Drug‐coated balloon versus plain old balloon angioplasty in femoropopliteal disease: An updated meta‐analysis of randomized controlled trials

Abstract

Background Drug‐coated balloon (DCB) angioplasty has emerged as a mainstay of therapy for the treatment of peripheral arterial disease (PAD) involving the superficial femoral and popliteal arteries. We performed a meta‐analysis including all available randomized controlled trials (RCTs) to date which compare DCB to plain balloon angioplasty (POBA) in femoropopliteal disease (FPD). Methods Five databases were analyzed including EMBASE, PubMed, Cochrane, Scopus, and Web‐of‐Science from January 2000 to September 2018 for RCTs comparing DCB to POBA in patients with FPD. Heterogeneity was determined using Cochrane's Q‐statistics. Random effects model was used. Results Twenty‐two RCTs, including five trials of in‐stent restenosis (ISR) intervention, with 3,217 patients were included in the analysis. Mean follow‐up was approximately 21.6 ± 14.4 months. Overall, DCB use was associated with a 51% reduction in target vessel revascularization (TLR) when compared to POBA at follow‐up (relative risk [RR]: 0.49, 95% confidence interval [CI]: 0.40–0.61, P < 0.0001). Rates of TLR were 45% lower in the DCB group when compared to POBA in patients with ISR (RR: 0.55, 95% CI: 0.37–0.81, P = 0.002). DCB was associated with lower rates of binary stenosis, late lumen loss and higher primary safety endpoints. Major amputation and mortality were not different between DCB and POBA. Conclusions Use of DCBs is associated with improved vessel patency and a lower risk of TLR when compared to POBA in patients with FPD, especially in the setting of ISR. There was no difference in mortality between DCB and POBA in our meta‐analysis. Extended follow‐up of the available RCT data will be essential to analyze long‐term device‐related mortality.

Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort

“…48 While the presence or causality of the late mortality signal is unclear, the benefit-risk analysis clearly demonstrated a consistent clinical benefit of paclitaxel-coated devices compared to uncoated devices across all studies. 38 , 41 , 49 – 51 Along this line, a recent update from the FDA recommends that for individual patients judged to be at particularly high risk for restenosis and repeat femoropopliteal interventions, clinicians may determine that the benefits of using a paclitaxel-coated device outweigh the risk of late mortality. 52 There is no doubt, however, that further investigations with large datasets are required and more research should be encouraged.…”

Laser atherectomy and drug‐coated balloons for the treatment of femoropopliteal in‐stent restenosis: 2‐Year outcomes

“…4,5,8 Among current treatment options for FP-ISR, balloon angioplasty (BA) alone has yielded poor results, with under 50% primary patency 6 months following revascularization. 9 Drug coated balloon (DCB) angioplasty has been one of the most well-studied methods to treat FP-ISR with a number of studies showing 1-year superiority compared to BA, [10][11][12][13] however the ability to treat long-segment FP-ISR and the ability to sustain patency over the long term have been viewed as a limitation of DCB angioplasty. 14,15 Debulking with atherectomy devices and especially laser atherectomy (LA) may play a role in the treatment of FP-ISR [16][17][18][19][20][21][22][23] However, the combination of debulking with an antirestenotic agent (paclitaxel) has the potential to further improve the outcomes of FP-ISR by combining vessel preparation and maximum paclitaxel effectiveness.…”

Risk of mortality with drug coated balloon use in femoropopliteal disease

“…We read with interest a meta-analysis published in the catheterization and cardiovascular interventions titled--"Drug-coated balloon versus plain old balloon angioplasty in femoropopliteal disease: An updated meta-analysis of randomized controlled trials." 1 We would like to congratulate the author for this publications. However, we had the following observations to make.…”