SWEDEHEART Exempel på registerdata använt i forskning. Bo Lagerqvist, Överläkare Akademiska sjukhuset Uppsala

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1 SWEDEHEART Exempel på registerdata använt i forskning Bo Lagerqvist, Överläkare Akademiska sjukhuset Uppsala

2 SWEDEHEART National coverage Hospitals No Patients Annual No RIKS-HIA coronary intensive care registry SCAAR (coronary angiography and PCI) 100 % % % % Thoracic surgery 100 % 8 100% 7000 SEPHIA Secondary Prevention After Myocardial Infarction(<75 yrs) 85% 65 55% 5500 TAVI 100 % % 150

3 Swedish Coronary Angiography and Angioplasty Registry (SCAAR) Founded and managed by the profession Supported by the Swedish health authorities Independent of the Industry All 29 PCI centers contributes : PCI procedures Angiography only procedures

4 Ballongvidgning PCI Percutaneous Coronary Intervention

5 Kranskärl

6 PCI Percutan Transluminal Intervention

7

8 Stent-thrombosis

9

10

11 Other registries: NDR, SCB, Cancer, FK. SCAAR merging example of Events /Endpoints: From SCAAR: Complications New procedures (angio/pci) Restenosis Stent occlusions/stent thrombosis From other part of SWEDEHEART: Infarctions (STEMI NSEMI) From Registry of Population (merge every month): Death From Registry of death cause (every year, 1-2 yrs lag): Cause of death From Registry of diagnosis (every year, 1-2 yrs lag): Hospitalizations due to ICD (AMI, stroke, renal failure) Op codes ( CABG, dialysis ) From Prescribed Drug Register: Drug prescription since July 2005.

12 SCAAR Scientific presentations :

13 Register studier Svagheter Confounding factors ofta omöjliga att fullt kompensera för trots avancerad statistik Data kvalitén ofta sämre Missing values kan ge oönskad selektion Fodrar ofta avancerad statistik med multivarabel analys och propensity score, svårvärderat, svarta lådan effekten, risk för övervärdering. Styrkor Kliniskt viktiga endpoints sällan surrogat endpoints Stora studerade grupper tillåter analys av ovanliga händelser och endpoints Oselekterade populationer generaliserbara resultat till alla patienter Alla centers är med resultaten kan generaliseras till alla typer av sjukhus Billigare Snabbare

14 Randomiserade Studier (RCT) Icke randomiserade Observations studier

15 Randomiserade Studier (RCT) Icke randomiserade Observations studier

16 Rangordning av olika behandlingsstudier 1. Randomiserade studier 2. Metaanalys av randomiserade studier ( ej signifikanta ) 3. Register studier men en bra registerstudie kan vara bättre än en dålig randomi-serad studie 4. Metaanalys av register och randomiserade studier 5. Metaanalys av register studier

17 Registerstudier vs RCT Vid studier av behandlingseffekter är Randomiseringen kunskapens moder När det inte finns randomiserade studier eller när dessa är otillräckliga är registerstudier ett alternativ men måste då tolkas med försiktighet. Kan hjälpa till att utöka till grupper som är för små eller som är exkluderade ifrån randomiserade studier.

18 Example 1 Restenoses after treatment of In-Stent Restenosis (ISR)? 7,806 ISR treated in Sweden Original stent: DES 2,629 BMS 5,177 Schwalm T. et al, Eurointervention 2013

19 Example 1 Restenoses after treatment of In-Stent Restenosis (ISR)? 7,806 ISR treated in Sweden Original stent: DES 2,629 BMS 5,177 BMS DES Schwalm T. et al, Eurointervention 2013

20 SCAAR Results of different ISR-treatment SWEDE HEART Original stent -BMS DEB vs BMS 0.52 ( ) DES vs BMS 0.46 ( ) Schwalm T. et al, Eurointervention 2013

21 SCAAR Results of different ISR-treatment SWEDE HEART Original stent -BMS Original stent -DES DEB vs BMS 1.06 ( ) DEB vs BMS 0.52 ( ) DES vs BMS 0.99 ( ) DES vs BMS 0.46 ( ) Schwalm T. et al, Eurointervention 2013

22 In DES-ISR, does a change of desdrugs helps? SWEDE SCAAR HEART Schwalm T. et al, Eurointervention 2013

23 In DES-ISR, does a change of desdrugs helps? SWEDE SCAAR HEART Change vs Same drug 1.14 ( ) Schwalm T. et al, Eurointervention 2013

24 None, of these results are definite answers,. they have to be further evaluated in other clinical studies were the treatment selection is based on randomization, not on doctors choice

25 Sometimes is the difference between treatments so big that observational data can also early and in small materials can give strong signals.

26 Example 2 Comparison of restenosis rate with 2 different Drug-Eluting Balloons SCAAR April September ,236 patients treated with : Braun SeQuent Please N=919 Aachen Resonance ELUTAX, N=217 Bondesson P. et al, Eurointervention 2012

27 Example 2 Comparison of restenosis rate with 2 SCAAR different Drug-Eluting Balloons April September ,236 patients treated with : Braun SeQuent Please N=919 Aachen Resonance ELUTAX, N=217 SWEDE SCAAR HEART Bondesson P. et al, Eurointervention 2012

28 Example 3 Reported stent thrombosis SWEDE SCAAR HEART Stents from 2007 Group Total BS Libertè Abbott Xience Prime BS Promus Element Medtronic Driver Medtronic Integrity BS Taxus Liberté Medtronic Resolute Integrity Abbott multilink Vision Other stents Cordis Cypher XienceV or Promus BS Omega Medtronic Endeavor Hexacath Titan2 Medtronic Endeavor Resolute Braun Coroflex Blue Abbott Multilink8 Sorin Chrono Biosensors BioMatrix Biotronik Orsiro Count Mean Std Deviation

29 Example 3 Reported stent thrombosis SWEDE SCAAR HEART

30 Example 3 Reported stent thrombosis SWEDE SCAAR HEART Adjusted

31 Example 3 Reported stent thrombosis SWEDE SCAAR HEART Can the differences in SAT risk be explained by The stent it self or by how the different stents are used???

32 Example 3 Reported stent thrombosis SWEDE SCAAR HEART Thrombectomy SAT

33 Example 4 Puncture site Thrombectomy

34 RIVAL Study NSTE-ACS and STEMI (n=7021) Randomization Radial Access (n=3507) Femoral Access (n=3514) Blinded Adjudication of Outcomes Primary Outcome: Death, MI, stroke or non-cabg-related Major Bleeding at 30 days Jolly SS et al. Am Heart J. 2011;161:

35 Other Outcomes Radial (n=3507) % Femoral (n=3514) % HR 95% CI P Death MI Stroke Stent Thrombosis

36 Från SCAAR N >

37 SCAAR , 30-day Mortality Total Population N= 1581 (1.2%) vs. 5091(2.4%); HR: 0.44, 95% CI ( ) PCIs SA N= 959 (1.6%) vs (3.1%); HR: 0.48, 95% CI ( ) N= 85 (0.3%) vs. 225 (0.4%); HR: 1.18, 95% CI ( ) UA/ NSTEMI N= 655 (1.2%) vs (1.9%); HR: 0.54, 95% CI ( ) STEMI N= 565 (4.3%) vs (7.6%) ; HR: 0.54, 95% CI ( ) 0.1 Radial better 1 Femoral better 10

38 SCAAR , 30-day Mortality

39 Mina slutsatser är: INTE att punktion i handen resulterar i en lägre mortalitet. Utan Patientgruppen som vi sticker i handen har en genomsnittligt lägre mortalitet än patientgruppen som vi sticker i ljumsken.

40 Ljumsk punktion används selektivt - oftare på svårt sjuka patienter. Detta kan inte kompenseras för

41 Låt lotten avgöra.

42 Example 4 Thrombectomy SWEDE SCAAR HEART Bondesson P. et al, Eurointervention 2012

43

44 Trombaspiration

45 Bakgrund Trots primär PCI har ST elevations AMI fortfarande en hög 1 års mortalitet Trombaspiration förbättrar Incidens av stenttrombos TIMI flow grade Myocardial blush ST-segment resolution efter STEMI - och (därför) kanske också no reflow Ett antal randomiserade trombaspirationsstudier har visat vinst på surrogat endpoints En single center studie, TAPAS, med 1071 patienter, visade bättre överlevnad efter 1 år

46 TAPAS 4,6% 2,3%

47 SCAAR ESC guidelines SWEDE HEART Specific PCI devices and pharmacotherapy Joint 2010 ESC - EACTS Guidelines on Myocardial Revascularisation

48 Thrombus aspiration in Sweden SWEDE SCAAR HEART

49 Cumulative risk of death Registry Studies SWEDE SCAAR HEART 0,20 Thrombus aspiration in Sweden ,15 Yes (N=3 666) 0,10 No (N=16 417) 0,05 HR (95% CI): 1.21 ( ) 0, Years after PCI 4 5

50 TASTE trial enrollment flow chart Enrolled in Denmark N=247 All patients with STEMI in Sweden and Iceland undergoing primary or rescue PCI. N= * ) Erroneous enrollments N=15 Enrolled in TASTE N=7259 Randomized in TASTE N=7244 Not enrolled N=4697 N=3621 assigned to thrombus aspiration N=3623 assigned to conventional PCI N=3399 underwent thrombus aspiration N=222 underwent conventional PCI N=3445 underwent conventional PCI N=178 underwent thrombus aspiration N=1162 underwent thrombus aspiration N=3535 underwent conventional PCI N=3621 were followed up N=3623 were followed up N=1162 were followed up N=3535 were followed up

51 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?

52 Did the patient consent? Are inclusion and exclusion crieteria met? Information for consent

53 Did the patient consent? Are inclusion and exclusion crieteria met? Randomize and store data

54

55 All-cause mortality at 30 days HR 0.94 ( ), P=0.63 Per protocol analysis based on actual treatment: HR 0.88 ( ), P=0.38

56 Ongoing and planned R-RCTs DETOX-AMI DETermination of the role of OXygen in Acute Myocardial Infarction, N=7000 VALIDATE Bivalirudin versus Heparin in NST and ST- Elevation myocardial infarction in patients on modern antiplatelet therapy, N=6000 SWEDEPAD SWEdish Drug Elution trial in Peripheral Arterial Disease N=2500 Prospect II-Absorb Evaluate future events from colesterol plaques detected by near infrared spectroscopi and the Absorb Bioresorbable Vascular Scaffold (BVS) for non flow limiting stenoses with plaques burden >70%. N=300 AKA Evaluate if patients with out of hospital cardiac arrest should undergo routine coronary angiography