Percutaneous Coronary Intervention With Second-Generation Paclitaxel-Eluting Stents Versus Everolimus-Eluting Stents in United States Contemporary Practice (REWARDS TLX Trial)

MedStar Washington Hospital Center/MedStar Health Research Institute, Washington, DC. Electronic address: .
The American journal of cardiology (Impact Factor: 3.43). 07/2012; 110(8):1119-24. DOI: 10.1016/j.amjcard.2012.05.050
Source: PubMed

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 (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.

1 Follower
  • [Show abstract] [Hide abstract]
    ABSTRACT: Background/Purpose DELIVER (DELiverability of the Resolute Integrity Stent In All-Comer Vessels and Cross-OvER stenting) was a prospective, multicenter, all-comers registry to assess the deliverability of the Resolute Integrity™ zotarolimus-eluting stent (R-ZES). Methods/Materials Patients (n = 7740 patients, 10449 lesions) undergoing percutaneous coronary intervention and deemed suitable for R-ZES implantation were enrolled and treated according to standard practice of the participating centers in 30 countries. Outcomes included delivery success and in-hospital target lesion failure (TLF), major adverse cardiac event (MACE), and Academic Research Consortium definite/probable stent thrombosis. We performed a post hoc analysis comparing deliverability, in-hospital clinical outcomes and resource utilization with radial vs femoral access. Results A high proportion of the population had complex disease (71%): mean lesion length was 26.7 ± 17.5 mm, 35% of lesions were moderately/severely calcified and 17% were bifurcated. Femoral and radial access were used in 53% and 46% of patients, respectively. Patients treated using femoral access had more complex coronary artery disease. Primary delivery success was 98.9% and did not differ by approach. Radial access was associated with lower stent and balloon utilization, but higher guide catheter utilization, lower procedure duration, and contrast administered compared with femoral access. In-hospital TLF and MACE occurred in 1.6% of patients; definite or probable stent thrombosis occurred in 0.2%. Clinical outcomes did not differ by vascular access. Conclusions R-ZES was found to be highly deliverable in a complex, all-comers, international population, regardless of whether radial or femoral access was used. In-hospital outcomes were excellent with very low risk of complications.
    Cardiovascular Revascularization Medicine 07/2014; DOI:10.1016/j.carrev.2014.07.002
  • [Show abstract] [Hide abstract]
    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
  • [Show abstract] [Hide abstract]
    ABSTRACT: Everolimus-eluting stent (EES) reduces the risk of late and very late stent thrombosis (ST) in a number of randomized controlled trials (RCTs). However, the benefits have been variable. We evaluated the effect of EES and paclitaxel-eluting stent (PES) on the risk of late and very late ST in patients with coronary artery disease. We identified RCTs by a systematic search of MEDLINE, EMBASE, and Cochrane Database. Seven RCTs (8162 patients) were included. Overall, EES therapy lowered the risk of very late ST significantly [relative risk (RR), 0.40; 95% confidence interval (CI), 0.20-0.80; I=0.0%; P=0.009] compared with PES. Meanwhile, EES was associated with a significantly lower incidence of major adverse cardiac events (RR, 0.76; 95% CI, 0.67-0.86; I=34.2%; P=0.00) driven by a markedly lower rate of myocardial infarction and target-vessel revascularization in the EES group. However, there was no significant difference in the risk of late ST (RR, 0.45; 95% CI, 0.15-1.39; I=30.7%; P=0.166) between the two groups. A subgroup analysis showed that EES might not decrease the risk of very late ST significantly in patients older than 63.5 years or in patients with diabetes, those presenting with acute coronary syndrome, or those with a longer follow-up. Compared with PES, EES treatment decreased risk of very late ST significantly. However, the risk of late ST was similar between the two groups. More studies are needed to confirm the subgroup findings.
    Coronary artery disease 05/2014; 25(5). DOI:10.1097/MCA.0000000000000109 · 1.30 Impact Factor