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Role of Sex in Determining Treatment Type for Patients Undergoing Endovascular Lower Extremity Revascularization.

ABSTRACT: Background Limited data exist to describe factors that influence the use of different endovascular treatments for peripheral arterial disease. Therefore, we studied sex differences in the utilization of endovascular treatment modalities and their impact on arterial patency. Methods and Results We analyzed procedures from 2010 to 2016 in the Vascular Quality Initiative for arteries treated with percutaneous transluminal angioplasty (PTA) alone, stenting (with/without PTA), and atherectomy (with/without PTA). We explored sex differences in treatment modality by arterial segment (iliac, femoropopliteal, and tibial) with multivariable logistic regression. We used Kaplan-Meier survival analysis and multivariable Cox regression to study sex differences in arterial reintervention and occlusion. In this cohort, patients (n=58 247, mean age 68 years, 41% women,) had 106 073 arteries treated (median=2 arteries, interquartile range=1-3). Half (50%) of these arteries were treated with stents, 39% with PTA alone, and 11% with atherectomy. After risk adjustment, women were less likely to undergo stenting or atherectomy (versus PTA alone) in the femoropopliteal (stent risk ratio=0.78 [0.74-0.82]; atherectomy risk ratio=0.69 [0.58-0.82]) and tibial arteries (stent risk ratio=0.70 [0.55-0.89]; atherectomy risk ratio=0.87 [0.70-1.07]). In the iliac arteries there was no sex difference in stenting, and atherectomy was rarely used (0.2%). Women underwent reintervention in the femoropopliteal arteries (hazard ratio=1.28 [1.17-1.40]) or developed an occlusion in the iliac (hazard ratio=1.42 [1.12-1.81]) and femoropopliteal arteries (hazard ratio=1.19 [1.06-1.34]) more frequently than men. Conclusions Women were less likely to undergo stenting or atherectomy and had higher rates of occlusion and reintervention, especially in the femoropopliteal arteries. Evidence-based guidelines are needed to guide optimal use of endovascular treatments for men and women.

SUBMITTER: Ramkumar N

PROVIDER: S-EPMC6755836 | biostudies-other | 2019 Sep

REPOSITORIES: biostudies-other

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Role of Sex in Determining Treatment Type for Patients Undergoing Endovascular Lower Extremity Revascularization.

Ramkumar Niveditta N Suckow Bjoern D BD Brown Jeremiah R JR Sedrakyan Art A MacKenzie Todd T Stone David H DH Cronenwett Jack L JL Goodney Philip P PP

Journal of the American Heart Association 20190831 17

Background Limited data exist to describe factors that influence the use of different endovascular treatments for peripheral arterial disease. Therefore, we studied sex differences in the utilization of endovascular treatment modalities and their impact on arterial patency. Methods and Results We analyzed procedures from 2010 to 2016 in the Vascular Quality Initiative for arteries treated with percutaneous transluminal angioplasty (PTA) alone, stenting (with/without PTA), and atherectomy (with/w ...[more]

PMID: 31475624

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Project description:IntroductionPatients with chronic kidney disease (CKD) have a high prevalence of peripheral artery disease. How best to manage lower extremity peripheral artery disease remains unclear in this patient population. We therefore sought to compare the outcomes after endovascular versus surgical lower extremity revascularization among patients with CKD.MethodsWe used data from Optum's de-identifed Clinformatics® Data Mart Database, a nationwide database of commercially insured persons in the United States to study patients with CKD who underwent lower extremity endovascular or surgical revascularization. We used inverse probability of treatment weighting to balance covariates. We employed proportional hazard regression to study the primary outcome of major adverse limb events (MALE), defined as a repeat revascularization or amputation. We also studied each of these events separately and death from any cause.ResultsIn our cohort, 60,057 patients underwent endovascular revascularization and 9,338 patients underwent surgical revascularization. Endovascular revascularization compared with surgical revascularization was associated with a higher adjusted hazard of MALE (hazard ratio (HR) 1.52; 95% confidence interval (CI) 1.46-1.59). Endovascular revascularization was also associated with a higher adjusted hazard of repeat revascularization (HR 1.65; 95% CI 1.57-1.72) but a lower adjusted risk of amputation (HR 0.71; CI 0.73-0.89). Patients undergoing endovascular revascularization also had a lower adjusted hazard for death from any cause (0.85; CI 0.82-0.88).ConclusionsIn this analysis of patients with CKD undergoing lower extremity revascularization, an endovascular approach was associated with a higher rate of repeated revascularization but a lower risk of subsequent amputation and death compared with surgical revascularization. Multiple factors must be considered when counseling patients with CKD, who have a high burden of comorbid conditions. Clinical trials should include more patients with kidney disease, who are often otherwise excluded from participation, to better understand the most effective treatment strategies for this vulnerable patient population.

Project description:Background The long-term effectiveness of atherectomy treatment for peripheral arterial disease is unknown. We studied 5-year clinical outcomes by endovascular treatment type among patients with peripheral arterial disease. Methods and Results We queried the Medicare-linked VQI (Vascular Quality Initiative) registry for endovascular interventions from 2010 to 2015. The exposure was treatment type: atherectomy (with or without percutaneous transluminal angioplasty [ PTA] ), stent (with or without PTA ), or PTA alone. The outcomes were major amputation, any amputation, and major adverse limb event (major amputation or any reintervention). We used the center-specific proportions of atherectomy procedures performed in the 12 months before a patient's procedure as the instruments to perform an instrumental-variable Cox model analysis. Among 16 838 eligible patients (median follow-up: 1.3-1.5 years), 11% underwent atherectomy, 40% received PTA alone, and 49% underwent stenting. Patients receiving atherectomy commonly underwent femoropopliteal artery treatment (atherectomy: 65%; PTA : 49%; stenting: 43%; P<0.001) and had worse disease severity (Trans-Atlantic Inter-Society Consensus score [TASC] B and greater; atherectomy: 77%; PTA : 68%; stenting: 67%; P<0.001). The 5-year rate of major adverse limb events was 38% in patients receiving atherectomy versus 33% for PTA and 32% for stenting (log rank P<0.001). Controlling for unmeasured confounding using instrumental-variable analysis, patients treated with atherectomy experienced outcomes similar to those of patients treated with PTA , except for a higher risk of any amputation (hazard ratio: 1.51; 95% CI , 1.08-2.13). However, compared with stenting, atherectomy patients had a higher risk of major amputation (hazard ratio: 3.66; 95% CI , 1.72-7.81), any amputation (hazard ratio: 2.73; 95% CI , 1.60-4.76), and major adverse limb event (hazard ratio: 1.61; 95% CI , 1.10-2.38). Conclusions Atherectomy is used to treat severe femoropopliteal and tibial peripheral arterial disease even though long-term adverse outcomes occur more frequently after this treatment modality.

Project description: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).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).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).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.

Project description:Prior studies have suggested treatment and outcome disparities between men and women for lower extremity peripheral arterial disease after surgical bypass. Given the recent shift toward endovascular therapy, which has increasingly been used to treat claudication, we sought to analyze sex disparities in presentation, revascularization, amputation, and inpatient mortality.We identified individuals with intermittent claudication and critical limb ischemia (CLI) using International Classification of Diseases, Ninth Revision codes in the Nationwide Inpatient Sample from 1998 to 2009. We compared presentation at time of intervention (intermittent claudication vs CLI), procedure (open surgery vs percutaneous transluminal angioplasty or stenting vs major amputation), and in-hospital mortality for men and women. Regional and ambulatory trends were evaluated by performing a separate analysis of the State Inpatient and Ambulatory Surgery Databases from four geographically diverse states: California, Florida, Maryland, and New Jersey.From the Nationwide Inpatient Sample, we identified 1,797,885 patients (56% male) with intermittent claudication (26%) and CLI (74%), who underwent 1,865,999 procedures (41% open surgery, 20% percutaneous transluminal angioplasty or stenting, and 24% amputation). Women were older at the time of intervention by 3.5 years on average and more likely to present with CLI (75.9% vs 72.3%; odds ratio [OR], 1.21; 95% confidence interval [CI], 1.21-1.23; P < .01). Women were more likely to undergo endovascular procedures for both intermittent claudication (47% vs 41%; OR, 1.27; 95% CI, 1.25-1.28; P < .01) and CLI (21% vs 19%; OR, 1.14; 95% CI, 1.13-1.15; P < .01). From 1998 to 2009, major amputations declined from 18 to 11 per 100,000 in men and 16 to 7 per 100,000 in women, predating an increase in total CLI revascularization procedures that was seen starting in 2005 for both men and women. In-hospital mortality was higher in women regardless of disease severity or procedure performed even after adjusting for age and baseline comorbidities (.5% vs .2% after percutaneous transluminal angioplasty or stenting for intermittent claudication; 1.0% vs .7% after open surgery for intermittent claudication; 2.3% vs 1.6% after percutaneous transluminal angioplasty or stenting for CLI; 2.7% vs 2.2% after open surgery for CLI; P < .01 for all comparisons).There appears to be a preference to perform endovascular over surgical revascularization among women, who are older and have more advanced disease at presentation. Percutaneous transluminal angioplasty or stenting continues to be popular and is increasingly being performed in the outpatient setting. Amputation and in-hospital mortality rates have been declining, and women now have lower amputation but higher mortality rates than men. Recent improvements in outcomes are likely the result of a combination of improved medical management and risk factor reduction.

Project description:ObjectiveOptimal patient selection for lower extremity revascularization remains a clinical challenge among the hemodialysis-dependent (HD). The purpose of this study was to examine contemporary real world open and endovascular outcomes of HD patients to better facilitate patient selection for intervention.MethodsA regional multicenter registry was queried between 2003 and 2013 for HD patients (N = 689) undergoing open surgical bypass (n = 295) or endovascular intervention (n = 394) for lower extremity revascularization. Patient demographics and comorbidities were recorded. The primary outcome was overall survival. Secondary outcomes included graft patency, freedom from major adverse limb events, and amputation-free survival (AFS). Multivariate analysis was performed to identify independent risk factors for death and amputation.ResultsAmong the 689 HD patients undergoing lower extremity revascularization, 66% were male, and 83% were white. Ninety percent of revascularizations were performed for critical limb ischemia and 8% for claudication. Overall survival at 1, 2, and 5 years survival remained low at 60%, 43%, and 21%, respectively. Overall 1- and 2-year AFS was 40% and 17%. Mortality accounted for the primary mode of failure for both open bypass (78%) and endovascular interventions (80%) at two years. Survival, AFS, and freedom from major adverse limb event outcomes did not differ significantly between revascularization techniques. At 2 years, endovascular patency was higher than open bypass (76% vs 26%; 95% confidence interval [CI], 0.28-0.71; P = .02). Multivariate analysis identified age ≥80 years (hazard ratio [HR], 1.9; 95% CI, 1.4-2.5; P < .01), indication of rest pain or tissue loss (HR, 1.8; 95% CI, 1.3-2.6; P < .01), preoperative wheelchair/bedridden status (HR, 1.5; 95% CI, 1.1-2.1; P < .01), coronary artery disease (HR, 1.5; 95% CI, 1.2-1.9; P < .01), and chronic obstructive pulmonary disease (HR, 1.4; 95% CI, 1.1-1.8; P = .01) as independent predictors of death. The presence of three or more risk factors resulted in predicted 1-year mortality of 64%.ConclusionsOverall survival and AFS among HD patients remains poor, irrespective of revascularization strategy. Mortality remains the primary driver for these findings and justifies a prudent approach to patient selection. Focus for improved results should emphasize predictors of survival to better identify those most likely to benefit from revascularization.

Project description:Preprocedural computed tomography angiography (CTA) assists in evaluating vascular morphology and disease distribution and in treatment planning for patients with lower extremity peripheral artery disease (PAD). The aim of the study was to determine the predictive value of radiographic findings on CTA and technical success of endovascular revascularization of occlusions in the superficial femoral artery-popliteal (SFA-pop) region.Medical records and available imaging studies were reviewed for patients undergoing endovascular intervention for PAD between January 2013 and December 2015 at a single academic institution. Radiologists reviewed preoperative CTA scans of patients with occlusions in the SFA-pop region. Radiographic criteria previously used to evaluate chronic occlusions in the coronary arteries were used. Technical success, defined as restoration of inline flow through the SFA-pop region with <30% stenosis at the end of the procedure, and intraoperative details were evaluated.From 2013 to 2015, there were 407 patients who underwent 540 endovascular procedures for PAD. Preprocedural CTA scans were performed in 217 patients (53.3%), and 84 occlusions in the SFA-pop region were diagnosed. Ten occlusions were excluded as no endovascular attempt to cross the lesion was made because of extensive disease or concomitant iliac intervention. Of the remaining 74 occlusions in the SFA-pop region, 59 were successfully treated (80%) and 15 were unsuccessfully crossed (20%). The indications for revascularization were claudication in 57% of patients and critical limb ischemia in the remaining patients. TransAtlantic Inter-Society Consensus A, B, and C occlusions were treated with 87% success, whereas D occlusions were treated with 68% success (P = .047). There were nine occlusions with 100% vessel calcification that was associated with technical failure (P = .014). Longer lengths of occlusion were also associated with technical failure (P = .042). Multiple occlusions (P = .55), negative remodeling (P = .69), vessel runoff (P = .56), and percentage of vessel calcification (P = .059) were not associated with failure. On multivariable analysis, 100% calcification remained the only significant predictor of technical failure (odds ratio, 9.0; 95% confidence interval, 1.8-45.8; P = .008).Analysis of preoperative CTA shows 100% calcification as the best predictor of technical failure of endovascular revascularization of occlusions in the SFA-pop region. Further studies are needed to determine the cost-effectiveness of obtaining preoperative CTA for lower extremity PAD.

Dataset Information

Role of Sex in Determining Treatment Type for Patients Undergoing Endovascular Lower Extremity Revascularization.

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Role of Sex in Determining Treatment Type for Patients Undergoing Endovascular Lower Extremity Revascularization.

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