scholarly journals Oral Anticoagulant and Antiplatelet Therapy for Peripheral Arterial Disease: A Meta-analysis of Randomized Controlled Trials

2021 ◽  
Vol 27 ◽  
pp. 107602962199681
Author(s):  
Tao Tang ◽  
Ming Zhang ◽  
Wendong Li ◽  
Nan Hu ◽  
Xiaolong Du ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Antiplatelet Therapy ◽  
Intracranial Hemorrhage ◽  
Major Bleeding ◽  
Oral Anticoagulant ◽  
Limb Ischemia ◽  
Major Amputation ◽  
Acute Limb Ischemia ◽  
Bleeding Events ◽  
Fatal Bleeding

Peripheral artery disease (PAD) is a common disease affecting over 200 million people worldwide. PAD is associated with significant limb and cardiovascular morbidity and mortality which is reduced by antiplatelet and antithrombotic therapy. However, the optimal type, dose, and time of antithrombotic therapy is still uncertain.We searched 4 electronic databases from January 1, 1990, to June 1, 2020, for randomized controlled trials of patients who received oral anticoagulant and antiplatelet therapy for PAD. The primary outcome was a composite of acute limb ischemia, major amputation, myocardial infarction, ischemic stroke, death from cardiovascular events, or death from any cause. Secondary outcomes included major bleeding, fatal bleeding, and intracranial hemorrhage events.We identified 3 studies that satisfied inclusion and exclusion criteria. Compared with antiplatelet alone, oral anticoagulant plus antiplatelet therapy improved acute limb ischemia (p < 0.00001), stroke (p = 0.005), and major amputation events (p = 0.11). However, oral anticoagulant plus antiplatelet therapy was not effective for prevention of myocardial infarction (p = 0.23), death from cardiovascular events (p = 0.65), or death from any cause (p = 0.66). Additionally, a significant increase in major bleeding events was demonstrated (p < 0.00001). There was no significant difference in fatal bleeding (p = 0.16) or intracranial hemorrhage events (p = 0.43). This meta-analysis showed that oral anticoagulant plus antiplatelet therapy for PAD may improve acute limb ischemia and major amputation or stroke risk compared with antiplatelet therapy alone, but could increase the risk of major bleeding events. On the other hand, measuring myocardial infarction, death, fatal bleeding, or intracranial hemorrhage risk remains controversial.

scholarly journals The efficacy and safety of dual-pathway inhibition therapy among patients with peripheral arterial disease – a meta-analysis

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
J Mapili ◽  
A S Davin ◽  
L M Villanueva
Keyword(s):  
Myocardial Infarction ◽  
Antiplatelet Therapy ◽  
Major Bleeding ◽  
Meta Analysis ◽  
Cardiovascular Death ◽  
Acute Limb Ischemia ◽  
Cardiovascular Morbidity And Mortality ◽  
Increased Risk ◽  
Dual Pathway ◽  
Pathway Inhibition

Abstract Background and objectives Peripheral artery disease (PAD) affects more than 200 million people worldwide and it is associated with an increased risk for cardiovascular morbidity and mortality. Current recommendations regarding the management of PAD have been controversial. Our meta-analysis investigated the efficacy of direct Xa inhibitor plus antiplatelet, also known as dual-pathway inhibition (DPI), on the individual components of major adverse cardiovascular events (stroke, myocardial infarction, and cardiovascular death) and major adverse limb events (amputation, restenosis, revascularization, and acute limb ischemia), the composite of MACE and MALE and its safety, in terms of bleeding, compared to antiplatelet therapy among patients with PAD. Methodology We performed a random-effects meta-analysis among patients with PAD comparing DPI to antiplatelet therapy. PubMed, EMBASE, CENTRAL, and ClinicalTrials.gov were searched from their dates of inception to August 2020 for Randomized Controlled Trials. Three studies met the inclusion criteria for final analysis. The selected studies were assessed for risk of bias using the Cochrane RoB2 tool and the overall quality of evidence was assessed using the GRADE approach. Results Among patients with PAD, DPI significantly reduces the risk of adverse limb events excluding amputation (RR 0.69, 95% CI 0.57–0.83) and composite MACE and MALE (RR 0.80, 95% CI 0.69–0.93) but significantly increases risk of major bleeding (RR 1.43, 95% CI 1.06–1.93) compared to antiplatelet therapy alone. Overall, DPI did not reduce myocardial infarction, stroke, cardiovascular death, or amputation, or increase the risk of fatal bleeding. Conclusions Among patients with PAD, DPI is more effective than antiplatelet therapy alone in preventing adverse limb events excluding amputation with an increased risk of major bleeding. We recommend the use of DPI among patients with PAD who are at a low risk of bleeding. FUNDunding Acknowledgement Type of funding sources: None.

scholarly journals Rivaroxaban and Aspirin in Peripheral Artery Disease Lower Extremity Revascularization

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 ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Lower Extremity ◽  
International Society ◽  
Major Bleeding ◽  
Limb Ischemia ◽  
Hazard Ratio ◽  
Acute Limb Ischemia ◽  
Peripheral Artery ◽  
Artery Disease ◽  
Lower Extremity Revascularization

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.

Efficacy and Safety of Rivaroxaban Therapy for Patients With Peripheral Artery Disease: A Systematic Review and Meta-Analysis

2021 ◽  
pp. 153857442110129
Author(s):  
Yujun Hao ◽  
Weitao Han ◽  
Detang Mou ◽  
Jintao Wang
Keyword(s):  
Systematic Review ◽  
Major Bleeding ◽  
Meta Analysis ◽  
Limb Ischemia ◽  
Major Amputation ◽  
Cochrane Library ◽  
Acute Limb Ischemia ◽  
Primary Efficacy ◽  
Efficacy And Safety ◽  
Artery Disease

Objective: We performed a systematic review and meta-analysis to evaluate the efficacy and safety of rivaroxaban in patients with PAD for the first time. Methods: We searched MEDLINE, EMBASE and the Cochrane Library database for randomized controlled trials (RCTs) conducted for PAD. Results: Three trials which contained 14873 patients were included for final meta-analysis. The results showed patients with rivaroxaban was associated with reduction in primary efficacy outcome (RR 0.83; 95% CI 0.76 to 0.90; p < 0.001). The RR was 0.85 (0.71 to 1.01) for patients with rivaroxaban alone and 0.81 (0.74 to 0.89) for those with rivaroxaban plus aspirin (p for heterogeneity between groups = 0.65). Patients with rivaroxaban showed a lower rate of acute limb ischemia (0.56; 0.47 to 0.66; p < 0.001). There was a trend toward a reduction in the rate of major amputation for vascular causes in the rivaroxaban arm (0.81; 0.63 to 1.03; p = 0.08). Compared with control, rivaroxaban therapy did not reduce the risks of myocardial infarction (0.87, 0.73 to 1.04, p = 0.12), ischemic stroke (0.85, CI 0.68 to 1.06, p = 0.15), death from cardiovascular causes (0.99, 0.85 to 1.15, p = 0.91) or death from any cause (1.00, 0.90 to 1.12, p = 0.98). Rivaroxaban therapy was associated with a 1.57-fold higher major bleeding rate as compared with those with aspirin or warfarin alone. Conclusions: Overall, the risks of the primary efficacy outcomes or adverse limb events were significantly lower with rivaroxaban than with aspirin or warfarin alone in patients with PAD. It also points out the significant major bleeding that occur because of such therapies.

Safety aspect of intraoperative, local urokinase lysis in patients with acute lower limb ischemia

2021 ◽  
pp. 1-10
Author(s):  
Schierling Wilma ◽  
Bachleitner Kathrin ◽  
Kasprzak Piotr ◽  
Betz Thomas ◽  
Stehr Alexander ◽  
...  
Keyword(s):  
Major Bleeding ◽  
Lower Limb ◽  
Limb Ischemia ◽  
Major Amputation ◽  
Artery Occlusion ◽  
Outflow Tract ◽  
Intracranial Bleeding ◽  
Minor Bleeding ◽  
Free Survival ◽  
Lower Limb Ischemia

BACKGROUND: Acute lower limb ischemia (ALI) is associated with a high risk of limb loss and death. OBJECTIVE: The present study evaluates the safety of intraoperative, local urokinase lysis in patients with ALI and crural artery occlusion. METHODS: A total of 107 patients (115 legs) were treated surgically for ALI with additional intraoperative urokinase lysis to improve the outflow tract. Minor and major bleeding as well as efficacy of treatment and amputation-free survival were investigated. RESULTS: Complete restoration of at least one run-off vessel was achieved in 64%. Collateralization was improved in 34%. Lysis failed in 2%. Major amputation rate was 27%overall (12%within 30 days) and depended on Rutherford class of ALI (overall/30 day: IIa 11%/6%; IIb 20%/17%; III 37%/15%). Amputation-free survival turned out to be 82%after 30 days, 58%after one, and 41%after five years. Minor bleeding occurred in 21%(24/115) and major bleeding in 3.5%(4/115). One of these patients died of haemorrhage. No patient experienced intracranial bleeding. CONCLUSION: Intraoperative urokinase lysis improves limb perfusion and causes low major and intracranial bleeding. It can be safely applied to patients with severe ischaemia when surgical restoration of the outflow tract fails.

Assessing the management of major bleeding events in patients treated by direct oral anticoagulant in an emergency department

2021 ◽  
Vol 79 (4) ◽  
pp. 315-324
Author(s):  
Julien Durand ◽  
Stéphanie Parat ◽  
Jean-Christophe Lega ◽  
Yessim Dargaud ◽  
Véronique Potinet ◽  
...  
Keyword(s):  
Emergency Department ◽  
Major Bleeding ◽  
Oral Anticoagulant ◽  
Direct Oral Anticoagulant ◽  
Bleeding Events ◽  
Major Bleeding Events

scholarly journals The Role of Catheter Directed Thrombolysis on Acute Limb Ischemia (an Evidence-Based Case Report)

2021 ◽  
Vol 49 (1) ◽  
pp. 3-24
Author(s):  
Ali Farhan Fathoni ◽  
Raden Suhartono
Keyword(s):  
Case Report ◽  
Adult Patient ◽  
Controlled Trial ◽  
Limb Ischemia ◽  
Evidence Based ◽  
Acute Limb Ischemia ◽  
First Line ◽  
Bleeding Events ◽  
Catheter Directed Thrombolysis ◽  
Significant Difference

Introduction. Acute limb ischemia can be managed both with surgery and thrombolysis, especially catheter-directed thrombolysis. The risk, benefit and indication of thrombolysis is already well known. However, as a first line therapy, it is unclear which intervention is more beneficial; the catheter directed thrombolysis or surgery. This report aims to elucidate which technique is more effective and safer. Method. This is an Evidence-Based Case Report based on a case of a geriatric, diabetic patient whom suffered acute limb ischemia. The report systematically search for meta-analysis, systematic review, randomized controlled trial and cohort studies from Cochrane central and PubMed for all adult patient suffering from acute limb ischemia whose are treated with catheter-directed thrombolysis or surgery as first-line intervention and comparing the outcome in terms of efficacy (clinical outcome such as patency and amputation-free rates) and safety (mortality and morbidity). Results. Subjects’ characteristics should be placed first to draw the demography. Put the study finding(s) here with no interpretation. For all adult patient regardless of their diabetic status and age there is no statistically significant difference for limb salvage, amputation, and mortality between two technique, however catheter directed thrombolysis showed reduced need for additional intervention whilst increasing risk of bleeding events. Conclusion. Neither techniques are more superior than the other but catheter-directed thrombolysis can be considered given that it reduce the need for further intervention, less invasive and even though it has risks for bleeding complication it is still lower compared to systemic thrombolysis. The selection of which technique can be up to clinician’s discretion in consideration of risk and benefit for each patient.

scholarly journals Adverse prognosis of incidentally detected ambulatory atrial fibrillation

2014 ◽  
Vol 112 (08) ◽  
pp. 276-286 ◽  
Author(s):  
Carlos Martinez ◽  
Anja Katholing ◽  
Saul Freedman
Keyword(s):  
Myocardial Infarction ◽  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Antithrombotic Therapy ◽  
Oral Anticoagulant ◽  
Incidence Rates ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
Antiplatelet Treatment ◽  
Stroke Incidence

SummaryIt was the aim of this study to determine prognosis of incidentally detected ambulatory atrial fibrillation (IA-AF) and its response to antithrombotic therapy. We performed a cohort study of 5,555 patients with IA-AF (mean age 70.9 ± 10.1, 38.4% female) and 24,705 age- and gender-matched controls without AF followed three years using UK Clinical Practice Research Datalink. We measured incidence rates of stroke, all-cause mortality, myocardial infarction, major bleeding, and effect of antithrombotic therapy. Patients with IA-AF had mean CHA2DS2VASc score 2.5 ± 1.5, 73% with score ≥2. The stroke incidence rate (IR) was 19.4 (95% confidence interval 17.1 – 21.9)/1,000 person-years vs 8.4 (7.7 – 9.1) in controls (p<0.001), mortality 40.1 (36.8 – 43.6)/1,000 person-years vs 20.9 (19.8 – 22.0) in controls (p<0.001), and myocardial infarction 9.0 (7.5 – 10.8)/1,000 person-years vs 6.5 (5.9 – 7.2) in controls (p<0.001). IRs of all endpoints increased with age. Oral anticoagulant ± antiplatelet therapy received by 51.0% in year following IA-AF was associated with adjusted hazard ratio (HR) of 0.35 (0.17 – 0.71) for stroke, and 0.56 (0.36 – 0.85) for death compared to no therapy, while antiplatelet treatment was associated with a non-significant reduction of HR: 0.81 (0.51 – 1.29) for stroke, and 0.80 (0.55 – 1.15) for death, though both carried a similar small non-significant adjusted excess IR of major bleeding. In conclusion, asymptomatic AF detected incidentally is associated with a significant adverse effect on stroke and death, with reduction in both associated with oral anticoagulant but not antiplatelet treatment. This provides justification to assess cost-effectiveness of community screening to detect unknown AF.

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