TY - JOUR
T1 - Outcomes in diabetic and nondiabetic patients treated with everolimus- or paclitaxel-eluting stents
T2 - Results from the SPIRIT IV clinical trial (Clinical Evaluation of the XIENCE v Everolimus Eluting Coronary Stent System)
AU - Kereiakes, Dean J.
AU - Cutlip, Donald E.
AU - Applegate, Robert J.
AU - Wang, John
AU - Yaqub, Manejeh
AU - Sood, Poornima
AU - Su, Xiaolu
AU - Su, Guoping
AU - Farhat, Naim
AU - Rizvi, Ali
AU - Simonton, Charles A.
AU - Sudhir, Krishnankutty
AU - Stone, Gregg W.
N1 - Funding Information:
This work was supported by Abbott Vascular , Santa Clara, California. Dr. Kereiakes has received grant/research support from, been a consultant to, and served on the advisory board for Abbott Vascular and Boston Scientific . Dr. Cutlip has received research support from Medtronic . Dr. Applegate has received grant/research support from and served as consultant for Abbott Vascular . Dr. Wang has served on the Speakers' Bureau for Abbott, Boston Scientific, Medtronic, and Cordis. Drs. Yaqub, Sood, Xiaolu Su, Guoping Su, Simonton, and Sudhir are Abbott Vascular employees. Dr. Farhat reports that he has no relationships to disclose. Dr. Stone has received grant/research support from and served on the advisory board for Abbott Vascular and Boston Scientific .
PY - 2010/12/14
Y1 - 2010/12/14
N2 - Objectives We compared the safety and efficacy of the XIENCE V (Abbott Vascular, Santa Clara, California) everolimus-eluting stent (EES) with the TAXUS Express (Boston Scientific, Natick, Massachusetts) paclitaxel-eluting stent (PES) among the large cohort of randomized diabetic patients enrolled in the SPIRIT IV (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) trial. Background Diabetes mellitus remains a significant predictor of adverse clinical outcomes after percutaneous coronary intervention with drug-eluting stents, and the comparative outcomes of different drug-eluting stents in diabetic patients remains ill-defined. Methods In the SPIRIT IV trial, 3,687 patients with up to 3 de novo native coronary artery lesions were prospectively randomized 2:1 to receive EES or PES. Randomization was stratified by the presence of diabetes and lesion complexity. The primary end point was the occurrence of target lesion failure (TLF) (cardiac death, target-vessel myocardial infarction, or ischemia-driven target lesion revascularization) at 1 year. Clinical outcomes were evaluated in randomized diabetic (n = 1,185 [786 EES; 399 PES]) and nondiabetic patients (n = 2,498 [1,669 EES; 829 PES]). Results The EES compared with PES reduced TLF in nondiabetic patients (3.1% vs. 6.7%, p < 0.0001), with significant reductions in myocardial infarction, stent thrombosis, and target lesion revascularization. In contrast, no difference in TLF (6.4% vs. 6.9%, respectively, p = 0.80) or any of its components was present among diabetic patients, regardless of insulin use. A significant interaction between the presence of diabetes and stent type on TLF (pinteraction = 0.02) was observed. Conclusions In the SPIRIT IV randomized trial, EES compared with PES provided similar clinical outcomes in diabetic patients and superior clinical outcomes in nondiabetic patients at 1 year. (SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions; NCT00307047)
AB - Objectives We compared the safety and efficacy of the XIENCE V (Abbott Vascular, Santa Clara, California) everolimus-eluting stent (EES) with the TAXUS Express (Boston Scientific, Natick, Massachusetts) paclitaxel-eluting stent (PES) among the large cohort of randomized diabetic patients enrolled in the SPIRIT IV (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) trial. Background Diabetes mellitus remains a significant predictor of adverse clinical outcomes after percutaneous coronary intervention with drug-eluting stents, and the comparative outcomes of different drug-eluting stents in diabetic patients remains ill-defined. Methods In the SPIRIT IV trial, 3,687 patients with up to 3 de novo native coronary artery lesions were prospectively randomized 2:1 to receive EES or PES. Randomization was stratified by the presence of diabetes and lesion complexity. The primary end point was the occurrence of target lesion failure (TLF) (cardiac death, target-vessel myocardial infarction, or ischemia-driven target lesion revascularization) at 1 year. Clinical outcomes were evaluated in randomized diabetic (n = 1,185 [786 EES; 399 PES]) and nondiabetic patients (n = 2,498 [1,669 EES; 829 PES]). Results The EES compared with PES reduced TLF in nondiabetic patients (3.1% vs. 6.7%, p < 0.0001), with significant reductions in myocardial infarction, stent thrombosis, and target lesion revascularization. In contrast, no difference in TLF (6.4% vs. 6.9%, respectively, p = 0.80) or any of its components was present among diabetic patients, regardless of insulin use. A significant interaction between the presence of diabetes and stent type on TLF (pinteraction = 0.02) was observed. Conclusions In the SPIRIT IV randomized trial, EES compared with PES provided similar clinical outcomes in diabetic patients and superior clinical outcomes in nondiabetic patients at 1 year. (SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions; NCT00307047)
KW - diabetes
KW - drug-eluting stent(s)
KW - everolimus
KW - majoradverse cardiac event(s)
UR - http://www.scopus.com/inward/record.url?scp=78650002551&partnerID=8YFLogxK
U2 - 10.1016/j.jacc.2010.10.006
DO - 10.1016/j.jacc.2010.10.006
M3 - Article
C2 - 21144968
AN - SCOPUS:78650002551
SN - 0735-1097
VL - 56
SP - 2084
EP - 2089
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 25
ER -