scholarly journals Major Limb Outcomes Following Lower Extremity Endovascular Revascularization in Patients With and Without Diabetes Mellitus

2017 ◽  
Vol 24 (3) ◽  
pp. 376-382 ◽  
Author(s):  
Andrew N. Shammas ◽  
Haekyung Jeon-Slaughter ◽  
Shirling Tsai ◽  
Houman Khalili ◽  
Mujtaba Ali ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Lower Extremity ◽  
Peripheral Artery Disease ◽  
Endovascular Procedures ◽  
Major Amputation ◽  
Peripheral Artery ◽  
Entire Study ◽  
Endovascular Revascularization ◽  
Increased Risk ◽  
Artery Disease

Purpose: To determine whether diabetes mellitus has an independent impact on major limb outcomes at 1 year after endovascular treatment of lower extremity peripheral artery disease (PAD). Methods: The study involved 1906 consecutive patients (mean age 66 years; 1469 men) enrolled in the observational Excellence in Peripheral Artery Disease (XLPAD) registry ( ClinicalTrials.gov identifier NCT01904851) between January 2005 and October 2015 after undergoing index endovascular procedures in 2426 limbs for arterial occlusive disease. Patient outcomes included 12-month target limb amputation (above ankle) and target limb revascularization as well as all-cause death. Kaplan-Meier analysis and adjusted Cox proportional hazard models were used for time-to-event analysis of outcomes for the entire study sample as well as for the critical limb ischemia (CLI) and claudication subgroups. Results of the Cox regression models are reported as the hazard ratio (HR) and 95% confidence interval (CI). Results: Diabetics undergoing endovascular procedures had higher rates of comorbid conditions (p<0.001), CLI (p<0.001), heavily calcified lesions (p=0.002), multivessel disease (p=0.030), and fewer infrapopliteal runoff vessels (p<0.001). Regression analysis after adjusting for confounders revealed significantly higher target limb major amputation in diabetics compared with nondiabetics (HR 5.02, 95% CI 1.44 to 17.56, p=0.011). However, repeat revascularization rates were similar. When considering CLI and claudication subgroups, diabetes was associated with a nonsignificant increased risk of 12-month major amputation only for patients presenting with CLI (HR 3.48, 95% CI 0.97 to 12.51, p=0.056). Diabetes was also associated with an increased risk of 12-month all-cause mortality in the overall study sample (HR 4.64, 95% CI 2.01 to 10.70, p<0.001) and in the CLI subgroup (HR 14.15, 95% CI 3.16 to 63.32, p<0.001) but not in the claudication subgroup (HR 1.42, 95% CI 0.45 to 4.54, p=0.552). Conclusion: Diabetes increases the risk of major amputation and all-cause death at 12 months following endovascular revascularization in patients with symptomatic PAD. These risks are especially heightened in patients presenting with CLI.

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.

scholarly journals 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

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.

1053-P: Predictors of Nontraumatic Lower Extremity Amputations in Patients with Diabetes Mellitus and Peripheral Artery Disease

Diabetes ◽  
2021 ◽  
Vol 70 (Supplement 1) ◽  
pp. 1053-P
Author(s):  
GEETHANJALI RAJAGOPAL ◽  
JEREMY B. PROVANCE ◽  
BETTY DREES ◽  
MAHA ABU KISHK
Keyword(s):  
Diabetes Mellitus ◽  
Lower Extremity ◽  
Peripheral Artery Disease ◽  
Peripheral Artery ◽  
Patients With Diabetes ◽  
Artery Disease

scholarly journals Chronic kidney disease and risk for cardiovascular and limb outcomes in patients with symptomatic peripheral artery disease: The EUCLID trial

2019 ◽  
Vol 24 (5) ◽  
pp. 422-430 ◽  
Author(s):  
Charles W Hopley ◽  
Sarah Kavanagh ◽  
Manesh R Patel ◽  
Cara Ostrom ◽  
Iris Baumgartner ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Ischemic Stroke ◽  
Kidney Disease ◽  
Peripheral Artery Disease ◽  
Major Bleeding ◽  
Cardiovascular Death ◽  
Major Amputation ◽  
Peripheral Artery ◽  
Increased Risk ◽  
Artery Disease

In patients with symptomatic peripheral artery disease (PAD), the impact of chronic kidney disease (CKD) on major adverse cardiovascular events has not been fully evaluated. The Examining Use of Ticagrelor In PAD (EUCLID) trial randomized 13,885 patients with PAD to ticagrelor 90 mg twice daily or clopidogrel 75 mg daily. This post hoc analysis compared the incidence of the primary composite endpoint (cardiovascular death, myocardial infarction (MI), or ischemic stroke) in patients with CKD (eGFR < 60 mL/min/1.73 m2) with those without CKD (eGFR ⩾ 60 mL/min/1.73 m2). The primary safety endpoint was thrombolysis in MI (TIMI) major bleeding. A total of 13,483 patients were included; 3332 (25%) had CKD, of whom 237 had stage 4/5 disease. Median follow-up was approximately 30 months. After statistical adjustment, patients with CKD had a higher rate of the primary endpoint compared with those without CKD (6.75 vs 3.72 events/100 patient-years; adjusted hazard ratio (HR) 1.45, 95% CI 1.30–1.63). CKD was not associated with increased risk of hospitalization for acute limb ischemia (ALI) (adjusted HR 0.96, 95% CI 0.69–1.34) or major amputation (adjusted HR 0.92, 95% CI 0.66–1.28). CKD was not associated with a significantly increased risk of major bleeding (adjusted HR 1.21, 95% CI 0.89–1.64), but minor bleeding was significantly increased (adjusted HR 1.51, 95% CI 1.07–2.15). In conclusion, patients with PAD and CKD had higher rates of cardiovascular death, MI, and ischemic stroke, but similar rates of ALI, major amputation, and TIMI major bleeding when compared with patients without CKD. ClinicalTrials.gov Identifier: NCT01732822

scholarly journals Prevalence and Predictors of Lower Extremity Peripheral Artery Disease among Adults with Type 2 Diabetes Mellitus Attending a Tertiary Hospital in Owerri, Nigeria

2019 ◽  
pp. 1-11
Author(s):  
Patrick Chinedu Obi ◽  
Anthony Chinedum Anyanwu ◽  
Chidimma Brenda Nwatu ◽  
Chinonso Ekwueme ◽  
Adaure Mbaike ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Lower Extremity ◽  
Peripheral Artery Disease ◽  
Peripheral Artery ◽  
Dorsalis Pedis Artery ◽  
Artery Disease ◽  
And Control

Background: Lower extremity peripheral artery disease [LEAD] is common among patients with Diabetes mellitus (DM) and is under-diagnosed and under-treated.  Early diagnosis and treatment will prevent associated cardiovascular events, minimize long term disability and improve quality of life. There is paucity of data on LEAD in Owerri and Southeastern Nigeria in general. Study Objectives: To determine the prevalence and predictors of LEAD among adults with type 2 diabetes mellitus (T2DM). Study Design: Cross-sectional analytical. Study Site: Endocrinology Clinic, Federal Medical Centre, Owerri, Nigeria. Methodology: Two hundred and seventy (270) T2DM patients and 135 non-diabetic controls were recruited consecutively between January and June, 2016. Questionnaires  were  used  to  collect  relevant  information,  followed  by  focused  physical examination and anthropometry. A portable Ankle Brachial Index (ABI) kit was used for measurement of ABI and participants with values < 0.9 were diagnosed as having LEAD. For participants with ABI ≥ 1.3, a toe pressure kit was used to measure their toe systolic pressure and those with toe brachial index (TBI) ≤ 0.7 were diagnosed as having LEAD. Fasting blood samples were also collected for assessment of glycated haemoglobin (HbA1c), fasting plasma glucose (FPG) and lipid profile. Data analysis was performed with SPSS version 22 and p-value < 0.05 was considered significant. Results: The mean ages of the T2DM and control participants were 59.8 ± 10.7 and 59.6 ± 12.3 years respectively (P = 0.89) while their mean ABIs were 0.97 ± 0.18 and 0.99 ± 0.16 respectively    (P = 0.26). The  prevalence  of  LEAD  was  31.1%  and  27.4%  among T2DM  and  control  participants respectively (P = 0.44) while among the T2DM participants that had LEAD, 57 (67.8%), 26 (31.0%) and 1 (1.2%) had mild, moderate and severe LEAD respectively. The only predictor of LEAD among T2DM participants was absent/reduced dorsalis pedis artery pulsation (AOR = 3.57, CI = 1.13 – 11.29, P = 0.03). Conclusions and Recommendations: There is a high prevalence of LEAD among adults with T2DM but this is not significantly higher than the prevalence among non-diabetic individuals. Regular screening of T2DM patients for LEAD should be encouraged. There is also need for regular palpation of dorsalis pedis artery among adults with T2DM to identify those with absent or reduced pulsation which may be an indication of the presence of LEAD.

French Guidelines for the Management of Ambulatory Endovascular Procedures for Lower Extremity Peripheral Artery Disease

2019 ◽  
Vol 59 ◽  
pp. 248-258 ◽  
Author(s):  
Yves Alimi ◽  
Alexandra Hauguel ◽  
Laurent Casbas ◽  
Pierre-Edouard Magnan ◽  
Jean-Luc Pin ◽  
...  
Keyword(s):  
Lower Extremity ◽  
Peripheral Artery Disease ◽  
Endovascular Procedures ◽  
Peripheral Artery ◽  
Artery Disease

scholarly journals Association of Hypertension and Arterial Blood Pressure on Limb and Cardiovascular Outcomes in Symptomatic Peripheral Artery Disease

2020 ◽  
Vol 13 (9) ◽  
Author(s):  
Marat Fudim ◽  
Charles W. Hopley ◽  
Zhen Huang ◽  
Sarah Kavanagh ◽  
Frank W. Rockhold ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Lower Extremity ◽  
Peripheral Artery Disease ◽  
Hazard Ratio ◽  
Peripheral Artery ◽  
Increased Risk ◽  
History Of ◽  
Artery Disease ◽  
Lower Extremity Revascularization

Background: Current guidelines recommend aggressive management of hypertension. Recent evidence suggested potential harm with low blood pressure targets in patients with peripheral artery disease. We investigated the association of a history of hypertension and office systolic blood pressure (SBP) with major adverse cardiovascular events (MACEs) and major adverse limb events (MALEs). Methods and Results: The EUCLID trial (Examining the Use of Ticagrelor in Peripheral Artery Disease) included 13 885 participants with symptomatic peripheral artery disease; median follow-up was 30 months. Cox proportional hazards regression was used to calculate hazard ratios (HRs) for any MACE, MALE, and MALE including lower extremity revascularization. A clinical history of arterial hypertension was present in 10 857 (78%) participants, and these participants were older and more likely to be female when compared with the 3026 (22%) patients without hypertension. In patients with a history of hypertension, the adjusted hazard ratio for MACE was 0.94, 95% CI, 0.82–1.08; P =0.39, and the adjusted hazard ratio for MALE was 1.08, 95% CI, 0.96–1.23; P =0.21. During follow-up, average SBP was 135 mm Hg (125–145). Every 10 mmHg increase in SBP>125 mmHg was associated with an increased risk of MACE (HR, 1.10 [95% CI, 1.06–1.14]; P <0.001), a marginally increased risk of MALE (HR, 1.07 [95% CI, 1.00–1.15]; P =0.062), and an increased risk of MALE/lower extremity revascularization (HR, 1.08 [95% CI, 1.04–1.11]; P <0.001). Every decrease in 10 mmHg SBP ≤125 mmHg was associated with an increased risk of MACE (HR, 1.19 [95% CI, 1.09–1.31]; P <0.001) but not MALE or MALE/lower extremity revascularization (HR, 1.02 [95% CI, 0.84–1.23], P =0.824; HR, 1.04 [95% CI, 0.95–1.13], P =0.392, respectively). Conclusions: History of hypertension was not associated with higher hazard for MACE or MALE in patients with peripheral artery disease. In contrast, there was a higher hazard of MACE in patients with out-of-target low and high SBP. High but not low SBP was associated with an increased risk of ischemic limb events. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01732822.

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