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...
The development of coronary stents has represented a revolution in the treatment of coronary heart disease. Beyond their many advantages, stents also have their limitations and complications. Allergic reactions to coronary stents are more common than acknowledged. These stented patients are exposed to foreign substances inserted in direct contact with the coronary intima. Hypersensitivity to stent components and drugs prescribed after stent insertion together with any environmental exposure seem to contribute to these adverse reactions. Patients can present to the hospital with a wide range of symptoms and multiple complications, the most important ones being instent restenosis and stent thrombosis. Although not very common (and not always easy to identify), allergic reactions after coronary or peripheral stents should be taken into account. Careful selection of patients (for elective stent implantation) depending on the propensity to allergies, although hard to achieve, represents a key factor in reducing the number of these complications.
The aim of this study was to evaluate the relation between inflammatory markers and the preatherosclerotic marker - flow mediated dilation (FMD). Thirty obese children (10-16 years old) and twenty controls were involved. The plasma inflammatory markers: CRP, fibrinogen, leptin, TNF-a, IL-6 were measured. Ultrasounds were used for FMD measurement, chemiluminescence for monocyte respiratory burst (RB), ELISA for C peptide and spectrophotometry for usual parameters. In the obese children versus the lean ones, the FMD was lower (p[0.001), the plasma values for TNF-a were similar (1.68 pg/mL vs 1.54 pg/mL), while plasma IL-6 was increased (4.01 pg/mL vs. 2.02 pg/mL, p[0.05). These cytokines were negatively correlated with FMD (r=-0.42, p[0.05) and positively with RB (r=50, p[0.05). The FMD was negatively correlated (p[0.05) with the values for diastolic blood pressure (r = -0.47), waist circumference (r = -0.55), uric acid (r = -0.47) and atherosclerotic index (r = -0.37). In conclusion, in the obese children, inflammation, dyslipidaemia, blood pressure and oxidative stress act in a cluster reducing the elasticity of the vessel walls.
Rationale: Coronary chest pain is usually ischemic in etiology and has various electrocardiographic presentations. Lately, it has been recognized that myocardial bridging (MB) with severe externally mechanical compression of an epicardial coronary artery during systole may result in myocardial ischemia. Such a phenomenon can be associated with chronic angina pectoris, acute coronary syndromes (ACS), coronary spasm, ventricular septal rupture, arrhythmias, exercise-induced atrioventricular conduction blocks, transient ventricular dysfunction, and sudden death. Patient concerns: We report the case of a 58-year-old woman presenting with recurrent episodes of constrictive chest pain during exercise within the last 2 weeks. Except for obesity, general and cardiovascular clinical examination on admission were normal. Diagnoses: The resting 12 lead electrocardiogram (ECG) revealed changes typically for Wellens syndrome. High-sensitive cardiac troponin I was normal. We established the diagnosis of low-risk non-ST-segment elevation acute coronary syndrome with a Global Registry of Acute Coronary Events risk score of 92 points. Interventions: The patient underwent coronary angiography, who showed subocclusive dynamic obstruction of the left anterior descending artery due to MB. Outcomes: The patient was managed conservatively. Her hospital course was uneventful and she was discharged on pharmacological therapy (clopidogrel, bisoprolol, amlodipine, atorvastatin, and metformin) with well-controlled symptoms on followup. Lessons: MB is an unusual cause of myocardial ischemia. Wellens syndrome is an unusual presentation of ACS. We present herein a rare case of Wellens syndrome caused by MB. This case highlights the importance of subtle and frequently overseen ECG findings when assessing patients with chest pain and second, the importance of considering nonatherosclerotic causes for ACS.
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