SCAAR, a success story Stefan James Professor of Cardiology - - PowerPoint PPT Presentation

▶
scaar a success story
SMART_READER_LITE
LIVE PREVIEW

SCAAR, a success story Stefan James Professor of Cardiology - - PowerPoint PPT Presentation

Jan 14, 2024 301 likes •626 views

Swedish experiences: SCAAR, a success story Stefan James Professor of Cardiology Uppsala Clinical Research Centre Uppsala University Uppsala, Sweden Number of cases annually: 80 000 RIKS-HIA 73 CCU hospitals, 100% SCAAR 30 PCI hospitals,

slide-1
SLIDE 1

Swedish experiences:

SCAAR, a success story

Stefan James

Professor of Cardiology Uppsala Clinical Research Centre Uppsala University Uppsala, Sweden

slide-2
SLIDE 2

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

>300 variables (Baseline data, procedural and outcome measures) At monitoring: 95-96% agreement between files and registry.

slide-3
SLIDE 3

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

>300 variables (Baseline data, procedural and outcome measures) At monitoring: 95-96% agreement between files and registry.

100-200 variables per patient

  • Patients characteristics
  • Procedural details (lesions, stents, devices

etc.)

  • Pharmacological treatment
  • Complications
slide-4
SLIDE 4

SWEDE HEART Data entry on line by the

  • perator

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

slide-5
SLIDE 5
slide-6
SLIDE 6

Doctor Doctor Doctor Doctor Doctor Doctor Doctor Doctor

slide-7
SLIDE 7

Quality indices SCAAR

slide-8
SLIDE 8

Quality Registries since 1995 EHRs Hospitals and primary care Sweden health statistics Prescription registry Data bases in Sweden based on personal number with patient characteristics, treatments and outcomes Hospital admission registry ICD Population registry Outpatient diagnosis registry Biobank

540219-9750

year month day place sex ctrl

Since 1947

slide-9
SLIDE 9

Data since 1989

Stent POBA

slide-10
SLIDE 10

3 6 9 12 15 18 21 24 1 2 3 4 5 6 7 8 9 10 DES n= 2 455 No DES n= 8 434 P=0.11

Månader AMI RIKS-HIA %

Patients with stents 2003

”… these findings are remarkable and may be of great importance but longer follow-up and randomised trials are needed.”

slide-11
SLIDE 11

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) Cumulative risk of death

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.

slide-12
SLIDE 12

BMS vs DMS Bare metal stents vs. Death metal stents

“The SCAAR registry is contaminated with flaw data….” M Leon 2007

The SCAAR Scare

“This clearly shows how inappropriate registry studies are….” Kastrati 2007 “What is rotten in the kingdom of Sweden”

  • P. Serruys 2008
slide-13
SLIDE 13

DES Barcelona 2009 SCAAR NEJM 1:st paper BMS

slide-14
SLIDE 14

Old DES NEW DES SCAAR NEJM 2:nd paper BMS Barcelona 2009 SCAAR NEJM 1:st paper

slide-15
SLIDE 15

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

Patients enrolled 2003-2006 and followed max 5 years N= 47.867

slide-16
SLIDE 16

Sirolimus Zotarolimus Everolimus Paclitaxel Biolimus

DES

slide-17
SLIDE 17

Adjusted n-DES; N= 10551

  • -DES; N=19202

BMS; N=64631

slide-18
SLIDE 18

Onyx Synergy Promus premier Orsiro Xience Ultimaster

slide-19
SLIDE 19

New DES 0.7% BMS 1.7% Old DES 2.9%

All stents implanted 2005- September 2016 N= 304 367 Crude rates

slide-20
SLIDE 20

Prosective randomized trial that uses a clinical registry for one or several major functions for trial conduct and

  • utcomes reporting.

Register based Randomized Clinical trials- R-RCT

slide-21
SLIDE 21

Randomize and store data

Did the patient consent? Are inclusion and exclusion crieteria met?

slide-22
SLIDE 22

Randomized All primary PCI:s 7244 patients

Date Patients

TASTE inclusion rate

Eligible

slide-23
SLIDE 23

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

The simplest and most pragmatic design

slide-24
SLIDE 24

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

slide-25
SLIDE 25

Thrombus aspiration post Taste

Mean use during trial SWEDE HEART Mean use immediately after trial

slide-26
SLIDE 26

Primary Endpoint: 1-year total mortality

Additional secondary endpoint and sub studies Data analysis through SWEDEHEART registry and national mortality registry

*Inclusion criteria:

  • symptoms suggestive of AMI

within 6h

  • SpO2 ≥ 90%
  • ≥ 30y
  • ECG changes indicating

ischemia and/or elevated troponin levels

R 1:1 Funding: Swedish Research council (VR)

slide-27
SLIDE 27

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

slide-28
SLIDE 28

VALIDATE (R-RCT)

 FU: Register data, combined with phone call endpoint follow up and CEC  Funding: Heart-lung foundation. Swedish research council, Astra Zeneca, The Medicines company.

STEMI (n=3000) or NSTEMI (n=3000) Pre-treatment with Ticagrelor, Prasugrel or Cangrelor Angiography: PCI intended

Primary Endpoint:

NACE: Death, Myocardial Infarction or Bleeding complication (BARC 2, 3 or 5) at 6 months Heparin only

(70-100U/kg)

Bivalirudin

(5000U Heparin pre-hospital

  • r 3000U pre-PCI)

R 1:1

slide-29
SLIDE 29

Primary Endpoint at 180 days

HR 0.96 95% CI, 0.83 – 1.10 P=0.54

slide-30
SLIDE 30

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

  • n angiography (50-99%) amenable

for PCI

FFR-guided PCI

  • f non-culprit lesions

during index admission* Initial conservative management of non-culprit lesions Eligible 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

  • f index procedure
slide-31
SLIDE 31