Prevention of in-stent restenosis with drug-eluting balloons in patients with postirradiated carotid stenosis accepting percutaneous angioplasty and stenting

Abstract

Objective: To investigate the technical safety and outcome of in-stent restenosis (ISR) prevention with drug-eluting balloon (DEB) in patients with postirradiated carotid stenosis (PIRCS) undergoing percutaneous angioplasty and stenting (PTAS).

Methods: Between 2017 and 2021, we prospectively recruited patients with severe PIRCS for PTAS. They were randomly separated into two groups based on endovascular techniques performed with and without DEB. Preprocedural and early postprocedural (within 24 hours) MRI, short-term ultrasonography (6 months after PTAS), and long-term CT angiography (CTA)/MR angiography (MRA), 12 months after PTAS, were performed. Technical safety was evaluated based on periprocedural neurological complications and the number of recent embolic ischemic lesions (REIL) in the treated brain territory on diffusion-weighted imaging of early postprocedural MRI.

Results: Sixty-six (30 with and 36 without DEB) subjects were enrolled, with one failure in techniques. For 65 patients in the DEB versus conventional groups, technical neurological symptoms within 1 month (1/29 (3.4%) vs 0/36; P=0.197) and REIL numbers within 24 hours (1.0±2.1 vs 1.3±1.5; P=0.592) after PTAS showed no differences. Peak systolic velocity (PSVs) on short-term ultrasonography was significantly higher in the conventional group (104.13±42.76 vs .81.95±31.35; P=0.023). The degree of in-stent stenosis (45.93±20.86 vs 26.58±8.75; P<0.001) was higher, and there were more subjects (n=8, 38.9% vs 1, 3.4%; P=0.029) with significant ISR (≥ 50%) in the conventional group than in the DEB group on long-term CTA/MRA.

Conclusions: We observed similar technical safety of carotid PTAS with and without DEBs. The number of cases of significant ISR were fewer and the degree of stenosis of ISR was less in primary DEB-PTAS of PIRCS than for conventional PTAS in the 12-month follow-up.

Keywords: Balloon; Intervention; Stenosis; Stent; Stroke.

Figure 1

Imaging protocols in this study. Five standardized imaging evaluations were arranged in this study. Preprocedural MRI was performed, and the endovascular procedures were arranged within 1 month after the preprocedural MRI. The endovascular procedures, including percutaneous transluminal angioplasty and stenting (PTAS), were performed with preprocedural digital subtractive angiography (DSA) in the same session. Early postprocedural MRI was conducted within 24 hours after PTAS to evaluate periprocedural safety. Short-term follow-up ultrasonography was performed 6 months after PTAS, and long-term postprocedural CT angiography (CTA) and MRI were performed 12 months after PTAS.

Figure 2

Technical failure due to difficult expansion of the drug-eluting balloon (DEB). An adult patient with 75.5% stenosis at the right internal carotid artery (ICA). (A) Preprocedural digital subtraction angiography revealed multisegmental stenosis from the right common carotid artery (CCA) to the ICA. Pre-dilatation was performed with a Sterling balloon (3.5×30 mm) at the (B) ICA and (C) CCA stenosis. The balloons were expanded until no narrowed waists were noted. However, a hard stenotic lesion and strong elastic recoil made the ICA stenosis not fully dilated (arrow in B) (D) The DEB failed to be introduced to the ICA owing to its significant residual stenosis by elastic recoil. We performed angioplasty with DEB in the CCA stenosis only. The case was excluded due to potential failure to deliver paclitaxel to the endothelium of ICA stenosis but was counted as technical failure in the statistics.

Figure 3

Conventional group with in-stent restenosis (ISR). An adult patient with left internal carotid artery stenosis. (A) Preprocedural digital subtraction angiography (DSA) revealed a stenosis of 84.9% (arrow). (B) The control DSA demonstrated a residual 15.11%, indicating technical success (≤ 30%). (C) Long-term postprocedural CT angiography (CTA) with curved multiplanar construction performed 350 days after stenting revealed an ISR of approximately 83.5% (arrow). (D) Long-term postprocedural contrast-enhanced magnetic resonance angiography performed 361 days after stenting demonstrates similar high-grade ISR (arrow) to the findings on delayed postprocedural CTA. The signal cancellations at both ends of the stents were due to metallic artifacts (arrowheads).

Figure 4

Primary angioplasty with a drug-eluting balloon (DEB) for postirradiated carotid stenosis showed no evidence of in-stent restenosis (ISR). An adult patient with left internal carotid artery and common carotid artery stenosis. (A) Preprocedural digital subtraction angiography (DSA) revealed a stenosis of 79.5%. (B) DEB angioplasty was successfully performed via a 5×60 mm Ranger balloon. (C) The control DSA demonstrated a residual of 10.8%, indicating technical success (≤30%). (D) Long-term postprocedural CT angiography with curved multiplanar construction performed 366 days and (E) contrast-enhanced magnetic resonance angiography performed 367 days after stenting revealed no significant ISR. The signal cancellation at the distal end was due to metallic artifacts (arrow).