Apr. 17, 2002 Heart attack patients may be better off with balloon angioplasty to open blocked blood vessels than with clot-busting drugs, even if their hospital lacks a cardiac surgery program, according to a Johns Hopkins-led study.
The Atlantic Cardiovascular Patient Outcomes Research Trial (C-PORT) looked at 451 heart attack patients admitted to 11 hospitals in Maryland and Massachusetts. The hospitals were given temporary waivers for this study to perform angioplasty even though they had no cardiac surgery capability. In most states, angioplasty may only be performed at hospitals with cardiac surgery programs in the event of complications that require more invasive treatment. Patients were assigned randomly to get an angioplasty or to be treated with clot-busting drugs.
Results, reported in the April 17 issue of the Journal of the American Medical Association, showed that the combined incidence of death, repeat heart attacks or strokes was lowered by 40 percent for the angioplasty patients six weeks (11 percent vs. 18 percent) and six months (12 percent vs. 20 percent) later. In addition, the angioplasty group had a shorter stay in the hospital, averaging four and one-half days compared to six days for the drug group.
"Our study and others suggest angioplasty is the better treatment, yet nearly two-thirds of heart attack patients present to hospitals that don't have that capability," says Thomas Aversano, M.D., lead author of the study and associate professor of medicine at Hopkins. "Given the superiority of primary angioplasty over thrombolytic therapy, it is important that health care policy be amended to provide the greatest number of patients access to this better form of therapy. It should not be a matter of chance or geography that determines what kind of care a heart attack patient receives."
During a balloon angioplasty, a doctor inserts a catheter with a deflated balloon at its tip into the narrowed part of the artery. Then the balloon is inflated, compressing the plaque and enlarging the inner diameter of the blood vessel so blood can flow more easily. In the C-PORT study, 70 percent of the patients also received a stent – a metallic device that looks somewhat like a spring in a ballpoint pen.
For the study, the investigators created a formal program to develop angioplasty capability at each hospital prior to recruiting patients. This program – consisting of setting standards, training staff, developing logistics and creating a quality and error management program – took approximately three months to complete and was tailored for each institution.
Study patients were recruited between July 29, 1996, and June 17, 1999. In most cases, patients came to the hospitals an average of 90 minutes after symptoms began. After treatment, follow-up at six weeks and six months was done by telephone. All medical records related to an identified heart event or stroke were reviewed both by the researchers and by experts not associated with the trial who were not told what treatment the patients received.
Each adverse outcome studied – death, recurrent heart attack, stroke and a combination of the three – was lower at six weeks and six months in the angioplasty group. At the hospital that enrolled the most patients (138), the overall event rate six months after treatment was 23.2 percent for the drug group and 13 percent for the angioplasty group. The rate for the other centers was 18.5 percent in the drug group and 11.5 percent in the angioplasty group.
The study was supported by GE Medical and Eli Lilly.
Other authors were Lynnet T. Aversano, R.N., B.S.N.; Eugene Passamani, M.D.; Genell L. Knatterud, Ph.D.; Michael L. Terrin, M.D.; David O. Williams, M.D.; and Sandra A. Forman, M.A.
Participating hospitals were Brockton Hospital, Brockton, Mass.; Cape Cod Hospital, Hyannis, Mass.; Caritas Norwood Hospital, Norwood, Mass.; Charlton Memorial Hospital, Fall River, Mass.; Holy Cross Hospital, Silver Spring, Md.; Johns Hopkins Bayview Medical Center, Baltimore; Northwest Hospital Center, Baltimore; Saint Agnes Hospital, Baltimore; Saint Luke's Hospital, New Bedford, Mass.; Shady Grove Adventist Hospital, Rockville, Md.; and Suburban Hospital, Bethesda, Md.
Aversano, T. et al, "A prospective, randomized trial comparing thrombolytic therapy and primary percutaneous coronary intervention for treatment of acute, ST-segment elevation myocardial infarction in patients presenting to hospitals without on-site cardiac surgery," Journal of the American Medical Association, April 17, 2002.
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