History, protocols, and the team.

Endovascular brachytherapy to suppress the inflammatory response and prevent restenosis after balloon angioplasty and stenting has become an important part of the care of patients with atherosclerosis. The implications of the findings from the first study in a remarkably small prospective trial (1) from the standpoint of the potentially great number of patients affected throughout the world were immediately recognized. However, careful confirmation in the setting of sophisticated multidisciplinary protocols was required by regulatory and reimbursement agencies before the technique could be adopted into clinical use. With such confirmation of the value of coronary artery radiation therapy (CART) came the widespread use of the technique as a small but important part of the care of patients with heart disease. Now that the procedure has become more routine, there are pressures to streamline the process, perhaps decrease the complexity of the team approach, and even to eliminate the team altogether and place the entire responsibility in the hands of the interventional cardiologist, the acknowledged captain of the team. The history of the therapeutic uses of ionizing radiations has provided a huge body of data that has resulted in the use of ionizing radiations being limited to those who specialize exclusively in the field. Although family physicians, dermatologists, general surgeons, gynecologists, and other surgical subspecialists used brachytherapy sources in the past, it is notable that none do now. The lessons learned about its adverse effects on normal tissues, increased cancer risks, and therapeutic misapplications are sufficiently far in the past that they have been forgotten by much of the medical community. Clinical investigations involving carefully developed protocols that include patient information documents leading to informed consent are relatively recent. Indeed, informed consent has only become a standard practice within the past 25 years. Evidence-based medicine advances most successfully on the basis of prospective clinical trials that compare investigational approaches with standard management approaches. The CART trials were exemplary in providing evidence of the value of endovascular brachytherapy in preventing restenosis. The team (i.e., the cardiologist, the radiation oncologist, and the radiation physicist) that was required to provide such evidence was a critical part of the success of the trial. Likewise, because the evidence is based on the accomplishments of the team, it seems prudent to continue two aspects of the successful approach to the prevention of coronary restenosis. One is to preserve the team intact and not to leap to the conclusion (unless it is investigated in a prospective manner) that components of the team are unnecessary. Second, it seems wise to continue a protocol-based approach to such patients in which there is a written understanding of the treatment plan among the participants—the cardiologist, radiation oncologist, radiation physicist—that is taken into account in the informed consent. In such a situation, it is entirely appropriate for the cardiologists to provide the patient information document and to obtain informed consent before proceeding with angioplasty. Such informed consent would include the possible need for radiation administration during the angioplasty. This is analogous to the request for intraoperative radiation therapy (IORT) during an often-lengthy surgical procedure that is undertaken with the possibility that a single application of external beam radiation therapy might be delivered at some time during the procedure. The enthusiasm for endovascular brachytherapy is at least as great within the radiation oncology community as it is among cardiologists. It is important to recall that most uses of ionizing radiation in the treatment of benign conditions have disappeared, either because more effective treatments have been found or because the risks came to be considered unacceptable. It is also well to recall here the admonition of George Santayana, that those who ignore history are doomed to repeat it. There-