药物涂层球囊与药物洗脱支架治疗初发冠状动脉疾病的随机对照试验荟萃分析
Drug-Coated Balloons versus Drug-Eluting Stents for the Treatment of De Novo Coronary Artery Disease: A Meta-Analysis of Randomized Controlled Trials.
作者信息
Niu Jialong, Wang Kexin, Wang Wenjie, Liu Yixuan, Yang Jiaxin, Sun Yan, Wang Furong, Gao Wen, Ge Hailong
机构信息
Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, 100069 Beijing, China.
Department of Cardiology, Inner Mongolia Ordos City Dalate Banner People's Hospital, 017000 Ordos, Inner Mongolia Autonomous Region, China.
出版信息
Rev Cardiovasc Med. 2024 Dec 19;25(12):446. doi: 10.31083/j.rcm2512446. eCollection 2024 Dec.
BACKGROUND
Because of the limitations in new-generation drug-eluting stents (DES), treatments advocating for non-stents with a drug-coated balloon (DCB) is now of great interest. Here, we conducted a meta-analysis to testify whether a DCB was more effective and safer than a DES in treating de novo coronary artery disease (CAD).
METHODS
We searched PubMed, Embase, Cochrane Library, and Web of Science to obtain high-quality trials comparing DCB with DES for the treatment of de novo CAD. The primary endpoint was target lesion revascularization (TLR), and the secondary endpoints were in-lesion late lumen loss (LLL), all-cause death, myocardial infarction and binary restenosis.
RESULTS
We enrolled 1661 patients from seven randomized clinical trials. Compared with the DES group, the MD (mean difference) of in-lesion LLL was significantly lower in the DCB group (MD -0.19, 95% CI -0.23 to -0.16, < 0.00001, I = 0%). The DCB group showed superiority in small vessel disease (SVD) in in-lesion LLL (MD -0.21, 95% CI -0.34 to -0.08, = 0.001).
CONCLUSIONS
The DCB group exhibited a lower in-lesion LLL compared to the DES group, and DCB was not inferior to DES in other endpoints, including in the SVD subgroup. Hence, to our knowledge, DCB is non-inferior to DES for de novo CVD and SVD. DCB in patients with CVD needs further large and long-term clinical trials to demonstrate its long-term efficacy.
THE PROSPERO REGISTRATION
CRD42021268965, https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=268965.
背景
由于新一代药物洗脱支架（DES）存在局限性，目前提倡使用药物涂层球囊（DCB）进行非支架治疗，这引起了广泛关注。在此，我们进行了一项荟萃分析，以验证在治疗初发冠状动脉疾病（CAD）方面，DCB是否比DES更有效、更安全。
方法
我们检索了PubMed、Embase、Cochrane图书馆和Web of Science，以获取比较DCB与DES治疗初发CAD的高质量试验。主要终点是靶病变血运重建（TLR），次要终点是病变内晚期管腔丢失（LLL）、全因死亡、心肌梗死和二元再狭窄。
结果
我们纳入了来自七项随机临床试验的1661名患者。与DES组相比，DCB组病变内LLL的平均差（MD）显著更低（MD -0.19，95%CI -0.23至-0.16，<0.00001，I = 0%）。DCB组在小血管疾病（SVD）的病变内LLL方面显示出优势（MD -0.21，95%CI -0.34至-0.08，= 照0.001）。
结论
与DES组相比，DCB组的病变内LLL更低，并且在包括SVD亚组在内的其他终点方面，DCB并不劣于DES。因此，据我们所知，对于初发心血管疾病（CVD）和SVD，DCB不劣于DES。CVD患者使用DCB需要进一步的大型长期临床试验来证明其长期疗效。
PROSPERO注册编号：CRD42021268965，https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=268965 。
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