The results of a clinical trial reported today showed that heart attack victims given "late" angioplasty did not fair significantly better than those with only medication
At today’s meeting of the American Heart Association in Chicago, the results of an NIH funded study demonstrated that heart attack patients who received angioplasty (inserting a balloon into the clogged artery plus the subsequent insertion of a stent) 3-to-28 days after the attack faired no better than those who received only medical treatments. In particular, the study (which was a randomized clinical trial) found that there was no statistically significant difference in the two groups in the subsequent occurrence of death, heart attacks, or heart failure.
What this illustrates from the standpoint of research ethics is the centrality of the idea of equipoise—that is, there must be substantial uncertainty between the treatment options to justify doing the clinical trial to resolve that uncertainty. As one of the leaders of the study, Dr. Judith S. Hochman observed in today’s New York Times, “This is why we have clinical trials.” She also noted that, because many cardiologists are strong believers in the angioplasty procedures, many medical centers refused to participate in the study. This conflict is a classic illustration of the sometimes divergent viewpoints of the clinician and the medical researcher. For the clinician, the primary focus is doing what is beneficial for current patients under his or her care—which would include administering procedures, like angioplasty, which many believe to be efficacious. For the medical researcher, by contrast, the primary focus is on answering a question about which there is scientific uncertainty, which will be beneficial for future patients who will suffer from the same condition.
