rivaroxaban and Chest-Pain

Rivaroxaban is an oral direct factor Xa inhibitor that has been effective in prevention of venous thromboembolism in patients undergoing elective orthopaedic surgery. However, its use after acute coronary syndromes has not been investigated. In this setting, we assessed the safety and efficacy of rivaroxaban and aimed to select the most favourable dose and dosing regimen.. In this double-blind, dose-escalation, phase II study, undertaken at 297 sites in 27 countries, 3491 patients stabilised after an acute coronary syndrome were stratified on the basis of investigator decision to use aspirin only (stratum 1, n=761) or aspirin plus a thienopyridine (stratum 2, n=2730). Participants were randomised within each strata and dose tier with a block randomisation method at 1:1:1 to receive either placebo or rivaroxaban (at doses 5-20 mg) given once daily or the same total daily dose given twice daily. The primary safety endpoint was clinically significant bleeding (TIMI major, TIMI minor, or requiring medical attention); the primary efficacy endpoint was death, myocardial infarction, stroke, or severe recurrent ischaemia requiring revascularisation during 6 months. Safety analyses included all participants who received at least one dose of study drug; efficacy analyses were by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00402597.. Three patients in stratum 1 and 26 in stratum 2 never received the study drug. The risk of clinically significant bleeding with rivaroxaban versus placebo increased in a dose-dependent manner (hazard ratios [HRs] 2.21 [95% CI 1.25-3.91] for 5 mg, 3.35 [2.31-4.87] for 10 mg, 3.60 [2.32-5.58] for 15 mg, and 5.06 [3.45-7.42] for 20 mg doses; p<0.0001). Rates of the primary efficacy endpoint were 5.6% (126/2331) for rivaroxaban versus 7.0% (79/1160) for placebo (HR 0.79 [0.60-1.05], p=0.10). Rivaroxaban reduced the main secondary efficacy endpoint of death, myocardial infarction, or stroke compared with placebo (87/2331 [3.9%] vs 62/1160 [5.5%]; HR 0.69, [95% CI 0.50-0.96], p=0.0270). The most common adverse event in both groups was chest pain (248/2309 [10.7%] vs 118/1153 [10.2%]).. The use of an oral factor Xa inhibitor in patients stabilised after an acute coronary syndrome increases bleeding in a dose-dependent manner and might reduce major ischaemic outcomes. On the basis of these observations, a phase III study of low-dose rivaroxaban as adjunctive therapy in these patients is underway.. Johnson & Johnson Pharmaceutical Research & Development and Bayer Healthcare AG.

Topics: Acute Coronary Syndrome; Administration, Oral; Aspirin; Chest Pain; Dose-Response Relationship, Drug; Double-Blind Method; Drug Therapy, Combination; Female; Hemorrhage; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Morpholines; Myocardial Infarction; Proportional Hazards Models; Pyridines; Recurrence; Risk Reduction Behavior; Rivaroxaban; Safety; Statistics, Nonparametric; Stroke; Thiophenes; Treatment Outcome

BACKGROUND Renal vein thrombosis is uncommon and can be associated with nephrotic syndrome. It is associated with high patient morbidity , and it may lead to thromboembolic event. CASE REPORT A 44-year-old woman presented with shortness of breath, chest pain and tightness, due to bilateral pulmonary embolism originating from right renal vein thrombosis. The diagnosis was made by transthoracic echocardiography and enhanced computed tomography (CT) scan of chest, abdomen, and pelvis. No underlying diseases were found. She was treated with heparin infusion therapy and rivaroxaban with good clinical outcome. CONCLUSIONS A rare case is presented of isolated unilateral right renal vein thrombosis diagnosed following bilateral pulmonary embolism in a previously healthy 44-year-old woman, which was successfully treated with the DOAC, rivaroxaban.

Topics: Adult; Anticoagulants; Chest Pain; Dyspnea; Female; Humans; Pulmonary Embolism; Renal Veins; Rivaroxaban; Tomography, X-Ray Computed; Venous Thrombosis

Stroke is a recognized clinical course of hypertrophic cardiomyopathy. This interesting case showed notable difference on the electrocardiogram of a patient 4 months prior to suffering a stroke and 10 days after suffering a stroke. The pre-stroke electrocardiogram showed atrial fibrillation with a narrow QRS complex, while the post-stroke electrocardiogram showed marked left ventricular hypertrophy. Left ventricular hypertrophy was diagnosed using the Sokolow-Lyon indices. The development of left ventricular hypertrophy a few days after suffering a stroke has not previously been reported.. An 83-year-old white British woman with a background history of permanent atrial fibrillation, hypertension, and previous stroke attended the emergency department with a 2-day history of exertional dyspnea, and chest tightness. On examination, she had bibasal crepitations with a systolic murmur loudest at the apex. In-patient investigations include an electrocardiogram, blood tests, chest X-ray, contrast echocardiogram, coronary angiogram, and cardiovascular magnetic resonance imaging. An electrocardiogram showed atrial fibrillation, with inferolateral T wave inversion, and left ventricular hypertrophy. A chest X-ray showed features consistent with pulmonary edema. A contrast echocardiogram showed marked hypertrophy of the mid to apical left ventricle, appearance consistent with apical hypertrophic cardiomyopathy. Coronary angiography showed eccentric shelf-type plaque with non-flow-limiting stenosis in the left coronary artery main stem. Cardiovascular magnetic resonance imaging reported findings highly suggestive of apical hypertrophic cardiomyopathy. Our patient was treated and discharged on rivaroxaban, bisoprolol, and atorvastatin with a follow-up in the cardiomyopathy outpatient clinic.. Electrocardiogram diagnosis of left ventricular hypertrophy led to the diagnosis of apical hypertrophic cardiomyopathy in this patient. Left ventricular hypertrophy was only evident a few days after our patient suffered a stroke. The underlying mechanisms responsible for this remain unclear. Furthermore, differential diagnosis of hypertrophic cardiomyopathy should be considered in people with electrocardiogram criteria for left ventricular hypertrophy. Cardiovascular magnetic resonance imaging is an important diagnostic tool in identifying causes of left ventricular hypertrophy. Family screening should be recommended in patients with new diagnosis of hypertrophic cardiomyopathy.

Topics: Aged, 80 and over; Antihypertensive Agents; Bisoprolol; Cardiomyopathy, Hypertrophic; Chest Pain; Coronary Angiography; Diagnosis, Differential; Dyspnea; Electrocardiography; Factor Xa Inhibitors; Female; Humans; Hypertrophy, Left Ventricular; Magnetic Resonance Imaging; Rivaroxaban; Stroke; Treatment Outcome

A 77-year-old woman presented to the hospital with symptoms of progressive shortness of breath with associated right-sided pleuritic pain. The patient had begun noting dyspnea on exertion, limiting her ability to go on hikes over the few days prior to admission. Her medical history is significant for carcinoid tumor status postresection in 2012 without recurrence. She has no history of thromboembolism or clotting disorders, and she has no history of smoking or drug abuse. Current medications include amlodipine, celecoxib, hydrochlorothiazide, and rosuvastatin.

Topics: Acute Disease; Aged; Chest Pain; Dyspnea; Echocardiography; Factor Xa Inhibitors; Female; Humans; Pulmonary Veno-Occlusive Disease; Rivaroxaban; Tomography, X-Ray Computed; Venous Thrombosis

Topics: Adult; Antihypertensive Agents; Aspirin; Chest Pain; Coronary Vasospasm; Dyspnea; Humans; Lisinopril; Male; Marijuana Smoking; Metoprolol; Muscle Tonus; Rivaroxaban; Tobacco Smoking; Treatment Outcome; Young Adult

Topics: Aged, 80 and over; Anticoagulants; Chest Pain; Endoscopy, Gastrointestinal; Esophagitis; Female; Humans; Pulmonary Embolism; Rivaroxaban; Tomography, X-Ray Computed; Treatment Outcome; Vomiting

Rivaroxaban is a novel anticoagulant approved for use in patients with atrial fibrillation for stroke prevention. It is a factor Xa inhibitor, and its activity cannot be monitored with use of the international normalized ratio. A 5.6% chance of major bleeding is associated with rivaroxaban use, including intracranial and gastrointestinal bleeds. We report the first case, to our knowledge, of isolated hemopericardium related to rivaroxaban use, which could potentially lead to death from cardiac tamponade. A 76-year-old man who was receiving rivaroxaban for atrial fibrillation presented to the emergency department with pleuritic chest pain and was found to have a hemopericardium. No signs of tamponade were evident, and his bleed remained stable after discontinuing rivaroxaban. The patient had also been taking saw palmetto, which may have contributed to the bleed by increasing rivaroxaban activity. A work-up for other causes of hemopericardium, including pacemaker lead misplacement and autoimmune disease-related pericarditis, was negative. Use of the Naranjo adverse drug reaction probability scale indicated a probable relationship (score of 5) between the patient's development of hemopericardium and rivaroxaban use. This case highlights the potential for bleeding complications associated with novel anticoagulants. Herbal products and various drugs may increase rivaroxaban levels by inhibiting P-glycoprotein and cytochrome P450 3A4 activity. Clinicians should be aware of these potential interactions with rivaroxaban and perform a review of not only the patient's drug therapy but also any herbal and food products that could alter the levels of anticoagulants. The lack of an antidote and the inability to dialyze rivaroxaban is a significant concern in situations of life-threatening bleeds. A laboratory test for monitoring rivaroxaban levels may be required for its safe use.

Topics: Aged; Atrial Fibrillation; Chest Pain; Factor Xa Inhibitors; Humans; Male; Morpholines; Pericardial Effusion; Rivaroxaban; Thiophenes