BACKGROUND Patients with peripheral artery disease have an increased risk of cardiovascular morbidity and mortality. Antiplatelet agents are widely used to reduce these complications. METHODS This was a multicentre, double-blind, randomised placebo-controlled trial for which patients were recruited at 602 hospitals, clinics, or community practices from 33 countries across six continents. Eligible patients had a history of peripheral artery disease of the lower extremities (previous peripheral bypass surgery or angioplasty, limb or foot amputation, intermittent claudication with objective evidence of peripheral artery disease), of the carotid arteries (previous carotid artery revascularisation or asymptomatic carotid artery stenosis of at least 50%), or coronary artery disease with an ankle-brachial index of less than 0·90. After a 30-day run-in period, patients were randomly assigned (1:1:1) to receive oral rivaroxaban (2·5 mg twice a day) plus aspirin (100 mg once a day), rivaroxaban twice a day (5 mg with aspirin placebo once a day), or to aspirin once a day (100 mg and rivaroxaban placebo twice a day). Randomisation was computer generated. Each treatment group was double dummy, and the patient, investigators, and central study staff were masked to treatment allocation. The primary outcome was cardiovascular death, myocardial infarction or stroke; the primary peripheral artery disease outcome was major adverse limb events including major amputation. This trial is registered with ClinicalTrials.gov, number NCT01776424, and is closed to new participants. FINDINGS Between March 12, 2013, and May 10, 2016, we ; HR 0·67, 95% CI 0·45-1·00, p=0·05). The median duration of treatment was 21 months. The use of the rivaroxaban plus aspirin combination increased major bleeding compared with the aspirin alone group (77 [3%] of 2492 vs 48 [2%] of 2504; HR 1·61, 95% CI 1·12-2·31, p=0·0089), which was mainly gastrointestinal. Similarly, major bleeding occurred in 79 (3%) of 2474 patients with rivaroxaban 5 mg, and in 48 (2%) of 2504 in the aspirin alone group (HR 1·68, 95% CI 1·17-2·40; p=0·0043). INTERPRETATION Low-dose rivaroxaban taken twice a day plus aspirin once a day reduced major adverse cardiovascular and limb events when compared with aspirin alone. Although major bleeding was increased, fatal or critical organ bleeding was not. This combination therapy represents an important advance in the management of patients with peripheral artery disease. Rivaroxaban alone did not significantly reduce major adverse cardiovascular events compared with asprin alone, but reduced major adverse limb events and increased major bleeding. FUNDING Bayer AG. Methods This was a multicentre, double-blind, randomised placebo-controlled trial for which patients were recruited at 602 hospitals, clinics, or community practices from 33 countries across six continents. Eligible patients had a history of peripheral artery disease of the lower extremities (previous peripheral bypass surgery or angioplasty, limb or foot amputation, i...

Peripheral arterial disease (PAD) is part of a global vascular problem of diffuse atherosclerosis. PAD patients die mostly of cardiac and cerebrovascular-related events and much less frequently due to obstructive disease of the lower extremities. Aggressive risk factors modifi cation is needed to reduce cardiac mortality in PAD patients. These include smoking cessation, reduction of blood pressure to current guidelines, aggressive low density lipoprotein lowering, losing weight, controlling diabetes and the use of oral antiplatelet drugs such as aspirin or clopidogrel. In addition to quitting smoking and exercise, cilostazol and statins have been shown to reduce claudication in patients with PAD. Patients with critical rest limb ischemia or severe progressive claudication need to be treated with revascularization to minimize the chance of limb loss, reduce symptoms, and improve quality of life. Keywords: peripheral arterial disease, epidemiology, risk factors, classifi cation Epidemiology of peripheral arterial disease (PAD)PAD affects 12%-14% of the general population and its prevalence increases with age affecting up to 20% of patients over the age of 75 (Hiatt et al 1995). Coexistent coronary artery disease (CAD) and cerebrovascular disease (CVD) are highly prevalent in patients with PAD particularly in the elderly population. Recent data from the Reduction of Atherothrombosis for Continued Health registry presented at the American College of Cardiology Annual Scientifi c Sessions (Bhatt 2005) showed that among 7013 patients with symptomatic PAD, polyvascular disease was present in 63%. Furthermore, patients over the age of 50 and with PAD in an academic, hospital-based geriatric practice have a 68% and 42% incidence of coexistent CAD and stroke respectively (Ness and Aronow 1999).The PAD patients are at an exceptionally high risk for cardiovascular events and the majority will eventually die of a cardiac or cerebrovascular etiology. The more symptomatic and severe the PAD as objectively measured by the ankle-brachial index (ABI), the worse the overall prognosis of the patient. Criqui et al (1992) evaluated the association of large-vessel PAD with rates of mortality from all CVD and CAD. The relative risk of dying among subjects with large-vessel PAD versus none was 3.1 (95% CI 1.9-4.9) for deaths from all causes, and 5.9 (95% CI 3.0-11.4) for all deaths from cardiovascular disease. Mortality due to cardiovascular disease was 15-fold more among symptomatic subjects with severe large-vessel PAD. Finally, PAD has been classifi ed as a coronary heart disease (CHD) risk equivalent, ie, carrying >20% risk of a coronary event in 10 years. The Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (2001) classifi ed diabetes, multiple cardiac risk factors that confer a 10-year risk of >20%, and PAD including carotid disease and abdominal aortic aneurysm as a CHD risk equivalent.

Debulking with orbital atherectomy appeared to increase the chance of reaching a desirable angioplasty result, with less acute need for bailout stenting and a higher procedure success. A negative association between procedure success and risk of serious adverse outcomes should encourage larger confirmatory studies.

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ObjectivesThe purpose of the DEFINITIVE Ca++ study was to evaluate the safety and effectiveness of directional atherectomy and distal embolic protection, used together to treat moderate to severely calcified femoropopliteal lesions.BackgroundDespite advances in endovascular treatment modalities, treatment of calcified lesions remains a challenge.MethodsA total of 133 subjects with 168 moderate to severely calcified lesions were enrolled. Lesions were treated with directional atherectomy devices, coupled with distal embolic protection.ResultsThe 30-day freedom from MAE rate was 93.1%. Per angiographic core laboratory assessment, the primary effectiveness endpoint (≤50% residual diameter stenosis) was achieved in 92.0% (lower confidence bound of 87.6%) of lesions. By core lab analysis, these results did not achieve the success criteria (90%) for the primary effectiveness objective. Per site assessment, the objective was met with the endpoint being achieved in 97.0% (lower confidence bound 93.8%). A mean residual diameter stenosis of 33.3% was achieved with the directional atherectomy device. This was further decreased to 24.1% with the use of adjunctive therapy. The proportion of asymptomatic subjects [Rutherford Clinical Category (RCC) = 0] increased from 0% at baseline to 52.3% at the 30-day follow-up visit. In total, 88.5% of subjects experienced an improvement of one or more Rutherford categories.ConclusionsThe results of the DEFINITIVE Ca++ study demonstrate that the SilverHawk™ and TurboHawk™ atherectomy devices are safe and effective in the endovascular treatment of moderate to severely calcified lesions in the superficial femoral and/or popliteal arteries when used with the SpiderFX™ distal embolic protection device. © 2014 Wiley Periodicals, Inc.