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Posted by plosmedicine on 30 Mar 2009 at 23:43 GMT
Author: Prof. B. M. Hegde
Position: No occupation was given
Institution: No affiliation was given
Submitted Date: May 25, 2005
Published Date: June 2, 2005
This comment was originally posted as a “Reader Response” on the publication date indicated above. All Reader Responses are now available as comments.
I must congratulate Richard Smith for this bold article. Instrument manufacturers (particularly instruments used for cardiac interventions) probably use the same tricks that are used by drug companies to get their wares sold.
Every time a large study shows any of the cardiac interventions in a bad light there appears an attempt by "thought leaders" in the field to rubbish those studies in favor of the smaller company-sponsored studies done earlier claiming the superiority of the cardiac interventions. A good example is angioplasty in acute coronary syndromes with drug eluting stents for blocked coronary arteries.1 Practicing doctors will be more confused now with these explanations of Lee Green about angioplasty as the best bet for a patient after a heart attack in the immediate post-infarction period. In a multinational cohort of unselected patients admitted for acute coronary syndromes the GRACE investigators found that patients admitted to hospitals with catheterization facilities had worse outcomes: no short-term survival benefit, worse long-term survival, and more bleeding and stroke complications in the short term.2 Similar was the experience of the VANQWISH group in a randomized study which showed conservative treatment to be superior to early intervention.3
The statistical fallacy is that if small studies give positive results larger studies of the same problem could reverse that trend. There is nothing new in this game. I only hope that the GRACE results are true as those are more in line with the non-linear human physiology. Altering the initial state of the human being partially might not hold good as time evolves. Hope something more natural will emerge in the future to replace these endothelium damaging percutaneous interventions in coronary artery syndromes.
Elderly patients in the US underwent coronary angiography 5.2 as often, percutaneous transluminal coronary angioplasty 7.7 times as often, and bypass surgery 7.8 times as often as older patients in Ontario.4 Despite these differences; the one-year mortality rates in the U.S. and Ontario cohorts were virtually identical. In a fee-for-service system, cardiac procedures generated billions of dollars of revenues each year. A high volume of procedures brought prestige and financial rewards to hospitals, physicians, and the vendors of medical equipment wrote Harlan M Krumholz of the Yale University Medical School. 5 Sexed up reporting of study results is another trick. The genuine results of a large audit of bypass surgeries, reported earlier as giving every recipient on an average 3.6 months of extra life turned out to be totally wrong. When analyzed properly it showed that 84% of the CABG recipients did not have any survival benefit. The other 16% did have some benefit ranging from few months to three years. The original authors had multiplied the benefit to the sixteen per cent and divided that by the one hundred percent to give everyone a share in the survival. 6
The story of interventions for acute coronary syndromes has been one long saga, of history repeating itself. People thought we had reached the end of all our troubles when in the 1960s we had anti-arrhythmics and CCUs; they were soon found wanting and thrombolysis came into the picture. The latter was thought to be the last word then. Later came Gruntzig's simple angioplasty, which today is denigrated by the divine interventionalists using drug eluting stents. Radiation follows that and, God knows what next, with LASERS popping in and out.
Poor physiologists are crying out loud that it is the content of the plaque that is important and not the size, as many blocks inside epi-cardial vessels are not dangerous. Attempts are being made to find out which plaques are hot and which are cold. Percutaneous coronary interventions go on, all those worries notwithstanding. Those who can "do" and, those who can't, worry about the hapless patients. "Free man is, by necessity, insecure; thinking man is, by necessity, uncertain" opines Erich Fromm. Primum Non Nocere!
1) Lee Green. Benefits of early invasive treatment for acute
coronary syndromes: lost in translation? BMJ 2005; 330: E351-352E
2) Eagle KA, Goodman SG, Avezum A, et. al for GRACE investigators. The Global Registry of Acute Coronary Events (GRACE) 2002; 359: 373-377.
3) Boden WE, ORourke RA, Crawford MH et. al. Outcome of patients with acute non-Q wave myocardial infract randomly assigned to invasive as compared to conservative treatment. N Engl J Med 1998; 338: 1785-1792.
4) Tu JV, Pashos CL, Naylor CD, et. al. Use of cardiac procedures and outcomes in elderly patients with myocardial infarction in the United States and Canada. N Engl J Med 1997; 336: 1500-1505.
5) Krumholz HM. Cardiac procedures, outcomes, and accountability. N. Engl. J Med 1997; 336: 1522-1523.
6) Hux JE, Naylor DC. In the eye of the beholder. Arch. Intern. Med. 1995; 155:2277-2280.