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

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• 作者：Bo Xu ; MBBS^a ; Runlin Gao ; MD^a ; ^{gaorunlin@citmd.com" class="auth_mail" title="E-mail the corresponding author} ; Yuejin Yang ; MD^a ; Xuebin Cao ; MD^b ; Lei Qin ; MD^c ; Yi Li ; MD^d ; Zhanquan Li ; MD^e ; Xueqi Li ; MD^f ; Hailong Lin ; MD^g ; Yong Guo ; MD^h ; Yitong Ma ; MDⁱ ; Jian&rsquo ; an Wang ; MD^j ; Shaoping Nie ; MD^k ; Liang Xu ; MSc^a ; Eric Cao ; MSc^l ; Changdong Guan ; MSc^a ; Gregg W. Stone ; MD^m ; on behalf of the PANDA III Investigators
• 关键词：coronary artery disease ; drug-eluting stents ; randomized controlled trial ; thrombosis
• 刊名：Journal of the American College of Cardiology
• 出版年：2016
• 出版时间：17 May 2016
• 年：2016
• 卷：67
• 期：19
• 页码：2249-2258
• 全文大小：861 K

文摘

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.

absSec_2">Objectives

abspara0015">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.

absSec_3">Methods

abspara0020">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.

absSec_4">Results

abspara0025">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).

absSec_5">Conclusions

abspara0030">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 BioDegradable Polymer Stent With EXCEL Biodegradable Polymer Sirolimus-eluting Stent in “Real-World” Practice [PANDA-III]; an id="intref0010" class="interref" data-locatorType="https" data-locatorKey="//clinicaltrials.gov/ct2/show/NCT02017275">NCT02017275a>an>)