Effect of postoperative antithrombotic therapy on lower extremity outcomes after infrapopliteal bypass for chronic limb-threatening ischemia.

OBJECTIVE: Although the current guidelines have recommended single antiplatelet therapy (SAPT) for patients undergoing revascularization for chronic limb-threatening ischemia (CLTI), antithrombotic management has varied by patient and provider. Our aim was to examine the effects of different postoperative antithrombotic regimens on 3-year clinical outcomes after infrapopliteal bypass for CLTI. METHODS: We identified patients who had undergone infrapopliteal bypass for CLTI in the Vascular Quality Initiative (VQI) registry from 2003 to 2017 with linkage to Medicare claims for long-term outcomes. We divided the patients into three cohorts according to the discharge antithrombotic regimen: SAPT (aspirin or clopidogrel), dual antiplatelet therapy (DAPT; aspirin and clopidogrel), or anticoagulation (AC) plus any antiplatelet (AP) agent. To reduce selection bias, we restricted the analysis cohorts to patients treated by providers who discharged >50% of patients with each antithrombotic regimen. Our primary outcome was 3-year major adverse limb events (MALE; major amputation or reintervention). The secondary outcomes included 3-year major amputation, reintervention, and mortality. We used Kaplan-Meier and Cox regression analyses to assess these outcomes stratified by antithrombotic regimen and adjusted for demographic, comorbid, clinical, and operative differences between the treatment groups with clustering at the center level. RESULTS: Among 1812 patients (median follow-up, >2 years), 693 (38%) were discharged with SAPT, 544 (30%) with DAPT, and 575 (32%) with AC+AP. At 3 years, the MALE rates were 75% with DAPT, 74% with AC+AP, and 68% with SAPT. In adjusted analyses with SAPT as the reference group, no differences were found in 3-year MALE with DAPT (adjusted hazard ratio [aHR], 1.0; 95% confidence interval [CI], 0.85-1.3; P = .71) or AC+AP (aHR, 1.1; 95% CI, 0.96-1.3; P = .14). Across the treatment groups, we also found no differences in the individual end points of 3-year major amputation (DAPT: aHR, 0.98; 95% CI, 0.72-1.3; AC+AP: aHR, 1.3; 95% CI, 0.96-1.7), reintervention (DAPT: aHR, 1.0; 95% CI, 0.84-1.3; AC+AP: aHR, 1.1; 95% CI, 0.96-1.3), or mortality (DAPT: aHR, 1.1; 95% CI, 0.88-1.4; AC+AP: aHR, 0.95; 95% CI, 0.74-1.2). In a sensitivity analysis evaluating patients treated by providers who discharged >60%, >70%, or >80% of patients with these regimens, the association between antithrombotic regimen and MALE was unchanged. CONCLUSIONS: Compared with SAPT, DAPT and anticoagulation therapy were not associated with improved outcomes among Medicare beneficiaries who had undergone infrapopliteal bypass for CLTI at VQI participating centers. These findings support current guidelines recommending SAPT after lower extremity bypass and suggest that the routine use of DAPT or anticoagulation therapy might not provide clinical benefit in this high-risk, elderly population. However, further evaluation of the risks and benefits of various antithrombotic regimens in relevant subgroups is warranted.

Endovascular Versus Surgical Revascularization for Acute Limb Ischemia: A Propensity-Score Matched Analysis.

BACKGROUND: The optimal revascularization strategy for acute limb ischemia (ALI) remains unclear, and contemporary comparative effectiveness data on endovascular versus surgical revascularization are lacking. METHODS: We used the 2010 to 2014 National Inpatient Sample databases to identify hospitalizations with a primary diagnosis of ALI. Patients were propensity-score matched on the likelihood of undergoing endovascular versus surgical revascularization using a logistic regression model. The primary outcome was in-hospital mortality. Secondary outcomes included myocardial infarction, stroke, composite of death/myocardial infarction/stroke, any amputation, fasciotomy, acute kidney injury, major bleeding, transfusion, vascular complications, length of stay, and hospital costs. RESULTS: Of 10 484 (weighted national estimate=51 914) hospitalizations for ALI, endovascular revascularization was performed in 5008 (47.8%) and surgical revascularization in 5476 (52.2%). In the propensity-score matched cohort (n=7746; 3873 per group), patients who underwent endovascular revascularization had significantly lower in-hospital mortality (2.8% versus 4.0%; P=0.002), myocardial infarction (1.9% versus 2.7%; P=0.022), composite of death/myocardial infarction/stroke (5.2% versus 7.5%; P<0.001), acute kidney injury (10.5% versus 11.9%; P=0.043), fasciotomy (1.9% versus 8.9%; P<0.001), major bleeding (16.7% versus 21.0%; P<0.001), and transfusion (10.3% versus 18.5%; P<0.001), but higher vascular complications (1.4% versus 0.7%; P=0.002), compared with those undergoing surgical revascularization. Rates of any amputation were similar between the 2 groups (4.7% versus 5.1%; P=0.43). Median length of stay was shorter and hospital costs higher with endovascular versus surgical revascularization. CONCLUSIONS: In patients with ALI, endovascular revascularization was associated with better in-hospital clinical outcomes compared with surgical revascularization. Contemporary randomized controlled trials are needed to determine the optimal revascularization strategy for ALI.

Development of a risk prediction model for transfusion in carotid endarterectomy and demonstration of cost-saving potential by avoidance of "type and screen".

OBJECTIVE: Preoperative testing for carotid endarterectomy (CEA) often includes blood typing and antibody screen (T&S). In our institutional experience, however, transfusion for CEA is rare. We assessed transfusion rate and risk factors in a national clinical database to identify a cohort of patients in whom T&S can safely be avoided with the potential for substantial cost savings. METHODS: With use of the National Surgical Quality Improvement Program database, transfusion events and timing were established for all elective CEAs in 2012-2013. Comorbidities and other characteristics were compared for patients receiving intraoperative or postoperative transfusion and those who did not. After random assignment of the total data to either a training or validation set, a prediction model for transfusion risk was created and subsequently validated. RESULTS: Of 16,043 patients undergoing CEA in 2012-2013, 276 received at least one transfusion before discharge (1.7%); 42% of transfusions occurred on the day of surgery. Preoperative hematocrit <30% (odds ratio [OR], 57.4; 95% confidence interval [CI], 29.6-111.1), history of congestive heart failure (OR, 2.8; 95% CI, 1.1-7.1), dependent functional status (OR, 2.7; 95% CI, 1.5-5.1), coagulopathy (OR, 2.5; 95% CI, 1.7-3.6), creatinine concentration ≥1.2 mg/dL (OR, 2.3; 95% CI, 1.6-3.3), preoperative dyspnea (OR, 2.0; 95% CI, 1.4-3.1), and female gender (OR, 1.6; 95% CI, 1.1-2.3) predicted transfusion. A risk prediction model based on these data produced a C statistic of 0.85; application of this model to the validation set demonstrated a C statistic of 0.81. In the validation set, 93% of patients received a score of 6 or less, corresponding to an individual predicted transfusion risk of 5% or less. Omitting a T&S in these patients would generate a substantial annual cost saving for National Surgical Quality Improvement Program hospitals. CONCLUSIONS: Whereas T&S are commonly performed for patients undergoing CEA, transfusion after CEA is rare and well predicted by a transfusion risk score. Avoidance of T&S in this low-risk population provides a substantial cost-saving opportunity without compromise of patient care.