Sammpris trial protocol

This study aims to evaluate the safety and efficacy of endovascular stenting for patients with symptomatic intracranial artery stenosis and poor collaterals in China and to identify the characteristics of the population that would benefit the most from endovascular stenting in Chinese patients.

Methods and analysis This multicentre prospective registry study will involve 20 stroke centres in China, and plans to recruit patients into the registry. Ethics and dissemination The protocol is approved by the ethics committee at the coordinating centre and by the local institutional review board at each participating centre. Findings will be shared with participating hospitals, policymakers and the academic community to promote quality monitoring, quality improvement and the efficient allocation and use of cerebral catheterisation and intracranial artery stenting in China.

Atherosclerotic intracranial artery stenosis is an important cause of ischaemic stroke. The Wingspan stent system has been widely used to treat patients with symptomatic intracranial atherosclerotic stenosis who have failed conventional therapy. SAMMPRIS compared the efficacy between aggressive medical treatment and endovascular stenting in patients with severe intracranial artery stenosis. Multicentre prospective studies in the Chinese population are urgently needed to assess the perioperative efficacy and safety of stenting with different types of stents in the Chinese population, as well as to identify which subgroup of patients would benefit the most from endovascular stenting.

This study is a multicentre prospective single-arm registry study and the protocol is approved by the ethics committee at the coordinating centre and by the local institutional review board at each participating centre. This study is initiated by the investigators, with 20 participating stroke centres see online supplementary appendix II , and plans to recruit consecutive patients who meet the inclusion and exclusion criteria.

After the enrolment, all participants would be evaluated at baseline, day 4, day 30, months 6, months 9 and year 1 see online supplementary appendix I. The Wingspan stent system is provided by the Boston Scientific company and the Apollo stent is provided by the MicroPort Company, but they will not participate in data collection, analysis, editing or make decisions about the publication.

This study is sponsored and conducted by the Cerebrovascular Disease Center of Tiantan Hospital in addition to its responsibility for data analysis. The study has been registered and the registration number is NCT The study protocol has been approved by the ethics committee and has started recruitment of patients since January and plans to end recruitment by January Non-atherosclerotic lesion, for example, moyamoya disease, vascular inflammatory disease due to infection, autoimmunity diseases, postirradiation, postpartum state, developmental or genetic abnormalities, for example, fibromuscular dysplasia, sickle-cell anaemia, suspected vasospasm.

According to the condition of the patients and the operation specifications and experience of the study centres, the investigators decide the means to treat by endovascular stenting. All the patients are treated under general anaesthesia. Device selection by the Wingspan or the Apollo stent depends on arterial access and lesion morphology. From our experience, the Gateway balloon catheter and Wingspan stent system is more suited to patients with tortuous vascular access, especially at the C4 segment, as this system has better flexibility in traversing curvatures.

The Apollo stent is more rigid compared with the Gateway—Wingspan system, but it is preferred for patients with smoother access, as the delivery of this balloon-expandable stent does not require exchanging and less procedural time is needed. Hence, for patients with smooth arterial access and a Mori A lesion, or if the lesion is located in the mid-basilar artery and distal M1 segment, the Apollo balloon-mounted stent would be selected.

For patients with tortuous arterial access and a Mori B or C lesion, or a lesion with a significant mismatch in the diameter between proximal and distal segment, angioplasty plus self-expanding stent Gateway balloon plus Wingspan stent system is preferred. If severe dissection or elastic recoil occurred after angioplasty, the Apollo stent for patients with less tortuous access or the Wingspan stent for patients with severe tortuous access or small target vessel would be implanted.

Ischaemic strokes are classified as in or out of the territory of the symptomatic intracranial artery. For death, efforts are made to obtain relevant records from the hospital, including death certificates, to determine the cause.

The results would be analysed primarily through the intention-to-treat method and secondarily by the per-protocol analysis. The influence of confounding factors on outcome would be analysed box 3. Box 3 Confounding factors for analysis Patient demographics. Compliance with medications in particular with the antiplatelets—aspirin and clopidogrel. Resistance to aspirin or clopidogrel tested by thrombelastography, plasma concentration or pharmacogenomics. The Mann-Whitney test would be used for ordinal variables, while the Student t test would be used for continuous variables.

Subsequent multivariate analysis by logistic regression would be performed to identify independent predictors of the primary outcome. This registration study will enrol about patients. This is a prospective clinical registry that will help clarify whether endovascular angioplasty and stenting is a safe and efficacious therapy as an alternative to aggressive medical treatment for patients with symptomatic severe intracranial atherosclerosis and poor collaterals.

The study evaluates a tailored endovascular treatment with currently available devices based on arterial access and lesion morphology for symptomatic severe intracranial atherosclerosis. However, this study has limitations. It focuses on the Chinese population and caution should be used when applying the findings to patients of other ethnicity. The study has inadequate statistical power to assess the impact of the endovascular treatment on major clinical outcomes.

DSMB members are independent of the researchers and the steering committee. This research is also supported by the Investigator-Sponsored Study Program of AstraZeneca that donates rosuvastatin Crestor to study patients.

Some of these authors receive additional support as listed below. He currently serves on the stroke adjudication committee of an industry funded osteoporosis drug trial Merck and Co.

L Gore and Associates and is compensated for those activities. He has also served as an expert witness in medical legal cases. He is also on the Scientific Advisory Board for W. Tanya N. She has also served as an expert witness in medical legal cases. Bethany F.

Lane RN has received consulting fees from Microvention Terumo. Michael J. National Center for Biotechnology Information , U. Author manuscript; available in PMC Oct 1. Marc I. Derdeyn , MD, 3 Tanya N. Turan , MD, 1 Bethany F.

Lane , RN, 4 L. Lynn , MS 4. Colin P. Scott Janis. Author information Article notes Copyright and License information Disclaimer.

Corresponding author: Marc I. Keywords: Intracranial stenosis, angioplasty and stenting, clinical trial. Copyright notice. The publisher's final edited version of this article is available at Stroke.

See other articles in PMC that cite the published article. Introduction Even before the early results of SAMMPRIS were published 1 , commentaries that were critical of the trial or that attempted to explain the poor outcome of patients treated with stenting in the trial were published or being submitted for publication 2 — 4.

Conclusion The results of SAMMPRIS were surprising and disappointing to many investigators in our field, some of whom are looking for alternative explanations for the study results 2 , 5 , References 1. All information pertaining to age, baseline demographics, past medical history, admission glucose, admission National Institutes of Health Stroke Scale NIHSS score and vascular risk factor indices [LDL, glycated hemoglobin A1C, smoking status, and blood pressure BP values] at 90 days was collected for the purposes of this analysis.

All patients underwent contrasted MR angiography, CT angiography or cerebral angiography. Symptomatic intracranial hemorrhage was defined as parenchymal hematomas type 1 or type 2 with space-occupying effects within the infarcted area. We encouraged all patients to maintain a BP log and adjusted BP medications based on home and in-office readings to achieve target.

All patients were placed on high-potency statins at baseline and had repeat lipid panels obtained at least 30 days or more after the initiation of their statin. The primary endpoint was the rate of recurrent stroke in any vascular territory, myocardial infarction MI , or vascular death. The safety outcome was the rate of any major hemorrhage, defined as any subdural or epidural hemorrhage or a systemic hemorrhage requiring hospitalization, blood transfusion, or surgery.

A two-sample t test and Mann-Whitney U test were performed to compare each normally and nonnormally distributed continuous variable between the two cohorts. Fisher's exact test was also used to compare categorical variables. A total of 25 consecutive patients presented to our University Stroke Center and met our study inclusion criteria.

A history of active smoking at the time of the symptomatic event was lower in our cohort 4 vs. Our cohort had less involvement of the internal carotid artery as the symptomatic artery 0 vs. Other baseline characteristics including sex, race, hypertension, dyslipidemia, diabetes mellitus, CAD and history of antithrombotic use at the time of the qualifying event were similar between the two cohorts.

However, persistence of smoking status in our cohort at 90 days was lower than what was reported for the patients that were evaluated at days in the SAMMPRIS cohort 0 vs.

The major bleeding event in our cohort was a single GI bleeding event requiring transfusion, which occurred while the patient was taking concomitant nonsteroidal anti-inflammatory medication in addition to DAPT. Endpoint outcome — the rate of recurrent stroke in any vascular territory, MI or death from a vascular pathophysiology; safety outcome — the rate of any major hemorrhage.

Our analysis provides real-world experience that aggressive medical management similar to the SAMMPRIS trial protocol is effective at reducing the risk of recurrent stroke [ 10 , 11 , 12 , 13 , 14 , 16 ].

The prolonged period of DAPT was not associated with a significant increase in the risk of major hemorrhage, which may be related to the utilization of H2 blocker agents for GI prophylaxis, which were a standard part of our treatment while patients were on DAPT.

Although this early decrease in vascular events in the SAMMPRIS group could be related to a more rigorous risk factor modification including LDL-lowering therapy, the rapid reduction in the vascular event risk is more likely to be explained by the effects of DAPT given their rapid onset of action and the lack of early cardiovascular risk reduction from statin therapy after MI [ 20 ].

Although reduction of microemboli detection by transcranial Doppler in patients on DAPT is a reasonable surrogate marker, it might not translate into clinical efficacy of reducing stroke or TIA with clopidogrel plus aspirin dual therapy in patients with symptomatic ICAD. On the other hand, the Secondary Prevention of Small Subcortical Strokes SPS3 trial, which was a randomized, double-blind, placebo-controlled trial that compared clopidogrel plus aspirin versus aspirin monotherapy in 3, patients who had a symptomatic lacunar perforator artery infarction confirmed by magnetic resonance imaging within 6 months of onset, failed to show any difference in the risk of recurrent stroke ischemic or hemorrhagic stroke between the two groups 2.

However, the DAPT group had a higher major bleeding rate than the aspirin monotherapy group 2. The MATCH trial did not show a significant difference in fatal bleeding or symptomatic intracranial hemorrhage, but there was a significant risk of life-threatening bleedings with DAPT [96 2. A randomized trial comparing the duration of DAPT 90 days vs.

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