Racial and ethnic differences in presentation severity and postoperative outcomes in vascular surgery.

BACKGROUND: We assessed the effect of race and ethnicity on presentation severity and postoperative outcomes in those with abdominal aortic aneurysms (AAAs), carotid artery stenosis (CAS), peripheral arterial disease (PAD), and type B aortic dissection (TBAD). METHODS: MEDLINE, Embase, and Cochrane Central Register of Controlled Trials from inception until December 2020. Two reviewers independently selected randomized controlled trials and observational studies reporting race and/or ethnicity and presentation severity and/or postoperative outcomes for adult patients who had undergone major vascular procedures. They independently extracted the study data and assessed the risk of bias using the Newcastle-Ottawa scale. The meta-analysis used random effects models to derive the odds ratios (ORs) and risk ratios (RRs) and their corresponding 95% confidence intervals (CIs). The primary outcome was presentation severity stratified by the proportion of patients with advanced disease, including ruptured vs nonruptured AAA, symptomatic vs asymptomatic CAS, chronic limb-threatening ischemia vs claudication, and complicated vs uncomplicated TBAD. The secondary outcomes included postoperative all-cause mortality and disease-specific outcomes. RESULTS: A total of 81 studies met the inclusion criteria. Black (OR, 4.18; 95% CI, 1.31-13.26), Hispanic (OR, 2.01; 95% CI, 1.85-2.19), and Indigenous (OR, 1.97; 95% CI, 1.39-2.80) patients were more likely to present with ruptured AAAs than were White patients. Black and Hispanic patients had had higher symptomatic CAS (Black: OR, 1.20; 95% CI, 1.04-1.38; Hispanic: OR, 1.32; 95% CI, 1.20-1.45) and chronic limb-threatening ischemia (Black: OR, 1.67; 95% CI, 1.14-2.43; Hispanic: OR, 1.73; 95% CI 1.13-2.65) presentation rates. No study had evaluated the effect of race or ethnicity on complicated TBAD. All-cause mortality was higher for Black (RR, 1.23; 95% CI, 1.01-1.51), Hispanic (RR, 1.90; 95% CI, 1.57-2.31), and Indigenous (RR, 1.24; 95% CI, 1.12-1.37) patients after AAA repair. Postoperatively, Black (RR, 1.54; 95% CI, 1.19-2.00) and Hispanic (RR, 1.54; 95% CI, 1.31-1.81) patients were associated with stroke/transient ischemic attack after carotid revascularization and lower extremity amputation (RR, 1.90; 95% CI, 1.76-2.06; and RR, 1.69; 95% CI, 1.48-1.94, respectively). CONCLUSIONS: Certain visible minorities were associated with higher morbidity and mortality across various vascular surgery presentations. Further research to understand the underpinnings is required.

A systematic review and meta-analysis of sex- and gender-based differences in presentation severity and outcomes in adults undergoing major vascular surgery.

BACKGROUND: Studies have investigated the effects of gender on vascular surgery care. However, to the best of our knowledge, no comprehensive synthesis of the literature has been performed on the presentation severity and postoperative outcomes for abdominal aortic aneurysms (AAAs), carotid artery stenosis (CAS), peripheral artery disease (PAD), and type B aortic dissection (TBAD). We conducted a systematic review and meta-analysis of the sex and gender differences in the presentation severity and outcomes for patients who had undergone major vascular surgery. METHODS: The MEDLINE, Embase, and Cochrane CENTRAL databases were searched from their inception to December 2020. All observational studies and randomized controlled trials that had evaluated the gender differences in presentation severity or outcomes for patients who had undergone open or endovascular AAA or TBAD repair, carotid endarterectomy or stenting, or lower extremity bypass or angioplasty were included. The presentation severity was defined as follows: AAA (symptomatic or ruptured vs asymptomatic), carotid artery disease (symptomatic vs asymptomatic), PAD (chronic limb-threatening ischemia [CLTI] vs claudication), and TBAD (complicated vs uncomplicated). The postoperative outcomes included long-term mortality, stroke, amputation, revascularization, and graft and/or stent thrombosis. A random effects model was used to derive the odds ratios (ORs), risk ratios (RRs), and 95% confidence intervals (CIs). RESULTS: A total of 236 studies met the inclusion criteria for our systematic review. Of the 236 studies, 86 (n = 2,099,534 patients), 62 (n = 2,300,888 patients), 28 (n = 2,394,143 patients), and 4 (n = 4525 patients) had evaluated the effects of gender on the outcomes for patients with AAA, CAS, PAD, and TBAD, respectively. The female patients were more likely to have presented with a ruptured AAA (OR, 1.18; 95% CI, 1.09-1.28) and CLTI (OR, 1.10; 95% CI, 1.02-1.19) than were the male patients. The all-cause mortality for those with an AAA (RR, 1.35; 95% CI, 1.20-1.52) and those with PAD (RR, 1.14; 95% CI, 1.05-1.23) was higher for the women. However, the female patients with CAS had had lower all-cause mortality (RR, 0.85; 95% CI, 0.76-0.94). No sex differences were found in the TBAD outcomes. CONCLUSIONS: We found that female patients who had undergone vascular surgery were associated with more severe disease at presentation, with a greater proportion of ruptured AAAs and CLTI. This potentially contributes to the higher mortality rates for female patients with AAAs and PAD compared with male patients. Future studies are needed to evaluate the reasons for these disparities, and greater efforts are required to support women in receiving more timely vascular surgical care.

Primary prevention of venous thromboembolism for cancer patients in randomized controlled trials: a bibliographical analysis of funding and trial characteristics.

Background: The majority of randomized controlled trials (RCTs) investigating venous thromboembolism (VTE) prophylaxis in patients with cancer involve commercial sponsorship. Commercial sponsorship overcomes feasibility limitations inherent in RCTs, such as recruitment and funding, but has attracted scrutiny for its potential for bias. Objectives: In RCTs of VTE prophylaxis in patients with cancer, how do trial characteristics compare between commercially sponsored RCTs and noncommercially sponsored RCTs? Methods: Medline, Embase, and Cochrane Central Register of Controlled Trials were searched for RCTs that investigated at least 1 pharmacologic intervention for VTE prophylaxis in adult patients with cancer. Screening and data extraction were conducted by independent reviewers. Outcomes included trial characteristics, reporting of favorable outcomes, protocol-manuscript discrepancies, and appraisal of spin. Outcomes were compared using the independent t-test, Mann-Whitney U-test, Pearson chi-squared test, and Fisher's exact test. Logistic regression was performed to identify factors associated with possible bias. Results: Of the 54 trials analyzed, 34 (63%) reported commercial sponsorship. Commercial sponsorship was not associated with the reporting of favorable outcomes, presence of spin, retrospective registration, or protocol-manuscript discrepancy. Spin was most prevalent in the abstract conclusions (9 out of 17 [53.3%]) and manuscript conclusions (8 out of 17 [46.7%]).Commercially sponsored trials had a higher rate of intention-to-treat analysis. Noncommercially sponsored trials were more likely to report retrospective registration of trial protocol and the use of composite primary outcomes. Conclusion: There were few significant differences between trial characteristics, suggesting that the evidence from commercially sponsored trials investigating VTE prophylaxis in patients with cancer is unlikely to be subject to bias attributable to commercial sponsorship.

Convalescent plasma therapy for coronavirus disease 2019 in ambulatory versus hospitalized patients: Efficacy and risk of thromboembolism.

Background: Although early evidence concluded a lack of clinical benefit of convalescent plasma therapy (CPT) in COVID-19 management, recent trials have demonstrated the therapeutic potential of CPT in ambulatory care. CPT may also potentiate thromboembolic events, given the presence of coagulation factors and the prothrombotic state of COVID-19. Objectives: The present study aimed to assess and compare the clinical efficacy and the risk of venous thromboembolism (VTE)/arterial thromboembolism (ATE) of CPT in ambulatory versus hospitalized patients with COVID-19. Methods: MEDLINE, Embase, and Cochrane CENTRAL were searched from December 2019 to December 2022 for randomized controlled trials that investigated the use of CPT against placebo or standard of care in adult patients with COVID-19. The primary outcome was nonmortality disease progression. Secondary outcomes include VTE, ATE, 28-day mortality, clinical improvement, length of hospitalization, sepsis/fever, and major adverse cardiovascular events. Results: Twenty randomized controlled trials, with 21,340 patients, were included. CPT significantly reduced nonmortality disease progression in ambulatory patients (odds ratio [OR], 0.72; 95% CI, 0.56-0.92; P = .009) but not in hospitalized patients (OR, 1.03; 95% CI, 0.94-1.12; P = .58). The risk of VTE and ATE did not differ between the CPT and the control group (OR, 1.16; 95% CI, 0.82-1.66; P = .40; and OR, 1.01; 95% CI, 0.37-2.79; P = .98, respectively). No conclusive differences between CPT and control groups were noted in 28-day mortality, clinical improvement, length of hospitalization, risk of sepsis/fever, and major adverse cardiovascular events. Conclusion: In conclusion, treatment of COVID-19 with CPT prevents the progression of COVID-19 in the ambulatory care. It is not associated with an increased risk of VTE, ATE, or other adverse events.