Welcome to Touch Briefings

Richard A Schatz and Rachel L Israel
American Heart Hospital Journal Volume 9 No.1

Five years ago we were given a mission to predict what the future would hold for interventional cardiology. We waxed of days past when angioplasty and bypass surgery were the only options and medical therapy was pedestrian for acute myocardial infarction (AMI), chronic angina and heart failure.

By 2006 stents had evolved into portable pharmacies, delivering a variety of drugs to the target site. This offered not just mechanical support for the vessel, but also a cerebral cocktail of molecular weapons to prevent restenosis. At the time there were only two drug-eluting stents (DES) on the market: the first being the sirolimus-eluting (Cypher®) stent (Cordis Corporation, Bridgewater, NJ) and later the paclitaxel-eluting (Taxus®) stent (Boston Scientific, Natick, MA). The Cypher stent by then had an excellent track record with three years of follow-up and excellent safety and efficacy data; the Taxus stent, which had entered the market more recently, was not far behind.^1-3 We predicted that the slotted tube design would remain the fundamental building block for all stents and this has proved to be true. Since then two new stents have been approved by the Federal Drug Administration (FDA) in the US: the everolimus-eluting (Xience®, Promus®) stent (Abbott Vascular, Abbott Park, IL and Boston Scientific, Natick, MA) and the zotarolimus-eluting (Endeavor®) stent (Medtronic, Minneapolis, MN). Both have enjoyed success and share the bulk of the market.

Data from all the stents look strikingly similar to Cypher with no obvious advantages emerging.⁴ Despite some negative reports in Europe in 2006 about DES being unsafe and a panic rush back to bare metal stents (BMS), further careful analysis proved that the initial reports were flawed owing to blurry registry data and a lack of rigorous randomization.⁵ DES have made a vigorous comeback and remain center-stage as a first line of defense for intervention with over 70 % of patients receiving them.⁶ In a surprising move, Cordis Corporation has temporarily abandoned the coronary stent market as it regroups around its next product into the marketplace, the Nevo®, which will probably be launched in Europe first. This stent still incorporates the slotted tube platform but has added multiple holes that act as drug reservoirs so that higher concentrations of drugs can be loaded as well as multiple drugs in a bidirectional pattern. Initial data look promising.⁷

We predicted the evolution of the bioabsorbable stent. Indeed, Abbott Laboratories has made considerable progress. Initial clinical data from Serruys et al. have been presented and look interesting.^8,9 Nonetheless, approval and widespread acceptance still appear to be some way off in the future as more data are needed. Stent thrombosis and restenosis remain challenges to this platform.

We were optimistic that multiple new drugs would be available as stent coatings but, alas, the regulatory pathway has become stifling, discouraging new innovation. More progress has been made with barriers than with new drugs and it seems unlikely that any new platform or drug will be approved in the future. We predicted progress with nanotechnology, which has made some headway, but it will be years before a nanoparticle-eluting stent enters the market.¹⁰

View Article Here

• Correspondence: Richard A Schatz, MD, Scripps Clinic Torrey Pines, 10666 N Torrey Pines Rd, SW206, La Jolla, CA 92037.E: Moreno.Cheryl@Scrippshealth.org