据3月7日公布的临床试验结果显示，采用支架治疗颈动脉严重阻塞的高危险患者，比用手术治疗大幅降低了患者中风和死亡的风险。

研究人员在美国心脏病学院（American College of Cardiologists）的科学会议上，公布了三项对Guidant制造的Acculink支架所做的安全性与有效性试验结果。

Guidant计划在本季末向美国管理当局提交最后数据，而颈动脉支架的使用有望在今年底或2005年初获得核准。

上述试验中的其中两项是针对先以汽球清除颈动脉内淤积后，再接受支架置入一年后的患者。而第三项，也就是最近一项试验，则对使用该架30天后的患者进行观察。

在第一项试验中，患者一年后的死亡、中风和心脏病发作总和机率为8.3%，第二项试验为10.2%。最后一项装支架后30天的试验资料则显示，有8.3%的人死亡、中风或心脏病发作。

虽然研究中没有包括接受手术治疗的病人组供比较，但过去的数据显示，接受手术治疗的类似情况高危险患者发生死亡、中风与心脏病发作的机率为14.5%。

这三项试验一共观察了581名患者，每人都至少有一项危险因素令他们不适合接受手术，其中42%的人同时有两种或更多危险因素。

领导这项研究的西雅图瑞典心脏病研究所的格雷（William Gray）博士相信，颈动脉支架一旦获准用于高危险患者身上，可能很快将成为标准疗法。

Carotid Stenting Cuts Stroke, Death Risk -Study

Sun Mar 7, 2004 03:38 PM ET

NEW ORLEANS (Reuters) - The use of stents in high-risk patients with a severely blocked carotid artery significantly reduced the risk of stroke and death compared with surgery, according to results of clinical trials presented on Sunday.

Data from a series of three so-called ARCHeR trials testing safety and effectiveness of the Acculink stent made by Guidant Corp. were presented at the American College of Cardiologists scientific meeting.

Guidant plans to provide its final submission of data to U.S. regulators by the end of this quarter. Approval for use of stents for the carotid artery -- the blood vessel in the neck that is the main supplier of blood to the brain -- could come late this year or early in 2005.

Two of the trials looked at patients one year after receiving the tiny metal tube used to prop open the carotid artery once its plaque had been cleared by inflating a balloon. Results from the third and most recent trial offered a look at data after 30 days.

After one year, the combined incidence of death, stroke and heart attack was 8.3 percent in the first ARCHeR trial and 10.2 percent in the second. A preliminary 30-day glimpse of those trials presented last year showed a 7.8 percent incidence.

The latest trial, after 30 days, had an 8.3 percent incidence.

While there was no comparative surgery group in the study, historical data of high-risk patients undergoing surgery for this condition show a 14.5 percent rate of death, stroke or heart attack.

"We found a significant improvement over that," said Dr. William Gray of Seattle's Swedish Heart Institute and a lead researcher of the Guidant-sponsored study.

About 25 percent of strokes are caused by carotid artery disease, commonly when particles of plaque in the clogged artery dislodge, travel through the bloodstream and block blood vessels in the brain. Surgeons can clear the blockage by scraping it out of the carotid artery, but stents may provide a safer alternative.

A total of 581 patients were enrolled in the three trials, all with at least one risk factor that made them either ineligible for surgery or a high-risk surgical candidate. Some 42 percent of them had two or more of these risk factors.

Gray said if just the most dire consequences of death and major stroke were culled from the results, they were even more impressive. "The rates are 1.5 percent at one year, which is remarkable."

Those results are similar to findings from surgery in low-risk patients, Gray said. "And these patients had considerably more heart disease, lung disease and other things that put them at risk for death."

More than 400 of the carotid stent patients also received Guidant's Accunet filter, a mesh net designed to catch blood clots and other plaque debris to prevent it from going to the brain during the stenting procedure.

While Accunet efficacy was not a goal of the trial, Gray said when the mesh nets were removed, about 60 percent of them contained trapped particles.

"It adds a margin of safety," he said.

Gray believes that once carotid stenting has been approved for use in high-risk patients it could quickly be adopted as the standard of care.

"Certainly if I were a patient and I saw those numbers, I wouldn't want the surgery," he said.