The comparison with DES is mainly based on a single study
The comparative benefit assessment of DES- and antibody-stents is mainly based on a single study (TRIAS-HR). This was comparatively large - with 600 patients - and the risk of bias was low. Of the 304 patients who had been given an antibody-stent, 13 (4.3%) suffered a myocardial infarction, in comparison with 5 of 318 patients (1.6%) in the control group with DES.
The results for antibody-stents were also less favourable with respect to revascularization: re-operation was necessary for 71 of 297 (23.9%) patients in the antibody-stent group, in comparison with 51 of 315 patients (16.2%) in the DES group. As this conclusion was only based on a single study, IQWiG considers that there is no proof, but only an indication, of lesser benefit. This applies both to the outcome of myocardial infarction and to the outcome of revascularization.
An additional outcome criterion was a composite outcome including myocardial infarction and deaths due to other types of heart failure (cardiac mortality). Here too the results suggest that the antibody-stents are at a disadvantage. However, this is not an indication, but only a hint.
Mechanism of action of antibody-stents is questionable
The manufacturer of the antibody-stent claims that clopidogrel can be administered for a shorter period with their product. This may be of particular importance for patients undergoing surgery, as platelet inhibitors increase the risk of bleeding. Moreover, antibody-stents are supposed to be particularly effective in preventing restenoses in the vessels that are primarily affected.
Jrgen Windeler, the IQWiG Director, commented that, if this was the case, the rate of revascularization in these vessels would be lower. However
|Contact: Anna-Sabine Ernst|
Institute for Quality and Efficiency in Health Care