I will be greatly anticipating the results of those studies.
"You have no rights what so ever with respect to studies done by private institutions"
It would be in there best interest to be as transparent as they can. Transparency leads to trust. . The lack of information and proper statistics can allow people to jump to there own true or untrue conclusions. This can lead to misconception. I geuss I will have to be a good little hamster and patiently wait for the results.
It is nice they are sharing preliminary information but need to wait for full results.
"When the study in Germany was closed to focus on the current larger USA trial "They will release the full study when it is done."
In 2010.
These two statement concradict each other.
"It is nice they are sharing preliminary information"
What have they really shared "that selectd patients were successfull on aspirin only trials and aspirin only group were not significantly statistically different from the Coumadin group." What we know is a new trial isstarting using aspirin and plavix. I fish in cloudy waters, sometimes I don't know what I will catch.
So IF you like playing detective and finding clues and coming up with your own conclusions ... and as always this is JUST MY opionion, and I'm not a medical professional, just a mom, but..
It is pretty hard to get the extact info on the now stopped trial, but as you said, when they started the trial in the US, following the German aspirin only trial, they did not put an aspirin only leg to the trial. There are a couple German studies with the same doctors about their experience with the ON-X that might give a little insight. Since they are one of the first (or first?) /longest center that has used the ON-X, that make me think there is a reason for that. Altho noone comes right out and says it and as you said you can't find the actual numbers, so you have to use your common sense. I would THINK that IF the German trial was going as well as they hoped they would not have close it to "focus on the larger US trial" since many trials can go on at the same time and this was already set up, had patients on it, data ect and IF the aspirin only trial was allowed to continue it would have been wonderful IF it showed aspirin only was safe. They had a couple newsletters about this trial, but they seemed to have stopped and i couldn't find any after #3
http://atamed.com/Clinical Update No 3.pdf
I know in the (now stopped) German trial the first year, after someone died they suspended the trial and changed who was allowed to be in it (from Robins thread )
http://www.valvereplacement.org/forums/archive/index.php/t-9951.html It doesn't say how many people were in it, (the goal was 100 according to the on-x newsletters) but after 1 year they had 15 patient years of result and the patients were on it from 6-13 month
"The study currently has a total patient experience of 15 pt/yrs, the first patient being placed on the aspirin protocol 13 months ago. Trends from the study will start to be apparent at 100 pt/yrs of experience, which should be achieved within the next 12 to 18 months.
Except for one adverse event (described below), all other patients have been on aspirin-only for a mean follow-up of 7.5 ± 2.9 (range: 6 to 13) months. Of the patients enrolled under the updated exclusion criteria survival is 100 percent, transthoracic echo (TTE) shows normally functioning On-X valves in all patients, and mean LDH is 234 ± 22 (normal: <240) U/l. Of all patients enrolled since initiation of the aspirin study, survival is 95.2%. One aspirin-only patient with carotid atherosclerosis had a minor transient ischemic attack (TIA) lasting only a few minutes at six weeks follow-up. Other than this patient and the one described below, there have been no additional thromboembolic events, valve thromboses or other complications.
Adverse Event
The only serious adverse patient event occurred in April of 2004 wherein a patient died. By protocol, the study was placed in a state of ?suspension,? meaning that no additional patients could be entered into the study. Patients already converted to the aspirin-only protocol were informed of the event, given additional instruction in compliance to the protocol and required to sign an additional informed consent agreement in order to remain in the study.
After reviewing the facts relating to the event, the Data and Safety Monitoring Committee (DSMC) of the On-X Aortic Valve Aspirin Study recommended continuation of the study subject to the same ethics committee reviews and re-approvals. Having fully investigated the adverse event, the immediately involved hospital ethics committee has determined that the study may be resumed. The study was modified to exclude patients with potentially complicating conditions similar to those in the patient who died, including the exclusion of patients with permanent pacemakers and those with a combination of other conditions that may predispose them to coagulation related complications. In addition, more frequent monitoring of the patients was instituted."
As for the other studies by this same group, IF you can get the entire article for "Single-Center Experience with the On-X Prosthetic Heart Valve between 1996 and 2005" - Tossios,\ P, Reber D, Oustria M, Holland-Letz T, Germing A, Buchwald D, Laczkovics A.
Department of Cardiothoracic Surgery, BG Universitätsklinikum Bergmannsheil, University of Bochum, Bochum, Germany. (pubmed has the abstract) it might be helpful to read.
It is by the same center/investigator/surgeons as the aspirin trial and includes the years the aspirin trial was going on. (at least some of them I don't know when the trial was stopped) They were using it for 10 years and had 428 patients recieve the ON-X
the results were RESULTS: Early mortality (< or = 30 days) was 3.7% after AVR and 14.0% after MVR, with valve-related mortality rates of 0.4% and 1.2%, respectively. At autopsy (n = 12) all implants were intact. Freedom from valve-related death at nine years was 85.0 +/- 3.9% after AVR and 87.6 +/- 3.2% after MVR. The overall survival rate was 67.9 +/- 4.3% after AVR and 52.7 +/- 8.1% after MVR. The linearized rate of thromboembolism for AVR and MVR was 1.49%/pt-yr and 1.61%/pt-yr; of thrombosis 0%/pt-yr and 0.35%/pt-yr; of hemorrhage 0.93%/pt-yr and 1.43%/pt-yr; of endocarditis 0.37%/pt-yr and 0.17%/pt-yr; of non-structural failure 0.18%/pt-yr and 1.43%/pt-yr; and of reoperation 0.28%/pt-yr and 0.53%/pt-yr. There were no cases of structural valve failure. CONCLUSION: After almost one decade of clinical experience in a single center, the On-X heart valve continues to be reliable and effective.
I can not find a free place to read the fulltext, but I have read quotes from the discussion (one was from a competitors site and in an old thread here)
“Inadequate or stopped anticoagulation, or low levels of anticoagulation, also rendered patients with an On-X valve prone to thromboembolic complications.” so to ME it looks like it didn't go all that well for aspirin only
