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...
Background-Mycotic aortic aneurysm (MAA) is a rare and life-threatening disease. The aim of this European multicenter collaboration was to study the durability of endovascular aortic repair (EVAR) of MAA, by assessing late infectionrelated complications and long-term survival. Methods and Results-All EVAR treated MAAs, between 1999 and 2013 at 16 European centers, were retrospectively reviewed. One hundred twenty-three patients with 130 MAAs were identified. Mean age was 69 years (range 39-86), 87 (71%) were men, 58 (47%) had immunodeficiency, and 47 (38%) presented with rupture. Anatomic locations were ascending/arch (n=4), descending (n=34), paravisceral (n=15), infrarenal aorta (n=63), and multiple (n=7). Treatments were thoracic EVAR (n=43), fenestrated/branched EVAR (n=9), and infrarenal EVAR (n=71). Antibiotic was administered for mean 30 weeks. Mean follow-up was 35 months (range 1 week to 149 months). Six patients (5%) were converted to open repair during follow-up. Survival was 91% (95% confidence interval, 86% to 96%), 75% (67% to 83%), 55% (44% to 66%), and 41% (28% to 54%) after 1, 12, 60, and 120 months, respectively. Infection-related death occurred in 23 patients (19%), 9 after discontinuation of antibiotic treatment. A Cox regression analysis demonstrated non-Salmonellapositive culture as predictors for late infection-related death. Conclusions-Endovascular
These data provide robust epidemiologic evidence that heritability contributes to aneurysm formation. Concordances and correlations were higher in MZ compared with DZ twins, indicating genetic effects. There was a 24% probability that an MZ twin of a person with AAA will have the disease. The twin of an MZ twin with AAA had a risk of AAA that was 71 times that of the MZ twin of a person without AAA. A heritability of 70% of the total trait variance was estimated. The remaining variance was explained by nonshared environmental factors with no support for a role of shared environmental influences.
Background There is a concern that civilian gunshot injuries in Europe are increasing but there is a lack of contemporary studies. The purpose of this study was to investigate the current epidemiology and outcome of firearm injuries. Methods Retrospective cohort study of all patients (n = 235) treated for firearm injuries admitted to a Scandinavian trauma center between 2005 and 2016. Local and national trauma registries were used for data collection. Results Mean age was 31.3 years (SD ± 12.9; range 16-88 years); 93.6% males; mean ISS was 14.3 (SD ± 15.9); 31.9% (75/235) had ISS > 15. There was a significant increase in penetrating trauma (P < 0.001) and firearm injuries (P < 0.001) over the years. The most common anatomical location of firearm injury was the lower extremity, (n = 138/235; 38%), followed by the abdomen (n = 69;19%), upper extremity (n = 53;15%), chest (n = 50; 14%), and head and neck (n = 50; 14%). Ninety patients (38.3%) had more than one anatomic injury location. There were in total 360 firearm injuries and 168 major surgical procedures were performed. 53% (n = 125) of patients underwent at least one surgical procedure. The most common procedures were fracture surgery 42% (n = 70/168), followed by laparotomy 30%% (n = 51), chest tube 17% (n = 29), and thoracotomy 11% (n = 18). Forty-one patients (17%) had at least one major vascular injury (n = 54). The most common vascular injury was lower extremity vessel injuries, 26/54 (48%), followed by vessels in chest and abdomen. There was a significant increase in vascular injuries during the study period (P < 0.006). The 30-day mortality was 12.8% (n = 30); 24 patients died within 24 h mainly due to injuries to the chest and the head and neck region. Conclusions Firearm injuries cause significant morbidity and mortality and are an important medical and public health problem. In a Scandinavian trauma center there has been an increase of firearm injuries in recent years. The lower extremities followed by the abdomen are the dominating injured regions and there has been an increase in associated vascular injuries.
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