Journal article
Comparison of zotarolimus- and everolimus-eluting coronary stents: final 5-year report of the RESOLUTE all-comers trial.
- Iqbal J From the Department of Interventional Cardiology, Erasmus Medical Centre, Rotterdam, The Netherlands (J.I., P.W.S.); Department of Cardiovascular Science, University of Sheffield, UK (J.I.); International Centre for Circulatory Health, Imperial College London, London, UK (P.W.S.); Department of Cardiology, Heart Centre at the Isar, Munich, Germany (S.S.); Righshospitalet, The Heart Center, Copenhagen, Denmark (H.K.); Herzzentrum der Segeberger Kliniken, Bad Segeberg, Germany (G.R.); Cardialysis BV, Rotterdam, The Netherlands (M.-A.M.); Medtronic, Santa Rosa, CA (M.N.); Department of Cardiology, Medical University of Silesia, Katowice, Poland (P.E.B.); and Department of Cardiology, Bern University Hospital, Bern, Switzerland (S.W.).
- Serruys PW From the Department of Interventional Cardiology, Erasmus Medical Centre, Rotterdam, The Netherlands (J.I., P.W.S.); Department of Cardiovascular Science, University of Sheffield, UK (J.I.); International Centre for Circulatory Health, Imperial College London, London, UK (P.W.S.); Department of Cardiology, Heart Centre at the Isar, Munich, Germany (S.S.); Righshospitalet, The Heart Center, Copenhagen, Denmark (H.K.); Herzzentrum der Segeberger Kliniken, Bad Segeberg, Germany (G.R.); Cardialysis BV, Rotterdam, The Netherlands (M.-A.M.); Medtronic, Santa Rosa, CA (M.N.); Department of Cardiology, Medical University of Silesia, Katowice, Poland (P.E.B.); and Department of Cardiology, Bern University Hospital, Bern, Switzerland (S.W.). patrick.w.j.c.serruys@gmail.com.
- Silber S From the Department of Interventional Cardiology, Erasmus Medical Centre, Rotterdam, The Netherlands (J.I., P.W.S.); Department of Cardiovascular Science, University of Sheffield, UK (J.I.); International Centre for Circulatory Health, Imperial College London, London, UK (P.W.S.); Department of Cardiology, Heart Centre at the Isar, Munich, Germany (S.S.); Righshospitalet, The Heart Center, Copenhagen, Denmark (H.K.); Herzzentrum der Segeberger Kliniken, Bad Segeberg, Germany (G.R.); Cardialysis BV, Rotterdam, The Netherlands (M.-A.M.); Medtronic, Santa Rosa, CA (M.N.); Department of Cardiology, Medical University of Silesia, Katowice, Poland (P.E.B.); and Department of Cardiology, Bern University Hospital, Bern, Switzerland (S.W.).
- Kelbaek H From the Department of Interventional Cardiology, Erasmus Medical Centre, Rotterdam, The Netherlands (J.I., P.W.S.); Department of Cardiovascular Science, University of Sheffield, UK (J.I.); International Centre for Circulatory Health, Imperial College London, London, UK (P.W.S.); Department of Cardiology, Heart Centre at the Isar, Munich, Germany (S.S.); Righshospitalet, The Heart Center, Copenhagen, Denmark (H.K.); Herzzentrum der Segeberger Kliniken, Bad Segeberg, Germany (G.R.); Cardialysis BV, Rotterdam, The Netherlands (M.-A.M.); Medtronic, Santa Rosa, CA (M.N.); Department of Cardiology, Medical University of Silesia, Katowice, Poland (P.E.B.); and Department of Cardiology, Bern University Hospital, Bern, Switzerland (S.W.).
- Richardt G From the Department of Interventional Cardiology, Erasmus Medical Centre, Rotterdam, The Netherlands (J.I., P.W.S.); Department of Cardiovascular Science, University of Sheffield, UK (J.I.); International Centre for Circulatory Health, Imperial College London, London, UK (P.W.S.); Department of Cardiology, Heart Centre at the Isar, Munich, Germany (S.S.); Righshospitalet, The Heart Center, Copenhagen, Denmark (H.K.); Herzzentrum der Segeberger Kliniken, Bad Segeberg, Germany (G.R.); Cardialysis BV, Rotterdam, The Netherlands (M.-A.M.); Medtronic, Santa Rosa, CA (M.N.); Department of Cardiology, Medical University of Silesia, Katowice, Poland (P.E.B.); and Department of Cardiology, Bern University Hospital, Bern, Switzerland (S.W.).
- Morel MA From the Department of Interventional Cardiology, Erasmus Medical Centre, Rotterdam, The Netherlands (J.I., P.W.S.); Department of Cardiovascular Science, University of Sheffield, UK (J.I.); International Centre for Circulatory Health, Imperial College London, London, UK (P.W.S.); Department of Cardiology, Heart Centre at the Isar, Munich, Germany (S.S.); Righshospitalet, The Heart Center, Copenhagen, Denmark (H.K.); Herzzentrum der Segeberger Kliniken, Bad Segeberg, Germany (G.R.); Cardialysis BV, Rotterdam, The Netherlands (M.-A.M.); Medtronic, Santa Rosa, CA (M.N.); Department of Cardiology, Medical University of Silesia, Katowice, Poland (P.E.B.); and Department of Cardiology, Bern University Hospital, Bern, Switzerland (S.W.).
- Negoita M From the Department of Interventional Cardiology, Erasmus Medical Centre, Rotterdam, The Netherlands (J.I., P.W.S.); Department of Cardiovascular Science, University of Sheffield, UK (J.I.); International Centre for Circulatory Health, Imperial College London, London, UK (P.W.S.); Department of Cardiology, Heart Centre at the Isar, Munich, Germany (S.S.); Righshospitalet, The Heart Center, Copenhagen, Denmark (H.K.); Herzzentrum der Segeberger Kliniken, Bad Segeberg, Germany (G.R.); Cardialysis BV, Rotterdam, The Netherlands (M.-A.M.); Medtronic, Santa Rosa, CA (M.N.); Department of Cardiology, Medical University of Silesia, Katowice, Poland (P.E.B.); and Department of Cardiology, Bern University Hospital, Bern, Switzerland (S.W.).
- Buszman PE From the Department of Interventional Cardiology, Erasmus Medical Centre, Rotterdam, The Netherlands (J.I., P.W.S.); Department of Cardiovascular Science, University of Sheffield, UK (J.I.); International Centre for Circulatory Health, Imperial College London, London, UK (P.W.S.); Department of Cardiology, Heart Centre at the Isar, Munich, Germany (S.S.); Righshospitalet, The Heart Center, Copenhagen, Denmark (H.K.); Herzzentrum der Segeberger Kliniken, Bad Segeberg, Germany (G.R.); Cardialysis BV, Rotterdam, The Netherlands (M.-A.M.); Medtronic, Santa Rosa, CA (M.N.); Department of Cardiology, Medical University of Silesia, Katowice, Poland (P.E.B.); and Department of Cardiology, Bern University Hospital, Bern, Switzerland (S.W.).
- Windecker S From the Department of Interventional Cardiology, Erasmus Medical Centre, Rotterdam, The Netherlands (J.I., P.W.S.); Department of Cardiovascular Science, University of Sheffield, UK (J.I.); International Centre for Circulatory Health, Imperial College London, London, UK (P.W.S.); Department of Cardiology, Heart Centre at the Isar, Munich, Germany (S.S.); Righshospitalet, The Heart Center, Copenhagen, Denmark (H.K.); Herzzentrum der Segeberger Kliniken, Bad Segeberg, Germany (G.R.); Cardialysis BV, Rotterdam, The Netherlands (M.-A.M.); Medtronic, Santa Rosa, CA (M.N.); Department of Cardiology, Medical University of Silesia, Katowice, Poland (P.E.B.); and Department of Cardiology, Bern University Hospital, Bern, Switzerland (S.W.).
- 2015-06-07
Published in:
- Circulation. Cardiovascular interventions. - 2015
drug-eluting stent
everolimus
percutaneous coronary interventions
zotarolimus
Aged
Antineoplastic Agents
Drug-Eluting Stents
Everolimus
Female
Follow-Up Studies
Humans
Male
Middle Aged
Percutaneous Coronary Intervention
Sirolimus
Treatment Outcome
English
BACKGROUND
Newer-generation drug-eluting stents that release zotarolimus or everolimus have been shown to be superior to the first-generation drug-eluting stents. However, data comparing long-term safety and efficacy of zotarolimus- (ZES) and everolimus-eluting stents (EES) are limited. RESOLUTE all-comers (Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention) trial compared these 2 stents and has shown that ZES was noninferior to EES at 12-month for the primary end point of target lesion failure. We report the secondary clinical outcomes at the final 5-year follow-up of this trial.
METHODS AND RESULTS
RESOLUTE all-comer clinical study is a prospective, multicentre, randomized, 2-arm, open-label, noninferiority trial with minimal exclusion criteria. Patients (n=2292) were randomly assigned to treatment with either ZES (n=1140) or EES (n=1152). Patient-oriented composite end point (combination of all-cause mortality, myocardial infarction, and any revascularizations), device-oriented composite end point (combination of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization), and major adverse cardiac events (combination of all-cause death, all myocardial infarction, emergent coronary bypass surgery, or clinically indicated target lesion revascularization) were analyzed at 5-year follow-up. The 2 groups were well-matched at baseline. Five-year follow-up data were available for 98% patients. There were no differences in patient-oriented composite end point (ZES 35.3% versus EES 32.0%, P=0.11), device-oriented composite end point (ZES 17.0% versus EES 16.2%, P=0.61), major adverse cardiac events (ZES 21.9% versus EES 21.6%, P=0.88), and definite/probable stent thrombosis (ZES 2.8% versus EES 1.8%, P=0.12).
CONCLUSIONS
At 5-year follow-up, ZES and EES had similar efficacy and safety in a population of patients who had minimal exclusion criteria.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00617084.
Newer-generation drug-eluting stents that release zotarolimus or everolimus have been shown to be superior to the first-generation drug-eluting stents. However, data comparing long-term safety and efficacy of zotarolimus- (ZES) and everolimus-eluting stents (EES) are limited. RESOLUTE all-comers (Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention) trial compared these 2 stents and has shown that ZES was noninferior to EES at 12-month for the primary end point of target lesion failure. We report the secondary clinical outcomes at the final 5-year follow-up of this trial.
METHODS AND RESULTS
RESOLUTE all-comer clinical study is a prospective, multicentre, randomized, 2-arm, open-label, noninferiority trial with minimal exclusion criteria. Patients (n=2292) were randomly assigned to treatment with either ZES (n=1140) or EES (n=1152). Patient-oriented composite end point (combination of all-cause mortality, myocardial infarction, and any revascularizations), device-oriented composite end point (combination of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization), and major adverse cardiac events (combination of all-cause death, all myocardial infarction, emergent coronary bypass surgery, or clinically indicated target lesion revascularization) were analyzed at 5-year follow-up. The 2 groups were well-matched at baseline. Five-year follow-up data were available for 98% patients. There were no differences in patient-oriented composite end point (ZES 35.3% versus EES 32.0%, P=0.11), device-oriented composite end point (ZES 17.0% versus EES 16.2%, P=0.61), major adverse cardiac events (ZES 21.9% versus EES 21.6%, P=0.88), and definite/probable stent thrombosis (ZES 2.8% versus EES 1.8%, P=0.12).
CONCLUSIONS
At 5-year follow-up, ZES and EES had similar efficacy and safety in a population of patients who had minimal exclusion criteria.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00617084.
- Language
-
- English
- Open access status
- hybrid
- Identifiers
-
- DOI 10.1161/CIRCINTERVENTIONS.114.002230
- PMID 26047993
- Persistent URL
- https://folia.unifr.ch/global/documents/44097
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