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Comparison of Two Biodegradable-Polymer-Based Sirolimus-Eluting Stents With Varying Elution and Absorption Kinetics in Patients With Acute Myocardial Infarction: A Subgroup Analysis of the PANDA III Trial Changdong Guan, Bo Xu, Shubin Qiao, Lei Qin, Yi Li, Zhanquan Li,Yong Guo, Zhongwei Sun, Lei Song,and Runlin Gao, on behalf of the PANDA III Investigators Catheterization and Cardiovascular Interventions 

 

Biodegradable Polymer-Based Sirolimus-Eluting Stents With Differing Elution and Absorption Kinetics-The PANDA III Trial

 

Bo Xu, Runlin Gao, Yuejin Yang, Xuebin Cao, Lei Qin, Yi Li, Zhanquan Li, Xueqi Li, Hailong Lin, Yong Guo, Yitong Ma, Jian’an Wang, Shaoping Nie, Liang Xu, Eric Cao, Changdong Guan, Gregg W. Stone, on behalf of the PANDA III Investigators

Journal of the American College of Cardiology
Polymer Biodegradation Kinetics. 
Do They Matter?
Carlos Collet, MD, Patrick W.Serruys, MD, PHD Journal of the American College of Cardiology

Optical coherence tomography assessment of a PLGA-polymer with electro-grafting base layer versus a PLA-polymer sirolimus-eluting stent at three-month follow-up: the BuMA-OCT randomised trial Qian J, Zhang YJ, Xu B, Yang YJ, Yan HB, Sun ZW, Zhao YL, Tang YD, Gao Z, Chen J, Cui JG, Gary S. Mintz, Gao RL EuroIntervention
Optical coherence tomography for evaluation of neointimal proliferation after placement of a new drug eluting stent Liu CF, Chen YD, Chen L, Sun ZJ, Gai LY, Liu HB, Tian F, Bai QC, Guo K. Journal of Southern Medical University
Investigation of long-term implantation of BuMA stent in a porcine coronary model Chen M, Wang XG, Zheng B, Peng HY, Zhang XY, Zhang B, Huo Y Chinese Medical Journal
A prospective multi center parallel controlled of BuMA™ vs. Endeavor™ clinical trial program Chen X, Tian R, Wang GZ, Shi DM, Wang ZJ, Chi YP, Dai WL, etc Chinese Journal of Interventional Cardiology
[ Abstracts ]

Biodegradble Polymer-Based Sirolimus-Eluting Stents With Differing Elution and Absorption Kinetics - The Panda III Trial

 

Journal of the American College of Cardiology 2016; 475: 2249-58

Bo Xu, Runlin Gao, Yuejin Yang, Xuebin Cao, Lei Qin, Yi Li, Zhanquan Li, Xueqi Li, Hailong Lin, Yong Guo, Yitong Ma, Jian’an Wang, Shaoping Nie, Liang Xu, Eric Cao, Changdong Guan, Gregg W. Stone, on behalf of the PANDA III Investigators

Background: Whether the rate of drug elution and polymer absorption affects clinical outcomes of biodegradable polymer-based drug-eluting stents (DES) is unknown. The widely used polylactide polymer-based Excel stent (JW Medical, Weihai, China) elutes sirolimus within 180 days, and the polylactide polymer is completely absorbed within 6 to 9 months. In contrast, the poly-lactide-co-glycolide polymer-based BuMA stent (Sino Medical, Tianjin, China) elutes sirolimus within 30 days, and the poly-lactide-co-glycolide polymer is completely absorbed within 3 months. Thus, both metallic DES elute sirolimus, isolating major differences to the polymer and elution kinetics.

Objectives: The goal of this study was to compare the safety and effectiveness between the BuMA sirolimus-eluting stent (SES) and Excel SES in an “all-comers” population.

Methods:PANDA III was a multicenter trial with few exclusion criteria, powered for sequential noninferiority and superiority testing. The primary endpoint was 1-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization.

Results: Between December 2013 and August 2014, 2,348 patients were randomly assigned to treatment with BuMA (n=1,174) or Excel SES (n=1,174). The 1-year primary endpoint of TLF occurred in 6.4% of patients in each group (difference: 0.06%; 95% confidence interval: 1.93% to 2.04%; p noninferiority=0.0003; p superiority=0.95). There were no significant between-group differences in any of the secondary endpoints other than the incidence of definite/probable stent thrombosis, which occurred less frequently with the BuMA stent (0.5% vs. 1.3%; log-rank p=0.048).

Conclusions: The BuMA SES was demonstrated to be noninferior to the Excel SES for 1-year TLF, with a lower incidence of stent thrombosis. (Comparison of BuMA eG Based Bio Degradable Polymer Stent With EXCEL Biodegradable Polymer Sirolimus-eluting Stent in “Real-World” Practice [PANDA-III]; NCT02017275) (J Am Coll Cardiol 2016; 67: 2249–58)

© 2016 by the American College of Cardiology Foundation.

 

Optical coherence tomography assessment of a PLGA-polymer with electro-grafting base layer versus a PLA-polymer sirolimus-eluting stent at three-month follow-up: the BuMA-OCT randomised trial

EuroIntervention2014;10:806-814

Qian J, Zhang YJ, Xu B, Yang YJ, Yan HB, Sun ZW, Zhao YL, Tang YD, Gao Z, Chen J, Cui JG, Gary S. Mintz, Gao RL

Aims: To compare stent strut coverage using optical coherence tomography (OCT) at three-month follow-up between a PLGA-polymer with electro-grafting base layer sirolimus-eluting stent (SES) (BuMA) and a PLA-polymer SES (EXCEL).

Methods and results: This prospective, single-centre, non-inferiority randomised BuMA-OCT trial enrolled patients with de novo coronary artery lesions, treated with either the BuMA or the EXCEL stent. The study primary endpoint was OCT-evaluated stent strut coverage at three months. Secondary endpoints were neointimal thickness of stent struts, and incomplete stent apposition evaluated with OCT. A total of 80 patients were randomly assigned to receive the BuMA (n=40) or the EXCEL (n=40) stent. In OCT follow-up (achieved in 86.3% of cases: BuMA, n=33; EXCEL, n=36), the percentage of stent strut coverage was significantly higher in the BuMA vs. the EXCEL group (strut level: 94.2% vs. 90.0%, p<0.01; pnon-inferiority<0.0001; psuperiority <0.0001), while the proportion of malapposed struts (strut level: 1.28% vs. 1.80%, p=0.51) and the mean neointimal thickness (strut level: 0.07±0.03 mm vs. 0.06±0.02 mm, p=0.31) were similar. Rates of myocardial infarction (periprocedural non-Q-wave, 7.5% vs. 7.5%, p=1.00) and target lesion failure (7.5% vs. 7.5%, p=1.00) were similar between groups, with no cardiac death or stent thrombosis.

Conclusions: In the BuMA-OCT randomised trial, the novel BuMA PLGA-polymer with electro-grafting base layer SES was superior to the EXCEL PLA-polymer SES in the primary endpoint of stent strut coverage at three-month follow-up.

 

Optical coherence tomography for evaluation of neointimal proliferation after placement of a new drug eluting stent

Journal of Southern Medical University, 2010 May;30(5):1063-5

Liu CF, Chen YD, Chen L, Sun ZJ, Gai LY, Liu HB, Tian F, Bai QC, Guo K.

Objective: To evaluate neointimal proliferation following placement of a new drug-eluting stent (BUMA) byoptical coherence tomography (OCT).

Methods: Twenty-two patients with coronary artery disease were randomized into BUMA group (n=15) and Endeavor group (n=7) and underwent OCT imaging after 9 months of stent implantation.

Results: The neointima hyperplasia (NIH) thickness in BUMA group were significantly smaller than that in endeavor group (0.220-/+0.140 mm vs 0.269-/+0.207 mm, P<0.001), and the uncovered Struts were significantly lower in BUMA group than in Endeavor group (5.65% vs 6.56%, P<0.0001). The luminal late loss in BUMA group was also significantly lower (34.87-/+11.50 vs 40.82-/+18.53, P=0.025).

Conclusion: BUMA stent is safe and effective for treatment of coronary artery disease.

 

Investigation of long-term implantation of BuMA stent in a porcine coronary model

Chinese Medical Journal (English) 2012 Nov;125(22):4083-7

Chen M, Wang XG, Zheng B, Peng HY, Zhang XY, Zhang B, Huo Y

Background: Stent-based delivery of sirolimus has been shown to reduce neointimal hyperplasia significantly. However, the long-term effect of the polymer is thought to initiate and sustain an inflammatory response and contribute to the occurrence of late complications. Our study aimed to evaluate the efficacy and safety of the BuMA biodegradable drug-coated sirolimus-eluting stent (BSES) for inhibiting neointimal hyperplasia in aporcine coronary model.

Methods: Four types of stents were implanted at random in different coronary arteries of the same pig: BSES (n = 24), bare metal stent (BMS) (n = 24), biodegradable polymer coated stent without drug (PCS) (n = 24) and only poly (n-butyl methacrylate) base layer coated stent (EGS) (n = 23). In total, 26 animals underwent successful random placement of 95 oversized stents in the coronary arteries. Coronary angiography was performed after 28 days, 90 days and 240 days of stent implantation. After 14 days, 28 days, 90 days and 240 days, 6 animals at each timepoint were sacrificed for histomorphologic analysis.

Results: The 28-day, 90-day and 240-day results of quantitative coronary angiography (QCA) showed reduction in luminal loss (LL) in the BSES group when compared with the BMS group; (0.20 ± 0.35) mm vs. (0.82 ± 0.51) mm (P = 0.035), (0.20 ± 0.30) mm vs. (0.93 ± 0.51) mm (P = 0.013), and (0.18 ± 0.16) mm vs. (0.19 ± 0.24) mm (P = 0.889), respectively. By 28-day, 90-day and 240-day histomorphomeric analysis results, there was also a corresponding significant reduction in neointimal tissue proliferation with similar injury scores of BSES compared with the BMS control; average neointimal area (0.90 ± 0.49) mm(2) vs. (2.16 ± 1.29) mm(2) (P = 0.049), (1.53 ± 0.84) mm(2) vs. (3.41 ± 1.55) mm(2) (P = 0.026), and (2.43 ± 0.95) mm(2) vs. (3.12 ± 1.16) mm(2) (P = 0.228), respectively. High magnification histomorphologic examination revealed similar inflammation scores and endothelialization scores in both the BSES and BMS groups.

Conclusions: The BuMA biodegradable drug-coated sirolimus-eluting stents can significantly reduce neointimal hyperplasia and in-stentrestenosis. Re-endothelialization of the BuMA stent is as good as that of the BMS in the porcine coronary model due to the reduced inflammation response to the BuMA stent.

 

A prospective multi center parallel controlled of BuMA™ vs. Endeavor™ clinical trial program

Chinese Journal of Interventional Cardiology, 2013-03

Objective: To evaluate the efficacy and safety of BuMA Biodegradable drug eluting coronary stent system compare with the Endeavor Coronary stent system.

Methods:This is a prospective,parallel-group controlled,multi-center,non-inferiority test study performed in nine centers in China.From Feb.2008 to Aug.2008,224 patients with silent myocardial ischemia,stable or unstable angina and myocardial infarction more than a week,who undertook coronary stent angiography,were enrolled in the study.Eligible patients were divided into BuMA stent group(test group,113 patients) and Endeavor stent group(control group,111 patients).The primary endpoint of the study was a 270(±30) day late lumen loss measured by quantitative coronary angiography(QCA).The sencondary endpoint was the incidence of major adverse cardiac events(MACE),stent thrombosis events after the stent implantation 30 days,90 days,180 days,270 days,360 days and 540 days,following up till 720 days.

Results: The late lumen loss in 270(±30) days in BuMA stent group and Endeavor stent group was 0.24 mm and 0.50 mm.The 540-day major adverse cardiac event rate in BuMA group and Endeavor group was 6.19% and 8.11%,respectively(χ2=0.3097,P=0.5778).The 720-day major adverse cardiac event rate in BuMA group and Endeavor group was 6.19% and 9.91%,respectively(χ2=1.0533,P=0.3048).

Conclusions: Compared with the Endeavor,BuMA Biodegradable drug eluting coronary stent reduced the late lumen loss,which indicates that BuMA may be superior to the Endeavor stent on reducing stent restenosis.The result also proved the safety and efficacy of BuMA.