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This article was originally published in The Gray Sheet

Executive Summary

NEW YORK PTCA STUDY: 58% RATE OF "APPROPRIATE" USE was found in a study published in the Feb. 10 Journal of the American Medical Association that evaluated a random sample of patients who underwent percutaneous transluminal angioplasty at 15 non-federal hospitals in New York state during 1990. Conducted by Lee Hilborne, MD, MPH, University of California, Los Angeles, et al. for the RAND research center in Santa Monica, California, the study retrospectively evaluated 1,306 PTCA patients. The researchers used criteria developed by a nine-person panel of clinicians to determine the appropriateness of the PTCA treatment. PTCA was considered "appropriate" when "the expected health benefit exceeded the negative consequences by a sufficient margin that the procedure was worth performing." The use of PTCA was considered "inappropriate" if it was "performed under circumstances where the medical risks exceeded the medical benefits." The value of the treatment was deemed "uncertain" if "the benefits and risks of the procedures for these indications were about equal." In addition to finding that 58% of the 1,306 PTCA procedures were appropriate, the study authors determined that 4% were inappropriate and 38% fell into the "uncertain" category. The authors concluded that "the large number of procedures performed for indications that were rated uncertain as to their net benefit requires further study and justification at both clinical and policy levels." They note several potential explanations for the high rate of uncertain cases, including a weakness in the appropriateness scale due to a shortage of "outcomes" data at the time it was developed. In addition, Hilborne et al. point out that "even when PTCA is successful, long-term results, particularly the high restenosis rate, have led some to question the long-term benefit of PTCA." Another reason for the uncertain cases is the "changing" nature of the coronary revascularization field. "New catheter designs and the introduction of alternatives such as coronary atherectomy and coronary stenting alter the feasibility and outcomes of nonsurgical coronary revascularization, continually changing the risks and benefits." The PTCA study was one of three RAND evaluations performed at the request of the New York Cardiac Advisory Committee and published in the Feb. 10 JAMA. A second study measured the appropriateness of the use of coronary bypass graft surgery. Using the same methodology as the PTCA study, the CABG study, conducted by Lucien Leape, MD, Harvard School of Public Health, et al., found nearly 91% of the 1,338 bypass operations performed in the same New York hospitals in 1990 were appropriate, 2.4% were inappropriate, and 7% met the uncertain criteria. The low inappropriateness rate differs "considerably" from the 14% rate found in a previous study of patients operated on in 1979, 1980, and 1982, Leape et al. note. They add that "the difference in rates was not due to more lenient criteria but to changes in practice" since the earlier study. For example, the fraction of patients receiving coronary bypass grafts for one- and two-vessel disease fell from 51% to 24% since the first studies were conducted. The third study, conducted by Steven Bernstein, MD, MPH, University of Michigan, Ann Arbor, et al., evaluated 1,335 patients who underwent coronary angiography in 1990 at the 15 New York hospitals. The authors determined that approximately 76% of coronary angiographies were appropriate, 4% were inappropriate, and 20% fell into the uncertain category. Bernstein et al. noted that the rate of inappropriate procedures was "significantly less" than the 17% rate reported in a previous study that evaluated a national sample of patients aged 65 and over who underwent angiography in 1981. However, in the New York study, 21% of the elderly patients received angiographies for uncertain indications; in the national study, there was a 9% uncertain rate. Bernstein et al. found the inappropriate rate in the New York study "differs significantly" from results recently reported by Thomas Graboys et al., who found 80% of patients seeking a second opinion on the need for coronary angiography "did not meet the criteria for angiography" ("The Gray Sheet" Nov. 16, p. 30). Explaining the discrepancy, Bernstein et al. assert that "the patients referred by the study by Graboys et al. were healthier . . . and were referred for elective angiography." In addition, Bernstein et al. maintain "that clinical reasons used to judge a case as inappropriate are not described in sufficient detail in the article by Graboys et al.," making it "impossible to tell whether patients with similar clinical characteristics would be judged the same with regard to appropriateness." Noting that the three studies were "designed to examine overuse," Bernstein et al. state that while "little evidence" was found of inappropriate use of any of these procedures, "a significant proportion" of PTCA and angiography procedures "are being performed for uncertain indications for which benefit and risk are thought to be about equal. Additional clinical research will help to define more precisely how much benefit or risk is associated with use for these indications." In an editorial published in the same issue of JAMA, Stephen Schoenbaum, MD, Harvard Community Health Plan, emphasized the need to reduce use of the three procedures. "A determination of appropriateness does not mean that a procedure should be performed ...It is difficult to see how a determination of necessity can be made by any group of experts unless there are sufficient comparative outcomes data so that one could be sure that virtually all competent patients presented with the data would choose the procedure." Schoenbaum further suggests that fewer procedures would be performed if stricter rules were adopted in which "payment would only be made for care that was supported by evidence that met a set of criteria in which a large group of experts agreed that the benefits outweighed the risks." He also suggests that bringing the patient into the decision-making process, especially those classified as "uncertain," would reduce the number of procedures performed.

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