de Liyis Bryan Gervais, Aryaweda Made Dhiyo Wiweka, Suastika Luh Oliva Saraswati
Faculty of Medicine, Udayana University, Denpasar, Bali, Indonesia.
Department of Cardiology and Vascular Medicine, Faculty of Medicine, Udayana University, Denpasar, Bali, Indonesia.
Glob Cardiol Sci Pract. 2024 Mar 3;2024(2):e202412. doi: 10.21542/gcsp.2024.12.
The efficacy of drug-coated balloons (DCB) versus drug-eluting stents (DES) for coronary artery disease (CAD) remains inconclusive. Despite paclitaxel's common use in both DES and DCB, there is a lack of meta-analyses comparing paclitaxel-eluting stents (PES) and paclitaxel-coated balloons (PCB). This meta-analysis aimed to evaluate and compare the outcomes of DES and DCB with paclitaxel. A systematic literature search of the Medline and Cochrane databases yielded six randomized controlled trials with 951 patients (1:1 ratio). Primary endpoints were mortality, target lesion vascularization (TLV), myocardial infarction (MI), target vessel revascularization (TVR), and major adverse cardiovascular events (MACEs). Secondary endpoints included in-device binary stenosis, in-segment binary stenosis, late luminal loss (LLL), post-minimal lumen diameter (MLD), and post-diameter stenosis. Within the study populations, the incidence of previous MI was significantly lower in the PES group than in the PCB group (26.70% vs. 39.22%, OR:0.56, 95% CI [0.41-0.76], = 0.0002). The meta-analysis results showed that mortality (OR:1.57, 95% CI [0.67-3.66], = 0.29), TLV (OR:0.74, 95% CI [0.37-1.48], = 0.39), MI (OR:1.76, 95% CI [0.79-3.88], = 0.16), TVR (OR:0.76, 95% CI [0.51-1.12], = 0.16), and MACEs (OR, 1.11; 95% CI [0.48-2.58]; = 0.81) did not exhibit significant differences between the PES and PCB groups in CAD. Furthermore, in stent or in balloon binary stenosis (OR:0.80, 95% CI [0.34-1.87], = 0.60), in segment binary stenosis (OR:1.16, 95% CI [0.48-2.80], = 0.74), LLL (MD:0.03, 95% CI [-0.11 to 0.17], = 0.65), post MLD (MD:0.04, 95% CI [-0.23 to 0.30], = 0.77), and post diameter stenosis (MD:-5.48, 95% CI [-13.88 to 2.92], = 0.20) were similar in both groups. Our comprehensive analysis concludes that both PES and PCB manifest comparable effectiveness and safety in CAD management.
药物涂层球囊(DCB)与药物洗脱支架(DES)治疗冠状动脉疾病(CAD)的疗效仍无定论。尽管紫杉醇在DES和DCB中都常用,但缺乏比较紫杉醇洗脱支架(PES)和紫杉醇涂层球囊(PCB)的荟萃分析。这项荟萃分析旨在评估和比较含紫杉醇的DES和DCB的疗效。对Medline和Cochrane数据库进行系统文献检索,得到六项随机对照试验,共951例患者(比例为1:1)。主要终点是死亡率、靶病变血管形成(TLV)、心肌梗死(MI)、靶血管血运重建(TVR)和主要不良心血管事件(MACE)。次要终点包括器械内二分叉狭窄、节段内二分叉狭窄、晚期管腔丢失(LLL)、最小管腔直径(MLD)后值和直径狭窄后值。在研究人群中,PES组既往MI的发生率显著低于PCB组(26.70%对39.22%,OR:0.56,95%CI[0.41 - 0.76],P = 0.0002)。荟萃分析结果显示,CAD患者中,PES组和PCB组在死亡率(OR:1.57,95%CI[0.67 - 3.66],P = 0.29)、TLV(OR:0.74,95%CI[0.37 - 1.48],P = 0.39)、MI(OR:1.76,95%CI[0.79 - 3.88],P = 0.16)、TVR(OR:0.76,95%CI[0.51 - 1.12],P = 0.16)和MACE(OR,1.11;95%CI[0.48 - 2.58];P = 0.81)方面未表现出显著差异。此外,支架或球囊内二分叉狭窄(OR:0.80,95%CI[0.34 - 1.87],P = 0.60)、节段内二分叉狭窄(OR:1.16,95%CI[0.48 - 2.80],P = 0.74)、LLL(MD:0.03,95%CI[-0.11至0.17],P = 0.65)、MLD后值(MD:0.04,95%CI[-0.23至0.30],P = 0.77)和直径狭窄后值(MD:-5.48,95%CI[-13.88至2.92],P = 0.20)在两组中相似。我们的综合分析得出结论,在CAD治疗中,PES和PCB表现出相当的有效性和安全性。