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Supplemental Digital Content is available in the text. Background: Evidence about sex differences in management and outcomes of critical limb ischemia (CLI) is conflicting. Methods: We identified Fee-For-Service Medicare patients within the 5% enhanced sample file who were diagnosed with new incident CLI between 2015 and 2017. For each beneficiary, we identified all hospital admissions, outpatient encounters and procedures, and pharmacy prescriptions. Outcomes included 90-day mortality and major amputation. Results: Incidence of CLI declined from 2.80 (95% CI, 2.72–2.88) to 2.47 (95% CI, 2.40–2.54) per 1000 person from 2015 to 2017, P <0.01. Incidence was lower in women compared with men (2.19 versus 3.11 per 1000) but declined in both groups. Women had a lower prevalence of prescription of any statin (48.4% versus 52.9%, P <0.001) or high-intensity statins (15.3% versus 19.8%, P <0.01) compared with men. Overall, 90-day revascularization rate was 52%, and women were less likely to undergo revascularization (50.1% versus 53.6%, P <0.01) compared with men. Women had a similar unadjusted (9.9% versus 10.3%, P =0.5) and adjusted 90-day mortality (adjusted rate ratio, 0.98 [95% CI, 0.85–1.12], P =0.7) compared with men. Over the study period, unadjusted 90-day mortality remained unchanged for men (10.4% in 2015 to 9.9% in 2017, P for trend=0.3), and women (9.5% in 2015 to 10.6% in 2017, P for trend=0.2). Men had higher unadjusted (12.9% versus 8.9%, P <0.001) and adjusted risk of 90-day major amputation (adjusted rate ratio, 1.30 [95% CI, 1.14–1.48], P <0.001). One-third of patients with CLI underwent major amputation without a diagnostic angiogram or trial of revascularization in the preceding 90 days regardless of the sex. Conclusions: Women with new incident CLI are less likely to receive statin or undergo revascularization at 90 days compared with men. However, the differences were small. There was no difference in risk of 90-day mortality between both sexes. [ABSTRACT FROM AUTHOR]

Supplemental Digital Content is available in the text. Background: Patients with end-stage renal disease on hemodialysis (ESRD-HD) and aortic stenosis have poor prognosis. The role of transcatheter aortic valve replacement (TAVR) in this high-risk population is debated. Methods: We compared the outcomes among ESRD-HD Medicare beneficiaries who were managed with TAVR, surgical AVR (SAVR), or conservative management for aortic stenosis between 2015 and 2017, using overlap propensity score weighting analysis to control for differences in treatment assignment. The primary outcome was all-cause mortality and was compared between treatment groups as well as to age-sex matched mortality for ESRD-HD in the US population. Secondary outcomes included trend of heart failure hospitalizations. Results: A total of 8107 ESRD-HD patients with aortic stenosis were included, 4130 (50%) underwent TAVR, 2565 (31.6%) underwent SAVR, and 1412 (17.4%) were managed conservatively. TAVR patients had more comorbidities and higher frailty compared with the other 2 groups. Thirty-day mortality was lower with TAVR compared with SAVR (4.6% versus 12.8%, P <0.01). After a median follow-up of 465 days (interquartile range, 261–759), on overlap propensity score weighting analysis, there was no difference in mortality between TAVR and SAVR (adjusted hazard ratio, 1.02 [95% CI, 0.91–1.15], P =0.7), and mortality was lower with TAVR compared with conservative management (adjusted hazard ratio, 0.53 [95% CI, 0.47–0.60], P <0.001). Standardized mortality ratios with TAVR, SAVR, and conservative management compared with age-sex matched ESRD-HD US population were 1.24, 1.27, and 1.83, respectively. The rate of heart failure admissions declined after TAVR (incidence rate ratio, 0.55 [95% CI, 0.48–0.62], P <0.001) and SAVR (incidence rate ratio, 0.76 [95% CI, 0.65–0.88], P <0.001). Conclusions: In ESRD-HD patients with aortic stenosis, mortality was lower in the short-term with TAVR compared with SAVR but comparable in the mid-term. AVR is associated with an improvement in survival and reduction in heart failure hospitalizations compared with conservative management. [ABSTRACT FROM AUTHOR]

Supplemental Digital Content is available in the text. Background: Management of coronary lesions with fractional flow reserve values in the gray zone (0.75–0.80) remains controversial due to conflicting data on the performance versus deferral of revascularization. Methods: We performed a systematic review and meta-analysis of 7 observational studies including 2683 patients that compared the outcomes of deferred versus performed revascularization of coronary lesions with gray-zone fractional flow reserve values. Results: During a mean follow-up of 31±9 months, the incidence of major adverse cardiovascular events (12.54 % versus 11.25%; odds ratio [OR], 1.64 [95% CI, 0.78–3.44]; P =0.19, I2=84%), cardiac mortality (1.25% versus 0.72%; OR, 1.78 [95% CI, 0.58–5.46]; P =0.31, I2=18%), and myocardial infarction (1.28% versus 2.66%; OR, 0.79 [95% CI, 0.22–2.79]; P =0.71, I2=65%) was similar with deferral versus performance of revascularization in coronary lesions with gray-zone fractional flow reserve. Deferral of revascularization was associated with a higher incidence of target vessel revascularization (9.12% versus 5.78%; OR, 1.85 [95% CI, 1.03–3.33]; P =0.04, I2=62%). When the analysis was limited only to studies that used percutaneous coronary intervention for revascularization, deferred revascularization remained associated with a higher risk of target vessel revascularization (18% versus 7.3%; OR, 3.04 [95% CI, 1.53–6.02]; P <0.001) and was associated with a higher risk of major adverse cardiovascular event (23.2% versus 13.4%; OR, 3.38 [95% CI, 1.92–5.95]; P <0.001). Conclusions: In lesions with gray-zone fractional flow reserve, revascularization was associated with a similar incidence of major adverse cardiovascular event but a lower incidence of target vessel revascularization over a mean follow-up of approximately 2.5 years. Clinical Trial Registration: URL: https://www.crd.york.ac.uk/prospero/. Unique identifier: CRD42019128076. [ABSTRACT FROM AUTHOR]

Supplemental Digital Content is available in the text. Background: Radial access (RA) is increasingly used in chronic total occlusion (CTO) percutaneous coronary intervention with encouraging results. However, there are concerns about its safety and efficacy because of higher complexity and the need for strong guide catheter support. Methods and Results: We performed a systematic review and meta-analysis of all studies published through November 2018 reporting the outcomes of RA versus femoral access in CTO percutaneous coronary intervention. Outcomes included major bleeding, access-site complications, in-hospital major adverse events, and technical success. Nine observational studies with 10 590 patients (10 617 lesions) were included in the meta-analysis. CTO lesions attempted using RA had lower Japan-CTO score (2.3±1.2 versus 2.5±1.3; P <0.001). Use of RA was associated with similar technical success (78.7% versus 78.5%; odds ratio, 1.11; 95% CI, 0.94–1.31; P =0.24; I 2=23%), lower risk of access-site complications (0.73% versus 1.79%; odds ratio, 0.34; 95% CI, 0.22–0.51; P <0.001; I 2=0%) and major bleeding (0.18% versus 0.9%; odds ratio, 0.22; 95% CI, 0.10–0.45; P <0.001; I 2=0%), and similar risk of in-hospital adverse events and in-hospital mortality (odds ratio, 0.36; 95% CI, 0.12–1.07; P =0.07; I 2=0%) as compared to femoral access. Results were similar when analyzing radial-only versus any femoral access and when excluding the largest study. Conclusions: As compared with femoral access, RA is used in CTO percutaneous coronary intervention of less complex lesions and is associated with fewer access-site complications and major bleeding and comparable technical success. [ABSTRACT FROM AUTHOR]