TY - JOUR
T1 - An abluminal biodegradable polymer sirolimus-eluting stent versus a durable polymer everolimus-eluting stent in patients undergoing coronary revascularization
T2 - 3-year clinical outcomes of a randomized non-inferiority trial
AU - Zhang, Haijun
AU - Zhang, Xiaoping
AU - Yin, Yuxia
AU - Zhou, Chao
AU - Deng, Wei
AU - Zhang, Junwei
AU - Hou, Wenbo
AU - Lu, Shoutao
AU - Song, Caixia
AU - Cui, Xiaoshan
AU - Wang, Shenguo
AU - Yang, Fei
AU - Liu, Guang
AU - Duan, Cuihai
AU - Ge, Junbo
PY - 2019/12
Y1 - 2019/12
N2 - The Cordimax stent has proved non-inferior to the Cypher Select durable polymer sirolimus-eluting stent for the primary endpoint of angiographic in-stent late luminal loss and in-stent mean diameter stenosis at 9 months. The trial was designed to compare the efficacy and safety of the Cordimax stent with the Xience V stent in patients undergoing coronary revascularization. This randomized, multicenter trial enrolled 3697 patients treated with Cordimax stent (2460 patients) and Xience V stent (1237 patients). The primary efficacy endpoint was a target-lesion failure (TLF) at 1 year and the primary safety endpoint was a composite of death or myocardial infarction (MI) at 3 years. 3399 patients (91.9%) completed 3-year follow-up. At 1 year, the primary efficacy endpoint occurred in 86 (3.5%) patients in the Cordimax group versus 40 (3.2%) patients in the Xience V group (0.3% absolute risk difference, 95% CI -1.0-1.5%, Pnon-inferiority < 0.0001). At 3 years, the primary safety endpoint occurred in 39 (1.6%) patients in the Cordimax group versus 19 (1.5%) patients in the Xience V group (0.05% absolute risk difference, 95% CI -0.8-0.9%, Pnon-inferiority < 0.0001). The incidence of target lesion revascularization was low in Cordimax group compared with Xience V group (3.6% versus 5.1%, P = 0.03). There were no differences between Cordimax and Xience V in terms of Cardiac death (0.3% versus 0.4%, P = 0.70), myocardial infarction (1.2% versus 0.9%, P = 0.37), and the stent thrombosis (0.4% versus 0.6%, P = 0.61). In conclusion, safety and efficacy outcomes of Cordimax stent were non-inferior to the Xience V stent 3 years after stent implantation.
AB - The Cordimax stent has proved non-inferior to the Cypher Select durable polymer sirolimus-eluting stent for the primary endpoint of angiographic in-stent late luminal loss and in-stent mean diameter stenosis at 9 months. The trial was designed to compare the efficacy and safety of the Cordimax stent with the Xience V stent in patients undergoing coronary revascularization. This randomized, multicenter trial enrolled 3697 patients treated with Cordimax stent (2460 patients) and Xience V stent (1237 patients). The primary efficacy endpoint was a target-lesion failure (TLF) at 1 year and the primary safety endpoint was a composite of death or myocardial infarction (MI) at 3 years. 3399 patients (91.9%) completed 3-year follow-up. At 1 year, the primary efficacy endpoint occurred in 86 (3.5%) patients in the Cordimax group versus 40 (3.2%) patients in the Xience V group (0.3% absolute risk difference, 95% CI -1.0-1.5%, Pnon-inferiority < 0.0001). At 3 years, the primary safety endpoint occurred in 39 (1.6%) patients in the Cordimax group versus 19 (1.5%) patients in the Xience V group (0.05% absolute risk difference, 95% CI -0.8-0.9%, Pnon-inferiority < 0.0001). The incidence of target lesion revascularization was low in Cordimax group compared with Xience V group (3.6% versus 5.1%, P = 0.03). There were no differences between Cordimax and Xience V in terms of Cardiac death (0.3% versus 0.4%, P = 0.70), myocardial infarction (1.2% versus 0.9%, P = 0.37), and the stent thrombosis (0.4% versus 0.6%, P = 0.61). In conclusion, safety and efficacy outcomes of Cordimax stent were non-inferior to the Xience V stent 3 years after stent implantation.
KW - Absorbable Implants/adverse effects
KW - Aftercare
KW - Aged
KW - Coronary Stenosis/complications
KW - Delayed-Action Preparations/administration & dosage
KW - Drug-Eluting Stents/adverse effects
KW - Everolimus/administration & dosage
KW - Female
KW - Humans
KW - Male
KW - Middle Aged
KW - Myocardial Infarction/epidemiology
KW - Percutaneous Coronary Intervention/adverse effects
KW - Polymers/chemistry
KW - Sirolimus/administration & dosage
KW - Thrombosis/epidemiology
KW - Treatment Outcome
U2 - 10.1038/s41598-019-54964-8
DO - 10.1038/s41598-019-54964-8
M3 - Journal article
C2 - 31811206
SN - 2045-2322
VL - 9
JO - Scientific Reports
JF - Scientific Reports
IS - 1
M1 - 18549
ER -