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Infrapopliteal DES linked to lower rates of restenosis, TLR, amputation vs. other devices
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Compared with plain balloon angioplasty or bare-metal stents, infrapopliteal drug-eluting stents appear to yield significantly lower rates of restenosis, target lesion revascularization and amputation, and promote wound healing, according to recent findings.
In the systematic review and Bayesian network meta-analysis, researchers identified randomized clinical trials comparing various endovascular devices for management of below-the-knee arteries.
Eligible trials were randomized controlled trials with open-label, single blind or double blind designs that investigated any type of balloon or stent placed in the infrapopliteal arteries for de novo lesions in patients with critical limb ischemia or intermittent claudication. Eligible studies also had at least 6-month clinical and/or angiographic follow-up. Researchers independently evaluated the quality of the randomized controlled trials, and quality of evidence was evaluated through the GRADE system.
The study’s efficacy outcome measures included restenosis, clinically driven TLR, complete wound healing and target limb amputation. The researchers identified 16 randomized controlled trials (n = 1,805) with 1-year median follow-up.
The researchers performed direct pairwise meta-analyses of head-to-head comparisons using standard frequentist approaches. All endpoints were evaluated with Bayesian binomial model to determine relative ORs with 95% credible intervals (CrI) between the different treatments. The researchers performed sensitivity, heterogeneity and specificity analyses. Angiographic follow-up was available in nine trials.
Decreased restenosis
According to the researchers, there was high quality of evidence that DES resulted in significantly decreased restenosis vs. BMS (OR = 0.26; 95% CrI, 0.12-0.51) and balloon angioplasty (OR = 0.22; 95% CrI, 0.11-0.45).
The need for TLR also was significantly reduced by infrapopliteal DES vs. balloon angioplasty (OR = 0.41; 95% CrI, 0.22-0.75) and BMS (OR = 0.26; 95% CrI, 0.15-0.45). Paclitaxel-coated balloons also significantly decreased TLR rates vs. balloon angioplasty (OR = 0.55; 95% CrI, 0.34-0.9) and BMS (OR = 0.35; 95% CrI, 0.18-0.67), but with low to moderate quality of evidence, according to the researchers. Balloon angioplasty was superior to BMS (OR = 0.63; 95% CrI, 0.4-0.99), with high quality of evidence.
DES was found to be the best option in terms of limb amputation and significantly decreased lower-extremity amputation vs. balloon angioplasty (OR = 0.58; 95% CrI, 0.35-0.96) and BMS (OR = 0.38; 95% CrI, 0.19-0.72), with high quality of evidence. Significantly improved wound healing was achieved with DES vs. balloon angioplasty (OR = 2.02; 95% CrI, 1.01-4.07) and BMS (OR = 3.45; 95% CrI, 1.41-8.73), the researchers wrote.
Pragmatic approach
In a related commentary, Arturo Giordano, MD, of the Unità Operativa di Interventistica Cardiovascolare, Presidio Ospedaliero Pineta Grande, Castel Volturno, Italy, and colleagues wrote that this information could be useful in guiding device choice in patients with infrapopliteal lesions.
“Once we consider this evidence base as established, we can propose a pragmatic approach for device choice for infrapopliteal revascularization, largely based on lesion features,” the authors wrote. “Specifically, short lesions with limited complexity could be safely treated with [drug-coated balloons] or DES, whereas more diffuse and complex disease should probably be treated only with DES or a combination of DCB with spot DES implantation.” – by Jennifer Byrne
Disclosure: The researchers report no relevant disclosures. One of the authors of the commentary reports consulting for Abbott Vascular, Bayer, Novartis and St. Jude Medical.
Perspective
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Curtiss T. Stinis, MD, FACC, FSCAI
The treatment of infrapopliteal disease and critical limb ischemia can be complex, and our goal in these cases is to heal wounds, relieve ischemic pain, and to prevent amputation. Most of these patients have long lesions and multi-level disease, and clinical success depends upon achieving inline flow and maintaining patency for as long as possible. DES and drug-coated balloons have revolutionized the treatment of femoropopliteal disease, but there are currently no FDA-approved drug-eluting technologies available for the treatment of infrapopliteal disease in the U.S. Many operators, myself included, were early adopters of the use of DES for the treatment of infrapopliteal disease in patients with complex critical limb ischemia. This study confirms what we already know from individual smaller studies and from our own clinical experience — that DES (marketed for coronary use in the U.S.) work very well for the treatment of tibial vessel occlusive disease. Importantly, this study supports the notion that DCB may not be as effective for the treatment of tibial vessels as they are for treatment of the femoropopliteal segment. This study reinforces that optimal clinical outcomes in this population are achieved using DES and not by BMS or angioplasty alone.
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