Cómo trasladar las nuevas evidencias en Cardiopatía Isquémica a la vida real

Tratamiento médico de la angina en diabéticos
José López-Sendón
Hospital Universitario La Paz. Idipaz
Madrid. Spain
Cambios en el paradigma del tratamiento de la
cardiopatía isquémica
Cómo trasladar las nuevas evidencias en Cardiopatía Isquémica
a la vida real

ACS. An Extraordinary Journey
Innovation Year Impact
CCU ¨Blue Code¨. Nurses 60´ & 70´ Mortality
B-Blockers 70´ Mortality
Thrombolysis 80´ Mortality
ASA 80´ Mortality
1º PCI 90´ Mortality
Statins Late 90´ Mortality
ASA+Clopi Late 90´ Morbidity
Better anticoagulation 00´ Morbi-mortality
Prasugrel, Ticagrelor 00´ Morbi-mortality
Team Work, STEMI code 00´ Mortality?
Hypothermia 10´ Mortality?
30
%
5%

Cambios de paradigma
1. Angina estable  Revascularizar a todos?
2. Fin de los betabloqueantes en CI crónica sin IC?
3. Colesterol: cuanto mas bajo mejor!
4. Nuevos antitrombóticos en SCA
5. Ticagrelor en cardiopatía isquémica crónica
6. Prevención de riesgo: es cosa de todos!

Treatment
Chronic, Stable
CAD
Life Style
Medical Therapy Revascularization

2665 Enrolled
1550 Randomized
178 Pending Confirmation of Eligibility
Insufficient ischemia = 332/2665 (12.5%)
Left Main disease = 170/17321 (9.8%)
No obstructive disease = 259/17321 (15.0%)
As of 3/24/15
Incidental Findings = 7/17321 (0.4%)
Other = 169/2665 (6.3%)
1 Denominator = CCTA screened

Stergiopolus et al. JAMA Int Med 2013
Revascularización vs Tratamiento Médico en Angina Estable

¿Como trasladar la nueva evidencia?
• Nuevos estudios, se necesita más evidencia

Blinded CCTA1
Core lab anatomy eligible?2
RANDOMIZE
Late screen failure
INVASIVE Strategy
OMT3 + Cath +
Optimal Revascularization
CONSERVATIVE Strategy
OMT3 alone
Cath reserved for OMT failures
Stable Patient
Moderate or Severe Ischemia
no
yes
1CCTA will be performed in all patients with eGFR >60 mL/min
2Exclude patients with LM disease or no obstructive disease
3OMT=Optimal medical therapy
Average 4 Years of Follow-up
Primary Endpoint: Composite of CV Death and MI

Bangalore S et al. Circ Cardiovasc Qual Outcomes. 2014;7
Primary Outcome
Composite of CV Death, Nonfatal MI, or Stroke
Prior MI

Primary Outcome
Composite of CV Death, Nonfatal MI, or Stroke
Known CAD
Bangalore S et al. Circ Cardiovasc Qual Outcomes. 2014;7

• Ineffective reduction of central aortic pressures
• Adverse metabolic profile
– New onset diabetes
– Hypercholesterolemia
– Weight gain
• Potential interaction with statins
• Side effects and poor compliance
Why are Beta Blockers not effective?

• Educación
• Reforma de guías práctica clínica

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

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

Medical treatment. Ranolazine
Drug Function Benefit
HMG CoA
reductase inh.
Decreases LDL Benefit, limited LDL
lowering
CETP inh. Increases HDL Failure
LP-PLA2 inh. Reduces plaque inflammation Failure
VIA-2291 Reduces plaque inflammation Failure
PPAR (fibrates) Reduces triglycerides Failure Limited benefit
Nicotinic acid Redudes LDL Failure
Cholesterol
absortion inh.
Impairs cholesterol absorption Benefit
MAPK Inh. Reduces plaque inflammation Ongoing
Apo A-1 Milano Arginine -> cysteine mutation in Apo A-1 Ongoing
i-PCSK9 Ultra-lowering of LDL Ongoing
Medical Treatment of Dyslipemia
J Lopez-Sendon 2014

• Se necesitan más estudios con los nuevos fármacos
• Educación
• Aplicación de guías práctica clínica

Recent ACS

Placebo
0 24
Rivaroxaban
2.5 mg BID
All Cause Death
0 24
Cardiovascular Death
Months
CV Death / MI / Stroke
EstimatedCumulativeincidence(%)
0 24
Months Months
HR 0.85
mITT
p=0.039
ITT
p=0.011
HR 0.62
mITT
p<0.001
ITT
p<0.001
2.7%
4.5%
4.2%
2.5%
10.4%
9.0%
Rivaroxaban
2.5 mg BID
Rivaroxaban
2.5 mg BID
PlaceboPlacebo HR 0.64
mITT
p<0.001
ITT
p<0.001
NNT = 56NNT = 71 NNT = 59
12 12 12
12%
5% 5%
EFFICACY ENDPOINTS:
Very Low Dose 2.5 mg BID
Patients Treated with ASA + Thienopyridine
N Engl J Med 2012;366:9-19.
Recent ACS

• Aprobación agencias reguladoras
• Inclusión en guías práctica clínica

An Academic Research Organization of
Brigham and Women’s Hospital and Harvard Medical School
Months from Randomization
Ticagrelor 60 mg
HR 0.84 (95% CI 0.74 – 0.95)
P=0.004
CVDeath,MI,orStroke(%)
3 6 9 120 15 18 21 24 27 30 33 36
Ticagrelor 90 mg
HR 0.85 (95% CI 0.75 – 0.96)
P=0.008
Placebo(9.0%)
Ticagrelor 90 (7.8%)
Ticagrelor 60 (7.8%)
Primary Endpoint
6
5
4
3
10
9
8
7
2
1
0
N = 21,162
Median follow-up 33 months

• Aprobación agencias reguladoras
• Inclusión en guías práctica clínica
• Financiación

Who is responsible for
Cardiovascular Disease Prevention & Treatment?
Who What
Cardiologist, other
physicians
• Identification of candidates for therapy
• Appropriate therapies

Who is responsible for
Cardiovascular Disease Prevention & Treatment?
Who What
Cardiologist, other
physicians
• Identification of candidates for therapy
• Appropriate therapies
Health Authorities • Health care policy
Health care providers • Availability of therapies (reimbursment)
Educators • Life style
Legislators • Health care legislation
Families • Life stile, medicacions
The Patient • Follow instructions
• Life style

Cómo trasladar las nuevas evidencias en Cardiopatía Isquémica a la vida real

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Cómo trasladar las nuevas evidencias en Cardiopatía Isquémica a la vida real