Rivaroxaban Plus Aspirin Versus Standard Dual Antiplatelet Therapy Following Angioplasty for Lower Extremity Peripheral Arterial Disease in Patients With Critical Limb Ischemia and Claudication (RIVAL-PAD): 12-Month Results of a Randomized Trial

Abstract Introduction Guideline recommendations for antithrombotic (antiplatelet and anticoagulant) therapy during and after endovascular intervention are patchy and conflicted, in part due to a lack of evidence. The aim of this systematic review was to examine the antithrombotic specifications in randomised trials for peripheral arterial endovascular intervention. Method This review was conducted according to PRISMA guidelines. Randomised trials including participants with peripheral arterial disease undergoing endovascular arterial intervention were included. Trial methods were assessed to determine whether an antithrombotic protocol had been specified, its completeness, and the agent(s) prescribed. Antithrombotic protocols were classed as periprocedural (preceding/during intervention), immediate postprocedural (up to 14 days following intervention) and maintenance postprocedural (therapy continuing beyond 14 days). Trials were stratified according to type of intervention. Result Ninety-four trials were included. Only 29% of trials had complete periprocedural antithrombotic protocols, and 34% had complete post-procedural protocols. In total, 64 different periprocedural protocols, and 51 separate postprocedural protocols were specified. Antiplatelet monotherapy and unfractionated heparin were the most common choices of regimen in the periprocedural setting, and dual antiplatelet therapy (55%) was most commonly utilised postprocedure. There is an increasing tendency to use dual antiplatelet therapy with time or for drug-coated technologies. Conclusion Randomised trials comparing different types of peripheral endovascular arterial intervention have a high level of heterogeneity in their antithrombotic regimens, and there has been an increasing tendency to use dual antiplatelet therapy over time. Antiplatelet regimes need to be standardised in trials comparing endovascular technologies. Take-home message To determine the benefits of any endovascular intervention within a randomised trial, antithrombotic regimens should be standardised to prevent confounding. This systematic review demonstrates a high level of heterogeneity of antithrombotic prescribing in randomised trials of endovascular intervention, and an increasing tendency to utilise dual antiplatelet therapy, despite a lack of evidence of benefit, but an increased risk of harm.

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Abstract P250: Incidence of Hospitalized Peripheral Arterial Disease and Critical Limb Ischemia: The Atherosclerosis Risk in Communities (ARIC) Study

Circulation ◽

10.1161/circ.125.suppl_10.ap250 ◽

2012 ◽

Vol 125 (suppl_10) ◽

Author(s):

Corey A Kalbaugh ◽

Anna Kucharska-Newton ◽

Laura Loehr ◽

Elizabeth Selvin ◽

Aaron R Folsom ◽

...

Keyword(s):

Risk Factors ◽

African Americans ◽

Peripheral Arterial Disease ◽

Lower Extremity ◽

Limb Ischemia ◽

Arterial Disease ◽

Atherosclerosis Risk In Communities ◽

Atherosclerosis Risk ◽

Baseline Characteristics ◽

Peripheral Arterial

Introduction: Lower extremity peripheral arterial disease (PAD) affects between 12% and 20% of Americans over the age of 65. PAD compromises quality of life, contributes a high burden of disability and its related health care costs exceed $4 billion/year, yet this preventable CVD outcome remains understudied. Aims: Assess the incidence of hospitalized PAD, and of the most severe form of PAD, critical limb ischemia (CLI), in middle-aged men and women, and evaluate their risk factors in a bi-ethnic, population-based cohort. We hypothesized that incidence of hospitalized PAD and CLI are higher in African Americans, and that modifiable atherosclerosis risk factors in middle age predict these sequelae of PAD. Methods: We analyzed data from 13,865 participants from the Atherosclerosis Risk in Communities Study aged 45–64 without PAD at baseline (1987–89). Incident PAD and CLI events were identified using ICD-9 codes from active surveillance of all hospitalizations among cohort participants from 1987 through 2008. All estimates are incidence rates per 10,000 person-years; nominal statistical significance was achieved for all baseline characteristic comparisons reported. Results: There were 707 incident hospitalized PAD during a median of 18 years of follow-up (249,570 person-years). The overall age-adjusted incidence of PAD and limb-threatening CLI were 26.0 and 9.6 per 10,000 person-years, respectively. Incidence of hospitalized PAD was higher in African Americans than whites (34.7 vs. 23.2) and in men compared to women (32.4 vs. 26.7). Baseline characteristics associated with age-adjusted incident PAD (per 10,000 person-years) compared to their referent groups were diabetes (91.2 vs. 19.0), history of smoking (33.6 vs. 16.2), hypertension (42.6 vs. 18.6), coronary heart disease (81.4 vs. 24.1), and obesity (41.5 vs. 20.2). Incidence of CLI also was higher among African Americans (21.0 vs. 5.9) and in men (10.5 vs. 8.9 per 10,000 person-years). Baseline characteristics associated with incident CLI were similar to those for PAD. Conclusions: The absolute risk of hospitalized lower extremity PAD in this community-based cohort is of a magnitude similar to that of heart failure and of stroke. As modifiable factors are strongly predictive of the long-term risk of hospitalized PAD and CLI, particularly among African Americans, our results highlight the need for effective risk factor prevention and control.

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