Drug coated balloons for coronary artery bifurcation lesions: A systematic review and focused meta-analysis

Abstract

Objectives We sought to systematically review the evidence supporting the role of drug coated balloons (DCBs) in the treatment of coronary bifurcation lesions. Background DCBs are emerging as an attractive alternative treatment strategy for treating coronary bifurcations due to simplifying the approach and reducing rates of stent related complications. We systematically reviewed the evidence for DCB use in coronary bifurcations and conducted a focused meta-analysis on late lumen loss in the side branch comparing DCB and plain old balloon angioplasty (POBA). Methods This study was conducted in line with the PRISMA statement. All studies (including both RCTs and observational studies, excluding case reports) using DCB as part of a bifurcation strategy were included in this review. A literature search identified a total of ten studies for inclusion. A focused meta-analysis was undertaken for the use of DCB in side-branch compared with POBA. Mean late lumen loss was used with a random effects model due to heterogeneity. Results DCB was found to be superior to POBA for side branch treatment in bifurcations (p = 0.01). There are four studies that investigated the use of DCB for main branch treatment in a bifurcation, with evidence supporting its safety in main branches of bifurcation lesions, while prospective observational studies have demonstrated favourable target lesion revascularisation rates. Conclusion Although there is a lack of robust RCTs comparing DCBs with current generation DES, DCBs appear safe in main branch bifurcation lesions with improved side branch late lumen loss when compared with DES or POBA.

Efficacy and safety of drug-coated balloon combined with cutting balloon for side branch of true coronary bifurcation lesions: Study protocol for a multicenter, prospective, randomized controlled trial

“…As a complement to a provisional stenting strategy, DCB remains very attractive for bifurcation lesion management. However, many questions, including selection for SB, technology (DCB with or without final kissing balloon or proximal optimization technology), and the actual impact on clinical endpoints remain unanswered ( 5 , 23 ). To date, studies exploring the efficacy of DCB in de novo coronary bifurcation lesions have many limitations, and no conclusive evidence has been provided.…”

Drug-Coated versus Uncoated Balloon for Side Branch Protection in Coronary Bifurcation Lesions Treated with Provisional Stenting Using Drug-Eluting Stents: A Meta-analysis

“…Although these results should be validated in large-scale RCTs with adequate sample sizes and longer follow-up durations, provisional stenting with DCB for SB protection may be applied as a promising treatment strategy for CBLs. Some previous meta-analyses evaluated the role of DCB in the treatment of CBLs [33][34][35]. Although these studies generally suggested a favorable role of DCB in improving the angiographic and/or clinical outcomes in patients with CBLs, the inclusion criteria of the meta-analyses were relatively extensive, and signifcant clinical heterogeneity could be observed among the included studies [33][34][35].…”

Drug-coated balloon in the treatment of coronary bifurcation lesions: A hope or hype?

“…Corballis et al 43 observed that DCB outperformed POBA in the SB treatment for bifurcation in a focused meta-analysis. DCBs appear to be safe in the MB with improved SB LLL.…”

“…This has been demonstrated in the recent meta-analysis. 43 It is indeed fascinating to see the scarce data for a DCB-only bifurcation strategy. DCB was found to be superior than POBA in the PEPCAD-BIF 30 trial whether used in either the SB or distal MB, however it included both small and large vessels.…”

“…DCB has been shown to be superior to POBA in a meta-analysis. 43 Another approach is proximal optimization technique (POT)-sideDCB-POT 55 method for true bifurcation lesions which adopts the recommendation of EBC 56 consisting of sequential approach to bifurcation stenting using the provisional strategy. The POT-sideDCB-POT is easy to perform and the geometry of all the three bifurcation segments is catered for by using this technique.…”