scholarly journals Vorapaxar for Prevention of Major Adverse Cardiovascular and Limb Events in Peripheral Artery Disease

2022 ◽  
Vol 27 ◽  
pp. 107424842110561
Author(s):  
Justin T. Morrison ◽  
Nicholas Govsyeyev ◽  
Connie N. Hess ◽  
Marc P. Bonaca
Keyword(s):  
Peripheral Artery Disease ◽  
Limb Ischemia ◽  
Major Amputation ◽  
Acute Limb Ischemia ◽  
Peripheral Artery ◽  
Cellular Effects ◽  
Thrombin Inhibition ◽  
Severe Manifestation ◽  
Artery Disease

Peripheral artery disease (PAD) is a severe manifestation of atherosclerosis. Patients with PAD are at heightened risk for atherothrombotic complications, including myocardial infarction and stroke (MACE); however, there is also an equal or greater risk of major adverse limb events (MALE), such as acute limb ischemia (ALI) and major amputation. Therefore, there is a need for effective medical therapies to reduce the risk of both MACE and MALE. Recent trials have demonstrated the role of thrombin inhibition in reducing the risk of MACE and MALE in PAD patients. One such medical therapy, vorapaxar, is a potent inhibitor of protease activated receptor-1 which mediates the cellular effects of thrombin. Vorapaxar, used in addition to aspirin, has demonstrated robust reductions in MACE and MALE in PAD patients. In this article, we provide a contemporary review of the current state of PAD and the role of antithrombotic medications in the treatment of PAD, as well as the current clinical data on vorapaxar and strategies to integrate vorapaxar into contemporary medical management of peripheral artery disease.

scholarly journals Reduction in Acute Limb Ischemia with Rivaroxaban versus Placebo in Peripheral Artery Disease after Lower Extremity Revascularization: Insights from VOYAGER PAD

Circulation ◽  
2021 ◽  
Author(s):  
Connie N. Hess ◽  
E. Sebastian Debus ◽  
Mark R. Nehler ◽  
Sonia S. Anand ◽  
Manesh R. Patel ◽  
...  
Keyword(s):  
Lower Extremity ◽  
Peripheral Artery Disease ◽  
Cumulative Incidence ◽  
Low Dose ◽  
Limb Ischemia ◽  
Major Amputation ◽  
Acute Limb Ischemia ◽  
Peripheral Artery ◽  
Artery Disease ◽  
Lower Extremity Revascularization

Background: Patients with peripheral artery disease (PAD) are at heightened risk of acute limb ischemia (ALI), a thrombotic event associated with amputation, disability, and mortality. Prior lower extremity revascularization (LER) is associated with increased ALI risk in chronic PAD. However, the pattern of risk, clinical correlates, and outcomes after ALI early after LER are not well-studied, and effective therapies to reduce ALI post-LER are lacking. Methods: VOYAGER PAD (NCT02504216) randomized patients with PAD undergoing LER to rivaroxaban 2.5 mg twice daily or placebo on a background of low-dose aspirin. The primary outcome was a composite of ALI, major amputation of vascular cause, myocardial infarction, ischemic stroke, or cardiovascular death. ALI was prospectively ascertained and adjudicated by a blinded committee. The cumulative incidence of ALI was calculated using Kaplan Meier estimates, and Cox proportional-hazards models were used to generate hazard ratios and associated confidence intervals. Analyses were performed as intention-to-treat. Results: Among 6,564 patients followed for a median of 2.3 years, 382 (5.8%) had a total of 508 ALI events. In placebo patients, the 3-year cumulative incidence of ALI was 7.8%. After multivariable modeling, prior LER, baseline ABI <0.50, surgical LER, and longer target lesion length were associated with increased risk of ALI. Incident ALI was associated with subsequent all-cause mortality (HR 2.59, 95% CI 1.98-3.39) and major amputation (HR 24.87, 95% CI 18.68-33.12). Rivaroxaban reduced ALI relative to placebo by 33% (absolute risk reduction 2.6% at 3 years, HR 0.67, 95% CI 0.55-0.82, P=0.0001), with benefit starting early (HR 0.45, 95% CI 0.24-0.85, P=0.0068 at 30 days). Benefit was present for severe ALI (associated with death, amputation, or prolonged hospitalization and ICU stay, HR 0.58, 95% CI 0.40-0.83, P=0.003) and regardless of LER type (surgical vs endovascular revascularization, p-interaction=0.42) or clopidogrel use (p-interaction=0.59). Conclusions: After LER for symptomatic PAD, ALI is frequent, particularly early after LER, and is associated with poor prognosis. Low-dose rivaroxaban plus aspirin reduces ALI after LER, including ALI events associated with the most severe outcomes. The benefit of rivaroxaban for ALI appears early, continues over time, and is consistent regardless of revascularization approach or clopidogrel use.

Under-Prescription of Medical Treatment for Peripheral Artery Disease in the Under 50s: A Retrospective Study

Angiology ◽  
2021 ◽  
pp. 000331972110421
Author(s):  
Simon Soudet ◽  
Lorène Bultel ◽  
Lamrani Adnane ◽  
Thierry Reix ◽  
Marie Antoinette Sevestre
Keyword(s):  
Medical Treatment ◽  
Peripheral Artery Disease ◽  
Young Patients ◽  
Limb Ischemia ◽  
Major Amputation ◽  
University Hospital ◽  
Acute Limb Ischemia ◽  
Peripheral Artery ◽  
Artery Disease

Peripheral artery disease (PAD) is a common cause of morbidity and mortality; however, data on its etiology and evolution in patients under 50 years old are scarce. Therefore, we performed a retrospective analysis of data from medical records, including cardiovascular risk factors, etiology, medical and surgical treatment, and follow-up. We included all patients with PAD aged between 18 and 50 years attending our university hospital between 2005 and 2015. Of the 87 patients included, 32 (36%) were women. Smoking was acknowledged by 81 patients (93%), and 37 had dyslipidemia (42.5%). Median follow-up was 24 months (10-59). Recurrence occurred in 41 patients (47.1%), all active smokers, with a median delay of 14 months (7-47). Acute limb ischemia at diagnosis was significantly associated with major amputation, odds ratio (OR) 5.95 (95%CI 1.41-40.90, P = .029), which was needed by 11 patients (12.6%). Treatments included antiplatelet therapy (76; 87.4%), statins (67; 77%), and anti-hypertensives (60; 69%), and 29 (32.1%) patients benefited from vascular rehabilitation. This cohort of relatively young patients with PAD showed a high level of symptom recurrence. Atherosclerosis was the most common etiology. Our study revealed that medical treatment is often under-prescribed in this age group and needs to be improved.

Advances in Revascularization for Peripheral Artery Disease: Revascularization in PAD

2021 ◽  
Vol 128 (12) ◽  
pp. 1885-1912
Author(s):  
Joshua A. Beckman ◽  
Peter A. Schneider ◽  
Michael S. Conte
Keyword(s):  
Intermittent Claudication ◽  
Peripheral Artery Disease ◽  
Clinical Presentation ◽  
Rapid Development ◽  
Microvascular Disease ◽  
Limb Ischemia ◽  
Medical Emergency ◽  
Acute Limb Ischemia ◽  
Peripheral Artery ◽  
Artery Disease

Effective revascularization of the patient with peripheral artery disease is about more than the procedure. The approach to the patient with symptom-limiting intermittent claudication or limb-threatening ischemia begins with understanding the population at risk and variation in clinical presentation. The urgency of revascularization varies significantly by presentation; from patients with intermittent claudication who should undergo structured exercise rehabilitation before revascularization (if needed) to those with acute limb ischemia, a medical emergency, who require revascularization within hours. Recent years have seen the rapid development of new tools including wires, catheters, drug-eluting technology, specialized balloons, and biomimetic stents. Open surgical bypass remains an important option for those with advanced disease. The strategy and techniques employed vary by clinical presentation, lesion location, and lesion severity. There is limited level 1 evidence to guide practice, but factors that determine technical success and anatomic durability are largely understood and incorporated into decision-making. Following revascularization, medical therapy to reduce adverse limb outcomes and a surveillance plan should be put in place. There are many hurdles to overcome to improve the efficacy of lower extremity revascularization, such as restenosis, calcification, microvascular disease, silent embolization, and tools for perfusion assessment. This review highlights the current state of revascularization in peripheral artery disease with an eye toward technologies at the cusp, which may significantly impact current practice.

Abstract 13474: Rivaroxaban Reduces Major Cardiovascular and Limb Events in Patients With the High-risk Triad of Chronic Kidney Disease, Peripheral Artery Disease and Recent Lower Extremity Revascularization: Insights From VOYAGER PAD

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Judith A Hsia ◽  
Sonia Anand ◽  
Mark R Nehler ◽  
Rupert Bauersachs ◽  
Manesh R Patel ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
High Risk ◽  
Kidney Disease ◽  
Lower Extremity ◽  
Limb Ischemia ◽  
Major Amputation ◽  
Acute Limb Ischemia ◽  
Peripheral Artery ◽  
Artery Disease ◽  
Lower Extremity Revascularization

Introduction: Chronic kidney disease (CKD) is common among patients undergoing lower extremity revascularization (LER) for peripheral artery disease (PAD) and identifies a population at high risk for adverse outcomes. The VOYAGER PAD trial demonstrated the efficacy of rivaroxaban in PAD patients after LER on a composite of cardiovascular (CV) and limb ischemic events (HR 0.85 vs placebo, 95% CI 0.76-0.96; p=0.009); this analysis examines the prespecified subgroup of patients with CKD. Methods: VOYAGER PAD (NCT02504216) was a double-blind, placebo-controlled trial which randomized PAD patients with recent LER to rivaroxaban 2.5 mg twice daily or placebo on a background of aspirin 100 mg daily. The primary endpoint was a composite of acute limb ischemia, major amputation for vascular cause, myocardial infarction, ischemic stroke or CV death. The primary safety endpoint was TIMI major bleeding. Analysis of the intention-to-treat population utilized Kaplan Meier estimates and Cox proportional-hazards models. Results: Among 6319 VOYAGER patients with baseline estimated glomerular filtration rate (eGFR), 21% were <60 (mostly CKD stage 3) and 79% were ≥60 ml/min/1.73m 2 . During 28-month (median) follow up, patients with CKD had a higher rate of major CV and limb events: placebo group 10.0 events/100 patient-years (95% CI 8.5, 11.8) for eGFR <60 vs 7.4 (95% CI 6.7, 8.2) for eGFR ≥60. Rivaroxaban reduced primary outcome events with no heterogeneity by eGFR category (Figure, p for interaction 0.62). Acute limb ischemia and major amputation were significantly reduced among patients with eGFR<60 (HR 0.55, 95% CI 0.36, 0.86) as well as ≥60 (HR 0.77, 95% CI 0.63, 0.94). TIMI major bleeding was numerically more frequent among patients with CKD with no heterogeneity by treatment group (Figure, p for interaction 0.37). Conclusions: Rivaroxaban reduced major CV and limb events in patients with PAD undergoing LER, including those with CKD, a particularly high-risk population.

scholarly journals Acute Limb Ischemia and Outcomes With Vorapaxar in Patients With Peripheral Artery Disease

Circulation ◽  
2016 ◽  
Vol 133 (10) ◽  
pp. 997-1005 ◽  
Author(s):  
Marc P. Bonaca ◽  
J. Antonio Gutierrez ◽  
Mark A. Creager ◽  
Benjamin M. Scirica ◽  
Jeffrey Olin ◽  
...  
Keyword(s):  
Peripheral Artery Disease ◽  
Limb Ischemia ◽  
Acute Limb Ischemia ◽  
Peripheral Artery ◽  
Artery Disease

scholarly journals Acute Limb Ischemia in Peripheral Artery Disease

Circulation ◽  
2019 ◽  
Vol 140 (7) ◽  
pp. 556-565 ◽  
Author(s):  
Connie N. Hess ◽  
Zhen Huang ◽  
Manesh R. Patel ◽  
Iris Baumgartner ◽  
Jeffrey S. Berger ◽  
...  
Keyword(s):  
Peripheral Artery Disease ◽  
Limb Ischemia ◽  
Acute Limb Ischemia ◽  
Peripheral Artery ◽  
Artery Disease

scholarly journals Incidence and Factors Associated With Major Amputation in Patients With Peripheral Artery Disease

2020 ◽  
Vol 13 (7) ◽  
Author(s):  
Chandler A. Long ◽  
Hillary Mulder ◽  
F. Gerry R. Fowkes ◽  
Iris Baumgartner ◽  
Jeffrey S. Berger ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Mortality Rate ◽  
Peripheral Artery Disease ◽  
Limb Ischemia ◽  
Major Amputation ◽  
Peripheral Artery ◽  
Factors Associated ◽  
Increased Risk ◽  
Baseline Group ◽  
Artery Disease

Background: Peripheral artery disease (PAD) is associated with increased risk of mortality, cardiovascular morbidity, and major amputation. Data on major amputation from a large randomized trial that included a substantial cohort of patients without critical limb ischemia (CLI) have not been described. The objective was to describe the incidence and types of amputations in the EUCLID trial (Examining Use of Ticagrelor in Peripheral Artery Disease) population, subcategorize amputations in the CLI versus no CLI cohorts, and describe the events surrounding major amputation. Methods and Results: Postrandomization major amputation was analyzed in the EUCLID trial. Patients were stratified by baseline CLI status. The occurrence of major amputation was ascertained and defined as the highest level. Perioperative events surrounding major amputation were obtained including acute limb ischemia, revascularization, and all-cause mortality. All variables were assessed for significance in univariable and multivariable models. The rate of major amputation during the course of the trial was 1.6% overall, 8.4% in the CLI at baseline group, and 1.2% in the no CLI at baseline group. The annualized rate of major amputation was 0.6% in PAD overall, 3.9% in the CLI at baseline group, and 0.5% in the no CLI at baseline group. Several factors were associated with increased risk of major amputation, including history of amputation, the presence of diabetes mellitus, baseline Rutherford category 4 to 6, and an ankle-brachial index <0.8. Factors associated with a lower risk for major amputation included prior statin use. The 30-day mortality rate after major amputation was 6.5% overall, 5.6% in the CLI at baseline group, and 6.8% in the no CLI at baseline group. The annual mortality rate following major amputation was 22.8% in the CLI at baseline group and 16.0% in the no CLI at baseline group. Conclusions: The risk factors for major amputation in EUCLID patients are similar to previous large registries’ reports except for diabetes mellitus in patients with CLI. The mortality following major amputation is lower in the EUCLID trial compared with registry data. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01732822.

P935Effect of hypertension and systolic blood pressure on cardiovascular and limb outcomes in patients with symptomatic peripheral artery disease: the EUCLID trial

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
W Hiatt ◽  
C W Hopley ◽  
S Kavanagh ◽  
M R Patel ◽  
I Baumgartner ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Systolic Blood Pressure ◽  
Peripheral Artery Disease ◽  
Limb Ischemia ◽  
Acute Limb Ischemia ◽  
Peripheral Artery ◽  
Cardiac Events ◽  
Increased Risk ◽  
History Of ◽  
Artery Disease

Abstract Background Hypertension is a risk factor for major adverse cardiac events (MACE) in patients with symptomatic peripheral artery disease (PAD). Purpose The effects of a history of hypertension and baseline systolic blood pressure (SBP) on MACE and major adverse limb events (MALE), including acute limb ischemia and major amputation, were evaluated in the Examining Use of tiCagreLor In paD (EUCLID) trial. Methods EUCLID randomized 13,885 patients with PAD and found no benefit of ticagrelor compared with clopidogrel on risk of MACE or MALE. The median duration of follow up was approximately 30 months. This post hoc, subgroup analysis evaluated the effects of hypertension history at baseline on the hazard for MACE and MALE. An adjusted restricted cubic spline regression analysis evaluated the association of SBP with MACE and MALE. Results A clinical history of hypertension was present in 10,857 (78%) patients at baseline and these patients were more likely to be older, female, white or African American, and reside in North America compared with the 3026 without hypertension. Hypertension was associated with a higher prevalence of concomitant cardiovascular diseases, polyvascular disease, diabetes, and prior coronary interventions. MACE occurred at a rate of 4.63 events/100 pt-yrs in participants with hypertension and 3.64 events/100 pt-yrs in participants without hypertension, (adjusted hazard ratio [aHR] 0.94, 95% CI 0.82–1.08; p=0.38). MALE occurred at a rate of 1.11 events/100 pt-yrs in those with hypertension and 1.38 events/100 pt-yrs in those without hypertension (p=0.054) (aHR 0.93 (95% CI 0.73, 1.18) p=0.55. The adjusted spline model for MACE and SBP demonstrated a significantly non-linear relationship with a HR 1.08 (95% CI 1.01, 1.15), p=0.0275 for every 10-unit decrease <135 mmHg SBP and HR 1.11 (1.06, 1.16), p<0.0001 for every 10-unit increase >135 mmHg (figure). There was no association between baseline SBP and MALE events. Conclusions A history of hypertension was not associated with a higher adjusted hazard for MACE or MALE in participants with PAD. In contrast, SBP at baseline was associated with increased risk of MACE at values both above and below 135 mmHg. Acknowledgement/Funding EUCLID was sponsored by AstraZeneca

Characteristics and outcomes of patients with peripheral artery disease undergoing endovascular revascularization: A community hospital perspective

Vascular ◽  
2020 ◽  
pp. 170853812095885
Author(s):  
S Michael Gharacholou ◽  
Zhuo Li ◽  
Jonathan J Uy ◽  
Lee H Eckstein ◽  
Carolyn R Flock ◽  
...  
Keyword(s):  
Intermittent Claudication ◽  
Peripheral Artery Disease ◽  
Critical Limb Ischemia ◽  
Community Hospital ◽  
Limb Ischemia ◽  
Study Cohort ◽  
Acute Limb Ischemia ◽  
Peripheral Artery ◽  
Endovascular Revascularization ◽  
Artery Disease

Background There are limited data on outcomes for patients with peripheral artery disease undergoing endovascular revascularization by multi-disciplinary teams in a community hospital setting. Methods From January 2015 through December 2015, we assembled a multi-disciplinary program comprised of cardiologists, surgeons, radiologists, nurses, and administrative staff for managing patients with peripheral artery disease undergoing endovascular revascularization. Demographic, procedural, and outcomes data were collected with use of a template from the Society for Vascular Surgery Vascular Quality Initiative database. We compared characteristics and outcomes of patients with intermittent claudication and critical limb ischemia. We used Kaplan–Meier methods to estimate the rate of overall survival and freedom from rehospitalization between groups. Results After excluding patients with acute limb ischemia ( n = 5), peripheral intervention to the upper extremity ( n = 6), or abdominal aorta ( n = 11), there were 82 patients in the study cohort; 45 had intermittent claudication and 37 had critical limb ischemia. Baseline and procedural characteristics were similar between groups, although critical limb ischemia patients were more likely to have hyperlipidemia (75.7% vs. 53.3%, P = .42). Procedural success was achieved in 91.3% of cases. Actionable access site bleeding occurred in 2.4% of patients. High rates of aspirin (91.5%) and statin (87.8%) were noted at discharge. After two years of post endovascular revascularization, survival was 57.5% for critical limb ischemia patients and 94.4% for intermittent claudication patients ( P < .001). Freedom from rehospitalization was 32.7% for critical limb ischemia patients and 83.5% for intermittent claudication patients ( P < .001). Conclusions We found that favorable outcomes may be achieved with a multi-disciplinary peripheral artery disease program at community hospitals. The incorporation of quality improvement practices may further help to develop standardized and regionalized approaches to care delivery for patients with peripheral artery disease.

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