TPA AND PATIENT MONITORING IS AS EFFECTIVE AS TPA PLUS PTCA

TPA AND PATIENT MONITORING IS AS EFFECTIVE AS TPA PLUS PTCA in preventing mortality within six weeks of a myocardial infarction, Eugene Braunwald, Brigham and Women's Hospital, told the American Heart Association Nov. 14 in Washington. Announcing the results of the 3,262-patient TIMI-116 trial, Braunwald noted that "most patients with acute MI [who are tissue plasminogen activator candidates] may be managed with TPA and heparin and aspirin and watchful waiting." The study found that 20% of acute MI patients are eligible for TPA, based on patient age, medical factors and time elapsed since the MI began. Under the design of this phase of the TIMI (Thrombolysis In Myocardial Infarction) trial, 1,636 MI patients were randomized to an invasive strategy that consisted of TPA administration within four hours of onset of the heart attack, followed by angioplasty, if anatomically possible, 18-48 hours after drug treatment. The remaining 1,626 MI patients were treated under a "conservative" regimen that included TPA administration within four hours of the MI, with coronary arteriography and angioplasty performed only if spontaneous or exercise-induced ischemia occurred. Preliminary data from the trial show an overall 95% survival rate at the end of the six-week trial. At the end of one year, about 93% of patients in both groups were still alive. About 26% (421) of the patients in the conservative group had a recurring ischemic event within two weeks, with about half of that group - 13.5% - undergoing angioplasty at that point. At the end of six weeks, about 17% of the conservative group had received angioplasty. Of the invasive group, 89% (1,461) received heart catheterization after TPA, with 60% of that group (878) going on to angioplasty. "Invasive, as compared to conservative, strategy leads to no significant reduction in the occurrence of death and nonfatal infarction at 42 days - 10.9% for the invasive [versus] 9.7% for the conservative," Braunwald stated. Braunwald estimated a net savings of $2.35 mil. per 1,000 patients treated via the conservative strategy versus the standard invasive treatment. Extrapolated over 300,000 MI patients in the U.S. per year, Braunwald projected an incremental cost savings of $704 mil. per year. Braunwald predicted that, per 1,000 patients, there would be: 74 more catheterizations without PTCA using the invasive regimen compared to the conservative approach; 431 more angioplasties received; and 15 more coronary artery bypass grafts performed. At $1,145 per patient under the Medicare DRGs, the 74 additional catheterizations would cost $85,000. The 431 PTCAs, at an incremental per-patient cost of $4,408, would cost $1.9 mil. more than the conservative approach. And the 15 additional bypass grafts, at $24,000 per patient, would cost an additional $362,000.