Document Detail


Rationale and design of the Patient Related OuTcomes with Endeavor versus Cypher stenting Trial (PROTECT): randomized controlled trial comparing the incidence of stent thrombosis and clinical events after sirolimus or zotarolimus drug-eluting stent implantation.
MedLine Citation:
PMID:  19958855     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Drug-eluting stents (DES) reduce restenosis rates compared to bare-metal stents. Most trials using DES enrolled selected patient and lesion subtypes, and primary endpoint focused on angiographic metrics or relatively short-term outcomes. When DES are used in broader types of lesions and patients, important differences may emerge in long-term outcomes between stent types, particularly the incidence of late stent thrombosis. PROTECT is a randomized, open-label trial comparing the long-term safety of the zotarolimus-eluting stent and the sirolimus-eluting stent. The trial has enrolled 8,800 patients representative of those seen in routine clinical practice, undergoing elective, unplanned, or emergency procedures in native coronary arteries in 196 centers in 36 countries. Indications for the procedure and selection of target vessel and lesion characteristics were at the operator's discretion. Procedures could be staged, but no more than 4 target lesions could be treated per patient. Duration of dual antiplatelet therapy was prespecified to achieve similar lengths of treatment in both study arms. The shortest predefined duration was 3 months, as per the manufacturer's instructions. The primary outcome measure is the composite rate of definite and probable stent thrombosis at 3 years, centrally adjudicated using Academic Research Consortium definitions. The main secondary end points are 3-year all-cause mortality, cardiac death, large nonfatal myocardial infarction, and all myocardial infarctions. This large, international, randomized, controlled trial will provide important information on comparative rates of stent thrombosis between 2 different DES systems and safety as assessed by patient-relevant long-term clinical outcomes.
Authors:
Edoardo Camenzind; William Wijns; Laura Mauri; Eric Boersma; Keyur Parikh; Volkhard Kurowski; Runlin Gao; Christoph Bode; John P Greenwood; Anthony Gershlick; William O'Neill; Patrick W Serruys; Brenda Jorissen; P Gabriel Steg;
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  American heart journal     Volume:  158     ISSN:  1097-6744     ISO Abbreviation:  Am. Heart J.     Publication Date:  2009 Dec 
Date Detail:
Created Date:  2009-12-04     Completed Date:  2010-01-06     Revised Date:  2010-03-03    
Medline Journal Info:
Nlm Unique ID:  0370465     Medline TA:  Am Heart J     Country:  United States    
Other Details:
Languages:  eng     Pagination:  902-909.e5     Citation Subset:  AIM; IM    
Affiliation:
Cardiology Department, University Hospital, Geneva, Switzerland. edoardo@camenzind-cardio.net
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00476957
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MeSH Terms
Descriptor/Qualifier:
Drug-Eluting Stents / adverse effects*
Humans
Incidence
Prosthesis Design
Research Design*
Sirolimus / administration & dosage*,  analogs & derivatives*
Thrombosis / epidemiology*,  etiology*
Chemical
Reg. No./Substance:
0/zotarolimus; 53123-88-9/Sirolimus
Investigator
Investigator/Affiliation:
Edoardo Camenzind / ; Laura Mauri / ; William O'Neill / ; Patrick W Serruys / ; Philippe Gabriel Steg / ; William Wijns / ; F W A Verheugt / ; M E Bertrand / ; R Califf / ; D DeMets / ; L Wallentin / ; J Bosmans / ; C Hanet / ; J-P R Herrman / ; H Kelbaek / ; E Mc Fadden / ; P W Radke / ; Wolfgang RutschC / ; H H Tilsted / ; E Boersma / ; C Alvarez / ; A Rodriguez / ; I Meredith / ; D Muller / ; R Whitbourn / ; S Worthley / ; A Whelan / ; D Walters / ; S Shetty / ; G New / ; S Cox / ; R Batra / ; W van Gaal / ; G Bellamy / ; H Mayr / ; M Heigert / ; K Huber / ; F Leisch / ; W Wijns / ; W Desmet / ; J Boland / ; P Chenu / ; V Legrand / ; M Labinaz / ; P Teefy / ; O Bertrand / ; R Gao / ; J Ge / ; P Kala / ; P Cervinka / ; P Urena / ; J Hartikainen / ; G Steg / ; J Fajadet / ; D Carri? / ; M Gilard / ; P Barragan / ; J-M Lablanche / ; R Koning / ; H Eltchaninoff / ; O Darremont / ; F Leroy / ; B Bertrand / ; G Robert / ; F Schiele / ; S Chassaing / ; P Brunel / ; L Quilliet / ; J Brunet / ; M Pansieri / ; V Stratiev / ; E Teiger / ; H Lebreton / ; J-L Bonnet / ; B Karsenty / ; N Delarche / ; J Cassagnes / ; J Brachmann / ; V Kurowski / ; M Buerke / ; B Schieffer / ; M Wiemer / ; V Sch?chinger / ; P Boekstegers / ; S Genth-Zotz / ; C Bode / ; N Frey / ; F-J Neumann / ; K Pels / ; R Strasser / ; K-H Kuck / ; K-E Hauptmann / ; T Heitzer / ; M Haude / ; E Hoffmann / ; W Jung / ; S Hoffmann / ; C Schmitt / ; M Dissmann / ; M Pauschinger / ; G Werner / ; R Braun-Delleus / ; M Manz / ; V Voudris / ; D Sionis / ; M Kang-Yin / ; T-S Tse / ; B Merkely / ; A Mehta / ; K Parikh / ; P Chandra / ; P Rath / ; S Hiremath / ; G Manoharan / ; P Crean / ; K Daly / ; R Kornowski / ; A Kerner / ; M Mosseri / ; G Jafari / ; P Giudice / ; C Trani / ; A Manari / ; F Prati / ; A Pangrazi / ; L Bolognese / ; M-H Jeong / ; M-H Kim / ; H Kim / ; S-J Park / ; A Erglis / ; A Kalnins / ; D Wagner / ; R Zambahari / ; K Sim / ; P den Heijer / ; Y Appelman / ; M-J Suttorp / ; B de Smet / ; J Koolen / ; P Stella / ; S Harding / ; A Maslowski / ; M Abernethy / ; G Devlin / ; S Rotevatn / ; Y Myreng / ; D Ciecwierz / ; J Peruga / ; K Reczuch / ; R Campante Teles / ; P Farto E Abreu / ; A Leit?o-Marques / ; H Pereira / ; D Vinereanu / ; S Alkasab / ; M Al Kurdi / ; F Al Turki / ; P Wong / ; S Teo / ; F-J Goicolea Ruigomez / ; M Vald?s Ch?varri / ; A Bethencourt Gonzalez / ; A I?iguez Romo / ; J L?pez Minguez / ; J-M Hern?ndez Garc?a / ; J Diaz Fern?ndez / ; R Ruiz Salmeron / ; L Martinez Elbal / ; J Zueco / ; R Lopez-Palop / ; R Melgares / ; O Herterich / ; G Olivencrona / ; O Fr?bert / ; M Roffi / ; G Girod / ; A Vuilliomenet / ; I-C Hsieh / ; C-J Wu / ; A Gershlick / ; C Densem / ; S Doshi / ; P McCarthy / ; M De Belder / ; J Mills / ; F Fath-Ordoubadi / ; I Simpson / ; J Greenwood / ; Z Khan / ; J Cotton / ; M Gunning / ; D Smith / ; S Talwar / ; S Holmberg / ; I Purcell / ; R Anderson / ; F Alamgir / ; K Beatt / ; P Kelly / ; M Moussavian / ; J Aji / ; R Prashad / ; S Banerjee / ; S Lewis / ; B McLauren / ; J Douglas / ; S Brenner / ; A Gupta / ; L Walters / ; M Driesman / ; R Aycock / ; C Mego / ; D Fisher / ; R Frankel / ; L Satler /

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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