Laskey, Warren K.

Introduction . The addition of percutaneous coronary intervention (PCI) to the treatment options for patients with atherothrombotic (AT) coronary heart disease (CHD) has resulted in considerable debate regarding its overall clinical benefit. Although rates of “hard” clinical endpoints have been used as measures of both clinical outcome and disease burden, a comprehensive, clinically relevant measure of disease burden in the general population of patients undergoing PCI is lacking. Hypothesis . A comprehensive measure of AT clinical burden in patients undergoing PCI can be used to detect the qualitative and quantitative impact of PCI over time. Methods . Four distinct cohorts (Waves) of ~ 2,000 patients each participating in the NHLBI Dynamic Registry beginning in 1997 (Wave 1) and terminating in 2005 (Wave 4) and surviving to hospital discharge comprise the study population (n= 7,750). A composite clincally relevant measure of AT disease burden over the year following PCI was defined as: any death, myocardial infarction (MI), hospitalization for recurrent angina (A) or congestive heart failure (HF), stroke, any repeat PCI or coronary bypass surgery. Cumulative event rates, expressed as the presence of any of the above-cited components by one year, were calculated using Kaplan-Meier statistics. Comparison of rates across Waves was accomplished using Cochran- Mantel-Haenszel method. Results. see Table Exclusion of patients requiring PCI for restenosis did not substantially change the overall AT burden. Conclusion. There was a statistically significant decrease in AT disease burden over the time studied. However, the burden of disease in patients undergoing PCI remains substantial for 25% of patients. This measure of AT burden may be of clinical value in assessing the contribution of PCI to patient outcomes and strongly supports more comprehensive treatment strategies for patients following PCI. Component and composite rates at one year

Background— Diabetes portends an adverse prognosis in patients undergoing percutaneous coronary intervention (PCI). Whether improvements in current clinical practice (stents, IIb/IIIa antagonists) have resulted in substantial improvement of these outcomes remains an issue. The aim of this study was to determine the influence of diabetes on 9-month outcomes of patients undergoing PCI in the current era. Methods and Results— The 11 482 patients enrolled in the Prevention of REStenosis with Tranilast and its Outcomes (PRESTO) Trial were stratified according to the presence (n=2694) or absence (n=8798) of diabetes. Diabetic patients were older; were more likely to be female; had a higher proportion of congestive failure, hypertension, prior CABG, and unstable angina; and had higher body mass index and lower ejection fraction than nondiabetic patients ( P <0.01 for all comparisons). The degree of multivessel disease was similar between the two groups. American College of Cardiology/American Heart Association type C lesions were more common in diabetic patients (17% versus 15%, P <0.01). Angiographic and procedural success rates and in-hospital events were similar between the two groups. The primary end point of death, myocardial infarction, or target vessel revascularization (TVR) was analyzed as time-to-first event within 9 months of the index PCI. After adjusting for certain baseline characteristics, diabetes was independently associated with death at 9 months (relative risk [RR], 1.87; 95% CI, 1.31 to 2.68, P <0.01) and with an increased likelihood of TVR (RR, 1.27; 95% CI, 1.14 to 1.42, P <0.01), as well as the composite end point of death/myocardial infarction/TVR (RR, 1.26; 95% CI, 1.13 to 1.40, P <0.01). Conclusions— Despite advances in interventional techniques, diabetes remains a significant independent predictor of adverse events in the intermediate term after PCI.