THE EVOLUTION OF A CLINICAL DATABASE TO EVALUATE THE TREATMENT OF CORONARY-ARTERY DISEASE

Background The field of invasive cardiology has evolved rapidly since the initial use of catheters for treatment of coronary artery disease in the late 1970's. The pace of this change coupled with the complexit y of the clinical setting and proliferation of devices and drugs used for therapy have made it extremely difficult to construct and maintain a viable clinical database. Methods Using a standard hardware and sof tware system with the direct clinical input from a multidisciplinary t eam of physicians, nurses and biostatisticians, a clinical database wa s developed that is capable of tracking complex in-hospital and longte rm follow-up data in patients undergoing treatment of coronary artery disease. Results The database has provided the basis for in-depth anal ysis of angioplasty results in patients with vessels and lesions of va rying morphology, showing greater than 90% success in most complex les ion morphology using contemporary balloon technology and/or new device s. Longterm analysis (14 years) of patients after angioplasty has demo nstrated that 76% survived without major cardiac events. Other analyse s of various clinical and morphologic subsets have shown favorable res ults with angioplasty. The databases for angioplasty and coronary bypa ss surgery have been combined, showing comparable survival and freedom from cardiac events in multivessel disease patients treated with thes e procedures. Conclusions The development of a dynamic and clinically relevant database that has evolved has contributed valuable informatio n to the understanding and effective management of patients with coron ary artery disease. The complexity of its structure and the capability to define multiple dimensions within the patient and multiple points across time affords the maximum flexibility in retrieving information. This approach to information management has relevance to a range of m edical specialties, and may be important in defining and monitoring qu ality indicators of medical care.