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)

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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