The sirolimus-eluting cypher select coronary stent for the treatment of bare-metal and drug-eluting stent restenosis

Objectives This study sought to compare the 1-year safety and efficacy of Cypher Select or Cypher SelectPlus (Cordis Corporation, Bridgewater, New Jersey) sirolimus-eluting stents (SES) with the treatment of baremetalstents (BMS) and drug-eluting stent (DES) in-stent restenosis (ISR) in nonselected, real-world patients.Background There is paucity of consistent data on DES for the treatment of ISR, especially, DES ISR.Methods The e-SELECT (Multicenter Post-Market Surveillance) registry is a Web-based, multicenterand international registry encompassing virtually all subsets of patients and lesions treated with atleast 1 SES during the period from 2006 to 2008. We enrolled in this pre-specified subanalysis allpatients with at least 1 clinically relevant BMS or DES ISR treated with SES. Primary endpoint wasmajor adverse cardiac events and stent thrombosis rate at 1 year.Results Of 15,147 patients enrolled, 1,590 (10.5%) presented at least 1 ISR (BMS group, n 1,235,DES group, n 355). Patients with DES ISR had higher incidence of diabetes (39.4% vs. 26.9%,p 0.001), renal insufficiency (5.8% vs. 2.3%, p 0.003), and prior coronary artery bypass graft(20.5% vs. 11.8%, p 0.001). At 1 year, death (1.4% for BMS vs. 2.1% for DES, p 0.3) and myocardialinfarction (2.4% for BMS and 3.3% for DES, p 0.3) rates were similar, whereas ischemia-driven target lesion revascularization and definite/probable late stent thrombosis were higher inpatients with DES ISR (6.9% vs. 3.1%, p 0.003, and 1.8% vs. 0.5%, p 0.04, respectively).Conclusions Use of SES for either BMS or DES ISR treatment is safe and associated with low target lesionrevascularization recurrence and no apparent safety concern. (J Am Coll Cardiol Intv 2012;5:64–71) © 2012by the American College of Cardiology Foundation.

Sirolimus-eluting coronary stentsin octogenarians: a 1-year analysis of the worldwide e-SELECT Registry

Objectives The aim of this study was to identify the worldwide practice of Cypher Select (CordisCorporation, Bridgewater, New Jersey) or Cypher Select Plus sirolimus-eluting stent (SES) in patients80 years of age (octogenarian) and to identify clinical outcomes in this patient population.Background The use of drug-eluting stents in elderly patients may have different features comparedwith younger patients.Methods Between 2006 and 2008, 15,147 patients from 320 hospitals in 56 countries were enrolledin a registry. Initial implantation and follow-up outcome information obtained at 1-year follow-up in675 octogenarian patients were compared with those in 14,472 nonoctogenarian patients.Results Octogenarians had significantly more comorbidities and had higher Charlson comorbidityindex scores (1.5 1.6 vs. 1.0 1.3, p 0.001). Rates of cardiac death (3.3% vs. 0.9%, p 0.001),myocardial infarction (2.3% vs. 1.9%, p 0.021), and definite or probable stent thrombosis (2.3% vs.0.9%, p 0.0002), and major bleeding (2.0% vs. 0.9%, p 0.015) were significantly higher in octogenariansat 1 year; however, there was no significant difference in the rate of target lesion revascularizationbetween the 2 groups (3.2% vs. 2.2%, p 0.12). In octogenarians, a high Charlson comorbidityindex was an independent predictor of death and stent thrombosis up to 360 days from theindex procedure (hazard ratio: 1.3, 95% confidence interval: 1.1 to 1.5, p 0.001, and hazard ratio:1.5, 95% confidence interval: 1.3 to 1.8, p 0.001, respectively).Conclusions Stenting with SES may be an effective therapeutic option in elderly patients, with acceptablerates of complications and a very low rate of repeat revascularization as demonstrated bythis e-SELECT (A Multi-Center Post-Market Surveillance Registry) subgroup analysis. (J Am CollCardiol Intv 2011;4:982–91) © 2011 by the American College of Cardiology Foundation.