Tuesday, 21. of October 2014
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Early Self Controlled Anticoagulation Trial (ESCAT II)

Lower INR values are possible in aortic valve – and mitral valve replacements

 

“A healing of a valvular heart disease is not possible in most of the cases as the anatomical mutations of the valves are not removable” (Source: Neuer Hausschatz der Heilkunde, 1941).

In 1960 it was the first time when a heart valve was replaced with an artificial ball valve.
During the 80`s the development of good hemodynamic heart valves was put in focus.
And this was the starting point to think about a limitation of the therapeutic range. In the past the typical range was defined with an INR of 2.5-4.5. Due to different clinical studies it was possible to further constrain the range with regard to the type of heart valve replacement and without an increased rate of thromboembolism.
However it is a precondition that an artificial heart valve from a newer generation was implanted.
Among others the artificial heart valves from ST. Jude Medical (bileaflet valve) and Medtronic Hall tilting disc (both were selected for ESCAT II) are appropriate. And of course the possibility of doing Coagulation Self Management is also considered as important precondition.

The ESCAT I (from the Heart and Diabetes Center North Rhine-Westphalia Bad Oyenhausen, Germany) has demonstrated reduced bleeding rates if patients can monitor their INR-values by themselves.
Another result: 80% of the results conducted by them were in the therapeutic range versus only 65% of the INR-values determined by the home physician.

Based on these positive results a second study (ESCAT II) should confirm the possibility of reducing the therapeutic range to INR 1.8-2.8 for prostheses in aortic position and 2.5-3.5 for prostheses in mitral position in combination with a lower oral anticoagulant dosage, without increasing the complication rates.

So far 1.818 patients from different heart centers were enrolled in the ESCAT II – study under the lead of Heinrich Körtke, MD.

Every month the study center received the INR values recorded by the patients themselves. Patients were asked to report any complication immediately.
Also the risk factors (age, weight, body mass index, gender atrial fibrillation, hypertension and diabetes) had to be reported.
All patients were asked to visit the study center for a cardiology check-up every 6 months.
The average age of the patients was 59,7 years. 1.459 had an aortic valve replacement, 271 mitral valve replacement and 86 combined valve replacement.  First interim results of 1.818 patients were presented. 908 were categorized as having low-dose target range, which was INR 1.8 to 2.8 for prostheses in aortic position and 2.5 to 3.5 for prostheses in mitral position or combined valve replacement. The control group with 910 patients aimed at an INR of 2.5-4.5 for all valve positions.
It was interesting that the low-dose patients with a reduced and narrowed INR target range were indeed able to keep 72% of their values within the allowed range. The broader target range of the conventional group was reached in 74.4% of all measurements.
It was obvious that only 8 patients out of the low-dose group suffered from a bleeding event, but 13 from the conventional group.
From each group 3 patients had to face a thromboembolic event.
These interim results from the ESCAT II are really encouraging.
A more narrow therapeutic range with a dosage reduction of oral Anticoagulants in combination with Coagulation Self Management can reduce the rate of possible bleeding events without increasing the thromboembolic risk.

As soon as all data from the 3.300 patients which will be included in the study, will be available and analyzed, the positive results for the heart valve patients will be definitely confirmed.

Christian Schaefer, Ratingen (Germnany)