By Gary Roubin, MD, PhD
Moderator: L. Nelson Hopkins, MD
Panelists: Jiri Vitek, MD and Tyrone Collins, MD
The CREST Trial was the largest, most rigorous and because of the way it was conducted, the most relevant investigation into the role of carotid stenting to date.
The National Institute of Neurological Diseases after critical review concluded that the study “Demonstrated that Endarterectomy and Stenting were equally efficacious methods of preventing stroke caused by carotid bifurcation stenoses.”
The primary endpoint was unequivocal but the components of this combined endpoint have been dissected by various groups to support different conclusions. Vascular surgeons have pointed to more minor strokes in the stenting group and cardiologists to more myocardial infarctions in the CEA cohort. The CREST Trial demonstrated remarkable safety from both procedures with a very low and similar major stroke and death rate. The small numbers of excess strokes in the stenting group were minor strokes and importantly further analyses of temporal trends have demonstrated this delta disappeared over the course of the study. Stenting stroke rates improved over time probably related to better selection of younger patients with more suitable anatomy for stenting.
If CREST was to restart in 2012, it is extremely unlikely that any difference whatsoever would be seen in comparing CEA and Stenting.
Importantly, minor strokes were not associated with a later excess mortality while a periprocedural MI was associated with death over the follow up period.
Quality of life analyses reflected the minor, non disabling nature of the small number of excess minor strokes. The comprehensive panel of SF36 mental and physical quality of life measures demonstrated no difference whatsoever between stenting and CEA.
Despite completing the study with first generation stents and embolic protection devices, the outcomes were gratifying. A critical FDA panel subsequently approved the extension of labeling for stenting use in standard risk CEA patients.
Now we await a considered response from CMS to acknowledge the demonstration of “reasonable safety and efficacy” and long awaited reimbursement for this patient friendly, percutaneous procedure.
We now are experiencing a curious push back from some in the neurological community and even some surgeons who argue that neither CEA nor stenting are needed in the treatment of asymptomatic patients.
- This—despite multiple trials that have demonstrated the superiority of revascularization and markedly improved revascularization results.
- This—despite no scientific evidence to support the equivalence of medical therapy in preventing stroke in carotid bifurcation disease.
- NICK HOPKINS: The CREST data stand on their own merits. Looking at the survival curves for minor stroke versus myocardial infarction, as a surgeon who does a large volume of CEA and stenting, I am impressed with the benign outcome in the minor strokes and the bad outcomes associated with M.I. Again, as a surgeon, I doubt we can do anything to reduce the incidence of MI, but as a stent operator, I feel we can do much more to further reduce the incidence of stroke events. For example, the neurological community has focused on the ICSS Trial sub-study that demonstrated a significant incidence of MRI-DWI defects after stenting……
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