Clinical outcomes following implantation of the ION™ paclitaxel-eluting platinum chromium coronary stent in routine clinical practice: Results of the ION U.S. post-approval study.

ABSTRACT

BACKGROUND: The ION Study assessed clinical outcomes for the thin-strut, ION™ (TAXUS Element) Paclitaxel-Eluting Platinum Chromium Coronary Stent System (Boston Scientific, Marlborough, MA) in unselected patients. METHODS: This prospective, open-label registry enrolled the first 1,120 consenting patients treated with the ION stent without clinical or angiographic inclusion criteria at 40 clinical sites. Follow-up was at discharge, 30 days, 180 days, 1 and 2 years. The primary endpoint, the 1-year rate of cardiac death or MI (CD/MI) in PERSEUS-like patients (i.e., patients similar to those enrolled in PERSEUS, the pivotal approval trial), was tested in patients pooled from the ION study (N = 316), the European TAXUS Element post-approval registry (TE-PROVE; N = 306 PERSEUS-like patients), and the PERSEUS WH/SV populations (N = 1,166); and then compared with a prespecified performance goal. Additional outcomes were examined in the overall ION patient population. RESULTS: A total of 1,111 (out of 1,120) enrolled patients received a study stent. Most patients were male (70%) and mean age was 64 years. At 1 year, the primary endpoint of CD/MI occurred in 2.1% (6/292) of PERSEUS-like patients in ION, and 2.3% (40/1,729) of patients in the combined analysis. The upper one-sided 95% confidence interval for the combined analysis was 2.9%, which was significantly less than the performance goal of 7.6% (P < 0.001). Within patients enrolled in the ION study (N = 1,111), the rate of CD/MI was 4.5% at 1 year and 7.5% at 2 years. Definite/probable stent thrombosis occurred in 2.1% of patients at 1 year and 2.5% at 2 years. CONCLUSIONS: The results of the ION Study confirm the mid-term safety and effectiveness of the ION stent for the treatment of coronary artery disease in everyday clinical practice.