Differential long-term outcomes of zotarolimus-eluting stents compared with sirolimus-eluting and paclitaxel-eluting stents in diabetic and nondiabetic patients: two-year subgroup analysis of the ZEST randomized trial.

To evaluate the differential treatment effects of zotarolimus-eluting stents (ZES), sirolimus-eluting stents (SES), and paclitaxel-eluting stents (PES) according to diabetic status. Diabetic patients have a higher risk of ischemic complications after stenting than nondiabetic patients. Using data from the ZEST randomized trial, comparing ZES with SES and PES, we evaluated relative outcomes among stents in diabetic and nondiabetic patients. The primary outcome was a major adverse cardiac event (MACE), defined as a composite of death, myocardial infarction, or ischemia-driven target-vessel revascularization. Of the 2,645 patients enrolled in the ZEST trial, 760 (29%) had diabetes mellitus. Baseline clinical and angiographic characteristics were similar in the three stent groups, regardless of diabetic status. In diabetic patients, ZES showed similar rates of MACE as compared to PES (13.8% vs. 15.3%, P = 0.58), but higher rates of MACE than SES (13.8% vs. 7.7%, P = 0.05). In nondiabetic patients, ZES showed similar rates of MACE as compared to SES (10.3% vs. 10.8%, P = 0.72), whereas significantly lower rates of MACE compared to PES (10.3% vs. 15.3%, P = 0.01). In comparing the ZES and SES groups, there was a substantial interaction between diabetic status and stent types on MACE occurrence (Interaction P = 0.07). However, in comparison of ZES and PES, there were no significant interactions between diabetes and stent type on MACE (Interaction P = 0.25). In diabetic patients, SES showed the lowest rate of MACE compared with ZES and PES. But, in nondiabetic patients, SES and ZES showed significantly lower rates of MACE than PES. ZES shows a diabetes-related interaction on MACE compared with SES, but not with PES.

Jang SJ ，Park DW ，Kim WJ ，Kim YH ，Yun SC ，Kang SJ ，Lee SW ，Lee CW ，Park SW ，Park SJ ... -  《-》

The "final" 5-year follow-up from the ENDEAVOR IV trial comparing a zotarolimus-eluting stent with a paclitaxel-eluting stent.

This study sought to report the final 5-year outcomes of the ENDEAVOR IV (A Randomized, Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions) trial comparing the Endeavor zotarolimus-eluting stent (E-ZES) (Medtronic, Santa Rosa, California) with the Taxus paclitaxel-eluting stent (PES) (Boston Scientific, Natick, Massachusetts) in patients with single de novo coronary lesions. Primary results of the ENDEAVOR IV trial demonstrated similar clinical outcomes with E-ZES and PES. Concerns with regard to late adverse clinical events with drug-eluting stents highlight the need for long-term follow-up with these devices. Late outcomes after the use of E-ZES and PES were examined in the multicenter randomized ENDEAVOR IV trial in cumulative and landmark analyses. Assessed outcomes were related to device efficacy and patient safety. At 5 years, clinical data were available for 722 (93.4%) E-ZES patients and 718 (92.6%) PES patients. Overall rates of target lesion revascularization (7.7% vs. 8.6%, p = 0.70) and target vessel failure were similar (17.2% vs. 21.1%, p = 0.061) with E-ZES compared with PES. The incidence of cardiac death or myocardial infarction (MI) was lower with E-ZES (6.4% vs. 9.1%, p = 0.048), primarily driven by a lower rate of target vessel MI with E-ZES (2.6% vs. 6.0%, p = 0.002). Although overall definite/probable stent thrombosis rates were similar between stents (1.3% vs. 2%, p = 0.42), rates of very late stent thrombosis (0.4% vs. 1.8%, p = 0.012) and late MI events (1.3% vs. 3.5%, p = 0.008) were significantly lower with E-ZES compared with PES. These data demonstrate the durable efficacy and safety of E-ZES compared with PES for the treatment of de novo coronary lesions. Significant improvements in late safety outcomes were observed with E-ZES but should be considered hypothesis-generating, given the limited statistical power of the trial. (The ENDEAVOR IV Clinical Trial: A Trial of a Coronary Stent System in Coronary Artery Lesions; NCT00217269).

Kirtane AJ ，Leon MB ，Ball MW ，Bajwa HS ，Sketch MH Jr ，Coleman PS ，Stoler RC ，Papadakos S ，Cutlip DE ，Mauri L ，Kandzari DE ，ENDEAVOR IV Investigators ... -  《-》

Comparison of 2-year clinical outcomes between zotarolimus-, sirolimus-, and paclitaxel-eluting stents in real life clinical practice.

Kim JH ，Park KW ，Lim WH ，Shin DH ，Chae IH ，Choi DJ ，Kim HS ... -  《-》

Safety and efficacy of everolimus-eluting stents versus paclitaxel-eluting stents in a diabetic population.

This study aimed to analyze the use of everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) in an unrestricted diabetic population and to compare the performance of these two drug-eluting stents. EES have demonstrated superiority in efficacy when compared to PES in a general population. However, it is controversial whether this superiority holds true in a diabetic population. From March 2004 to May 2010, 968 patients with consecutive diabetes who underwent percutaneous coronary intervention and implantation of an EES (n = 388) or PES (n = 580) at our institution. In-hospital, 1-month, 6-month, and 1-year clinical outcomes were analyzed and compared. Correlates of major adverse cardiac events (MACE) were identified. Baseline clinical characteristics were similar between stent types except for more family history of coronary artery disease in the PES group and more insulin-dependent diabetes and unstable angina at initial diagnosis in the EES group. The PES group had higher number of lesions treated, longer stents used, and a higher proportion of intravascular ultrasound and glycoprotein IIb/IIIa inhibitor use. The EES group had more type C and distal lesions. There was higher target lesion revascularization (TLR)-MACE in the PES group (3.3% vs. 1.0%, P = 0.03) as well as a higher rate of stent thrombosis (ST) (8 patients vs. 0 in the EES group, P = 0.03). ST continued to be higher in the PES group at 6 and 12 months and mortality was higher at 12 months in the PES group (9.4% vs. 5.2%, P = 0.02). After adjustment, no significant differences were found between stent types on Cox regression analysis for hazard ratios at 1-year follow-up of TLR-MACE. In a diabetic population undergoing PCI, the use of an EES compared to PES was associated with lower rates of stent thrombosis; but after adjustment the composite TLR-MACE at 1 year was similar between both stents.

Laynez A ，Sardi G ，Hauville C ，Barbash IM ，Pakala R ，Torguson R ，Xue Z ，Satler LF ，Pichard AD ，Waksman R ... -  《-》

Six-year clinical outcomes of first-generation drug-eluting stents: a propensity-matched analysis.

Tarantini G ，Barioli A ，Facchin M ，Frigo AC ，Napodano M ，Buja P ，D'Amico G ，Iliceto S ，Isabella G ... -  《-》