Comparative effectiveness study of self-directed walking exercise, lower extremity revascularization, and functional decline in peripheral artery disease

Introduction: Although data suggests higher rates of functional decline and inferior outcomes in women compared to men after interventions for peripheral artery disease (PAD), women remain underrepresented in contemporary studies. We used a large national database to better understand gender-based differences in presentation and outcomes for patients undergoing endovascular treatment for PAD. Methods: Patients in the Vascular Quality Initiative (VQI) database that underwent lower extremity (LE) endovascular interventions for symptomatic PAD from 2010-2019 were included. Descriptive statistics and multivariable analysis were performed. Results: 128,688 patients (40% female) underwent endovascular LE interventions for symptomatic PAD. Women were more likely to have chronic limb threatening ischemia compared to men (54% vs 51%) and more likely to have a preoperative ABI <0.4 (20% vs 14%). Compared to men, women were older (mean [SD]: 68 [11] vs 70 [12]), more likely to be Black (19% vs 14%), and less likely to be smokers (34% vs 36%), diabetic (50% vs 54%), have CAD (28% vs 35%), or be on dialysis (8% vs 9%) (Table 1). Women were less likely to have exclusively infrapopliteal interventions (8% vs 14%) compared to men (p<0.001 for all). Despite shorter procedural times in women, female gender was an independent predictor of in hospital mortality (OR 1.25, 95% CI 1.09-1.44) in a hierarchical multivariable model adjusting for age, race, smoking, and comorbidities. Women were more likely to be discharged to a rehab or nursing home (11% vs 10%, p< 0.001) and less likely to be taking a statin medication (73% vs 78%, p<0.001). Conclusions: Compared to men, women undergoing endovascular LE interventions for PAD are older, present with more severe disease, and have higher adjusted rates of in hospital mortality. More aggressive screening and medical treatment for PAD in women is needed to address these gender-based differences in disease presentation and clinical outcomes.

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Effect of vorapaxar on cardiovascular and limb outcomes in patients with peripheral artery disease with and without coronary artery disease: Analysis from the TRA 2°P-TIMI 50 trial

Vascular Medicine ◽

10.1177/1358863x19892690 ◽

2020 ◽

Vol 25 (2) ◽

pp. 124-132 ◽

Cited By ~ 1

Author(s):

Arman Qamar ◽

David A Morrow ◽

Mark A Creager ◽

Benjamin M Scirica ◽

Jeffrey W Olin ◽

...

Keyword(s):

Coronary Artery Disease ◽

Coronary Artery ◽

Lower Extremity ◽

Peripheral Artery Disease ◽

Absolute Risk ◽

Major Adverse Cardiovascular Events ◽

Number Needed To Treat ◽

Peripheral Artery ◽

Artery Disease ◽

Lower Extremity Revascularization

Intensive antithrombotic therapy reduces major adverse cardiovascular events (MACE) and major adverse limb events (MALE) in patients with peripheral artery disease (PAD). Recent studies have suggested heterogeneity in risk and benefit in those with and without concomitant coronary artery disease (CAD) and peripheral revascularization. We evaluated the risk of MACE and MALE in patients with PAD stratified by history of concomitant CAD and prior peripheral revascularization and whether the efficacy and safety of vorapaxar were similar in these subgroups. The TRA 2°P-TIMI 50 trial randomized 26,449 patients with prior MI, ischemic stroke, or PAD to vorapaxar or placebo. This analysis examined the effect of vorapaxar in a broad population of 6136 patients with PAD. Overall, vorapaxar significantly reduced MACE (HR 0.85, 95% CI 0.73, 0.99; p = 0.034) and MALE (HR 0.70, 95% CI 0.53, 0.92; p = 0.011) in patients with PAD. The absolute risk reduction (ARR) for MACE was greater in patients with PAD and CAD versus those with PAD alone (–2.2% vs 0.1%: number needed to treat (NNT) 45 vs 1000). Conversely, the ARR for MALE was higher in those with prior lower extremity revascularization (2.5% vs 0.2%: NNT 40 vs 500). Vorapaxar increased major bleeding (HR 1.39, 95% CI 1.12, 1.71; p = 0.003). The net clinical outcome in all patients with PAD was reduced with vorapaxar (HR 0.82, 95% CI 0.72, 0.94; p = 0.004), with benefits driven by reductions in MACE for those with CAD and by reductions in MALE for those with prior peripheral revascularization. Among patients with PAD, vorapaxar resulted in a net clinical benefit; however, the drivers of benefit were heterogeneous, with greater reductions in MACE in those with concomitant CAD and greater reductions in MALE in those with prior lower extremity revascularization, and unclear benefit in patients with neither. These clinical characteristics may be useful in identifying the subgroups of patients with PAD most likely to benefit from potent antithrombotic therapies. ClinicalTrials.gov Identifier: NCT00526474

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Letter by Moris et al Regarding Article, “Ticagrelor Compared With Clopidogrel in Patients With Prior Lower Extremity Revascularization for Peripheral Artery Disease”

Circulation ◽

10.1161/circulationaha.116.026865 ◽

2017 ◽

Vol 135 (23) ◽

Author(s):

Demetrios Moris ◽

Nikolaos Patelis ◽

Stavros Kakkos

Keyword(s):

Lower Extremity ◽

Peripheral Artery Disease ◽

Peripheral Artery ◽

Artery Disease ◽

Lower Extremity Revascularization

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Ankle-Brachial Index for Risk Stratification in Patients With Symptomatic Peripheral Artery Disease With and Without Prior Lower Extremity Revascularization: Observations From the EUCLID Trial

Circulation Cardiovascular Interventions ◽

10.1161/circinterventions.120.009871 ◽

2021 ◽

Author(s):

William R. Hiatt ◽

Connie N. Hess ◽

Marc P. Bonaca ◽

Sarah Kavanagh ◽

Manesh R. Patel ◽

...

Keyword(s):

Lower Extremity ◽

Peripheral Artery Disease ◽

Ankle Brachial Index ◽

Cubic Spline ◽

Hazard Ratio ◽

Acute Limb Ischemia ◽

Peripheral Artery ◽

Increased Risk ◽

Artery Disease ◽

Lower Extremity Revascularization

Background: A reduced ankle-brachial index (ABI) is a measure of atherosclerosis and is associated with ischemic risk in the general population. Whether this relationship is maintained in peripheral artery disease after lower extremity revascularization (LER), which can modify ABI, is unknown. Methods: The EUCLID (Examining Use of Ticagrelor in Peripheral Artery Disease) enrolled 13 885 patients with symptomatic peripheral artery disease; 57% with prior LER, and 43% with ABI ≤0.80. The primary major adverse cardiovascular events (MACE) outcome was a composite of cardiovascular death, myocardial infarction, or ischemic stroke. Major adverse limb events (MALE) included acute limb ischemia and major amputation. An adjusted Cox proportional hazards model demonstrated a nonlinear relationship between ABI and outcomes. A restricted cubic spline model with 4 knots was developed to identify the best fitting model to describe the relationship between ABI and MACE and MALE risk. Results: Baseline ABI (mean±SD) was 0.77±0.21 in participants with prior LER and 0.63±0.14 in those without prior LER ( P <0.0001). There was no statistical interaction between prior LER and ABI, meaning the shapes of the cubic spline models were similar between groups. In those with prior LER, for every 0.10 unit lower ABI below an ABI of 1.00, the hazard ratio for MACE was 1.08 (95% CI, 1.04–1.12; P <0.0001), below an ABI of 0.80 the hazard ratio for MALE was 1.32 (95% CI, 1.21–1.43; P <0.0001). In patients without prior LER, every 0.10 unit lower ABI below an ABI of 0.70 was associated with increased risk for MACE (hazard ratio, 1.14 [95% CI, 1.06–1.23]; P =0.0004) and MALE (hazard ratio, 1.27 [95% CI, 1.08–1.49]; P =0.003). Conclusions: Patients with established peripheral artery disease, particularly those with prior LER, have an increased risk of MACE and MALE. The ABI remains a strong predictor of MACE and MALE ischemic events with an inverse relationship below an ABI threshold for patients with and without prior LER. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01732822.

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