News | November 18, 2010

Researchers Call for New Trials to Resolve Carotid Stenting Debate

November 18, 2010 – After the initial findings from the CREST trial, debate continues to swirl as proponents of both carotid endarterectomy (CEA) and carotid angioplasty and stenting (CAS) claim superiority for their preferred intervention.

As a result, Wesley S. Moore, M.D., professor and chief emeritus of the division of vascular surgery at UCLA Medical Center, has proposed a moratorium on both procedures as a way to accelerate a new, clarifying clinical trial for patients with carotid stenosis.

During the VEITHsymposium, Moore called attention to the initial delay and difficulties in recruiting patients and the subsequent decision to include asymptomatic patients in order to reach the 2,500 cohort. Including both asymptomatic and symptomatic patients diluted the study’s power to compare the two procedures because asymptomatic patients tend to have fewer complications than symptomatic patients.

That flaw attenuated the somewhat conflicting findings that have fueled the ongoing controversy over CREST’s outcomes. In aggregate, the primary endpoints of death, stroke and myocardial infarction were 4.5 percent for CEA and 5.2 percent for CAS, which were not statistically significant. However, when the primary endpoints of death and stroke were analyzed alone, the rate was 2.3 percent for CEA versus 4.4 percent for CAS and those differences were statistically significant at P=0.005. There were more non-fatal myocardial infarctions with CEA, which resulted in equalizing the aggregate of the three primary endpoints between the two procedures.

Attempts at subset analysis designed to separate results in symptomatic versus asymptomatic patients were limited by sample size. Nonetheless, the stroke rate for CEA in symptomatic patients was 3.2 percent versus 6 percent in CAS with P=0.019. The stroke rate for CEA in asymptomatic patients was 1.4 percent versus 2.5 percent for CAS, but that difference did not achieve statistical significance in spite of a clear trend in favor of CEA.

That apparent tilt towards CEA is also reflected in the results of a nationwide sample of more than 400,000 hospital patients who underwent either CAS or CEA for carotid revascularization between 2005 and 2007. As reported by Mohammed H. Eslami, M.D., of the division of vascular and endovascular surgery at the University of Massachusetts Medical School, CAS significantly increased the odds of stroke in asymptomatic patients. However, the data also showed that utilization of CAS jumped 66 percent between 2005 and 2006, with some improvement in outcomes in that period as well.

Further complicating the matter, Moore said that treating asymptomatic patients with statins and ACE inhibitors has greatly reduced the risks for stroke and death for patients with carotid disease. This calls into question whether either surgical intervention on its own, as was the case in CREST, is the appropriate therapy for those patients.

To resolve these issues, he endorsed the need for a new three-arm trial of asymptomatic patients comparing outcomes of CAS combined with optimal medical treatment, CEA combined with optimal medical treatment, and medical treatment alone. Also, he called for a temporary halt for CAS or CEA treatment of asymptomatic patients with carotid stenosis so that the pool of potential subjects for the new trial would be as large as possible.

For more information:

Related Content

Transplanting Pig Hearts Into Humans One Step Closer. A pig heart, shown here,  is very similar in size and anatomy to a human heart. For this reason, pigs are used extensively in pre-clinical animal testing testing for new implantable cardiovascular devices. If pig hearts could be used for human transplantation, it were greatly alleviate shortages of donor human hearts.

A pig heart, shown here,  is very similar in size and anatomy to a human heart. For this reason, pigs are used extensively in pre-clinical animal testing testing for new implantable cardiovascular devices. If pig hearts could be used for human transplantation, it were greatly alleviate shortages of donor human hearts.

News | Cardiovascular Surgery | December 11, 2018
The scientific journal Nature recently published an article from Munich University Hospital which describes the long-...
Bilateral Artery Use Does Not Improve 10-Year CABG Outcomes
News | Cardiovascular Surgery | September 06, 2018
While it is firmly established that the use of one internal thoracic artery can improve life expectancy in coronary...
Mandatory Public Coronary Artery Bypass Grafting Reporting Associated With Better Patient Outcomes
News | Cardiovascular Surgery | April 30, 2018
Mandatory public reporting of coronary artery bypass grafting (CABG) results in Massachusetts was associated with...
Gecko Biomedical Receives CE Mark Approval for Setalum Sealant
News | Cardiovascular Surgery | September 19, 2017
Gecko Biomedical announced it has received CE Mark approval for its Setalum Sealant, allowing the company to market its...
ClearFlow Inc. Announces Positive U.S. Clinical Trial Results
News | Cardiovascular Surgery | September 08, 2017
September 8, 2017 — ClearFlow Inc.
Videos | Cardiovascular Surgery | July 19, 2017
This video educational session, provided in partnership with the American Society of Echocardiography (ASE), is title
Intensive Glycemic Control Program Produces Significant Per-Patient Cost Savings for CABG Surgery
News | Cardiovascular Surgery | May 25, 2017
A new study from Emory University observed a near-20 percent reduction in perioperative complications, a 1.2-day...
Risk of Heart Transplant Rejection Reduced by Desensitizing Patient Antibodies
News | Cardiovascular Surgery | May 23, 2017
The risk of heart transplant rejection can be reduced by desensitizing patient antibodies, according to research...
Scientists Show How Cells React to Injury From Open-Heart Surgery
News | Cardiovascular Surgery | May 04, 2017
Cedars-Sinai Heart Institute investigators have learned how cardiac muscle cells react to a certain type of injury that...
Overlay Init