Carotid stenting shows promise for high-risk CV patients: shift away from endarterectomy predicted.
Results of the Guidant Corp.-sponsored Acculink for Revascularization of Carotids in High-Risk Patients (ARCHeR) trials, taken together with prior trials in which carotid stenting has outperformed endarterectomy, suggest a bright future for this percutaneous alternative to surgery, said Dr. Gray, director of endovascular care at the Swedish Medical Center in Seattle.
"When these devices are approved--hopefully later this year--we should see a fairly rapid transition to the use of carotid stenting with embolic protection in high-risk patients," he predicted.
"In the lower-risk patients, where the clinical trials are still ongoing, the adoption of the technology will be a little slower, but I suspect those trials will be quite similar [to completed studies in high-risk patients] in terms of their outcomes. I think we're going to continue to see low major stroke and death rates with this procedure. As a clinician, I'd add that when given a choice between surgery and stenting, patients generally choose the nonsurgical technique," the cardiologist continued.
ARCHeR was actually a series of three single-arm nonrandomized studies involving 581 high-risk patients at 48 centers. The comparison group consisted of historical controls from the published surgical literature. The credibility of this use of historical controls was demonstrated by the fact that their outcomes mirrored those seen in the surgical arm of the previously reported randomized Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) trial, Dr. Gray said.
ARCHeR 1 involved 158 patients treated with Guidant's Acculink carotid stent system without embolic protection. ARCHeR 2 included 278 patients treated with the same stent plus a first-generation embolic protection device. ARCHeR 3 involved 145 patients who received the latest-generation versions.
The primary end point in ARCHeRs 1 and 2 was a composite of the 30-day death/stroke/MI rate plus any ipsilateral strokes occurring between 31 days and 1 year. The 30-day death/stroke/MI rates in ARCHeRs 1-3 were 7.6%, 8.6%, and 8.3%. The composite 1-year end point occurred in 8.3% of ARCHeR 1 participants and 10.2% in ARCHeR 2, compared with 14.5% of surgical controls. ARCHeR 3 did not include 1-year data; the study was designed simply to establish that the newer embolic protection devices were equivalent to the first-generation versions used in ARCHeR 2.
The 30-day rates of major and/or fatal strokes in ARCHeRs 1, 2, and 3 were 1.9%, 1.4%, and 1.4%, respectively, similar to what was observed earlier in the major carotid endarterectomy trials. Between 31 days and 1 year, one major ipsilateral stroke occurred among the 436 patients in ARCHeRs 1 and 2. All nondisabling strokes that occurred during the first month in these two studies showed no lasting neurologic impact at 1 year.
An economic impact analysis of the ARCHeR studies is ongoing. An earlier study suggested that carotid stenting with embolic protection costs about one-third less than endarterectomy, Dr. Gray said.
Session cochair Dr. John McB. Hodgson of Case Western Reserve University, Cleveland, observed that embolic protection didn't seem all that effective, since it merely reduced the 30-day major and/or fatal stroke rate from 1.9% in ARCHeR 1 to 1.4% in ARCHeRs 2 and 3. "Obviously the embolic protection device is not the answer for those," he added.
Dr. Gray replied that the collective experience in ARCHeR--along with trials involving other stent systems with embolic protection as well as the major endarterectomy studies--suggests that a 30-day rate of about 1%-1.5% "may be a floor we can't get below, but we're still in an early phase of development with these embolic protection devices and I think with generational improvements we're likely to see lower rates."
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|Title Annotation:||Focus on Heart Disease; cardiovascular|
|Publication:||Family Practice News|
|Date:||May 1, 2004|
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