scholarly journals Impact of frailty on super elderly patients with peripheral artery disease from the I-PAD 3 year registry

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K Nishikawa ◽  
A Nagae ◽  
T Miura ◽  
T Katoh ◽  
Y Kanzaki ◽  
...  
Keyword(s):  
Elderly Patient ◽  
Elderly Patients ◽  
Peripheral Artery Disease ◽  
Cardiovascular Death ◽  
Major Amputation ◽  
Peripheral Artery ◽  
Clinical Frailty Scale ◽  
Treatment Indications ◽  
Artery Disease ◽  
Patient Prognosis

Abstract Background Unlike age, frailty is often not taken into account in treatment indications of Endovascular treatment (EVT). One of the reason is that there was little known the relationship between frailty and the outcome of EVT for super elderly patients with peripheral artery disease (PAD). We investigate impacts of frailty on the super elderly patient prognosis who underwent EVT. Purpose To investigate impacts of frailty on the super elderly patient prognosis who underwent EVT. Methods From August 2015 to July 2016, 335 consecutive patients who underwent EVT were enrolled in the I-PAD registry from 7 institutes in Nagano prefecture. Among them, we selected and analyzed 91 super elderly PAD patients (≥80 years-old) and divided them into two groups:those with moderate or higher frailty (Clinical Frailty Scale (CFS) ≥6, n=28) and those without (CFS ≤5, n=63). The primary endpoints were cardiovascular death and major adverse cardiovascular and limb events (MACLE), defined as a composite of cardiovascular death, myocardial infarction, stroke, admission for heart failure, major amputation and revascularization. Results The median follow-up period was 2.7 years. Freedom rate from cardiovascular death and MACLE were significantly lower among patients with moderate or higher frailty than among those without (47.0% vs. 58.0%, P=0.03; 39.1% vs. 68.5%, P<0.01). Conclusion The prognosis of super elderly patients with moderate or higher frailty is worse than those without. Funding Acknowledgement Type of funding source: None

Impact of Frailty and Age on Clinical Outcomes in Patients Who Underwent Endovascular Therapy

2021 ◽  
pp. 152660282110677
Author(s):  
Ken Nishikawa ◽  
Soichiro Ebisawa ◽  
Takashi Miura ◽  
Tamon Kato ◽  
Kanzaki Yusuke ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Endovascular Therapy ◽  
Young Patients ◽  
The Elderly ◽  
Cardiovascular Death ◽  
Major Amputation ◽  
Clinical Frailty Scale ◽  
Treatment Indications ◽  
Artery Disease ◽  
The Impact

Purpose: Information on the relationship between frailty and the outcome of endovascular therapy (EVT) in elderly patients with lower extremity peripheral artery disease (PAD) is scarce. This study aimed to reveal the impact of frailty on the prognosis of super-elderly patients who underwent EVT. Materials and Methods: From August 2015 to August 2016, 335 consecutive patients who underwent EVT were enrolled in the I-PAD registry from 7 institutes in Nagano prefecture. Among them, we categorized 323 patients into 4 groups according to age and the presence or absence of frailty as follows: elderly with frailty (age ≥ 75, Clinical Frailty Scale [CFS] ≥ 5), elderly without frailty (age ≥ 75, CFS ≤ 4), young with frailty (age < 75, CFS ≥ 5), and young without frailty (age < 75, CFS ≤ 4); we analyzed them accordingly. The primary endpoints were major adverse cardiovascular and limb events (MACLE), defined as a composite of cardiovascular death, myocardial infarction, stroke, admission for heart failure, major amputation, and revascularization. The secondary endpoint was cardiovascular death. Results: The median follow-up period was 2.7 years. In the elderly with frailty, elderly without frailty, young with frailty, and young without frailty groups, the freedom rates from MACLE were 34.9%, 55.7%, 35.4%, and 63.0%, respectively (p<0.001) and from all-cause death were 43.5%, 73.4%, 50.7%, and 90.9%, respectively (p<0.001). The freedom rates from MACLE were significantly higher among elderly patients with frailty than among young patients without frailty (55.7% vs 35.4%, p=0.01). In multivariate analysis, frailty was independently associated with MACLE incidence. Conclusion: Frailty as defined by CFS might be a predictor of MACLE incidence in patients with PAD who underwent EVT. By considering treatment indications for patients with PAD by focusing on frailty rather than age, we may examine whether EVT policies are appropriate and manage patient and caregiver expectations for potential improvement in functional outcomes. Further studies are expected to investigate whether changes in frailty after EVT change prognosis.

P1957Impact of fraility on the super elderly patients with peripheral artery disease

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
K Nishigawa ◽  
A Nagae ◽  
T Miura ◽  
T Katoh ◽  
M Hirabayashi ◽  
...  
Keyword(s):  
Overall Survival ◽  
Elderly Patients ◽  
Peripheral Artery Disease ◽  
Major Amputation ◽  
Peripheral Artery ◽  
Clinical Frailty Scale ◽  
Multicenter Observational Study ◽  
Primary Endpoints ◽  
Artery Disease

Abstract Background The current consensus is that frail patients have high risks of mortality. However, it remains unclear whether frailty is associated with mortality risks in super-elderly patients with peripheral artery disease (PAD). Methods The I-PAD registry was a prospective multicenter observational study involving 12 institutions in Nagano prefecture in Japan. From July 2015 to July 2016, the I-PAD registry enrolled 371 consecutive PAD patients who had undergone endovascular therapy (EVT). Among them, we selected and analysed 109 PAD patients who were >80 years old when they had undergone EVT and divided them into two groups: those with frailty (Clinical Frailty Scale≥5, n=47) and those without frailty (Clinical Frailty Scale≤4, n=62). The primary endpoints were overall survival and major adverse limb events (MALE), defined as a composite of all-cause death, major amputation and revascularization. Results The median follow-up period was 1.58±0.3 years. Overall, 109 patients with a mean age of 84.8±4.0 years, of whom 63.3% were men, were included. Overall survival and freedom from MALE were significantly lower among patients with frailty than among those without frailty (60.5% vs. 91.6%, P<0.001; 51.4% vs. 87.5%, P<0.001; respectively). Conclusion The prognosis of super-elderly patients with frailty is worse than that of patients without frailty.

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 Cardiovascular consequences of discontinuing low-dose rivaroxaban in people with chronic coronary or peripheral artery disease

Heart ◽  
2021 ◽  
pp. heartjnl-2020-318758
Author(s):  
Gilles R Dagenais ◽  
Leanne Dyal ◽  
Jacqueline J Bosch ◽  
Darryl P Leong ◽  
Victor Aboyans ◽  
...  
Keyword(s):  
Peripheral Artery Disease ◽  
Low Dose ◽  
Cardiovascular Death ◽  
Stroke Rate ◽  
Early Stopping ◽  
Peripheral Artery ◽  
Once Daily ◽  
Registration Number ◽  
Artery Disease

ObjectiveIn patients with chronic coronary or peripheral artery disease enrolled in the Cardiovascular Outcomes for People Using Anticoagulation Strategies trial, randomised antithrombotic treatments were stopped after a median follow-up of 23 months because of benefits of the combination of rivaroxaban 2.5 mg two times per day and aspirin 100 mg once daily compared with aspirin 100 mg once daily. We assessed the effect of switching to non-study aspirin at the time of early stopping.MethodsIncident composite of myocardial infarction, stroke or cardiovascular death was estimated per 100 person-years (py) during randomised treatment (n=18 278) and after study treatment discontinuation to non-study aspirin (n=14 068).ResultsDuring randomised treatment, the combination compared with aspirin reduced the composite (2.2 vs 2.9/100 py, HR: 0.76, 95% CI 0.66 to 0.86), stroke (0.5 vs 0.8/100 py, HR: 0.58, 95% CI 0.44 to 0.76) and cardiovascular death (0.9 vs 1.2/100 py, HR: 0.78, 95% CI 0.64 to 0.96). During 1.02 years after early stopping, participants originally randomised to the combination compared with those randomised to aspirin had similar rates of the composite (2.1 vs 2.0/100 py, HR: 1.08, 95% CI 0.84 to 1.39) and cardiovascular death (1.0 vs 0.8/100 py, HR: 1.26, 95% CI 0.85 to 1.86) but higher stroke rate (0.7 vs 0.4/100 py, HR: 1.74, 95% CI 1.05 to 2.87) including a significant increase in ischaemic stroke during the first 6 months after switching to non-study aspirin.ConclusionDiscontinuing study rivaroxaban and aspirin to non-study aspirin was associated with the loss of cardiovascular benefits and a stroke excess.Trial registration numberNCT01776424.

scholarly journals Risk factors and clinical outcomes in chronic coronary and peripheral artery disease: An analysis of the randomized, double-blind COMPASS trial

2019 ◽  
Vol 27 (3) ◽  
pp. 296-307 ◽  
Author(s):  
Thomas Vanassche ◽  
Peter Verhamme ◽  
Sonia S Anand ◽  
Olga Shestakovska ◽  
Keith AA Fox ◽  
...  
Keyword(s):  
Risk Factors ◽  
Risk Factor ◽  
Peripheral Artery Disease ◽  
Low Dose ◽  
Cardiovascular Death ◽  
Peripheral Artery ◽  
Double Blind ◽  
Artery Disease ◽  
Risk Factor Status ◽  
Ischemic Events

Aims Secondary prevention in patients with coronary artery disease and peripheral artery disease involves antithrombotic therapy and optimal control of cardiovascular risk factors. In the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) study, adding low-dose rivaroxaban on top of aspirin lowered cardiovascular events, but there is limited data about risk factor control in secondary prevention. We studied the association between risk factor status and outcomes, and the impact of risk factor status on the treatment effect of rivaroxaban, in a large contemporary population of patients with coronary artery disease or peripheral artery disease. Methods and results We reported ischemic events (cardiovascular death, stroke, or myocardial infarction) in participants from the randomized, double-blind COMPASS study by individual risk factor (blood pressure, smoking status, cholesterol level, presence of diabetes, body mass index, and level of physical activity), and by number of risk factors. We compared rates and hazard ratios of patients treated with rivaroxaban plus aspirin vs aspirin alone within each risk factor category and tested for interaction between risk factor status and antithrombotic regimen. Complete baseline risk factor status was available in 27,117 (99%) patients. Status and number of risk factors were both associated with increased risk of ischemic events. Rates of ischemic events (hazard ratio 2.2; 95% confidence interval 1.8–2.6) and cardiovascular death (hazard ratio 2.0; 1.5–2.7) were more than twofold higher in patients with 4–6 compared with 0–1 risk factors ( p < 0.0001 for both). Rivaroxaban reduced event rates independently of the number of risk factors ( p interaction 0.93), with the largest absolute benefit in patients with the highest number of risk factors. Conclusion More favorable risk factor status and low-dose rivaroxaban were independently associated with lower risk of cardiovascular events.

scholarly journals Awareness of Scleroderma Peripheral Artery Disease Presenting With Critical Limb Ischemia in Elderly Patients

2019 ◽  
Vol 83 (5) ◽  
pp. 1081
Author(s):  
Sayaka Funabashi ◽  
Osami Kawarada ◽  
Toru Hirano ◽  
Shinobu Ayabe ◽  
Takeshi Yagyu ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Peripheral Artery Disease ◽  
Critical Limb Ischemia ◽  
Limb Ischemia ◽  
Peripheral Artery ◽  
Artery Disease

Stromal Cell–Derived Factor-1 Plasmid Treatment for Patients With Peripheral Artery Disease (STOP-PAD) Trial: Six-Month Results

2020 ◽  
Vol 27 (4) ◽  
pp. 669-675
Author(s):  
Tarek A. Hammad ◽  
John Rundback ◽  
Matthew Bunte ◽  
Leslie Miller ◽  
Parag D. Patel ◽  
...  
Keyword(s):  
Wound Healing ◽  
Peripheral Artery Disease ◽  
Stromal Cell ◽  
Biological Therapy ◽  
Target Lesion ◽  
Major Amputation ◽  
Peripheral Artery ◽  
Below The Knee ◽  
Stromal Cell Derived Factor ◽  
Artery Disease

Purpose: To present the 6-month results of the Stromal Cell–Derived Factor-1 Plasmid Treatment for Patients with Peripheral Artery Disease (STOP-PAD) trial. The trial was an attempt to alter the course of chronic limb-threatening ischemia (CLTI) with a biological agent vs placebo after successful arterial revascularization at or below the knee. Materials and Methods: The multicenter, randomized, double-blinded, placebo-controlled, phase 2B STOP-PAD trial ( ClinicalTrials.gov identifier NCT02544204) randomized 109 patients (mean age 71 years; 68 men) with Rutherford category 5 or 6 CLTI and evidence of persistent impaired forefoot perfusion following recent successful revascularization to 8- (n=34) or 16-mg (n=36) intramuscular injections of a non-viral DNA plasmid–based treatment vs placebo (n=34). The primary efficacy outcome was the 6-month wound healing score evaluated by an independent wound core laboratory; the primary safety endpoint was major adverse limb events (MALE), a composite of major amputation plus clinically-driven target lesion revascularization at 6 months. Results: Only one-third of the patients had complete wound healing at 6 months in the placebo (31%), 8-mg injection (33%), and 16-mg injection (33%) groups. In addition, the observed increase in the toe-brachial index from baseline to 6 months was statistically significant in each group; however, this did not result in lower rates of MALE at 6 months (24% in the placebo, 29% in the 8-mg injection, and 11% in the 16-mg injection groups). During the 6-month period, 6 patients (6%) died, and 24 patients (23%) had an amputation [only 4 (4%) major]. Conclusion: Combining revascularization and biological therapy failed to improve outcomes in CLTI at 6 months. STOP-PAD has provided insights for future trials to evaluate biological therapy.

scholarly journals Vorapaxar in the treatment of cardiovascular diseases

2020 ◽  
Vol 16 (5) ◽  
pp. 373-384
Author(s):  
Udaya S Tantry ◽  
Kevin P Bliden ◽  
Rahul Chaudhary ◽  
Marko Novakovic ◽  
Amit Rout ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Peripheral Artery Disease ◽  
Coronary Revascularization ◽  
Bleeding Risk ◽  
Cardiovascular Death ◽  
Severe Bleeding ◽  
Peripheral Artery ◽  
Primary Hemostasis ◽  
History Of ◽  
Artery Disease

Vorapaxar specifically and effectively inhibits protease activated receptor-1 and may reduce thrombin-mediated ischemic events without interfering primary hemostasis. In the TRA-2P-TIMI 50 trial, vorapaxar reduced the risk of primary ischemic outcome but with increased bleeding risk. In the post hoc analysis, in patients with a history of myocardial infarction, peripheral artery disease, the net clinical outcome favored vorapaxar therapy with 10% reduction in cardiovascular death, myocardial infarction, stroke, urgent coronary revascularization and moderate or severe bleeding. Based on these favorable results, vorapaxar was approved for the reduction of thrombotic cardiovascular events in patients with prior myocardial infarction or with peripheral artery disease on top of standard antiplatelet therapy. A careful patient selection is needed to balance efficacy versus safety.

Predictive Value of Underweight Status for Patients With Peripheral Artery Disease With Claudication

Angiology ◽  
2017 ◽  
Vol 69 (6) ◽  
pp. 513-522 ◽  
Author(s):  
Keisuke Senda ◽  
Takashi Miura ◽  
Masatoshi Minamisawa ◽  
Yasushi Ueki ◽  
Tomoaki Mochidome ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Peripheral Artery Disease ◽  
Limb Ischemia ◽  
Cardiovascular Death ◽  
Peripheral Artery ◽  
Reactive Protein ◽  
Overweight Group ◽  
Underweight Patients ◽  
Artery Disease ◽  
Cox Analysis

We evaluated whether underweight status is associated with poor prognosis in patients with peripheral artery disease (PAD) with claudication, excluding critical limb ischemia. We identified 441 claudicants hospitalized for cardiovascular disease between 2005 and 2012. Patients were divided into 4 groups according to body mass index (BMI): an underweight group (BMI < 18.5 kg/m2; n = 48), a normal group (BMI = 18.5-25.0 kg/m2; n = 286), an overweight group (BMI = 25.0-30.0 kg/m2; n = 92), and an obese group (BMI ≥ 30.0 kg/m2; n = 15). The mean follow-up period was 3.5 ± 1.9 years. The underweight group had significantly lower levels of hemoglobin, albumin, estimated glomerular filtration rate, triglycerides, and hemoglobin A1c; higher levels of C-reactive protein and B-type natriuretic peptide; and a higher prevalence of hemodialysis. The incidence of all-cause death and cardiovascular death was significantly higher in the underweight group (underweight vs normal, 77.1% vs 33.0%; P < .001 and 43.3% vs 14.4%; P < .001, respectively). In a multivariate Cox analysis, underweight status was an independent predictor of all-cause death (hazard ratio, 2.53; 95% confidence interval, 1.58-4.18; P < .001). Therefore, promoting weight gain, as well as managing cardiovascular disease, may be important for underweight patients with PAD.

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