Patrice Desvigne-Nickens

Trends and Disparities in Coronary Heart Disease, Stroke, and Other Cardiovascular Diseases in the United States Findings of the National Conference on Cardiovascular Disease Prevention

A workshop was held September 27 through 29, 1999, to address issues relating to national trends in mortality and morbidity from cardiovascular diseases; the apparent slowing of declines in mortality from cardiovascular diseases; levels and trends in risk factors for cardiovascular diseases; disparities in cardiovascular diseases by race/ethnicity, socioeconomic status, and geography; trends in cardiovascular disease preventive and treatment services; and strategies for efforts to reduce cardiovascular diseases overall and to reduce disparities among subpopulations. The conference concluded that coronary heart disease mortality is still declining in the United States as a whole, although perhaps at a slower rate than in the 1980s; that stroke mortality rates have declined little, if at all, since 1990; and that there are striking differences in cardiovascular death rates by race/ethnicity, socioeconomic status, and geography. Trends in risk factors are consistent with a slowing of the decline in mortality; there has been little recent progress in risk factors such as smoking, physical inactivity, and hypertension control. There are increasing levels of obesity and type 2 diabetes, with major differences among subpopulations. There is considerable activity in population-wide prevention, primary prevention for higher risk people, and secondary prevention, but wide disparities exist among groups on the basis of socioeconomic status and geography, pointing to major gaps in efforts to use available, proven approaches to control cardiovascular diseases. Recommendations for strategies to attain the year 2010 health objectives were made.

Myocardial Viability and Survival in Ischemic Left Ventricular Dysfunction

BACKGROUND The assessment of myocardial viability has been used to identify patients with coronary artery disease and left ventricular dysfunction in whom coronary-artery bypass grafting (CABG) will provide a survival benefit. However, the efficacy of this approach is uncertain. METHODS In a substudy of patients with coronary artery disease and left ventricular dysfunction who were enrolled in a randomized trial of medical therapy with or without CABG, we used single-photon-emission computed tomography (SPECT), dobutamine echocardiography, or both to assess myocardial viability on the basis of prespecified thresholds. RESULTS Among the 1212 patients enrolled in the randomized trial, 601 underwent assessment of myocardial viability. Of these patients, we randomly assigned 298 to receive medical therapy plus CABG and 303 to receive medical therapy alone. A total of 178 of 487 patients with viable myocardium (37%) and 58 of 114 patients without viable myocardium (51%) died (hazard ratio for death among patients with viable myocardium, 0.64; 95% confidence interval [CI], 0.48 to 0.86; P=0.003). However, after adjustment for other baseline variables, this association with mortality was not significant (P=0.21). There was no significant interaction between viability status and treatment assignment with respect to mortality (P=0.53). CONCLUSIONS The presence of viable myocardium was associated with a greater likelihood of survival in patients with coronary artery disease and left ventricular dysfunction, but this relationship was not significant after adjustment for other baseline variables. The assessment of myocardial viability did not identify patients with a differential survival benefit from CABG, as compared with medical therapy alone. (Funded by the National Heart, Lung, and Blood Institute; STICH ClinicalTrials.gov number, NCT00023595.).

Coronary Bypass Surgery with or without Surgical Ventricular Reconstruction

BACKGROUND Surgical ventricular reconstruction is a specific procedure designed to reduce left ventricular volume in patients with heart failure caused by coronary artery disease. We conducted a trial to address the question of whether surgical ventricular reconstruction added to coronary-artery bypass grafting (CABG) would decrease the rate of death or hospitalization for cardiac causes, as compared with CABG alone. METHODS Between September 2002 and January 2006, a total of 1000 patients with an ejection fraction of 35% or less, coronary artery disease that was amenable to CABG, and dominant anterior left ventricular dysfunction that was amenable to surgical ventricular reconstruction were randomly assigned to undergo either CABG alone (499 patients) or CABG with surgical ventricular reconstruction (501 patients). The primary outcome was a composite of death from any cause and hospitalization for cardiac causes. The median follow-up was 48 months. RESULTS Surgical ventricular reconstruction reduced the end-systolic volume index by 19%, as compared with a reduction of 6% with CABG alone. Cardiac symptoms and exercise tolerance improved from baseline to a similar degree in the two study groups. However, no significant difference was observed in the primary outcome, which occurred in 292 patients (59%) who were assigned to undergo CABG alone and in 289 patients (58%) who were assigned to undergo CABG with surgical ventricular reconstruction (hazard ratio for the combined approach, 0.99; 95% confidence interval, 0.84 to 1.17; P=0.90). CONCLUSIONS Adding surgical ventricular reconstruction to CABG reduced the left ventricular volume, as compared with CABG alone. However, this anatomical change was not associated with a greater improvement in symptoms or exercise tolerance or with a reduction in the rate of death or hospitalization for cardiac causes. (ClinicalTrials.gov number, NCT00023595.)

Comparison of Clinical Outcomes for Women and Men after Acute Myocardial Infarction

Drugs Generic Name Brand Name alteplase Activase Abbreviations rt-PA = recombinant tissue plasminogen activator The decline in coronary heart disease-related deaths, which began in the mid-1960s [1-6], has been greater for men than for women [4]. Data from several large epidemiologic [7] and clinical [8-12] studies suggest that the prognosis after acute myocardial infarction is worse for women. Some investigators relate these differences to age, risk factor profile, and the severity of preexisting coronary disease [10-15], whereas others relate them to sex [8, 9, 12]. Epidemiologic research on coronary heart disease among women has been limited, particularly in the thrombolytic era. Although several population- and community-based studies have been done [7, 10, 14-16], different methods, diagnostic criteria, end points, and definitions have made direct comparisons between women and men difficult and unreliable. The Thrombolysis in Myocardial Infarction Phase II (TIMI-II) trial [17] provides a valuable opportunity to investigate the potential influence of sex on clinical outcome after myocardial infarction. In a secondary observational analysis, we assessed possible differences in morbidity and mortality between men and women with myocardial infarction treated with thrombolytic therapy. We also analyzed the relation of any differences to baseline patient characteristics and clinical features. Methods Patient Selection Details of the TIMI-II protocol have been reported before [17, 18]. Briefly, women and men younger than 76 years who had ischemic chest pain lasting 30 minutes or more, in whom treatment with recombinant tissue plasminogen activator (rt-PA) (alteplase; Activase, Genentech, South San Francisco, California) within 4 hours of symptom onset was feasible, were considered for the study. Exclusion criteria included a history of cerebrovascular disease; blood pressure greater than 180 mm Hg systolic or 110 mm Hg diastolic; systemic bleeding disorders; major surgery within the previous 2 weeks; recent prolonged cardiopulmonary resuscitation; percutaneous transluminal coronary angioplasty or severe trauma within the previous 6 months; previous coronary artery bypass grafting or prosthetic heart valve replacement; left bundle-branch block; dilated cardiomyopathy; and other serious illness. Thrombolytic Therapy The rt-PA used in the TIMI-II study was produced by the suspension culture method (G11044, supplied by Genentech). The total dosage of rt-PA used in the first 520 patients was 150 mg administered intravenously during a period of 6 hours. Because of an unacceptably high rate of intracranial hemorrhage [19], however, the dosage was reduced to 100 mg given during 6 hours in the remaining patients. Assigned Strategies and Beta-Blocker Treatment Patients were assigned randomly to receive one of two treatment regimens: 1) routine coronary angiography done 18 to 48 hours after study entry and percutaneous transluminal coronary angioplasty or coronary artery bypass grafting if angiography showed that the patients anatomy was suitable [invasive strategy]; or 2) conventional care without coronary angiography and percutaneous transluminal coronary angioplasty, unless evidence showed either spontaneous or exercise-induced myocardial ischemia (conservative strategy) [17]. Coronary artery bypass grafting was done in patients assigned to either group for appropriate clinical indications. In the TIMI-IIA substudy [18], 195 patients were assigned to receive an immediate invasive strategy and were excluded from the analysis. Enrollment of patients in TIMI-IIB (the -blocker substudy) [20] at the seven TIMI-IIA clinical sites did not begin until enrollment in TIMI-IIA was completed. In TIMI-IIB, patients assigned to receive immediate intravenous -blocker therapy were given 15 mg of metoprolol as three 5-mg intravenous injections at 2-minute intervals, followed by oral metoprolol. Those assigned to receive deferred -blocker therapy received 50 mg of oral metoprolol twice on day 6 and 100 mg twice each day thereafter. Concomitant Care Patients received intravenous lidocaine for 24 hours and intravenous heparin for 5 days. Aspirin (80 mg) was administered on the day of study entry according to the protocol in the first 488 patients and on the next day in the remaining patients; it was increased to 325 mg per day on day 6, when intravenous heparin was replaced by subcutaneous heparin. End Points The primary end point in TIMI-II was survival with no recurrent myocardial infarction at 42 days. Secondary end points included the ejection fraction at rest and during exercise at hospital discharge and at 6 weeks. Complications of therapy were also assessed. Follow-up examinations were conducted 6 weeks and 1 year after study entry. The vital status of all patients not individually examined was determined by telephone interview. Statistical Analysis Probability values and confidence intervals for percentages and proportions were calculated using standard methods to test differences between two independent proportions [21, 22]. Because of multiple comparisons in the TIMI-II secondary analyses, probability values between 0.01 and 0.001 for two-sided tests were considered to provide some evidence of differences, and values less than 0.001 were thought to provide strong evidence of differences. Comparisons between mortality and either mortality or myocardial infarction rates are based on Cox regression analysis [23, 24]. The Cox proportional-hazards model was examined for validity of assumptions using the Kaplan-Meier [23] estimates of survival (S[t]) for each covariate in graphs plotting the log (log[S(t)]) against time to events (death and death or myocardial infarction), and the assumptions were tested for the comparison of men with women by introducing time-dependent variables for interaction [24]. Adjustment, when appropriate, was made for assignment to conservative or invasive strategy, rt-PA dose, and the TIMI-II baseline patient characteristics (age, previous myocardial infarction, anterior myocardial infarction, history of diabetes, history of hypertension, time from onset of symptoms to study entry, ongoing chest pain when rt-PA infusion was begun, history of congestive heart failure, race, and history of angina). Crude event rates and Kaplan-Meier event rates for mortality and for death or myocardial infarction were almost identical because of the completeness of follow-up information. Tests of interaction were done using crude event rates and the Breslow-Day statistic [25]. This report is based on an analysis file prepared at the TIMI Coordinating Center in January 1991. Results Patient Characteristics Women were older than men, with mean ages of 62.2 and 56.6 years (P < 0.001), respectively, and more commonly had past medical histories that included congestive heart failure (P < 0.001), systemic hypertension (P < 0.001), or diabetes mellitus (P < 0.001). As a group, women were less likely than men to be classified as low risk (P < 0.001). The time from symptom onset to study entry was delayed in women compared with men (2.8 hours compared with 2.6 hours; P < 0.001). Fewer women than men were considered eligible for the -blocker study (P < 0.001) (Table 1). Invasive Procedures and Medical Treatments The frequency of invasive procedures done within 6 weeks of study entry is summarized in Table 2. No differences between men and women were found in either the invasive or conservative treatment groups. Throughout this period, women were less likely than men to receive -blockers, but calcium channel blockers were prescribed more frequently for women. Aspirin was used with similar frequency. Table 1. Baseline Characteristics and Clinical Features of Patients* Complications Coronary Angioplasty Although coronary arterial dissection was observed more frequently in women than in men (17.2% compared with 10.0%; P = 0.002), within 24 hours after percutaneous transluminal coronary angioplasty, the frequencies of recurrent myocardial infarction, death, or the need to do emergent coronary bypass surgery did not differ statistically between women and men assigned to receive invasive procedures. Sex was not associated with the frequency of successful percutaneous transluminal coronary angioplasty [26]. Left Ventricular Function More of the 597 women in the TIMI-II study had resting left ventricular ejection fractions greater than 55% on radionuclide ventriculography than did the 2742 men before hospital discharge (33.5% compared with 29.0%; P = 0.03) and at 6-week follow-up (32.8% compared with 27.1%; P = 0.005). However, a greater proportion of these women than men did not have radionuclide studies analyzed because of death or inability to measure ejection fraction at hospital discharge (24.0% compared with 16.6%; P < 0.001) and 6-week follow-up (34.2% compared with 25.5%; P < 0.001). Patient Outcome: Mortality and Morbidity One-year follow-up data were available for 3316 (99.3%) patients [27]. Event rates according to sex and treatment strategy are summarized in Table 3. The cumulative 6-week mortality rate was higher for women than for men (9% compared with 4%; P < 0.001). Combined reinfarction and death also was more common among women than men (15.9% compared with 9.5%; P < 0.001). These differences (for both the invasive and conservative treatments) persisted at 1-year follow-up (Figures 1 and 2). Table 2. Invasive Procedures and Medications at 6 Weeks from Study Entry according to Sex and Treatment Strategy* Figure 1. One-year Kaplan-Meier mortality curves for women and men. Figure 2. One-year Kaplan-Meier event rates for reinfarction in women and men. The occurrence of myocardial infarction or death was predictably lower for low-risk women and men. The mortality rate was 1.9% for women compared with 1.6% for men (P = 0.78) 6 weeks after study entry, and it was 3.1% compared with 2.5% (P = 0.66) 1 year after study entry. Among high

Left Ventricular Assist Device as Destination for Patients Undergoing Intravenous Inotropic Therapy: A Subset Analysis From REMATCH (Randomized Evaluation of Mechanical Assistance in Treatment of Chronic Heart Failure)

Background—Left ventricular assist devices (LVADs) have improved survival in patients with end-stage heart failure. Compared with previous trials, the Randomized Evaluation of Mechanical Assistance in Treatment of Chronic Heart Failure (REMATCH) trial enrolled patients with more advanced heart failure and high prevalence of intravenous inotropic therapy. This study analyzes, on a post hoc basis, outcomes in patients undergoing inotropic infusions at randomization. Methods and Results—Of 129 patients randomized, 91 were receiving intravenous inotropic therapy at randomization to LVAD or optimal medical management (OMM). Mean systolic pressure was 100 versus 107 mm Hg in those not receiving inotropes, serum sodium was 134 versus 137 mEq/L, and left ventricular ejection fraction was 17% for both groups. LVADs improved survival throughout follow-up for patients undergoing baseline inotropic infusions (P=0.0014); for the LVAD group versus the OMM group, respectively, 6-month survival was 60% versus 39%, 1-year survival rates were 49% versus 24%, and 2-year survival rates were 28% versus 11%. For 38 patients not undergoing inotropic infusions, 6-month survival was 61% for those with LVADs and 67% for those with OMM, whereas 1-year rates were 57% and 40%, respectively (P=0.55). Quality-of-life scores for survivors improved. Median days out of hospital for patients on inotropic therapy at randomization were 255 with LVAD and 105 with OMM. Conclusions—Despite severe compromise, patients undergoing inotropic infusions at randomization derived major LVAD survival benefit with improved quality of life. Patients not undergoing inotropic infusions had higher survival rates both with and without LVAD, but differences did not reach significance. Future studies should prespecify analyses of inotropic and other therapies to determine how disease severity and parallel medical treatment influence the benefits offered by mechanical circulatory support.

Coronary-Artery Bypass Surgery in Patients with Ischemic Cardiomyopathy

BACKGROUND The survival benefit of a strategy of coronary-artery bypass grafting (CABG) added to guideline-directed medical therapy, as compared with medical therapy alone, in patients with coronary artery disease, heart failure, and severe left ventricular systolic dysfunction remains unclear. METHODS From July 2002 to May 2007, a total of 1212 patients with an ejection fraction of 35% or less and coronary artery disease amenable to CABG were randomly assigned to undergo CABG plus medical therapy (CABG group, 610 patients) or medical therapy alone (medical-therapy group, 602 patients). The primary outcome was death from any cause. Major secondary outcomes included death from cardiovascular causes and death from any cause or hospitalization for cardiovascular causes. The median duration of follow-up, including the current extended-follow-up study, was 9.8 years. RESULTS A primary outcome event occurred in 359 patients (58.9%) in the CABG group and in 398 patients (66.1%) in the medical-therapy group (hazard ratio with CABG vs. medical therapy, 0.84; 95% confidence interval [CI], 0.73 to 0.97; P=0.02 by log-rank test). A total of 247 patients (40.5%) in the CABG group and 297 patients (49.3%) in the medical-therapy group died from cardiovascular causes (hazard ratio, 0.79; 95% CI, 0.66 to 0.93; P=0.006 by log-rank test). Death from any cause or hospitalization for cardiovascular causes occurred in 467 patients (76.6%) in the CABG group and in 524 patients (87.0%) in the medical-therapy group (hazard ratio, 0.72; 95% CI, 0.64 to 0.82; P<0.001 by log-rank test). CONCLUSIONS In a cohort of patients with ischemic cardiomyopathy, the rates of death from any cause, death from cardiovascular causes, and death from any cause or hospitalization for cardiovascular causes were significantly lower over 10 years among patients who underwent CABG in addition to receiving medical therapy than among those who received medical therapy alone. (Funded by the National Institutes of Health; STICH [and STICHES] ClinicalTrials.gov number, NCT00023595.).

Influence of gender on in-hospital clinical and angiographic outcomes and on one-year follow-up in the New Approaches to Coronary Intervention (NACI) registry.

Higher complication rates and lower success rates for treatment of women compared with men have been reported in prior studies of coronary angioplasty and in most early reports of outcome with new coronary interventional devices. In multivariate analysis this has been attributed largely to older age and other unfavorable clinical characteristics. These results are reflected in the current guidelines for coronary angioplasty. Women in prior studies have also had different distributions of vessel and lesion characteristics, but the influence of these differences on the outcome of new-device interventions have not been adequately evaluated. This article evaluates the influence of gender on clinical and angiographic characteristics, interventional procedure and complications, angiographic success, and clinical outcomes at hospital discharge and 1-year follow-up, as observed in the New Approaches to Coronary Intervention (NACI) registry. The NACI registry methodology has been reported in detail elsewhere in this supplement. This study focuses on the 90% of patients-975 women and 1,880 men-who had planned procedures with a single new device and also had angiographic core laboratory readings. Women compared with men were older, had more recent onset of coronary ischemic pain that was more severe and unstable, and had more frequent histories of other adverse clinical conditions. The distributions of several but not all angiographic characteristics before intervention were considered more favorable to angioplasty outcome in women. Differences were observed in device use and procedure staging. Angiographically determined average gain in lumen diameter after new-device intervention, with or without balloon angioplasty, was significantly less in women (1.38 mm) than in men (1.53 mm; p < 0.001); this 0.15 mm difference is consistent with the 0.16-mm smaller reference vessel lumen diameter of women. However, final percent diameter stenoses and TIMI flow and lesion compliance characteristics were similar. Among procedural complications, only treatment for hypotension, blood transfusion, and vascular repair occurred more often in women. More women than men were clinically unstable (2.1% vs 1.1%) or went directly to emergent coronary artery bypass graft surgery (CABG; 1.2% vs 0.6%) on leaving the interventional laboratory. However, in-hospital death (1.4% vs 1.1%), Q-wave myocardial infarction (MI) (0.9% vs 1.1%), and emergent CABG (1.5% vs 1.0%, for women and men, respectively) were not significantly different. Nonemergent CABG was more frequent in women (1.8% vs 0.9%; p < 0.05) and length of hospital stay after device intervention was longer (4.4 days vs 3.8 days in men; p < 0.01). In both univariate and multivariate analyses gender did not emerge as a significant variable in relation to the combined endpoint, death, Q-wave MI, or emergent CABG at hospital discharge. At 1-year follow-up more women than men reported improvement in angina (70% vs 62%) and fewer women than men had had repeat revascularization (32% vs 36%). Similar proportions were alive and free of angina, Q-wave MI and repeat revascularization (46% of women vs 45% of men). Although several procedure-related complications were more frequent in women than men after coronary interventions with new devices, no important disadvantages were observed for women in the rates of major clinical events at hospital discharge and at 1-year clinical follow-up. Additional studies are needed to evaluate the complex interplay of clinical, vessel, and lesion characteristics on success and complications of specific interventional techniques and to determine whether gender, per se, is a risk factor and whether gender specific interventional strategies may be beneficial.

Mechanical Cardiac Support 2000: Current Applications and Future Trial Design

The conference was conducted with financial and other support from the following organizations: American College of Cardiology, American Heart Association, International Society for Heart and Lung Transplantation, American Society of Transplantation, Heart Failure Society of America, American Association for Thoracic Surgery, the Society of Thoracic Surgeons, and the American Society of Transplant Surgeons.* Additionally, participants included members of these agencies: Food and Drug Administration, National Institutes of Health, and the American Society for Artificial Internal Organs. ### TABLE OF CONTENTS Impact Statement 337 Introduction 338 Executive Summary 338 Heart failure presents an increasing public health burden of morbidity and mortality even as the mortality from coronary artery disease and hypertension is decreasing. While effective pharmacologic therapies have improved outcomes for mild-moderate heart failure, the impact of newer therapies and mechanical circulatory support for advanced heart failure has not yet been realized. Implantable devices have been shown to be safe and effective as bridges to cardiac transplantation, but further work is needed to establish the role of mechanical support for myocardial recovery and for long-term support. This conference was held to assess current mechanical support applications and future trial designs for investigation affecting this public health issue. The participants concluded that important differences between devices and drugs may warrant novel study designs characterized by innovation and flexibility. While the randomized clinical trial remains the most powerful tool for unambiguous comparison of interventions, variations may include timed graduation from control to investigational therapies, assignment influenced by patient risk or patient preferences and criteria for an optional crossover to compassionate device use. A major impact would result from a national outcomes database for advanced heart failure that identifies high-risk populations with the greatest potential for benefit from newer therapies and thus facilitates the design of devices and device trials. A separate registry with industry of outcomes after …

Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest

BACKGROUND Antiarrhythmic drugs are used commonly in out-of-hospital cardiac arrest for shock-refractory ventricular fibrillation or pulseless ventricular tachycardia, but without proven survival benefit. METHODS In this randomized, double-blind trial, we compared parenteral amiodarone, lidocaine, and saline placebo, along with standard care, in adults who had nontraumatic out-of-hospital cardiac arrest, shock-refractory ventricular fibrillation or pulseless ventricular tachycardia after at least one shock, and vascular access. Paramedics enrolled patients at 10 North American sites. The primary outcome was survival to hospital discharge; the secondary outcome was favorable neurologic function at discharge. The per-protocol (primary analysis) population included all randomly assigned participants who met eligibility criteria and received any dose of a trial drug and whose initial cardiac-arrest rhythm of ventricular fibrillation or pulseless ventricular tachycardia was refractory to shock. RESULTS In the per-protocol population, 3026 patients were randomly assigned to amiodarone (974), lidocaine (993), or placebo (1059); of those, 24.4%, 23.7%, and 21.0%, respectively, survived to hospital discharge. The difference in survival rate for amiodarone versus placebo was 3.2 percentage points (95% confidence interval [CI], -0.4 to 7.0; P=0.08); for lidocaine versus placebo, 2.6 percentage points (95% CI, -1.0 to 6.3; P=0.16); and for amiodarone versus lidocaine, 0.7 percentage points (95% CI, -3.2 to 4.7; P=0.70). Neurologic outcome at discharge was similar in the three groups. There was heterogeneity of treatment effect with respect to whether the arrest was witnessed (P=0.05); active drugs were associated with a survival rate that was significantly higher than the rate with placebo among patients with bystander-witnessed arrest but not among those with unwitnessed arrest. More amiodarone recipients required temporary cardiac pacing than did recipients of lidocaine or placebo. CONCLUSIONS Overall, neither amiodarone nor lidocaine resulted in a significantly higher rate of survival or favorable neurologic outcome than the rate with placebo among patients with out-of-hospital cardiac arrest due to initial shock-refractory ventricular fibrillation or pulseless ventricular tachycardia. (Funded by the National Heart, Lung, and Blood Institute and others; ClinicalTrials.gov number, NCT01401647.).

Balloon angioplasty versus new device intervention: Clinical outcomes. A comparison of the NHLBI PTCA and NACI registries

OBJECTIVES We sought to compare outcomes of patients treated in the National Heart, Lung, and Blood Institute (NHLBI) Percutaneous Transluminal Coronary Angioplasty (PTCA) and New Approaches to Coronary Intervention (NACI) registries. BACKGROUND Coronary angioplasty has numerous shortcomings. New devices for performing coronary interventions have been introduced in an effort to improve clinical outcomes. METHODS Under the sponsorship of the NHLBI, a registry of consecutive patients treated with PTCA during 1985 to 1986 was established. In 1990, the NHLBI funded a second registry, the NACI. The two registries used the same data coordinating center to collect detailed baseline and follow-up information. RESULTS Patients enrolled in the NACI registry were older, had undergone more previous bypass surgery procedures and had more stenoses located in bypass grafts than patients in the NHLBI PTCA registry. Procedural success was achieved in 72.1% and 82.6% of patients in the PTCA and NACI registries, respectively; however, in-hospital and 1-year mortality rates were 1.0% versus 1.8% and 3.1% versus 5.9% for the PTCA versus NACI registries, respectively. After risk adjustment, there was no difference in 1-year mortality. Rates of target lesion revascularization (TLR) were 21.5% for the PTCA registry and 24.2% for the NACI registry. NACI registry patients had a higher risk for TLR and the composite end point of death, myocardial infarction or revascularization (relative risk 1.28 and 1.23, respectively). However, the NACI registry patients who received stents tended to have a lower adjusted TLR rate. CONCLUSIONS This comparative study found no overall superiority of these newer devices in terms of patient survival or freedom from TLR after adjustment for baseline risk profiles. Although technologic improvements (especially improved stenting) continue, these observations highlight the importance of careful assessment of clinical results in the broad population of patients in whom interventions are used.