Dataset Information

Sex Differences in Outcomes Following Endovascular Treatment for Symptomatic Peripheral Artery Disease: An Analysis From the K- VIS ELLA Registry.

ABSTRACT: Background With advances in peripheral artery disease ( PAD ) treatments such as endovascular treatment ( EVT ), personalized patient assessment is important. Data on sex differences in clinical outcome for PAD patients undergoing EVT have been limited, and studies have produced conflicting results. This study sought to compare midterm clinical outcomes between women and men in a large population of patients with PAD undergoing EVT . Methods and Results The K- VIS ELLA (Korean Vascular Intervention Society Endovascular Therapy in Lower Limb Artery Disease) registry is a nationwide, multicenter, observational study that includes 3073 PAD patients undergoing EVT . The study population was divided into men (n=2523) and women (n=550). The primary outcome was a composite of death, myocardial infarction, and major amputation; the secondary outcome included major adverse limb events. Women had more comorbidities and more severe and complex target lesions than men. Women showed higher rates of death, myocardial infarction, or major amputation than men (14.8% versus 9.8%, adjusted hazard ratio 1.350, 95% CI 1.017-1.792, P=0.038), and higher rates of major adverse limb events (19.9% versus 14.5%, adjusted hazard ratio 1.301, 95% CI 1.014-1.670, P=0.039) and procedural complications (10.2% versus 5.9%, P<0.001) based on multivariable analysis. In patients with claudication, the primary outcome incidence was significantly higher in women (hazard ratio 2.088, 95% CI 1.421-3.068, P<0.001). In contrast, there was no significant difference in primary outcome for patients with critical limb ischemia between the 2 groups (hazard ratio 1.164, 95% CI 0.800-1.694, P=0.426). A significant interaction ( P=0.035) between patient presentation and outcome was observed. Conclusions In a large population of patients with PAD undergoing EVT , women had higher rates of death, myocardial infarction, or major amputation than men and higher rates of complex lesions, procedural complications, and limb-specific adverse events.

SUBMITTER: Choi KH

PROVIDER: S-EPMC6497340 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Sex Differences in Outcomes Following Endovascular Treatment for Symptomatic Peripheral Artery Disease: An Analysis From the K- VIS ELLA Registry.

Choi Ki Hong KH Park Taek Kyu TK Kim Jihoon J Ko Young-Guk YG Yu Cheol Woong CW Yoon Chang-Hwan CH Lee Jae-Hwan JH Min Pil-Ki PK Koh Yoon Seok YS Chae In-Ho IH Choi Donghoon D Choi Seung-Hyuk SH

Journal of the American Heart Association 20190101 2

Background With advances in peripheral artery disease ( PAD ) treatments such as endovascular treatment ( EVT ), personalized patient assessment is important. Data on sex differences in clinical outcome for PAD patients undergoing EVT have been limited, and studies have produced conflicting results. This study sought to compare midterm clinical outcomes between women and men in a large population of patients with PAD undergoing EVT . Methods and Results The K- VIS ELLA (Korean Vascular Intervent ...[more]

PMID: 30663486

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Project description:Background Despite high female prevalence of peripheral artery disease (PAD), little is known about sex-based outcomes after lower extremity revascularization (LER) for symptomatic PAD. The effects of rivaroxaban according to sex following LER have not been fully reported. Methods and Results In VOYAGER PAD (Vascular Outcomes Study of ASA [acetylsalicylic acid] Along with Rivaroxaban in Endovascular or Surgical Limb Revascularization for Peripheral Artery Disease), low-dose rivaroxaban versus placebo on a background of aspirin reduced the composite primary efficacy outcome of cardiovascular and limb events in patients with PAD undergoing LER. Unplanned index limb revascularization was prespecified and prospectively ascertained. The primary safety outcome was Thrombolysis in Myocardial Infarction major bleeding. Analyses of outcomes and treatment effects by sex were performed using Cox proportional hazards models. Among 6564 randomly assigned patients followed for a median of 28 months, 1704 (26.0%) were women. Among patients administered placebo, women were at similar risk for the primary efficacy outcome (hazard ratio [HR], 0.90; [95% CI, 0.74-1.09]; P=0.29) as men, while female sex was associated with a trend toward higher risk of unplanned index limb revascularization (HR, 1.18; [95% CI, 1.00-1.40]; P=0.0499). Irrespective of sex, effects of rivaroxaban were consistent for the primary efficacy outcome (P-interaction=0.22), unplanned index limb revascularization (P-interaction=0.64), and bleeding (P-interaction=0.61). Women were more likely than men to discontinue study treatment (HR, 1.13; [95% CI, 1.03-1.25]; P=0.0099). Conclusions Among >1700 women with PAD undergoing LER, women and men were at similar risk for the primary outcome, but a trend for greater risk of unplanned index limb revascularization among women was observed. Effects of rivaroxaban were consistent by sex, though women more often discontinued treatment. Better understanding of sex-based outcomes and treatment adherence following LER is needed. Registration URL: http://clinicaltrials.gov; Unique identifier: NCT02504216.

Project description:ObjectiveA physically active lifestyle reduces the risk of cardiovascular events and functional impairment in patients with peripheral artery disease (PAD). There are limited data on the patterns of physical activity in patients with PAD compared between countries.MethodsSelf reported physical activity (sedentary vs. not) was obtained at enrolment, 3, 6, and 12 months in the US and Netherlands' cohorts of the Patient-centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT) registry of patients with new or worsening claudication. Multivariable repeated measures using modified Poisson regression analysis compared the proportion of sedentary participants over time between countries to identify factors that attenuate intercountry differences.ResultsOf 1 098 participants, 743 (67.7%) and 355 (32.3%) were recruited from the USA and the Netherlands respectively. Compared with the Netherlands, participants from the US were older (mean age 68.6 vs. 65.3 years; p < .001), more obese (41.3% vs. 20.5%; p < .001), and more likely to be female (41.3% vs. 31.4%; p = .002). There were fewer current smokers (30.1% vs. 52.8%; p < .001) and supervised exercise referrals (1.6% vs. 63.9%; p < .001) in the US compared with the Netherlands. US participants were more sedentary at baseline (43.7% vs. 34.1%; p < .001). Sedentary behaviour decreased after three months in both countries, then diverged with an increase in sedentary participants in the USA. Risk of sedentary behaviour was significantly greater in the USA compared with the Netherlands at 12 months, after adjustment of sociodemographic, lifestyle factors, and comorbidities (relative risk [RR] 1.56, 95% confidence interval [CI] 1.08-2.25; p = .020) but was attenuated after accounting for referral to supervised exercise (RR 1.20, 95% CI 0.67-2.16; p = .54).ConclusionReferral to supervised exercise was key in explaining the observed difference in the physical activity levels between patients with PAD in the USA and the Netherlands. Further promotion of supervised exercise for PAD may improve physical activity in patients with PAD and modify cultural norms of inactivity in the US.

Dataset Information

Sex Differences in Outcomes Following Endovascular Treatment for Symptomatic Peripheral Artery Disease: An Analysis From the K- VIS ELLA Registry.

Publications

Sex Differences in Outcomes Following Endovascular Treatment for Symptomatic Peripheral Artery Disease: An Analysis From the K- VIS ELLA Registry.

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