Michael A Gaglia1, Randy Goodroe2, Greg Mishkel3, Wassim Gharib4, Ali Tabrizchi5, Tamim Nazif6, John Wang7, Thomas Scott8, Mario Lopez9, Daniel Steinberg10, Jiaxiang Gai1, Rebecca Torguson1, Ron Waksman11. 1. MedStar Cardiovascular Research Network/MedStar Washington Hospital Center, Washington, DC, USA. 2. Grand Strand Regional Medical Center, Myrtle Beach, SC, USA. 3. Prairie Education and Research Cooperative, Springfield, IL, USA. 4. West Virginia University Heart Institute, Morgantown, WV, USA. 5. Sinai Hospital, Baltimore, MD, USA. 6. Columbia University Medical Center, New York, NY, USA. 7. Medstar Union Memorial Hospital, Baltimore, MD, USA. 8. Geisinger Medical Center, Danville, PA, USA. 9. Charlotte Heart Research Group, Port Charlotte, FL, USA. 10. Medical University of South Carolina, Charleston, SC, USA. 11. MedStar Cardiovascular Research Network/MedStar Washington Hospital Center, Washington, DC, USA. Electronic address: ron.waksman@medstar.net.
Abstract
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.
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.