were significantly associated with increased risk of MALE. On adjusted analysis stratified by wound grade, MAC score was found to be associated with MALE only in patients with a low wound grade. CONCLUSION: Increased severity of MAC is associated with increased risk of MALE for subjects undergoing infrageniculate angioplasty with a low wound grade. Further research is needed to better understand the complex relationships of MAC, PAD, DFU, and interventions aimed at promoting healing of DFU.

WIfI Classification Versus Angiosome Concept: A Change in the Infrapopliteal Angioplasties Paradigm.

OBJECTIVE: The objective of this study was to determine whether the angiosome concept and WIfI classification in patients undergoing endovascular treatment is associated with the limb salvage rate and wound healing rate in patients with critical limb ischemia(CLI). METHODS: This was a retrospective, consecutive cohort study of CLI patients who underwent infrapopliteal angioplasty at the Vascular and Endovascular Surgery Service of the Hospital do Servidor Público Estadual, São Paulo, between January 2013 and January 2019. The primary outcome variable was the limb salvage rate and wound healing rate. The secondary outcome variables were patency, survival, time free from reintervention, and operative mortality rate. RESULTS: Overall, 95 infrapopliteal endovascular procedures were performed in 95 patients. The initial technical success rate was 100%. The mean ± standard deviation outpatient follow-up time was 775 ± 107.5 days. The analyses were performed at 360 days for wound healing rate and 720 days for limb salvage rates, overall survival, and time freedom from reintervention. According to the angiosome concept, there were 54 patients (56.8%) classified in the direct group and 41 patients (43.2%) in the indirect group. Regarding the WIfI classification subanalysis, there were 22 patients WIfI 0-1 (23.2%) and 73 patients WIfI 2-3 (76.8%). Furthermore, the indirect group had a higher ulcer healing rate than the direct group; however, it was not statistically significant (82.9%; 66.7%%, respectively, P = 0.059). However, the time to heal the ulcer was faster in the WIfI 0-1 groups than WIfI 2-3 groups (164.82 days versus 251,48; P = 0.017). The limb salvage rates at 720 days were similar among indirect and direct Groups (92.6% and 85.4%, P = 0.79). Likewise, the freedom from reintervention rates at 720 days were also similar in Indirect and direct groups (74.6% and 64%, P = 0.23). The survival rates at 720 days were similar in both indirect and direct groups (86.8 and 85.6%, respectively; P = 0.82). The amputation free survival rate at 720 days by the Kaplan-Meier method was 91.3% in the indirect group and 85.9% in the direct group, but with no statistical significance between the groups (P = 0.37) CONCLUSIONS: This study concluded that, in endovascular treatment, the angiosome concept is no longer important to limb salvage rates, nor ulcer/wound healing rates. Moreover, the WIfI classification 0-1 is associated with faster and higher wound/ulcer healing rates than WIfI classification 2-3.

Wound location is independently associated with adverse outcomes following first-time revascularization for tissue loss.

OBJECTIVE: Few studies adequately evaluate the impact of wound location on patient outcomes after lower extremity revascularization. Consequently, we evaluated the relationship between lower extremity wound location and long-term outcomes. METHODS: We reviewed all patients at our institution undergoing any first-time open surgical bypass or percutaneous transluminal angioplasty with or without stenting for tissue loss between 2005 and 2014. We categorized wounds into three distinct groups: forefoot (ie, toes and metatarsal heads), midfoot (ie, dorsal, plantar, lateral, medial surfaces excluding toes, metatarsal heads, or heel), and heel. Limbs with multiple wounds were excluded from analyses. We compared rates of perioperative complications, wound healing, reintervention, limb salvage, amputation-free survival, and survival using χ2, Kaplan-Meier, and Cox regression analyses. RESULTS: Of 2869 infrainguinal revascularizations from 2005 to 2014, 1126 underwent a first-time revascularization for tissue loss, of which 253 patients had multiple wounds, 197 had wounds proximal to the ankle, 100 had unreliable wound information, and 576 (forefoot, n = 397; midfoot, n = 61; heel, n = 118) fit our criteria and had a single foot wound with reliable information regarding wound specifics. Patients with forefoot, midfoot, and heel wounds had similar rates of coronary artery disease, hypertension, diabetes, and smoking history (all P > .05). Conversely, there were significant differences in patient age (71 vs 69 vs 70 years), prevalence of gangrene (41% vs 5% vs 21%), and dialysis dependence (18% vs 17% vs 30%) (all P < .05). There were no statistically significant differences in perioperative mortality (1.3% vs 4.9% vs 4.2%; P = .06) or postoperative complications among the three groups. Between forefoot, midfoot, and heel wounds, there were significant differences in unadjusted 6-month rates of complete wound healing (69% vs 64% vs 53%), 3-year rates of amputation-free survival (54% vs 57% vs 35%), and survival (61% vs 72% vs 41%) (all P < .05). After adjustment, compared with forefoot wounds, heel wounds were associated with higher rates of incomplete 6-month wound healing (hazard ratio [HR], 1.6; 95% confidence interval [CI], 1.1-2.]), major amputation or mortality (HR, 1.7; 95% CI, 1.1-2.7), and all-cause mortality (HR, 1.8; 95% CI, 1.1-3.0), but not major amputation alone (HR, 2.1; 95% CI, 0.9-4.5). In open surgical bypass-first patients, heel wounds were solely associated with an increased risk of all-cause mortality (HR, 1.7; 95% CI, 1.1-2.8), whereas heel wounds in percutaneous transluminal angioplasty-first patients were associated with an increased risk of incomplete wound healing (HR, 2.2; 95% CI, 1.3-3.7), major amputation or mortality (HR, 2.3; 95% CI, 1.1-5.4), and all-cause mortality (HR, 2.8; 95% CI, 1.1-7.2). CONCLUSIONS: Heel wounds confer considerably higher short- and long-term morbidity and mortality compared with midfoot or forefoot wounds in patients undergoing any first-time lower extremity revascularization.

Long-Term Outcomes of Endovascular Interventions in More than 500 patients with Budd-Chiari Syndrome.

PURPOSE: To assess and compare the long-term outcomes of various endovascular interventions in patients with Budd-Chiari syndrome (BCS). MATERIALS AND METHODS: In this single-center retrospective study, 510 consecutive patients with BCS who had undergone a total of 618 endovascular procedures from January 2001 to December 2019 were included. Details of the type of endovascular intervention, technical success, clinical success, patency rate, complications, and survival outcomes were analyzed. RESULTS: The overall technical success rate was 96% (593 of 618 procedures; 500 in treatment-naïve patients and 93 repeat interventions for recurrent disease). Endovascular procedures included recanalization procedures (angioplasty and stent placement) in 355 patients (71%) and transjugular intrahepatic portosystemic shunt (TIPS) creation in 145 (29%). Major postprocedure complications occurred in 14 patients (2.8%). Vascular/stent restenosis occurred in 95 patients (19%), and successful repeat intervention was performed in 82 of those 95 (86.3%). An additional 11 of these 82 (13.4%) underwent a third intervention for restenosis. In the recanalization and TIPS groups, the 1- and 5-y cumulative patency rates were 87% and 74% and 95% and 68%, respectively. The 1- and 5-y survival rates were 96% and 89% and 90% and 76%, respectively. CONCLUSIONS: Endovascular interventions for BCS are feasible and safe in the majority of patients, with excellent short- and long-term patency and survival rates.

Association of Mortality with Antiplatelet Treatment in Patients with Stent Placement or Angioplasty: A Population-Based Nested Case-Control Study.

PURPOSE: Antiplatelet drugs are essential in patients with cardiovascular disease who undergo stent placement. We hypothesized that risks of mortality would differ according to adherence to antiplatelet agents, number of antiplatelet agents, and antiplatelet regimens in patients undergoing stent placement or angioplasty. MATERIALS AND METHODS: Between 2002 and 2013, we initially enrolled 8671 subjects who underwent stent placement or angioplasty in the National Health Insurance Service-National Sample Cohort in Korea. Using the International Classification of Diseases, 10th revision, the incidence of all-cause death, including cardiovascular disease, cerebrovascular disease, and cancer, was defined. Using a nested case-control study design, controls were matched to cases at a ratio of 4:1, and a total of 5415 subjects were eligible for this study. RESULTS: During a median follow-up period of 3.51 years, the incidence rate of all-cause death was 40 per 1000 person-years. We found that adherence to antiplatelet monotherapy significantly decreased risk of death by cerebro-cardiovascular disease, compared with discontinuation of antiplatelets [adjusted odds ratio (OR) 0.62, 95% confidence interval (CI) (0.41-0.96)]. Compared with dual antiplatelet therapy (DAPT), aspirin and clopidogrel monotherapy significantly reduced death by cerebro-cardiovascular disease [adjusted OR 0.65, 95% CI (0.44-0.95) and adjusted OR 0.58, 95% CI (0.35-0.96), respectively]. There was no significant difference of mortality between aspirin monotherapy and clopidogrel monotherapy. CONCLUSION: Our study demonstrated that adherence to antiplatelet therapy and antiplatelet monotherapy, compared with DAPT, in patients with stent placement or angioplasty may have a beneficial effect on mortality in cerebro-cardiovascular disease.

Comparative Analysis of Patch Angioplasty Versus Selective Primary Closure during Carotid Endarterectomy Performed at a Single Vascular Center in China.

BACKGROUND: One of the ongoing debates about carotid endarterectomy (CEA) is the closure technique of arterial wall in the operation. Current guidelines recommend routine patch closure (PAC); this recommendation is based on the evidence reported 10-20 years ago. Therefore, the exact role of PAC and primary closure (PRC) remains uncertain. The objectives of this study were to compare the perioperative and long-term outcomes of patients who underwent CEA with different closure techniques. METHODS: From January 2013 and December 2018, one senior vascular surgeon performed CEA for 126 patients in the First Affiliated Hospital, Sun Yat-sen University. The closure technique (PAC or PRC) was determined on the characteristics (diameter and level) of carotid arteries. Patient demographics and clinical data were retrospectively collected by two research fellows by reviewing the hospital medical records and relevant radiologic studies, as were carotid duplex reports, indications, intraoperative data, closure technique, and perioperative complications. Data of long-term outcomes were gathered by reviewing outpatient clinic visits and associated supplementary examinations. RESULTS: PRC was performed in 78 operations (61.9%), and PAC was performed in 48 operations (38.1%). There were no statistical differences in demographic and clinical data between the two groups. Carotid clamp time (P < 0.001) and operating time (P < 0.001) were significantly longer when performing PAC (P < 0.001), and intraoperative blood loss was significantly more when performing PAC than that of PRC (P < 0.001). The postoperative outcome and the follow-up results showed that there was no significant difference in the short-term and middle-term overall survival rate and restenosis-free survival rate between the two groups. CONCLUSIONS: There are no differences in postoperative and middle-term outcomes between PAC and selective PRC, whereas PRC technique can save operation time and shorten the intraoperative carotid clamp time. PRC can be safely applied in patients with a greater than 5 mm internal carotid artery (ICA).

Use of Dual-Layered Stents for Carotid Artery Angioplasty: 1-Year Results of a Patient-Based Meta-Analysis.

OBJECTIVES: This study sought to evaluate 1-year safety and efficacy of dual-layered mesh-covered carotid stent systems (DLS) for carotid artery stenting (CAS). BACKGROUND: Small clinical studies evaluating 1-year outcomes of CAS performed with 2 available DLS, Roadsaver (RS) (Terumo Corp., Tokyo, Japan) and CGuard (CG) (InspireMD, Boston, Massachusetts), have been published. METHODS: The authors performed an individual patient-level meta-analysis including studies enrolling more than 100 CAS with DLS. The primary endpoint was the death and stroke rate; secondary endpoints were restenosis and in-stent thrombosis rates at 1 year. RESULTS: Patients were divided into 2 groups according to DLS (RS n = 250; CG n = 306). At 1 year, 11 patients died (1.97%), 7 patients in the group RS (2.8%) and 4 patients in the CG one (1.31%); and 10 strokes occurred, 4 in the group RS (1.6%) and 6 in the CG one (1.96%). Overall death and stroke rate was 3.77% (n = 21), 11 events in the group RS group (4.4%) and 10 in the CG group (3.27%). Symptomatic status was the only predictor of death and or stroke. At 1 year, restenosis occurred in 12 patients (2.1%), 10 in the group RS (4%) and 2 in the CG one (0.65%) (p = 0.007). In-stent thrombosis occurred in 1 patient (0.18%) in the CG group (0.32%). RS use was the only independent predictor of restenosis. CONCLUSIONS: This study suggests that DLS use for CAS is associated with a low 1-year death and stroke rate, and the specific DLS stent used could affect the restenosis rate.

Popliteal Artery Angioplasty for Chronic Total Occlusions with versus without the Distal Landing Zone.

BACKGROUND: The purpose of this study was to evaluate the outcome of percutaneous transluminal angioplasty in patients with critical limb ischemia due to popliteal artery (PA) chronic total occlusions depending on the presence of a patent portion of the PA distal to the occlusive lesion-the distal landing zone (DLZ). MATERIALS AND METHODS: We retrospectively analyzed 80 patients with critical limb ischemia (all Rutherford class 5-6), who underwent percutaneous transluminal angioplasty with or without stenting for PA chronic total occlusions with no inflow disease. Baseline demographic and clinical variables, periprocedural outcome, 12-month overall survival, limb salvage, primary patency, freedom from target lesion revascularization (TLR), amputation-free survival, and freedom from major adverse limb events in DLZ versus no-DLZ lesions were assessed. RESULTS: Of all patients (43 men; mean age 70.2 y), 40 (50%) had DLZ in the PA, whereas another 40 (50%) did not (no-DLZ). Diabetes was significantly more common among DLZ patients and was found to be a risk factor for DLZ compared with no-DLZ lesions (HR 2.58; 95% CI 1.03-6.46; P = 0.04). Other demographic and clinical variables were similar between the groups. The stenting rate was 45.0% versus 42.5% in DLZ versus no-DLZ (P = 1.0). At 12 months, there was no significant difference in primary patency (64.7% vs. 51.6%; P = 0.156), overall survival (73.4% vs. 84.0%; P = 0.283), amputation-free survival (60.0% vs. 68.8%; P = 0.432), and limb salvage rate (93.6% vs. 82.2%; P = 0.126) between DLZ and no-DLZ groups, respectively. However, freedom from TLR (92.1% vs. 67.7%; P = 0.03) and major adverse limb events (80.1% vs. 41.8%; P = 0.003) was significantly higher in DLZ compared with no-DLZ lesions (92.1% vs. 67.7%; P = 0.03). CONCLUSIONS: Diabetes was found to be a significant risk factor for DLZ compared to no-DLZ lesions. Technical success and stenting rates were similar in DLZ versus no-DLZ patients. At 12 months, there was no significant difference in limb salvage, primary patency, and overall survival between the study groups. The DLZ lesions were associated with a significantly higher freedom from TLR than no-DLZ lesions.

Clinical Effectiveness and Resource Utilization of Surgery versus Endovascular Therapy for Chronic Limb-Threatening Ischemia.

BACKGROUND: The clinical effectiveness of surgical versus endovascular therapy for chronic limb-threatening ischemia (CLTI) continues to be debated, and the resources required for each therapy are unclear. METHODS: Systematic review of randomized controlled trials (RCTs) and observational studies comparing surgery with endovascular therapy for CLTI, which reported clinical effectiveness and resource utilization. Short-term and long-term clinical outcomes were examined. RESULTS: The search yielded 4,231 titles, of which 17 publications met our inclusion criteria. Five publications were all from 1 RCT, and 12 publications were observational studies. In the RCT, the surgical approach had greater resource use in the first year (total hospital days across all admissions for surgery versus angioplasty: 46.14 ± 53.87 vs. 36.35 ± 51.39; P < 0.001; also true for days in high-dependency and intensive therapy units), but differences were not statistically significant in subsequent years. All-cause mortality presented a nonsignificant difference favoring angioplasty in the first 2 years (adjusted hazard ratio [aHR], 1.27; 95% confidence interval [95% CI], 0.75-2.15), but after 2 years, it favored surgical treatment (aHR, 0.34; 95% CI, 0.17-0.71). The observational studies reported short-term effectiveness and resource utilization favoring endovascular therapy, but most differences were not statistically significant. Long-term outcomes were more mixed; in particular, mortality outcomes generally favored surgery, although concluding that cause and effect is not possible as endovascularly treated patients tended to be older and may have had a shorter life expectancy regardless of therapy. CONCLUSIONS: The clinical effectiveness and resource utilization of surgery compared with endovascular therapy for CLTI is not known with certainty and will not be known until ongoing trials report results. It is likely that findings will vary by the time horizon, where initial outcomes and utilization tend to favor endovascular interventions, but long-term outcomes favor surgical revascularization.

Endovascular Therapy Provides Similar Results of Bypass Graft Surgery in the Treatment of Infrainguinal Multilevel Arterial Disease in Patients with Chronic Limb-Threatening Ischemia in All GLASS Stages.

BACKGROUND: Extensive infrainguinal arterial disease still pose a challenge for technical and clinical success of percutaneous angioplasty. The purpose of this study was to compare the results of concomitant femoropopliteal and infrapopliteal percutaneous angioplasty/stenting (PTA/S) with distal bypass graft surgery (BGS) in patients with chronic limb-threatening ischemia (CLTI). METHOD: In a single-center retrospective investigation between 2011 and 2017, 668 revascularization procedures for CLTI were reviewed. Concomitant femoropopliteal and infrapopliteal disease was identified in 153 CLTI patients, treated with BGS (48) using autogenous veins as substitute or PTA/S in a single procedure (105). A subgroup of patients with complex, extensive arterial lesions (GLASS stage III) received additional analysis. Primary outcomes were limb salvage and survival. RESULTS: The mean follow-up time was 21.4 months. Patients treated with PTA/S were significantly older and with predominance of females, diabetes and chronic kidney disease. Smoking was more common in patients treated with BGS. The BGS group showed a 36-month survival rate of 73.4%, whereas the PTA/S group presented a survival of 61.3% in the same interval (P = 0.25). The 36-month cumulative limb salvage rate was 53.3 and 59.7% for BGS and PTA/S, respectively (P = 0.24). For GLASS stage III patients, 36-month limb salvage rates were 54.4% for the PTA/S group and 50.2% for the BGS group (P = 0.29). Multivariate analysis pointed poor runoff status (all endovascular patients) and diabetes (GLASS III endovascular patients) as risk factors for limb loss. CONCLUSION: PTA/S and BGS presented similar results of limb salvage and survival in the treatment of concomitant femoropopliteal and infrapopliteal arterial disease in patients with CLTI, even for patients with extensive and complex arterial disease.

Hemodynamic events during carotid stenting are associated with significant periprocedural stroke and adverse events.

BACKGROUND: There are limited data on the impact of carotid angioplasty and stenting (CAS)-related changes in blood pressure, heart rate, and preprocedural medications on periprocedural stroke in contemporary, real-world practice. This study evaluates the risk attributable to the CAS-related hemodynamic events and the impact preprocedural medications have on mitigating this risk in a large, population-based cohort. METHODS: We studied all patients in the Vascular Quality Initiative who underwent CAS between January 2006 and December 2016. Kaplan-Meier, multivariable logistic, and Cox regression analyses were used to evaluate the impact of periprocedural hypertension, hypotension, bradycardia, and medication use on immediate periprocedural stroke (IPPS), 30-day, and 1-year stroke. RESULTS: Of the 13,698 CAS procedures studied, 1239 (9.1%), 1824 (13.3%), and 1333 (9.7%) patients experienced periprocedural hypertension, hypotension, and bradycardia, respectively. IPPS was 3.2% vs 2.1% vs 0.65% (P < .001), comparing patients with periprocedural hypertension vs hypotension vs normotension and 1.4 vs 1.0% (P = .19) for bradycardic vs nonbradycardic patients. Periprocedural hypertension was associated with a four-fold increase in IPPS (adjusted odd ratio [aOR], 3.97; 95% confidence interval [CI], 2.63-5.99; P < .001). periprocedural hypotension and bradycardia were associated with 5.5-fold (aOR, 5.56; 95% CI, 3.24-9.52; P < .001) and 2.3-fold (aOR, 2.31; 95% CI, 1.26-4.25; P = .007) increases in IPPS among patients with carotid symptoms. There was 76% decrease in IPPS for patients who did not experience a periprocedural hemodynamic event (aOR, 0.24; 95% CI, 0.16-0.35; P < .001). Unlike preprocedural beta-blockers and angiotensin-converting enzyme inhibitors, prophylactic antibradyarrhythmic agents conferred a 58% reduction in IPPS among patients with carotid symptoms (aOR, 0.42; 95% CI, 0.23-0.78; P = .006). The periprocedural hemodynamic events were also associated with 7.7-fold increase in myocardial infarction (aOR, 7.70; 95% CI, 4.77-12.45; P < .001), a 2.2-fold increase in 30-day mortality (aOR, 2.24; 95% CI, 1.61-3.12; P < .001), and a 16% increase in length of stay (aOR, 1.16; 95% CI, 0.04-2.28; P = .042). The occurrence of these hemodynamic events is higher in patients with prior cardiac disease and the difference in periprocedural outcomes extended to 1 year. CONCLUSIONS: Periprocedural hemodynamic events are associated with an increase in periprocedural stroke, myocardial infarction, death, and length of stay. Periprocedural hypertension in all patients; hypotension and bradycardia in patients with symptomatic carotid disease are associated with significant increase in IPPS. Prophylactic antibradyarrhythmic agents are associated with decrease in bradycardia and IPPS. These results heighten the need to anticipate and promptly address these CAS-related hemodynamic events, especially in susceptible patients.

Stent-Only Versus Adjunctive Balloon Angioplasty Approach for Saphenous Vein Graft Percutaneous Coronary Intervention: Insights From DIVA Trial.

BACKGROUND: Direct stenting without pre-dilation or post-dilation has been advocated for saphenous vein graft percutaneous coronary intervention to decrease the incidence of distal embolization, periprocedural myocardial infarction, and target lesion revascularization. METHODS: We performed a post hoc analysis of patients enrolled in the DIVA (Drug-Eluting Stents Versus Bare Metal Stents in Saphenous Vein Graft Angioplasty; NCT01121224) prospective, double-blind, randomized controlled trial. Patients were stratified into stent-only and balloon-stent groups. Primary end point was 12-month incidence of target vessel failure (defined as the composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization). Secondary end points included all-cause death, stent thrombosis, myocardial infarction, and target lesion revascularization during follow-up. RESULTS: Of the 575 patients included in this substudy, 185 (32%) patients underwent stent-only percutaneous coronary intervention. Patients in the stent-only versus balloon-stent group had similar baseline characteristics and similar incidence of target vessel failure at 12-months (15% versus 19%; hazard ratio, 1.34 [95% CI, 0.86-2.08]; P=0.19). During long-term follow-up (median of 2.7 years), the incidence of definite stent thrombosis (1% versus 5%; hazard ratio, 9.20 [95% CI, 1.23-68.92]; P=0.0085), the composite of definite or probable stent thrombosis (5% versus 11%; hazard ratio, 2.52 [95% CI, 1.23-5.18]; P=0.009), and target vessel myocardial infarction (8% versus 14%; hazard ratio, 1.92 [95% CI, 1.08-3.40]; P=0.023) was lower in the stent-only group. Multivariable analysis showed that a higher number of years since coronary artery bypass grafting and >1 target saphenous vein graft lesions were associated with increased target vessel failure during entire follow-up, while preintervention Thrombolysis in Myocardial Infarction-3 flow was protective. CONCLUSIONS: In patients undergoing percutaneous coronary intervention of de novo saphenous vein graft lesions, there was no difference in target vessel failure at 12 months and long-term follow-up in the stent-only versus the balloon-stent group; however, the incidence of stent thrombosis was lower in the stent-only group, as was target vessel myocardial infarction. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01121224.

Duration of blood flow reversal during transcarotid artery revascularization does not affect outcome.

OBJECTIVE: Transcarotid artery revascularization (TCAR) has become an increasingly popular alternative for the treatment of carotid bifurcation stenosis. TCAR employs carotid blood flow reversal through an ex vivo common carotid artery to femoral vein shunt for neuroprotection during the placement and angioplasty of the carotid artery stent. There is a lack of data regarding an association between the duration of flow reversal and neurologic complications or other adverse events. We analyzed TCAR flow reversal time in relation to major adverse events. METHODS: There were 307 patients who underwent TCAR at four high-volume academic institutions. Patients were separated on the basis of the duration of carotid flow reversal as follows: group I, ≤8 minutes (n = 138); group II, 9-13 minutes (n = 105); group III, 14-20 minutes (n = 42); and group IV, >20 minutes (n = 22). Adverse events including stroke (assessed by a National Institute of Health Stroke Scale-certified examiner), myocardial infarction (MI), and death at discharge and 30 days were collected in all patients and were compared between groups using one-way analysis of variance and χ2 analysis. RESULTS: There were four strokes in the total cohort, yielding an overall stroke rate of 1.3%. All strokes were minor in nature; two were ipsilateral and two were contralateral. All patients demonstrated full recovery at 30 days. We found no significant difference in the stroke rate between any of the groups: I, 1.5% (2/138); II, 1.9% (2/105); III, 0% (0/42); and IV, 0% (0/22; P = .76). The four strokes occurred in patients with flow reversal time of 6, 7, 11, and 12 minutes. There was also no difference in the 30-day composite stroke/death or stroke/death/MI rates among the groups. CONCLUSIONS: The length of flow reversal during TCAR does not affect rates of stroke, MI, or death. These data suggest that operators should focus on the technical aspects of the procedure during flow reversal rather than on its duration.

Treatment of Carotid Restenoses after Endarterectomy: A Retrospective Monocentric Study.

BACKGROUND: To compare the different techniques for the treatment of carotid restenosis after carotid artery endarterectomy (CAE). METHODS: Among 1,218 carotid surgeries carried out in our center between January 2010 and November 2017, 45 procedures were performed for carotid restenosis after CAE, including 11 by iterative conventional surgery and 34 with endovascular techniques (7 transluminal angioplasties alone [TLA], 9 carotid artery stenting [CAS], and 18 angioplasties with active balloons [drug-coated balloon {DCB}]). Perioperative data (cumulated rate of morbimortality [CRMM], duration of hospitalization) and postoperative results (survival, symptomatic restenoses > 50% or asymptomatic stenoses > 70% on ultrasound, reinterventions) were collected retrospectively and analyzed with Fisher's exact test. The long-term results were estimated according to the Kaplan-Meier estimator and were compared with the log rank test (P < 0.05 was regarded as significant). RESULTS: There was one secondary death due to a massive postoperative stroke in the endovascular (ENDO) group. No significant difference regarding CRMM (2.9%, P = 0.756) between the iterative conventional surgery (open surgery; OS) and the ENDO groups of was observed. Three hematomas were found in the OS group versus one in the ENDO group (P = 0.04). The length of hospital stay was shorter in the ENDO group (P < 0.001). No difference was found between the ENDO group and the OS group regarding the two-year survival or the survival without recurrent restenosis (86 vs. 100%, log rank = 0.804, and log rank = 0.114). There were 5 restenoses >70% and two reinterventions in the ENDO group (P > 0.05). The comparison of the different endovascular techniques did not show significant differences regarding the CRMM, the one-year overall survival, the survival without recurrent restenosis, or the survival without reintervention (89% in the DCB and CAS groups vs. 100% in the percutaneous transluminal angioplasty [PTA] group, log rank = 0.286; 87% in the DCB group vs. 100% in the PTA and CAS groups, log rank = 0.137; and 94% in the DCB group vs. 100% in the PTA and CAS groups, log rank = 0.585, respectively). CONCLUSIONS: In our experience, endovascular procedures are equivalent to iterative conventional surgery for the treatment of carotid restenoses in terms of major complications, news restenoses, or survival with less hematoma and a shorter duration of hospitalization. We however could not identify the best endovascular strategy in this indication, and a controlled study comparing the various endovascular strategies is proposed.

Comparative Analysis Using Propensity Score Matching Analysis: Primary Closure versus Patch Angioplasty During Carotid Endarterectomy.

BACKGROUND: Primary closure (PC) and patch angioplasty (PA) during carotid endarterectomy (CEA) have been disputed in many studies. Some studies announced that PC is associated with a higher restenosis rate. The aim of this study was to evaluate the outcomes of PC and PA using propensity score matching (PSM). METHODS: Between November 1994 and October 2016, 1,044 patients underwent primary CEA procedures at our institution and were retrospectively analyzed. The study endpoints included rates of ipsilateral stroke, any clinical stroke, cranial nerve palsy, hematoma, bleeding warranting repeat surgery within 30 postoperative days. We also investigated the restenosis rates, overall survival, stenosis-free survival, and stroke-free survival during follow-up (median follow-up 37.1 months). RESULTS: This study includes 435 cases of PC and 476 cases of PA. After PSM analysis, baseline characteristics (age, gender, hypertension, diabetes, dyslipidemia, smoking, atrial fibrillation, previous percutaneous coronary intervention or coronary artery bypass grafting, contralateral carotid occlusion, degree of carotid stenosis, and symptomatic status within 6 months) were balanced. Finally, 377 pairs of matched cases were analyzed. Statistical analysis showed no significant differences between the 2 groups in ipsilateral stroke (P = 0.45), clinical stroke (P = 0.75), cranial nerve palsy (P = 1), hematoma (P = 0.18), bleeding which required reoperation (P = 0.12) within 30 postoperative days, and restenosis rates during follow-up (P = 0.16). In addition, there were no differences between the 2 groups during follow-up in overall, stroke-free, and restenosis-free survival with P values of 0.136, 0.07, and 0.06, respectively. CONCLUSIONS: According to the analysis using PSM, there were no significant differences between PC and PA closure during CEA in perioperative and long-term outcomes.

Long-term outcomes of patients with stable coronary disease and chronic kidney dysfunction: 10-year follow-up of the Medicine, Angioplasty, or Surgery Study II Trial.

BACKGROUND: Chronic kidney disease (CKD) is associated with a worse prognosis in patients with stable coronary artery disease (CAD); however, there is limited randomized data on long-term outcomes of CAD therapies in these patients. We evaluated long-term outcomes of CKD patients with CAD who underwent randomized therapy with medical treatment (MT) alone, percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG). METHODS: Baseline estimated glomerular filtration rate (eGFR) was obtained in 611 patients randomized to one of three therapeutic strategies in the Medicine, Angioplasty, or Surgery Study II trial. Patients were categorized in preserved renal function and mild or moderate CKD groups depending on their eGFR (≥90, 89-60 and 59-30 mL/min/1.73 m2, respectively). The primary clinical endpoint, a composite of overall death and myocardial infarction, and its individual components were analyzed using proportional hazards regression (Clinical Trial registration information: http://www.controlled-trials.com. Registration number: ISRCTN66068876). RESULTS: Of 611 patients, 112 (18%) had preserved eGFR, 349 (57%) mild dysfunction and 150 (25%) moderate dysfunction. The primary endpoint occurred in 29.5, 32.4 and 44.7% (P = 0.02) for preserved eGFR, mild CKD and moderate CKD, respectively. Overall mortality incidence was 18.7, 23.8 and 39.3% for preserved eGFR, mild CKD and moderate CKD, respectively (P = 0.001). For preserved eGFR, there was no significant difference in outcomes between therapies. For mild CKD, the primary event rate was 29.4% for PCI, 29.1% for CABG and 41.1% for MT (P = 0.006) [adjusted hazard ratio (HR) = 0.26, 95% confidence interval (CI) 0.07-0.88; P = 0.03 for PCI versus MT; and adjusted HR = 0.48; 95% CI 0.31-0.76; P = 0.002 for CABG versus MT]. We also observed higher mortality rates in the MT group (28.6%) compared with PCI (24.1%) and CABG (19.0%) groups (P = 0.015) among mild CKD subjects (adjusted HR = 0.44, 95% CI 0.25-0.76; P = 0.003 for CABG versus MT; adjusted HR = 0.56, 95% CI 0.07-4.28; P = 0.58 for PCI versus MT). Results were similar with moderate CKD group but did not achieve significance. CONCLUSIONS: Coronary interventional therapy, both PCI and CABG, is associated with lower rates of events compared with MT in mild CKD patients >10 years of follow-up. More study is needed to confirm these benefits in moderate CKD.