Swedish experiences:

National registries – for quality improvement and research

Stefan James

Professor of Cardiology

Uppsala Clinical Research Centre

Uppsala University Uppsala, Sweden

Registers – self evaluation

Clinical reality

Scientific evidence - Guidelines

Quality development

New treatments - Clinical trials

Diagnostic methods

Basic research

Evidence based health care development

www.ucr.uu.se

Number of cases annually: 80 000

RIKS-HIA 73 CCU hospitals, 100%

SCAAR 30 PCI hospitals, 100%

Percutaneous valves 7 hospitals, 100%

Heart surgery 7 hospitals, 100%

Secondary prevention 65 hospitals, 85%

Cardiogenetic registry New

>200 variables

(Baseline data, procedural and outcome measures)

At monitoring: 95-96% agreement between files and registry.

SWEDE HEART

Data entry on line by the

operator

Automatic linkage with

population registry to provide

name, sex

Automated data checks

Clinical background and prior CV disease

Angiographic background data

Administrative data

Name, personal ID number

Refered from

Date of procedure

Type of registration

Office /call service

Local hospital

Body length

Body length (cm)

S-creatinine (ug/L

Creatinine clearance (ml/min)

Prior PCI

Prior CABG

Diabetes

Smoking

Auto populated fields from

previous registrations

Calculated variables

History is presented and all previously

implanted stents have to be checked

To staffTo business developer

Feedback

To patients

To the public

Quality indikator 0,5 points 1 points

Reperfusion for STEMI/LBBB. 80% 85%

Reperfusion for STEMI/LBBB within

recommended time (PCI within 90 min and

thrombolysis within 30 min)

75% 90%

Coronary angiogram for target

population with NSTEMI

75% 80%

LMW Heparin/ Heparin/

Fondaparinux for NSTEMI

90% 95%

ASA, other platelet inibitor or

anticoag for MI

90% 95%

P2Y12-blocker for NSTEMI 85% 90%

Betablocker for MI. 85% 90%

Lipid lowerer post MI 90% 95%

ACEinh/ARB for target population

post MI.

85% 90%

SWEDE HEARTRIKS-HIA quality index

RIKS-HIA Quality Index

2005 20102014

Larsson et al. Health Affairs 2012; 31(1)

Association to start of public reporting

RIKS-HIA Quality Index

Quality indikator 0,5

points

1 points

Reperfusion for STEMI/LBBB. 80% 85%

Reperfusion for STEMI/LBBB

within recommended time

75% 90%

Coronary angiogram for target

population with NSTEMI

75% 80%

P2Y12-blocker for NSTEMI 85% 90%

ACEinh/ARB for target population

post MI.

85% 90%

Proportion < 75 y with sec prev 75% 90%

Proportion quit smoking 12-14 m 60% 70%

Physical training program 12-14 m 50% 60%

LDL <2.5 mmol/L 12-14 m 60% 70%

BP < 140 mmHg 12-14 m 70% 75%

Swedeheart new quality index

2.6 years

Jernberg JAMA. 2011;305(16):1677-1684

Mortality after ST- elevation MI

Comparative effectiveness

Registries are saving lives

Over 50 high ranked publications annually

20

HR 0.84

(0.77–0.92)

p=0.0003

NNT = 54

Days after randomization

0 60 120 180

12

11

10

9

8

7

6

5

4

3

2

1

0

Cu

mu

lati

ve

in

cid

en

ce

(%

)

9.8

11.7Clopidogrel

Ticagrelor

Wallentin L, et al. N Engl J Med. 2009;361:1045-57.

Primary Endpoint

(CV death, MI, Stroke)

CV deathClopidogrel

Ticagrelor

4.0

5.1 HR 0.79

(0.69–0.91)

p=0.001

NNT = 90

N=18,624

ADP receptor inhibitors for STEMI. Patients < 80 years

Ticagrelor

Clopidogrel

Clopidogrel

Clopidogrel

Clopidogrel

Clopidogrel

Ticagrelor

TicagrelorTicagrelor

Ticagrelor

Ticagrelor

adj HR:0.85 (0.78 – 0.93)

adj HR:0.89 (0.78 – 1.01)

Adjusted Outcome

adj HR:0.83 (0.75 – 0.92)

adj HR:0.81 (0.65 – 1.01)

adj HR:1.20 (1.04 – 1.40)

Sahlén et al. EHJ 2016

RR: 1.03 (0.84,1.26)

0.0 0.5 1.0 1.5 2.0 2.5 3.0

0.00

0.02

0.04

0.06

0.08

0.10

Time (years)

Cum

ulat

ive

risk

of d

eath

RR: 1.32 (1.11,1.57)

BMS 12880 12473 12354 12228 9298 5966 3199

DES 5770 5605 5541 5471 3434 1777 626

RR 1.3 (1.1-1.6)

Future potential increased mortality?

??

5 y

Patients enrolled 2003-2004 and

followed max 3 years

N=19 771

N Engl J Med 2007;356:1009-19.

0 1 2 3 4 5

0.00

0.05

0.10

0.15

Time (years)

Cum

ulat

ive ri

sk o

f dea

th

BMS

DES

BMS 28286 26843 19429 13592 6682 7

DES 19681 18893 12691 6065 1964 0

RR: 0.82 (0.73, 0.92)

RR: 1.06 (0.97, 1.17)

Patients enrolled 2003-2006 and

followed max 5 years

N= 47.867

James, N Engl J Med 2009;360(19):1933-45

Time (Years after stenting)

543210

Cu

mu

lati

ve r

isk o

f R

este

no

sis

0,12

0,11

0,10

0,09

0,08

0,07

0,06

0,05

0,04

0,03

0,02

0,01

0,00

Adjusted

November 8th 2009. Copyright SCAAR.

SCAAR

XienceV / Promus, N=1,849

BS Taxus Liberté, N=16,357

Braun Coroflex Blue, N=3,761

BS Liberté, N=28,735

Other, N=3,654

Stents used <1000 times excluded

N=104,142 stents

Medtronic Endeavor, N=4,891

Medtronic Driver, N=15,954

BS Taxus Express, N=3,165

Sorin Chrono, N=2,465

Abbott Flexmaster Fl, N=1,311

Hexacath Titan2, N=1,974

Cordis Cypher, N=11,513

Abbott Vision, N=8,565

2.3%

1.4%

3.0%

James, Eurointervention 2009

SWEDE HEART

SCAAR

Thrombus aspiration

SWEDE HEART

SCAAR

Thrombus aspiration

Prosective randomized trial that uses a clinical registry

for one or several major functions for trial conduct and

outcomes reporting.

Register based Randomized Clinical trials- R-RCT

Two questions need to be

answered:

Did the patient consent orally?

Are inclusion and no exclusion

criteria met?

Did the patient consent?

Are inclusion and exclusion crieteria met?

Information for consent

Did the patient consent?

Are inclusion and exclusion crieteria met?

Randomize and store data

Did the patient consent?

Are inclusion and exclusion crieteria met?

Randomized

All primary PCI:s

7244 patients

Date

Patients

TASTE inclusion rate

Eligible

All-cause mortality up to 1 year

HR up to 1 year 0.94 (0.78 – 1.15), P=0.57

HR 30 days 0.94 (0.72 - 1.22), P=0.63

All-cause mortality up to 1 year

HR 1 year 0.94 (0.78 – 1.15), P=0.57

HR up to 30 days 0.94 (0.72 - 1.22), P=0.63

Thrombus aspiration post Taste

Mean use during trial

SWEDE HEART

Title Citation Class LOE

2012 ESC Guidelines ST-

segment elevation myocardial

infarction .

European Heart Journal

2012 Oct;33(20):2569-619

Routine aspiration should

be considered

IIa B

2014 ESC/EACTS guidelines on

myocardial revascularization

Eur Heart J. 2014 Oct

1;35(37):2541-619

May be considered in

selected patients

IIb A

2015 ACC/AHA focused update

PPCI

JACC Routine thrombectomy

not useful

III A

2015 ACC/AHA focused update

PPCI

JACC Selective and bailout

Thrombectomy not well

established

IIb C

2017 ESC Guidelines ST-

segment elevation myocardial

infarction

European Heart Journal

2017

Routine use of thrombus

aspiration is not

recommended.

III A

Guidelines

Primary Endpoint at 12 months(Death, MI, Unplanned revascularization)

0 2 4 6 8 10 12

0

10

20

30

No. at Risk

Cu

mu

lati

ve

ris

k o

f c

om

po

sit

e e

nd

po

int

(%)

Months

HR (95% CI) = 1.12 (0.79-1.58), P=0.53

6.7 %

6.1%

iFR (n=1012)

FFR (n=1008)

iFR (n=1012)

FFR (n=1007)

6.7%

6.1%

HR (95% CI) =

1.12 (95% CI: 0.79, 1.58)

P=0.53

iFR

Primary Endpoint up to 365 days

Ambient air

Oxygen treatment

Oxygen treatment 5.0 %

Ambient air 5.1 %

HR 0.97

95% CI, 0.79 – 1.21

P=0.8

www.escardio.org/guidelines2017 ESC Guidelines for the Management of AMI-STEMI (European Heart Journal 2017 - doi:10.1093/eurheartj/ehx095)

Relief of hypoxaemia and symptoms

RecommendationsClas

sLevel

Hypoxia

Oxygen is indicated in patients with hypoxaemia (SaO2 <90% or PaO2<60 mmHg).

I C

Routine oxygen is not recommended in patients with SaO2≥90%.

III B

NEW

Primary Endpoint at 180 days

HR 0.96

95% CI, 0.83 – 1.10

P=0.54

Primary PCI of STEMI/rescue-

PCI/risk evaluation following

thrombolysis/very high risk

NSTEMI

> 1 non-culprit lesions

non-culprit vessel at least 2.5 mm

on angiography (50-99%) amenable

for PCI

FFR-guided PCI

of non-culprit lesions

during index admission*

Initial conservative

management of non-culprit

lesionsEligible but not randomized

Trial follow-up for endpoints at 30 days and at least 1 year

*Admission meaning initial PCI-capable unit or after transfer to another

PCI-capable unit

Visual estimation

1:1

Randomization

Registry follow-up

Exclude:

Previous CABG

Left main disease

Cardiogenic chock

Total n=4052 patients

2026 patients in each arm

Within 6 h from puncture time

of index procedure

FULL REVAC study design (N=4052)

"Unfortunately, too many of the decisions made today about health and

healthcare are not supported by high quality evidence,”

"Prospectively designed registries and cohort studies are highly valuable, and

randomized trials conducted in the context of clinical practice, often called a pragmatic

clinical trial may be the most important source of knowledge in the future,”

Reasons for success

Initiated by cardiologists, driven by National and local

enthusiasts (champions)

Highly motiverated users

Immediate benefit in the local unit – on-line-reports, local

variables, local development

Open comparison of hospital performances

All hospitals part of the same system

Published studies in high ranked journal

Euroheart

Hospital

National

registry

National

registry

National

registry

National

registry

National

registry

HospitalHospitalHospital

Hospital

Hospital

Hospital

Hospital

Hospital

Hospital

Hospital

Hospital Hospital

Hospital

Hospital

Hospital

Hospital

Hospital

- Not difficult to build – already done by European catarct surgeons

- EU Directive 95/46/EC regulates processing of personal data within in EU