New research proves drug-coated stents effectively combat death, heart attack and repeat procedures in the real world.//
A new study from researchers in the Netherlands indicates that patients in clinical trials of drug-coated stents represented a very select group of the total population. This new study takes a closer look at the effects of drug-coated stents on real-world patients, patients the researchers say tend to be older and sicker than those selected for clinical trials.
The study included more than 500 patients with previously untreated blocked arteries who were treated with drug-eluting stents. An additional 450 patients with comparable blockages were treated with bare metal stents. Sixty-eight percent of the patients in this trial did not meet the selection criteria of previous clinical trials.
Results of the one-year study show 9.7 percent of patients who received drug-eluting stents had a major adverse cardiac event, compared with 14.8 percent of patients treated with bare metal stents. Only 3.7 percent of patients with drug-eluting stents experienced renarrowing of the treated vessel, a common complication that leads to corrective procedures. However, 10.9 percent of patients with bare metal stents required repeat procedures to correct renarrowing of the artery.
Lead investigator Patrick W. Serruys, M.D., Ph.D., from Erasmus Medical Center in the Netherlands, says, “The treatment effects -- particularly the reduction of re-interventions -- were similar across very different subgroups of patients.” He says drug-eluting stents are the next major step in interventional cardiology.
In an accompanying editorial, David P. Fason, M.D., from the University of Chicago, says the research results “go a long way in re-assuring the practitioner that drug-eluting stents are in fact safe and effective in a wide variety of patients undergoing ‘real world’ angioplasty.” He concludes that the next step shoul
d be a mandatory registry established by the Food and Drug Administration to report problems.
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