November 14, 2008 - A stent that entices artery-lining cells to coat it works as well, or better than, drug-eluting stents (DES) in keeping arteries open in coronary heart disease patients, according to two research studies presented this week at the American Heart Association's Scientific Sessions 2008 in New Orleans.
The new endothelial progenitor cell-capturing (EPC) stent made by OrbusNeich is coated with an antibody that binds endothelial progenitor cells circulating in the blood. A number of smaller, randomized studies have shown that the stent is effective in carefully selected patients.
The new findings came from real-world patients who typically receive stents to restore adequate blood flow to the heart instead of carefully selected trial patients.
"Randomized trials have the advantage of a very good control group, but they usually have very restrictive exclusion and inclusion criteria; so results from randomized trials cannot be extrapolated to everyday patients," said Sigmund Silber, M.D., chief of cardiology at Moller Hospital Munich in Munich, Germany, and the first author of the large, multicenter stenting study.
In one study, Dr. Silber and colleagues reported the one-year outcomes of 1,640 patients treated with the stent in an international study conducted outside the U.S.
"The most significant finding was that the rate of stent blockage was really low," Dr. Silber said. "The number of patients who needed another catheterized heart intervention within a year was also low."
Patients were treated at 144 sites around the world and entered into an electronic registry. Their average age was 62.8 years, 78.7 percent were males, 25 percent had diabetes, and 36.7 percent had suffered a prior heart attack.
Based on results of previous studies, physicians pretreated 73.8 percent of the patients with statin drugs, which increase the number of endothelial progenitor cells in the blood.
Most patients received two anti-clotting drugs, generally aspirin and clopidogrel, for one month.
Researchers found one year after stenting:
- Only 1 percent of the patients suffered a stent-related blood clot.
- 2.1 percent of the patients died of cardiac causes; 1.8 percent of those were heart attacks.
- 5.4 percent required a revascularization procedure on the treated artery; a catheter-based procedure was used in 5.1 percent to restore blood flow.
- 9.3 percent experienced major adverse cardiac events (MACE), which included heart attacks, unexpected bypass surgery, treatment-related catheter-based revascularization, and cardiac death.
- Among diabetic patients, 4.7 percent had undergone revascularization procedures, the MACE rate was 10.3 percent, and 1.1 percent had stent-related blood clots.
"The stent appears very safe, even in diabetics," Dr. Silber said. "I don't think EPC-capturing stents will replace drug-eluting stents, but whenever you decide not to use a drug-eluting stent, this stent is a good alternative."
In a separate study, researchers reported the one-year clinical outcome of 236 mainly high-risk patients treated with an EPC-capturing stent at the Academic Medical Center of the University of Amsterdam in The Netherlands.
Until recently, two types of stents were used in daily practice; the bare-metal stent and the DES. The latter is coated with an antiproliferative drug to reduce the risk of restenosis.
"The long-term safety concerns of the drug-eluting stent are late stent thrombosis (stent-related blood clots) and an associated increased risk of bleeding, due to long-term dual antiplatelet therapy," said Margo Klomp, M.D., first author of the Amsterdam study and a medical fellow at the Academic Medical Center.
In the single-center Dutch study, Klomp and her colleagues reported on patients with mainly complex lesions who were stented at the Amsterdam center between September 2005 and March 2007. The patients' average age was 65, 72 percent were male, and 14 percent had diabetes.
The researchers' one-year follow-up findings included:
- 3 percent of the patients died, of whom 0.8 percent died of cardiac causes.
- 10.2 percent required a repeat revascularization procedure of the treated vessel.
- 1.2 percent (three patients) had suffered stent thrombosis, which were angiographically documented and occurred within 24 hours, at seven days, and at 18 days, respectively.
- The MACE rate, composed of cardiac death, target lesion revascularization and myocardial infarction, was 13.6 percent.
"Further research on the stent is being performed in a two-armed study, the TRIAS Program, at the Academic Medical Center," Dr. Klomp said. "In one arm, TRIAS LR, the EPC-capturing stent is being compared with the bare-metal stent in patients with a low risk of develop a new blockage. In the other arm, TRIAS HR, the EPC-capturing stent is being compared with conventional drug-eluting stents in people with a high risk of restenosis."
OrbusNeich funded the international study. The Academic Medical Center funded the single-center Amsterdam study.
For more information: www.americanheart.org