Adverse Event Clinical Trial
Official title:
Safety and Efficacy of Distal Embolic Protection Device in Vertebral Artery Origin Stent Angioplasty :A Prospective, Multicenter, Randomized Controlled Trial
This is a prospective single-center,randomized controlled trial,aiming to investigate the safety and efficacy of distal EPD in vertebral artery origin stenting(VAOS);256 subjects will be recruited in this study,after randomized recruitment, treatment group(128 subjects each group) undergo VAOS with adjuvant distal embolic protection device(EPD),control group undergo routine VAOS without distal embolic protection device.Intraprocedural and postprocedural in-hospital adverse events,including stroke,death and dis-retrieval of EPD,will be noted and cost-effectiveness analysis also will be conduct,including economic cost,hospital stays.
Ischemic cerebrovascular diseases are associated with a high rate of mortality and disability
rate, as a consequence, many related trials were conducted to perfect prophylaxis and
treatment of ischemic stroke. 2/3 of cerebral blood supply is offered by Internal carotid
artery(ICA) , due to high morbility and disability rate of carotid territory stroke, stoke
caused by ICA stenosis is always emphasized by authors. With the development to the depth in
this field, ischemic stroke in posterior circulation related to vertebral artery stenosis is
gradually paid attention recently. Outcome from New England medical center posterior
circulation registry study revealed that 20% of patients were found to have vertebral artery
origin(VAO) stenosis, in 9% of these patients, no other cause of stroke was identified. The
relative risk of having a stroke or dying in patients with VAO stenosis was 6 times than that
of patients without VAO stenosis. Therefore, VAO stenosis need appropriate management to
prevent potentiality of ischemic stroke.
Nowadays there are three treatment alternatives for extracranial VAO stenosis: medicine,
surgery and endovascular stent angioplasty. However, medical therapy mainly focus on
prevention and delay of severe ischemic events other than radical therapy, and it's not
always effective to improve symptoms of posterior circulation ischemia. Surgery are limited
by its serious trauma and the combined postoperative morbidity and mortality rates ranging
from 10% to 20%.Endovascular stent angioplasty was feasible in ICA stenosis as reported in
literatures, and that promotes the utilization of stent in VAO stenosis in recent years.
Related retrospective studies have demonstrated the safety and efficacy of vertebral artery
origin stenting(VAOS) in VAO stenosis. In a Meta analysis that summarized 27 articles about
extracranial vertebral artery stenting, Stayman observed that the rate of transient ischemic
attack(TIA) and stroke within postprocedural 30 days was 1.1% and 0.8% respectively. Compter
etc. are conducting a prospective case-control study to assess the safety and feasibility of
VAOS, which final outcome is thought to be relatively authentic.
However, some drawbacks in VAOS needs additional resolution, like embolization caused by
plaque debris, high restenosis rate, vasospasm, vessel dissection. Especially, embolization
is associated with not only plaque characteristic, but also anatomy of the vertebral
arteries, which is potentially essential to high risk of plaque debris dislodgment. The
origin of vertebral artery is characterized with small diameter and tortuous course. Dodevski
analyzed 30 patients' vertebral arteries and found that 40% of patients' vertebral artery was
tortuous, the diameter of the VAO on the left side was in the range between 1.60-5.2 mm, mean
3.33 ± 0.89 mm, and on the right side from 1.64-5.40 mm, mean 3.19 ± 0.98 mm. Tortuosity and
small diameter in VAO will increase operation difficulty and procedural time.
Borhanisummarized 27 articles focusing on vertebral origin angioplasty and concluded that of
the 808 patients underwent stent angioplasty, the combined rate of stroke and TIA within 1
month after stenting was 6.9%.
Concerning dislodgement of plaque debris, embolic protection device(EPD) is applied recently
to decrease the risk of embolization. But utilization of EPD in VAOS is mainly based on its
safety and feasibility in carotid artery stenting(CAS). In CAS, cerebral embolic protection
devices can effectively reduce the incidence of transient ischemic attack, stroke and other
related adverse events. The U.S. Safety Committee recommended stopping unprotected CAS,
because the 30-day rate of stroke was 3.9 times higher than that of CAS with cerebral
protection. However, VAOS is different from CAS, and its performance in CAS cann't serve as
medical science evidence for distal EPD in VAOS. Firstly, the rate of postoperative
restenosis after VAOS is higher than that of CAS, ranging from 20% to 66.7%.Secondly, VAO are
characterized by concentric, fibrous, and smooth lesions with lower incidence of ulceration
and intraluminal hemorrhage compared with extracranial carotid artery circulation[13].
Thirdly, the microscopic structure of VAO is featured with elastic fibers and smooth muscles.
These distinctions indicate that investigators should make a distinction between CAS and VAOS
in terms of intravascular intervention. As to the use of EPD in VAOS, no Class Ⅰ evidence can
verify the safety and efficacy of EPD and clinicians share discrepant opinions. Some authors
thought that distal protection devices will suspend operation process, increase
operation-related risk and may cause embolization during crossing lesion and retrieval which
may be referable to transient shear stress. In addition, some patients are intolerable to
flow cessation caused by distal EPD. Moreover, foreign case reports even noted that
utilization of distal EPD was probable to induce vasospasm and difficult retrieval of distal
EPD was finally managed by secondary surgery in some cases[14, 15]. However, small
sample-size studies demonstrated it's safe and feasible to use distal EPD in VAOS. Qureshi
etc.retrospectively analyzed clinical data of 12 patients underwent VAOS with filter
protection, outcome revealed that no stroke and death events occured within 1 month
follow-up. In a multicenter study, Edgell etc. contrastively analyzed the data of patients
underwent VAOS with and without distal EPD, the rate of TIA and stroke within 1 month between
the two groups showed no significant difference. Divani etc. analyzed plaque debris captured
by EPDs in 14 patients who underwent VAOS with distal protection devices, the outcome
revealed that relative to the size of the filter, the proportion of captured debris ranged
from 0.1% to 22% in the VA filters, hence, Divani recommended the use of distal EPD in VAOS.
In summary, the use of distal EPD in VAOS is debatable, no class I evidence can support the
advantage of use of distal EPD in VAOS. Here, the investigators will conduct this
prospective, single-center, randomize controlled trial aiming to analyzed the safety and
efficacy of distal EPD in VAOS.
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