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Percutaneous transluminal coronary angioplasty—II
LEllERS
TO THE EDITOR
mands for medical and surgical services (certainly advocate any form of “rationing”!). Nevertheless, cians and responsible citizens, all of us must give attention to the economic impact (and, indeed, the feasibility) of health care recommendations that stantially affect so many of our fellow citizens.
we do not as physiadequate economic will sub-
Stephen E. Epstein, MD, FACC Kenneth M. Kent, MD, FACC Robert E. Goldstein, MD, FACC Jeffrey S. Borer, MD, FACC Douglas R. Rosing, MD, FACC National institutes of Health Bethesda, Maryland
PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY-I
The letter (position paper) on balloon coronary angioplastyl includes a description of the technique with its history and appropriate caveats about its complications. Yet, it is shocking that this piece, by outstanding investigators and in cardiology’s principal publication, does not include the slightest reference to appropriately designed, controlled clinical trials. The case for such trials with random allocation of qualifying patients has already been made.2 It need not be repeated. Yet, otherwise reasonable, highly skilled physicians seem to exhibit schizoid behavior in maintaining a double standard for assessing mechanical procedures versus medical treatment (or no treatment).3 The double standard must become unacceptable, lest we get into the long wrangles that have marked the history of other mechanical procedures, such as surgery for coronary artery disease, peptic ulcers, breast cancer, and others. Let us keep this genie in its bottle until it earns the right to emerge. David H. Spodick, MD, DSc, FACC Department of Medicine University of Massachusetts Medical School and Division of Cardiology St. Vincent Hospital Worcester, Massachusetts
It is commonly accepted and required that research proposals be submitted to the appropriate human research committee of the hospital sponsoring the research. The Institute should recommend that this be done for percutaneous transluminal coronary angioplasty in accordance with guidelines of the Department of Health, Education, and Welfare. It should also be a firm recommendation that this new procedure be evaluated by well controlled studies, also in accord with such guidelines. Furthermore, until this procedure is validated as safe and efficacious, there should be no third party reimbursement that would stimulate an uncontrolled use of the procedure. Percutaneous transluminal coronary angioplasty may well evolve to be of enormous benefit, and proper investigation of the technique should have maximal support of the National Heart, Lung, and Blood Institute. It is critical, however, that we take steps to safeguard the rights and welfare of patients through adherence to the accepted rules of research, without being forced to do so by government regulation. The Institute, as representative of the government and the public, has a responsibility to ensure that this research be handled properly. Thomas A. Preston, MD, FACC U.S. Public Health Service Hospital Seattle, Washington
REPLY
We are in agreement that percutaneous transluminal coronary angioplasty (PTCA) requires an adequate scientific evaluation. In our position paper we call for more scientific evaluation before this procedure is adopted as a standard clinical tool. When we called for additional scientific evaluation we were calling for the consideration of a broad spectrum of research activities from animal studies through the use of controlled clinical trials. As noted in the paper, we have scheduled a workshop on PTCA to be held in Bethesda in June 1979. The possibility of an appropriately designed clinical trial will be among the topics discussed at that time. Robert I. Levy, MD, FACC Michael B. Mock, MD, FACC National Heart, Lung, and Blood Institute National Institutes of Health Bethesda, Maryland
RdWSftCeS 1. Lwy RI, Jona MJ, Mock MS. NHLBI posItion on percutaneous bansluminal coronary an@bplasty (FTCA) [fetter]. Am J Cardiol 1979;43:867. 2. S@o&k OH. Revascukvizatlon of the heart-numerators In search of denomlnatws. Am l+at J 1971;81:149-57. 3. Spadfck Dn. The auplcal mystique and me double stanbard: controlled trials Of medlcal and sur~lcal tfwapy for cardiac disease: analysis. hypothesis, proposal. Am Heart J 1973;85:679-93.
PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY-II
In stating their position on percutaneous transluminal coronary angioplasty (PTCA), the leaders of the National Heart, Lung, and Blood Institute make it very clear that the procedure is a research technique.’ The designation of research occurs four times in a relatively short statement. The Institute remains silent, however, on insisting or even suggesting that potential users of the technique follow research protocols. They do suggest that such research “be conducted in a rational, scientific manner,” but rational and scientific are variously interpreted by the medical community.
344
August 1990
The American Journal of CARDIOLOGY
CORONARY ARTERIAL VASOSPASM
Maron and associates1 state: “Although it is possible that vasospasm of either the extramural or abnormal intramural coronary arteries was responsible for myocardial infarction in our patients with hypertrophic cardiomyopathy and ‘normal’ extramural coronary arteries, we cannot be definite about such a mechanism.” Recently we* reported on three patients with hypertrophic obstructive cardiomyopathy and coronary vasospasm. The two with angiographically normal coronary arteries had episodic angina at rest, reversible S-T segment elevation and demonstrable spasm of the right coronary artery. The concept of vasospasm is particularly attractive in patients with hypertrophic obstructive cardiomyopathy because it has been suggested that these patients have an abnormal myocardial response to normal levels of circulating catecholamines.3 The latter hypothesis in conjunction with recent observations concerning alpha adrenergic mediation of coronary vasoepasm
Volume 48
TO THE EDITOR
mands for medical and surgical services (certainly advocate any form of “rationing”!). Nevertheless, cians and responsible citizens, all of us must give attention to the economic impact (and, indeed, the feasibility) of health care recommendations that stantially affect so many of our fellow citizens.
we do not as physiadequate economic will sub-
Stephen E. Epstein, MD, FACC Kenneth M. Kent, MD, FACC Robert E. Goldstein, MD, FACC Jeffrey S. Borer, MD, FACC Douglas R. Rosing, MD, FACC National institutes of Health Bethesda, Maryland
PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY-I
The letter (position paper) on balloon coronary angioplastyl includes a description of the technique with its history and appropriate caveats about its complications. Yet, it is shocking that this piece, by outstanding investigators and in cardiology’s principal publication, does not include the slightest reference to appropriately designed, controlled clinical trials. The case for such trials with random allocation of qualifying patients has already been made.2 It need not be repeated. Yet, otherwise reasonable, highly skilled physicians seem to exhibit schizoid behavior in maintaining a double standard for assessing mechanical procedures versus medical treatment (or no treatment).3 The double standard must become unacceptable, lest we get into the long wrangles that have marked the history of other mechanical procedures, such as surgery for coronary artery disease, peptic ulcers, breast cancer, and others. Let us keep this genie in its bottle until it earns the right to emerge. David H. Spodick, MD, DSc, FACC Department of Medicine University of Massachusetts Medical School and Division of Cardiology St. Vincent Hospital Worcester, Massachusetts
It is commonly accepted and required that research proposals be submitted to the appropriate human research committee of the hospital sponsoring the research. The Institute should recommend that this be done for percutaneous transluminal coronary angioplasty in accordance with guidelines of the Department of Health, Education, and Welfare. It should also be a firm recommendation that this new procedure be evaluated by well controlled studies, also in accord with such guidelines. Furthermore, until this procedure is validated as safe and efficacious, there should be no third party reimbursement that would stimulate an uncontrolled use of the procedure. Percutaneous transluminal coronary angioplasty may well evolve to be of enormous benefit, and proper investigation of the technique should have maximal support of the National Heart, Lung, and Blood Institute. It is critical, however, that we take steps to safeguard the rights and welfare of patients through adherence to the accepted rules of research, without being forced to do so by government regulation. The Institute, as representative of the government and the public, has a responsibility to ensure that this research be handled properly. Thomas A. Preston, MD, FACC U.S. Public Health Service Hospital Seattle, Washington
REPLY
We are in agreement that percutaneous transluminal coronary angioplasty (PTCA) requires an adequate scientific evaluation. In our position paper we call for more scientific evaluation before this procedure is adopted as a standard clinical tool. When we called for additional scientific evaluation we were calling for the consideration of a broad spectrum of research activities from animal studies through the use of controlled clinical trials. As noted in the paper, we have scheduled a workshop on PTCA to be held in Bethesda in June 1979. The possibility of an appropriately designed clinical trial will be among the topics discussed at that time. Robert I. Levy, MD, FACC Michael B. Mock, MD, FACC National Heart, Lung, and Blood Institute National Institutes of Health Bethesda, Maryland
RdWSftCeS 1. Lwy RI, Jona MJ, Mock MS. NHLBI posItion on percutaneous bansluminal coronary an@bplasty (FTCA) [fetter]. Am J Cardiol 1979;43:867. 2. S@o&k OH. Revascukvizatlon of the heart-numerators In search of denomlnatws. Am l+at J 1971;81:149-57. 3. Spadfck Dn. The auplcal mystique and me double stanbard: controlled trials Of medlcal and sur~lcal tfwapy for cardiac disease: analysis. hypothesis, proposal. Am Heart J 1973;85:679-93.
PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY-II
In stating their position on percutaneous transluminal coronary angioplasty (PTCA), the leaders of the National Heart, Lung, and Blood Institute make it very clear that the procedure is a research technique.’ The designation of research occurs four times in a relatively short statement. The Institute remains silent, however, on insisting or even suggesting that potential users of the technique follow research protocols. They do suggest that such research “be conducted in a rational, scientific manner,” but rational and scientific are variously interpreted by the medical community.
344
August 1990
The American Journal of CARDIOLOGY
CORONARY ARTERIAL VASOSPASM
Maron and associates1 state: “Although it is possible that vasospasm of either the extramural or abnormal intramural coronary arteries was responsible for myocardial infarction in our patients with hypertrophic cardiomyopathy and ‘normal’ extramural coronary arteries, we cannot be definite about such a mechanism.” Recently we* reported on three patients with hypertrophic obstructive cardiomyopathy and coronary vasospasm. The two with angiographically normal coronary arteries had episodic angina at rest, reversible S-T segment elevation and demonstrable spasm of the right coronary artery. The concept of vasospasm is particularly attractive in patients with hypertrophic obstructive cardiomyopathy because it has been suggested that these patients have an abnormal myocardial response to normal levels of circulating catecholamines.3 The latter hypothesis in conjunction with recent observations concerning alpha adrenergic mediation of coronary vasoepasm
Volume 48