Promus Premier versus Xience V and Taxus Liberte in contemporary United States practice (REWARDS premier registry).

BACKGROUND/PURPOSE: Drug-eluting stents (DES) reduce in-stent restenosis and repeat revascularization in comparison to bare metal stents. Individual DES vary, however, in regard to rates of restenosis and stent thrombosis; they also differ in regard to their platform and physical characteristics. The Promus Premier was designed to improve the performance of the Promus Element, with respect to conformability, trackability, and avoidance of longitudinal stent deformation; there is little published data, however, on clinical outcomes with Promus Premier. METHODS: We performed a registry study that compared 952 patients who underwent percutaneous coronary intervention with Promus Premier to 595 patients who received Taxus Liberte and 600 patients who received Xience V for a variety of indications. The primary endpoint was a composite of all-cause mortality, definite or probable stent thrombosis, myocardial infarction, and target vessel revascularization (TVR-MACE). Kaplan-Meier analysis and Cox proportional hazards regression were performed in order to compare the three stents in regard to outcomes at 1year. RESULTS: Procedural success was highest with Premier (99.4%) when compared to Xience V (98.0%) and Taxus Liberte (97.3%; p<0.001). Unadjusted survival analysis showed that TVR-MACE was less frequent with Premier in comparison to Taxus Liberte (p=0.003), and similar frequency in comparison to Xience V (p=0.16). Following multivariable adjustment, and using Xience V as the reference, there was only a borderline association of Promus Premier and lower rates of TVR-MACE (HR 0.69, 95% CI 0.45-1.04; p=0.075). CONCLUSION: Promus Premier demonstrates excellent procedural success rates and real-world outcomes that are similar to Xience V.

Percutaneous coronary intervention with second-generation paclitaxel-eluting stents versus everolimus-eluting stents in United States contemporary practice (REWARDS TLX Trial).

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.

Severe left ventricular hypertrophy 1 year after transplant predicts mortality in cardiac transplant recipients.

BACKGROUND: Left ventricular hypertrophy (LVH) is a known predictor of morbidity and mortality in patients with essential hypertension. The prevalence and significance of LVH in heart transplant recipients is unknown. METHODS: Transthoracic echocardiograms were performed as part of a routine protocol 1 year after heart transplantation in 141 consecutive patients. Demographic and echocardiographic data were collected using patients' records and center-specific data from the Cardiac Transplant Research Database and analyzed to determine the prevalence and predictors of LVH at 1 year post-transplantation. Patients were divided into three groups based on left ventricular mass (LVM): normal (LVM <150 g); mild-moderate LVH (LVM 150 to 250 g); and severe LVH (LVM >250 g). RESULTS: LVH was common at 1 year after heart transplantation, present in 83% of heart transplant recipients. Univariate predictors of severe LVH were increased body mass index (p < 0.01), pre-transplant diabetes mellitus (p = 0.02) and pre-transplant hypertension (p = 0.01). By multivariate analysis, pre-transplant hypertension was the only independent predictor of severe LVH (hazard ratio [HR] 2.3, 95% confidence interval [CI] 1.1 to 5.4, p = 0.05). Heart transplant recipients with severe LVH had significantly decreased survival, as compared to patients with normal LVM and mild-moderate LVH (p = 0.03). After multivariate analysis adjusting for age, race, gender, pre-transplant hypertension and diabetes, severe LVH remained a strong, independent predictor of mortality (HR 3.6, 95% CI 1.0 to 12.1, p = 0.04). CONCLUSIONS: LVH is common at 1 year after heart transplantation and is a strong, independent predictor of increased mortality. Hypertension before transplantation is an independent predictor of the presence of severe LVH at 1 year after heart transplantation.