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The TE-PROVE study was supported by Boston Scientific Corporation.

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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)

Publicado en:EuroIntervention. 10 (11): 1261-1266 - 2015-03-01 10(11), DOI: 10.4244/EIJY15M01_01

Autores: Tamburino, Corrado; Capodanno, Davide; Erglis, Andrejs; Menown, Ian B A; Horvath, Ivan G; Moreno, Raul; Gilbert, Timothy J; Crowley, James J; Calabria, Paolo; Allocco, Dominic J; Dawkins, Keith D

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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.

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