Global Insight Perspective | |
Significance | Some of the more interesting data presented at the EuroPCR meeting indicates the superiority of Abbott's Xience over Boston Scientific's Taxus stent, while separate data from Johnson and Johnson (J&J) suggests its drug-eluting Cypher stent is more effective than the older generation metal stents. |
Implications | The release of new data touting the safety and efficacy of stents comes after months of declining sales for the devices. There has been an overall decline in stenting, as well as a switch back to older and cheaper bare metal stents, as doctors and patients have grown increasingly concerned about reports of late-stent thrombosis in patients implanted with drug-eluting stents. |
Outlook | The EuroPCR data has shed some light on the potential winners and losers in the contest for market share. For the immediate future, however, the challenge will be to restore general trust in stents. |
Stent Makers Tout Safety of Their Devices
Broad-based U.S. healthcare company Abbott released data from the SPIRIT FIRST trial indicating no additional Major Adverse Cardiac Events (MACE) and no late-stent thrombosis in patients implanted with its Xience V everolimus-eluting coronary stent or its Multi-Link Vision metallic coronary stent. The results are based on patient follow-up until three years after stenting. A separate meta-analysis of the SPIRIT II and SPIRIT III data shows that Xience outperformed Boston Scientific's Taxus paclitaxel-eluting stent on measures such as MACE incidence, number of treatments due to ischemia and blood vessel renarrowing.
Meanwhile, J&J's Cypher sirolimus-eluting stent was found to have a similar effectiveness to bypass surgery at three years follow-up, as 80.6% of Cypher patients were MACE-free compared to 83.8% of those who underwent cardiovascular surgery. Importantly, Cypher outperformed bare metal stents on this indicator, as only 66% of those implanted with bare metal stents were MACE-free at three years.
The Ones to Watch out for
In addition to traditional stents, Abbott presented data on a fully bioabsorbable stent. A small-scale (30 patient study) found no stent thrombosis at nine months and a 4% rate of MACE.
Meanwhile, a stent from Medtronic (U.S.) was found to be superior to bare metal stents in terms of late-stent thrombosis risks. The rate of late-stent thrombosis with the drug-coated Endeavor stent was 0.5%, compared to a rate of 1.5% in patients implanted with bare metal stents. Endeavor is yet to be approved for marketing in the United States.
Outlook and Implications
The safety and efficacy data released this year appears to be focused on comparisons to angioplasty and bare metal stents—a trend that reflects the main dangers facing stent makers. There has been a notable increase in doctors and patients opting for the older and cheaper bare metal stents as they seek to mitigate the late-stent thrombosis risks reported for drug-eluting stents in recent months. In April, the total number of stenting procedures fell by 15% year-on-year to 71,200. Meanwhile, the use of drug-coated stents in stenting procedures fell from 90% in June 2006 to 69.7% in April 2007 (see United States: 17 May 2007: Stenting Procedures Tumble in April).
With doctors, patients and the FDA increasingly concerned about thrombosis risks associated with drug-eluting stents, the industry has a difficult challenge ahead. Not only do companies need to convince users that their particular stent is good, but they also need to convince them that stenting in general is worthwhile. The latter task is now even more difficult, given the recent release of data showing that management of patients with pharmaceuticals could be just as effective as stenting (see United States: 28 March 2007: Courage Study Results Rekindle Drugs Versus Stents Debate). As the debate continues, stents such as Abbott's biodegradable stent (although this is still a few years away from marketing) and Medtronic's Endeavor could be the ultimate winners. Endeavor could be approved in the United States by year-end and would raise the heat on rival devices from Boston Scientific, J&J and Abbott.