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Drug coated balloons (DCBs) represent a significant advancement in endovascular treatment of peripheral artery disease. In the US, two different DCBs (the IN.PACT™ DCB [Medtronic Inc, MN] and Lutonix™DCB [Bard PV, NJ]) were approved in recent years for the treatment of femoropopliteal artery disease. However, these two DCBs are distinctly different in their drug-excipient composition with a different mechanism of action, which in turn is attributed to differences observed in their clinical efficacy. Treating physicians now require comparative evidence on which DCB is the most effective for their patients/lesion subtypes. In the absence of head to head trials, this indirect comparison analysis is intended to assess the relative clinical effectiveness of IN.PACT™ DCB vs LUTONIX™ DCB.
A systematic review of the published literature was conducted to identify clinical trials that utilized IN.PACT™ or LUTONIX™ DCBs in adults with femoropopliteal artery disease. Comparative randomized controlled trials (RCTs) reporting efficacy and safety outcomes of all lengths of follow-up were included. An adjusted indirect comparison (AIC) was carried out by comparing the risk estimates from the head-to-head meta-analyses of IN.PACT™ vs plain balloon angioplasty (PTA) and LUTONIX™ vs PTA. Target lesion revascularization (TLR), primary patency, all-cause mortality, thrombosis and major adverse events (MAEs) at 12 months were included. Statistical analyses were performed using Stata version 14.2.
A total of 255 unique citations were identified from the database searches after the removal of duplicates. Five RCTs (IN.PACT™ vs PTA = 3 RCTs) and (LUTONIX™ vs PTA = 2 RCTs) were included in this AIC. The odds ratio (OR) of the indirect treatment effect estimate for TLR at 12 months for IN.PACT™ DCB compared with LUTONIX™ DCB was 0.18 with the 95% CI (0.08 to 0.39; p<0.001). The result indicates that patients treated with IN.PACT™ DCB had statistically significantly lower rates of TLR compared to those treated with LUTONIX™ DCB at 12 months follow-up. This result was similar to that of primary patency at 12 months (OR 2.50, 95% CI 1.29 to 4.81; p=0.006). Of note, there were no differences in all-cause mortality or thrombosis events between the two DCB brands at 12 months using the AIC method (p>0.9).
Results from this indirect meta-analysis of IN.PACT™ vs LUTONIX™ using PTA as a common comparator suggest that there are significant differences in efficacy between the two DCB devices in the treatment of symptomatic PAD of the femoropopliteal region. Direct, head-to-head studies are required to confirm this result.
CORONARY: Drug-Eluting Balloons and Local Drug Delivery