Race Ii Trial

[Ermengardi Atkisson]

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Background: This study was conducted to compare rate- and rhythm-control therapy in patients with persistent atrial fibrillation (AF) and mild to moderate chronic heart failure (CHF). Rate control is not inferior to rhythm control in preventing mortality and morbidity in patients with AF. In CHF, this issue is still unsettled.

Methods: In this predefined analysis of the RACE study, a total of 261 patients were in New York Heart Association (NYHA) classes II and III at baseline. These patients were analyzed. The primary end point was a composite of cardiovascular mortality, hospitalization for CHF, thromboembolic complications, bleeding, pacemaker implantation, and life-threatening drug side effects. Furthermore, quality of life was compared.

Results: After 2.3 +/- 0.6 years, the primary end point occurred in 29 (22.3%) of the 130 rate-control patients and in 32 (24.4%) of the 131 rhythm-control patients. More cardiovascular deaths, hospitalization for CHF, and bleeding occurred under rate control. Thromboembolic complications, drug side effects, and pacemaker implantation were more frequent under rhythm control. Quality of life did not differ between strategies. In patients successfully treated with rhythm control, the prevalence of end points was not different from those who were in AF at study end. However, the type of end point was different: mortality, bleeding, hospitalization for heart failure, and pacemaker implantation occurred less frequently.

Conclusions: In patients with mild to moderate CHF, rate control is not inferior to rhythm control. However, if sinus rhythm can be maintained, outcome may be improved. A prospective randomized trial is necessary to confirm these results.

Although rate control has been shown to be associated with similar outcomes, as compared with rhythm control in patients with atrial fibrillation (AF), the optimal level of heart rate (HR) control/lowering is unclear. Current guidelines recommend strict rate control, although data to support this approach are lacking. Accordingly, the RACE II trial sought to investigate whether lenient rate control would be noninferior to strict rhythm control in patients with permanent AF.

A total of 614 patients were randomized, 311 to lenient control, and 303 to strict control. Baseline characteristics were fairly similar between the two arms. The resting baseline HR was 96 bpm. The median duration of AF was 18 months, while the median duration of permanent AF was 3 months. About 20% had coexisting valvular heart disease. About 56.7% of these patients had symptomatic AF, and 1.8% had lone AF. The majority of patients had a CHADS2 score of 0 or 1 (60.7%), whereas 13.4% had a CHADS2 score >2.

The mean HR at the end of the dose-adjustment phase was 93 9 bpm in the lenient control group, as compared with 76 12 bpm in the strict control group (p In the subgroup of patients with available echocardiographic data, there were no significant differences in measures of LA or LV remodeling between the two arms at the end of follow-up: change in LA diameter 0.8 vs. -0.8, LA volume 5.0 vs. 1.7, and LVEDD -0.3 vs. 1.4 (p > 0.05 for all). Of the various predictors tested, female gender was noted to be associated with adverse LA and LV remodeling.

Smit MD, Crijns HJ, Tijssen JG, et al., on behalf of the RACE II Investigators. Effect of Lenient Versus Strict Rate Control on Cardiac Remodeling in Patients With Atrial Fibrillation: Data of the RACE II (RAte Control Efficacy in permanent atrial fibrillation II) Study. J Am Coll Cardiol 2011;58:942-949.

Van Gelder CI, Groenveld HF, Crijns HJ, et al. Lenient versus strict rate control in patients with atrial fibrillation. N Engl J Med 2010;Mar 15:[Epub ahead of print].

Presented by Dr. Isabelle C. Van Gelder at the ACC.10/i2 Summit, Atlanta, GA, March 2010.

AFFIRM (2002) suggested a mortality benefit in management of AF with rate control over rhythm control. The 2010 Rate Control Efficacy in Permanent Atrial Fibrillation: a Comparison between Lenient versus Strict Rate Control II (RACE II) trial directly addressed the issue of optimal rate control for patients with permanent AF and found that a lenient rate control strategy (resting HR

Of note, the strict rate control group met their resting targets in 78% of cases (compared to 98% in the lenient rate control group) and required nine times as many visits (684 vs. 75) in order to achieve rate control targets.

Based upon the results of RACE II, very stringent HR control is not necessary in many physically active patients with AF who are minimally symptomatic. A more lenient rate control strategy offers the advantages of less medication and fewer outpatient visits to achieve HR control.

Supported by Netherlands Heart Foundation and unrestricted educational grants from multiple companies, including AztraZeneca, Biotronik, Boehringer Ingelheim, Boston Scientific, Medtronic, Roche, and Sanofi Aventis France.

More recent analyses shed further light on racial justice in pretrial decision-making, even though their samples are not nationally representative. I looked at 16 of these more geographically-limited studies, with subjects ranging from federal drug cases in the Midwest to misdemeanor cases in Harris County (Houston), Texas. In all, they include samples from 11 states spread across the U.S., and major cities including New York City, San Francisco, Philadelphia, and Miami.

Of course, no single estimate of racial disparity in pretrial detention will apply to all counties nationwide. In the studies I reviewed, the racial gap in pretrial detention between Black and white defendants ranges widely, from about 10% to 80% depending on the study and jurisdiction (that is, the county or city).

More humans die in the intensive care unit from sepsis than from any other cause. Death from sepsis is the culmination of widespread hypoperfusion, cellular hypoxia, and multiple organ failure. A growing body of evidence shows that early therapeutic intervention improves outcomes for patients with sepsis. Novel targeted strategies that bolster a strong and durable systemic hemodynamic response have been proven to reduce or even reverse organ dysfunction in patients with sepsis.

The Rapid Administration of Carnitine in sEpsis (RACE) trial has the overall goal to investigate L-carnitine as a novel adjunctive treatment of septic shock. The trial is a phase II, double blinded, placebo controlled, adaptive randomized trial of 250 eligible patients with vasopressor-dependent septic shock. Study subjects will be assigned to one of four arms: low (6g), medium (12g) or high (18g) dose intravenous L-carnitine or placebo for 12 hours as a part of early resuscitative care. Our first aim is to assess whether L-carnitine reduces cumulative organ failure in patients with septic shock.

The first efficacy endpoint of the trial is reduction in cumulative organ failure, defined as a decrease in the sequential organ failure assessment (SOFA) score at 48 hours after treatment. The SOFA data will be used to preferentially allocate subsequent patients to the L-carnitine dose that is most effective. As the trial progresses 28-day mortality data will be used to determine the probability that the dose of L-carnitine associated with the largest decrease in SOFA score would demonstrate efficacy in a subsequent phase III trial. An ancillary aim of the trial is to assess if L-carnitine improves blood flow in the sublingual microvasculature during septic shock. We will use sidestream dark-field video-microscopy imaging of the sublingual microcirculation to directly visualize microcirculatory flow and to determine the effect of L-carnitine and placebo treatment on change in flow.

CRIC researchers found that even when adjusting for a wide range of factors, using serum creatinine to calculate eGFR without using a race term can lead to systematic bias and race-related misclassification of kidney disease status in people tested.

About the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): The NIDDK, a component of the National Institutes of Health (NIH), conducts and supports research on diabetes and other endocrine and metabolic diseases; digestive diseases, nutrition and obesity; and kidney, urologic and hematologic diseases. Spanning the full spectrum of medicine and afflicting people of all ages and ethnic groups, these diseases encompass some of the most common, severe, and disabling conditions affecting Americans. For more information about the NIDDK and its programs, see www.niddk.nih.gov.

About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

The RACE-CARS Trial aims to improve outcomes for out-of-hospital cardiac arrest (OHCA) victims. A cardiac arrest occurs when the heart either stops or has an irregular heartbeat. It is an electrical problem where the heart is not able to pump blood to the rest of the body. This causes the person to become unresponsive and to stop breathing normally (either no breathing or gasping). Cardiac arrest is different from a heart attack. A heart attack is a plumbing (circulation) problem. An artery becomes blocked and oxygen cannot get to the heart. If the artery is not opened quickly, the heart becomes damaged. The longer the delay in treatment, the worse the heart damage.

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