|Bioresorbable Vascular Scaffolds Versus Metallic Stents in Patients With Coronary Artery Disease ABSORB China Trial|
|Gao, Runlin1; Yang, Yuejin1; Han, Yaling2; Huo, Yong3; Chen, Jiyan4; Yu, Bo5; Su, Xi6; Li, Lang7; Kuo, Hai-Chien8; Ying, Shih-Wa8; Cheong, Wai-Fung8; Zhang, Yunlong8; Su, Xiaolu8; Xu, Bo1; Popma, Jeffery J.9; Stone, Gregg W.10,11; ABSORB China Investigators|
|关键词||Bioresorbable Vascular Scaffold Everolimus Randomized Controlled Trial Stent|
|刊名||JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY|
|WOS标题词||Science & Technology|
|类目[WOS]||Cardiac & Cardiovascular Systems|
|研究领域[WOS]||Cardiovascular System & Cardiology|
|关键词[WOS]||DRUG-ELUTING STENTS ; RANDOMIZED-TRIALS ; END-POINTS ; OUTCOMES ; DEVICES ; IMPACT|
BACKGROUND The everolimus-eluting bioresorbable vascular scaffold (BVS) is designed to achieve results comparable to metallic drug-eluting stents at 1 year, with improved long-term outcomes. Whether the 1-year clinical and angiographic results of BVS are noninferior to current-generation drug-eluting stents has not been established.
OBJECTIVES This study sought to evaluate the angiographic efficacy and clinical safety and effectiveness of BVS in a randomized trial designed to enable approval of the BVS in China.
METHODS Eligible patients with 1 or 2 de novo native coronary artery lesions were randomized to BVS or cobalt-chromium everolimus-eluting stents (CoCr-EES) in a 1: 1 ratio stratified by diabetes and the number of lesions treated. Angiographic and clinical follow-up were planned at 1 year in all patients. The primary endpoint was angiographic in-segment late loss (LL), powered for noninferiority with a margin of 0.15 mm.
RESULTS A total of 480 patients were randomized (241 BVS vs. 239 CoCr-EES) at 24 sites. Acute clinical device success (98.0% vs. 99.6%; p = 0.22) and procedural success (97.0% and 98.3%; p = 0.37) were comparable in BVS- and CoCr-EES-treated patients, respectively. The primary endpoint of in-segment LL at 1 year was 0.19 +/- 0.38 mm for BVS versus 0.13 +/- 0.38 mm for CoCr-EES; the 1-sided 97.5% upper confidence limit of the difference was 0.14 mm, achieving noninferiority of BVS compared with CoCr-EES (P-noninferiority = 0.01). BVS and CoCr-EES also had similar 1-year rates of target lesion failure (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization; 3.4% vs. 4.2%, respectively; p = 0.62) and definite/probable scaffold/stent thrombosis (0.4% vs. 0.0%, respectively; p = 1.00).
CONCLUSIONS In the present multicenter randomized trial, BVS was noninferior to CoCr-EES for the primary endpoint of in-segment LL at 1 year. (A Clinical Evaluation of Absorb Bioresorbable Vascular Scaffold [Absorb BVS] System in Chinese Population-ABSORB CHINA Randomized Controlled Trial [RCT]; NCT01923740) (C) 2015 by the American College of Cardiology Foundation.
|作者单位||1.Abbott Vasc, Santa Clara, CA USA|
2.Beth Israel Deaconess Med Ctr, Boston, MA 02215 USA
3.Cardiovasc Res Fdn, New York, NY USA
4.Guangdong Gen Hosp, Guangzhou, Guangdong, Peoples R China
5.Wuhan Asia Heart Hosp, Wuhan, Peoples R China
6.Shenyang Mil Reg, Gen Hosp, Shenyang, Peoples R China
7.Peking Univ, Hosp 1, Beijing 100871, Peoples R China
8.Chinese Acad Med Sci, Fu Wai Hosp, Natl Ctr Cardiovasc Dis, Beijing 100037, Peoples R China
9.Harbin Med Univ, Affiliated Hosp 2, Key Lab Myocardial Ischemia, Chinese Minist Educ, Harbin, Peoples R China
10.Guangxi Med Univ, Affiliated Hosp 1, Nanning, Peoples R China
11.Columbia Univ, Med Ctr, New York Presbyterian Hosp, New York, NY USA
|Gao, Runlin,Yang, Yuejin,Han, Yaling,et al. Bioresorbable Vascular Scaffolds Versus Metallic Stents in Patients With Coronary Artery Disease ABSORB China Trial[J]. JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY,2015,66(21):2298-2309.|
|APA||Gao, Runlin.,Yang, Yuejin.,Han, Yaling.,Huo, Yong.,Chen, Jiyan.,...&ABSORB China Investigators.(2015).Bioresorbable Vascular Scaffolds Versus Metallic Stents in Patients With Coronary Artery Disease ABSORB China Trial.JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY,66(21),2298-2309.|
|MLA||Gao, Runlin,et al."Bioresorbable Vascular Scaffolds Versus Metallic Stents in Patients With Coronary Artery Disease ABSORB China Trial".JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY 66.21(2015):2298-2309.|