TY - JOUR
T1 - Clinical follow-up 3 years after everolimus- and paclitaxel-eluting stents
T2 - A pooled analysis from the SPIRIT II (A Clinical Evaluation of the XIENCE v Everolimus Eluting Coronary Stent System in the Treatment of Patients with de Novo Native Coronary Artery Lesions) and SPIRIT III (A Clinical Evaluation of the Investigational Device XIENCE v Everolimus Eluting Coronary Stent System [EECSS]
AU - Caixeta, Adriano
AU - Lansky, Alexandra J.
AU - Serruys, Patrick W.
AU - Hermiller, James B.
AU - Ruygrok, Peter
AU - Onuma, Yoshinobu
AU - Gordon, Paul
AU - Yaqub, Manejeh
AU - Miquel-Hebert, Karine
AU - Veldhof, Susan
AU - Sood, Poornima
AU - Su, Xiaolu
AU - Jonnavithula, Lalitha
AU - Sudhir, Krishnankutty
AU - Stone, Gregg W.
N1 - Funding Information:
Sponsored by Abbott Vascular . Dr. Lansky has received research grants from The Medicines Co. , Cordis , Boston Scientific , Medtronic , and Abbott . Dr. Hermiller is a research consultant for Abbott Vascular. Dr. Gordon has received research support from Abbott Vascular . Dr. Yaqub, Dr. Miquel-Hebert, Susan Veldhof, Dr. Sood, Xiaolu Su, Lalitha Jonnavithula, and Dr. Sudhir are employed by and hold equity in Abbott Vascular. Dr. Stone serves on the scientific advisory boards for and has received honoraria from Abbott Vascular and Boston Scientific. All other authors have reported that they have no relationships to disclose.
PY - 2010/12
Y1 - 2010/12
N2 - Objectives: The purpose of this study was to investigate long-term 3-year clinical outcomes of an everolimus-eluting stent (EES) versus a paclitaxel-eluting stent (PES). Background Compared with PES, EES reduced target vessel failure and major adverse cardiac events at 2 years. Whether the benefits of EES are sustained at 3 years has not been reported. Methods In the SPIRIT II (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) and SPIRIT III (A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) trials, 1,302 patients were randomly assigned to EES (n = 892) or PES (n = 410). We report the 3-year clinical follow-up of this patient-level pooled analysis. Results At 3 years, EES compared with PES resulted in a significant reduction in myocardial infarction (3.8% vs. 6.7%; relative risk [RR]: 0.56; 95% confidence interval [CI]: 0.34 to 0.94; p = 0.04), and target lesion revascularization (6.8% vs. 12.7%; RR: 0.53; 95% CI: 0.37 to 0.77; p = 0.001). Everolimus-eluting stents resulted in a significant reduction in target vessel failure (13.7% vs. 19.5%; RR: 0.70; 95% CI: 0.54 to 0.92; p = 0.01), and major adverse cardiac events (9.1% vs. 16.3%; RR: 0.56; 95% CI: 0.41 to 0.76; p = 0.0004). The cumulative rates of Academic Research Consortiumdefined definite or probable stent thrombosis were 1.2% in EES patients and 1.9% in PES patients (RR: 0.64; 95% CI: 0.25 to 1.68; p = 0.43). Conclusions In this patient-level pooled analysis, EES compared with PES resulted in a significant and persistent reduction in target vessel failure and major adverse cardiac events at 3 years due to fewer myocardial infarction and ischemic target lesion revascularization events, which is consistent with superior safety and efficacy of the EES platform. (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions [SPIRIT II]; NCT00180310) (SPIRIT III: A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With De Novo Native Coronary Artery Lesions [SPIRIT III]; NCT00180479)
AB - Objectives: The purpose of this study was to investigate long-term 3-year clinical outcomes of an everolimus-eluting stent (EES) versus a paclitaxel-eluting stent (PES). Background Compared with PES, EES reduced target vessel failure and major adverse cardiac events at 2 years. Whether the benefits of EES are sustained at 3 years has not been reported. Methods In the SPIRIT II (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) and SPIRIT III (A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) trials, 1,302 patients were randomly assigned to EES (n = 892) or PES (n = 410). We report the 3-year clinical follow-up of this patient-level pooled analysis. Results At 3 years, EES compared with PES resulted in a significant reduction in myocardial infarction (3.8% vs. 6.7%; relative risk [RR]: 0.56; 95% confidence interval [CI]: 0.34 to 0.94; p = 0.04), and target lesion revascularization (6.8% vs. 12.7%; RR: 0.53; 95% CI: 0.37 to 0.77; p = 0.001). Everolimus-eluting stents resulted in a significant reduction in target vessel failure (13.7% vs. 19.5%; RR: 0.70; 95% CI: 0.54 to 0.92; p = 0.01), and major adverse cardiac events (9.1% vs. 16.3%; RR: 0.56; 95% CI: 0.41 to 0.76; p = 0.0004). The cumulative rates of Academic Research Consortiumdefined definite or probable stent thrombosis were 1.2% in EES patients and 1.9% in PES patients (RR: 0.64; 95% CI: 0.25 to 1.68; p = 0.43). Conclusions In this patient-level pooled analysis, EES compared with PES resulted in a significant and persistent reduction in target vessel failure and major adverse cardiac events at 3 years due to fewer myocardial infarction and ischemic target lesion revascularization events, which is consistent with superior safety and efficacy of the EES platform. (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions [SPIRIT II]; NCT00180310) (SPIRIT III: A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With De Novo Native Coronary Artery Lesions [SPIRIT III]; NCT00180479)
KW - drug-eluting stent(s)
KW - percutaneous coronary intervention
KW - randomized clinical trial
UR - https://www.scopus.com/pages/publications/78651427578
U2 - 10.1016/j.jcin.2010.07.017
DO - 10.1016/j.jcin.2010.07.017
M3 - Article
C2 - 21232715
AN - SCOPUS:78651427578
SN - 1936-8798
VL - 3
SP - 1220
EP - 1228
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 12
ER -