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SAPPHIRE Worldwide: Carotid stenting outcomes in large registry consistent with trial results
LAS VEGAS — A registry study of more than 21,000 patients undergoing carotid artery stenting showed results consistent with those from randomized controlled trials and smaller registries.
Among those who had the best outcomes after carotid artery stenting (CAS) for obstructive carotid artery disease were younger patients, asymptomatic patients and patients with anatomic risk factors, D. Christopher Metzger, MD, FACC, FSCAI, said during a presentation at VIVA 15.
“This trial provides yet further validation for the safety of carotid stenting in a high-risk cohort of patients in a real-world setting,” he said during a press conference.
The SAPPHIRE Worldwide study, the largest-ever prospective trial on CAS, aimed to determine rates of major adverse events and identify which subgroups benefit most from the procedure, Metzger said.
Metzger, from Wellmont CVA Heart Institute in Kingsport, Tennessee, and colleagues enrolled 21,008 patients (mean age, 72 years; 61% men) who had been treated with CAS using a nitinol carotid stent (Precise, Cordis) and distal embolic protection with an emboli capture guidewire (Angioguard XP/RX, Cordis) between October 2006 and May 2014.
All patients were considered high-risk for carotid endarterectomy, and 30% had symptomatic carotid artery disease, according to Metzger. Patients were eligible if they had at least 80% stenosis if asymptomatic and at least 50% stenosis if symptomatic, he said.
At 30 days, the rate of major adverse events was 4.4%. Overall, 3.3% of patients had a stroke, 1.2% died and 0.5% had MI. Metzger said the rate of events observed is similar to those seen in previous studies.
Major adverse events were more likely to occur in patients aged 75 years and older compared with younger patients (5.9% vs. 3.2%; P < .0001), those at high physiologic risk compared with high anatomic risk (5.1% vs. 3%; P < .0001) and those who were symptomatic compared with those who were asymptomatic (5.7% vs. 3.8%; P < .0001), Metzger said. He also noted that outcomes did not differ based on sex.
“As in every previous trial, symptomatic patients had more events than asymptomatic patients,” he said. “But ... both the symptomatic and asymptomatic [patients] basically meet the [American College of Cardiology/American Heart Association] guidelines for carotid revascularization in patients who are by definition at high risk for endarterectomy.”
He added that patients enrolled because they were at high anatomic risk “did extremely well with carotid artery stenting.”
The largest predictor of stroke after CAS was age 75 years or older (OR = 2.05; 95% CI, 1.76-2.39). Other predictors included symptoms, need for concomitant carotid revascularization with bypass surgery and renal insufficiency.
“The results are getting better over time because we better realize who we should be [performing CAS] in,” Metzger said. “What I hope is that these data will help CMS see which patients are being excluded from [CAS] who shouldn’t be. For example, a patient who is asymptomatic and at anatomic risk has a less than 2% stroke and death rate, and yet those are excluded from reimbursement, despite the fact that those patients do less well with endarterectomy as a redo operation, but there is reimbursement for that.” by Erik Swain
Reference:
Metzger DC, et al. Late-Breaking Clinical Trials. Presented at: VIVA 15; Nov. 2-5, 2015; Las Vegas.
Disclosure: The study was funded by Cordis. Metzger reports financial ties with Abbott Vascular, Bard, Boston Scientific and Trivascular.
Perspective
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This is a remarkable registry of 21,000 patients who have undergone carotid artery stenting. Ours was one of the sites. It is a standard high-risk registry with symptomatic patients with greater than 50% stenosis or asymptomatic patients with at least 80% stenosis of the internal carotid artery. The primary endpoint was a typical composite of stroke, 30-day death and MI. Overall, the results were excellent, with a composite endpoint of 4.4% at 30 days. That’s very competitive with the outcomes in the randomized CREST trial, despite the fact that these are high-risk patients and, in many cases, high-risk lesions.
The investigators identified several higher-risk situations as well as patients that could potentially have better outcomes with carotid stenting. The SAPPHIRE registry also adds significantly to our knowledge base about patients we need to be cautious about referring for carotid stenting. This is a recurring theme, put patients older than 75 years or 80 years of age seem to do worse with carotid stenting than the younger patients. Also, patients with physiologic high-risk situations such as coronary disease, lung disease or congestive HF, also tend to do worse.
Overall, the results of the SAPPHIRE registry should allow us to move forward with carotid stenting as a viable treatment option for high-risk patients with carotid artery disease, given the fact that quite good results were achieved in this high-risk patient population, and excellent results in patients with anatomic high risk.