Drug eluting balloons for de novocoronary lesions – a systematic review and meta-analysis

Abstract

BackgroundThe role of drug-eluting balloons (DEB) is unclear. Increasing evidence has shown a benefit for the treatment of in-stent restenosis. Its effect on de novo coronary lesions is more controversial. Several smaller randomized trials found conflicting results.MethodsThis is a systematic review and meta-analysis of randomized controlled trials (RCT) evaluating the effect of local Paclitaxel delivery/drug eluting balloons (DEB) (+/− bare metal stent) compared to current standard therapy (stenting) to treat de novo coronary lesions. Data sources for RCT were identified through a literature search from 2005 through 28 December 2012. The main endpoints of interest were target lesion revascularization (TLR), major adverse cardiac events (MACE), binary in-segment restenosis, stent thrombosis (ST), myocardial infarction (MI), late lumen loss (LLL) and mortality. A random effects model was used to calculate the pooled relative risks (RR) with 95% confidence intervals.ResultsEight studies (11 subgroups) and a total of 1,706 patients were included in this analysis. Follow-up duration ranged from 6 to 12 months. Overall, DEB showed similar results to the comparator treatment. The relative risk (RR) for MACE was 0.95 (0.64 to 1.39); P = 0.776, for mortality it was 0.79 (0.30 to 2.11), P = 0.644, for stent thrombosis it was 1.45 (0.42 to 5.01), P = 0.560, for MI it was 1.26 (0.49 to 3.21), P = 0.629, for TLR it was 1.09 (0.71 to 1.68); P = 0.700 and for binary in-stent restenosis it was 0.96 (0.48 to 1.93), P = 0.918. Compared to bare metal stents (BMS), DEB showed a lower LLL (− 0.26 mm (−0.51 to 0.01)) and a trend towards a lower MACE risk (RR 0.66 (0.43 to 1.02)).ConclusionOverall, drug-eluting balloons (+/− bare metal stent) are not superior to current standard therapies (BMS or drug eluting stent (DES)) in treating de novo coronary lesions. However, the performance of DEB seems to lie in between DES and BMS with a trend towards superiority over BMS alone. Therefore, DEB may be considered in patients with contraindications for DES. The heterogeneity between the included studies is a limitation of this meta-analysis; different drug-eluting balloons have been used.

Stent Coverage and Neointimal Proliferation in Bare Metal Stents Postdilated With a Paclitaxel-Eluting Balloon Versus Everolimus-Eluting Stents

“…Yet, no final conclusion can be drawn for the value and the long-term outcome of a BMS+DEB procedure, but as suggested by a recent meta-analysis this strategy is promising when only bare metal stenting is possible and the risk of restenosis is deemed high. 31 Finally, patients who underwent the BMS+DEB procedure had higher low-density lipoprotein levels and a lower glomerular filtration rate compared with the DES group what might have contributed to more stent proliferation in this trial.…”

Elutax paclitaxel-eluting balloon followed by bare-metal stent compared with Xience V drug-eluting stent in the treatment of de novo coronary stenosis: A randomized trial

“…25 Finally, 2 very recent meta-analyses have confirmed the lack of efficacy of PEB + BMS strategy compared with DES, although both have shown important heterogeneity, as the employed devices (balloon plus stent) were different in each trial. 26,27 Several reasons can be claimed to explain the lack of efficacy of PEB + (systematic) BMS. First, it is reasonable that the paclitaxel released by PEB can prevent restenosis when vessel injury is confined to BA, but might not be able to negotiate the more powerful intimal response derived from stent implantation.…”

Peer Review #1 of "Comparison of clinical outcomes after drug-eluting balloon and drug-eluting stent use for in-stent restenosis related acute myocardial infarction: a retrospective study (v0.1)"

“…Paclitaxel has been identified as the primary drug for use in DEBs because of its long-lasting antiproliferative effect and retained uptake by vascular smooth muscle cells up to 1 week (Waksman & Pakala, 2009). On the other hand, DEB also has been applied for de novo coronary lesions, small vessel disease, long lesions, and bifurcations, and presented good results (Fröhlich et al, 2013;Vaquerizo et al, 2015;Richelsen, Overvad & Jensen, 2016).…”

“…Most trials and real-world practice also use DEB for relative stable conditions such as stable angina and unstable angina (Wöhrle et al, 2013;Lee et al, 2016;Fröhlich et al, 2013).…”