PROTECT Trial Highlights Improvements in Carotid Artery Stenting

Issue: March/April 2012

In the PROTECT trial, patients at high risk for carotid endarterectomy had improved outcomes with carotid artery stenting compared with early carotid stenting trials, culminating in the lowest rate of periprocedural complications yet observed in comparable carotid stenting single-arm trials, according to a study published in the Journal of Vascular Surgery.

Perspective from John R. Laird, MD

The prospective, multicenter trial involved 220 consecutive patients enrolled between Nov. 29, 2006, and Jan. 14, 2008, as well as a second cohort of 102 patients enrolled between Jan. 14 and June 18, 2008. Patients (mean age, 72.6 years) were at high risk for carotid endarterectomy and had carotid stenosis of at least 50% for those considered symptomatic or at least 80% for those deemed asymptomatic. Researchers treated patients with a new embolic protection device (Emboshield Pro, Abbott Vascular) in conjunction with a self-expanding nitinol carotid stent system (Xact, Abbott Vascular).

At 30 days, the composite endpoint of death, stroke and MI (DSMI) was 2.3% (95% CI, 0.74-5.22) among the first 220 patients, with a combined rate of death and major stoke of 0.5% (95% CI, 0.01-2.51). For the 322-patient cohort, long-term follow-up (median, 2.8 years) revealed 95.4% of patients were free from the composite of DSMI plus ipsilateral stroke.

For More Information:

Matsumura JS. J Vasc Surg. 2011;doi:10.1016/j.jvs.2011.10.120.

Perspective

John R. Laird, MD

The PROTECT study demonstrated remarkably good carotid artery stenting outcomes with a closed-cell stent and a second-generation embolic protection device. The periprocedural composite endpoint (DSMI) of 2.3% was the lowest that has been seen for any of the high-risk registries. The traditional endpoint of death and stroke occurred in only 1.8% of cases with a 0.5% rate of death and major stroke. Very importantly, carotid stenting was effective in preventing future ipsilateral stroke with an annualized ipsilateral stroke rate of only 0.4%. This study highlights the continued improvement in carotid artery stenting outcomes, which is likely a result of better patient selection, evolving operator technique and better stents and methods of embolic protection.

John R. Laird, MD

Cardiology Today Intervention Editorial Board Member

Disclosures: Dr. Laird serves as a consultant/scientific advisory board member for Abbott Vascular.