“If the 10-year data confirms the stellar outcomes seen at four years, then the study validates the use of stenting in these patients,” says Gary S. Roubin, MD, PhD, medical director of Cardiovascular Associates (CVA) in Birmingham. “The CREST study demonstrated the importance of low peri-procedural complications and emphasizes that stenting should be performed only at centers that have validated good outcome metrics. It is essential to have highly experienced and skilled operators with the necessary cognitive aptitudes to know when and when not to treat these patients with stenting.”
To further define the best way to prevent strokes in carotid stenosis patients, the investigators have started the CREST 2 trial to compare different methods of stroke prevention. The CREST 2 trial is designed to identify the most effect treatment for patients who present with severe carotid blockage but no specific neurological symptoms. The investigators are comparing intensive best medical management alone to intensive medical management combined with revascularization for treatment of plaque buildup. The two revascularization procedures available in the study are CAS and CEA.
“We have started a trial at Brookwood where we rank among the top in the country in recruitment of patients into CREST 2. This is exciting for Birmingham and for Brookwood,” Roubin says. “Currently, the study has about 200 patients participating in the trial, and ultimately we need about 1,400. We have made good progress over the past six months.
“At this point, the literature indicates that the data on medical therapy for stroke prevention looks good. We don’t know yet if it is better than stenting or endarterectomy revascularization, but it does look very good. An important new therapeutic message has emerged from early data on treating asymptomatic patients with best medical therapy. Even for severe blockages, there is no reason to feel a sense of panic. Doctors and patients will have time to navigate the process in a thoughtful way, because we know now that once you start statin drugs and antiplatelet drugs and control blood pressure, the risk of having a stroke is low. We still don’t know if it’s better than getting rid of the blockage, but it does avoid an invasive procedure. That’s the question that we hope the CREST 2 trial will answer.”
The trial, sponsored by the NIH, will be conducted in Canada and the United States by physicians who were carefully selected based on their ability to perform the procedures at low risk. Another key component of the trial is that important stroke risk factors, including hypertension, diabetes, high cholesterol, cigarette smoking, physical activity, and diet will be managed intensively. Participants will remain in the study for four years.
“CREST 2 is the biggest NIH study comparing best medical therapy alone versus best medical therapy and revascularization with the stent or surgical operation. It is a very important trial and is going to answer important questions for us,” Roubin says. “The CREST 2 trial is going well at the present time. With four years of follow up, it may be eight years before we know the final results.”
Roubin and the other investigators are optimistic that CREST 2 will provide answers that will enable medical personnel to provide the best treatment for patients with carotid stenosis. “In the future, I believe we will understand with much more precision which patients and which blockages should be treated with either medical therapy alone or medical therapy plus stenting or medical therapy plus surgery,” he says. “We are establishing, and publishing on a monthly basis, rigorous outcome data that is helping us determine the best treatment for our patients. At the conclusion of this trial, we are going to be much better at treating this disease.”