Data di Pubblicazione:
2010
Citazione:
Comparison of zotarolimus-eluting and everolimus-eluting coronary stents / P.W. Serruys, S. Silber, S. Garg, R.J. van Geuns, G. Richardt, P.E. Buszman, H. Kelbaek,
A.J. van Boven, S.H. Hofma, A. Linke, V. Klauss, W. Wijns, C. Macaya, P. Garot, C. DiMario, G. Manoharan, R. Kornowski, T. Ischinger, A. Bartorelli, J. Ronden, M. Bressers, P. Gobbens, M. Negoita, F. van Leeuwen, S. Windecker. - In: NEW ENGLAND JOURNAL OF MEDICINE. - ISSN 0028-4793. - 363:2(2010 Jul 08), pp. 136-146. [10.1056/NEJMoa1004130]
Abstract:
BACKGROUND
New-generation coronary stents that release zotarolimus or everolimus have been shown to reduce the risk of restenosis. However, it is unclear whether there are differences in efficacy and safety between the two types of stents on the basis of prospectively adjudicated end points endorsed by the Food and Drug Administration.
METHODS
In this multicenter, noninferiority trial with minimal exclusion criteria, we randomly assigned 2292 patients to undergo treatment with coronary stents releasing either zotarolimus or everolimus. Twenty percent of patients were randomly selected for repeat angiography at 13 months. The primary end point was target-lesion failure, defined as a composite of death from cardiac causes, any myocardial infarction (not clearly attributable to a nontarget vessel), or clinically indicated target-lesion revascularization within 12 months. The secondary angiographic end point was the extent of in-stent stenosis at 13 months.
RESULTS
At least one off-label criterion for stent placement was present in 66% of patients. The zotarolimus-eluting stent was noninferior to the everolimus-eluting stent with respect to the primary end point, which occurred in 8.2% and 8.3% of patients, respectively (P<0.001 for noninferiority). There were no significant between-group differences in the rate of death from cardiac causes, any myocardial infarction, or revascularization. The rate of stent thrombosis was 2.3% in the zotarolimus-stent group and 1.5% in the everolimus-stent group (P=0.17). The zotarolimus-eluting stent was also noninferior regarding the degree (+/- SD) of in-stent stenosis (21.65 +/- 14.42% for zotarolimus vs. 19.76 +/- 14.64% for everolimus, P=0.04 for noninferiority). In-stent late lumen loss was 0.27 +/- 0.43 mm in the zotarolimus-stent group versus 0.19 +/- 0.40 mm in the everolimus-stent group (P=0.08). There were no significant between-group differences in the rate of adverse events.
CONCLUSIONS
At 13 months, the new-generation zotarolimus-eluting stent was found to be noninferior to the everolimus-eluting stent in a population of patients who had minimal exclusion criteria. (ClinicalTrials.gov number, NCT00617084.)
Tipologia IRIS:
01 - Articolo su periodico
Elenco autori:
P.W. Serruys, S. Silber, S. Garg, R.J. van Geuns, G. Richardt, P.E. Buszman, H. Kelbaek, A.J. van Boven, S.H. Hofma, A. Linke, V. Klauss, W. Wijns, C. Macaya, P. Garot, C. Dimario, G. Manoharan, R. Kornowski, T. Ischinger, A. Bartorelli, J. Ronden, M. Bressers, P. Gobbens, M. Negoita, F. van Leeuwen, S. Windecker
Link alla scheda completa:
Link al Full Text: