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PROTECT: Primary Results from PROTECT: thePatient Related Outcomes with Endeavor versus Cypher Stenting Trial

See the press release:
Munich, Germany – August 27 2012: Rates of stent thrombosis at three years were low and comparable between zotarolimus-eluting and sirolimus-eluting stents, according to findings from the PROTECT study described here today at ESC Congress 2012.
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Presenter: WilliamWijns | see Discussant report

List of Authors: Dr. William Wijns / Belgium
Co-authors: Edoardo Camenzind/Laura Mauri/Volkhard Kurowski/Keyur Parikh/Runlin Gao/Christoph Bode/John P. Greenwood/Eric Boersma/Pascal Vranckx/Eugene McFadden/Patrick W. Serruys/William O’Neill/Brenda Jorissen/Frank van Leeuwen/P. Gabriel Steg
On behalf of the PROTECT Study Investigators

Abstract:

 

Purpose
Differing components (stent, polymer, drug) of drug-eluting stent (DES) platforms impact their efficacy and safety; short-, mid- and long-term. PROTECT was designed to compare the long-term clinical safety of two DES with different vascular healing characteristics: the Endeavor™ zotarolimus-eluting stent (E-ZES) and the Cypher™ sirolimus-eluting stent (C-SES).

Methods
PROTECT, a prospective, multicentre, international, randomised trial enrolled 8.800 patients with obstructive coronary artery disease amenable for stenting of up to 4 lesions at 196 centres around the world between May 2007 and December 2008.  Patients were randomised to receive either E-ZES or C-SES (1:1). The primary endpoint is the 3 year overall rate of definite and probable stent thrombosis (ST) according to ARC. Major secondary endpoints include the following composite events: all death and large myocardial infarction (MI); all death and all MI; cardiac death and large MI, and cardiac death and all MI. A large MI is defined as an acute ST segment elevation MI, or cardiac biomarkers >5 times the ULN, or new Q-waves on ECG. Dual antiplatelet therapy was prescribed for at least 3 months, and up to 12 months based on local DES-specific instructions for use and published guidelines. Details of trial design can be found elsewhere**.  ClinicalTrials.gov. RCT no. NC T00476957.

Results
Baseline characteristics for all patients (E-ZES and C-SES groups combined) were as follows: mean age 62.2±10.6; 76.3% male, 27.2% diabetes, 20.5% prior MI, and 12.5% prior PCI. Acute coronary syndrome (unstable angina or MI) was present in 44.7% of patients. Most (98.2%) lesions were de novo, 46.6% in the left anterior descending artery and the incidence of B2/C lesions was 54.8%. The mean number of lesions treated per patient was 1.4±0.7, with 1.6±1.0 stents implanted per patient.  Follow-up was obtained in more than 95% of all patients. Primary clinical outcomes by randomised groups will be available for presentation for the first time at the ESC 2012 annual congress (data lock scheduled mid-May).

Conclusions
PROTECT is the largest randomised, open label trial comparing two DES, and the only trial to date powered to evaluate ST and clinical events that matter to patient safety late after permanent DES implant. Data from PROTECT are important to the many patients worldwide having received either device and findings are relevant to the long-term tissue biocompatibility of newer generation DES.

** Camenzind E, Wijns W, Mauri L, Boersma E, Parikh K, Kurowski V, Gao R, Bode C, Greenwood JP, Gershlick A, O'Neill W, Serruys PW, Jorissen B, Steg PG; PROTECT Steering Committee and Investigators. 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. Am Heart J. 2009;158:902-909.

 

Discussant: Stephan Windecker | see Presenter abstract

References


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SessionTitle:

Hot Line II: Late Breaking Trials on Interventions

The content of this article reflects the personal opinion of the author/s and is not necessarily the official position of the European Society of Cardiology.