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PROTECT: Final Five Year Results from the Randomized Drug Eluting Stent Trial PROTECT: the Patient Related Outcomes wiTh Endeavor versus Cypher stenting Trial.

ESC Congress 2014 - Hot Line report



 

Presentation

By Edoardo Camenzind, FESC (Nancy, France)
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List of Authors:
Edoardo Camenzind, Ph Gabriel Steg, Laura Mauri, William Wijns for the PROTECT Steering Committee and Investigators

CHU Nancy, Institut Lorrain du Coeur et des Vaisseaux, F54511 Vandoeuvre-Lès-Nancy, France. (E Camenzind MD);
AP-HP, Hôpital Bichat, F75018, Paris, France (Ph G Steg MD);
Harvard Medical School and Brigham and Women’s Hospital, Boston, MA (L Mauri MD);
Cardiovascular Center, OLV Hospital, Aalst, Belgium (W Wijns MD)

Abstract

Aims
To compare the long-term clinical safety between two drug-eluting stents with different healing characteristics in the Patient Related Outcomes with Endeavor (E-ZES) versus Cypher (C-SES) Stenting Trial (PROTECT). At 3 years, there was no difference in the primary outcome of definite or probable stent thrombosis or in the other main secondary clinical outcomes consisting of the composite of death or myocardial infarction. Pre-specified five year clinical follow-up was analysed.
Methods and Results
PROTECT was a prospective, open-label randomized controlled superiority trial powered to look at differences in long-term clinical safety, including stent thrombosis. Dual antiplatelet therapy (DAPT) was prescribed for ≥3 months and up to 12 months based on current guidelines. PROTECT enrolled 8791 patients undergoing elective or emergency PCI to E-ZES or C-SES. There was no difference in DAPT usage between the two groups up to 5 years. At 5 year follow-up, the primary outcome occurred in 1.7% of E-ZES vs. 2.8% of C-SES patients (HR 0.60 [95% CI 0.45–0.81], p=0.0007) (Figure 1 and 2). The composite of all-cause death or large myocardial infarction occurred in 8.2% of E-ZES vs 9.6% of C-SES treated patients (HR 0.85 [95% CI 0.73–0.98], p=0.021) and of all-cause death or all myocardial infarction occurred in 10.8% of E-ZES vs 12.7% of C-SES treated patients (HR 0.85 [95% CI 0.75–0.96], p=0.008) (Figure 3).
Conclusions
Drug-eluting coronary stents with different healing characteristics demonstrated different late safety profiles: after 5 years, compared to C-SES, E-ZES reduced the risk of stent thrombosis and the risk of the composite endpoints of death or myocardial infarction. Appropriately-powered large-scale trials with long term follow-up are critical to determine clinical safety and efficacy of implanted coronary stents.
Reference online ahead of print
PROTECT 4 year result:
Wijns W, Steg PG, Mauri L, Boersma E, Kurowski V, Parikh K, Gao R, Bode C, Greenwood JP, Lipsic E, Alamgir F, Rademaker-Havinga T, Boersma E, Radke P, van Leuwen F, Camenzind E, Committee PS, Investigators. Endeavor zotarolimus-eluting stent reduces stent thrombosis and improves clinical outcomes compared with cypher sirolimus-eluting stent: 4 year results of the PROTECT randomized trial. European Heart Journal doi:10.1093/eurheartj/ehu318

Discussion

By Roxana Mehran, FESC (New York, United States of America)
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References


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SessionTitle:

Clinical Trial Update Hot Line: Infarction, interventions and outcome

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.