Efficacy and safety evaluation of paclitaxel-loaded metal stents in patients with malignant biliary obstructions.

Paclitaxel-eluting covered metal stents (PECMSs) and metallic stents covered with a paclitaxel-incorporated membrane (MSCPMs) have been developed to increase stent patency by preventing tumor ingrowth. However, few studies have compared their efficacy and safety compared with conventional covered metal stents (CMSs). This study aimed to compare differences in efficacy and safety between PECMS/MSCPM and CMS by meta-analysis. A search of PubMed and Embase was conducted for randomized controlled trials of PECMS/MSCPM and CMS in patients with malignant biliary obstructions published between January 1966 and August 2017. A meta-analysis was performed to compare clinical outcomes and complications between stent types. A total of 221 patients from three studies were included. There were no significant differences between PECMS/MSCPM and CMS in stent patency duration (P = 0.128) or survival time (P = 0.363). Risk did not differ between PECMS/MSCPM and CMS for stent malfunction (hazard ratio [HR]: 1.13, 95% confidence interval [CI]: 0.63-2.02, P = 0.677 for all stent malfunction; HR: 1.39, 95% CI: 0.68-2.85, P = 0.362 for stent occlusion caused by tumor ingrowth; HR: 0.80, 95% CI: 0.34-1.91, P = 0.617 for stent occlusion caused by distal stent migration or sludge impaction), or complications (HR: 1.54, 95% CI: 0.70-3.39, P = 0.280 for all complications; HR: 0.42, 95% CI: 0.14-1.30, P = 0.131 for pancreatitis). The exception was cholangitis-like symptoms, the risk for which was higher in PECMS/MSCPM compared with CMS (HR: 3.93, 95% CI: 1.08-14.29, P = 0.038). Although PECMS/MSCPM may be associated with higher risk of cholangitis-like symptoms, the overall results were similar between PECMS/MSCPM and CMS. Further studies are warranted in larger populations of patients.