P1256THE ASSOCIATION PROTEIN-ENERGY WASTING AND INFLAMMATION STATUS WITH MORTALITY AFTER LOWER EXTREMITIES REVASCULARIZATION IN PATIENTS ON HAEMODIALYSIS

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Hiroshi Takahashi ◽  
Yoshitaka Kumada ◽  
Hideki Ishii ◽  
Norio Umemoto ◽  
Ryuta Ito ◽  
...  

Abstract Background and Aims Although lower extremity revascularization has been commonly performed in chronic haemodialysis (HD) patients with peripheral artery disease (PAD), poorer prognosis still remains major problems in such population. Recently, protein-energy wasting (PEW) or malnutrition have been considered to be strongly associated with chronic inflammation and advanced atherosclerosis in HD patients. We investigated the association of geriatric nutritional risk index (GNRI) as a surrogate marker of the PEW, C-reactive protein (CRP) and these joint role with prediction of amputation and/or mortality after lower extremity revascularization in chronic HD patients. Method We enrolled a total of 862 HD patients (age 67±10 years, diabetes 62.9%, critical limb ischemia 53.5%) who successfully underwent lower extremity revascularization (552 with endovascular therapy and 310 with bypass surgery). Patients were divided into tertiles according to GNRI levels; tertile 1 (T1): <80.0, T2: 80.0-96.6and T3: >96.6, and CRP levels; T1: <2.0mg/l, T2: 2.0-12.6mg/l and T3: >12.6mg/l, respectively. They were followed up for up to 8 years. Results During follow-up period (median: 43 months), 63 (7.3%) patients needed major amputation and 202 (23.4%) patients died. Kaplan-Meier analysis shows that amputation-free survival rates for 8 years were 47.5%, 51.6% and 66.5% in T1, T2 and T3 of GNRI, and were 65.8%, 58.7% and 33.2% in T1, T2 and T3 of CRP, respectively (p<0.0001 in both). After adjustment for age, previous coronary artery disease and critical limb ischemia as covariates with p<0.05 by univariate analysis, declined GNRI [hazard ratio (HR) 2.18, 95% confidence interval (CI) 1.57-3.07, p<0.0001 for T1 vs. T3] and elevated CRP (HR 1.78, 95%CI 1.24-2.59, p=0.0016 for T3 vs. T1) were identified as independent predictors of amputation and/or mortality. In the combined setting of both variables, the risk of amputation and/or mortality was 3.77-fold higher (95%CI 1.97-7.69, p<0.0001) in theT1 of GNRI with T3 of CRP than in the T3 of GNRI with T1 of CRP. Similar results were obtained for amputation and mortality, respectively (Figure). Conclusion Among HD patients undergoing lower extremity revascularization, those with pre-procedural declined GNRI and elevated CRP frequently experienced amputation and/or mortality, furthermore, combination of both variables could stratify the risk of amputation and/or mortality.

2013 ◽  
Vol 57 (5) ◽  
pp. 13S-14S
Author(s):  
Benjamin S. Brooke ◽  
David H. Stone ◽  
Brian Nolan ◽  
Randall R. De Martino ◽  
David C. Goodman ◽  
...  

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Judith A Hsia ◽  
Sonia Anand ◽  
Mark R Nehler ◽  
Rupert Bauersachs ◽  
Manesh R Patel ◽  
...  

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.


Circulation ◽  
2020 ◽  
Vol 142 (23) ◽  
pp. 2219-2230
Author(s):  
William R. Hiatt ◽  
Marc P. Bonaca ◽  
Manesh R. Patel ◽  
Mark R. Nehler ◽  
Eike Sebastian Debus ◽  
...  

Background: The VOYAGER PAD trial (Vascular Outcomes Study of ASA Along With Rivaroxaban in Endovascular or Surgical Limb Revascularization for Peripheral Artery Disease) demonstrated superiority of rivaroxaban plus aspirin versus aspirin to reduce major cardiac and ischemic limb events after lower extremity revascularization. Clopidogrel is commonly used as a short-term adjunct to aspirin after endovascular revascularization. Whether clopidogrel modifies the efficacy and safety of rivaroxaban has not been described. Methods: VOYAGER PAD was a phase 3, international, double-blind, placebo-controlled trial in patients with symptomatic PAD undergoing lower extremity revascularization randomized to rivaroxaban 2.5 mg twice daily plus 100 mg aspirin daily or rivaroxaban placebo plus aspirin. The primary efficacy outcome was a composite of acute limb ischemia, major amputation of a vascular cause, myocardial infarction, ischemic stroke, or cardiovascular death. The principal safety end point was TIMI (Thrombolysis in Myocardial Infarction) major bleeding, with International Society on Thrombosis and Haemostasis major bleeding a secondary safety outcome. Clopidogrel use was allowed at the discretion of the investigator for up to 6 months after the qualifying revascularization. Results: Of the randomized patients, 3313 (50.6%) received clopidogrel for a median duration of 29.0 days. Over 3 years, the hazard ratio for the primary outcome of rivaroxaban versus placebo was 0.85 (95% CI, 0.71–1.01) with clopidogrel and 0.86 (95% CI, 0.73–1.01) without clopidogrel without statistical heterogeneity ( P for interaction=0.92). Rivaroxaban resulted in an early apparent reduction in acute limb ischemia within 30 days (hazard ratio, 0.45 [95% CI, 0.14–1.46] with clopidogrel; hazard ratio, 0.48 [95% CI, 0.22–1.01] without clopidogrel; P for interaction=0.93). Compared with aspirin, rivaroxaban increased TIMI major bleeding similarly regardless of clopidogrel use ( P for interaction=0.71). With clopidogrel use >30 days, rivaroxaban was associated with more International Society on Thrombosis and Haemostasis major bleeding within 365 days (hazard ratio, 3.20 [95% CI, 1.44–7.13]) compared with shorter durations of clopidogrel ( P for trend=0.06). Conclusions: In the VOYAGER PAD trial, rivaroxaban plus aspirin reduced the risk of adverse cardiovascular and limb events with an early benefit for acute limb ischemia regardless of clopidogrel use. The safety of rivaroxaban was consistent regardless of clopidogrel use but with a trend for more International Society on Thrombosis and Haemostasis major bleeding with clopidogrel use >30 days than with a shorter duration. These data support the addition of rivaroxaban to aspirin after lower extremity revascularization regardless of concomitant clopidogrel, with a short course (≤30 days) associated with less bleeding. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02504216.


2014 ◽  
Vol 59 (2) ◽  
pp. 427-434 ◽  
Author(s):  
Vincent J. Santo ◽  
Phong T. Dargon ◽  
Amir F. Azarbal ◽  
Timothy K. Liem ◽  
Erica L. Mitchell ◽  
...  

2020 ◽  
Vol 8 ◽  
pp. 205031212092923
Author(s):  
Jihad A Mustapha ◽  
Bynthia M Anose ◽  
Brad J Martinsen ◽  
George Pliagas ◽  
Joseph Ricotta ◽  
...  

This review is intended to help clinicians and patients understand the present state of peripheral artery disease, appreciate the progression and presentation of critical limb ischemia/chronic limb-threatening ischemia, and make informed decisions regarding inflow and outflow endovascular revascularization and surgical treatment options within the context of current debates in the medical community. A controlled literature search was performed to obtain research on outcomes of critical limb ischemia patients undergoing complete leg revascularization for peripheral artery disease inflow and outflow disease. Data for this review were identified by queries of medical and life science databases, expert referral, and references from relevant papers published between 1997 and 2019, resulting in 48 articles. The literature review herein indicates that endovascular revascularization—including ballooning, stenting, and atherectomy—is an effective peripheral artery disease therapy for both above the knee and below the knee disease, and can safely and effectively treat both inflow and outflow disease. As such, it plays a leading role in the therapy of lower extremity artery disease.


2020 ◽  
Vol 67 ◽  
pp. 417-424
Author(s):  
Mitri K. Khoury ◽  
John E. Rectenwald ◽  
Shirling Tsai ◽  
Melissa L. Kirkwood ◽  
Bala Ramanan ◽  
...  

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
B Kim ◽  
B.G Kim ◽  
J.K Seo ◽  
G.S Kim ◽  
H.Y Lee ◽  
...  

Abstract Background Patients with peripheral arterial disease (PAD) have a higher mortality rate than age-matched patients without PAD. Also more than half of patients with symptomatic PAD have polyvascuar disorder including coronary artery disease (CAD). Purpose This study aimed to identify the predictors of mortality outcomes in patients with peripheral artery disease undergoing lower extremity endovascular intervention. Methods We studied 300 consecutive patients admitted for symptomatic low extremity arterial disease. A total of 196 patients without angina and prior coronary revascularization (72±10 years, 156 men) who underwent lower extremity endovascular intervention (claudication, n=74; critical limb ischemia, n=122) were retrospectively analyzed. All patients underwent coronary angiography but not simultaneous coronary revascularization. CAD was defined as angiographically significant (≥50%) stenosis of coronary arteries and severity was classified as none, 1-, 2-, or 3-vessel disease (VD). All-cause mortality and major adverse cardiac and cerebrovascular event (MACCE) rate were compared between the patients with CAD and those without CAD. MACCE included any of the following adverse events: cardiac death, cerebrovascular death, acute myocardial infarction, stroke, and congestive heart failure. Results Mean duration of follow-up was 3 years. All-cause mortality and MACCE were 16.3% and 19.8%, respectively. The independent risk factors for all-cause mortality were old age (HR=1.05, P=0.043), lower body mass index (HR=0.83, P=0.016), critical limb ischemia (HR=3.74, P=0.033) and the presence of CAD (HR=2.85, P=0.027). This variable surpassed all classical risk factors (including smoking and history of hypertension or diabetes mellitus). Of the 196 patients, 101 patients (52%) had asymptomatic CAD; 1-VD (n=35, 18%); 2-VD (n=32, 16%); 3-VD (n=28, 14%). Patients with CAD had significantly higher all-cause mortality (19% vs. 11%, P=0.018) and higher MACCE rate (26% vs. 8%, P=0.001) compared to those without CAD. Furthermore, the severity of CAD had graded associations with the all-cause mortality and MACCE rate (Figure). Independent predictors of CAD were critical limb ischemia (CLI) (OR = 2.43, P=0.018) and presence of the below-the-knee lesions (OR = 2.04, P=0.019). In addition, CAD was more prevalent in the patients with lower BMI (61% vs. 41%, p=0.007). Conclusion Asymptomatic coronary artery disease (CAD) was found in half of the patients undergoing endovascular intervention for lower extremity arterial disease and associated with higher mortality and MACCE rate. Therefore, detection of CAD might be important for risk stratification for these patients, especially with lower body mass index or critical limb ischemia. Funding Acknowledgement Type of funding source: None


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