Drug-coated balloon angioplasty versus balloon angioplasty for treating patients with in-stent restenosis in the femoropopliteal artery

Abstract

Background: The introduction of endovascular surgery has led to frequent stent use, although in-stent restenosis (ISR) remains a challenging issue. Drug-coated balloon (DCB) and conventional balloon angioplasty (BA) are common endovascular procedures for addressing ISR in the femoropopliteal artery. However, there is controversy regarding which procedure provides the greatest benefit to patients. Methods: The PubMed, EMBASE, and Cochrane Central Register of Controlled Trials databases were searched for prospective controlled trials that compared DCB and BA for patients with ISR in the femoropopliteal artery. The study has been approved by Ethics Committee of Wuhan Central Hospital. Results: The meta-analysis included 6 prospective trials with 541 patients. We found that DCB use was associated with significant reductions in binary restenosis at 6 months (relative risk [RR]: 0.45, 95% confidence interval [CI]: 0.33–0.63; P < .00001), binary restenosis at 1 year (RR: 0.44, 95% CI: 0.34–0.57; P < .00001), target lesion revascularization (TLR) at 6 months (RR: 0.36, 95% CI: 0.20–0.65; P = .0006), and TLR at 1 year (RR: 0.38, 95% CI: 0.27–0.54; P < .00001). The DCB group also had significantly better clinical improvement (RR: 1.39, 95% CI: 1.13–1.71; P = .002), although we did not detect inter-group differences in terms of death, target vessel thrombosis, or ipsilateral amputation. The brand of DCB may a cause of heterogeneity. Conclusion: Relative to BA, DCB use increases the durability of treatment for ISR in the femoropopliteal artery, based on significant reductions in binary restenosis and TLR at 6–12 months after the procedure. Furthermore, DCB use was associated with better clinical improvement. However, additional randomized controlled trials are needed to validate these findings.

Efficacy and Prediction Model Construction of Drug-Coated Balloon Combined with Cutting Balloon Angioplasty in the Treatment of Drug-Eluting Stent In-Stent Restenosis

“…Domestic studies have shown that, compared with conventional high-pressure balloons, cutting balloon angioplasty (CBA) can squeeze and cut plaques to a certain extent, reduce complications such as vascular dissection and loss, and can increase immediate lumen acquisition rate and minimum lumen area after stent implantation [ 8 ]. Previous studies have pointed out that because of its ability to provide anti-restenosis drugs to the vascular endothelium and the avoidance of multilayer stent implantation, the drug-coated balloon (DCB) has received different clinical indications including the treatment of ISR in the past few years [ 9 ]. Therefore, this study combined the two in the clinical treatment of DES-ISR, aiming to explore its clinical efficacy on DES-ISR, and to construct a prediction model for the occurrence of DES-ISR, so as to provide reference for the clinical prevention and treatment of the disease.…”

The Diagnostic Value of Circulating Biomarkers and Role of Drug-Coated Balloons for In-Stent Restenosis in Patients with Peripheral Arterial Disease

“…There is a focus on more complex and combined techniques for the treatment of ISRs which are producing more encouraging results such as DES, again with major limitations such as a stent length which excludes treating long stenosis. DCB shows superior results compared to traditional re-PTA with a stent and is becoming the technique of choice for ISRs [ 12 , 13 , 14 , 15 , 62 ]. Combined techniques such as laser atherectomy and DCB are also being developed and appear to be candidates to become the reference technique, but adequate studies are warranted [ 1 , 11 , 18 , 19 ].…”

“…Another problem for which we are turning to combined procedures, as described above, is the degree of stenosis or calcification that does not allow for the passage of devices. For this reason, many stenoses or ISRs must be pretreated with traditional balloons to fragment the stenosing plaque, bringing the vessel back to an adequate caliber and allowing the absorption of drugs in situ [ 12 , 13 , 14 , 15 ].…”

“…Angiographic and clinical data highlight the superiority of this technique, and the European clinical practice guidelines endorsed its use in the treatment of ISR (class I, Evidence A) [ 11 , 12 , 13 ]. The DCB is a traditional drug-coated balloon, mainly with Paclitaxel, which significantly improves the short- and medium-term patency of angioplasty by minimizing neo-intimal hyperplasia [ 14 , 15 , 16 , 17 ]. Paclitaxel, with a nominal dose between 2 and 3.5 μg/mm 2 , has lipophilic and hydrophobic properties and, together with a hydrophilic agent, allows the drug to be released to the surface of the artery ( Figure 1 ).…”

Drug‐coated balloon treatment of complex femoropopliteal disease yields favorable and durable outcomes at 5 years

“…CD‐TLR and restenosis were also significantly less frequent with paclitaxel DCBs employing urea as the excipient such as the IN.PACT Admiral DCB. Similarly, a meta‐analysis of six trials with 541 patients with FP in‐stent restenosis demonstrated a relative risk of CD‐TLR of 0.38 [95% CI: 0.27–0.54] at 1 year 2 . The DCB groups had greater symptomatic improvement than PTA as well.…”