Randomized Controlled Trial of Symptomatic Middle Cerebral Artery Stenosis

Abstract

Another study demonstrated anatomic features related to high complication rate of intracranial angioplasty and stenting, Background and Purpose-To investigate the efficacy and safety of percutaneous transluminal angioplasty and stenting (PTAS) for symptomatic middle cerebral artery stenosis compared with standard medical treatment in a low-risk Chinese population. Methods-A prospective, randomized, controlled, single-center clinical trial was conducted comparing PTAS with medical treatment for symptomatic middle cerebral artery stenosis (≥70%). Patients were enrolled according to 1:1 enroll ratio (PTAS: medical). The PTAS group received stenting or balloon angioplasty, whereas the medical treatment group received standard medical treatment (aspirin 100 mg plus clopidogrel 75 mg/d), and all the patients were under strict control of the risk factors. The end point events were any kind of ipsilateral stroke or transient ischemic attack, or death from any origin during 1-year follow-up. Results-The enrollment was stopped after 70 patients were enrolled from August 2007 to December 2010, with a 30-day rate of end point events of 8.3% versus 5.9% (P=0.69) for PTAS and medical group, respectively, and 1-year rate of end point events of 19.4% versus 17.6% (P=0.85), respectively. There was no significant difference in baseline characteristics between the 2 groups. The mean follow-up time, which was ongoing, was 9.9 ± 3.9 and 9.7 ± 4.4 months, respectively. Among the risk factors, hypertension was the independent related to the outcome (P=0.015). Conclusions-This study showed that endovascular treatment is as safe but not better than medical treatment for symptomatic middle cerebral artery stenosis in a low-risk Chinese population. History of hypertension increases the risk of recurrent ischemic events.

What's New in Stroke? Phase III Randomized Clinical Trials of 2012–2014

“…Thirty-three trials (97%) were known to be truly randomized (randomization method not reported for one (29)), and 12 (35%) were double blinded ( Table 1). Most (65%) were international trials; of the RCTs restricted to a single country, China led with four (12%) RCTs (16,19,28,33) (Table 1). Main sponsorship (several trials had multiple contributors) was national governments for 19 (56%) RCTs, while eight (24%) were primarily sponsored by the pharmaceutical or device industry (Table S1).…”

Natural History of Intracranial Atherosclerotic Disease

“…This study not only indicated mechanism of embolization in stroke recurrence, but also showed a new method to confirm patients at high-risk – MES detection. Recently, Miao et al (15) performed a prospective, randomized, controlled, and single-center clinical trial to compare PTAS with medical treatment for symptomatic MCA stenosis (≥70%). The PTAS group received stenting or balloon angioplasty, whereas the medical treatment group received standard medical treatment (aspirin 100 mg plus clopidogrel 75 mg/day), and all the patients were under strict control of the risk factors.…”

Intracranial Angioplasty and Stenting before and after SAMMPRIS: “From Simple to Complex Strategy – The Chinese Experience”

“…We also independently reported our prospective registry focused on symptomatic MCA stenosis, which demonstrated a relatively high 1-year complication rate of 19.4%, compared to the medical group of 17.6% ( p  = 0.85) (14). This result was very similar to the later published SAMMPRIS study.…”