Swedish experiences: National registries for quality ... · Swedish experiences: National...
Transcript of Swedish experiences: National registries for quality ... · Swedish experiences: National...
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