William Wijns1, Ph Gabriel Steg2, Laura Mauri3, Volkhard Kurowski4, Keyur Parikh5, Runlin Gao6, Christoph Bode7, John P Greenwood8, Erik Lipsic9, Farqad Alamgir10, Tessa Rademaker-Havinga11, Eric Boersma12, Peter Radke13, Frank van Leeuwen14, Edoardo Camenzind15. 1. Cardiovascular Center, OLV Hospital, Aalst, Belgium. 2. Département Hospitalo-Universitaire FIRE, INSERM U-1148, F75018 Paris, France Université Paris-Diderot, Sorbonne-Paris Cité, Paris, France AP-HP, Hôpital Bichat, F75018 Paris, France NHLI Imperial College, ICMS, Royal Brompton Hospital, London, UK. 3. Harvard Medical School and Brigham and Women's Hospital, Boston, MA, USA. 4. Universitätsklinikum Lübeck, Lübeck, Germany. 5. The Heart Care Clinic, Ahmedabad, India. 6. Cardiovascular Institute and Fuwai Hospital, Beijing, China. 7. University Hospital Freiburg, Freiburg im Breisgau, Germany. 8. Leeds General Infirmary, Leeds, UK. 9. University Medical Center Groningen, Groningen, The Netherlands. 10. Castle Hill Hospital, Cottingham, UK. 11. Cardialysis BV, Rotterdam, The Netherlands. 12. Erasmus Medical Center, Rotterdam, The Netherlands. 13. Schön Klinik Neustadt, Neustadt, Germany. 14. Medtronic Bakken Research Center, Maastricht, The Netherlands. 15. University of Geneva, 1 rue Micheli-Servet, Geneva, Switzerland CHU Nancy, Institut Lorrain du Coeur et des Vaisseaux, F54511 Vandoeuvre-lès-Nancy, France edoardo@camenzind-cardio.net.
Abstract
AIMS: To compare the long-term clinical safety between two drug-eluting stents with different healing characteristics in the Patient Related Outcomes with Endeavour (E-ZES) vs. 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 (MI). Prespecified 4-year clinical follow-up was analysed. METHODS AND RESULTS: Patient Related OuTcomes with Endeavour vs. Cypher Stenting Trial 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. Patient Related OuTcomes with Endeavour vs. Cypher Stenting Trial 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 4 years. At 4-year follow-up, the primary outcome occurred in 1.6% of E-ZES vs. 2.6% of C-SES patients [HR 0.63 (95% CI 0.46-0.85), P = 0.003]. The composite of all-cause death or large MI occurred in 6.7% of E-ZES vs. 8.0% of C-SES-treated patients [HR 0.84 (95% CI 0.71-0.98), P = 0.024]. CONCLUSIONS: Drug-eluting coronary stents with different healing characteristics demonstrated different late safety profiles: after 4 years, compared with C-SES, E-ZES reduced the risk of stent thrombosis and the risk of the composite endpoints of death or MI. Appropriately powered large-scale trials with long-term follow-up are critical to determine clinical safety and efficacy of permanently implanted coronary stents. This trial is registered with ClinicalTrials.gov, number NCT00476957. Published on behalf of the European Society of Cardiology. All rights reserved.
RCT Entities:
AIMS: To compare the long-term clinical safety between two drug-eluting stents with different healing characteristics in the Patient Related Outcomes with Endeavour (E-ZES) vs. 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 (MI). Prespecified 4-year clinical follow-up was analysed. METHODS AND RESULTS:Patient Related OuTcomes with Endeavour vs. Cypher Stenting Trial 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. Patient Related OuTcomes with Endeavour vs. Cypher Stenting Trial 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 4 years. At 4-year follow-up, the primary outcome occurred in 1.6% of E-ZES vs. 2.6% of C-SESpatients [HR 0.63 (95% CI 0.46-0.85), P = 0.003]. The composite of all-cause death or large MI occurred in 6.7% of E-ZES vs. 8.0% of C-SES-treated patients [HR 0.84 (95% CI 0.71-0.98), P = 0.024]. CONCLUSIONS: Drug-eluting coronary stents with different healing characteristics demonstrated different late safety profiles: after 4 years, compared with C-SES, E-ZES reduced the risk of stent thrombosis and the risk of the composite endpoints of death or MI. Appropriately powered large-scale trials with long-term follow-up are critical to determine clinical safety and efficacy of permanently implanted coronary stents. This trial is registered with ClinicalTrials.gov, number NCT00476957. Published on behalf of the European Society of Cardiology. All rights reserved.
Authors: Laura Mauri; Dean J Kereiakes; Robert W Yeh; Priscilla Driscoll-Shempp; Donald E Cutlip; P Gabriel Steg; Sharon-Lise T Normand; Eugene Braunwald; Stephen D Wiviott; David J Cohen; David R Holmes; Mitchell W Krucoff; James Hermiller; Harold L Dauerman; Daniel I Simon; David E Kandzari; Kirk N Garratt; David P Lee; Thomas K Pow; Peter Ver Lee; Michael J Rinaldi; Joseph M Massaro Journal: N Engl J Med Date: 2014-11-16 Impact factor: 91.245