JAMA: Professor Jiao Liqun's team from Xuanwu Hospital confirmed that endovascular treatment of symptomatic intracranial arterial stenosis has no benefit (CASSSISS study)

：JAMA、，

In the early morning of August 10, 2022, led by the team of Professor Jiao Liqun from the Department of Neurosurgery of Xuanwu Hospital of Capital Medical University, a multi-center, randomized controlled clinical trial jointly carried out with 8 hospitals in China - the results of the CASSISS study were published online in the top international medical journal "JAM.

background

Stroke is the leading cause of death in Chi.

Endovascular therapy such as interventional stenting has been regarded as a potential treatment for intracranial atherosclerotic stenos.

In recent years, multiple prospective registration studies and real-world studies at home and abroad have shown that intracranial artery stents are still safe, and the risk of complications is only 0%-3%, which is in sharp contrast with the 17% of the SAMMPRIS stu.

In view of the fact that the SAMMPRIS study is based on Caucasians in the United States and the shortcomings of its own trial design, the era urgently needs Chinese data, with the help of Chinese doctors' efforts and contributions, to verify the safety and effectiveness of endovascular therapy in Chinese da.

The CASSISS study (China Angioplasty and Stenting for Symptomatic Severe Intracranial Arterial Stenosis: A Multicenter, Randomized Controlled Clinical Trial) is currently the third in the world and the first in China and As.

method

In response to the design flaws of the SAMMPRIS study, the CASSISS study proposes two important improvements:

1 Select more experienced doctors and more rigorous screening of patients, reducing 30-day complications (safety);

2 Extend the follow-up time to 3 years to observe the long-term protection (efficacy) of endovascular treatment for intracranial artery stenos.

Therefore, the CASSISS study was designed to re-evaluate the safety and efficacy of endovascular therapy for intracranial artery stenosis, and to provide Chinese evidence for the treatment of intracranial artery stenosis international.

Mace's comments: JAMA almost simultaneously published two research results of neurology led by Chinese scholars, and both were negati.

background

Stroke is the leading cause of death in Chi.

Endovascular therapy such as interventional stenting has been regarded as a potential treatment for intracranial atherosclerotic stenos.

In recent years, multiple prospective registration studies and real-world studies at home and abroad have shown that intracranial artery stents are still safe, and the risk of complications is only 0%-3%, which is in sharp contrast with the 17% of the SAMMPRIS stu.

In view of the fact that the SAMMPRIS study is based on Caucasians in the United States and the shortcomings of its own trial design, the era urgently needs Chinese data, with the help of Chinese doctors' efforts and contributions, to verify the safety and effectiveness of endovascular therapy in Chinese da.

The CASSISS study (China Angioplasty and Stenting for Symptomatic Severe Intracranial Arterial Stenosis: A Multicenter, Randomized Controlled Clinical Trial) is currently the third in the world and the first in China and As.

method

In response to the design flaws of the SAMMPRIS study, the CASSISS study proposes two important improvements:

1 Select more experienced doctors and more rigorous screening of patients, reducing 30-day complications (safety);

2 Extend the follow-up time to 3 years to observe the long-term protection (efficacy) of endovascular treatment for intracranial artery stenos.

Therefore, the CASSISS study was designed to re-evaluate the safety and efficacy of endovascular therapy for intracranial artery stenosis, and to provide Chinese evidence for the treatment of intracranial artery stenosis international.

The CASSISS study innovatively set up a two-phase trial: a pilot phase I trial and a phase II randomized controlled tri.

Pilot test phase:

A prospective, single-arm observational stu.

From July 2013 to March 2014, according to the inclusion and exclusion criteria of follow-up randomized controlled trials, 100 patients were consecutively enrolled for stent treatment, to evaluate the risk of perioperative surgery, to ensure the safety of the subjects and the qualification of participating centers, and to verify the follow-up RCTs Test operabili.

The results showed that the 30-day stroke or death rate after stenting in this group of patients was 0%, which was much lower than the results of the SAMMPRIS and VISSIT studi.

The pilot test verified the operability of the follow-up RCT test, and through this phase of the study, the research center was compressed from 13 to 8 more qualifi.

Randomized controlled trial phase:

A multicenter, open-label, blinded-assessed randomized controlled clinical tri.

From March 2014 to November 2016, from 8 medical centers, 380 patients with ischemic events over 3 weeks after onset, manifesting as TIA or non-disabling, non-perforator ischemic stroke, with severe stenosis (70%-99%) of patients with intracranial atherosclerotic stenos.

According to the ratio of 1:1, they were randomly divided into two groups: stent combined with drug therapy and drug therapy alo.

The primary outcomes were stroke or death within 30 days and stroke in the vascular region of responsibility from 30 days to 1 year, and secondary outcomes included stroke or death in the vascular region of responsibility at 2 or 3 yea.

The follow-up period was 3 years, and the follow-up of the last patient ended on November 10, 201

result

Of the 380 patients, 358 patients were finally confirmed eligible for enrollment and completed the trial, including 176 in the stent group and 181 in the drug gro.

The primary outcome showed that there was no statistically significant difference between stent and medical therapy compared with medical therapy alone ( 0% [14/176] .

2% [13/181]; hazard ratio: 10, 95%CI 52-35 ; P=8
None of the 5 secondary outcomes showed statistically significant differenc.

For example, 3-year responsible vessel area stroke (13% [19/168] .

12% [19/170]; hazard ratio 00, 95% CI 53-90; P=0
The 3-year mortality rates were 4% [7/160] and 3% [2/159], respectively (hazard ratio, 75 [95% CI 77-113]; P = 0

primary and secondary endings

KM curves for the primary outcome

in conclusion

For patients with TIA or ischemic stroke caused by symptomatic intracranial atherosclerotic stenosis, the risk of stroke or death within 30 days and the risk of stroke or death within 30 days and 30-day to There was no significant difference in the risk of stroke in the responsible vessel region at 1 ye.

(The CASSISS study is supported by the National Science and Technology Support Program of the “Twelfth Five-Year Plan”, the project number is 2011BAI08B04, and the ClinicalTria.

gov registration number is NCT01763320)

With high-quality research data and high-level evidence, the CASSISS study has resolved two decades of controversy in this field, and may become the "final work" of clinical guidelines in this fiel.

The important conclusions are:

1 Experienced Chinese doctors can obtain significantly better safety than US studies, and efficacy is not inferior to drug treatment;

2 Under the current diagnostic evaluation system for intracranial atherosclerotic stenosis , interventional stent therapy has no additional benefit to patients compared with drug therapy alo.

The CASSISS study also provides important implications for the future research direction of intracranial atherosclerotic stenos.

Future research will focus on conceptual and technological innovations in disease diagnosis and assessment, as well as advances in interventional devices and technologi.

work together

Gao Peng, Deputy Chief Physician, Doctor of Medici.

Deputy Chief Physician of Neurosurgery, Doctor of Medicine, Beijing Science and Technology Rising Star, and a public student sent by the Ministry of Educati.

Deputy director of the Youth Committee of the Interventional Medicine Branch of the Beijing Medical Association, member and secretary of the Neurointerventional Group of the Interventional Medicine Branch of the Beijing Medical Association, and member of the Youth Committee of the Neurointerventional Professional Committee of the Chinese Medical Associati.

Has been committed to the clinical diagnosis and treatment of ischemic cerebrovascular disea.

From 2007 to 2009, he studied at the Institute of Cerebrovascular Diseases, University of California, San Francis.

Published 12 SCI papers as the first author , and participated in the editing of one of the refereed wor.

Presided over one of the National Natural Science Foundation of China Youth Fund and the Beijing Science and Technology Commission Science and Technology Rising Star Progr.

Participated in the national "Twelfth Five-Year" scientific and technological support plan project "Research on the minimally invasive technology system for cerebral revascularization in ischemic cerebrovascular disease" and the "Thirteenth Five-Year" national key scientific and technological support plan "Digital cerebral blood flow reserve function diagnosis and evaluation technology and Its Applied Resear.

Wang Tao, attending physician, doctor of medici.

In 2017, he graduated from the Peking Union Medical College (Tsinghua University School of Medicine) with an eight-year clinical medicine progr.

Committed to the surgical and interventional diagnosis and treatment of ischemic cerebrovascular diseases such as intracranial artery stenosis, carotid artery stenosis and moyamoya disea.

So far, he has published 20 SCI papers and 1 Chinese core journal paper as the first author or co-first auth.

Participated in 2 boo.

Participated in the "13th Five-Year" National Key R&D Program, Beijing Municipal Science and Technology Commission and other provincial and ministerial-level projects, and presided over 3 projects including the Beijing Medical Management Center Cultivation Progr.

He has a deep understanding of data mining and information analysis in the clinical context, and is good at clinical research design and systematic review metho.

Successful registration of multiple Cochrane systematic reviews investigating the diagnosis, assessment and treatment of intracranial and carotid stenos.

Wang Daming, chief physician, professor, doctoral supervisor, member of the National Committee of the Chinese People's Political Consultative Conferen.

He is currently the chief expert of neurosurgery in Beijing Hospit.

He is also a member of the Chinese Society of Neurosurgery and the deputy director of the Beijing Neurosurgery Bran.

Under the tutelage of Professor Ling Feng, a famous Chinese neurointerventional expert, and Professor Luc PICARD, President of the World Federation of Interventional Neuroradiolo.

Specializes in the interventional treatment of cerebral and spinal vascular diseas.

The first work carried out or reported in domestic or international are: establishment of cerebral arteriovenous malformation animal model, hemodynamic model and embolization research, electrolytic detachable coil embolization for intracranial aneurysm, embolization standard of intracranial aneurysm Special research on three-dimensional cerebral angiography in the diagnosis and treatment of intracranial aneurysms, stent placement for intracranial artery stenosis, endovascular dilation and stent placement for carotid and vertebral artery stenosis under cerebral protection devices, e.

David.

Liebeskind, MD

Professor of Neurology at the University of California, Los Angeles (UCLA), Director of the UCLA Stroke Center, Director of the Neurovascular Imaging Research Core, leading global efforts to advance data science and precision medicine of stroke imaging for prevention, acute therapies and recovery after stro.

Director of the UCLA Cerebral Blood Flow Laboratory, Director of Outpatient Stroke and Neurovascular Programs and Director of the UCLA Vascular Neurology Residency Program, training the next generation of vascular neurologists and stroke exper.

Corresponding Author

Jiao Liqun, chief physician, profess.

Director of Interventional Radiology Department, Xuanwu Hospital, Capital Medical University, Deputy Director of Neurosurgery, Director of Cerebral Revascularization Center, Doctoral Supervis.

Vice-Chairman of the Neurointerventional Committee of the Chinese Medical Doctor Association; Chairman of the Neurointerventional Committee of the National Health and Health Commission's Education Center; Vice-chairman of Ischemic Stroke Intervention Special Committee; editor-in-chief of "Chinese Journal of Cerebrovascular Diseases"; central health care consultation expert; vice-chairman of Beijing Interventional Medicine Associati.

Graduated from Shandong Medical University, successively studied under Professor Zhu Shugan and Professor Ling Feng, obtained a master's degree and a doctorate degree in neurosurgery, and completed postdoctoral research at Peking University under the guidance of Professor Bao Sheng.