This monthly column in Cath Lab Digest reviews important points of distinction in drug-eluting stents, from characteristics to techniques, to provide valuable and relevant information about this technology.

Dr. Kereiakes received his undergraduate and medical degrees from the University of Cincinnati. He completed an internship and residency at the University of California, San Francisco, a senior residency at Massachusetts General Hospital in Boston and a chief residency at the University of California, San Francisco. He then completed fellowships in adult cardiology at the University of California, San Francisco, and in coronary angioplasty at the San Francisco Heart Institute and the Sequoia Hospital. In addition to his clinical practice, Dr. Kereiakes serves as Medical Director at the Heart Center of Greater Cincinnati and the Carl and Edyth Lindner Center for Research and Education. Dr. Kereiakes is also a Professor of Clinical Medicine at Ohio State University and was previously the Chief Executive Officer of Ohio Heart and Vascular Center. His accomplishments include being prior section editor for Circulation, the official medical journal of the American Heart Association and editorial board member for The Journal of the American College of Cardiology, The American Heart Journal, The American Journal of Cardiology, The Journal of Invasive Cardiology, Circulation and Reviews in Cardiovascular Medicine. Dr. Kereiakes is board-certified in internal medicine and cardiovascular disease.

What is the primary objective of the PERSEUS Clinical Program?

The PERSEUS clinical program is designed to study the safety and efficacy of the TAXUS® Element™ Stent in de novo coronary lesions. The PERSEUS program consists of two trials — a workhorse trial studying native coronary arteries 2.75mm to 4.0mm in diameter, and a small vessel trial studying coronary arteries from 2.25 up to 2.75 millimeters.

How is the TAXUS Element Stent different from the TAXUS® Express Stent?

The TAXUS Element Stent has a new design and is made of platinum chromium, which provides thinner struts and improved radiopacity compared to the TAXUS Express or Liberté® Stent platforms.

As the Principal Investigator of the PERSEUS Program, could you provide an overview of the workhorse trial design?

We enrolled 1,264 patients in the workhorse study across 94 sites in the United States, Australia, New Zealand and Singapore. The primary endpoint was target lesion failure at 12 months, which is a composite of death, myocardial infarction and target lesion revascularization. The secondary endpoint was in-segment percent diameter stenosis at 9 months. A subset of patients was randomly assigned to angiographic follow-up at nine months.

Patients were randomly assigned in a 3 to 1 basis to either the TAXUS Element Stent or the TAXUS Express Stent control. This is a single-blinded study, which means that the patients do not know whether they received the TAXUS Element Stent or TAXUS Express Stent. However, the interventional cardiologist doing the procedure knows because the stents are different. Patients in the study could have one- or two-vessel disease, and if applicable, the non-target vessel lesion was required to be successfully treated with a commercially available TAXUS Stent before treating the target lesion in a randomized fashion.

Could you provide an overview of the small vessel trial design?

We enrolled 224 patients in the small vessel study across 35 sites. The primary endpoint was in-stent late loss at nine months and the secondary endpoint was target lesion failure at 12 months. All patients enrolled in the small vessel study had angiographic follow-up at nine months.

The small vessel study is a single arm, open-label administration of the TAXUS Element Stent compared to a historic bare-metal stent control from the TAXUS V randomized trial.

How do the trial designs differ from previous DES clinical trial designs?

The PERSEUS Clinical Program was designed with the latest FDA requirements in mind, including the Academic Research Consortium’s (ARC) stent thrombosis definition, dual antiplatelet duration recommendations, and a primary target lesion failure (TLF) endpoint that emphasizes both general stent safety as well as focal efficacy around the target lesion.

The PERSEUS Workhorse Program involves an active control drug-eluting stent (DES) instead of a bare-metal stent. The active control in the workhorse trial is the TAXUS Express Stent.

The other important difference in the workhorse trial is that the angiographic cohort of 330 patients was randomly assigned to angiographic follow-up throughout the trial. This is novel because in previous trials the angiographic cohort involved the first sequential 100 to 300 patients in a trial or a sequential subset of patients. In PERSEUS Workhorse, a patient could be enrolled late in the trial and still be randomly assigned to angiographic follow up.

What is the current enrollment status and what are some of the key factors to the success of the PERSEUS Trials?

I am pleased to say enrollment for the PERSEUS Trials is now complete. We completed enrollment in the small vessel trial in August and enrollment in the workhorse trial was completed early October.

I had a superb co-principal investigator, Louis Cannon, who was a key component to the success of the PERSEUS Trials. We also had an incredible group of investigators and regional leaders. The regional clinical leadership program also built considerable camaraderie and enthusiasm.

How would you characterize your experience with the TAXUS Element Stent?

While the safety and efficacy of the TAXUS Element Stent has not yet been established, I think the TAXUS Element Stent is a high-performance device from a mechanical perspective. It is the easiest DES to use of any that I have tested in terms of deliverability, flexibility and radiopacity.

CAUTION: Investigational device. Limited by U.S. Federal law to investigational use. Not for sale in the U.S.

Sponsored and prepared by Boston Scientific Corporation.