One-year outcomes in unselected patients treated with a thinstrut, platinum-chromium, paclitaxel-eluting stent

Primary endpoint results from the TAXUS Element European postapproval surveillance study (TE-PROVE)

Corrado Tamburino, Davide Capodanno, Andrejs Erglis, Ian B A Menown, I. Horváth, Raul Moreno, Timothy J. Gilbert, James J. Crowley, Paolo Calabria, Dominic J. Allocco, Keith D. Dawkins

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Aims: To evaluate clinical outcomes in patients receiving the next-generation, paclitaxel-eluting, platinumchromium 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, allcause 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.

Original languageEnglish
Pages (from-to)1261-1266
Number of pages6
JournalEuroIntervention
Volume10
Issue number11
DOIs
Publication statusPublished - Mar 1 2015

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Chromium
Paclitaxel
Platinum
Stents
AIDS-Related Complex
Myocardial Infarction
Clinical Trials
Registries
Cause of Death
Thrombosis
Safety
Mortality

Keywords

  • Drug-eluting stent
  • Paclitaxel
  • Platinumchromium

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

One-year outcomes in unselected patients treated with a thinstrut, platinum-chromium, paclitaxel-eluting stent : Primary endpoint results from the TAXUS Element European postapproval surveillance study (TE-PROVE). / Tamburino, Corrado; Capodanno, Davide; Erglis, Andrejs; Menown, Ian B A; Horváth, I.; Moreno, Raul; Gilbert, Timothy J.; Crowley, James J.; Calabria, Paolo; Allocco, Dominic J.; Dawkins, Keith D.

In: EuroIntervention, Vol. 10, No. 11, 01.03.2015, p. 1261-1266.

Research output: Contribution to journalArticle

Tamburino, Corrado ; Capodanno, Davide ; Erglis, Andrejs ; Menown, Ian B A ; Horváth, I. ; Moreno, Raul ; Gilbert, Timothy J. ; Crowley, James J. ; Calabria, Paolo ; Allocco, Dominic J. ; Dawkins, Keith D. / One-year outcomes in unselected patients treated with a thinstrut, platinum-chromium, paclitaxel-eluting stent : Primary endpoint results from the TAXUS Element European postapproval surveillance study (TE-PROVE). In: EuroIntervention. 2015 ; Vol. 10, No. 11. pp. 1261-1266.
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abstract = "Aims: To evaluate clinical outcomes in patients receiving the next-generation, paclitaxel-eluting, platinumchromium 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, allcause 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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T2 - Primary endpoint results from the TAXUS Element European postapproval surveillance study (TE-PROVE)

AU - Tamburino, Corrado

AU - Capodanno, Davide

AU - Erglis, Andrejs

AU - Menown, Ian B A

AU - Horváth, I.

AU - Moreno, Raul

AU - Gilbert, Timothy J.

AU - Crowley, James J.

AU - Calabria, Paolo

AU - Allocco, Dominic J.

AU - Dawkins, Keith D.

PY - 2015/3/1

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N2 - Aims: To evaluate clinical outcomes in patients receiving the next-generation, paclitaxel-eluting, platinumchromium 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, allcause 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.

AB - Aims: To evaluate clinical outcomes in patients receiving the next-generation, paclitaxel-eluting, platinumchromium 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, allcause 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.

KW - Drug-eluting stent

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