New endothelial progenitor cell-capturing
stent is as effective as a drug-coated stent in preventing restenosis
A stent that entices endothelial cells to coat it works
as well or better than drug-eluting stents in keeping arteries open in coronary
heart disease patients, according to research presented at the American Heart
Association's Scientific Sessions 2008.
The new endothelial progenitor cell-capturing (EPC) stent
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 Muller Hospital Munich
in Munich, Germany, and the first author of the large, multicenter stenting study.
Silber and colleagues reported the one-year outcomes
of 1,640 patients treated with the stent in an international study conducted outside
the United States.
"The most significant finding was that the rate of stent
blockage was really low," 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, 25.0 percent had diabetes, and 36.7 percent had suffered a prior myocardial
infarction.
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 that one year after stenting:
- Only 1.0 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," 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."
Co-authors with Silber in the international study are:
Robbert de Winter, M.D., Ph.D.; Manfred Grisold, M.D.; Jaroslaw Wojcik, M.D.;
Harry Suryapranata, M.D.; Expedito Ribeiro, M.D.; and Sim Kui Hian Sarawak, M.D.
OrbusNeich, maker of the EPC-capturing stent, funded
the study.
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