Case Example 9Designing a Registry To Study Outcomes

DescriptionThe Carotid Artery Stenting with Emboli Protection Surveillance Post-Marketing Study (CASES-PMS) was designed to assess the outcomes of carotid artery stent procedures for the treatment of obstructive artery disease during real-world use. The primary purpose of the registry was to evaluate outcomes in the periapproval setting, including the use of a detailed training program for physicians not experienced in carotid artery stenting.
SponsorCordis Corporation
Year Started2004
Year Ended2006
No. of Sites74
No. of Patients1,493

Challenge

In 2004, the sponsor received approval for a carotid stent procedure from the U.S. Food and Drug Administration (FDA), largely because of the results of the Stenting and Angioplasty With Protection in Patients at HIgh Risk for Endarterectomy (SAPPHIRE) clinical trial. The SAPPHIRE trial studied the results of stent procedures performed by experts in the field. While the trial provided strong data to support the approval of the carotid stent, FDA and the Centers for Medicare & Medicaid Services (CMS) both questioned whether the outcomes of the trial were generalizable to procedures performed by physicians without prior experience in carotid artery stenting.

To respond to the FDA and CMS requests, the sponsor needed to design a study to confirm the safety and effectiveness of carotid artery stenting in a variety of settings. The study needed to gather data from academic and nonacademic settings, from physicians with various levels of carotid stenting experience, from settings with varying levels of carotid stenting volume, and from a geographically diverse mix of sites. The study would also need to examine the effectiveness of a training program that the sponsor had designed to teach physicians about the stenting procedure.

Proposed Solution

The sponsor designed a comprehensive training program for physicians and other health care professionals. The training program, which began in 2004, included didactic review, case observations and simulation training, and hands-on experience. To study the effectiveness of the training program and to provide data on the clinical safety and effectiveness of carotid stenting in a variety of settings, the sponsor designed and launched the registry in 2004.

The registry was a multicenter, prospective, observational study designed to assess stenting outcomes in relation to the outcomes of the SAPPHIRE trial (historic comparison group). The study enrolled 1,493 patients from 74 sites, using inclusion and exclusion criteria that matched those of the SAPPHIRE trial. The patients in the study were high-surgical-risk patients with de novo atherosclerotic or postendarterectomy restenotic obstructive lesions in native carotid arteries. Study participants completed clinical followups at 30 days and again at 1 year after the procedure. The 30-day assessments included a neurological examination by an independent neurologist and an evaluation of adverse events. The study defined the 30-day major adverse event rate as the 30-day composite of all deaths, myocardial infarctions, and strokes.

Results

The 30-day major adverse event rate of 5.0 percent met the criteria for noninferiority to the outcomes of stented patients from the pivotal SAPPHIRE trial. Outcomes were similar across levels of physician experience, carotid stent volume, geographic location, and presence/absence of the training program. The initial findings show that a comprehensive, formal training program in carotid stenting enables physicians from multiple specialties with varying levels of experience in carotid stenting to achieve outcomes similar to those achieved by the experts in the clinical trial

Key Point

An observational registry can provide the necessary data for a postmarket evaluation of devices that are dependent on newly acquired skills. The registry can provide data to assess both the clinical safety of the device and the effectiveness and success of a training program.

For More Information

  1. Katzen B, Criado F, Ramee S. et al. on behalf of the CASES-PMS Investigators: Carotid artery stenting with emboli protection surveillance study: 30-day results of the CASES-PMS study. Catheter Cardiovasc Interv. 2007;70:316–23. [PubMed: 17630678]
  2. Yadav JS, Wholey MH, Kuntz RE. et al. Protected carotid-artery stenting versus endarterectomy in high-risk patients. N Engl J Med. 2004;351:1493–501. [PubMed: 15470212]

From: Chapter 3, Registry Design

Cover of Registries for Evaluating Patient Outcomes: A User's Guide
Registries for Evaluating Patient Outcomes: A User's Guide. 2nd edition.
Gliklich RE, Dreyer NA, editors.

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