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.
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ABSTRACT: Drug-eluting stents (DES) are routinely used in complex patients, but the impact of 1st- versus 2nd-generation DES on clinical outcomes has not been well described. This study aimed to assess the efficacy and safety of 2nd-generation (everolimus-eluting) DES compared to 1st-generation (sirolimus- and paclitaxel-eluting) DES in a selected, higher-risk population with complex clinical and angiographic features. The study included 5693 consecutive patients with the presence of ≥1 predefined complex clinical and angiographic characteristic treated with either generation DES. Using propensity score matching, the clinical outcomes of 1076 patients treated with 2nd-generation DES were compared with the outcomes of a matched population treated with 1st-generation DES over 1-year follow-up. After matching, baseline clinical and angiographic characteristics were similar between groups. At 1-year follow-up, the rate of major adverse cardiac events was 9.4% with 2nd-generation DES and 11.3% with 1st-generation DES (p=0.16). There were no significant differences in the rates of death (3.2 vs. 4.0%, p=0.30), myocardial infarction (1.6 vs. 1.3%, p=0.57), target vessel revascularization (5.9 vs. 7.3%, p=0.17) or target lesion revascularization (4.4 vs. 5.0%, p=0.50). Definite stent thrombosis was less frequent with 2nd-generation DES (0.1 vs. 0.8%, p=0.011), as was definite or probable stent thrombosis (0.7 vs. 1.6%, p=0.040). In this propensity score matched patient population with complex features undergoing percutaneous coronary intervention, the use of 2nd-generation DES was associated with lower rates of stent thrombosis, and similar 1-year major adverse cardiac events compared to 1st-generation DES.International journal of cardiology 10/2013; · 6.18 Impact Factor
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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. · 0.84 Impact Factor