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2nd CUTEHeart Workshop Conclusions

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Main Results and Lessons Learned from the CUTEheart project Mariana F Lobo, Claudia Nisa Leonor Bacelar Nicolau, Elisabete Fernandes
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Page 1: 2nd CUTEHeart Workshop Conclusions

Main Results and Lessons Learned from the CUTEheart project

Mariana F Lobo, Claudia Nisa Leonor Bacelar Nicolau, Elisabete Fernandes

Page 2: 2nd CUTEHeart Workshop Conclusions

To analyze health technology use in hospital managementof coronary heart disease (CHD) focusing on:

Portugal and US health systems

Health technologies diffusion

Clinical effectiveness of CHD treatment

High‐risk patients

Health impact assessment and HTA

MAIN RESEARCH GOALS

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Page 3: 2nd CUTEHeart Workshop Conclusions

Public (PT) vs. Private (US)100% public health insurance (PT) vs. 29% (US)74% (PT) vs. 25% (US) beds per capita in public hospitals

Strikingly high health expenditure in US10.4 (PT) vs. 17.9 (U.S.) % of GDP

Health technologies approval systemCentralized in US vs. Variable in PT (drug type, # countries)Fewer new drug launches and longer launch delays in PTCentralized in US vs. Decentralized in PT35 months faster in EU than US

All‐cause of death (age‐sex‐adjusted)1041 (PT) vs. 1075 (US) per million population

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HEALTH SYSTEMS COMPARED – 2010Background

16% UNINSURED

$$

HEALTH COSTS

Page 4: 2nd CUTEHeart Workshop Conclusions

• Except for hypertension, US > CHD risk factors obesity 71.6% (US) vs. 51.3 % (PT)

• US CHD hospitalizations twice PT435.2 (US) vs. 171.0 (PT) crude hospitalizations

• Large infrastructure differences 60% more diagnostic facilities in US4xmore cardio thoracic wards per capita in US

• US > double CHD‐related death rate but no differences in AMI deaths168.3 (US) vs.  72.8 (PT) age‐sex‐adjusted CHD deaths

HEALTH SYSTEMS COMPAREDCHD epidemiology and patient care

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Page 5: 2nd CUTEHeart Workshop Conclusions

HEALTH TECHNOLOGIES DIFFUSIONMedical devices & Drugs in CHD Treatment

Med

ical Devices

Drugs

Although, most medical devices were approved soonerin PT, at least five devices considered were adopted first or diffused faster in the US

Most drugs were available sooner in the US, despite often approved earlier in PT

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Page 6: 2nd CUTEHeart Workshop Conclusions

Characteristic Portugal United States(20% Sample)

No. Hospitals 83 3863

No. Discharges 123,442 7.2 million

Mean [SD] Age 68 [13] 68 [14]

Emergently Admitted, % 96 84

IN‐HOSPITAL AMI MANAGEMENTPORTUGAL versus US – 2000‐2010 

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Page 7: 2nd CUTEHeart Workshop Conclusions

AMI HOSPITALIZATIONSPORTUGAL versus US – 2000‐2010 

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Page 8: 2nd CUTEHeart Workshop Conclusions

Adjusted Analyses

• Females less likely to get revascularization interventions, regardless of country

• Females 20%more likely to die than males after AMI in Portugal

• % of hospitals with lowrevascularization‐volume higher in PT

• Dramatic between‐hospital heterogeneity in survival in Portugal

In‐hospital Procedures use and outcomes, PT and US

2010 Rate Ratio: Portugal/U.S.

Diagnostic Catheterization 0.88

PCI 1.09

Stenting 0.94

CABG 0.19

Off‐Pump 0.38

Revascularization 0.99 

In‐hospital Mortality 2.14

Length of Stay 50%  > 

CLINICAL EFFECTIVENESS OF CHD TREATMENTIn‐hospital AMI management PORTUGAL versus US – 2000‐2010 

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Page 9: 2nd CUTEHeart Workshop Conclusions

CLINICAL EFFECTIVENESS OF CHD TREATMENTHospital AMI readmission in Portugal – June 1st to November 30th 2012 

Purpose: To characterize acute myocardial infarction (AMI) 

readmissions occurred within 30 days post‐discharge in Portugal

To determine the 30‐day readmission rate

for patients with AMI 

To identify risk factorsassociated with AMI 30‐day 

readmission

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Page 10: 2nd CUTEHeart Workshop Conclusions

30‐Day Readmission Rate (%)

94.4%

5.6%

In‐patients (n=3696)

Patient Inclusion Criteria

• Adults (age ≥ 18 years)• Patients admitted with AMI diagnosis

• Patients with at least one hospitalization

• All unplanned admissions• First admission until  November 30 2012

• Patients alive after their first hospital stay

CLINICAL EFFECTIVENESS OF CHD TREATMENTHospital AMI readmission in Portugal – June 1st to November 30th 2012 

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206 (5.6%) patients were readmitted within 30 days

Page 11: 2nd CUTEHeart Workshop Conclusions

CharacteristicsCrude Odds Ratios 

(95% CI)

DemographicsAge ≥ 65 1.3 (0.9 ‐ 1.7)Male 1.1 (0.7 ‐ 1.4)

Comorbidities

Atherosclerosis 3.3 (2.3 ‐ 4.7)

Hypertension 3.0 (2.1 ‐ 4.3)

Diabetes 1.8 (1.4 ‐ 2.4)

Obesity 1.9 (1.4 ‐ 2.7)

In‐Procedures

Cardiac Catheterization 2.5 (1.8 ‐ 3.4)

PCI 0.8 (0.5 ‐ 1.2)

CABG 2.2 (0.6 ‐ 7.5)

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CLINICAL EFFECTIVENESS OF CHD TREATMENTHospital AMI readmission in Portugal – June 1st to November 30th 2012 

These factors are associated with a higher likelihood of 30‐day 

readmission.

Page 12: 2nd CUTEHeart Workshop Conclusions

HIGH RISK PATIENTSReview of Systematic Reviews of Randomized Controlled Trials

N=45 Diabetes

N=18 Kidney Disease

N=11 Old Age 70+

N=8 Women

N=5 Mixed comorbidities

N=87 Specific to high‐riskpatients

N=759 Meta‐analyses related to CHD treatment

Aim: To summarize the evidence from randomized controlled trials examining CHD treatment in high risk patients

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0

2

4

6

8

10

2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

Num

ber o

f reviews pe

r year Revascularization Medical Therapy

Page 13: 2nd CUTEHeart Workshop Conclusions

REVIEW Included Studies Follow‐up

Mortality MI Repeat revascularization Stroke Potential sources 

of biasFavors Favors Favors Favors

Tu et a 2014

FREEDOM, CARDia, VA 

CARDS, ARTS I & ARTS II, 

ERACI II & III, SYNTAX, 

PRECOMBAT

Min 30 days max 5 

yearsCABG n.s. CABG Not

reported

ARTS II and ERACI III not RCTs Mixing pre‐specified with 

post‐hoc diabetic subgroup analysis

Fanari et al 2014

SYNTAX, FREEDOM, CARDia

Min 1y max 5 y

1y n.s.; 5y CABG

1y n.s.; 5y CABG Not reported DES

Incomplete search; Mixing 

pre‐specified with post‐hoc diabetic subgroup analysis

HIGH RISK PATIENTSInconsistencies identified in the evidence about revascularization strategies

CABG versus PCI 13 Meta‐analyses IdentifiedExample of reviews comparing CABG with drug‐eluting stents

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Page 14: 2nd CUTEHeart Workshop Conclusions

HIGH RISK PATIENTSReassessment of primary trials about revascularization strategies

CABG versus PCI 

2 to 3 years 4 to 5 years Longest follow‐up

13 RCTs included (4372 patients)

Only 6 RCTs with pre‐specified subgroup analysis (46%) for diabetics

Results overall favoring CABG at 5 years only;

Identified only in trials with a pre‐specified subgroup comparison;

Meta‐regression model with dummy for pre‐specification (0=post‐hoc; 1=pre‐specified) not significant but funnel plotsuggests that larger studies with lower variance favor CABG.

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Page 15: 2nd CUTEHeart Workshop Conclusions

assessesproperties, effects, and/or impacts (social, economic, organizational and ethical) of a health intervention or health technology

ofhealth technology (Diagnostic and treatment methods, medical equipment, pharmaceuticals, rehabilitation & prevention methods, but also organisationaland support systems used to deliver healthcare)

to inform a policy decision making

assesseshealth impacts of policies, plans and projects in diverse economic sectors using quantitative, qualitative and participatory techniques

ofpolicies, plans and projects in diverse economic sectors using quantitative, qualitative and participatory techniques, taking equity issues into account (effects on vulnerable or disadvantaged groups)

toproduce recommendations for decision‐makers and stakeholders, to maximize/minimize the proposal's positive/negative health effects

HTA HIA

HEA

LTH TECHNOLO

GY ASSESSM

ENT

HEA

LTH IM

PACT

 ASSESSM

ENT

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Health Technology Assessment & Health Impact AssessmentComplementary approaches

Page 16: 2nd CUTEHeart Workshop Conclusions

Making HIA m

ore qu

antitative 

and ad

ding

 value

 to HTA Screening through policies to select targets 

for assessment: focus policies related with cardiovascular disease that linked hospital 

and primary care

Propose a conceptual quantitative path of analysis to study the association between a 

public policy and health impacts while taking equity into account

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Health Technology Assessment & Health Impact AssessmentComplementary approaches

Page 17: 2nd CUTEHeart Workshop Conclusions

Clusters of policies maybe ranked by differentcombinationsof priorities

The registration of different health indicatorsis not uniform throughoutthe regions which maylead to regional inequities

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Health Technology Assessment & Health Impact AssessmentComplementary approaches

Page 18: 2nd CUTEHeart Workshop Conclusions

Thank you for your attention

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Page 19: 2nd CUTEHeart Workshop Conclusions

LESSONS LEARNED

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Page 20: 2nd CUTEHeart Workshop Conclusions

FUTURE RESEARCHProof of Concept for a Visualization Platform for Evidence Synthesis

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CLINICAL EFFECTIVENESS OF CHD TREATMENT

• PT> double AMI‐related death rate (hospital administrative data) & no statistically significant differences in AMI deaths (vital statistics). (Factors that may explain the differences)

- Population risk profilesHigher STEMI burden in PT- Health technology diffusion ratesLonger delays in adoption of new health technologies in PT, despite an expedite approval system (large infrastructure differences, differences in incidence)- Practice patternsLower procedure utilization rates in PTPT > US between‐hospital variability in survival after controlling for procedure use- Deaths outside the hospital

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