The State of the Stent: Drug-eluting stents in the U.S.

A commentary from Boston Scientific Corporation

After two years of intense debate in the interventional cardiology community, drug-eluting stents (DES) saw more and more positive clinical data and began the process of restoring confidence in 2008. The following commentary by Jeff Mirviss, Vice President Interventional Cardiology Marketing at Boston Scientific, Maple Grove, Minnesota, provides a snapshot of the state of the DES industry, which saw the introduction of two new stents, focused on the treatment of small vessels and continued to evaluate safety issues with effective clinical data over the past year.

Expanding Options for Physicians

In 2008, interventional cardiologists had more stenting options than ever before, with multiple DES platforms and drugs now on the market. For example, Medtronic’s Endeavor® zotarolimus-eluting coronary stent system and Abbott’s Xience™ V everolimus-eluting coronary stent system — two new players in the DES market — were both approved by the U.S. Food and Drug Administration (FDA). Boston Scientific also received approval for Promus® everolimus-eluting coronary stent system, its private-labeled version of Abbott’s Xience V stent. The two stents are identical and share equal parts of the everolimus segment of the DES market.

The Promus stent gave Boston Scientific the distinction of being the only company to offer physicians a choice of two distinct drugs (everolimus and paclitaxel) on multiple stent platforms. Boston Scientific additionally received FDA approval for the Taxus® Liberté® paclitaxel-eluting coronary stent system, the Taxus Express2® Atom™ paclitaxel-eluting coronary stent system, expanded in-stent restenosis indication for the Taxus® Express® stent for use in bare-metal stents and Apex™ Monorail® and Over-The-Wire percutaneous transluminal coronary angioplasty dilatation catheters.

New stents arrived as the market for DES continued to improve, with penetration rates rising from an a low of 61 percent in November 2007 to 74 percent at the end of 2008, according to Millenium Research Group. The Promus and Taxus stents, combined, made up 49 percent of the market during the fourth quarter of 2008. Abbott’s Xience V stent had an estimated 28-percent market share, followed by Cordis’ Cypher® drug-eluting coronary stent at approximately 14 percent and Medtronic’s Endeavor® stent at just over 9 percent.

Thinking Small

Last year, interventional cardiologists also welcomed an alternative to bare-metal stents for the treatment of small coronary vessels. Boston Scientific’s Taxus Express Atom Stent (2.25mm) reduces the risk of restenosis typically seen with bare-metal stents in these small vessels. Currently, the Taxus Express Atom stent is the only DES approved for small coronary vessels. With the approval of the Taxus Express Atom stent, Boston Scientific now offers the largest size matrix available to treat the widest range of vessel diameters and lesion lengths in the industry.

Other options for the treatment of small vessels are under investigation. Boston Scientific’s Taxus Liberté Atom stent has been submitted for FDA approval. In December 2008, Abbott initiated the SPIRIT Small Vessel trial, which will evaluate a 2.25 mm size of the Xience V stent. Cordis is conducting small-vessel trials with the Cypher stent.

Post-PCI Medical Therapy

Recognizing the importance of clinical data, the stent industry continued to provide additional data in 2008. Additionally, two device manufacturers launched support programs designed to prevent premature discontinuation of anti-platelet therapy — the single biggest predictor of stent thrombosis — in DES patients. Abbott’s Xience V Co-Pay Assistance Program provides educational materials and discounts toward prescription co-pays on anti-platelet medications for patients receiving the Xience stent. Boston Scientific’s Stentplus™ Program is an integrated patient adherence program with several components including a website for patients and health care providers. It provides patient education, individualized services and financial assistance information for all patients who receive a DES, regardless of stent brand.

Boston Scientific: Reflecting on 2008, Looking to 2009

Boston Scientific (BSC) helped deliver important clinical data in 2008. The SYNTAX™ Trial compared the use of DES against bypass surgery in hard-to-treat cases such as three-vessel disease and left main disease. In addition, the HORIZONS AMI Trial* evaluated the Taxus Express stent compared to bare-metal stenting in patients experiencing an acute myocardial infarction (AMI). The FDA approval of the Promus, Taxus Liberté and Taxus Express Atom stents enabled BSC to bring to market two distinct drugs on unique stent platforms.

On the horizon, we can expect to see continued advancements in stent technology. Boston Scientific’s R&D pipeline of next-generation products, including the platinum-chromium based Element™ series of stents — Taxus Element and Promus Element stents. (The Perseus clinical trial has closed enrollment to evaluate the Taxus Element stent and enrollment began in early 2009 for the Platinum Trial evaluating the Promus Element stent.) The Taxus Petal™ bifurcation stent, bioabsorbable polymer stent systems and a drug-eluting stent designed with a reduced drug and polymer load located only on the outside surface of the stent are also in development. We can also expect to see developments from Boston Scientific’s recently acquired Labcoat technology, which allows drug elution from a series of “drug dots” on the stent surface.

Overall, the year ahead looks positive for the DES industry, with a full arsenal of new DES products for physicians and patients, and a continued pipeline of clinical trials testing the safety and efficacy of future stents.

*Horizons - AMI is sponsored by the Cardiovascular Research Foundation with research grant support from Boston Scientific and the Medicines Company.

Promus Stent is a private-labeled Xience V™ Everolimus–Eluting Coronary Stent System manufactured by Abbott and distributed by Boston Scientific Corporation.

Promus is a trademark of Boston Scientific Corporation or its Affiliates. Xience V is a trademark of Abbott Laboratories group of companies.

Endeavor is a trademark of Medtronic Vascular, Inc.
Cypher is a trademark of Cordis Corporation.

© Boston Scientific Corporation or its Affiliates. All rights reserved.