Daily practice of ACS management in the Gulf: Data from Gulf COAST

Transcription

1 Daily practice of ACS management in the Gulf: Data from Gulf COAST Mohammad Zubaid, MB, ChB, FRCPC, FACC Professor of Medicine, Kuwait University Head, Division of Cardiology Mubarak Alkabeer Hospital Kuwait 1 st Al Wakra Hospital Medical Conference January 31, 2014 Intercontinental hotel, Doha, Qatar

2 Do we always do what we claim we do? Reperfusion therapy in STEMI patients in hospitals with Primary PCI policy Routinely do Primary PCI Hospitals with primary PCI 7 of 18 hospitals (39%) Reperfused STEMI 329 Thrombolytic therapy 213 (65%) Primary PCI 116 (35%) Al-Zakwani I et al, Int J Clin Pharm Jun;34(3):445-51

3 Clinical trials vs. observational registries Carefully-conducted, observational registries reveal what we do in our daily practice. What we do, not what we know, impacts our patients outcomes. Randomized trials tell us about the efficacy of an agent/intervention in certain protected set up. Randomized trials cannot emulate daily practice.

4 Regional observational ACS registries

5 Gulf COAST Registry Gulf locals with acute coronary Syndrome events Registry The study was approved by the ethics committees of each institution/country.

6 IMPORTANT FEATURES OF GULF COAST DESIGN 1 Prospective 2 Observational 3 Standardized data definitions 4 Consecutive 5 Enrolled locals (citizen) 6 Admitted to hospital (or planned for admission) 7 Discharge diagnosis of the admission event is ACS 8 Follow up: 1, 6 and 12 months

7 Standardized Data Definitions Enhance Data Accuracy and Allow for Better Comparisons Across Studies

8 Why Gulf COAST? Gulf RACE Gulf COAST Year Design Prospective, observational Prospective, observational enrolment 6 months 12 months Countries 6 4 Geographic coverage area At least 80% of each country At least 80% of each country Ethics approval Yes Yes Consent form No Yes Sponsor Sanofi/GHA AstraZeneca/Kuwait University

9 Overview of Gulf RACE and Gulf COAST Gulf RACE Gulf COAST Hospitals Cath labs 18 (29%) 12 (36%) Population Citizens and expatriates Citizens only Inclusion criteria Definitions Data entry consecutive patients admitted and discharged with ACS ACC key data elements and definitions (JACC 2001) Paper CRF centralized data entry at PI Patients 8176 (3184 citizens) consecutive patients admitted and discharged with ACS ACC key data elements and definitions (JACC 2001) Paper CRF online data entry by investigators 4080 All citizens Follow-up Hospital discharge One year

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11 3 Types of Hospitals and Paper CRFs Hospitals without onsite cath lab e.g. Jahra H, Kuwait; Salmaniya H, Bahrain; Sohar H, Oman; Dibba H, UAE Hospital without onsite cath lab CRF Hospitals with onsite cath lab that both enroll patients and also receive in-hospital transfers for cath e.g. Adan H, Kuwait; BDF H, Bahrain; Royal H, Oman; SKMC H, UAE. Hospital with onsite cath lab CRF Transfer for Cath CRF Non Gulf COAST Hospital Hospital with onsite cath lab that only receives in-hospital transfers for cath Only example: Chest Diseases H, Kuwait Transfer for Cath CRF

12 Data Accuracy: continuous data cleaning from the start Built in data checks in ecrf with alerts immediately displayed to user Site Visits Monthly analysis of data using SPSS Quality Control Reports ed to SO and CSO missing values. out of range values. contradictory entries related to multiple data fields

13 BARC classification for bleeding

14 Internal Data Checks: Alert to 3 Important Outcomes We Don t Want to Miss

15 Sponsor AstraZeneca Gulf Study oversight Kuwait University

16 Distribution of ACS type Discharge diagnosis ACS type Gulf COAST 2012 (n=3896 ) GRACE (n=10,709) GRACE (n=31,982) STEMI (%) NSTEMI (%) UA (%) Steg et al, Am J Cardiol 2002;90: Shaun et al, Am Heart J 2009;158:

17 Risk Profiles

18 Gulf COAST Baseline characteristics NSTEMI (1827) n (%) STEMI (994) n (%) Age (Mean±SD) 62.1± ±13.4 Female 630 (35) 224 (23) Hypertension 1291 (71) 466 (47) Diabetes 1056 (58) 460 (46) Smoking 375 (21) 357 (36) Prior MI 598 (33) 118 (12) Prior PCI 419 (23) 84 (9) Prior CABG 169 (9) 21 (2) Prior TIA 58 (3) 14 (1) Prior stroke 140 (8) 51 (5)

19 Our ACS patients are young Gulf COAST 2012 (n= 3188) GRACE (n= 10,709) GRACE (n=31,982) EHS-ACSII (n=6,385) Age (mean) (median) 64 Male (%) Steg et al, Am J Cardiol 2002;90: Shaun et al, Am Heart J 2009;158: Mandelzweig et al, Euro Heart J 2006;27:

20 Risk Factor profile in ACS patients Gulf COAST 2012 (n=3188) GRACE (n=5,720) GRACE (n=31,982) EHS-ACSII (n=6,385) Current Smoker * 37 Known DM * Current or past smoker 1 Fox et al, JAMA 2007;297: Shaun et al, Am Heart J 2009;158: Mandelzweig et al, Euro Heart J 2006;27:

21 ACS patients risk profile Past medical history Gulf COAST 2012 (n=3188) GRACE (n=5720) GRACE (n=31,982) EHS-ACSII (n=6,385) Angina (%) MI (%) PCI (%) CABG (%) Prior ASA (%) Fox et al, JAMA 2007;297: Shaun et al, Am Heart J 2009;158: Mandelzweig et al, Euro Heart J 2006;27:

22 Adherence to medical therapy

23 Gulf COAST STEMI/NSTEMI Gulf COAST 2012 Gulf RACE 2007¹ EHS-ACS-II 2004² NRMI ³ Aspirin at arrival (%) Aspirin prescribed at discharge (%) Beta- blocker at discharge (%) Statin at discharge (%) Clopidogrel at discharge for medically treated AMI patients (%)

24 In-hospital cardiac catheterization

25 In-hospital catheterization Gulf COAST 2012 Gulf RACE GRACE* GRACE* EHS-ACS-II* NRMI (n=3896) N=5720 N=31,982 3 N= % 20 % 60% 67% 70-86% * derived/recalculated data 1 Zubaid et al, Acta Cardiol 2009;64: Fox et al, JAMA 2007;297: Shaun et al, Am Heart J 2009;158: Mandelzweig et al, European Heart Journal 2006; 27: Peterson et al, Am Heart J 2008;156:

26 In-hospital catheterization Per country Kuwait Oman UAE Bahrain (n=1225) (n=1399) (n=694) (n=578) 33% 24% 68% 51%

27 Gulf COAST In hospital catheterization for NSTEMI patients Hospitals with cath (n=747) n (%) Hospitals without cath (n=1080) n (%) Cath during hospital stay 547 (73) 186 (17) PCI during hospital stay 352 (47) 105 (10) Hospital arrival to cath, Mean ±SD, Median (days) 2.2±2.4 (2) 6.5±6.4 (5)

28 Gulf COAST Inhospital catheterization for STEMI patients Hospitals with cath (n=285) n (%) Hospitals without cath (n=709) n (%) Cath during hospital stay 253 (89) 174 (25) PCI during hospital stay 223 (78) 126 (18) Hospital arrival to cath, Mean ±SD, Median (days) 1.07±2.1 (0) 4.8±9 (4)

29 Gulf COAST PCI indications in STEMI patients N=349 n (%) Primary PCI 104 (30) Rescue PCI (after failed full-dose lytics) 38 (11) PCI Post MI 181 (52) Cardiogenic shock 3 (1) Unstable angina (including Post MI) 16 (4) Elective/physician preference 7 (2)

30 Reperfusion Therapy for STEMI

31 Use of reperfusion in eligible patients (%) Gulf COAST 2012 Gulf RACE GRACE GRACE EHS-ACSII* (n= 822 ) (n= 480) (n=1215) (n=7,107) (n=2,678) PPCI Lysis Shortfall * derived/recalculated data 1 Zubaid et al, Acta Cardiol 2009;64: Eagle et al, European Heart Journal 2008;29: Shaun et al, Am Heart J 2009;158: Mandelzweig et al, Euro Heart J 2006;27:

32 reperfusion in eligible patients Per country Kuwait Oman UAE Bahrain (n=259) (n= 315) (n= 129) (n= 119) PPCI Lysis Shortfall

33 Choice of reperfusion in Hospitals with onsite angiographic facilities Gulf COAST Gulf RACE GRACE* (n=217) (n=686) (n=7,657) Primary PCI 48% 24% 63% Thrombolytic Therapy 52% 76% 37% 1 Zubaid et al, Acta Cardiol 2009;64: Anderson et al, Heart 2007;93:

34 Reperfusion therapy in STEMI Patients Per hospital policy Routinely do Primary PCI No Routine Primary PCI No. of hospitals 6 4 Reperfused STEMI Lytic therapy 48 (37) 65 (75) Primary PCI 82 (63) 22 (25)

35 Was reperfusion administered in time?

36 Reperfusion Timeline Primary PCI Primary PCI Gulf COAST 2012 (n= 107) Gulf RACE (n=16) GRACE Jul Jun (n=1215) GRACE (n=1,592) EHS-ACS-II NRMI Median D2B (min) 67 min 80 min 80 min 110 min 70 min 79 min D2B 90 min (%) Zubaid et al, Acta Cardiol 2009;64: Eagle et al, European Heart Journal 2008;29: Shaun et al, Am Heart J 2009;158: Mandelzweig et al, European Heart Journal 2006; 27: Gibson et al, Am Heart J 2008; 156:

37 Reperfusion Timeline Primary PCI Per country Primary PCI Kuwait Oman UAE Bahrain (n= 17) (n= 6) (n= 46) (n=38 ) Median D2B (min) D2B 90 min (%)

38 Reperfusion Timeline Thrombolysis Thrombolysis Gulf COAST 2012 (n=654 ) Gulf RACE (n=475) GRACE (n=1215) GRACE (n=3,153) EHS- ACS-II NRMI Median D2NT (min) 40 min 44 min 34 min 32 min 37 min 29 min D2NT 30 min (%) Zubaid et al, Acta Cardiol 2009;64: Eagle et al, European Heart Journal 2008;29: Shaun et al, Am Heart J 2009;158: Mandelzweig et al, European Heart Journal 2006; 27: Gibson et al, Am Heart J 2008; 156:

39 Reperfusion Timeline Thrombolysis Per country Thrombolysis Kuwait Oman UAE Bahrain (n=225) (n= 294) (n= 65) (n= 70) Median D2NT (min) D2NT 30 min (%)

40 Reperfusion in elderly with STEMI Variable Gulf COAST 2012 *Gulf RACE 2007 **Euro heart N=305 n (%) N=1325 n (%) N=5534 n (%) Eligible Primary PCI 24 (10) 4 (2) 264 (19) Thrombolytic therapy 186 (77) 150 (82) 533 (38) Short fall 33 (13) 29 (16) 610 (43) *Zubaid et al, Acta Cardiologica 2009; 37: **Rosengren et al, EHJ 2006; 27:

41 Gulf COAST STEMI reperfusion strategy elderly vs. young Variable 65 years old <65 years old N=305 n (%) N=673 n (%) Eligible Primary PCI 24 (10) 80 (14) Thrombolytic therapy 186 (77) 460 (79) Short fall 33 (13) 41 (7) *Zubaid et al, Acta Cardiologica 2009; 37: **Rosengren et al, EHJ 2006; 27:

42 Door to balloon in hospital with and without cath labs in Kuwait Adan Hospital Door to ECG ECG to Cardiology reg Cardiology registrar respons time Door to balloon time Mubarak AlKabeer Hospital Door to ECG ECG to Cardiology reg Cardiology registrar respons time Ambulance notification Ambulance respons time Ambulance trip time Door to balloon time

43 Conclusions It is critical that we examine what we do. Gulf citizens with ACS are much younger than their European and North American peers, yet have a similar if not worse risk profile. They receive good medical therapy at discharge from hospital. The majority of hospitals do not have onsite cath labs and a minority of patients receive inhospital catheterization at those hospitals.

44 Conclusions In hospitals with onsite cath labs, majority of patient receive inhospital cath. However, the use of primary PCI is not widespread. When carried out, primary PCI was performed efficiently in terms of the door to balloon time. Lytic administration is still seeing unacceptable delay. Compared to 2007 Gulf RACE, there are positive signs.

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