Kyung Woo Park1, Si-Hyuck Kang1, Hyun-Jae Kang1, Bon-Kwon Koo1, Byoung-Eun Park2, Kwang Soo Cha3, Jay Young Rhew4, Hui-Kyoung Jeon5, Eun-Seok Shin6, Ju Hyeon Oh7, Myung-Ho Jeong8, Sanghyun Kim9, Kyung-Kuk Hwang10, Jung-Han Yoon11, Sung Yun Lee12, Tae-Ho Park13, Keon Woong Moon14, Hyuck-Moon Kwon15, Seung-Ho Hur16, Jae-Kean Ryu17, Bong-Ryul Lee18, Yong Whi Park19, In-Ho Chae20, Hyo-Soo Kim21. 1. Seoul National University Hospital, Seoul, Republic of Korea. 2. Dankook University Hospital, Cheonan, Republic of Korea. 3. Busan National University Hospital, Busan, Republic of Korea. 4. Presbyterian Medical Center, Jeonju, Republic of Korea. 5. Uijeongbu St. Mary's Hospital, Uijeongbu, Republic of Korea. 6. Ulsan University Hospital, Ulsan, Republic of Korea. 7. Samsung Changwon Hospital, Changwon, Republic of Korea. 8. Chonnam National University Hospital, Gwangju, Republic of Korea. 9. Boramae Medical Center, Seoul, Republic of Korea. 10. Chungbuk National University Hospital, Cheongju, Republic of Korea. 11. Wonju Christian Hospital, Wonju, Republic of Korea. 12. Inje University Ilsan Paik Hospital, Goyang, Republic of Korea. 13. Dong-A Medical Center, Busan, Republic of Korea. 14. St. Vincent's Hospital, Suwon, Republic of Korea. 15. Gangnam Severance Hospital, Seoul, Republic of Korea. 16. Keimyung University Dongsan Medical Center, Daegu, Republic of Korea. 17. Daegu Catholic University Medical Center, Daegu, Republic of Korea. 18. Daegu Fatima Hospital, Daegu, Republic of Korea. 19. Gyeongsang National University Hospital, Jinju, Republic of Korea. 20. Seoul National University Bundang Hospital, Seongnam, Republic of Korea. Electronic address: ihchae@snu.ac.kr. 21. Seoul National University Hospital, Seoul, Republic of Korea. Electronic address: hyosoo@snu.ac.kr.
Abstract
OBJECTIVES: This study sought to test whether the newly developed platinum chromium (PtCr)-based everolimus-eluting stent (EES) is noninferior to the cobalt chromium (CoCr)-based zotarolimus-eluting stent (ZES) in all-comers receiving percutaneous coronary intervention (PCI). BACKGROUND: PtCr provides improved radial strength, conformability, and visibility compared with the CoCr alloy, but PtCr-based stents have not been tested in a wide range of patients receiving PCI. Also, recent case series have raised the issue of longitudinal stent deformation (LSD) with newer drug-eluting stents. METHODS: We randomly assigned 3,755 all-comers receiving PCI to PtCr-EES or CoCr-ZES. The primary outcome was target lesion failure (TLF) at 1-year post-PCI, defined as the composite of cardiac death, nonfatal target vessel-related myocardial infarction, and ischemia-driven target lesion revascularization. Post-hoc angiographic analysis was performed to qualitatively and quantitatively analyze LSD. RESULTS: At 1 year, TLF occurred in 2.9% and 2.9% of the population in the PtCr-EES and CoCr-ZES groups, respectively (superiority p = 0.98, noninferiority p = 0.0247). There were no significant differences in the individual components of TLF as well as the patient-oriented clinical outcome. Of 5,010 stents analyzed, LSD occurred in 0.2% and 0% in the PtCr-EES and CoCr-ZES groups, respectively (p = 0.104). There was no significant difference in post-deployment stent length ratio between the 2 stents (p = 0.352). CONCLUSIONS: At 1 year, PtCr-EES was noninferior to CoCr-ZES in all-comers receiving PCI. Although LSD was observed only in PtCr-EES, both the stent length ratio and the frequency of LSD were not significantly different between the 2 stent types, and PtCr-EES was not associated with adverse clinical outcomes. (Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis-SAfety & EffectiveneSS of Drug-ElUting Stents & Anti-platelet REgimen [HOST-ASSURE]; NCT01267734).
RCT Entities:
OBJECTIVES: This study sought to test whether the newly developed platinum chromium (PtCr)-based everolimus-eluting stent (EES) is noninferior to the cobalt chromium (CoCr)-based zotarolimus-eluting stent (ZES) in all-comers receiving percutaneous coronary intervention (PCI). BACKGROUND:PtCr provides improved radial strength, conformability, and visibility compared with the CoCr alloy, but PtCr-based stents have not been tested in a wide range of patients receiving PCI. Also, recent case series have raised the issue of longitudinal stent deformation (LSD) with newer drug-eluting stents. METHODS: We randomly assigned 3,755 all-comers receiving PCI to PtCr-EES or CoCr-ZES. The primary outcome was target lesion failure (TLF) at 1-year post-PCI, defined as the composite of cardiac death, nonfatal target vessel-related myocardial infarction, and ischemia-driven target lesion revascularization. Post-hoc angiographic analysis was performed to qualitatively and quantitatively analyze LSD. RESULTS: At 1 year, TLF occurred in 2.9% and 2.9% of the population in the PtCr-EES and CoCr-ZES groups, respectively (superiority p = 0.98, noninferiority p = 0.0247). There were no significant differences in the individual components of TLF as well as the patient-oriented clinical outcome. Of 5,010 stents analyzed, LSD occurred in 0.2% and 0% in the PtCr-EES and CoCr-ZES groups, respectively (p = 0.104). There was no significant difference in post-deployment stent length ratio between the 2 stents (p = 0.352). CONCLUSIONS: At 1 year, PtCr-EES was noninferior to CoCr-ZES in all-comers receiving PCI. Although LSD was observed only in PtCr-EES, both the stent length ratio and the frequency of LSD were not significantly different between the 2 stent types, and PtCr-EES was not associated with adverse clinical outcomes. (Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis-SAfety & EffectiveneSS of Drug-ElUting Stents & Anti-platelet REgimen [HOST-ASSURE]; NCT01267734).
Authors: Joseph P Drozda; Jove Graham; Joseph B Muhlestein; James E Tcheng; James Roach; Tom Forsyth; Stacey Knight; Andrew McKinnon; Heidi May; Natalia A Wilson; Jesse A Berlin; Edgar P Simard Journal: JAMIA Open Date: 2022-05-25
Authors: Stephen Hamshere; Alex Byrne; Tawfiq Choudhury; Sean M Gallagher; Krishnaraj S Rathod; Julia Lungley; Charles J Knight; Akhil Kapur; Daniel A Jones; Anthony Mathur Journal: Open Heart Date: 2018-04-05