Dr. Stone said the TOTAL results should change practice and that the guideline recommendation should be downgraded to IIb.
“There are some patients who have a very large thrombus burden who have trouble dealing with all that thrombus in the cath lab who might benefit, and it is impossible to design randomized trials for small sections and groups of patients,” he said. “I wouldn’t make it class III by any means, but I think it’ll take a long time for that reduction in use to actually transmit through clinical practice, because I must say interventional cardiologists love the idea of simply removing thrombus with a relatively easy-to-use device.”
Dr. David Kandzari, director of interventional cardiology at the Piedmont Heart Center in Atlanta, said in an interview that TOTAL will make operators much more selective and cautious in their performance of thrombectomy until further insights into the stroke issue are available. Thrombectomy should be reserved for bailout instances and not as a front-line therapy, he said.
On the other hand, the stroke rate in the early phase was not significantly different between groups in an as-treated analysis, and an opportunity exists to investigate potential differences between stroke and nonstroke patients to determine whether other comorbidities rather than thrombectomy per se may account for the stroke signal, Dr. Kandzari observed.
TOTAL was funded by the Canadian Institutes of Health Research, Canadian Network and Centre for Trials Internationally, and Medtronic. Dr. Jolly disclosed receiving consulting fees and honoraria from AstraZeneca, speaking fees for St. Jude, and research grants from Medtronic. Dr. Nissen has received research support from and is a consultant/adviser to numerous pharmaceutical companies; all honoraria or consulting fees go directly to charity so that he receives neither income nor a tax deduction. Dr. Stone reported consulting honoraria from Guided Delivery Systems, Miracor, and Reva, and ownership interest or partnership in Arstasis, Caliber, VNT, Micardia, Biostar family funds, and Medfocus family funds. Dr. Kandzari reported research and grant support from Medtronic, Biotronic, Abbott Vascular, and Boston Scientific.
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