Stent thrombosis and major clinical events at 3 years after zotarolimus-eluting or sirolimus-eluting coronary stent implantation: a randomised, multicentre, open-label, controlled trial.
Details
Serval ID
serval:BIB_EB3999475963
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Stent thrombosis and major clinical events at 3 years after zotarolimus-eluting or sirolimus-eluting coronary stent implantation: a randomised, multicentre, open-label, controlled trial.
Journal
Lancet
Working group(s)
PROTECT Steering Committee, Investigators
Contributor(s)
Camenzind E., Mauri L., O'Neill W., Serruys PW., Steg PG., Wijns W., Verheugt FW., Bertrand ME., Califf R., DeMets D., Wallentin L., Bocksch W., Bosmans J., Garcia H., Garg S., Hanet C., Herrman JP., Kelbaek H., Mc Fadden E., Radke PW., Rutsch W., Tilsted HH., Wykrzykowska J., Boersma E., Alvarez C., Rodriguez A., Meredith I., Muller D., Whitbourn R., Worthley S., Whelan A., Walters D., Shetty S., New G., Cox S., Batra R., van Gaal W., Bellamy G., Mayr H., Heigert M., Huber K., Leisch F., Wijns W., Desmet W., Boland J., Schroeder E., Chenu P., Legrand V., Labinaz M., Teefy P., Bertrand O., Gao R., Ge J., Kala P., Cervinka P., Ureña P., Hartikainen J., Steg G., Fajadet J., Carrie D., Gilard M., Barragan P., Lablanche JM., Koning R., Eltchaninoff H., Darremont O., Leroy F., Bertrand B., Robert G., Schiele F., Chassaing S., Bressollette E., Brunel P., Quilliet L., Brunet J., Pansieri M., Sideris G., Stratiev V., Teiger E., Lebreton H., Bonnet JL., Karsenty B., Delarche N., Lusson JR., Cassagnes J., Brachmann J., Kurowski V., Buerke M., Schieffer B., Scholtz W., Wiemer M., Goethe JW., Fichtlscherer S., Schächinger V., Kupatt C., Boekstegers P., Genth-Zotz S., Bode C., Frey N., Neumann FJ., Witzenbichler B., Pels K., Strasser R., Kuck KH., Hauptmann KE., Baldus S., Heitzer T., Haude M., Hoffmann E., Jung W., Hoffmann S., Schmitt C., Dissmann M., Pauschinger M., Werner G., Braun-Delleus R., Burkhardt D., Manz M., Voudris V., Sionis D., Kang-Yin ML., Tse TS., Merkely B., Mehta A., Parikh K., Kumar V., Chandra P., Rath P., Hiremath S., Crean P., Daly K., Kornowski R., Kerner A., Mosseri M., Jafari G., Giudice P., Trani C., Manari A., Prati F., Pangrazi A., Bolognese L., Jeong MH., Kim MY., Kim HS., Park SJ., Erglis A., Kalnins A., Wagner D., Zambahari R., Ong TK., Sim K., den Heijer P., Appelman Y., Suttorp MJ., de Smet B., Koolen J., Stella P., Harding S., Warwick J., Maslowski A., Abernethy M., Devlin G., Rotevatn S., Myreng Y., Ciecwierz D., Peruga J., Reczuch K., Campante Teles R., Farto P., Abreu E., Leitão-Marques A., Pereira H., Vinereanu D., Alkasab S., Mhish H., Al Kurdi M., Al Turki F., Wong P., Teo SG., Goicolea Ruigomez FJ. , Valdés Chávarri M., Bethencourt Gonzalez A., Iñiguez Romo A., López Minguez J., Hernández García JM. , Diaz Fernández J., Ruiz Salmeron R., Martinez Elbal L., Zueco J., López-Palop RF., Melgares R., Diderholm E., Kåregren A., Herterich O., Olivencrona G., Fröbert O., Roffi M., Verin V., Girod G., Vuilliomenet A., Hsieh IC., Wu CJ., Gershlick A., Densem C., Doshi S., Manoharan G., McCarthy P., De Belder M., Mills J., Fath-Ordoubadi F., Simpson I., Greenwood J., Chamberlain-Webber R., Khan Z., Cotton J., Gunning M., Smith D., Talwar S., Holmberg S., Purcell I., Anderson R., Alamgir F., Beatt K., Kelly P., Moussavian M., Aji J., Prashad R., Zankar A., Banerjee S., Lewis S., McLaurin B., Douglas J., Brener S., Gupta A., Walters L., Driesman M., Aycock R., Mego C., Fisher D., Frankel R., Satler L.
ISSN
1474-547X (Electronic)
ISSN-L
0140-6736
Publication state
Published
Issued date
2012
Volume
380
Number
9851
Pages
1396-1405
Language
english
Notes
Publication types: Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov'tPublication Status: ppublish. Grégoire Girod fait partie de PROTECT Steering Committee Investigators.
Abstract
BACKGROUND: We sought to compare the long-term safety of two devices with different antiproliferative properties: the Endeavor zotarolimus-eluting stent (E-ZES; Medtronic, Inc) and the Cypher sirolimus-eluting stent (C-SES; Cordis, Johnson & Johnson) in a broad group of patients and lesions.
METHODS: Between May 21, 2007 and Dec 22, 2008, we recruited 8791 patients from 36 recruiting countries to participate in this open-label, multicentre, randomised, superiority trial. Eligible patients were those aged 18 years or older undergoing elective, unplanned, or emergency procedures in native coronary arteries. Patients were randomly assigned to either receive E-ZES and C-SES (ratio 1:1). Randomisation was stratified per centre with varying block sizes of four, six, or eight patients, and concealed with a central telephone-based or web-based allocation service. The primary outcome was definite or probable stent thrombosis at 3 years and was analysed by intention to treat. Patients and investigators were aware of treatment assignment. This trial is registered with ClinicalTrials.gov, number NCT00476957.
FINDINGS: PROTECT randomised 8791 patients, of whom 8709 provided consent to participate and were eligible: 4357 were allocated to the E-ZES group and 4352 patients to the C-SES group. At 3 years, rates of definite or probable stent thrombosis did not differ between groups (1·4% for E-ZES [predicted: 1·5%] vs 1·8% [predicted: 2·5%] for C-SES; hazard ratio [HR] 0·81, 95% CI 0·58-1·14, p=0·22). Dual antiplatelet therapy was used in 8402 (96%) patients at discharge, 7456 (88%) at 1 year, 3041 (37%) at 2 years, and 2364 (30%) at 3 years.
INTERPRETATION: No evidence of superiority of E-ZES compared with C-SES in definite or probable stent thrombosis rates was noted at 3 years. Time analysis suggests a difference in definite or probable stent thrombosis between groups is emerging over time, and a longer follow-up is therefore needed given the clinical relevance of stent thrombosis.
FUNDING: Medtronic, Inc.
METHODS: Between May 21, 2007 and Dec 22, 2008, we recruited 8791 patients from 36 recruiting countries to participate in this open-label, multicentre, randomised, superiority trial. Eligible patients were those aged 18 years or older undergoing elective, unplanned, or emergency procedures in native coronary arteries. Patients were randomly assigned to either receive E-ZES and C-SES (ratio 1:1). Randomisation was stratified per centre with varying block sizes of four, six, or eight patients, and concealed with a central telephone-based or web-based allocation service. The primary outcome was definite or probable stent thrombosis at 3 years and was analysed by intention to treat. Patients and investigators were aware of treatment assignment. This trial is registered with ClinicalTrials.gov, number NCT00476957.
FINDINGS: PROTECT randomised 8791 patients, of whom 8709 provided consent to participate and were eligible: 4357 were allocated to the E-ZES group and 4352 patients to the C-SES group. At 3 years, rates of definite or probable stent thrombosis did not differ between groups (1·4% for E-ZES [predicted: 1·5%] vs 1·8% [predicted: 2·5%] for C-SES; hazard ratio [HR] 0·81, 95% CI 0·58-1·14, p=0·22). Dual antiplatelet therapy was used in 8402 (96%) patients at discharge, 7456 (88%) at 1 year, 3041 (37%) at 2 years, and 2364 (30%) at 3 years.
INTERPRETATION: No evidence of superiority of E-ZES compared with C-SES in definite or probable stent thrombosis rates was noted at 3 years. Time analysis suggests a difference in definite or probable stent thrombosis between groups is emerging over time, and a longer follow-up is therefore needed given the clinical relevance of stent thrombosis.
FUNDING: Medtronic, Inc.
Keywords
Aged, Coronary Artery Disease/pathology, Coronary Artery Disease/therapy, Coronary Restenosis/etiology, Drug-Eluting Stents/adverse effects, Female, Humans, Male, Middle Aged, Sirolimus/administration & dosage, Sirolimus/analogs & derivatives, Thrombosis/etiology
Pubmed
Web of science
Create date
27/02/2013 17:39
Last modification date
20/08/2019 17:13
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