National Institutes of Health, National Heart, Lung, and Blood Institute, Contracts Operations Branch, 6701 Rockledge Drive, Room 6100, MSC 7902, Bethesda, MD 20892

A -- STUDY OF CORONARY REVASCULARIZATION AND THERAPEUTICS EVALUATIONS (SOCRATES) SOL NIH-NHLBI-98-RFI-01 DUE 073198 POC William M. Stevens, Contract Specialist, 301/435-0345/Contracting Officer, Cheryl A. Jennings, 301/435-0345 WEB: NHLBI RFP Home Page, http://www.nhlbi.nih.gov/nhlbi/rafs/rfas.htm#rfp. E-MAIL: William M. Stevens, Contracts Specialist, StevensW@gwgate.nhlbi.nih.gov. The National Heart, Lung and Blood Institute (NHLBI) is soliciting information for the Study of Coronary Revascularization and Therapeutics Evaluations (SOCRATES) to determine whether capitation rates (i.e. total cost per subject or task as a fixed rate) can be utilized for a Clinical Coordinating Center. Respondents are asked to study the Statement of Work located at http://www.nhlbi.nih.gov/nhlbi/rafs/rfas.htm#rfp, decide whether capitation rates are an appropriate mechanism for reimbursement and provide information on projected rates should the answer be affirmative. Below is a general description of the study. The SOCRATES trial will assess the benefits and risks from a strategy of early Revascularization and medical anti-ischemic strategies with respect to long term morbidity and mortality, and the information will provide a rational basis for safe and effective therapy for these types of patients with stable CHD. The SOCRATES trial will also provide scientific insight into the role of ischemia inthe long-term clinical outcome of CHD patients. Furthermore, the results will be evaluated for significant health care cost implications. The trial will address two key questions of therapeutic strategy in the management of coronary heart disease (CHD): first, in medical management, does anti-ischemic therapy escalated to a maximum tolerated regimen, targeted to alleviate all of the ischemia, confer long-term morbidity and mortality benefits beyond anti-ischemic therapy targeted just for relief of angina; and second, have advances in medical management of CHD, i.e., particularly aggressive lipid management, anti-thrombotic therapy, and life style risk factor modification, changed the threshold at which mechanical Revascularization is warranted? These questions will be addressed in patients with stable CHD and objective evidence of ischemia who are eligible for catheter-based Revascularization (such as PTCA) or surgical revascularization with coronary artery bypass surgery (CABG). Functional status and healthcare costs related to the above strategies will also be assessed. The study will enroll a total of 6,000 patients with stable coronary disease (CHD) and other eligibility and exclusion criteria detailed below, and in whom there is equipoise between medical therapy and revascularization (catheter-based or surgical). The choice between the potential revascularization approach that might be used, PTCA or CABG, will be made by physician and patient before randomization. The draft protocol, including study design, entry criteria, randomization procedures, and treatment strategies are provided in the attachment. Drug regimens for medical strategies and analyses which will be incorporated into the final protocol will be defined collaboratively during the implementation phase developed by a planning committee that will include representation from the successful offeror. The planning committee is already in existence and will have many remaining details established before the contract is awarded. The respondent should provide an estimate of reimbursement costs that they consider appropriate for the tasks involved as well as information on how the reimbursement was calculated. The proposed reimbursement schedule is as follows: Randomization (Entry), 3 month Follow up (includes visits 1 and 2), 6 month Follow up, Annual Follow up, and Semiannual Follow up. The respondent should address any potential problems or concerns with reimbursement of costs using capitation rates. This Request For Information (RFI) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Government to issue a Request for Proposal or award a contract. The Government does not intend to award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted or the Government's use of such information. Acknowledgment of receipt of responses will not be made, nor will respondents be notified of the Government's evaluation of the information received. However, should such a requirement materialize, no basis for claims against the Government shall arise as a result of a response to this Request For Information or the Government's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. Responses should be identified with NHLBI No. 98-RFI-01, and are due by July 31, 1998. Please submit three copies of your response to: William M. Stevens, Contracts Operations Branch, National Heart, Lung and Blood Institute, II Rockledge Centre, 6701 Rockledge Drive MSC 7902, Sixth Floor, Room 6118, Bethesda, MD. 20892-7902. Phone (301) 435-0345, Email: StevensW@gwgate.nhlbi.nih.gov. Posted 06/30/98 (0181)

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