Anticoagulation Therapy Research
Anticoagulation therapy is recommended for patients with mechanical heart
valves. The American College of Cardiology/American Heart Association and the
American College of Chest Physicians (ACCP) have established guidelines for the
management of patients with prosthetic heart valves. St. Jude Medical
recommends that you consult with your physician about these guidelines and what
anticoagulation regimen is right for you.
St. Jude Medical is committed to improving the quality and convenience of
anticoagulation therapy for patients who receive our mechanical heart valves.
We've taken a multi-faceted approach that includes sponsoring studies to
determine the best anticoagulation regimens, education about patient
self-testing of INR levels and the support of efforts to evaluate alternative
anticoagulation therapies.
Select a link below to jump down the page:
Sponsorship of Prospective Randomized Studies
In recent years, St. Jude Medical has sponsored numerous randomized studies to
determine the safest and most effective anticoagulation treatment plan.
Examples of trials that St. Jude Medical has supported include:
GELIA (German Experience with Low Intensity Anticoagulation) Study:
Results from this trial demonstrated that patients on warfarin therapy can take
a lower dosage of the medication than had previously been standard without
increased risk of blood clots or bleeding complications. Data from this trial
supported the guidelines established by ACCP.
ESCAT (Early Self-Controlled Anticoagulation Trial): This study
evaluated the benefits of patient self-testing of anticoagulation levels, a
measurement expressed as International Normalized Ration (INR). Results from
ESCAT I, the first phase of the trial, showed that patients who use
self-testing devices are more likely to keep their INR levels within their
target range as opposed to patients who do not self-test. Patients who
self-test are also much less likely to experience serious complications. ESCAT
II later demonstrated that patients who self-monitor their INR levels could
safely follow a low-dose anticoagulant regimen. St. Jude Medical continues to
sponsor ongoing ESCAT research.
Advocacy of Patient Self-Testing
 St. Jude
Medical is committed to supporting new treatment strategies, such as INR
self-testing, that increase patient convenience and minimize complications from
warfarin therapy. With a self-testing service such as INR@Home, created by
Raytel Cardiac Services, you can check your own INR levels with a
weekly finger-stick test. The results are communicated directly to the
patient's physician so INR levels can be closely monitored and dosage
adjustments can be made during a brief phone call with their medical team.
Patient self-testing is only available upon a physician's prescription and does
not replace the need for regular follow-up visits with the patient's physician.
Numerous clinical trials have demonstrated that patients who self-test their INR
levels on a regular schedule have fewer anticoagulation-related complications
and stay within their target INR range more frequently than patients who do not
self-test.1 A study published in The Lancet in February 2006 evaluated data
from 14 randomized clinical trials of self-testing. Results demonstrated
significant benefits from self-testing compared with conventional lab testing:
Self-testing reduced the risk of blood clots by 55% and lowered the risk of
major bleeding complications by 35%.2
Although INR self-testing has proven to be highly effective, physician and
patient knowledge about this option is still low. To help increase awareness of
and access to self-testing systems, St. Jude Medical has joined with
Raytel Cardiac Services in the U.S. and with
HemoSense, Inc. in Europe to develop educational campaigns that will
reach the medical community.
1 National Coverage Analysis: Prothrombin Time (INR) Monitor for Home
Anticoagulation Management (#CAG00087N), Sep 18, 2001. Available on the web at:
Centers for Medicare and Medicaid Services U.S. Department of Health and Human
Services https://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=72. Accessed March
1, 2005.
2 Heneghan, C; Alonso-Coello, P; Garcia-Alamino, JM; Perera, R; Meats, E;
Glasziou, P. Self-monitoring of oral anticoagulation: a systematic review and
meta-analysis. Lancet 2006; 367: 404-11
Evaluation of Alternative Anticoagulation
Researchers continue to explore new approaches to safe and effective
anticoagulation. St. Jude Medical provides support for these efforts, such as a
physician-directed study currently underway that is looking at the use of
Plavix (clopidogrel) and aspirin as an alternative anticoagulation therapy with
our mechanical heart valves. While this research is still in its early phases,
St. Jude Medical is committed to providing long-term support for investigation
of alternative anticoagulation agents.
Until there is sufficient data to indicate otherwise, St. Jude Medical
recommends that patients implanted with the St. Jude Medical® mechanical heart
valve be routinely maintained on anticoagulants, unless for other reasons it is
not medically indicated. The ACC/AHA and ACCP have established INR guidelines
for management of patients with prosthetic heart valves. St. Jude Medical makes
no recommendations regarding specific anticoagulation regimens and instead
recommends that patients contact their physician to discuss anticoagulation.
Living Well on Anticoagulant Therapy
If you're considering heart disease treatment options that require long-term use
of anticoagulants (blood thinners), chances are you're asking these important
questions:
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Will I have to radically change my diet?
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Will I be unable to travel?
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Will frequent follow-up visits be necessary?
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Will I have to live my life as though I'm fragile, avoiding physical adventure?
For the great majority of people on anticoagulants, the answer to all of these
questions is a resounding no.
It's true that you may have to make some adjustments to your diet and lifestyle
to ensure that blood thinners work for you. And for a short time after you
begin anticoagulants, you may need frequent visits with your medical team to
establish the right dosage for you. But your doctor will gather details about
the foods and activities that matter most to you, and will tailor a treatment
and check-up program that frees you as quickly and broadly as possible to enjoy
these pleasures. Consider that others on lifelong anticoagulant therapy have
climbed mountains,
run marathons, and completed
70-day bike treks.
Of course, what concerns you most is probably not whether you'll be able to
scale Mt. Everest while taking anticoagulants. Like most people, you likely
just want to continue enjoying daily life to the fullest: Setting a fresh green
salad on the table with the family dinner each night. Teaching your
children-and grandchildren-to swim. Finally booking that dreamed of cruise in
the Mediterranean. All of these things are entirely possible with blood thinner
therapy. In fact, the limits created by anticoagulants pale in comparison to
what's possible with a healthy heart.
Many people on long-term anticoagulant therapy are able to safely and
effectively use self-testing devices. If frequent medical appointments are high
on your list of concerns about anticoagulants, your doctor may determine that a
self-testing device is an option for you. If concerns about diet and lifestyle
changes are causing you to question whether blood thinners are right for you,
start talking with your doctor now about potential solutions. You'll almost
certainly find them. If you choose anticoagulant therapy, the medications won't
define your life. You will continue defining your life.
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