Efficacy and safety of DOACs in patients with peripheral arterial disease: A systematic review and meta-analysis

Vascular ◽  
2021 ◽  
pp. 170853812098793
Author(s):  
Yuan-Su Zhang ◽  
Jin-Hui Chen ◽  
Tong Mei ◽  
Shuai Li ◽  
Yong-Ming Lu

Background The efficacy and safety of direct oral anticoagulants (DOACs) in patients with peripheral arterial disease are not completely understood. Therefore, we conducted a meta-analysis to explore the effects of DOACs in this population. Methods We systematically searched the PubMed, Cochrane Library, and Web of Science till April 2020 for relevant randomized controlled trials and observational studies, with no linguistic restrictions. The efficacy outcomes were cardiovascular death, stroke, myocardial infraction, major adverse cardiovascular events (MACE), acute limb ischemia, amputation, and target lesion revascularization. The safety outcome was major bleeding events. Random effects risk ratios with 95% confidence intervals were calculated. Results A total four randomized controlled trials were included in this meta-analysis. Among peripheral arterial disease patients, DOACs did not reduce the risk of cardiovascular death (RR = 1.02 95%CI 0.75–1.37, P = 0.92), stroke (RR = 0.73 95%CI 0.46–1.14, P = 0.16), myocardial infraction (RR = 0.85 95%CI 0.70–1.03, P = 0.10), MACE (RR = 0.73 95%CI 0.46–1.14, P = 0.16), or amputation (RR = 0.73 95%CI 0.46–1.14, P = 0.16) compared with control. However, DOACs were associated with reduction in acute limb ischemia (RR = 0.67 95%CI 0.55–0.80, P < 0.01) and target lesion revascularization (RR = 0.89 95%CI 0.81–0.99, P = 0.02) at the expense of major bleeding events (RR = 1.43 95%CI 1.16–1.77, P < 0.01) compared with control. Conclusions Based on current evidence, no significant difference in cardiovascular death, stroke, myocardial infraction, MACE, and amputation was found when DOACs were compared to antiplatelet monotherapy. The benefits of preventing target lesion revascularization and acute limb ischemia were balanced by amplified risk of major bleeding. Larger randomized controlled trials are needed to figure out the uncertainty around efficacy and safety of medications for peripheral arterial disease.

2020 ◽  
Vol 77 (4) ◽  
pp. 269-276
Author(s):  
Daria Zavgorodnyaya ◽  
Tamara B Knight ◽  
Mitchell J Daley ◽  
Pedro G Teixeira

Abstract Purpose Evidence on the use of antithrombotic pharmacotherapy in patients undergoing revascularization of lower extremities for symptomatic peripheral arterial disease (PAD) is reviewed. Summary Individuals with PAD can experience leg pain, intermittent claudication, critical limb ischemia, and acute limb ischemia. In such patients, revascularization may be indicated to improve the quality of life and to prevent amputations. Antithrombotic therapy is often intensified in the postrevascularization period to prevent restenosis of the index artery and to counteract the prothrombotic state induced by the intervention. Therapeutic modalities include dual antiplatelet therapy (DAPT), anticoagulation, a combination of antiplatelet and anticoagulation therapy, and addition of cilostazol to single antiplatelet therapy. Subgroup analyses of data from randomized clinical trials provided low-quality evidence for the use of DAPT in patients with a below-knee prosthetic bypass graft and anticoagulation for those with a venous bypass graft. Cilostazol, when added to aspirin therapy, has been shown to prevent index vessel reocclusion after an endovascular intervention in patients at low risk for thrombosis in several small randomized trials. Conclusion There is a considerable paucity of high-quality evidence on the optimal antithrombotic regimen for patients undergoing lower extremity revascularization, with no particular therapy shown to consistently improve patient outcomes. The decision to initiate intensified antithrombotic therapy should include a close examination of its risk–benefit profile. The demonstrated benefit of such treatment is restricted to the prevention of index artery reocclusion, while an increased risk of bleeding may lead to significant morbidity and mortality.


VASA ◽  
2013 ◽  
Vol 42 (5) ◽  
pp. 331-339 ◽  
Author(s):  
Alexandra Hammer ◽  
Sabine Steiner

Background: Beyond pharmacological, endovascular and surgical treatment strategies for peripheral arterial disease (PAD), therapeutic angiogenesis has been advocated to relieve symptoms and support limb salvage, in particular in patients with critical limb ischemia. We aimed to systematically review randomized controlled trials (RCTs) of gene therapy in PAD. Patients and methods: A systematic search of electronic databases was performed to identify RCTs studying local administration of pro-angiogenic growth factors (VEGF, FGF, HGF, Del-1, HIF-1alpha) using plasmid or viral gene transfer by intra-arterial or intra-muscular injections. Outcomes of interest comprised all-cause mortality, amputations, ulcer healing, walking distance and ankle-brachial index. If feasible, standard meta-analysis should be performed with subgroup analysis for claudicants and patients with critical limb ischemia (CLI). Results: The systematic search yielded 12 RCTs for analysis from 1163 citations. In total, 1494 patients (29 % females) were included with the majority suffering from CLI (64 %). Various endpoints were improved by single studies, but none by a majority of studies. Meta-analysis showed neither a significant benefit nor harm for gene therapy when synthesizing data for all-cause mortality (OR 0.88, 95 % CI 0.62 - 1.26) amputations (OR 0.64, 95 % CI 0.31 - 1.31) or ulcer healing (OR 1.79, 95 % CI 0.8 - 4.01). No differences were seen between patients with intermittent claudication or CLI. Conclusions: Despite promising results in single studies, no clear benefit could be identified for gene therapy in PAD patients, irrespective of disease severity.


Sign in / Sign up

Export Citation Format

Share Document