Helen Vlachos

Percutaneous Coronary Intervention in the Current Era Compared With 1985–1986 The National Heart, Lung, and Blood Institute Registries

Background—Although refinements have occurred in coronary angioplasty over the past decade, little is known about whether these changes have affected outcomes. Methods and Results—Baseline features and in-hospital and 1-year outcomes of 1559 consecutive patients in the 1997–1998 Dynamic Registry who were having first coronary intervention were compared with 2431 patients in the 1985–1986 National Heart, Lung, and Blood Institute Registry. Compared with patients in the 1985–1986 Registry, Dynamic Registry patients were older (mean age, 62 versus 58 years;P <0.001) and more often female (32.1% versus 25.5%;P <0.001). In the Dynamic Registry, procedures were more often performed for acute myocardial infarction (22.9% versus 9.9%;P <0.001) and treated lesions were more severe (84.5% versus 82.5% diameter reduction;P <0.001), thrombotic (22.1% versus 11.3%;P <0.001) or calcified (29.5% versus 10.8%;P <0.001). Stents were used in 70.5% of Dynamic Registry patients, whereas 1985–1986 patients received balloon angioplasty alone. Procedural success was higher in the Dynamic Registry (92.0% versus 81.8%;P <0.001) and the rate of in-hospital death, myocardial infarction, and emergency coronary bypass surgery combined was lower (4.9% versus 7.9%;P =0.001) than in the 1985–1986 Registry. The 1-year rate for CABG was lower in the Dynamic Registry (6.9% versus 12.6%;P <0.001). Conclusions—Although Dynamic Registry patients had more unstable and complex coronary disease than those in the 1985–1986 Registry, their rate of procedural success was higher whereas rates of complications and subsequent CABG were lower. Results of percutaneous coronary intervention have improved substantially over the past decade.

A comparison of bare-metal and drug-eluting stents for off-label indications.

BACKGROUND Recent reports suggest that off-label use of drug-eluting stents is associated with an increased incidence of adverse events. Whether the use of bare-metal stents would yield different results is unknown. METHODS We analyzed data from 6551 patients in the National Heart, Lung, and Blood Institute Dynamic Registry according to whether they were treated with drug-eluting stents or bare-metal stents and whether use was standard or off-label. Patients were followed for 1 year for the occurrence of cardiovascular events and death. Off-label use was defined as use in restenotic lesions, lesions in a bypass graft, left main coronary artery disease, or ostial, bifurcated, or totally occluded lesions, as well as use in patients with a reference-vessel diameter of less than 2.5 mm or greater than 3.75 mm or a lesion length of more than 30 mm. RESULTS Off-label use occurred in 54.7% of all patients with bare-metal stents and 48.7% of patients with drug-eluting stents. As compared with patients with bare-metal stents, patients with drug-eluting stents had a higher prevalence of diabetes, hypertension, renal disease, previous percutaneous coronary intervention and coronary-artery bypass grafting, and multivessel coronary artery disease. One year after intervention, however, there were no significant differences in the adjusted risk of death or myocardial infarction in patients with drug-eluting stents as compared with those with bare-metal stents, whereas the risk of repeat revascularization was significantly lower among patients with drug-eluting stents. CONCLUSIONS Among patients with off-label indications, the use of drug-eluting stents was not associated with an increased risk of death or myocardial infarction but was associated with a lower rate of repeat revascularization at 1 year, as compared with bare-metal stents. These findings support the use of drug-eluting stents for off-label indications.

Troponin and Cardiac Events in Stable Ischemic Heart Disease and Diabetes

BACKGROUND Cardiac troponin concentrations are used to identify patients who would benefit from urgent revascularization for acute coronary syndromes. We hypothesized that they might be used in patients with stable ischemic heart disease to identify those at high risk for cardiovascular events who might also benefit from prompt coronary revascularization. METHODS We measured the cardiac troponin T concentration at baseline with a high-sensitivity assay in 2285 patients who had both type 2 diabetes and stable ischemic heart disease and were enrolled in the Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes trial. We tested for an association between the troponin T concentration and a composite end point of death from cardiovascular causes, myocardial infarction, or stroke; we then evaluated whether random assignment to prompt revascularization reduced the rate of the composite end point in patients with an abnormal troponin T concentration (≥14 ng per liter) as compared with those with a normal troponin T concentration (<14 ng per liter). RESULTS Of the 2285 patients, 2277 (99.6%) had detectable (≥3 ng per liter) troponin T concentrations and 897 (39.3%) had abnormal troponin T concentrations at baseline. The 5-year rate of the composite end point was 27.1% among the patients who had had abnormal troponin T concentrations at baseline, as compared with 12.9% among those who had had normal baseline troponin T concentrations. In models that were adjusted for cardiovascular risk factors, severity of diabetes, electrocardiographic abnormalities, and coronary anatomy, the hazard ratio for the composite end point among patients with abnormal troponin T concentrations was 1.85 (95% confidence interval [CI], 1.48 to 2.32; P<0.001). Among patients with abnormal troponin T concentrations, random assignment to prompt revascularization, as compared with medical therapy alone, did not result in a significant reduction in the rate of the composite end point (hazard ratio, 0.96; 95% CI, 0.74 to 1.25). CONCLUSIONS The cardiac troponin T concentration was an independent predictor of death from cardiovascular causes, myocardial infarction, or stroke in patients who had both type 2 diabetes and stable ischemic heart disease. An abnormal troponin T value of 14 ng per liter or higher did not identify a subgroup of patients who benefited from random assignment to prompt coronary revascularization. (Funded by the National Institutes of Health and Roche Diagnostics; BARI 2D ClinicalTrials.gov number, NCT00006305.).

Survival Following Coronary Angioplasty Versus Coronary Artery Bypass Surgery in Anatomic Subsets in Which Coronary Artery Bypass Surgery Improves Survival Compared With Medical Therapy Results From the Bypass Angioplasty Revascularization Investigation (BARI)

OBJECTIVES We sought to compare survival after coronary artery bypass graft (CABG) and percutaneous transluminal coronary angioplasty (PTCA) in high-risk anatomic subsets. BACKGROUND Compared with medical therapy, CABG decreases mortality in patients with three-vessel disease and two-vessel disease involving the proximal left anterior descending artery (LAD), particularly if left ventricular (LV) dysfunction is present. How survival after PTCA and CABG compares in these high-risk anatomic subsets is unknown. METHODS In the Bypass Angioplasty Revascularization Investigation (BARI), 1,829 patients with multivessel disease were randomized to an initial strategy of PTCA or CABG between 1988 and 1991. Stents and IIb/IIIa inhibitors were not utilized. Since patients in BARI with diabetes mellitus had greater survival with CABG, separate analyses of patients without diabetes were performed. RESULTS Seven-year survival among patients with three-vessel disease undergoing PTCA and CABG (n = 754) was 79% versus 84% (p = 0.06), respectively, and 85% versus 87% (p = 0.36) when only non-diabetics (n = 592) were analyzed. In patients with three-vessel disease and reduced LV function (ejection fraction <50%), seven-year survival was 70% versus 74% (p = 0.6) in all PTCA and CABG patients (n = 176), and 82% versus 73% (p = 0.29) among non-diabetic patients (n = 124). Seven-year survival was 87% versus 84% (p = 0.9) in all PTCA and CABG patients (including diabetics) with two-vessel disease involving the proximal LAD (n = 352), and 78% versus 71% (p = 0.7) in patients with two-vessel disease involving the proximal LAD with reduced LV function (n = 72). CONCLUSION In high-risk anatomic subsets in which survival is prolonged by CABG versus medical therapy, revascularization by PTCA and CABG yielded equivalent survival over seven years.

Comparison of in-hospital and one-year outcomes in patients with and without diabetes mellitus undergoing percutaneous catheter intervention (from the National Heart, Lung, and Blood Institute Dynamic Registry) ☆

Extrapolation of improvements in percutaneous coronary intervention (PCI) and outcomes to patients with diabetes has not been systematically examined in clinical practice. Two waves of consecutive patients (n = 4,629) who underwent PCI from July 1997 to June 1999 enrolled in the National Heart, Lung, and Blood Institute Dynamic Registry comprise the study population. There were 1,058 patients with treated diabetes and 3,571 patients without clinically evident diabetes. As a group, patients with diabetes tended to have more clinical, angiographic, and procedural risk factors. Although crude in-hospital mortality rates were higher in patients with diabetes (diabetics 2.3%, nondiabetics 1.3%; p = 0.02), the adjusted risk of in-hospital death (odds ratio 1.46, 95% confidence interval [CI] 0.80 to 2.66) was not significantly different. At 1 year, patients with diabetes had a significantly higher adjusted risk of mortality (risk ratio [RR] 1.80, 95% CI 1.35 to 2.41) and need for repeat revascularization (RR 1.40, 95% CI 1.13 to 1.74). There was a significant interaction between stent use and diabetic status with the need for repeat revascularization (adjusted RR in nondiabetics 0.73, 95% CI 0.61 to 0.88; adjusted RR in patients with diabetes 1.20, 95% CI 0.88 to 1.65). Beta blockers at the time of hospital discharge were significantly associated with reduced mortality rates at 1 year in both groups.

Changes in the practice of percutaneous coronary intervention: a comparison of enrollment waves in the national heart, lung, and blood institute (NHLBI) dynamic registry

The National Heart, Lung, and Blood Institute Dynamic Registry includes 15 clinical sites in wave 1, and 16 sites in wave 2 as well as a data-coordinating center. The first wave of enrollment began in July 1997 and was completed in February 1998. The second wave began in February 1999 and ended in June 1999. There were a total of 2,526 patients in wave 1 and 2,109 patients in wave 2. Comprehensive pre-, intra-, and postprocedure (in-hospital) data were analyzed for changes between recruitment waves. Patients in wave 2 were more frequently nonwhite (p < or = 0.001), hypertensive by history (p < or = 0.001), had more significant noncardiac comorbidity (p < or = 0.01), and had more frequently undergone prior percutaneous coronary intervention (p < 0.05). Patients in wave 2 underwent percutaneous coronary intervention in a setting of acute coronary syndromes more frequently than wave 1 patients (p < or = 0.001). However, most interventions in both waves were performed on 1 vessel, irrespective of the extent of disease. Attempted lesions in wave 2 were longer (p < or = 0.001), less frequently totally occluded (p < or = 0.001), and more frequently in vessels with a prior stent (p < or = 0.01). Using the American Heart Association/American College of Cardiology lesion classification scheme, attempted lesions in wave 2 were less complex than those in wave 1 (p < or = 0.001). Stent use increased significantly from wave 1 (67%) to wave 2 (79%, p < or = 0.001) as did the use of platelet glycoprotein IIb/IIIa antagonists (wave 1, 24%; wave 2, 32%: p < 0.001). Procedural outcomes (angiographic success without major in-hospital adverse events) were excellent in both waves 1 (94.6%) and 2 (95.6%) and were not significantly different. However, the frequency of significant procedural coronary dissection and in- and out-of-laboratory abrupt closure were significantly less in wave 2 (p < or = 0.001) Discharge medications were more likely to include angiotensin-converting enzyme inhibitors, beta-adrenergic blocking agents, and hypolipidemic treatment in wave 2 than in wave 1 (p < or = 0.001). These data indicate a continuing aggressive approach to patient care over the time interval analyzed. Although overall procedural outcomes are excellent, procedural safety has been further enhanced. There is also a growing awareness of the importance of secondary prevention among interventional cardiologists.

Percutaneous Coronary Intervention of Moderate to Severe Calcified Coronary Lesions: Insights from the National Heart, Lung and Blood Institute Dynamic Registry

Objectives: To evaluate the efficacy and safety of drug eluting stents (DES) when compared with bare metal stents (BMS) in patients with moderate to severe calcified coronary lesions. Background: Calcified coronary lesions present unique technical challenges during percutaneous coronary intervention (PCI) and it is not known if DES are as safe and as effective in the presence of calcium, as randomized trials typically exclude this common patient subset. Methods: We evaluated patients with PCI of a single calcified lesion enrolled across five recruitment waves in the National Heart, Lung, and Blood Institute Dynamic Registry between 1997 and 2006. Patients were divided into two groups based on the stent type‐ BMS and DES. The primary efficacy outcome was the need for repeat revascularization at 1 year and the primary safety outcome was a composite of death and myocardial infarction at 1 year. Results: Among the 1,537 patients included in the analysis, 884 (57%) underwent PCI with BMS and 653 (43%) with DES. DES use was associated with a significant reduction in the risk of repeat revascularization (10.0% vs. 15.3%; P = 0.003) with no significant higher risk of primary safety outcome (9.3% vs. 10.5%; P = 0.45) when compared to the BMS group. In a propensity score adjusted analysis, DES use was associated with a significantly lower risk in repeat revascularization (HR = 0.57; 95% CI 0.40–0.82; P = 0.002) and no significant difference in the risk of death and myocardial infarction (HR = 0.78; 95% CI 0.53–1.15; P = 0.20) compared to BMS group. Conclusion: In this large multicenter registry of patients with a moderate to severe calcified coronary lesion, use of DES compared to BMS was associated with significant reduction in the risk of repeat revascularization without any increase in death and myocardial infarction.

Impact of drug-eluting stents among insulin-treated diabetic patients: a report from the National Heart, Lung, and Blood Institute Dynamic Registry.

OBJECTIVES This study sought to evaluate the safety and efficacy of drug-eluting stents (DES) compared with bare-metal stents (BMS) in patients with insulin- and noninsulin-treated diabetes. BACKGROUND Diabetes is a powerful predictor of adverse events after percutaneous coronary interventions (PCI), and insulin-treated diabetic patients have worse outcomes. The DES are efficacious among patients with diabetes; however, their safety and efficacy, compared with BMS, among insulin-treated versus noninsulin-treated diabetic patients is not well established. METHODS Using the National Heart, Lung, and Blood Institute Dynamic Registry, we evaluated 1-year outcomes of insulin-treated (n = 817) and noninsulin-treated (n = 1,749) patients with diabetes who underwent PCI with DES versus BMS. RESULTS The use of DES, compared with BMS, was associated with a lower risk for repeat revascularization for both noninsulin-treated patients (adjusted hazard ratio [HR] = 0.59, 95% confidence interval [CI] 0.45 to 0.76) and insulin-treated subjects (adjusted HR = 0.63, 95% CI 0.44 to 0.90). With respect to safety in the overall diabetic population, DES use was associated with a reduction of death or myocardial infarction (adjusted HR = 0.75, 95% CI 0.58 to 0.96). However, this benefit was confined to the population of noninsulin-treated patients (adjusted HR = 0.57, 95% CI 0.41 to 0.81). Among insulin-treated patients, there was no difference in death or myocardial infarction risk between DES- and BMS-treated patients (adjusted HR = 0.95, 95% CI 0.65 to 1.39). CONCLUSIONS Drug-eluting stents are associated with lower risk for repeat revascularization compared with BMS in treating coronary artery disease among patients with either insulin- or noninsulin-treated diabetes. In addition, DES use is not associated with any significant increased safety risk compared with BMS. These findings suggest that DES should be the preferred strategy for diabetic patients.

Ethnic Differences in the Presentation, Treatment Strategy, and Outcomes of Percutaneous Coronary Intervention (A Report from the National Heart, Lung, and Blood Institute Dynamic Registry)

Information about the impact of race/ethnicity on adverse outcomes after percutaneous coronary intervention (PCI) in the modern era is limited. Using consecutive patients from the National Heart, Lung, and Blood Institute Dynamic Registry, this study investigated differences in clinical presentation, treatment strategy, and acute and long-term outcomes in 3,669 white, 446 black, 301 Hispanic, and 201 Asian patients who underwent PCI. All comparisons were made to whites. Blacks were more likely than whites to be younger, women, and to present with a higher prevalence of cardiovascular risk factors (hypertension, diabetes, and smoking). Hispanics tended to be younger, hypertensive, diabetic, and to be undergoing their first cardiovascular procedure. Asians were, on average, younger, men, and presented more often with hypertension and diabetes than whites. Although the rate of stent implantation was significantly lower in blacks compared with whites (63% vs 74%, p <0.001), angiographic and procedural success rates were high (> or =95%) and did not differ by race/ethnicity. In-hospital mortality (0.2% vs 1.7%, p <0.05) and death/myocardial infarction (MI)/coronary artery bypass grafting (CABG) (3.1% vs 5.5%, p <0.05) were lower in blacks. All other in-hospital complications were similar to whites. At 1 year, there were no statistical differences in cumulative adverse event rates by ethnicity; however by 2 years there was a modestly higher mortality rate (adjusted RR 1.87; 95% confidence interval 1.15 to 3.04) and adverse event rate (death/MI, death/MI/CABG) among black patients. Thus, although differences in patient demographics, clinical presentation, angiographic characteristics and treatment strategies did not impact the incidence of acute and 1-year adverse outcomes of non-whites, there appears to be a significant reduction in event-free survival among blacks by 2 years.

Temporal changes in the outcomes of patients with diabetes mellitus undergoing percutaneous coronary intervention in the National Heart, Lung, and Blood Institute dynamic registry.

BACKGROUND Patients with diabetes mellitus (DM) are at higher risk for adverse outcomes following percutaneous coronary intervention (PCI). METHODS To determine whether outcomes have improved over time, we analyzed data from 2,838 consecutive patients with medically treated DM, including 1,066 patients (37.6%) treated with insulin, in the National Heart, Lung, and Blood Institute Dynamic Registry undergoing PCI registered in waves 1 (1997-1998), 2 (1999), 3 (2001-2002), 4 (2004), and 5 (2006). We compared baseline demographics and 1-year outcomes in the overall cohort and in analyses stratified by recruitment wave and insulin use. RESULTS Crude mortality rates by chronological wave were 9.5%, 12.5%, 8.9%, 11.6%, and 6.6% (P value(trend) = .33) among those treated with insulin and, respectively, 9.7%, 6.5%, 4.1%, 5.4%, and 4.7% (P value(trend) = .006) among patients treated with oral agents,. The adjusted hazard ratios of death, myocardial infarction (MI), and overall major adverse cardiovascular events (death, MI, revascularization) in insulin-treated patients with DM in waves 2 to 5 as compared with wave 1 were either higher or the same. In contrast, the similar adjusted hazard ratios for oral agent-treated patients with DM were either similar or lower. CONCLUSIONS Significant improvements over time in adverse events by 1 year were detected in patients with DM treated with oral agents. In insulin-treated diabetic patients, despite lower rates of repeat revascularization over time, death and MI following PCI have not significantly improved. These findings underscore the need for continued efforts at optimizing outcomes among patients with DM undergoing PCI, especially those requiring insulin treatment.