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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Predictive factors for ischemic target vessel revascularization in the Prevention of Restenosis with Tranilast and its Outcomes (PRESTO) trial

Mandeep Singh, MD^*, Bernard J. Gersh, MB, ChB, DPhil^*, Robyn L. McClelland, PhD, Kalon K.L. Ho, MD, MSc, James T. Willerson, MD, William F. Penny, MD^|| and David R. Holmes, Jr, MD^*,*

^* Division of Internal Medicine and Cardiovascular Diseases
Division of Biostatistics, Mayo Clinic and Mayo Foundation, Rochester, Minnesota
Harvard Clinical Research Institute, Boston, Massachusetts
Texas Heart Institute, Houston, Texas
^|| University of California, San Diego, California

Manuscript received March 25, 2004; revised manuscript received May 10, 2004, accepted May 11, 2004.

^* Reprint requests and correspondence: Dr. David R. Holmes, Jr., Division of Cardiovascular Diseases, Department of Internal Medicine, Mayo Clinic, 200, 2nd Street SW, Rochester, Minnesota 55905 (Email: holmes.david{at}mayo.edu).

OBJECTIVES: The aim of the present study was to determine the rates of target vessel revascularization (TVR) and to determine predictors of TVR from clinical and angiographic variables available in the Prevention of Restenosis With Tranilast and its Outcomes (PRESTO) database.

BACKGROUND: The rates of TVR after percutaneous revascularization procedures, and its prediction with available clinical and angiographic variables, is less well known.

METHODS: We studied nine-month TVR in 11,484 patients enrolled in the PRESTO trial. Clinical, lesion-related, and procedural characteristics were analyzed in a logistic regression model. Study data were divided at random into an 80% training set on which the models were developed and a 20% hold-out set on which the model properties were evaluated.

RESULTS: A total of 14% (n = 1,609) had ischemic TVR. Clinical variables with increased risk for TVR included younger age; hypertension; diabetes mellitus; nonsmokers; unstable angina; previous coronary artery bypass grafting; peripheral vascular disease; procedure- and lesion-related such as ostial location, multilesion angioplasty, location in the left anterior descending artery, length 20 mm, in-stent restenosis at baseline, and use of rotablator. There was significant increase in the risk of ischemic TVR at U.S. treatment sites. Smoking and stent placement were associated with lower risk of ischemic TVR. The mean area (± SD) under the receiver-operating characteristic curve of the bootstrap samples was 0.66, indicating a modest ability of the model to discriminate patients who needed TVR on follow-up.

CONCLUSIONS: Despite being the largest prospective trial designed to test restenosis, the discriminatory ability of the clinical and angiographic variables to predict TVR is modest.

Abbreviations and Acronyms   PCI = percutaneous coronary intervention   PRESTO = Prevention of Restenosis With Tranilast and its Outcomes trial   ROC = receiver-operating characteristic   TVR = target vessel revascularization

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