Navigation Links
Low-dose anticoagulation therapy can be used safely with new design mechanical heart valve
Date:5/15/2014

Beverly, MA, May 15, 2014 Less aggressive anticoagulation therapy, combined with low-dose aspirin, can be used safely in conjunction with a newer generation mechanical heart valve. These findings from the first phase of a randomized clinical trial are published in The Journal of Thoracic and Cardiovascular Surgery, an official publication of the American Association for Thoracic Surgery.

Patients under 65 years of age requiring heart valve replacement have had to choose between a mechanical valve that may last a lifetime but requires aggressive anti-clotting treatment with warfarin, and a biological (cow or pig) valve that does not require warfarin treatment but will need replacement in 10-20 years. Aggressive anti-clotting treatment is accompanied by significant risk of bleeding, while inadequate treatment can result in an increased incidence of stroke.

Therefore, the choice between valve types for physicians and patients narrows to one of avoidance of the risk, pain, and costs of reoperation for valve obsolescence versus avoidance of the lifetime composite risk of bleeding and thromboembolism and the nuisance of ongoing anticoagulation management. Both valve types can develop complications which, although rare, can result in reoperation, stroke, or death.

The US Food and Drug Administration (FDA) approved a randomized trial to test the safety of less aggressive anti-clotting treatment than the American Heart Association/American College of Cardiology guidelines currently recommend, in patients implanted with a newer generation On-X heart valve. "This is a bileaflet mechanical valve approved by the FDA, which is designed to function with less anticoagulation, or in some cases, antiplatelet therapy only," explains John D. Puskas, MD, Professor of Cardiothoracic Surgery at the Icahn School of Medicine at Mount Sinai, and Chairman of the Department of Cardiothoracic Surgery, Mount Sinai Beth Israel, New York, NY.

In this first phase of the three-phase Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT), conducted under an FDA investigational device exemption, 375 aortic valve replacement patients with elevated risk factors for clotting were randomized into control (190) and test (185) groups from September 2006 to December 2009 at 33 US centers. Patients in the control group received standard treatment of warfarin to maintain a target range of the International Normalized Ratio (INR) of 2.0-3.0. Patients in the treatment group received low-dose warfarin, targeting an INR of 1.5-2.0, after an initial 90 postoperative days of standard therapy. All patients received 81 mg aspirin daily.

The patients were followed up by in-person visits at three months, six months, and one year after surgery and then annually for between five and eight postoperative years to accrue the necessary 800 patient-years of follow-up mandated by the FDA. During these visits, electrocardiography or echocardiography was performed as required by the protocol and as clinically indicated. All patients maintained with warfarin therapy were followed up using weekly home INR testing through a central telephone or online database.

"The results show that anticoagulation may be safely reduced in patients following aortic valve replacement with this approved bileaflet mechanical prosthesis," says Dr. Puskas. "INR can be safely maintained between 1.5 and 2.0. With low-dose aspirin, this resulted in a significantly lower risk of bleeding, without a significant increase in thromboembolism. In high-risk recipients of On-X valves, the INR should be assiduously kept above 1.5 to maximize the safety and effectiveness of this therapeutic change," he concludes.

The investigators caution that results from the present trial should not be extrapolated to other prostheses, mechanical mitral valve replacements, or patients undergoing double aortic valve/mitral valve replacement. The present standard of care for all mechanical AVR patients outside the PROACT study remains conventional anticoagulation, as indicated by the American Heart Association/American College of Cardiology guidelines.

Two further phases of PROACT are planned. The second will be used to compare current anticoagulant therapy versus aspirin and/or clopidogrel only in selected lower risk patients requiring atrial valve replacement. The third will compare standard anticoagulation therapy versus INR goal of 2 to 2.5 in patients requiring mitral valve replacement.


'/>"/>

Contact: Nicole Baritot
press@aats.org
978-299-4520
American Association for Thoracic Surgery
Source:Eurekalert

Related medicine news :

1. Low-dose whole-body CT finds disease missed on standard imaging for patients with multiple myeloma
2. Low-dose CT screening may benefit individuals at increased risk for lung cancer
3. Maturitas publishes clinical guide on low-dose vaginal estrogens for vaginal atrophy
4. Resistance to low-dose aspirin therapy extremely rare
5. Low-Dose Pill Linked to Pain During Orgasm, Study Finds
6. Low-dose anticoagulation therapy used with new design mechanical heart valve lowers bleeding risk
7. Study Supports Using Low-Dose CT Scans to Spot Early Lung Cancer
8. Daily Low-dose Aspirin Can Prevent Heart Attack and Stroke But is Often Misused, from the January 2014 Harvard Heart Letter
9. North Shore-LIJ Completes Last Phase of $50M Upgrade of its Diagnostic Imaging Systems, $12M for GE Low-Dose CT Scanners to Reduce Patients’ Radiation Exposure
10. One-quarter of high risk patients denied anticoagulation after AF ablation
11. KRAS gene mutation and amplification status affects sensitivity to antifolate therapy
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/2/2016)... , ... May 02, 2016 , ... Pregnancy Awareness Month ... trying to conceive. , “If you are ready to have a baby, ... “My book, HealthChequesTM: Journal Babies is your Personal Conception & Pregnancy Organizer, written ...
(Date:5/2/2016)... (PRWEB) , ... May 02, 2016 , ... ... division of Permobil, recently completed two groundbreaking studies that determined that the adjustability ... – are critical in the prevention of pressure injuries, which are now referred ...
(Date:5/2/2016)... ... May 02, 2016 , ... Atlantic Information Services, Inc. (AIS) is pleased ... Model Could Transform the Pharma Landscape .” CMS recently proposed a test of alternate ... provider-administered drugs while preserving care provided to beneficiaries. The webinar will review the details ...
(Date:5/2/2016)... ... , ... The Evolve Paddle Board Company- which specializes in the production and ... their partnership with Yoloha Yoga- producers of high quality cork yoga mats. Together they ... seen a dramatic rise in popularity throughout the last few years. The makers of ...
(Date:5/2/2016)... ... May 02, 2016 , ... Summit BHC (Summit), a leading ... Twin Lakes Recovery Center. Located east of Atlanta in Monroe, Georgia, the ... residential facility is set on 34 acres of beautiful, secluded property that will ...
Breaking Medicine News(10 mins):
(Date:4/28/2016)... , Net Sales of $1.90 billion represent an increase of ... and an increase of 1.2% on an adjusted pro forma, ... quarter were $0.52 reported, a decrease of 47.5% from the ... over the prior year period , The Company increases ... Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH) today ...
(Date:4/28/2016)... , April 28, 2016  ValGenesis, Inc., ... Management Solutions (VLMS) today announced that a ... for sufferers of chronic kidney failure has ... manage their corporate validation process. The global ... software solution to manage their validation processes ...
(Date:4/27/2016)... April 27, 2016 ... Forums in Zürich gab Strekin AG den ... STR001 zur Erhaltung des Resthörvermögens von Patienten, ... Für die umfassende Phase-II-Doppelblindstudie mit Placebo-Kontrollgruppe werden ... STR001 wird während der Operation direkt ins ...
Breaking Medicine Technology: