Background The Medical Devices Commission of United Hospitals of Ancona (UHA) was asked to authorise a coronary stent made of steel, coated with bioactive titanium nitride (TITAN 2).
Purpose To consider whether Titan 2 is cost-effective compared to Bare Metal Stents (BMSs) and Drug Eluting Stents (DESs eluting paclitaxel, everolimus or sirolimus) in patients requiring Percutaneous Transluminal Coronary Angioplasty (PTCA).
Materials and methods The commission conducted a cost-effectiveness evaluation of the required stent with BMS and paclitaxel, everolimus and sirolimus-eluting stents. The direct healthcare costs were considered as overlapping, assuming that the only difference was the cost of the devices. Efficacy data were retrieved through a systematic review of the literature intended to provide conclusions with respect to relevant outcomes such as Composite Myocardial Infarction, target lesion revascularisation (TLR) and Major Adverse Cardiovascular Events (MACE).
Results The literature search showed that MACE was less frequent at six months in patients treated with Titan 2 compared to controls treated with BMSs of identical design (7% vs 17%). Based on the initial processed data, Titan 2 did not show a favourable cost-effectiveness ratio (C/E), 914 Euro compared to a BMS C/E of 890 Euro. The commission contacted the medical device distributor and obtained a discount on the price of 2.58%. A favourable C/E for Titan 2 was obtained comparing this stent to paclitaxel-eluting stents for MACE after 2 years of follow-up (11.2% vs 21.8%). This stent has proven cost-effective even with respect to everolimus and sirolimus-eluting stents showing non-inferiority in MACE end point.
Conclusions With the cost-effectiveness analysis conducted comparing with EBM methodology, it has been possible use Titan 2 stents with a discount of 24 Euro compared to the steel stents for patients with allergies to metals and their alloys and they require only a month of dual antiplatelet therapy.
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