Department of Cardiovascular Surgery, The second xiangya hospital of Central South University, Changsha, Hunan, China.
Engineering Laboratory of Hunan Province for Cardiovascular Biomaterials, Changsha, Hunan, China.
BMJ Open. 2022 Jun 8;12(6):e058075. doi: 10.1136/bmjopen-2021-058075.
To compare the safety and effectiveness between biodegradable polymer drug-eluting stents (BP-DES) and durable polymer drug-eluting stents (DP-DES) in patients with acute coronary syndrome (ACS).
Meta-analysis of randomised controlled trials (RCTs).
Major adverse cardiovascular events (MACEs) were considered the primary endpoint. Efficacy endpoints included target vessel revascularisation (TVR) and target lesion revascularisation (TLR). Safety endpoints included all-cause death, cardiac death, target vessel myocardial infarction and stent thrombosis (ST).
We searched PubMed, Medline, Embase and the Cochrane Controlled Register of Trials for comparative studies of BP-DES and DP-DES in patients with ACS from January 2000 to July 2021. Statistical pooling was performed to estimate incidence using a random-effects model with generic inverse-variance weighting. Risk estimates were computed with 95% CIs.
Eight articles with seven RCTs that compared BP-DES and DP-DES in patients with ACS were identified and included in the qualitative and quantitative analyses. There was no difference in the baseline characteristics, except for the number of smoking patients (OR: 1.13, 95% CI 1.03 to 1.24; p=0.008, I=29%), which was significantly lower in the BP-DES group. The meta-analysis demonstrated that MACEs, efficacy endpoints and safety endpoints were similar between the groups at 1 year. However, the incidence of total ST was significantly different between the BP-DES and DP-DES groups in the follow-up period (p=0.0001). Further analysis showed a statistically significant difference in MACEs (OR: 0.71, 95% CI 0.57 to 0.88; p=0.002, I=0 %), TLR (OR: 0.71, 95% CI 0.51 to 1.01; p=0.05, I=0%), TVR (OR: 0.70, 95% CI 0.52 to 0.94; p=0.002, I=15%), total ST incidence (OR: 0.59, 95% CI 0.46 to 0.77; p=0.0001, I=48%) and ST incidence (OR: 0.63, 95% CI 0.47 to 0.85; p=0.002, I=0%) over 2 years.
This meta-analysis revealed that both stent types demonstrated excellent safety and efficacy profiles at 12 months. However, a slight increase in MACEs, TLR, TVR and ST incidence was observed in the DP-DES group over the 2-year follow-up period, suggesting that BP-DES may be more favourable when treating patients with ACS.
NCT00389220.
比较急性冠状动脉综合征（ACS）患者中生物可降解聚合物药物洗脱支架（BP-DES）和耐用聚合物药物洗脱支架（DP-DES）的安全性和有效性。
随机对照试验（RCT）的荟萃分析。
主要心血管不良事件（MACEs）被认为是主要终点。疗效终点包括靶血管血运重建（TVR）和靶病变血运重建（TLR）。安全性终点包括全因死亡、心脏死亡、靶血管心肌梗死和支架血栓形成（ST）。
我们检索了从 2000 年 1 月至 2021 年 7 月发表的比较 ACS 患者中 BP-DES 和 DP-DES 的PubMed、Medline、Embase 和 Cochrane 对照试验注册库中的比较研究。使用具有通用倒数方差加权的随机效应模型进行统计汇总，以估计发生率。使用 95%CI 计算风险估计值。
共确定了 8 篇文章，其中包含 7 项 RCT，比较了 ACS 患者中 BP-DES 和 DP-DES 的疗效。两组在基线特征方面没有差异，除了吸烟患者的数量（OR：1.13，95%CI 1.03 至 1.24；p=0.008，I=29%），BP-DES 组明显较低。荟萃分析表明，两组在 1 年时 MACEs、疗效终点和安全性终点相似。然而，在随访期间，BP-DES 和 DP-DES 组之间总 ST 的发生率存在显著差异（p=0.0001）。进一步分析显示，MACEs（OR：0.71，95%CI 0.57 至 0.88；p=0.002，I=0%）、TLR（OR：0.71，95%CI 0.51 至 1.01；p=0.05，I=0%）、TVR（OR：0.70，95%CI 0.52 至 0.94；p=0.002，I=15%）、总 ST 发生率（OR：0.59，95%CI 0.46 至 0.77；p=0.0001，I=48%）和 ST 发生率（OR：0.63，95%CI 0.47 至 0.85；p=0.002，I=0%）在 2 年时差异有统计学意义。
这项荟萃分析显示，两种支架在 12 个月时均具有良好的安全性和疗效。然而，在 2 年的随访期间，DP-DES 组的 MACEs、TLR、TVR 和 ST 发生率略有增加，这表明在治疗 ACS 患者时，BP-DES 可能更有利。
NCT00389220。
