Percutaneous Coronary Intervention With Second-Generation Paclitaxel-Eluting Stents Versus Everolimus-Eluting Stents in United States Contemporary Practice (REWARDS TLX Trial)
ABSTRACT Registry Experience at the Washington Hospital Center, DES - Taxus Liberte Versus Xience V (REWARDS TLX) is a physician-initiated, retrospective, real-world, multicenter, observational study for all patients >18 years of age subjected to percutaneous coronary intervention with everolimus-eluting stents (EESs) or paclitaxel-eluting stents (PESs). Outcomes of patients receiving a TAXUS Liberté or XIENCE V drug-eluting stent were compared. Baseline clinical, procedural, and follow-up data at 12 months were collected from 10 clinical centers by an electronic data capture system. The study's primary end point was major adverse cardiac events: a composite of all-cause death, Q-wave myocardial infarction, target vessel revascularization, and stent thrombosis. The trial is registered with http://www.clinicaltrials.gov (NCT01134159). Data were entered for 1,195 patients (PES, n = 595; EES, n = 600). Baseline clinical characteristics were similar except for higher dyslipidemia, systemic hypertension, and family history of coronary artery disease in the EES group. In-hospital outcome was similar between groups, with an overall in-hospital stent thrombosis rate of 0.2%. The primary end point at 12 months was similar (EES 7.8% vs 10.8%, p = 0.082). Overall stent thrombosis rate was lower in the EES group (0.3% vs 1.2%, respectively, p = 0.107); however, target lesion revascularization was similar (PES, hazard ratio 1.46, 95% confidence interval 0.98 to 2.19, p = 0.064). There was no difference in overall mortality between groups. In conclusion, second-generation EESs and PESs demonstrated similar efficacy and safety profiles for broadened patient and lesion subsets compared to a selected population from the pivotal trials. However, for composite efficacy and safety end points, EESs outperformed second-generation PESs.
- SourceAvailable from: Dong-Gu Shin
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- "Recently the results of the retrospective REWARD TLX trial were published. It was found that mortality rates were similar for the Xience V EES and Taxus Liberte PES (10). However, in terms of composite efficacy and safety, EES exceeded PES. "
ABSTRACT: We aimed comparing two-year clinical outcomes of the Everolimus-Eluting Promus and Paclitaxel-Eluting TAXUS Liberte stents used in routine clinical practice. Patients with objective evidence of ischemia and coronary artery disease eligible for PCI were prospectively randomized to everolimus-eluting stent (EES) or paclitaxel-eluting stent (PES) groups. The primary end-point was ischemia-driven target vessel revascularization (TVR) at 2 yr after intervention, and the secondary end-point was a major adverse cardiac event (MACE), such as death, myocardial infarction (MI), target lesion revascularization (TLR), TVR or stent thrombosis. A total of 850 patients with 1,039 lesions was randomized to the EES (n=425) and PES (n=425) groups. Ischemic-driven TVR at 2 yr was 3.8% in the PES and 1.2% in the EES group (P for non-inferiority=0.021). MACE rates were significantly different; 5.6% in PES and 2.5% in EES (P = 0.027). Rates of MI (0.8% in PES vs 0.2% in EES, P = 0.308), all deaths (1.5% in PES vs 1.2% in EES, P = 0.739) and stent thrombosis (0.3% in PES vs 0.7% in EES, P = 0.325) were similar. The clinical outcomes of EES are superior to PES, mainly due to a reduction in the rate of ischemia-driven TVR.Journal of Korean medical science 11/2013; 28(11):1609-1614. DOI:10.3346/jkms.2013.28.11.1609 · 1.25 Impact Factor
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ABSTRACT: We evaluate differences in outcomes in younger (<65 years) and older (≥65 years) patients for target lesion failure (TLF) at 2-year follow-up in an unselected consecutive series of patients treated with the everolimus- (EES) and paclitaxel-eluting (PES) stents at a tertiary medical center. 348 consecutive patients (younger 150; older 198) stented with the EES and PES were retrospectively analyzed. The primary endpoint was TLF (composite endpoint of cardiac death, non fatal myocardial infarction due to index vessel and target lesion revascularization (TLR)). At 2 years follow up, younger versus older patients had the following outcomes respectively: TLF 27.7% versus 25.5% (P = 0.71), TLR 24.8% versus 21.4% (P = 0.52), cardiac death 3.4% versus 2.5% (P = 0.75) and definite and probable stent thrombosis (2.0% versus 1.0%). Multivariate analysis showed that renal failure (odds ratio: 2.55, P = 0.045), number of stents per patient (odds ratio: 1.60, P = 0.001) and younger age (odds ratio: 0.97; P = 0.010), but not gender, diabetes or type of DES stent (EES versus PES) predicted TLF. We conclude that older age was not a predictor of TLF at 2-year follow-up after adjusting for renal insufficiency, number of stents used per patient, gender, diabetes and type of DES used.Journal of aging research 06/2013; 2013:471026. DOI:10.1155/2013/471026
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ABSTRACT: In this study, we compare the outcomes of the paclitaxel-eluting stent (PES) versus the everolimus-eluting stent (EES) treated patients at a tertiary medical center and up to 2 years follow-up. Unselected consecutive patients were retrospectively recruited following stenting with PES (159 patients) or EES (189 patients). The primary endpoint of the study was target lesion failure (TLF), defined as the combined endpoint of cardiac death, nonfatal myocardial infarction (MI), or target lesion revascularization (TLR). Secondary endpoints included target vessel revascularization (TVR), TLR, target vessel failure (TVF), acute stent thrombosis (ST), total death, cardiac death, and nonfatal MI. Patients treated with the PES stent had less congestive heart failure and restenotic lesions, but a higher prevalence of longer lesions, nonleft main bifurcations, required more stents per patient (4.3 ± 2.8 vs. 2.9 ± 2.1). TLF occurred in 32.3% PES versus 21.5% EES (p = 0.027). The secondary unadjusted endpoints for PES versus EES, respectively, were TVF 38.6 versus 30.7% (p = 0.140), TVR 35.7 versus 26.5% (p = 0.079), definite and probable ST 1.2 versus 0.0%, nonfatal MI 4.5 versus 4.2%, and mortality 9.6 versus 4.0%. Logistic regression analysis showed that the numbers of stents per patient (p = 0.001), age (p = 0.01), and renal failure (p = 0.045) were independent predictors of TLF. Using univariate analysis, EES had lower TLF than PES in a cohort of unselected patients undergoing percutaneous coronary intervention at 2 years follow-up. Multivariate analysis showed that the numbers of stents per patient, age, and renal failure, but not stent type, were predictors of TLF.International Journal of Angiology 09/2013; 22(3):165-70. DOI:10.1055/s-0033-1347931