This report is an HTA on drug eluting stents. It is an application of the HTA Core Model for medical and surgical interventions and hence called a “Core HTA”. The aim is to test the model and provide feedback that will be adjusted based on the experiment. Besides the more theoretical work, the Core HTA functions as an example of a future generic report that facilitates information sharing within Europe. The work is based on the HTA Core Model for a generic, transferable HTA report which was developed by the participants in EUnetHTA Work Package 4 (WP4). This model is limited to assessing medical and surgical interventions. It defines and standardises elements of a health technology assessment, providing tools to tackle variation in the structure and contents of HTA reports.
Drug eluting stenting (DES) is a technology indicated in certain patients with coronary artery disease suitable for percutaneous coronary intervention (PCI). Stenting is a quickly evolving field of therapy, where the most recent development has been the addition of slow-release drugs to bare metal stents (BMS). The next generation of bioabsorbable DESs is likely to appear on the market in the near future. A large number of cardiac centers worldwide have been rapid to extend the use of DES beyond the indications proposed by regulatory authorities such as FDA and NHS, and the ―off label‖ use has been extensive. The main reason for extending the indications has been an observed reduction in the rate of restenosis in patients treated with DES compared to those treated with BMS. After a period of widespread use recently published safety data indicating an increased risk of late stent thrombosis in patients treated with DES have led to a more restrictive use in many countries.