A novel ultra-thin bare metal stent (BMS): results from a worldwide registry

AIMS: To evaluate a new generation, thin strut, stainless steel Tsunami coronary stent in a contemporary percutaneous coronary intervention (PCI) practice across a wide geographical area. METHODS AND RESULTS: Patients (n=1,437) with single or multiple vessel coronary artery disease undergoing PCI in 82 sites in Europe, Asia, and Australia were enrolled in the MATSURI registry. Clinical follow-ups were scheduled at 1, 6 and 18 months. Primary endpoint was major adverse cardiac events (MACE) rate at 6 months. Diabetes was present in 25% of patients, 40% had unstable angina, 54% multivessel disease and 31% previously underwent PCI/CABG. Procedural success was achieved in 98.1% of patients. MACE rate was 1.8%, 7.3%, and 12.6% for 1, 6 and 18 month follow-up, respectively. At 6 months, the incidence of cardiac death, MI and TLR were 1%, 1.9% and 4.5% respectively, and confirmed stent thrombosis occurred in 0.2% of patients. Lower risk patients (43% of registry population) had six months MACE free survival of 96.7%. CONCLUSIONS: Based on the results of this large registry we can conclude that the Tsunami BMS combines excellent deliverability and safety for all, together with very low MACE rates for lower risk patients. Long term follow-up confirmed sustained clinical benefit.