Comparison of Antithrombotic Treatments After Aortic Valve Replacement. Rivaroxaban: A New Antithrombotic Treatment for Patients With Mechanical Prosthetic Aortic Heart Valve.

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Apr 29, 2014

Keywords

ClinConnect Summary

Background

Although the overall incidence of complications associated with prosthetic cardiac valve implantation has decreased considerably since its introduction more than 3 decades ago, valvular thrombosis and systemic thromboembolism remain a major concern for cardiothoracic surgeons, cardiologists, and other practicing clinicians because of the well-known potential to cause devastating events including ischemic stroke and death.

Factors that contribute to the thrombogenicity of prosthetic heart valves include: altered blood flow and haemostatic activation caused by vessel-wall disrupt...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * All patients receiving a mechanical aortic valve replacement. This includes also the following combined procedures:
• • Coronary artery bypass
• • Composite graft
• • Coronary re-implantation
• • Aortic root, ascending aorta, arch or hemi-arch replacement
• • Redo surgery
• • Aortic root enlargement
• • Three days after end of the primary aortic valve surgery: no mechanical ventilation in the last 12 hours
• • Left ventricular ejection fraction \>/=30% preoperative.
• • Written informed consent
• • Exclusion Criteria
• • Contraindication to Phenprocoumon or rivaroxaban treatment.
• • Premenopausal and fertile women (menopause defined as 1 year free of period)
• • Mitral valve surgery
• • Aneurysmectomy
• • Maze ablation
• • Peripheral vascular surgery
• • Aortic type A or B dissection
• • Patients following mitral valve replacement
• • Patients in need of platelets inhibitors other than Aspirin.
• • Active infective endocarditis
• • Preoperative atrial fibrillation
• • Myocardial infarction or percutaneous coronary intervention within 6 months prior to start of rivaroxaban
• • Stroke within 6 months prior to start of rivaroxaban
• • Systemic embolism within 6 months prior to start of rivaroxaban
• • Severe renal impairment (estimated creatinine clearance ≤30 mL/min)
• * Conditions associated with an increased risk of bleeding within 6 months prior to start of rivaroxaban:
• • Active liver disease, including but not limited to
• • Anemia (hemoglobin level \<85g/L) or thrombocytopenia (platelet count \<100 × 109/L)
• • Women who are pregnant or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study
• • Patients considered unreliable by the investigator