Download - 1st Al Wakra Hospital Conference on General Medicine

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
1st Al Wakra Hospital Medical Conference
January 31, 2014 – Intercontinental hotel, Doha, Qatar
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
Reperfused STEMI
7 of 18 hospitals (39%)
329
Thrombolytic therapy
213 (65%)
Primary PCI
116 (35%)
Al-Zakwani I et al, Int J Clin Pharm. 2012 Jun;34(3):445-51
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.
Regional observational ACS registries
2007
2012
Gulf COAST Registry
Gulf loCals with acute cOronAry
Syndrome evenTs Registry
The study was approved by the ethics committees of each institution/country.
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
Standardized Data Definitions Enhance Data Accuracy
and Allow for Better Comparisons Across Studies
Why Gulf COAST?
Gulf RACE
Gulf COAST
2007
2012
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
Sanofi/GHA
AstraZeneca/Kuwait University
Year
Design
Sponsor
Overview of Gulf RACE and Gulf COAST
Gulf RACE
Gulf COAST
63
33
Hospitals
Cath labs
Population
18
(29%)
12
(36%)
Citizens and expatriates
Citizens only
consecutive patients admitted
and discharged with ACS
consecutive patients admitted
and discharged with ACS
Definitions
ACC key data elements and
definitions (JACC 2001)
ACC key data elements and
definitions (JACC 2001)
Data entry
Paper CRF
centralized data entry at PI
Paper CRF
online data entry by investigators
8176
(3184 citizens)
4080
All citizens
Hospital discharge
One year
Inclusion criteria
Patients
Follow-up
www.gulfcoastregistry.org
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
Hospital with onsite cath lab that only
receives in-hospital transfers for cath
Only example: Chest Diseases H, Kuwait
Transfer for Cath CRF
Non Gulf COAST Hospital
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
emailed to SO and CSO
 missing values.
out of range values.
contradictory entries related to
multiple data fields
BARC classification for bleeding
Internal Data Checks: Alert to 3 Important
Outcomes We Don’t Want to Miss
Sponsor
AstraZeneca Gulf
Study oversight
Kuwait University
Distribution of ACS type
Discharge diagnosis
ACS type
Gulf COAST
2012
(n=3896 )
GRACE
20001
(n=10,709)
GRACE 2
20072
(n=31,982)
STEMI (%)
25
32
31
NSTEMI (%)
47
27
32
UA (%)
28
41
26
1 Steg et al, Am J Cardiol 2002;90:358-363.
2 Shaun et al, Am Heart J 2009;158:193-201.
Risk Profiles
Gulf COAST
Baseline characteristics
Age (Mean±SD)
Female
Hypertension
Diabetes
Smoking
Prior MI
Prior PCI
Prior CABG
Prior TIA
Prior stroke
NSTEMI (1827)
n (%)
62.1±12.4
630 (35)
1291 (71)
1056 (58)
375 (21)
598 (33)
419 (23)
169 (9)
58 (3)
140 (8)
STEMI (994)
n (%)
58.03±13.4
224 (23)
466 (47)
460 (46)
357 (36)
118 (12)
84 (9)
21 (2)
14 (1)
51 (5)
Our ACS patients are young
Gulf COAST
2012
(n= 3188)
GRACE
20001
(n= 10,709)
GRACE
20072
(n=31,982)
EHS-ACSII
20043
(n=6,385)
Age (mean)
60
66
65 (median)
64
Male (%)
66
67
67
71
1 Steg
et al, Am J Cardiol 2002;90:358-363.
et al, Am Heart J 2009;158:193-201.
3 Mandelzweig et al, Euro Heart J 2006;27:2285-2293.
2 Shaun
Risk Factor profile in ACS patients
Gulf COAST
2012
(n=3188)
GRACE
20051
(n=5,720)
GRACE 2
20072
(n=31,982)
EHS-ACSII
20043
(n=6,385)
Current Smoker
39
26
47*
37
Known DM
53
26
26
24
* Current or past smoker
1
Fox et al, JAMA 2007;297:1892-1900.
2 Shaun et al, Am Heart J 2009;158:193-201.
3 Mandelzweig et al, Euro Heart J 2006;27:2285-2293.
ACS patients risk profile
Past medical history
Gulf COAST
2012
(n=3188)
GRACE
20051
(n=5720)
GRACE 2
20072
(n=31,982)
EHS-ACSII
20043
(n=6,385)
Angina (%)
39
48
49
-
MI (%)
26
29
26
23
PCI (%)
21
19
13
15
CABG (%)
7
13
8
Prior ASA (%)
60
-
34
1 Fox
et al, JAMA 2007;297:1892-1900.
et al, Am Heart J 2009;158:193-201.
3 Mandelzweig et al, Euro Heart J 2006;27:2285-2293.
2 Shaun
-
Adherence to medical therapy
Gulf COAST
STEMI/NSTEMI
Gulf COAST
2012
Gulf RACE
2007¹
EHS-ACS-II
2004²
NRMI-5
2004-2006³
Aspirin at arrival (%)
99
98
97
90
Aspirin prescribed at discharge (%)
97
97
90
91
Beta- blocker at discharge (%)
85
78
71
89
Statin at discharge (%)
97
84
80
82
Clopidogrel at discharge
for medically treated AMI patients (%)
67
57
63
-
In-hospital cardiac catheterization
In-hospital catheterization
Gulf COAST
2012
(n=3896)
Gulf RACE
20071
39%
20 %
GRACE*
20052
GRACE*
20073
EHS-ACS-II*
20044
N=5720
N=31,9823
N=6385
60%
67%
* derived/recalculated data
1 Zubaid
et al, Acta Cardiol 2009;64:439-446.
et al, JAMA 2007;297:1892-1900.
3 Shaun et al, Am Heart J 2009;158:193-201.
4 Mandelzweig et al, European Heart Journal 2006; 27:2285-2293.
5 Peterson et al, Am Heart J 2008;156:1045-55.
2 Fox
NRMI-5
20065
70-86%
In-hospital catheterization
Per country
Kuwait
Oman
UAE
Bahrain
(n=1225)
(n=1399)
(n=694)
(n=578)
33%
24%
68%
51%
Gulf COAST
In hospital catheterization for NSTEMI patients
Cath during hospital stay
Hospitals with cath
(n=747)
n (%)
547 (73)
Hospitals without cath
(n=1080)
n (%)
186 (17)
PCI during hospital stay
352 (47)
105 (10)
2.2±2.4 (2)
6.5±6.4 (5)
Hospital arrival to cath, Mean ±SD, Median (days)
Gulf COAST
Inhospital catheterization for STEMI patients
Cath during hospital stay
Hospitals with cath
(n=285)
n (%)
253 (89)
Hospitals without cath
(n=709)
n (%)
174 (25)
PCI during hospital stay
223 (78)
126 (18)
1.07±2.1 (0)
4.8±9 (4)
Hospital arrival to cath, Mean ±SD, Median (days)
Gulf COAST
PCI indications in STEMI patients
Primary PCI
Rescue PCI (after failed full-dose lytics)
PCI Post MI
Cardiogenic shock
Unstable angina (including Post MI)
Elective/physician preference
N=349
n (%)
104 (30)
38 (11)
181 (52)
3 (1)
16 (4)
7 (2)
Reperfusion Therapy for STEMI
Use of reperfusion in eligible
patients (%)
Gulf COAST
2012
Gulf RACE
20071
GRACE
20062
GRACE 2
20073
EHS-ACSII*
20044
(n= 822 )
(n= 480)
(n=1215)
(n=7,107)
(n=2,678)
44
25
42
16
49
30
33
26
28
PPCI
12.5
3
Lysis
78.5
86
9
10
Shortfall
* derived/recalculated data
1 Zubaid
et al, Acta Cardiol 2009;64:439-446.
et al, European Heart Journal 2008;29:609-617.
3 Shaun et al, Am Heart J 2009;158:193-201.
4 Mandelzweig et al, Euro Heart J 2006;27:2285-2293.
2 Eagle
reperfusion in eligible patients
Per country
Kuwait
Oman
UAE
Bahrain
(n=259)
(n= 315)
(n= 129)
(n= 119)
40.3
29.4
48.9
57.1
10.9
13.4
PPCI
5.8
0.3
Lysis
86.4
92.1
Shortfall
7.7
7.6
Choice of reperfusion in Hospitals with
onsite angiographic facilities
Gulf COAST
Gulf RACE
GRACE*
2012
20071
20042
(n=217)
(n=686)
(n=7,657)
Primary PCI
48%
24%
63%
Thrombolytic Therapy
52%
76%
37%
1 Zubaid et al, Acta Cardiol 2009;64:439-446.
2 Anderson et al, Heart 2007;93:177-182.
Reperfusion therapy in STEMI Patients
Per hospital policy
Routinely do
Primary PCI
No Routine
Primary PCI
6
4
130
87
Lytic therapy
48 (37)
65 (75)
Primary PCI
82 (63)
22 (25)
No. of hospitals
Reperfused STEMI
Was reperfusion administered in time?
Reperfusion Timeline
Primary PCI
Primary PCI
Gulf COAST
2012
(n= 107)
Gulf RACE
20071
GRACE
Jul 2005 - Jun
20062
(n=16)
GRACE 2
2001-20073
EHS-ACS-II
20044
NRMI-5
2004-20065
(n=1,592)
(n=1215)
Median D2B (min)
67 min
80 min
80 min
110 min
70 min
79 min
D2B ≤ 90 min (%)
62
63
58
39
-
54
1 Zubaid
et al, Acta Cardiol 2009;64:439-446.
et al, European Heart Journal 2008;29:609-617.
3 Shaun et al, Am Heart J 2009;158:193-201.
4 Mandelzweig et al, European Heart Journal 2006; 27:2285-2293.
5 Gibson et al, Am Heart J 2008; 156:1035-44.
2 Eagle
Reperfusion Timeline
Primary PCI Per country
Primary PCI
Kuwait
Oman
UAE
Bahrain
(n= 17)
(n= 6)
(n= 46)
(n=38 )
Median D2B (min)
90
195
70
46
D2B ≤ 90 min (%)
53
0
61
76
Reperfusion Timeline
Thrombolysis
Thrombolysis
Gulf COAST
2012
Gulf RACE
20071
GRACE
20062
GRACE 2
2001-20073
(n=475)
(n=1215)
(n=3,153)
40 min
44 min
34 min
33
39
48
(n=654 )
Median D2NT (min)
D2NT ≤30 min (%)
1 Zubaid
et al, Acta Cardiol 2009;64:439-446.
et al, European Heart Journal 2008;29:609-617.
3 Shaun et al, Am Heart J 2009;158:193-201.
4 Mandelzweig et al, European Heart Journal 2006; 27:2285-2293.
5 Gibson et al, Am Heart J 2008; 156:1035-44.
2 Eagle
EHSACS-II
20044
NRMI-5
200420065
32 min
37 min
29 min
42
-
-
Reperfusion Timeline
Thrombolysis Per country
Thrombolysis
Kuwait
Oman
UAE
Bahrain
(n=225)
(n= 294)
(n= 65)
(n= 70)
Median D2NT (min)
40
41
41
38
D2NT ≤30 min (%)
37
30
23
43
Reperfusion in elderly with STEMI
Variable
Gulf COAST
2012
*Gulf RACE
2007
**Euro heart
N=305
n (%)
N=1325
n (%)
N=5534
n (%)
243
183
1407
Primary PCI
24 (10)
4 (2)
264 (19)
Thrombolytic therapy
186 (77)
150 (82)
533 (38)
Short fall
33 (13)
29 (16)
610 (43)
Eligible
*Zubaid et al, Acta Cardiologica 2009; 37:1126-1131.
**Rosengren et al, EHJ 2006; 27:789-795.
Gulf COAST
STEMI reperfusion strategy
elderly vs. young
Variable
≥65 years old
<65 years old
N=305
n (%)
N=673
n (%)
243
581
Primary PCI
24 (10)
80 (14)
Thrombolytic therapy
186 (77)
460 (79)
Short fall
33 (13)
41 (7)
Eligible
*Zubaid et al, Acta Cardiologica 2009; 37:1126-1131.
**Rosengren et al, EHJ 2006; 27:789-795.
Door to balloon in hospital with and without cath labs in Kuwait
Adan Hospital
ECG to
Cardiology reg
Door to ECG
Cardiology
registrar
respons time
9
7
Door to balloon time
64
4
Mubarak AlKabeer Hospital
Door to ECG
18
Cardiology
ECG to
Ambulance
Cardiology registrar
respons time notification
reg
20
3
5
Ambulance
respons time
13
Ambulance
trip time
30
Door to balloon time
111
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.
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.