Investigators conducted the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial to find an anticoagulant that is more manageable than warfarin for the prevention of stroke in patients with atrial fibrillation [1]. Warfarin, considered the standard treatment for atrial fibrillation, has many drawbacks and limitations, and numerous efforts have been made to find a drug that does not require frequent monitoring and dose adjustments.

In this study, investigators evaluated the use of rivaroxaban vs. warfarin in a double-blind, double-dummy, randomized, event-driven trial. There were 14,264 participants enrolled in 45 countries who were randomized to receive either a daily dose of 20 mg rivaroxaban or dose-adjusted warfarin. The primary hypothesis was to determine that rivaroxaban would be noninferior to warfarin for the prevention of stroke or systemic embolism. However, the interpretation of ROCKET AF depended on results from three different protocol-specific analyses of the primary outcome of stroke or systemic embolism. The primary analysis, termed “per-protocol, as-treated,” and included only patients treated according to protocol, showed that rivaroxaban was noninferior to warfarin. Investigators also tested for results using an intention-to-treat analysis and an as-treated safety population analysis.

In the per-protocol population, the primary end-point occurred in 188 patients in the rivaroxaban group, 1.7% per year, and 241 patients in the warfarin group, 2.2% per year (rivaroxaban HR, 0.79; 95% confidence index [CI], 0.66–0.96; P<0.001 for noninferiority). In the intention-to-treat analysis, the primary end point occurred in 269 rivaroxaban patients, 2.1% per year, and in 306 warfarin patients, 2.4% per year, (HR, 0.88; 95% CI, 0.74–1.03; P<0.001 for noninferiority; P=0.12 for superiority). Supplemental information included with the publication of this study contained the analysis of the as-treated patient population.

In an accompanying editorial [2], the authors stated that they regarded the multiple analyses as having “muddied the waters” in the effort to clearly understand rivaroxaban’s efficacy and effectiveness over warfarin. They also stated their belief that effective oral alternatives to warfarin have been found. Investigators in the trial concluded that the results of the trial showed rivaroxaban was noninferior to warfarin for the prevention of stroke or systemic embolism and that intracranial and fatal bleeding occurred less frequently in the rivaroxaban group.

[1] Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation (ROCKET AF). N Engl J Med 2011;365:883-91

[2] del Zoppo GJ, Eliasziw M. New options in anticoagulation for atrial fibrillation. N Engl J Med 2011;365:952-3

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Investigators conducted the Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Standard Therapy in Subjects with Acute Coronary Syndrome-Thrombolysis in Myocardial Infarction 51 Trial (ATLAS ACS 2-TIMI 51) in order to find a treatment that will prevent recurrent cardiovascular events in patients who have had an acute coronary syndrome (termed unstable angina) [1]. Although many efforts have been made to reduce the risk of death and recurrent heart attacks and stroke in such patients, including long-tem antiplatelet therapy with aspirin and an adenosine diphosphate-receptor blocker, patients have remained at risk. With the knowledge that heart attack patients make too much thrombin, a clot-forming enzyme activated by Factor Xa, the investigators tested the use of low-dose rivaroxaban, an inhibitor of Factor Xa, by conducting a double-blind, placebo-controlled trial that enrolled 15,526 acute coronary syndrome (ACS) patients . Patients were randomly assigned to receive twice-daily doses of either 2.5 mg or 5 mg of rivaroxaban or placebo for a mean of 13 months and up to 31 months. The primary efficacy end-point was a composite of death from cardiovascular causes, myocardial infarction, or both.

Rivaroxaban, as compared to placebo, reduced the end point with respective rates of 8.9% and 10.7% (hazard ratio in the rivaroxaban group, 0.84; 95% confidence interval, 0.74–0.96; P=0.008. Improvement was shown in both the twice-daily 2.5 mg dose (9.1% vs. 10.7%, P=0.02) and the twice-daily 5 mg dose (8.8% vs. 10.7%, P=0.03). The twice-daily 2.5 mg dose of rivaroxaban reduced death rates from cardiovascular causes (2.7% vs. 4.1%, P=0.002) and from any cause (2.9% vs. 4.5%, P=0.002). The same survival benefit was not seen with the twice-daily 5 mg dose. There was an increase in major bleeding with rivaroxaban, but it was without a significant increase in fatal bleeding, with the twice-daily 2.5 mg dose resulting in fewer fatal bleeding events.

In an accompanying editorial [2], the authors stated that the results of this study are important for relatively young and healthy ACS patients, but since many ACS patients are elderly and have coexisting illnesses, there is a delicate balance that must be found between the risk of bleeding and the benefits of treatment. The authors believe that further studies will define the role that rivaroxaban will play in the ongoing effort in secondary prevention.

[1] Mega JL, Braunwald E, Wiviott SD, et al. Rivaroxaban in patients with acute coronary syndrome (ATLAS ACS2-TIMI 51). N Engl J Med 2012;366:9-19

[2] Roe MT, Ohman M. A new era in secondary prevention after acute coronary syndrome. N Engl J Med 2012;366:85-7

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The wisdom of discouraging the performance of percutaneous coronary intervention (PCI) in non-infarct related arteries (non-IRA) concurrently with primary PCI was evaluated by investigators in the Assessment of Pexelizumab in Acute Myocardial Infarction (APEX-AMI) trial [1]. Guidelines from the European Society of Cardiology (ESC) and the American College of Cardiology/American Heart Association (ACC/AHA) discourage the practice of performing PCI in non-IRAs concurrently with primary PCI in stable ST-elevation myocardial infarction (STEMI) patients. However, additional examination of the issue was needed because the guideline recommendations were based on observational studies from an earlier era. Therefore, the investigators used the data from the APEX-AMI trial, the largest report of its kind to date, to reach a more timely recommendation by examining 90 day outcomes following non-IRA interventions performed at the time of primary PCI. After comparing the current data with the data obtained from the earlier studies, the investigators found the interventions were associated with increased mortality and adverse outcomes, and they continue to strongly support the ESC and ACC/AHA guideline recommendations.

[1] Toma M, Buller CE, Westerhout CM, et al. Non-culprit coronary artery percutaneous coronary intervention during acute ST-segment elevation myocardial infarction: insights from the APEX-AMI trial. Eur Heart J 2010;31:1701-7

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Further information: Antiarrhythmic Drugs (see p2085) from Cardiovascular Medicine, 3rd Edn*

On March 30, 2011, a summary of the published results of the Apixaban Versus Acetylsalicylic Acid (ASA) to Prevent Stroke in Atrial Fibrillation Patients Who Have Failed or are Unsuitable for Vitamin K Antagonist Treatment (AVERROES) trial [1] was published on this website [2]. As the trial progressed, data were clearly in favor of apixaban, and in fact, the trial was terminated early. The current study, Apixaban Versus Warfarin in Patients with Atrial Fibrillation [3], further confirms the safety and efficacy of apixaban.

Investigators conducted a randomized, double-blind trial to compare a 5-g twice-daily dose of apixaban with dose-adjusted warfarin in patients with atrial fibrillation and at least one additional risk factor for stroke. Apixaban, like the anticoagulant drug rivaroxaban [4], is a factor Xa inhibitor. From December 19, 2006 through April 2, 2010, 18,201 patients were enrolled at 1034 sites in 39 counties. Of the total, 9120 were assigned to the apixaban group and 9801 to the warfarin group. The primary outcome was ischemic or hemorrhagic stroke or systemic embolism. The trial tested for noninferiority, and the secondary objective tested for superiority in regard to the primary outcome and to the rate of major bleeding and death from any cause. The rate of the primary outcome was 1.27% per year in the apixaban group and 1.60% per year in the warfarin group (HR with apixaban, 0.79; 95% CI, 0.66–0.95%; P<0.001 for noninferiority; P=0.01 for superiority). The rates for each of the additional risk factors also showed apixaban to be superior to warfarin.

In an accompanying editorial by Dr. Mega [5], the author compared the recent trials that evaluated trial results for dabigatran [6] and rivaroxaban [3], as well as apixaban [3], and concluded that the direct thrombin and factor Xa inhibitors have done more than prove noninferiority to warfarin, they have shown to have a more favorable bleeding profile and are as efficacious. The author stated that a new era of anticoagulation has emerged for patients with atrial fibrillation.

[1] Connolly SJ, Eikelboom J, Joyner C, et al. Apixaban in patients with atrial fibrillation. N Engl J Med 2011;364:806-17

[2] Apixaban in patients with atrial fibrillation. http://cardiovascular-medicine.com/?p=309

[3] Granger CB, Alexander JH, McMurray JJV, et al. Apixaban versus warfarin in patients with atrial fibrillation (ARISTOTLE). N Engl J Med 2011;365:981-92

[4] Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation (ROCKET AF). N Engl J Med 2011;365:883-91

[5] Mega JL. A new era for anticoagulation in atrial fibrillation. N Engl J Med 2011;365:1052-3

[6] Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009;361:1139-51

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According to an Editorial [1] written on two articles in the September 1, 2011 issue of The New England Journal of Medicine, the rate of survival for individuals having an out-of-hospital cardiac arrest has not improved in 30 years. The two articles on which the editorial was written [2,3] were reports of randomized trials that were conducted in an effort to find improved methods to manage out-of-hospital cardiac arrest. Stiell et al [2] performed a cluster-randomized trial that included 9933 patients enrolled from 10 Resuscitation Outcomes Consortium (ROC) sites in the US and Canada with the trial being conducted at 150 of the 260 emergency medical service (EMS) agencies that participate in the ROC. One cohort of patients was randomized to a brief strategy (30–60 sec) of cardiopulmonary resuscitation (CPR) before the first analysis of rhythm by electrocardiogram (ECG). The second cohort of patients was assigned to a longer period of CPR (180 sec) before having the initial ECG. The primary outcome was survival to hospital discharge with satisfactory functional status, and secondary outcomes were survival to discharge, survival to hospital admission, and return of spontaneous circulation upon arrival at an ER. Of the 9933 patients, 5290 were assigned to the strategy of brief CPR with early ECG, and 4643 were assigned to the strategy of longer CPR and later ECG. The lower number of patients in the second group was due to the fact that the data safety monitoring board (DSMB) terminated the trial early because continuing recruitment was unlikely to change the outcome of the study. In the early analysis group, 310 patients (5.9%) met the criteria for primary outcome, and in the later analysis group, 273 (5.9%) met that criteria, with a cluster-adjusted difference of -0.2 percentage points (95% confidence interval [CI] -1.1 to 0.7; P=0.59). No difference in outcome was found between the two options, and there was no survival benefit for either study group.

In an effort to improve venous return and cardiac output during CPR, an impedance threshold device (ITD) was used in this trial [3] to increase the degree of negative intrathoracic pressure. The trial was conducted concurrently with the aforementioned ROC PRIMED trial, with many patients enrolled simultaneously in both trials. The patients had nontraumatic, out-of-hospital cardiac arrest. A total of 8718 were included, and 4345 were randomly assigned to treatment with a sham ITD and 4373 were randomized to treatment with an active ITD. Primary outcome was survival to hospital discharge with satisfactory functional status, and secondary outcomes were return of spontaneous circulation on arrival at the ER, survival to hospital admission, and survival to hospital discharge. In the sham ITD group, 6%, or 260 patients, met the primary outcome, with 5.8%, or 254 patients, in the active group meeting primary outcome (risk difference adjusted for sequential monitoring, -0.1 percentage points; 95% CI -1.1 to 0.8; P=0.71). In addition, there were no significant differences in secondary outcomes. Use of the ITD did not result in increased survival for patients.

In the accompanying Editorial [1], the author stated that although the studies were well planned and well performed, there were several clinical issues that negatively impacted their effectiveness. One of the issues he raised involved the question of whether or not any CPR at all should be applied prior to rhythm analysis. Another issue involved the fact that the many problems of dealing with patients having an out-of-hospital cardiac arrest make any trial problematic, and it could be that a randomized controlled trial is not the best way to improve the management of such patients. In recent years, deviations from standard guidelines for treatment of patients with out-of-hospital cardiac arrest have been developed and implemented, and the published results showed improvements in the rate of survival.

[1] Sanders AB. Cardiac arrest and the limitations of clinical trials. N Engl J Med 2011;365:850-1

[2] Stiell IG, Nichol G, Leroux BG, et al. Early versus later rhythm analysis in patients with out-of-hospital cardiac arrest. N Eng J Med 2011;365:787-97

[3] Aufderheide TP, Nichol G, Rea TD, et al. The trial of an impedance threshold device in out-of-hospital cardiac arrest. N Eng J Med 2011;365:798-806

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An inflammatory disease of the arteries, atherosclerosis, leads to myocardial infarction (MI) and stroke, and researchers have long recognized the need to impede the formation and growth of atherosclerotic plaques before they rupture. Biomarkers that predict the progression of the disease have been identified, and the biomarker, adipocyte fatty acid binding protein (FABP4), has been associated with the progression of atherosclerosis in animal studies. Because human studies are lacking, the authors of this study [1] investigated FABP4 in carotid atherosclerotic lesions as related to systemic plaque composition and future adverse events. From 591 patients undergoing carotid endarterectomy, atherosclerotic plaques were obtained and analyzed to determine the composition of macrophages, lipid core, smooth-muscle cells, collagen, calcification, and intraplaque hemorrhage. The patients had a 3-year follow-up. Primary outcome was any vascular event or intervention, such as death of presumed vascular origin, non-fatal stroke, non-fatal MI, or any other unplanned vascular surgery or intervention.

The investigators found that in patients with increased FABP4 plaque levels, there was a two-fold increased risk [hazard ratio (HR) 1.99, 95% confidence interval (CI) 1.30–3.04, P=0.005] to reach primary outcome during follow-up.

The investigators concluded that FABP4 levels in carotid atherosclerotic specimens were associated with unstable atherosclerotic plaques, but the study needs to be reproduced in a similar cohort of patients by other investigators in order to determine the predictive clinical value of the presence of FABP4 in human atherosclerotic plaques.

[1] Peeters W, de Kleijn DPV, Vink A, et al. Adipocyte fatty acid binding protein in atherosclerotic plaques is associated with local vulnerability and is predictive for the occurrence of adverse cardiovascular events. Eur Heart J 2011;32:1758-68

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Results reported here were of a retrospective cohort study that was conducted by investigators to compare the incidence of cardiovascular-related hospitalization and death in patients treated for cancer by hematopoietic stem cell transplantation (HSCT) with the general population [1]. The cohort included 1491 patients who had survived two-years after HSCT with no recurrent cancer, and the comparison cohort was comprised of frequency-matched individuals who were randomly selected from drivers’ license files in Washington state.

As the use of HSCT increased in the treatment of cancer and non-malignant conditions, physicians began to recognize that HSCT recipients were at greater risk for cardiovascular-related hospitalization and death (adjusted incidence rate difference, 3.6 per 1000 person-years [95% confidence interval (CI) 1.7–5.5]). When compared to the general population, HSCT recipients’ estimated standardized mortality ratios ranged from 1.4 to 2.3. HSCT patients were also at greater risk for ischemic heart disease, heart failure, vascular disease, including stroke, and for more serious conditions, such as dyslipidemia, hypertension, and diabetes. Additionally, patients who had experienced a relapse of their disease had increased hazards of cardiovascular death (HR 2.3 [CI 1.1–4.8]) and heart failure (HR 1.9 [CI, 1.1–3.3]). There was no significant difference between HSCT patients who received autologous versus allogenic cells, except for an increase in hypertension in patients who had received allogenic HSCT.

The investigators believe that their findings emphasize the need for physicians to be aware of the strong possibility of increased rates of cardiovascular mortality and morbidity for HSCT recipients.

[1] Chow EF, Mueller BA, Baker S, et al. Cardiovascular hospitalizations and mortality among recipients of hematopoietic stem cell transplantation. Ann Intern Med 2011;155:21-32

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The Bone Marrow in Acute Myocardial Infarction (BONAMI) trial was conducted between December 2004 and April 2009, and the results of the study are reported in an issue of the European Heart Journal [1]. Results of earlier studies have shown that injection of autologous bone marrow cells (BMCs) in patients after acute myocardial infarction (AMI) led to improved cardiac function as assessed by left ventricular ejection fraction (LVEF). These investigators conducted the BONAMI trial in order to also evaluate the effect of BMC therapy on myocardial viability.

The primary endpoint was improved myocardial viability 3 months after ST-elevation MI (STEMI), as evaluated by thallium scintigraphy. Secondary endpoints were evaluation of LVEF by radionuclide ventriculography at 3 and 12 months, and by echocardiography at 3, 6 and 12 months. Segmental LVEF and myocardial viability were evaluated by MRI at 3 months.

After having had AMI and successful percutaneous coronary intervention, 101 patients with LVEF ≤ 45% and decreased myocardial viability were randomized to either a control group (n=49) or a BMC group (n=52). The control group received optimal medical treatment, and the BMC group received optimal medical treatment plus an injection of autologous BMCs. Myocardial viability improved in 34% (n=16) of the patients in the BCM group and 16% (n=7) of the patients in the control group (P=0.06). The number of non-variable segments becoming variable was 0.8±1.1 in the control group and 1.2±1.5 in BCM group (P=0.13). Multivariate analysis showed significant improvement of myocardial variability in the BCM group vs. control group (P=0.03), as well as a significant adverse role for active smoking (P=0.04).

An editorial by Stefan Janssens [2] reported on the BONAMI trial, as well as on the “Intracoronary infusion of mononuclear cells from bone marrow or peripheral blood compared with standard therapy in patients after acute myocardial infarction treated by primary percutaneous coronary intervention: HEBE” trial [3]. The HEBE did not have the same positive results regarding the efficacy of BMC therapy, primarily due to differences in the trials themselves, but the editorialist believed that both trials indicated the need for large-scale, clinical-outcome studies that are adequately powered to show if there is a significant reduction in the combined endpoints of death, recurrent MI, and hospital admission for heart failure.

[1] Roncalli J, Mouquet F, Piot C, et al. Intracoronary autologous mononucleated bone marrow cell infusion for acute myocardial infarction: results of the randomized multicenter BONAMI trial. Eur Heart J 2011;32:1748-57

[2] Janssens SP. Cardiac bone marrow cell therapy: the proof of the pudding remains in the eating. Eur Heart J 2011;32:1607-700

[3] Hirsch A, Nijveldt R, van der Vleuten PA, et al. Intracoronary infusion of mononuclear cells from bone marrow or peripheral blood compared with standard therapy in patients after acute myocardial infarction treated by primary percutaneous coronary intervention: HEBE trial. Eur Heart J 2011;32:1736-47

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Although the role of infection and atherosclerosis has been studied for many years, and infectious organisms have been scrutinized regarding their involvement in the pathogenesis of atherosclerosis, trials using antibiotic therapy have not been conclusive in showing a clinical benefit. The investigators of the trial results reported here conducted the study to evaluate the effects of the influence vaccine on cardiovascular outcomes in acute coronary syndrome (ACS) patients [1].

The study was a prospective randomized open with blinded endpoint (PROBE) study, and included 439 patients who had been admitted to the hospital with ACS within 8 weeks who were randomly assigned to receive inactivated influenza vaccine in the vaccine group or no treatment in the control group. All patients were treated with standard medical therapy for ACS patients. For hospitalization with ACS, the patients had acute ST-segment elevation myocardial infarction (STEMI), non ST-segment elevation myocardial infarction (NSTEMI), or unstable angina (UA). Heart failure was defined a patient having clinical signs or symptoms requiring intravenous diuretics, and for stroke, the definition was sudden onset of neurological deficit. The primary endpoint included a combination of hospitalization for ACS, heart failure, stroke, and death. It occurred less frequently in the vaccine group than in the control group (9.5 vs. 19.3%, unadjusted hazard ratio [HR] 0.70 (0.57–0.86), P=0.004). In the incidence of cardiovascular death, there was no difference between the vaccine and control group (2.3 vs. 5.5%, unadjusted HR 0.39 [0.14–1.12], P=0.088). Investigators concluded the influenza vaccine should be encouraged for secondary prevention in this patient cohort.

In an editorial published with this article [2], the authors stated that although the study was a significant contribution to the understanding of infectious illness and its relationship to atherosclerotic cardiovascular disease, additional studies need to be conducted to determine whether or not to vaccinate against a heart attack.

[1] Phrommintikul A, Kuanprasert S, Wongcharoen W, et al. Influenza vaccination reduces cardiovascular events in patients with acute coronary syndrome. Eur Heart J 2011;32:1730-5

[2] Natarajan P, Cannon CP. Myocardial infarction vaccine: evidence supporting the influenza vaccine for secondary prevention. Eur Heart J 2011;32:1701-3

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A randomized clinical trial has been needed for a decade to help determine whether coronary artery bypass surgery (CABG) or percutaneous coronary intervention (PCI) yields better outcomes in patients with unprotected left main coronary artery disease. During this time, concerns have centered around the fact that of the two procedures, angioplasty is less invasive and has a shorter recovery time, requires more repeat procedures than CABG, and is also less effective in treating patients with multivessel disease. In an effort to address the concerns, investigators conducted the Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stents in Patients with Left Main Coronary Artery Disease (PRECOMBAT) trial [1].

PRECOMBAT was a prospective, open-label, randomized trial at 13 sites in Korea where 600 patients with unprotected left main coronary artery stenosis were randomized to receive either CABG (300 patients) or PCI (300 patients). The primary end-point was a composite of major adverse cardiac or cerebrovascular events, including death from any cause, myocardial infarction (MI), stroke, and ischemia-driven target-vessel revascularization (TVR) for a 12 month period. Secondary end-points included the primary end-points, as well as the composite of death, MI, stroke, or stent thrombosis. Statistical analysis was a comparison of noninferiority between the two treatments with regard to the primary end-point.

The data showed that the rates of major adverse cardiac or cerebrovascular events were similar in the two groups and that the criteria for noninferiority was met. In the PCI group, the primary end-point occurred in 26 of the 300 patients as compared with 20 of the 300 patients in the CABG group (cumulative event rate, 8.7% vs. 6.7%; absolute risk difference, 2.0 percentage points; 95% confidence interval [CI], -1.6 to 5.6; P=0.01 for noninferiority). However, a significant difference was found in the rates of TVR at 24 months. TVR occurred in 26 patients in the PCI group and 12 patients in the CABG group (cumulative event rate 9.0% vs. 4.2% hazard ratio, 2.18; 95% CI, 1.10–4.32; P=0.02). Because the noninferiority margin was wide, the results cannot be considered a clinical recommendation.

The Journal of the American Medical Association published an interesting overview in the Medical News & Perspective section of the journal regarding the use of drug-eluting stents (DESs) [2]. As the use of DESs increases, making them the device preferred by interventional cardiologists when performing PCIs for treating patients with cardiovascular disease, there are reports from critics who are concerned that the devices are being used inappropriately. At the April 2011 Scientific Sessions of the American College of Cardiology in New Orleans, investigators of several late-breaking clinical trials on the use of DESs reported positive results, and in 75–80% of angioplasty procedures, DESs are used. The author of this piece reported on new types of DESs that have been compared to each other in recently published articles. In contrast, Dr. Rita Redberg, professor of medicine at the University of California, San Francisco and editor of Archives of Internal Medicine, expressed her opinion regarding the use of optimal medical therapy instead of the more-invasive PCI in the following quote, “Why are we still using so many stents when they are not preventing heart attacks or helping people live longer compared with medical therapy.” Dr. John Spertus, professor of medicine at the University of Missouri in Kansas City and who volunteers for the National Cardiovascular Data Registry (NCDR), helped to compile data on appropriate-use criteria. His hope is that the NCRD can provide information to physicians to help them evaluate the appropriate treatment for their patients from the choices available.

[1] Park S-J, Kim Y-H, Park D-W, et al. Randomized trial of stents versus bypass surgery for left main coronary artery disease (PRECOMBAT). N Engl J Med 2011;364:1718-27

[2] Mitka, M. Researchers praise drug-eluting stents but appropriate use is still debated. JAMA 2011;305:2052-3

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