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.
Drug-eluting stents compared to bare-metal stents decrease rates of restenosis and revascularization. Comparisons among drug-eluting stent types, however, have often generated conflicting data; as such, the choice of an optimal stent platform and antiproliferative drug remains controversial. The purpose of the present study was to examine whether clinical differences exist between the TAXUS Liberté paclitaxel-eluting stent (PES; Boston Scientific, Natick, Massachusetts) and the XIENCE V everolimus-eluting stent (EES; Abbott Vascular, Abbott Park, Illinois) and to compare postapproval major adverse cardiac event (MACE) rate in hospital and at 12 months in all comers in a United States population.
Methods
Registry Experience at the Washington Hospital Center, DES – Taxus Liberte Versus Xience V (REWARDS TLX) was designed as a multicenter, nonrandomized, retrospective, real-world study of approximately 600 patients undergoing percutaneous coronary intervention (PCI) with the TAXUS Liberté compared to approximately 600 patients undergoing PCI with the XIENCE V irrespective of lesion complexity, co-morbidities, and acute presentation. Patients also underwent clinical follow-up ≥8 months after PCI. Data were collected from 10 United States hospitals. Selected sites were chosen to be a cross-sectional representation of interventional cardiology practices and met the following criteria: Demonstrating adequate volume of interventional procedures (750 PCI procedures/year), demonstrating adequate occurrence of patients undergoing PCI and receiving TAXUS Liberté or XIENCE V/Promus, demonstrating adequate staff and infrastructure to enable compliance with trial procedures and requirements, and the site principal investigator was willing to adhere to the protocol/procedures indicated by signing the investigator agreement.
All study subjects were identified retrospectively based on the following inclusion/exclusion criteria. All patients were >18 years of age and were subjected to PCI with XIENCE V alone or TAXUS Liberté alone before August 2009. Patients were excluded if they received TAXUS Liberté and XIENCE V stents during the index procedure or if they were not taking or were unable to take dual antiplatelet therapy at discharge (aspirin plus clopidogrel or prasugrel). Follow-up data were collected at 9 to 12 months after stent implantation. Given the retrospective nature of this analysis, stent selection and periprocedural antiplatelet and antithrombotic medications given were at the discretion of the treating physician. All patients were discharged with 12 months of dual antiplatelet therapy recommended.
Data were collected by a secure password-protected electronic data collection system in a de-identified manner. All study-related activity was conducted at local sites in accordance with the local or central institutional review board. These data were collected retrospectively by extraction from existing databases in consecutive fashion where index and follow-up data existed or from existing databases in consecutive fashion and follow-up was obtained by telephone contact. Data were collected 9 to 12 months after stent implantation.
The primary goal of this multicenter, retrospective registry was to collect data on subjects who developed MACEs. A MACE was defined as a composite of all-cause death, Q-wave myocardial infarction (MI), and target vessel revascularization. Components and additional variables were defined as all-cause death, cardiac death, stent thrombosis (Academic Research Consortium probable or definite stent thrombosis occurring in target vessel), Q-wave MI (appearance of new pathologic Q waves in the coronary distribution of the target vessel with an increase of creatine kinase-MB to ≥2 times reference values, if available), target vessel revascularization (need for repeat PCI within target vessel), target lesion revascularization (need for repeat PCI within target lesion), and periprocedural creatine kinase-MB (peak level of in-hospital creatine kinase-MB after PCI). The secondary objective was to assess MACEs for a prespecified subset, specifically diabetic compared to nondiabetic patients, in regard to which drug-eluting stent they received.
Categorical variables are reported as number and frequency and continuous variables are reported as mean ± SD and median with range, where applicable. Multivariable proportional Cox regression was used to identify predictors of time to MACEs and stent thrombosis, cardiac death, and target vessel revascularization.
The corresponding author had full access to all the data in the study; all authors accept full responsibility for the decision to submit for publication.
Results
In total 1,195 patients were enrolled in the registry. Of these, 595 patients received a PES and 600 received an EES. Baseline clinical characteristics are listed in Table 1 . In the total population, 686 (57.9%) presented with acute coronary syndrome; of these, 98 (8.2%) had ST-segment elevation MI. In total 833 lesions were treated in the PES group and 857 in the EES group. There was no difference in patients presenting on maintenance clopidogrel therapy; however, there were more patients preloaded with clopidogrel in the PES group (56.4% vs 48.1% in EES group, p = 0.045). Use of intraprocedural low-molecular-weight heparin was similar in the 2 groups with a higher rate of bivalirudin use in the EES group (66.5% vs 31.1% in PES group, p <0.001; Table 2 ).
| TAXUS Liberté (n = 595) | XIENCE V (n = 600) | p Value | |
|---|---|---|---|
| Men | 69.9% | 69.3% | 0.83 |
| Age (years) | 64.6 ± 11.3 | 63.2 ± 11.2 | 0.02 |
| Previous myocardial infarction | 23.9% | 23.0% | 0.72 |
| Previous coronary artery bypass graft | 21.8% | 20.8% | 0.67 |
| Peripheral vascular disease | 9.2% | 11.8% | 0.15 |
| Diabetes mellitus | 33.4% | 35.2% | 0.53 |
| Insulin-dependent diabetes mellitus | 8.2% | 9.7% | 0.39 |
| Smoking (active) | 30.5% | 30.1% | 0.93 |
| Hyperlipidemia | 78.8% | 85.8% | 0.001 |
| Systemic hypertension ⁎ | 75.0% | 84.3% | <0.001 |
| Renal insufficiency | 5.5% | 6.7% | 0.41 |
| Family history | 40.0% | 51.0% | <0.001 |
| ST-segment elevation myocardial infarction | 10.3% | 6.2% | 0.01 |
| Cardiogenic shock | 0.2% | 0.7% | 0.37 |
| Unstable angina pectoris | 30.6% | 46.7% | <0.001 |
| Non–ST-segment elevation myocardial infarction | 15.5% | 12.6% | 0.15 |
| Stable angina pectoris | 25.7% | 19.3% | 0.008 |
| Positive functional test result | 32.4% | 43.2% | <0.001 |
| Other | 12.1% | 19.8% | 0.534 |
| Acute coronary syndrome | 54.5% | 60.6% | 0.03 |
⁎ History of systemic hypertension diagnosed and/or treated with medication or currently being treated with diet and/or medication by a physician.
| TAXUS Liberté (n = 595) | XIENCE V (n = 600) | p Value | |
|---|---|---|---|
| Thienopyridine therapy | |||
| Thienopyridine maintenance | 38.3% | 34.2% | 0.14 |
| Thienopyridine load before percutaneous coronary intervention | 56.4% | 48.1% | 0.03 |
| Thienopyridine load after percutaneous coronary intervention | 44.3% | 51.9% | 0.05 |
| Procedural anticoagulant | |||
| Unfractionated heparin | 62.7% | 29.9% | <0.001 |
| Bivalirudin | 31.1% | 66.5% | <0.001 |
| Low-molecular-weight heparin | 0.5% | 0.2% | 0.373 |
| Glycoprotein IIb/IIIa inhibitor | 24.2% | 13.7% | <0.001 |
Angiographic characteristics are presented in Table 3 . Vessel location was comparable between groups with 35.5% of lesions located in the left anterior descending coronary artery, 31.7% in the right coronary artery, 24.0% in the left circumflex coronary artery, and 6.0% in a saphenous vein graft. Overall, lesion complexity was similar between groups, except there were slightly more ostial lesions in the PES group (9.7% vs 3.2% in EES group, p <0.001) and more proximal lesions in the EES group (41.4% vs 29.1% in PES group, p <0.001). Although only 3.5% of lesions had been previously treated for in-stent restenosis, there were more lesions in the EES group (4.8% vs 2.1% in PES group, p = 0.002). Intravascular ultrasound-guided PCI was performed in a significantly larger proportion of the EES group (35.0% vs 11.3% in PES group, p <0.001) and more predilatation in the PES group (58.6% vs 51.2% in EES group, p = 0.003). There was no difference in number of stents placed per lesion between groups (1.1 ± 0.4 stents per lesion placed overall).
| TAXUS Liberté (n = 833) | XIENCE V (n = 857) | p Value | |
|---|---|---|---|
| Right coronary artery | 32.3% | 31.0% | 0.58 |
| Left main coronary artery | 2.8% | 1.9% | 0.22 |
| Left anterior descending coronary artery | 33.3% | 37.7% | 0.06 |
| Left circumflex coronary artery | 24.1% | 23.9% | 0.92 |
| Saphenous vein graft | 7.0% | 5.0% | 0.09 |
| Current in-stent restenosis | 8.7% | 6.9% | 0.18 |
| Proximal location | 29.1% | 41.4% | <0.001 |
| Mid location | 25.3% | 35.6% | <0.001 |
| Bifurcation | 0.8% | 0.6% | 0.53 |
| Diameter before stenosis (visual) | 85.2 ± 12.1 | 85.0 ± 10.1 | 0.80 |
| Number of lesions per patient | 1.4 ± 0.7 | 1.4 ± 0.7 | 0.49 |
| Intravascular ultrasound | 11.3% | 35.0% | <0.001 |
| Fractional flow reserve | 1.0% | 0.5% | 0.30 |
| Thrombus extraction | 5.7% | 3.2% | 0.01 |
| Stent (TAXUS Liberté or XIENCE V/Promus) | 99.0% | 98.9% | — |
| Rotational atherectomy | 1.9% | 1.5% | 0.51 |
| Cutting balloon | 1.1% | 1.6% | 0.34 |
| Balloon before procedure | 58.6% | 51.2% | 0.002 |
| Balloon after procedure | 47.5% | 29.3% | <0.001 |
| Number of stents per lesion | 1.1 ± 0.4 | 1.1 ± 0.3 | 0.53 |
Intraprocedural complications were low and similar between groups with angiographic success achieved in 97.7% of lesions overall. In-hospital outcome was also similar, with overall in-hospital stent thrombosis of 0.2% ( Table 4 ).
| TAXUS Liberté (n = 595) | XIENCE V (n = 600) | p Value | |
|---|---|---|---|
| Procedural success | 97.3% | 98.0% | 0.37 |
| Abrupt closure | 0.2% | 0.5% | 0.69 |
| No reflow | 0.4% | 0.0% | 0.12 |
| Perforation | 0.5% | 0.0% | 0.06 |
| Thrombolysis In Myocardial Infarction grade flow after procedure | |||
| 3 | 96.9% | 97.4% | 0.49 |
| 2 | 1.4% | 2.0% | 0.39 |
| 1 | 0.2% | 0.0% | 0.24 |
| 0 | 0.1% | 0.1% | 1.0 |
| Death | 0.3% | 0.3% | 1 |
| Myocardial infarction | 1.3% | 1.0% | 0.58 |
| Q-wave myocardial infarction | 0% | 0.2% | 1 |
| Target vessel revascularization | 1% | 0.5% | 0.34 |
| Target lesion revascularization | 0.7% | 0.3% | 0.45 |
| Stent thrombosis | 0.2% | 0.2% | 1 |
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