MD Conference Express ESC 2012 - (Page 25)
Kaplan-Meier Event Rates at 2 Years
of the prespecified subgroup in 7187 patients with STEMI in that trial. Effective long-term anticoagulant therapy has been of particular interest in this subpopulation because of prior studies that demonstrated an increase in thrombin production that lasted several months after STEMI. The patients were randomly assigned to treatment with rivaroxaban at 2.5 mg BID (n=2601) or 5 mg BID (n=2584) or to placebo (n=2632). The patients received thienopyridine at the physician’s discretion, as well as aspirin at a dose of 75 to 100 mg QD. The primary efficacy endpoint was a composite of CV death, MI, or stroke, and the primary safety endpoint was TIMI major bleeding not associated with coronary artery bypass grafting. The primary efficacy endpoint occurred in significantly fewer patients in both rivaroxaban groups (Figure 1). The benefit of rivaroxaban was apparent as early as 30 days— 1.7% in the combined rivaroxaban groups compared with 2.3% in the placebo group (HR, 0.71; 95% CI, 0.51 to 0.99; p=0.042 for the intention to treat group). When each rivaroxaban group was compared with placebo, both were associated with a lower rate of the primary efficacy endpoint: 10.6% for placebo versus 8.7% for the 2.5 mg group (p=0.047) versus 8.2% for the 5 mg group (p=0.051). However, only the lower dose was associated with a significantly lower rate of CV death: 4.2% for placebo versus 2.5% for the 2.5 mg group (p=0.006) versus 4.0% for the 5 mg group (p=0.64). Figure 1. Cardiovascular Death, MI, or Stroke.
10.6%
Figure 2. Other Safety Endpoints.
Placebo Rivaroxaban 2.5 mg BID Rivaroxaban 5 mg BID
7% 6% 5% 4% 3% 2% 1% 0%
1.08% 0.12% 0.04% 0.40% 2.46% 2.5 mg vs 5 mg p=0.019 4.51% 2.5 mg vs 5 mg p=0.018
Non-CABG TIMI Major or Minor Bleeding
Fatal Bleeding
2.5 mg vs Placebo p<0.001 5 mg vs Placebo p<0.001
2.5 mg vs Placebo p=0.33 5 mg vs Placebo p=0.12
CABG=coronary artery bypass graft; TIMI=thrombolysis in myocardial infarction. Reproduced with permission from J. Mega, MD, MPH.
Dr. Mega and colleagues concluded that treatment with rivaroxaban 2.5 mg BID offers an effective strategy to reduce thrombotic events in patients following STEMI.
Ivabradine Effect on Recurrent Hospitalization for HF
Written by Lori Alexander
10%
ITT: HR 0.81 (95% CI, 0.67-0.97) p=0.019
Placebo
n=2599
Cardiovascular Death, MI or Stroke
8.4%
8%
6%
Rivaroxaban
n=5128
4%
2%
mITT: HR 0.85 (95% CI, 0.70-1.03) p=0.09
0%
0
90
180
270
360 Days
450
540
630
720
ITT=intention to treat; MI=myocardial infarction; mITT=modified ITT. Reproduced with permission from J. Mega, MD, MPH.
The primary safety endpoint was significantly increased in both rivaroxaban groups, with rates of 1.7% (2.5 mg group), 2.7% (5 mg group), and 0.6% (placebo; p<0.001 for comparison of either dose with placebo; Figure 2). However, fatal bleeding was not significantly increased with rivaroxaban: 0.12% (placebo) versus 0.04% (2.5 mg rivaroxaban; p=0.33) versus 0.40% (5 mg rivaroxaban; p=0.12).
The Systolic Heart Failure Treatment with the If Inhibitor Ivabradine Trial [SHIFT] was a randomized, doubleblind, placebo-controlled trial in 6505 patients with moderate to severe chronic heart failure (HF), which tested whether isolated heart rate reduction with the If inhibitor ivabradine improves cardiovascular (CV) outcomes [Swedberg K et al. Lancet 2010]. Inclusion criteria included hospitalization for worsening HF within 12 months prior to randomization, left ventricular ejection fraction (LVEF) ≤35%, sinus rhythm and heart rate ≥70 beats per minute (bpm), and current treatment with guidelines-based background HF therapy, including maximized b-blockade. Ivabradine was significantly better than placebo for the primary endpoint of CV death or hospitalization for worsening HF, with an 18% reduction in the cumulative frequency of events (HR, 0.82; 95% CI, 0.75 to 0.90; p<0.0001). Ivabradine versus placebo also reduced the rate of hospitalization for HF by 26% (HR, 0.74; 95% CI, 0.66 to 0.83; p<0.0001). Since a significant proportion of healthcare resource and economic burden is attributable to recurrent hospitalization in patients with HF, the aim of the current analysis presented by Jeffrey S. Borer, MD, State University of New York Downstate Medical Center, Brooklyn and New York, New York, USA, was to assess the effect of treatment with ivabradine on
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Table of Contents for the Digital Edition of MD Conference Express ESC 2012
MD Conference Express ESC 2012
Contents
ESC 2012 Clinical Practice Guidelines
TAVI: 10 Years After the First Case
PARAMOUNT Trial Results
TRILOGY ACS Outcomes
Results from the ALTITUDE Trial
Results of the WOEST Trial
Results from the Aldo-DHF Trial
FAME 2 Results
Results from the IABP-SHOCK II Trial
STEMI Mortality Decreases in France While Some Key Risk Factors Increase
Results from the PURE Study
PURE: Treatment and Control of Hypertension
Genetic Determinants of Variability in Dabigatran Exposure
The RE-LY AF Registry
TRA 2°P-TIMI 50 Results
Rivaroxaban of Benefit in STEMI: ATLAS ACS 2-TIMI 51
Ivabradine Effect on Recurrent Hospitalization for HF
CLARIFY: Similar 1-Year Outcomes for Men and Women with Stable CAD
HPS2-THRIVE Study Results
PRoFESS Study Results
Outcomes from the CARDia Trial
Hypertension
Atrial Fibrillation
Heart Failure
MD Conference Express ESC 2012
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