Chief Medical Editor's Page
FDA Approval of Carotid Artery Stenting
At present, carotid endarterectomy (CEA) is the gold standard for most patients who have significant carotid stenosis. Since CEA was first performed in 1953, the number of procedures performed worldwide has increased dramatically. Currently, an estimated 180,000 cases are performed annually in the US, with an additional 100,000 beyond our borders. It is the most commonly performed major vascular operation in the US.
CEA is also one of the best procedures that vascular surgeons perform. Its benefit in preventing stroke has been well established by a number of randomized trials and it is the most scientifically sound operation in the field of vascular surgery. CEA is straightforward, rarely complex, and is the favorite procedure of many vascular surgeons. It is also the most profitable vascular operation for the hospital.
During the 1980s, CEA came under attack from other specialties that questioned its benefit. This resulted in a significant drop-off in the number of procedures performed during this period. Since the early 1990s, however, CEA has made a major comeback empowered by the positive results of randomized trials. Now, CEA is under attack for the second time.
Indeed, carotid stenting has begun to gnaw at the heels of CEA’s market share and franchise. Until very recently, many surgeons did not take this threat seriously, largely because of the inherent risk of embolization related to CAS. The solution to this problem came in the form of anti-embolization devices. The SAPPHIRE clinical trial randomized high-risk patients to CEA and CAS with anti-embolization devices. The results have been widely disseminated in major news outlets, such as The New York Times and The Wall Street Journal. CAS beat CEA in this select group of patients by reducing complication rates (death, stroke, MI) by 50% (5.8% vs 12.6%). One might criticize the conduct and interpretation of the trial, but the data speak for themselves.
In its 2003 annual report, Morgan Stanley estimates that, at present, only 4% of all cases are treated with CAS. Estimates for 2006 project that CAS could capture up to 75% of the domestic carotid market based on the fact that CAS will be approved by the FDA for market release by the second quarter of 2004. Reimbursement will remain an issue until the CMS reverses its current ?national noncoverage policy.? However, physicians will probably find a way to use these devices, especially when fueled by patient preference for minimally invasive therapy, and also supported by data from a randomized clinical trial. Ironically, randomized trials are what repopularized CEA.
In this issue, we cover the “nuts and bolts” of CAS as well as provide an update on various clinical trials, the results of which will strongly influence the direction of this field. CAS involves the participation of a number of specialties and will continue to be among the most controversial topics in the field of vascular disease management. Endovascular Today will be there to cover this evolving story.