Angioplasty with a drug-coated balloon improves outcomes over bare-metal stent placement in patients with intracranial atherosclerotic disease (ICAD), according to a study published January 20 in Radiology.
The finding is from among the first prospective clinical trials comparing the procedures, with patients who underwent drug-coated balloon angioplasty experiencing lower restenosis and recurrent stroke rates, noted first author Sheng Guan, MD, of the First Affiliated Hospital of Zhengzhou University in Zhengzhou, China, and colleagues.
“Compared with bare-metal stent placement, drug-coated balloon (DCB) angioplasty is a promising alternative for select patients with symptomatic intracranial atherosclerotic disease (ICAD), demonstrating lower risks of angiographic restenosis, symptomatic restenosis, and recurrent ischemic events,” the group wrote.
ICAD occurs when the arteries in the brain become hard, thick, and narrow due to a buildup of plaque inside the artery walls in the brain. The disease is a significant cause of stroke. Even after antiplatelet therapy or stenting procedures with bare-metal stents (BMS), patients remain at risk of stroke due to restenosis, or a renarrowing of blood vessels, the authors explained.
This has led to the development of DCB angioplasty, with drugs delivered directly to the vessel sites to suppress narrowing, they noted. While two previous retrospective studies indicate that DCBs can be used to efficiently treat patients, no prospective trial has validated the findings, they wrote.
To that end, the researchers conducted a trial across 14 Chinese tertiary hospitals to compare the efficacy and safety of the two techniques. Between July 2021 and March 2023, they recruited 209 participants (median age, 59; 157 men), 103 of whom underwent DCB and 106 of whom underwent BMS procedures. The primary outcome was restenosis assessed with digital subtraction angiography at six months.
Example angiographic images from drug-coated balloon (DCB) angioplasty and bare-metal stent (BMS) placement procedures. (A-D) Images in a 49-year-old female participant who underwent DCB (2 × 9 mm) angioplasty for severe stenosis in the M1 segment of the left middle cerebral artery. Images (A) before and (B) during the procedure are shown. (C) Image immediately after the procedure shows improvement of the stenosis. (D) Image at 6-month follow-up examination reveals no restenosis. (E-H) Images in a 55-year-old male participant who underwent BMS (2.5 × 9 mm) placement for severe stenosis in the M1 segment of the right middle cerebral artery. Images (E) before and (F) during the procedure are shown. (G) Image immediately after the procedure demonstrates significant improvement of the stenosis, but (H) image at 6-month follow-up examination shows the development of restenosis and occlusion.RSNAAccording to the results, the six-month angiographic restenosis rate was lower in the DCB group than in the BMS group (11% vs. 29%; p = 0.006). The DCB group also had a lower six-month symptomatic restenosis rate (1% vs. 10%; p = 0.02) and lower 30-day to one-year recurrent ischemic event rate (4% vs. 13%; p = 0.04). The 30-day stroke or death rate was similar between the groups, the researchers reported.
“In individuals with symptomatic ICAD with high-grade stenosis, DCB angioplasty reduced the six-month risks of angiographic restenosis and symptomatic restenosis and 30-day to one-year recurrent ischemic event rate compared with BMS placement,” Guan and colleagues wrote.
The findings indicate that DCB angioplasty is efficient and safe, warranting further investigation for stroke prevention in symptomatic ICAD, the researchers concluded.
In an accompanying editorial, Joan Wojak, MD, of LSU Health New Orleans, noted that the trial adds to the growing body of evidence supporting the efficacy of endovascular treatment for ICAD that remains symptomatic, despite best medical therapy.
“Although the efficacy of endovascular therapy for prevention of recurrent stroke in symptomatic ICAD is finally being established, many questions must still be answered,” she wrote.
For one, there was a “concerning” rate (10%) of dissection — where the artery wall tears during the procedure — in the DCB group, and further research is needed to determine whether changes in technique and/or balloon design can reduce this rate, Wojak suggested.
“Randomized trials comparing DCB angioplasty versus best medical therapy, angioplasty with uncoated balloons, and possibly stenting with drug-eluting stents are needed,” she concluded.
The full study is available here.