For years now, angioplasty plus stenting to clear clogged arteries has required patients to stay in the hospital for as much as two or three days before doctors felt they could safely return home. But an extensive new clinical study suggests that a single dose of a new blood thinner may make angioplasty an outpatient procedure for many heart patients.
The study analyzed the responses of 1,005 patients. One group received a dose of the antiplatelet drug abciximab and was discharged four to six hours after the procedure. The second group also received a dose plus infusion and stayed overnight. A third group with predetermined complications also stayed hospitalized overnight after receiving a dose plus infusion of the antiplatelet drug.
"We propose a practice with more comfort for the patients, less risk of complications and greater cost-savings due to shorter hospitalizations," said Olivier Bertrand, MD, PhD, assistant professor, faculty of medicine, Laval University in Quebec City, Canada and interventional cardiologist at Laval Hospital. Bertrand unveiled his trial results at a conference put on by the American Heart Association in Dallas. Eli-Lilly and Bristol-MyersSquibb/sanofi-aventis, which make and market the drug in the study, funded Bertrand's trial.
About 13.5 percent of the outpatient group experienced a serious adverse reaction after surgery – such as death, heart attack or repeat rehospitalization – after 30 days, compared to 10.2 percent of the group that stayed overnight. The difference was small and statistically insignificant.
Angioplasty plus stenting calls for the insertion of a balloon-tipped catheter into a blocked artery. The balloon is inflated, widening the blocked area, and a meshed stent is inserted to hold it open.
But more than the drug is needed to improve outpatient results, says Bertrand. Better results call for surgeons to use the smaller radial artery in the wrist to insert the balloon rather than the larger femoral artery in the leg.
"The use of the transradial approach instead of the traditional femoral approach has been associated with fewer complications and increased patient satisfaction, yet it is rarely used in the United States," Bertrand said. "Because a smaller artery is used, there is less risk of bleeding at the insertion point, which can be closed with a simple bandage. Patients can stand up immediately after the procedure. In part because of concern over navigating in the smaller vessel, which requires specific training, transradial catheterization is used in less than 10 percent of U.S. stenting procedures. While its use is slowly increasing in Europe and Asia, doctors there employ it only 10 percent to 30 percent of the time."
Another factor that could further improve results would be the regular use of drug-coated stents, which helps prevent arteries from reclogging. Many surgeons often avoid the more expensive stents because they are widely viewed as too expensive for common use. Bertrand hopes that by reducing the overall cost of the procedure, doctors can be encouraged to increase what is spent on the stent in exchange for lower hospitalization expenses.
"We have shown that there is no penalty for patients who skip perfusion of abciximab in cases of uncomplicated procedures," Bertrand said. "The next step would be to repeat this study as a large, multi-center trial."
"There's no doubt that the procedure has gotten considerably safer over the years," says Dr. Stephen Ellis, an interventionalist cardiologist at The Cleveland Clinic. The combinations of stents and antiplatelets like abciximab to deal with clotting issues have combined to reduce risks. And handled properly, angioplasty can be an outpatient procedure for low-risk patients.
The procedure still needs to be performed in a clinical setting with a modest – five-to-six- hour-long – observation period for low-risk patients. That way, if there is any question of risk the patients can be admitted to stay overnight for additional observation.
But healthcare professionals shouldn't expect to see any big savings as a result.
"Shaving 12 hours of hospital stay is substantial, but it's probably only 5 percent to 10 percent of the entire procedure," says Ellis, who is also professor of medicine at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University.
