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Clinical research

One year clinical follow-up of the XIENCE V Everolimus-eluting stent system in the treatment of patients with de novo native coronary artery lesions: the SPIRIT II study

Aims: The SPIRIT II study randomised 300 patients in a ratio of 3:1 to receive either a XIENCE V or a TAXUS stent. The six month clinical and angiographic results have previously been reported. This paper presents the clinical follow-up of these patients to one year.

Methods and results: As a continuation in the assessment of the safety and performance of the XIENCE V Everolimus-Eluting Coronary Stent System (EECSS) enrolled patients were requested to return for clinical follow-up one year following the procedure to assess the occurrence of ischaemia driven major adverse cardiac events (MACE).

Of the 300 patients recruited at 28 sites in Europe, New Zealand and India, 223 were randomised to receive an EECSS stent and 77 a TAXUS paclitaxel eluting coronary stent system (PECSS). One-year clinical follow-up was obtained in 220 of the 223 patients in the EECSS group (98.7%) with one withdrawal prior to 180 days and two non-cardiac deaths (pulmonary malignancy and pneumonia) between six and 12 months, and in 76 of 77 (98.7%) PECSS group of patients (one patient had a missed 270-day and 1-year visit). Between six and 12 months there were no new occurrences of late stent thrombotic events in either group. There were no additional MACE events in the EECSS compared to, two, both ischaemia driven target lesion revascularisations (TLR) in the PECSS group.

Conclusions: The clinical safety of the XIENCE V EECSS stent observed at six months was sustained at one year. There were no additional thrombotic or MACE events in the EECSS group. Although not a primary endpoint, there was a significant difference in MACE favouring the EECSS compared to PECSS (2.7% versus 9.2%, P=0.04).

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