In spite of arguments contesting whether bare metal or drug-eluting stents perform better, drug-eluting stents are here to stay and are still used in the majority of stent implantations. In fact, a plethora of studies have shown that DES can improve mortality rates and reduce the need for target vessel revascularization (TVR) compared with BMS.
In the largest study of its kind, researchers at Duke University Medical Center (DUMC) found that the clinical outcomes for DES patients were significantly better than for BMS patients. The researchers, led by Pamela Douglas, MD, compared outcomes in older individuals receiving DES and BMS as part of the American College of Cardiology’s National Cardiovascular Data Registry. (The study was also supported by the Agency for Healthcare Research and Quality.) The registry tracked 262,700 patients in 650 registry sites in 2004 through 2006 with procedural registry data linked to Medicare claims for follow-up. DES were implanted in 217,675 patients and BMS were implanted in 45,025 patients. The DES patients saw lower unadjusted rates of death (12.9% vs. 17.9%), MI (7.3 per 100 patients vs. 10.0), and revascularization (23.0 per 100 patients vs. 24.5) with no difference in stroke or bleeding. The results were obtained after 30 months of follow-up and across all pre-specified subgroups. The results were published online by the Journal of the American College of Cardiology (doi:10.1016/j.jacc.2009.03.005, March 28, 2009).
Drugs, coatings and other areas of focus in drug-eluting stent development are many, with multiple companies pursuing the same or similar approaches. There are also a wide number of unique directions being taken.
Below is a sampling of the drug/coating efforts in drug-eluting stent development:
- 17-ß-estradiol (XC-121)
- AVI-5126 (CoCr)
- Biolimus A9
- “Drug X”
- Dual drug: zotarolimus and dexamethasone
- Melatonin/paclitaxel combination
- Paclitaxel, bifurcation
- Paclitaxel, rapamycin (cobalt base)
- Paclitaxel, second generation
- Paclitaxel, third generation, platinum chromium alloy
- Pericardium covered stent
- Pimecrolimus bioabsorbable, CoCr
- Pimecrolimus; biodegradable, absorbable
- Polymer coated
- Polymer drug delivery system
- Rapamycin with biodegradable polymer coating
- Sirolimus (CoCr)
- Sirolimus with biodegradable coating
- Sirolimus with biodegradable polymer coating
- Sirolimus; bioabsorbable polymer
- Sirolimus; biodegradable to bare metal
- Tacrolimus with biodegradable polymer coating
- Undisclosed antiproliferative
- Undisclosed drug, biodegradable, absorbable
- Undisclosed; polymer-coated
The status of product, company, technology and market development of drug-eluting stents (and all coronary stent types) are the subject of the May 2009 report by MedMarket Diligence. Report #C245.