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Lo más relevante del 2014: Cardiólogo clínico
Francisco Martín Herrero
Complejo Asistencial
Universitario Salamanca
CVT- 27/11/2014
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AML
Trial Design
Type 2 DM and recent Acute Coronary Syndrome
(STEMI, NSTEMI or UA)
Event Driven – 950 positively-adjudicated 1o Endpoint events Anticipated ~2.5 years follow-up
Study visits: 1, 3, 6, 9, 12 mos, then alternative visits and phone q3 mos
N ~ 7000 Patients Randomized
Double blind, 1:1 Ratio
Up to 12 weeks after index event
Aleglitazar
150 mg/day in morning Placebo
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AML
Glycemic Control and Lipids
Mean value at baseline, (%)
Placebo: 7.8
Aleglitazar: 7.8
Mean value at baseline, (%)
Placebo: 7.8
Aleglitazar: 7.8
HbA1C
Mean value at baseline, (mg/dL)
Placebo: 154
Aleglitazar: 152
Mean value at baseline, (mg/dL)
Placebo: 154
Aleglitazar: 152
Triglycerides
Mean value at baseline, (mg/dL)
Placebo: 41.8
Aleglitazar: 42.2
Mean value at baseline, (mg/dL)
Placebo: 41.8
Aleglitazar: 42.2
HDL-C
Mean value at baseline, (mg/dL)
Placebo: 79.7
Aleglitazar: 78.9
Mean value at baseline, (mg/dL)
Placebo: 79.7
Aleglitazar: 78.9
LDL-C
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AML
Primary Efficacy Endpoint
Placebo 3610 3394 3252 2720 1706 773 118
Aleglitazar 3616 3387 3249 2731 1688 780 101
No. at risk:
HR = 0.96 (95% CI, 0.83-1.11)
p = 0.57
Cardiovascular Death, Non-Fatal MI, Non-Fatal Stroke
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AML
Heart Failure/Fluid Retention
Body Weight
4.6 kg vs. 0.9 kg, P <0.001
Hospitalization for HF
HR = 1.22 (95% CI, 0.94-1.59)
p = 0.14
Heart Failure Serious Adverse Event:
Aleglitazar 4.7% vs Placebo 3.8%, HR 1.24; 95% CI 0.99 to 1.66, P
= 0.06
Peripheral Edema:
Aleglitazar 14.0% vs Placebo 6.6%, P
<0.001
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Undetectable High Sensitivity Cardiac Troponin T Level in the Emergency Department and Risk of Myocardial Infarction
Nadia Bandstein, MD; Rickard Ljung, MD, PhD; Magnus Johansson, MD, PhD; Martin Holzmann, MD, PhD.
Department of Emergency Medicine
Karolinska University Hospital and Karolinska Institute
Stockholm, Sweden
Late Breaking Clinical Trial, ACC.14, Washington
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Hypothesis
All patients with chest pain, who have an undetectable high-sensitivity cardiac troponin T (< 5 ng/l), and an ECG without signs of ischemia, may be discharged directly from the emergency department (ED), since their risk of MI within 30 days is minimal.
Nadia Bandstein, M.D.
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330 000 ED visits / 2 years
n=14 636 (4,4%)
Hs-cTnT
< 5 ng/L
61%
Admitted
21%
Discharged
79%
5 – 14 ng/L
21%
Admitted
44%
Discharged
56%
> 14 ng/L
18%
Admitted
82%
Discharged
18%
Study period
2010 - 2012
Age > 25, chest pain,
hs-cTnT analyzed
Study population
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High-Sensitivity Cardiac Troponin T level (ng/L)
<5 5-14 >14
Myocardial infarction 30 days
Number of events 15 97 676
Negative pred. val. 99,8 (99,7-99,9) 96,9 (96,3-97,5) 73,8 (72,1-75,5)
365 days
Number of events 54 134 753
Negative pred. val. 99,4 (99,2-99,5) 95,7 (95,0-96,5) 70,8 (69,0-72,6)
Risk of Myocardial Infarction
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Characteristics of Stable versus Ruptured Plaques
Stable Plaque
Low Lp-PLA2 content (dark staining)
May have significant stenosis
Thick fibrous cap / high collagen
content
Modest lipid pool
Few inflammatory cells
Ruptured Plaque
High Lp-PLA2 content (dark staining)
May have minimal stenosis
Thin fibrous cap / low collagen
content
Large lipid pool
Many inflammatory cells
Modest Lipid Pool Large Lipid Pool
Lp-PLA2 Lp-PLA2
Thin Fibrous Cap Thick Fibrous Cap
Lumen Lumen
Corson et al. Am J Card 2008;101(Suppl):41F-50F
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Administration of Ticagrelor in the cath Lab or in the Ambulance for New ST elevation myocardial Infarction to
open the Coronary artery
G. Montalescot, COI are available at www.action-coeur.org
G. Montalescot, A.W. van’t Hof, F. Lapostolle, J Silvain, J.F. Lassen, L. Bolognese, W.J. Cantor, A. Cequier, M. Chettibi, S.G. Goodman, C.J. Hammett, K. Huber, M. Janzon,
B. Merkely, R.F. Storey, U. Zeymer, O. Stibbe, P. Ecollan, W.M.J.M. Heutz, E. Swahn, J.P. Collet, F.F. Willems, C. Baradat, M. Licour, A. Tsatsaris, E. Vicaut, C.W. Hamm,
for the ATLANTIC investigators
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Study population and design
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Median times to pre- and in-hospital steps
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1st Co-primary endpoint No ST-segment resolution (≥70%)
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2nd Co-primary endpoint No TIMI 3 flow in infarct-related artery
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Major adverse CV events up to 30 days
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Definite stent thrombosis up to 30 days
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Non-CABG-related bleeding events (PLATO definitions) - Safety population
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Matthew W Sherwood, Hussein R Al-Khalidi, James G Jollis,
Mayme L Roettig, Peter B Berger, Claire C Corbett,
Harold L Dauerman, Kathleen Fox, J Lee Garvey,
Timothy D Henry, Ivan C Rokos, B Hadley Wilson,
Christopher B. Granger for the Accelerator Project
Final Results of the Regional Systems of Care
Demonstration Project: Mission: Lifeline™
STEMI Accelerator Study
Regional Systems of Care Demonstration Project
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All Rights Reserved, Duke Medicine 2007
Atlanta
Tampa
Kern County
Colorado Front Range St. Louis
Wilkes-Barre/
Scranton
New York City
Columbus Philadelphia
Louisville
Northern New Jersey
Hartford
San Antonio
Houston
Pittsburgh
Oklahoma
16 regions
484 hospitals
1,253 EMS agencies
Intervention Sites
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All Rights Reserved, Duke Medicine 2007
ED time and Risk-adjusted in-hospital mortality Direct EMS patients
n=4939 n=3054
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All Rights Reserved, Duke Medicine 2007
In hospital mortality (rolling 12 months)
Accelerator
National
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Patients stabilized post ACS ≤ 10 days: LDL-C 50–125*mg/dL (or 50–100**mg/dL if prior lipid-lowering Rx)
Standard Medical & Interventional Therapy
Ezetimibe / Simvastatin
10 / 40 mg
Simvastatin
40 mg
Follow-up Visit Day 30, every 4 months
Duration: Minimum 2 ½-year follow-up (at least 5250 events)
Primary Endpoint: CV death, MI, hospital admission for UA,
coronary revascularization (≥ 30 days after randomization), or stroke
N=18,144
Uptitrated to
Simva 80 mg
if LDL-C > 79
(adapted per
FDA label 2011)
Study Design
*3.2mM
**2.6mM
Cannon CP AHJ 2008;156:826-32; Califf RM NEJM 2009;361:712-7; Blazing MA AHJ 2014;168:205-12
90% power to detect
~9% difference
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LDL-C and Lipid Changes
1 Yr Mean LDL-C TC TG HDL hsCRP
Simva 69.9 145.1 137.1 48.1 3.8
EZ/Simva 53.2 125.8 120.4 48.7 3.3
Δ in mg/dL -16.7 -19.3 -16.7 +0.6 -0.5
Median Time avg
69.5 vs. 53.7 mg/dL
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Primary Endpoint — ITT
Simva — 34.7%
2742 events
EZ/Simva — 32.7%
2572 events
HR 0.936 CI (0.887, 0.988)
p=0.016
Cardiovascular death, MI, documented unstable angina requiring
rehospitalization, coronary revascularization (≥30 days), or stroke
7-year event rates
NNT= 50
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39
Muchas Gracias
por vuestra
atención