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Statin therapy after infrainguinal bypass surgery for critical limb ischemia is associated with improved 5-year survival.

ABSTRACT: Although statin therapy has been linked to fewer short-term complications after infrainguinal bypass, its effect on long-term survival remains unclear. We therefore examined associations between statin use and long-term mortality, graft occlusion, and amputation after infrainguinal bypass.We used the Vascular Study Group of New England registry to study 2067 patients (71% male; mean age, 67 ± 11 years; 67% with critical limb ischemia [CLI]) who underwent infrainguinal bypass from 2003 to 2011. Of these, 1537 (74%) were on statins perioperatively and at 1-year follow-up, and 530 received no statin. We examined crude, adjusted, and propensity-matched rates of 5-year surviva1, 1-year amputation, graft occlusion, and perioperative myocardial infarction.Patients taking statins at the time of surgery and at the 1-year follow-up were more likely to have coronary disease (38% vs 22%; P < .001), diabetes (51% vs 36%; P < .001), hypertension (89% vs 77%; P < .001), and prior revascularization procedures (50% vs 38%; P < .001). Despite higher comorbidity burdens, long-term survival was better for patients taking statins in crude (risk ratio [RR], 0.7; P < .001), adjusted (hazard ratio, 0.7; P = .001), and propensity-matched analyses (hazard ratio, 0.7; P = .03). In subgroup analysis, a survival advantage was evident in patients on statins with CLI (5-year survival rate, 63% vs 54%; log-rank, P = .01) but not claudication (5-year survival rate, 84% vs 80%; log-rank, P = .59). Statin therapy was not associated with 1-year rates of major amputation (12% vs 11%; P = .84) or graft occlusion (20% vs 18%; P = .58) in CLI patients. Perioperative myocardial infarction occurred more frequently in patients on a statin in crude analysis (RR, 2.2; P = .01) but not in the matched cohort (RR, 1.9; P = .17).Statin therapy is associated with a 5-year survival benefit after infrainguinal bypass in patients with CLI. However, 1-year limb-related outcomes were not influenced by statin use in our large observational cohort of patients undergoing revascularization in New England.

SUBMITTER: Suckow BD

PROVIDER: S-EPMC4283106 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature

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Statin therapy after infrainguinal bypass surgery for critical limb ischemia is associated with improved 5-year survival.

Suckow Bjoern D BD Kraiss Larry W LW Schanzer Andres A Stone David H DH Kalish Jeffrey J DeMartino Randall R RR Cronenwett Jack L JL Goodney Philip P PP

Journal of vascular surgery 20140716 1

<h4>Objective</h4>Although statin therapy has been linked to fewer short-term complications after infrainguinal bypass, its effect on long-term survival remains unclear. We therefore examined associations between statin use and long-term mortality, graft occlusion, and amputation after infrainguinal bypass.<h4>Methods</h4>We used the Vascular Study Group of New England registry to study 2067 patients (71% male; mean age, 67 ± 11 years; 67% with critical limb ischemia [CLI]) who underwent infrain ...[more]

PMID: 25037607

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Project description:ObjectiveBlack and Hispanic patients have had higher rates of chronic limb-threatening ischemia (CLTI) and experienced worse perioperative outcomes after lower extremity bypass compared with White patients. The underlying reasons for these disparities have remained unclear, and data on 3-year outcomes are limited. Therefore, we examined the differences in 3-year outcomes after open infrainguinal bypass for CLTI stratified by race/ethnicity and explored the potential factors contributing to these differences.MethodsWe identified all CLTI patients who had undergone primary open infrainguinal bypass in the Vascular Quality Initiative registry from 2003 to 2017 with linkage to Medicare claims through 2018 for the 3-year outcomes. Our primary outcomes were the 3-year rates of major amputation, reintervention, and mortality. We also recorded the 30-day major adverse limb events (MALE) defined as major amputation or reintervention. We used Kaplan-Meier estimation methods and multivariable Cox regression analyses to evaluate the outcomes stratified by race/ethnicity and identify contributing factors.ResultsOf the 7108 patients with CLTI, 5599 (79%) were non-Hispanic White, 1053 (15%) were Black, 48 (1%) were Asian, and 408 (6%) were Hispanic patients. Compared with White patients, Black patients had higher rates of 3-year major amputation (Black vs White, 32% vs 19%; hazard ratio [HR], 1.9; 95% confidence interval [CI], 1.7-2.2), reintervention (Black vs White, 61% vs 57%; HR, 1.2; 95% CI, 1.1-1.3), and 30-day MALE (Black vs White, 8.1% vs 4.9%; HR, 1.3; 95% CI, 1.2-1.4) but lower mortality (Black vs White, 38% vs 42%; HR, 0.9; 95% CI, 0.8-0.99). Hispanic patients also experienced higher rates of amputation (Hispanic vs White, 27% vs 19%; HR, 1.6; 95% CI, 1.3-2.0), reintervention (Hispanic vs White, 70% vs 57%; HR, 1.4; 95% CI, 1.2-1.6), and MALE (Hispanic vs White, 8.7% vs 4.9%; HR, 1.5; 95% CI, 1.3-1.7. However, mortality was similar between the two groups (Hispanic vs White, 38% vs 42%; HR, 0.88; 95% CI, 0.76-1.0). The low number of Asian patients prevented a meaningful assessment of amputation (Asian vs White, 20% vs 19%; HR, 0.93; 95% CI, 0.44-2.0), reintervention (Asian vs White, 55% vs 57%; HR, 0.79; 95% CI, 0.51-1.2), MALE (Asian vs White, 8.5% vs 4.9%; HR, 0.71; 95% CI, 0.46-1.1), or mortality (Asian vs White, 36% vs 42%; HR, 0.83; 95% CI, 0.52-1.3). In the adjusted analyses, the association of Black race and Hispanic ethnicity with amputation and reintervention was explained by differences in the demographic characteristics (ie, age, sex) and baseline comorbidities (ie, tobacco use, diabetes, renal disease).ConclusionsCompared with White patients, Black and Hispanic patients had higher 3-year major amputation and reintervention rates. However, mortality was lower for Black patients than for the White patients and similar between Hispanic and White patients. Disparities in amputation and reintervention were partly attributable to differences in demographic characteristics and the higher prevalence of comorbidities in Black and Hispanic patients with CLTI. Future work is necessary to determine whether interventions to improve access to care and reduce the burden of comorbidities in these populations will confer limb salvage benefits.

Project description:Preoperative anemia in elderly patients undergoing surgery is prevalent and associated with adverse events; however, the interaction with other risk factors in patients with chronic limb-threatening ischemia (CLTI) is not well described. The purpose of this study was to assess the association between lower hematocrit (HCT) levels on admission and postoperative outcomes after infrainguinal bypass surgery.Patients with CLTI undergoing nonemergent infrainguinal bypass were identified in the targeted vascular module of National Surgical Quality Improvement Program (NSQIP; 2011-2014). The 30-day outcomes were compared across preoperative HCT levels: severe (?29%), moderate (29.1%-34%), mild (34.1%-39%), or no anemia (>39%), with no anemia serving as the reference group for all analyses. Independent associations between levels of anemia and postoperative outcomes were established using multivariable logistic regression. A sensitivity analysis was performed to assess interactions between preoperative anemia and blood transfusions.We identified 5081 patients undergoing bypass, of which 741 (15%) had severe, 1317 (26%) moderate, 1516 (30%) mild, and 1507 (30%) no anemia. Anemic patients were older and more commonly suffered from tissue loss and comorbidities (eg, hypertension, diabetes, and renal insufficiency; all P < .001). After adjustment for baseline conditions, mortality was higher in those with severe anemia (3.1%; odds ratio [OR], 2.8; 95% confidence interval [CI], 1.3-6.3) and moderate anemia (3.0%; OR, 2.6; 95% CI, 1.2-5.5) compared with those without anemia (0.7%). Severe anemia was independently associated with major amputation (6.9% vs 3.3%; OR, 1.6; 95% CI, 1.01-2.6) compared with no anemia. Anemia on admission was additionally associated with several other adverse outcomes, such as major adverse cardiovascular event (MACE; severe: OR, 1.9; 95% CI, 1.1-3.0; moderate: OR, 1.9; 95% CI, 1.3-2.9; mild: OR, 1.6; 95% CI, 1.1-2.4) and unplanned return to the operating room (severe: OR, 1.6; 95% CI, 1.2-2.1; moderate: OR, 1.5; 95% CI, 1.2-1.8; mild, OR: 1.3; 95% CI, 1.03-1.6). Moreover, mortality associated with preoperative anemia was not different in patients receiving postoperative blood transfusions compared with those who did not, whereas MACE was significantly higher in patients with preoperative anemia and blood transfusions (interaction; P < .001).Mortality and major adverse events in CLTI patients undergoing infrainguinal bypass are inversely associated with preoperative HCT levels, with the highest event rates in the most severely anemic patients. The correlation between anemia and MACE-but not mortality-was stronger in those patients receiving postoperative blood transfusions. Further research is needed to define an appropriate transfusion threshold, and attention should be focused on how to best optimize anemic CLTI patients before intervention.

Project description:BackgroundCritical limb ischemia remains a difficult disease to treat, with limited level one data. The BEST-CLI trial (Best Endovascular vs Best Open Surgical Therapy in Patients with Critical Limb Ischemia) is attempting to answer whether initial treatment with open surgical bypass or endovascular therapy improves outcomes, although it remains in enrollment. This study aims to compare amputation-free survival and reintervention rates in patients treated with initial open surgical bypass or endovascular intervention for ischemic ulcers of the lower extremities.Methods and resultsUsing California nonfederal hospital data linked to statewide death data, all patients with lower extremity ulcers and a diagnosis of peripheral artery disease who underwent a revascularization procedure from 2005 to 2013 were identified. Propensity scores were formulated from baseline patient characteristics. Inverse probability weighting was used with Kaplan-Meier analysis to determine amputation-free survival and time to reintervention for open versus endovascular treatment. Mixed-effects Cox proportional hazards modeling was used to adjust for patient ability to manage their disease and hospital revascularization volume. A total of 16 800 patients were identified. Open surgical bypass was the initial treatment in 5970 (36%) while 10 830 (64%) underwent endovascular interventions. Patients in the endovascular group were slightly younger compared with the open group (70 versus 71 years, ±12 years; P<0.001). Endovascular-first patients were more likely to have comorbid renal failure (36% versus 24%), coronary artery disease (34% versus 32%), congestive heart failure (19% versus 15%), and diabetes mellitus (65% versus 58%; all P values <0.05). After inverse propensity weighting as well as adjustment for patient ability to manage their disease and hospital revascularization experience, open surgery first was associated with a worse amputation-free survival (hazard ratio, 1.16; 95% CI, 1.13-1.20) with no difference in mortality (hazard ratio, 0.94; 95% CI, 0.89-1.11). Endovascular first was associated with higher rates of reintervention (hazard ratio, 1.19; 95% CI, 1.14-1.23).ConclusionsPatients with critical limb ischemia have multiple comorbidities, and initial surgical bypass is associated with poorer amputation-free survival compared with an endovascular-first approach, perhaps due to increased severity of wounds at the time of presentation.

Project description:Purpose: To investigate the outcomes of orbital atherectomy (OA) for the treatment of patients with peripheral artery disease (PAD) manifesting as claudication or chronic limb-threatening ischemia (CLTI). Materials and Methods: The database from the LIBERTY study (ClinicalTrials.gov identifier NCT01855412) was interrogated to identify 503 PAD patients treated with any commercially available endovascular devices and adjunctive OA for 617 femoropopliteal and/or infrapopliteal lesions. Cox regression analyses were employed to examine the association between baseline Rutherford category (RC) stratified as RC 2-3 (n=214), RC 4-5 (n=233), or RC 6 (n=56) and all-cause mortality, target vessel revascularization (TVR), major amputation, major adverse event (MAE), and major amputation/death at up to 3 years of follow-up. The mean lesion lengths were 78.7±73.7, 131.4±119.0, and 95.2±83.9 mm, respectively, for the 3 groups. Results: After OA, balloon angioplasty was used in >98% of cases, with bailout stenting necessary in 2.0%, 2.8%, and 0% of the RC groups, respectively. A small proportion (10.8%) of patients developed angiographic complications, without differences based on presentation. During the 3-year follow-up, claudicants were at lower risk for MAE, death, and major amputation/death than patients with CLTI. The 3-year Kaplan-Meier survival estimates were 84.6% for the RC 2-3 group, 76.2% for the RC 4-5 group, and 63.7% for the RC 6 group. The 3-year freedom from major amputation was estimated as 100%, 95.3%, and 88.6%, respectively. Among CLTI patients only, the RC at baseline was correlated with the combined outcome of major amputation/death, whereas RC classification did not affect TVR, MAE, major amputation, or death rates. Conclusion: Peripheral artery angioplasty with adjunctive OA in patients with CLTI or claudication is safe and associated with low major amputation rates after 3 years of follow-up. These results demonstrate the utility of OA for patients across the spectrum of PAD.

Project description:OBJECTIVE:Lower extremity bypass (LEB) has traditionally been the "gold standard" in the treatment of critical limb ischemia (CLI). Infrainguinal endovascular intervention (IEI) has become more commonly performed than LEB, but comparative outcomes are limited. We sought to compare rates of major adverse limb events (MALEs) and major adverse cardiovascular events (MACEs) after LEB and IEI in a propensity score-matched, national cohort of patients with CLI. METHODS:The National Surgical Quality Improvement Program (NSQIP) vascular targeted files (2011-2014) for LEB and IEI were merged. CLI patients were identified by ischemic rest pain or tissue loss. Patients were matched on a 1:1 basis for propensity to undergo LEB or IEI. Primary outcomes were 30-day MALEs and MACEs. Within the propensity-matched cohort, multivariate logistic regression was used to identify independent predictors of MALEs and MACEs. RESULTS:A total of 13,294 LEBs and IEIs were identified, with 8066 cases performed for CLI. Propensity matching identified 3848 cases (1924 per group). There were no differences in preoperative variables between the propensity-matched LEB and IEI groups (all P > .05). At 30 days, rates of MALEs were significantly lower in the LEB group (9.2% LEB vs IEI 12.2%; P = .003). On multivariate logistic regression, bypass with single-segment saphenous vein vs IEI (odds ratio [OR], 0.7; 95% confidence interval [CI], 0.54-0.92; P = .01), bypass with alternative conduit (prosthetic, spliced vein, or composite) vs IEI (OR, 0.7; 95% CI, 0.56-0.98; P = .04), antiplatelet therapy (OR, 0.8; 95% CI, 0.58-1.00; P = .049), and statin therapy (OR, 0.8; 95% CI, 0.62-0.99; P = .04) were protective against MALEs, whereas infrageniculate intervention (OR, 1.4; 95% CI, 1.09-1.72; P = .01) and a history of prior bypass of the same arterial segment (OR, 1.8; 95% CI, 1.41-2.41; P <. 0001) were predictive. Rates of 30-day MACEs were not significantly different (4.9% LEB vs 3.7% IEI; P = .07) between the groups. Independent predictors of MACEs included age (OR, 1.02; 95% CI, 1.01-1.04; P = .01), steroid use (OR, 1.8; 95% CI, 1.08-2.99; P = .03), congestive heart failure (OR, 1.7; 95% CI, 1.00-1.96; P = .02), beta blocker use (OR, 1.6; 95% CI, 1.09-1.43; P = .01), dialysis (OR, 2.3; 95% CI, 1.55-3.45; P < .0001), totally dependent functional status (OR, 3.1; 95% CI, 1.25-7.58; P = .02), and suboptimal conduit for LEB compared with IEI (OR, 1.6; 95% CI, 1.08-2.36; P = .02). CONCLUSIONS:Within this large, propensity-matched, national cohort, LEB predicted lower risk-adjusted 30-day MALE rate compared with IEI. Furthermore, there was no difference in 30-day MACE rate between the groups despite higher inherent risk with open surgical procedures. Therefore, this study supports the effectiveness and primacy of LEB for revascularization in CLI.

Project description:ObjectiveAlthough an increasing number of patients with peripheral arterial disease undergo multiple revascularization procedures, the effect of prior interventions on outcomes remains unclear. The purpose of this study was to evaluate perioperative outcomes of bypass surgery in patients with and those without prior ipsilateral treatment.MethodsPatients undergoing nonemergent infrainguinal bypass between 2011 and 2014 were identified in the National Surgical Quality Improvement Program Targeted Vascular module. After stratification by symptom status (chronic limb-threatening ischemia [CLTI] and claudication), patients undergoing primary bypass were compared with those undergoing secondary bypass. Within the secondary bypass group, further analysis compared prior bypass with prior endovascular intervention. Multivariable logistic regression analysis was used to establish the independent association between prior ipsilateral procedure and perioperative outcomes.ResultsA total of 7302 patients were identified, of which 4540 (62%) underwent primary bypass (68% for CLTI), 1536 (21%) underwent secondary bypass after a previous bypass (75% for CLTI), and 1226 (17%) underwent secondary bypass after a previous endovascular intervention (72% for CLTI). Prior revascularization on the same ipsilateral arteries was associated with increased 30-day major adverse limb event in patients with CLTI (9.8% vs 7.4%; odds ratio [OR], 1.4 [95% confidence interval (CI), 1.1-1.7]) and claudication (5.2% vs 2.5%; OR, 2.1 [95% CI, 1.3-3.5]). Similarly, secondary bypass was an independent risk factor for 30-day major reintervention (CLTI: OR, 1.4 [95% CI, 1.1-1.8]; claudication: OR, 2.1 [95% CI, 1.3-3.5]), bleeding (CLTI: OR, 1.4 [95% CI, 1.2-1.6]; claudication: OR, 1.7 [95% CI, 1.3-2.4]), and unplanned reoperation (CLTI: OR, 1.2 [95% CI, 1.0-1.4]; claudication: OR, 1.6 [95% CI, 1.1-2.1]), whereas major amputation was increased in CLTI patients only (OR, 1.3 [95% CI, 1.01-1.8]). Postoperative mortality was not significantly different in patients undergoing secondary compared with primary bypass (CLTI: 1.7% vs 2.2% [P = .22]; claudication: 0.4% vs 0.6% [P = .76]). Among secondary bypass patients with CLTI, those with prior bypass had higher 30-day reintervention rates (7.8% vs 4.9%; OR, 1.5 [95% CI, 1.0-2.2]) but fewer wound infections (7.3% vs 12%; OR, 0.6 [95% CI, 0.4-0.8]) compared with patients with prior endovascular intervention.ConclusionsPrior revascularization, in both patients with CLTI and patients with claudication, is associated with worse perioperative outcomes compared with primary bypass. Furthermore, prior endovascular intervention is associated with increased wound infections, whereas those with prior bypass had higher reintervention rates. The increasing prevalence of patients undergoing multiple interventions stresses the importance of the selection of patients for initial treatment and should be factored into subsequent revascularization options in an effort to decrease adverse events.

Dataset Information

Statin therapy after infrainguinal bypass surgery for critical limb ischemia is associated with improved 5-year survival.

Publications

Statin therapy after infrainguinal bypass surgery for critical limb ischemia is associated with improved 5-year survival.

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