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[Automatically generated] From the JAMA Network, this is JAMA Author Interviews.

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[Automatically generated] From the JAMA Network, this is JAMA Author Interviews.

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Conversations with authors exploring the latest clinical research, reviews, and opinion featured in JAMA.

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Hello, I'm Dr. Christopher Muth, Deputy Editor at JAMA, and I'm here today with Dr. Zhongrong Miao, Professor of Neurology at Beijing Tiantan Hospital at Capital Medical University in Beijing, China.

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We will be discussing an original research article published in JAMA, and authored by Dr.

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Miao and his colleagues titled, Balloon Angioplasty versus Aggressive Medical Management for Symptomatic Intracranial Artery Stenosis, the basis randomized clinical trial.

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Thank you for joining us today, Dr. Miao.

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Thank you. It's my pleasure.

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I want to start by talking about intracranial artery stenosis.

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So can you tell us how common is intracranial artery stenosis as a cause of transient ischemic attack or stroke, and what types of symptoms do patients usually present with?

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Thank you for your question.

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ICAST is the most ischemic stroke worldwide, especially in Asian population.

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According to the Chinese intracranial atherosclerotic study, the CCASA study, the prevalence of ICAST was nearly 15 percent.

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Patients with ICAST had a more severe stroke at the beginning and they stayed alone in hospitals compared with those without intracranial stenosis.

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In the ANGEL-ACT study, which was a national wide prospective registry, including 1,793 consecutive large vessel occlusion patients treated with EVT at 111 hospitals from 26 provinces in China.

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The incidence of large vessel occlusion due to underlying ICAST was 51 percent in posterior circulation and nearly 30 percent in anterior circulation respectively.

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Okay. So, as you say ICAST or intracranial artery stenosis is certainly a fairly common problem in Asian patients, but also I think in patients worldwide.

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And I know it can be particularly challenging to manage.

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It's a very challenging condition.

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Previous clinical trials have looked at percutaneous transluminal angioplasty and stenting for the treatment of intracranial stenosis.

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These studies demonstrated either harm or no benefit of angioplasty when combined with stenting, compared with aggressive medical management alone.

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In particular, the SAMPRAS trial over 10 years ago showed a higher stroke risk early after the procedure.

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And more recently, the CASIS study published in JAMA in 2022 improved patient selection and operator training, but still showed no benefit of stenting when looking at the primary composite endpoint of stroke or death within 30 days or stroke in the qualifying artery beyond 30 days through one year.

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So the basis trial that we're talking about today looked at balloon angioplasty, but without stenting.

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So this is a little bit different than some of the previous studies in the intracranial stenosis population.

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Can you tell us about the rationale for studying balloon angioplasty alone without stenting in this patient population?

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The basis trial studied at the end of 2017, after some pre- and visit studies.

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The experimental group of some pre- and visit trial were balloon dilation followed by the stenting.

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For the some pre-trial, use the self-expanding study, and the visit trial used the balloon expanded stent respectively.

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And both of them were under aggressive medical management was superior to under-vascular treatment.

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However, the subgroup analysis of some pre- and real-world studies all suggest low risk of peri-acetyl completions, length stenting, and a high probability of being effective for secondary stroke prevention.

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During clinical practice, we found that balloon angioplasty may reduce the proper rate of event arrest and complication.

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Moreover, although balloon angioplasty may not achieve complete revascularization as easily as stenting.

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Additionally, balloon angioplasty along with the dedicated intracranial balloon without stenting implantation, with easy navigation and the technique.

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And the short procedure duration compared to stenting.

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And so now to talk a little bit about your particular study.

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This was an open-label, randomized clinical trial with blinded endpoint adjudication, with over 500 patients at over 30 sites in China.

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Patients had to have a TIA or a stroke due to intracranial vessel stenosis, and they were already receiving antithrombotic drugs and or standard vascular risk factor management.

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They also had to be at least 14 days out from a recent stroke, if that was the reason that they qualified for the study.

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And then they were randomized to balloon angioplasty plus medical management versus medical management alone.

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The composite primary outcome was stroke or death within 30 days, or ischemic stroke or revascularization of the qualifying artery from 30 days to one year.

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Can you tell us what the main study findings were?

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Impatients with symptomatic ICAS, balloon angioplasty plus aggressive medical management compared with aggressive medical management alone significantly lowered the risk of composite outcome.

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The findings suggested that balloon angioplasty plus medical management may be an effective treatment for symptomatic ICAS, although the risk of stroke or death within 13 days of balloon angioplasty should be considered in clinical practice.

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Yes, as you mentioned, the rate of the composite primary outcome occurred in 4.4% in the balloon angioplasty plus medical management group compared with 13.5% in the medical management alone group, with a hazard ratio of 0.32.

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So that outcome was in favor of the angioplasty group.

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But as you mentioned, the composite included risk of stroke or death within 30 days, and that occurred in 3.2% in the angioplasty group versus 1.6% in the medical management alone group.

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So at some level, do you see these findings as sort of a trade-off between what might be perceived as an up-front periprocedural risk related to the procedure, which may involve slightly increased risk, but then perhaps a lower risk of stroke down the line due to secondary stroke prevention from the intervention?

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First, the doctors must have a very experienced technique to try to decrease the risk of the manipulation and the periprocedural complication.

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Second, the result is a balloon angiococci group of the balloon angiococci significantly decrease the periprocedural complication and the risk low the thumb crease and the visage and similar with the CASSIS trial.

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The second day is the under-vascular treatment improves the blood flow of the vessels to prevent the stroke risk.

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Third day is the way to select the high-risk patients to avoid the low-risk patients to treatment with the under-vascular technique.

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What are some of the more common or important adverse events that were seen and how often did they occur in the study?

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In the study, there were eight periprocedural complications in 249 patients who were treated with alone angioplasty, many still are perforating, infarction and bleeding from vessel rupture, including one case of death caused by vessel rupture, which is the most serious procedure-related risk during the periprocedure period.

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And these risks do occur more often in centers that are not skilled in operating techniques, including the management of some post-dilation dissection.

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It still requires more clinical experience, and this is the area that needs more attention, and the most standardized training in the operation of intracranial atherosclerosis.

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I believe the rates of symptomatic intracranial hemorrhage were about 1.2 percent in the balloon angioplasty group.

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And then as you mentioned, the experience of the clinician, the neurointerventionalist performing the procedure seems to be quite important.

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I'm wondering if you could talk about the training of the proceduralists involved in this study, and how that might relate to the generalizability of these findings from your study, and whether there might need to be additional studies in other settings, different hospitals and different patient populations to understand the generalizability of the findings, and whether or not balloon angioplasty could be something that's done more routinely for symptomatic intracranial artery stenosis.

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Enrollment in the basis trial was competitive enrollment.

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Although more than half the subjects were enrolled at one site.

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It's our hospital, Beijing Tiantan Hospital.

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The site has eight medical groups to treat the symptomatic eye cuts.

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The operators were different among the eight medical groups.

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However, each operator of all participating centers performed more than 15 eye cuts procedures per year and received the interventional operating training of Beijing Tiantan Hospital.

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Whether it was the offline refresher training or online operation training lectures, at the same time, most of them participated in the Tiantan Hospital intracranial stenosis intervention registry study, which provided homogeneous training on the management of the procedure.

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The selection of the patients and the clinical operation techniques.

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And in addition, several academic conferences was conducted on intracranial balloon dilation alone, especially patient selection, sub-satisfactory dilation concepts, and the operation specifications.

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And the Chinese consensus on the interventional treatment of intracranial artery stenosis was published during the study period, which detailed the concept of balloon dilation alone and the operation details.

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We believe that standardize the regular training system, assessment system, and the consensus promotion will be a great help in technical balance and standardization.

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I would say that this is certainly an important trial, testing the strategy of balloon angioplasty for treatment of patients with symptomatic intracranial artery stenosis.

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And although there is some upfront risk to the procedure, the balloon angioplasty group fared better overall.

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It seems that these findings will need to be confirmed in other populations and assessed when they're performed by other interventionalists.

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But overall, it seems that balloon angioplasty may represent an important potential treatment strategy for this challenging condition that can cause stroke and TIAs.

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Do you have any final comments for our listeners, Dr. Miao?

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Okay, thank you very much.

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In the more than 10 years since the publication of this important study, our sample rates, there has been a better understanding of the treatment of patients with ICARs, especially aggressive medical management, which is very important for the second reprievation of ICARs.

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The basis study is the first study to find positive findings comparing endovascular treatment with aggressive medical management.

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We need to try our best to find the patients who could benefit from endovascular treatment and to perform more studies on different and new devices such as drug codeine balloon or the drug eluting stent.

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We believe that it is the new starting point of endovascular treatment for ICARs.

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More studies with positive findings will be presented in the future.

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Thank you very much.

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I'm Dr. Christopher Muth and I've been speaking with Dr. Zhongrong Miao about his article reporting the results of the BASIS trial of balloon angioplasty for intracranial stenosis that was recently published in JAMA.

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You can find a link to the article in this episode's description.

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To follow this and other JAMA Network podcasts, please visit us online at jamanetworkaudio.com or search for JAMA Network wherever you get your podcasts.

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This episode was produced by Shelly Steffens at the JAMA Network.

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Thanks for listening.

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