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...
Among patients with unstable angina or myocardial infarction without ST-segment elevation, prasugrel did not significantly reduce the frequency of the primary end point, as compared with clopidogrel, and similar risks of bleeding were observed. (Funded by Eli Lilly and Daiichi Sankyo; TRILOGY ACS ClinicalTrials.gov number, NCT00699998.).
BackgroundAtrial fibrillation is associated with higher mortality. Identification of causes of death and contemporary risk factors for all‐cause mortality may guide interventions.Methods and ResultsIn the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) study, patients with nonvalvular atrial fibrillation were randomized to rivaroxaban or dose‐adjusted warfarin. Cox proportional hazards regression with backward elimination identified factors at randomization that were independently associated with all‐cause mortality in the 14 171 participants in the intention‐to‐treat population. The median age was 73 years, and the mean CHADS 2 score was 3.5. Over 1.9 years of median follow‐up, 1214 (8.6%) patients died. Kaplan–Meier mortality rates were 4.2% at 1 year and 8.9% at 2 years. The majority of classified deaths (1081) were cardiovascular (72%), whereas only 6% were nonhemorrhagic stroke or systemic embolism. No significant difference in all‐cause mortality was observed between the rivaroxaban and warfarin arms (P=0.15). Heart failure (hazard ratio 1.51, 95% CI 1.33–1.70, P<0.0001) and age ≥75 years (hazard ratio 1.69, 95% CI 1.51–1.90, P<0.0001) were associated with higher all‐cause mortality. Multiple additional characteristics were independently associated with higher mortality, with decreasing creatinine clearance, chronic obstructive pulmonary disease, male sex, peripheral vascular disease, and diabetes being among the most strongly associated (model C‐index 0.677).ConclusionsIn a large population of patients anticoagulated for nonvalvular atrial fibrillation, ≈7 in 10 deaths were cardiovascular, whereas <1 in 10 deaths were caused by nonhemorrhagic stroke or systemic embolism. Optimal prevention and treatment of heart failure, renal impairment, chronic obstructive pulmonary disease, and diabetes may improve survival.Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT00403767.
RESUMENAntecedentes: El cáncer cérvico uterino es la quinta causa de muerte por cáncer en la mujer chilena. Objetivo: Comparar entre agosto de 1999 y diciembre de 2002 la sobrevida por cáncer cérvico uterino según estadio clínico a 3 y 5 años diagnosticados en la Unidad de Patología Cervical del Hospital San José. Méto-do: La sobrevida se calculó con la totalidad de casos de cáncer cérvico uterinos diagnosticados, su estadio y mortalidad a 3 y 5 años obtenidos a través del Registro Civil de Chile. Resultados: La distribución por estadio fue: 22,2% para estadio I, 21,3% para estadio II, 53,7% para estadio III y 2,7% para estadio IV. En estadio I la sobrevida a 3 años fue de 83% (IC: 61,5 -93,4) y a 5 años de 78% (IC: 55,5 -90,5); en estadio II fue de 65% (IC: 42,4 -80,8) y de 60% (IC: 38,3 -77,4), respectivamente; en estadio III fue de 33% (IC: 21,6 -45,5) y 29% (IC: 18,6 -41,9), respectivamente; y en estadio IV la mortalidad a 3 y 5 años fue de 100% produciéndose el deceso durante los tres primeros meses desde su diagnóstico. Conclusión: La sobrevida se correlaciona directamente con el estadio clínico en el momento del diagnóstico, independiente de la edad de la paciente, debiendo aumentar la cobertura del tamizaje, mejorando los tiempos de confirmación diagnóstica y tratamiento óptimo, como también mejorando los sistemas de redes y registros. The overall survival rate was calculated with the totality of diagnosed cervical cancer, his stage and mortality in 3 and 5 years was obtained through the National Registry Office. Results: The distribution for stage was: 22.2% for stage I, 21.3% for stage II, 53.7% for stage III and 2.7% for stage IV. In stage I the survival at 3 years was 83% (CI: 61.5 -93.4), and at 5 years 78% (CI: 55.5 -90.5). In stage II the survival at 3 years was 65% (CI: 42.4 -80.8) and at 5 years 60% . In stage III the survival at 3 years was 33% (CI: 21.6 -45.5) and at 5 years 29% (CI: 18.6 -41.9). In stage IV the mortality at 3 and 5 years was 100% produced during the first 3 months from the diagnosis. Conclusions: The survival is directly correlative with the clinical stage in the moment of the diagnosis, independent of the age of the patients, by which it must increase the screening coverage, improving the times of diagnostic confirmation and optimum treatment, and also improving the network systems and registries.
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