One-year outcomes in unselected patients treated with a thin-strut, platinum-chromium, paclitaxel-eluting stent: primary endpoint results from the TAXUS Element European post-approval surveillance study (TE-PROVE).

AIMS

To evaluate clinical outcomes in patients receiving the next-generation, paclitaxel-eluting, platinum-chromium TAXUS Element stent in a real-world setting. The PERSEUS Workhorse and Small Vessel studies showed positive results with the TAXUS Element stent in a clinical trial setting.

METHODS AND RESULTS

TE-PROVE was a prospective, open-label, multicentre, "all-comers" study which enrolled 1,014 patients at 37 European sites. Follow-up was at 30 days, six months and one year, and will continue annually up to five years. The primary endpoint was overall and stent-related target vessel failure (TVF), defined as cardiac death, target vessel-related myocardial infarction (MI) and target vessel revascularisation (TVR) at one year post implantation. Secondary endpoints included the components of TVF, all-cause mortality, and ARC definite/probable stent thrombosis. Follow-up was available in 97.3% (987/1,014) of patients. Patients were 75.0% male (760/1,014), mean age was 65.1±10.8 years, 25.5% had medically treated diabetes (259/1,014), and 10.7% (109/1,014) were treated for STEMI. At baseline, mean lesion length among 1,299 treated lesions was 19.8±12.0 mm and mean reference vessel diameter was 3.1±0.5 mm. At one year, the rate of TVF (primary endpoint) was 6.0% (59/987) overall; 3.7% (37/987) of TVF events were stent-related. Cardiac death was 0.7% (7/987), target vessel-related MI was 1.1% (11/987), and TVR was 4.7% (46/987). All-cause death occurred in 1.2% (12/987) of patients and ARC definite/probable ST was 0.5% (5/987).

CONCLUSIONS

The primary endpoint results from the TE-PROVE registry demonstrate good performance and safety for the TAXUS Element paclitaxel-eluting stent at one year in everyday clinical practice.

CLINICAL TRIAL REGISTRATION INFORMATION

NCT01242696.