Device profile of the FLEX Vessel Prep System for the treatment of peripheral arterial disease: overview of its safety and efficacy

Abstract Funding Acknowledgements Type of funding sources: None. Background Lumbrokinase, an oral anti-thrombotic and fibrinolytic agent, was not yet part of the recommendations of any recommendations but had shown in two studies that it could increase the Ankle Brachial Index (ABI). ABI was used to evaluate the drug efficacy for PAD. Purpose Peripheral Arterial Disease was one of the most neglected, under-screened, and undertreated high-risk groups among cardiovascular diseases like myocardial infarction and stroke. Few studies were done to evaluate the treatment of fibrinolytic such as Lumbrokinase for this population. Methods We appraised two randomized control trials that evaluated the safety and efficacy of Lumbrokinase compared to placebo with the standard regimen and another study of Lumbrokinase compared to placebo with standard regimen versus Lumbrokinase with Prostaglandin E1 (PGE1) among adult patients for the reduction of symptoms of PAD and increase in ABI. Both trials treatment period lasted for 2 weeks. Two independent reviewers assess the identified trials for inclusion by applying the selection criteria and quality was assessed using the JADAD scale. The data was analyzed using Meta analyst statistical software. Main results After weeks of treatment, the effect size is 0.90; this is an increase of at least +0.06 from the baseline that supports the trend in increasing the ankle-brachial index. The study did not show significant side effects by Lumbrokinase Conclusions Lumbrokinase at 460 to 490 mg three times a day for 2 weeks to 3 months has no significant relationship but has a trend in increasing the ankle-brachial index to a borderline level compared to placebo. Additional studies regarding the effect of Lumbrokinase in increasing ABI must be done with larger sample size. Further research is needed to illuminate whether a longer duration of treatment with Lumbrokinase can increase the ankle-brachial index more. Eligible Trials Table 1. Eligible trials, characteristics, and demographics.AuthorYearControlPatient enrolled (N)Patient Analysed (%)Age Mean SDMales %Diabetes %Dyslipidemia %1. NDRAHA2013PlaceboL = 10 C= 10L = 100 C = 100L = 55.8 C = 53.2L = 5 C = 5L = 35 C = 25L = 30 C = 302. LUL= 31 C = 31L = 100 C = 100L = 68 C = 68.4L = 74 C = 74NANASUM/RAW MEANSL= 41 C = 41L = 100 C = 100L = 61.9 C = 60.8L = 39.4 C = 39.4NANAL= Lumbrokinase groupC= Control groupNA = not availableAbstract Figure. Efficacy of Lumbrokinase

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Clopidogrel for Atherothrombotic Event Management in Patients with Peripheral Arterial Disease (COOPER) Study: Safety and Efficacy of Clopidogrel versus Ticlopidine in Japanese Patients

Annals of Vascular Diseases ◽

10.3400/avd.oa.12.00039 ◽

2012 ◽

Vol 5 (3) ◽

pp. 364-375 ◽

Cited By ~ 6

Author(s):

Hiroshi Shigematsu ◽

Kimihiro Komori ◽

Kazuo Tanemoto ◽

Yuko Harada ◽

Masato Nakamura

Keyword(s):

Peripheral Arterial Disease ◽

Japanese Patients ◽

Arterial Disease ◽

Event Management ◽

Safety And Efficacy ◽

Atherothrombotic Event ◽

Peripheral Arterial

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Abstract T P338: To Evaluate the Efficacy and Safety of Cilostazol in Ischemic Stroke Patients with Peripheral Arterial Disease (SPAD) Study: Methodology and Baseline Data

Stroke ◽

10.1161/str.45.suppl_1.tp338 ◽

2014 ◽

Vol 45 (suppl_1) ◽

Author(s):

Jiann-Shing Jeng ◽

Li-Ming Lien ◽

Sien-Tsong Chen ◽

Chung Y. Hsu ◽

Keyword(s):

Diabetes Mellitus ◽

Ischemic Stroke ◽

Peripheral Arterial Disease ◽

Carotid Stenosis ◽

Smoking Habit ◽

Arterial Disease ◽

Stroke Patients ◽

Vascular Events ◽

Safety And Efficacy ◽

Peripheral Arterial

Background and Purpose: Ischemic stroke often co-exists with peripheral arterial disease (PAD). Patients with polyvascular diseases carry higher risks of vascular events and death. We initiated a study to evaluate the safety and efficacy of cilostazol in ischemic Stroke patients with PAD (SPAD) and have been taking aspirin for stroke prevention. Methods: The SPAD study is a prospective, multicenter, national, double-blinded, placebo-controlled, randomized trial. Patients with previous ischemic stroke or TIA who have been taking aspirin (100 mg per day), aged 50 years or older, with PAD in the lower limbs based on ankle-brachial index (ABI) <1.0 were randomized to the treatment group with cilostazol (200 mg/day) or the placebo group with a 1:1 basis. Each patient is periodically followed-up for one year. The primary endpoint of the study is the change in the ABI. The secondary endpoints are the change in the common carotid artery intima-media thickness (IMT); major cardiovascular events, including recurrent stroke, myocardial infarction, unstable angina, other vascular events, and all death; and the safety, including major bleeding events, hemorrhagic stroke, and any death. Results: From September, 2010 to July, 2012, a total of 800 patients (male, 59.9%; female, 40.1%; average age, 70.4±9.3 years) were enrolled in the SPAD study, including 722 (90.2%) with ischemic stroke or 78 (9.8%) with TIA. Several atherosclerotic risk factors were commonly seen in this study population, including hypertension (88%), diabetes mellitus (48%), hypercholesterolemia (54%), smoking habit (41%), and carotid stenosis (15%). The distribution of baseline ABI were 0.90-0.99 (n=294), 0.70-0.89 (n=371), and <0.70 (n=136). Patients with lower ABI were more frequently associated with old age, lower body mass index, smoking habit, diabetes mellitus, carotid stenosis ≥50%, and higher systolic blood pressure. Conclusions: The SPAD trial is the first study to evaluate the safety and efficacy of dual antiplatelets, aspirin plus cilostazol, in ischemic stroke patients with PAD. The trial findings are expected to help in choosing better strategy for prevention of vascular events in this polyvascular disease.

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