1
NCVD PCI Registry Interim Analysis
Malaysia LIVE (MyLIVE 2007)11-14th July 2007
Shangri-La, Kuala Lumpur
Dr. Robaayah ZambahariMBBS (M’sia), FRCP (Glasgow), FRCP (London), FACC, FAPSIC
(Asia Pac), FNHAM (M’sia), FASCC (ASEAN)National Heart Institute
Malaysia
Methodology♥ Sponsored by MOH and NHAM♥ Collaboration work with Melbourne
Intervention Group (MIG)♥ Case Report Form (CRF) –share the similar
data fields & definitions with MIG♥ Web application – online data entry♥ Data collection:
♥ Notification at index PCI procedure (beginning 2007)
♥ 30 days Follow Up♥ 6 months Follow Up♥ 12 months Follow Up
Objectives♥ To determine the number, evaluate and monitor the
outcomes of percutaneous coronary intervention (PCI) based on selected performance indicators.
♥ Determine the cost to the nation by cardiovascular disease and the cost- effectiveness of treatment and prevention programs.
♥ Determine the efficiency of, and adherence to current guidelines of treatment guidelines
♥ Stimulate and facilitate research of cardiovascular disease using this database.
♥ Facilitate quality improvement activities, e.g. DBT in Primary PCI.
♥ As a reference for future studies, etc volume, pattern of practice, temporal trend, etc. Facilitate future research; benchmark with other National Registries.
Registry ManagementChairman
Dato’ Dr Rosli Mohd Ali
Subject Matter ExpertiseDato Dato’ Seri Dr Robaayah Zambahari
Dato Dr Rosli Mohd AliProf. Dr Sim Kui Hian
Prof Dr Wan Azman Wan AhmadDato’ Dr. Omar IsmailDr Liew Houng BangDr Lee Chuey YenDr Tamil Selvan
Dr Kannan PasamanickamDr Hendrick Chia
Project ManagementMs S Gunavathy Selvaraj Ms Noor Amirah Muhamad
StatisticiansDr Sharon ChenMrs Raja’ah Meor
Database Administration & Web Application Development
Ms Lim Jie YingMs Amy Porle
Clinical Data ManagementMs Teo Jau Shya
Ms Huziana
2
SGH
HSA,JB
HUSMPH
SJMCDSHSMC
SUNMEDSH
IJNUMMCHUKM
Participating Sites……….12
RESULTS OF
INTERIM ANALYSIS
as of 15th June 2007
Number of PCI registered (online) by Source Data Providers (SDP)
18.7
51.8
12.8 14.5
1.2 1.0
0.0
10.0
20.0
30.0
40.0
50.0
60.0
Perc
enta
ge o
f PC
I (%
)
Total PCI = 1,249 as of 15th June 2007
SDPUMMC IJN SGH HSA,JB Selangor
MCHUKM
No of PCI by SDP based on Monthly Census
332515054704760PH
401
32
31
242
36
Jan
305
27
19
175
37
Feb
429
38
46
215
60
Mar
389
43
8
240
44
Apr
393
29
33
232
49
May
432
53
36
235
57
June
2349Total
222HSAJB
173SGH
1339IJN
283UMMC
TotalSDP
Patient’s Demographics
90.95 %Malaysian81.91 %Male
23, 86 yrs56.42 +10.1yrs
Age Min, Maxmean + sd
Baseline n=1,249
0.32 %Foreigner4.80 %Other Malaysian23.38 %Indians25.94 %Chinese44.60 %Ethnic : Malay
* For 12 cases, there is no information on ethnicity
* Other Malaysians include Sikh, Iban, Kadazan Dusun, Orang Asli, Melanau, Murut, Bajau, Bidayuh
Percentage of Ethnic Groups
Chinese, 25.94%
Indians, 23.38%
Other Malaysian, 4.80%
Foreigner, 0.32%
Malay, 44.60%
* Other Malaysians include Sikh, Iban, Kadazan Dusun, Orang Asli, Melanau, Murut, Bajau, Bidayuh
3
Clinical Background & CV Risk Factors
6.7 %Chronic renal failure1.5 %Peripheral vascular disease2.3 %Cerebrovascular disease0.3 %Chronic Lung Disease4.2 %CHF (> 2 weeks prior)
27.0 %New onset angina (< 2 weeks)44.4 %Documented CAD35.6 %MI history19.0 %Family History of premature CVD10.7 %Insulin73.1 %OHA42.8 %Diabetes70.5 %Hypertension70.3 %Dyslipidaemia
Baseline (n=1,249)
Total PCI = 1,249 as of 15th June 2007
Previous Revascularization
3.1 %Previous CABG
22.10 %Previous PCIBaseline (n=1,249)
Clinical Presentation
26.3 %Unstable Angina22.7 %NSTEMI48.4 %STEMI
24. 4 %Acute Coronary Syndrome (n=304)Baseline (n=1,249)
* For 8 cases, the information on ACS stratum are not available
PCI status
2.08 %Missing3.20 %Primary2.32 %Rescue 5.04 %Urgent (NSTEMI/UA)
87.35 %25.4 %
Elective (n =1,091)Staged PCI
Baseline (n=1,249)
Total PCI = 1,249 as of 15th June 2007
96.32 %Clopidogrel94.08 %Aspirin0.16 %Bivalirudin4.16 %Ticlopidine6.73 %LMWH75.82 %Heparin 5.68 %II b/ III a blockade5.04 %Thrombolytics
Adjunctive pharmacotheraphy PCIBaseline (n=1,249)
Total PCI = 1,249 as of 15th June 2007
Percutaneous entry
4.72 %Missing1.52 %Multiple site
59.33 %Femoral 33.87 %Radial 0.56 %Brachial
Baseline (n=1,249)
Total PCI = 1,249 as of 15th June 2007
Extent of coronary diseaseBaseline (n=1,249)
2.17 %Missing0.24 %Left Main 1.04 %Graft
55.40 %Multiple vessel disease 41.15 %Single vessel disease
Lesion characteristics
5.55 %Missing4.94 %In stent restenosis0.27 %Restenosis
0.22 %Acute stent thrombosis 89.02 %De novo
Baseline (n=1,821)
Total Lesion= 1,821 as of 15th June 2007
Lesion type
37.62 %C6.42 %Missing
17.02 %B226.63 %B112.30 %A
4
25.00 %Proximal
12.50 %Anastomosis25.00 %Distal18.75 %Mid
12.50 %OstialLocation in Graft (n=16)
Total Lesion= 1,821 as of 15th June 2007
Graft PCI….
* For 1 case, the information on Location in Graft PCI is not available
9.50 %Bifurcation 3.13 %CTO < 3 months6.75 %CTO > 3 months3.62 %Thrombus
60.79 %Others
6.97 %OstialLocation description
Total Lesion= 1,821 as of 15th June 2007
Total Lesion= 1,821 as of 15th June 2007
Procedural Characteristics
3.73 %Direct stenting
15.21 + 3.69Max stent/balloon deploy pressure (atm)
3.01+ 0.60Max balloon size (mm)
14.1 %Other stent (not specified)
Stent type
2.4 %Antibody coated -Bio-absorbable stent
40.0 %BMS49.1 %DES
Baseline (n=1,821)
3.0 + 0.46Stent diameter (mm)22.35 + 7.37Stent length (mm)
46.5
37.9
0 2.3
13.3
0
510
15
2025
30
3540
4550
Perc
enta
ge (%
)
DES BMS Bio-absorbable
Antibodycoated
Others
STENT
Type of stent used (n=1923)
Total Stent, n= 1,923 as of 15th June 2007
Other stents refer to stents other than listed in the Reference Stent List
1.65 %Cutting balloon34.93 %DES
-Flowire2.58 %IVUS0.55 %Rotablator
0.82 %Drug eluting balloon0.22 %Distal embolic protection (n=4)
44.43 %BMS
4.17 %Others
9.01 %Balloon only1.98 %Unsuccessful
Intracoronary devices used (total no of lesions treated)
Total Lesion= 1,821 as of 15th June 2007
Baseline (n=1,821)Procedural Characteristics
Target Vessel Complications
13.33Missing
89.62 %Angio success
0.16 %Perforation
1.65 %No Reflow (n=30)
73.34Transient
13.33Persistent
0.38 %Acute closure
3.73 %Dissection
Baseline (n=1,821)
5
0.08 %TIA/Stroke0.00 %Tamponade0.24 %Contrast reaction0.56 %New onset/ worsened HF0.16 %New renal impairment
0.80 %Cardiogenic shock0.64 %Arrhythmia (VT/VF/Brady)
-Bail out CABG
0.88 %72.70 %45.50 %18.20 %
Emergency Reintervention (n=11)Stent thrombosisDissectionOthers
0.80 %Periprocedural MI
Procedural ComplicationsBaseline (n=1,249)
Total PCI n= 1,249 as of 15th June 2007
5.26 %15.79 %63.16 %15.79 %
MinorMajorMinimalNA
85.99 %No
1.52 %Bleeding
Yes (n=19)
Vascular Complications
* For 156 cases, the information on Bleeding complication are Missing
In-hospital Outcome
-Lost to FU7.69 %Missing
1.36 %Death90.95 %Alive
OutcomeBaseline (n=1,249)
Total PCI, n= 1,249 as of 15th June 2007
82.35 %Out of Lab11.76 %In lab
23.53 %MissingLocation
5.88 %Pulmonary70.59 %Cardiac
Cause of death
45.00 %Others1.12 %Warfarin
11.69 %ARB46.28 %ACE inhibitor60.61 %Beta blocker
14.17 %Ticlopidine80.06 %Statin
85.67 %Clopidogrel85.11 %Aspirin
Medications at discharge
Baseline (n=1,249)
Total PCI, n= 1,249 as of 15th June 2007
Percentage of 30 days Follow Up completed by Source Data Providers (SDP)
16.73
32.17
19.85
29.23
2.02
0
5
10
15
20
25
30
35
Per
cent
age
(%)
Total 30 daqy FU completed = 544 as of 15th June 2007
SDPUMMC IJN SGH HSA,JB
SelangorMC
Outcome at 30 days Follow Up
1.84 %Lost to FU0.55 %Missing
0.37 %Death97.24 %Alive
Outcome
N=544 as of 15th June 2007
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At 30 days…….
3.13 %Missing21.87 %Others
5.88 %
56.25 %PCI – planned15.62 %Recurrent Angina3.13 %CHF
Readmission (n = 32)
67.65 %Others
65.63 %Clopidogrel4.23 %Ticlopidine
93.01 %AspirinMedication
30 days (n= 544)
Total 30 days FU, n= 544 as of 15th June 2007
SummaryFuture plan :
♥ More participation from other sites/centres♥ Data verification at sites; capture, missing cases?
Censored cases?♥ Events abjudication♥ Research : retrospective subgroup analysis♥ Collaboration : procedural outcomes compared to other
centres; Are we comparable to other established centres/registries? If equal footing, we can use as competitive edge to lobby for international PCI trials to give us a chance.
♥ Cost Implications : Pattern of practice, helatheconomics, useful for policymakers; Justify for funding main to maintain registry
♥ NHAM advisory regarding : Combination of antiplatelets compliance; Action group to address issue of PPCI, DBT, etc.
♥ Clinical practice guidelines formulation
Acknowledgement
♥ Melbourne Interventional Group (MIG),
Australia
♥ Clinical Research Centre
♥ National Heart Association of Malaysia
♥ Datamed Computing Services Sdn. Bhd.
♥ ClinResearch Sdn. Bhd.
Last but not the least…………
THANK YOU to all those participating centres who had and will continue contributing to NCVD …….
THANK YOU
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