SCAI and SVM Suggest Changes to California Assessment on CAS

September 27, 2010—The Society for Cardiovascular Angiography and Interventions (SCAI) and the Society for Vascular Medicine (SVM) issued a joint statement to the California Technology Assessment Forum (CTAF) to show shortcomings in CTAF's draft assessment of carotid artery stenting (CAS). SCAI and SVM stated that they are providing this statement to guide and inform the CTAF's assessment of CAS, which they said will be posted on CTAF's Web site in October.

CTAF's Web site states that the organization “is a community forum dedicated to objectivity and transparency regarding medical technologies; a community forum for dialog and decisions regarding the safety and effectiveness of new and emerging technologies.” The Blue Shield of California Foundation spearheads the CTAF, “managing technology assessment reviews and organizing all CTAF meetings and events.”

SCAI President Larry S. Dean, MD, and SVM President Thom W. Rooke, MD, issued the statement on behalf of the societies. Christopher White, MD, was the statement's lead author with contributions from Tyrone Collins, MD; Michael Jaff, DO; and Bonnie Weiner, MD.

According to SCAI, several areas in CTAF's 2009 statement on CAS misinterpret published and peer-reviewed data. SCAI and SVM stated that CTAF does not address the key clinical issue in the assessment of CAS and that its findings are based on an inaccurate representation of the evidence and are inappropriately broad.

The societies note that since their last correspondence with the CTAF, the results of the CREST trial (Carotid Revascularization Endarterectomy Versus Stenting Trial) have become available. They stressed that CREST, the largest trial comparing CAS to CEA in average- or low-surgical-risk patients, found no difference in the composite rate of stroke, myocardial infarction, or death during the periprocedural period or any ipsilateral stroke out to 4 years after randomizing 2,502 patients. The trial results confirm that both CEA and CAS are safe and effective treatment options for patients with atherosclerotic carotid disease.

The societies outline how CAS meets the five technical assessment criteria laid out by CTAF. According to the SCAI/SVM statement:

“With the focus on high-surgical-risk patients, it is clearly apparent that all five of the specific TA criteria are met for CAS. The crucial question is not whether CAS is a superior carotid revascularization technique to CEA, but rather, in which patient population is CAS as good and safe as CEA. There is now overwhelming evidence supporting CAS in selected patients as a valid alternative to CEA in patients with high-risk anatomic features and medical comorbidities. This is consistent with FDA labeling. The recent peer-reviewed publications of more than 8,000 high-surgical-risk patients meeting and exceeding published carotid revascularization benchmarks for 30-day stroke and death risks makes an irrefutable argument for accepting CAS indications that are broadly consistent with the FDA-labeled indications for the devices.”