Drug-eluting stents reduced the risk of revascularization, heart attack and death in diabetics as compared with bare-metal stents in the largest observational comparison.  The results were presented as a late-breaking clinical trial and is simultaneously published in circulation in the Journal of the American Heart Association.

People with diabetes make up about a third of all patients undergoing procedures to reopen blocked blood vessels.  In the largest population-based comparison of stents in diabetics, researchers used data from a mandatory state registry.  They identified 5,051 diabetics who underwent PCI at acute-care, non-federal hospitals between April 2003 and September 2004.  Diabetic patients at those hospitals were about twice as likely to get DES compared to BMS (66.1% vs. 33.9%).

Laura Mauri, M.D., M.Sc., principal investigator of the study and assistant professor of medicine at Brigham and Women’s Hospital and Harvard Medical School in Boston, Mass. said:  “We actually saw a significant benefit from using drug-eluting stents in this patient population…. First, they significantly reduced the need for repeat procedures which included repeat stenting or bypass surgery.  Second, they were associated with lower rates of death and heart attack.  So, as a result we can say that these stents appear to be safe in diabetic patients, whose diabetes puts them at higher risk of mortality and heart attack than the general population.”

Mauri also noted that at three years of follow-up, the unadjusted cumulative endpoint of death was 14.4% for drug-eluting stent patients compared to 22.2% for bare metal stents patients.  The researchers then matched a subset of 1,476 DES and 1,476 BMS patients to control for 63 potential confounders such as concurrent conditions and medications.  In that comparison, they found the risk-adjusted mortality at three years was 17.5% for DES patients vs. 20.7%, a small but significant 3.2 percent absolute reduction in mortality in DES patients, with no excess adverse events.  The choice of BMS or DES was not randomized, but was done at the direction of the treating physician, so it is possible that the patients given DES were different in the number of blood vessel or other characteristics.

Although three-year data were not yet available for rates of heart attack and target vessel revascularization, at two years of follow-up those rates were lower in the DES group compared to the BMS group.

This study showed lower mortality and adverse events, and this study was also larger than many of the prior studies which have showed safety concerns and damaged the reputation of DES vs. BMS use.

The study did not show which exact stents were under comparison, but it does at least give some timeframes.  Here are the companies making drug eluting stents:Cypher by Johnson & Johnson (NYSE: JNJ), and SurModics (NASDAQ: SRDX) is the molecule maker for Cypher; and Taxus by Boston Scientific (NYSE: BSX), and Angiotech (NASDAQ: ANPI) is the molecule maker for Taxus.

The newer stent players may benefit from this study, but these are newer on the market. Endeavor by Medtronic (NYSE: MDT) is a drug eluting stent system with approval in 2008.  Abbot Laboratories (NYSE: ABT) by Xience was not on the market at that time.  Abbott also supplies a private-label version of XIENCE V to Boston Scientific (NYSE: BSX) called the PROMUS.

Jon C. Ogg
November 11, 2008

Boston Scientific (NYSE: BSX) will get to sell basically the same exact stent under a different name. Boston Scientific also has the old Taxus stent. Angiotech (NASDAQ: ANPI) is also Boston’s Taxus stent coating partner for its molecule.

As far as the others, this will get to compete with the Medtronic Inc. (NYSE: MDT) Endeavor stent system as well as Johnson & Johnson (NYSE: JNJ) Cypher stent. Medtronic won the first Stent system approval in February after a 4-year hiatus. SurModics Inc. (NASDAQ: SRDX) is the molecule partner over at J&J for the drug-eluting coatings for teh Cypher stent.

This is being viewed as a key win for Abbott Labs with shares up 1.6% at $55.10 in after-hours trading.  The good news is that the dark clouds surrounding stents and drug-eluting stents is starting to lift.  The bad news on the topic is that this is now a highly competitive sub-sector in coronary  medical technology.

Jon Ogg
July 2, 2008

Interim data was compiled at six and 12 months using 435 patients and 200 patients, respectively. The corresponding EFS rates were 94% and 84%, and freedom from TLR was 96 percent and 88%.

Angiotech is a company that has not been in the brightest spot of late.  As the company makes polymers for stents (and other uses), the 2007 issues surrounding the safety and efficacy of stents had a severe negative impact on the company.

Even after a 6% rise this morning to $2.74, the stock is still down almost two-thirds from its 52-week highs of $7.90.  In late 2004 this stock traded well over $20.00.

Jon C. Ogg
June 11, 2008