Diabetes Mellitus & Multi vessel disease-part 1

Diabetes AndDiabetes And Multivessel Disease Multivessel Disease

Dr. Dev Pahlajani MD,FACC,FSCAI

Chief of Interventional Cardiology, Breach Candy Hospital, Mumbai

www.cardiositeindia.com

DIABETES EPIDEMIOLOGY


8.0

• About 150 million diabetic patients worldwide, expectedAbout 150 million diabetic patients worldwide, expectedto double by 2025 to double by 2025

• One million new patients diagnosed in the US each yearOne million new patients diagnosed in the US each year

• Prevalence in Europe ~5% to ~7%, expected to doublePrevalence in Europe ~5% to ~7%, expected to doublein next 25 years. in next 25 years.

The Diabetes Epidemic

Amos AF et al. Diabetic Medicine 1997; 17: S7-S85Mak KH et al. European Heart Journal 2003; 24: 1087-1103

IDF (International Diabetes Federation - 2000)

2.0 4.0 6.0

3.1UK

0-5% in Western Europe5-8% in Southern Europe

0.0

3.6Netherlands

7.1Italy

4.2Germany

4.0France

4.1Belgium

(%)


WORLD CAPITAL OF DIABETES WORLD CAPITAL OF DIABETES

India was the expected world capital of DM India was the expected world capital of DM

China has overtaken India to wrest the title of the ‘diabetes China has overtaken India to wrest the title of the ‘diabetes

capital of the world', going by the latest figures revealed by the capital of the world', going by the latest figures revealed by the

5th edition of Diabetes Atlas5th edition of Diabetes Atlas

At 90.0 million, China today has the largest number of people At 90.0 million, China today has the largest number of people

with diabetes. with diabetes.

India follows with about 61.3 millionIndia follows with about 61.3 million

The third on the list is far behind – United States at 23.7 million.The third on the list is far behind – United States at 23.7 million.


Global Burden of Diabetes Top 10 Countries With Diabetics (20-79 Years Of Age)

Country 2011 [Millions]

Country 2031[Millions]

China 90.0 China 129.7

India 61.3 India 101.2

USA 23.7 USA 29.6

Russian Federation 12.6 Brazil 19.6

Brazil 12.4 Bangladesh 16.8

Japan 10.7 Mexico 16.4

Mexico 10.3 Russian Federation 14.1

Bangladesh 8.4 Egypt 12.4

Egypt 7.3 Indonesia 11.8

Indonesia 7.3 Pakistan 11.4www.cardiositeindia.com

Multivessel disease in Diabetes

Balloon EraBalloon Era

BMS EraBMS Era

DES EraDES Era


Bypass Angioplasty Bypass Angioplasty Revascularization Investigation Revascularization Investigation

(BARI) Trial (BARI) Trial


BYPASS ANGIOPLASTY REVASCULARISATION BYPASS ANGIOPLASTY REVASCULARISATION INVESTIGATION (BARI)INVESTIGATION (BARI)

New Engl Jour Of Med 1996 (335): 217-225New Engl Jour Of Med 1996 (335): 217-225 Comparison of Coronary Bypass Surgery with Angioplasty in Comparison of Coronary Bypass Surgery with Angioplasty in

Patients with Multivessel DiseasePatients with Multivessel Disease 914 assigned to CABG914 assigned to CABG 915 assigned to PTCA915 assigned to PTCA Similar Similar

Demographic FeaturesDemographic Features Angiography FindingsAngiography Findings EFEF

Equally Distributed Co morbid Features Equally Distributed Co morbid Features


BARI: 5 Year MortalityDiabetic vs. Non-Diabetic Patients

Circulation 1997; 96: 1761-1769

40

30

Mor

talit

y (%

)

10

Diabetics Non-diabetics

Non-CV death

20

9

PTCA PTCACABG CABG

CV death

19

10

34

55

24

10

05

9 4

10

5


o Benefit only in CABG patients with internal mammary Benefit only in CABG patients with internal mammary arteryartery

o Greatest difference seen in diabetics treated with insulinGreatest difference seen in diabetics treated with insulin

o Difference due to a reduced mortality in patients with a Difference due to a reduced mortality in patients with a subsequent AMIsubsequent AMI

BARI study: Mortality in Diabetic Patients

“Diabetics with multi-vessel diseaseshould undergo CABG”


BARI Registry: No Difference in Long-term Outcome in Diabetics Treated by PTCA or CABG

Feit F et al, Circulation 2000;101:2795

100

80

0

20

70

1 2 3 4 5

40

60

6

CABG Patients PTCA Patients

Surv

ival

(%)

Registry (85.8)

Randomized (84.4)

100

80

0

20

70

1 2 3 4 5

40

60

6Su

rviv

al (%

)

Registry (86.1)

Randomized (80.9)

No. of patients No. of patients

Registry 625 590 436

Random. 914 860 590

Registry 1189 1124 769

Random. 915 842 579

569

814

1091

790

Unadjusted p<0.01Adjusted p=0.16

Unadjusted p=0.57Adjusted p=0.66

“PTCA is a safe alternative to CABG in diabetics when they are properly selected”


The BARI Investigators, J Am Coll Cardiol 2007;49:1600-1606

Cumulative Number of Subsequent Revascularization Procedures per 100 Patients by Randomization


PCI

CABG


Cumulative Number of Subsequent Revascularization Procedures per 100 Patients by Randomization

PCICABG


Overall Survival by Randomized Treatment Stratified by Diabetes Status



Overall Survival and Survival Free of Q-Wave MI by Randomized Treatment


Rates of Survival and Freedom from Major Cardiovascular Events, According to PCI and CABG Strata.

Source: The BARI 2D Study Group. N Engl J Med 2009;360:2503-2515.www.cardiositeindia.com


10-Year Survival Rates for Patients According to Subgroups Based on Characteristics at

Study Entry



Percent of Surviving Patients With Stable or Unstable Angina at Each Follow-Up by

Randomization



Freedom From Cardiac Death and Freedom From Cardiac Death or Any MI by Randomized Treatment


Diabetes is a Predictor of Late LossDiabetes is a Predictor of Late Loss

Late Loss vs. % of Diabetics in Bare (non-DES) Stent Study

1

0.80.97

0.7

0.83

0.9

0.93 1.19

0.54

0.98

0.6

0

5

10

15

20

25

30

0 0.5 1 1.5

Late Loss in mm.

% o

f Dia

betic

s in

the

stud

y

Series1

Trial LL

mm

% DM

Sirius-Ctrl/8mo. 1 28.2

Ravel-Ctrl/6mo. 0.8 21

Venus-6mo 0.97 23.4

Velvet-6mo 0.7 10.7

Vision-6mo 0.83 23

Penta-6mo 0.9 18.5

Multi-Link-ISAR2 -6mo 0.93 22

BX ISAR2 1.19 22.2

Bstent Heprincoated 0.54 12.2

Deliver Bare 0.98 26.8

Orbit 0.6 13.3www.cardiositeindia.com

Arterial Revascularization Arterial Revascularization Therapies Study (ARTS) Trial Therapies Study (ARTS) Trial


ARTS I

The primary objective of ARTS I was to compare intra-The primary objective of ARTS I was to compare intra-

coronary stenting to bypass surgery in patients with coronary stenting to bypass surgery in patients with

multivessel diseasemultivessel disease

Effectiveness was measured in terms of Major Cardiac Effectiveness was measured in terms of Major Cardiac

and Cerebrovascular Events (MACCE) – free survival at and Cerebrovascular Events (MACCE) – free survival at

one year one year


ARTS I – Patient FlowARTS I – Patient Flow

600600 INTENTION TO TREAT 605605

1 Medical Treatment only Medical Treatment only 3

6

Cross–over3 consent withdrawal2 LM disease1 inappropriate selection

Cross-over8 consent withdrawal8 exclusion criteria1 miscommunication1 QMI on waiting list1 UAP on waiting list

19

133 urgent CABG10 elective CABGwithin hosp stay

2 PTCAwithin hosp stay 2

580580(97%)(97%)

Successful treatment according to randomisation 581581(96%)(96%)

STENT CABG


ARTS IMACCE (30 day follow-up)ARTS IMACCE (30 day follow-up)

CABGCABG(605)(605)

StentStent(600)(600)

Death 8+3* 1.8% 9 1.5%

CVA 7+1 * 1.3% 5 0.8%

AMI (Q) 13+4* 2.8% 15+1* 2.7%

Re-CABG 2 0.3% 12 2.0%

Re-PTCA 3 0.5% 10 1.7%

Total 41 6.8% 52 8.7%**Events prior to assigned treatmentEvents prior to assigned treatment


The Stent Era: ARTS I Study

Abizaid A. Circulation 2001;104:533

• Less favorable long-term outcome with stenting in DMLess favorable long-term outcome with stenting in DM• 1-year mortality rate: 6.4% vs. 3.1%1-year mortality rate: 6.4% vs. 3.1%• Reduced rate of revascularization compared to balloon PTCAReduced rate of revascularization compared to balloon PTCA

CABG: Non Diabetes CABG: DiabetesStent: Non Diabetes

100

85

0

95

60

Eve

nt-

free

sur

viva

l (%

)

65

75

60 120 180 240 300 360Days after randomization

90

80

70

Stent: Diabetes

88.4%84.4%

76.2%

63.4%


ARTS I DIABETICSARTS I DIABETICS

Death/CVA/MI/CABG/RE- PTCA

DIABETIC SUBGROUP Repeat revascularization was higher in diabetic patients

randomized to the stent arm vs. CABG(42.9% VS 10.9%) Compared to non diabetic patients(27.5% vs 8.4%) Based on the available evidence, surgery should continue

to be viewed as the preferred therapy for diabetic patients with multivessel disease when using bare metal stents.

JACC, 2005, 46, 575-81www.cardiositeindia.com

0 150 300 450 600 750 900 1050 1200

100

80

60

40

20

0

Even

t Fr

ee S

urv

ival (%

)

Days since randomization

ARTS Trial (CABG v. PCI)Three year follow-up

ARTS Trial (CABG v. PCI)Three year follow-up

99.5%98.5%

97.5%97.2%

97.2%96.4%

96.3%95.5%

PCI

CABG

p=0.08 Log Rankp=0.09 FisherDeath


0 150 300 450 600 750 900 1050 1200

100

80

60

40

20

0

Even

t Fr

ee S

urv

ival (%

)


ARTS Trial (CABG v. PCI)Three year Follow-up


96.0%95.5%

91.2%90.3%

89.8%89.2%

88.8%87.0%

CABG

PCI

p=0.58 Log Rankp=0.62 Fisher

Death AMI CVA


0 150 300 450 600 750 900 1050 1200

100

90

80

70

60

50

Even

t Fr

ee S

urv

ival (%

)




91.8%

87.8%85.0%

83.6%

CABG

p=0.005 Log Rankp=0.006 FisherDeath AMI CVA CABG Re-PCI

PCI

73.5%

69.5%65.7%

95.7%


0 150 300 450 600 750 900 1050 1200

100

90

80

70

60

50

Even

t Fr

ee S

urv

ival (%

)


ARTS Trial (CABG v. PCI)Three year Follow-up (Diabetic subgroup)

ARTS Trial (CABG v. PCI)Three year Follow-up (Diabetic subgroup)

92.7%

CABG

p=0.0001 Log Rankp<0.0001 Fisher

CABG Re-PCIPCI

61.6%

Death, AMI, CVAPCI = CABG



Death/CVA/MI/CABG/RE- PTCADeath/CVA/MI/CABG/RE- PTCA

DIABETIC SUBGROUPDIABETIC SUBGROUP

• Repeat revascularization was higher in diabetic patients Repeat revascularization was higher in diabetic patients randomized to the stent arm vs. CABG(42.9% VS 10.9%)randomized to the stent arm vs. CABG(42.9% VS 10.9%)

• Compared to non diabetic patients(27.5% vs 8.4%)Compared to non diabetic patients(27.5% vs 8.4%)• Based on the available evidence, surgery should continnue Based on the available evidence, surgery should continnue

to be viewed as the preferred therapy for diabetic patients to be viewed as the preferred therapy for diabetic patients with multivessel disease when using bare metal stentswith multivessel disease when using bare metal stents..

JACC, 2005, 46, 575-81www.cardiositeindia.com

ARTS IIARTS II

PRIMARY OBJECTIVE To compare the effectiveness of coronary stent To compare the effectiveness of coronary stent

implantation using the Sirolimus drug eluting Bx Velocity™ implantation using the Sirolimus drug eluting Bx Velocity™ stent with that of surgery as observed in ARTS Istent with that of surgery as observed in ARTS I

Effectiveness will be measured in terms of Major Cardiac Effectiveness will be measured in terms of Major Cardiac and Cerebrovascular Events (MACCE) – free survival at 30 and Cerebrovascular Events (MACCE) – free survival at 30 days and six monthsdays and six months


Sirolimus Coating Modulates neointimaSirolimus Coating Modulates neointimain 30-Day Porcine Coronary Modelin 30-Day Porcine Coronary Model

Control + Sirolimus


ARTS II

CABG(n=605)

CROWN™ & CrossFlex LC™

(n=600)

ARTS I

Randomization

CYPHER®

(n=607)

ARTS II: Study Design

Serruys P. et al., JACC 2005 (Sunday March 6th); Oral Presentation.

Single arm, multicenter Single arm, multicenter trialtrial 607 patients in 45 centers607 patients in 45 centers from 19 countries from 19 countries Main goal of the ARTS II trial is to demonstrate non-Main goal of the ARTS II trial is to demonstrate non-

inferiority in clinical effectiveness and cost-effectiveness with inferiority in clinical effectiveness and cost-effectiveness with the CYPHERthe CYPHER®® stent compared to the previous results of the stent compared to the previous results of the ARTS I trialARTS I trial


Bare Metal Stent

2.8 stents per patientAvg total length: 48

mmn = 600

Sirolimus-eluting stent3.7 stents per patient

Avg total length: 73 mmn = 607

ARTS-II TrialARTS-II Trial

ACC 2005

Historical Controls from ARTS I: 1202 patients with multivessel coronary

lesions 18.2% diabetic

28% 3 vessel disease7.5% type C lesions

607 patients with multivessel coronary lesions

26.2% diabetic54% 3 vessel disease13.9% type C lesions

CABG

n = 602

Endpoints: Primary – Major adverse cardiac and cerebrovascular events (MACCE),

including death, cerebrovascular event, myocardial infarction, and revascularization, at 1 year for the comparison of CABG treated patients in the ARTS I trial with sirolimus-eluting stent patients in the ARTS II trial

Secondary – MACCE at 30 days, 6 months, 3 and 5 years.

– Total cost at 30 days

– Cost, cost effectiveness, quality of life at six mo, and 1, 3, and 5 years www.cardiositeindia.com

ARTS II – Diabetic population (MACCE at 1y)

36.614.615.7Any MACCE (%)

14.33.19.4(re) PCI (%)

8.01.03.1(re) CABG (%)

2.1

5.2

3.1

ARTS I (CABG)(n=96)

0.6

0.0

2.5

ARTS II(n=159)

6.3

1.8

6.3

ARTS I (PCI)(n=112)

MI (%)

Hierarchical MACCE up to 1 year

CVA (%)

Death (%)

No significant difference in MACCE (p=0.86) between ARTS IIand ARTS I (CABG)

Significant difference in MACCE (p=<0.001) between ARTS IIand ARTS I (PCI)

Morice M-C. EuroPCR 2005.

3.1} 10.4}12.5} 4.1}


26.511.610.4Any MACCE (%)

12.33.05.4(re) PCI (%)

4.70.72.0(re) CABG (%)

3.5

1.8

2.7

ARTS I (CABG)(n=602)

1.2

0.8

1.0

ARTS II(n=607)

5.0

1.8

2.7

ARTS I (PCI)(n=600)

MI (%)

Hierarchical MACCE up to 1 year

CVA (%)

Death (%)


3.0} 8.0}7.4} 3.7}

ARTS II - MACCE up to ARTS II - MACCE up to 1 year*1 year*

* Complete follow-up in 97% Morice M-C. EuroPCR 2005.

More extensive disease in ARTS II(% diabetes, 3-vessel involvement, lesions/patients) than ARTS I


ARTS II : Event free survivalAt one year, there was no difference in event-free survival between the one year, there was no difference in event-free survival between the ARTS II SES group and the ARTS I CABG group. However, the ARTS II ARTS II SES group and the ARTS I CABG group. However, the ARTS II group showed significantly higher rates of survival free from cardiac group showed significantly higher rates of survival free from cardiac death, MI, and reintervention than the ARTS I bare metal stent group. The death, MI, and reintervention than the ARTS I bare metal stent group. The groups were not significantly different in the primary endpoint of survival groups were not significantly different in the primary endpoint of survival free from MACCE.free from MACCE.

0

20

40

60

80

100

ARTS II : DES ARTS I : BMS ARTS I : CABG

Survival free fromDeath/CVE/MI

Survival free fromreintervention

Survival free fromMACE

96.9

90.7

92.0

91.5

78.1

95.9

89.5

73.7

88.5

P = < 0.001P = 0.003

P = 0.46


ARTS II studyARTS II study


ARTS II – Diabetic population

3.0 ± 1.5-3.6 ± 1.5# of stents implanted

Procedural characteristics

53-74Total stent length (mm)

2.5+1.12.8 ± 0.83.2 ± 1.2# of treated lesions

2.9+1.23.0 ± 1.13.6 ± 1.3# of lesions > 50% DS

-

8

15

6

ARTS I (CABG)patients (96)lesions (290)

12-179

17

33

15

ARTS IIpatients (159)lesions (568)

14-165

7

13

6

ARTS I (PCI)patients (112)lesions (309)

Type C lesions (%)

Range

Lesion characteristics(main differences)

Calcified lesion (%)

Lesion length > 20mm (%)


More extensive disease in ARTS II diabetic patients than ARTS I CABG


ARTS – 5 Yrs Outcome Major Adverse Cardiac Events ARTS – 5 Yrs Outcome Major Adverse Cardiac Events At 5 Years In Patients Without Diabetes Stratified At 5 Years In Patients Without Diabetes Stratified

According To TreatmentSTENTSTENT BYPASSBYPASS

NON-DIABETICNON-DIABETIC NON-DIABETICNON-DIABETIC STENT VS STENT VS

N = 488N = 488 N = 509N = 509 RELATIVE RISKRELATIVE RISK CABG CABG

N (%)N (%) N (%)N (%) (95% CI)(95% CI) p p VALUEVALUE

(RE) CABG(RE) CABG 46 (9.4) 46 (9.4) 5 (1.0)5 (1.0) 9.60 (3.85 – 23.95)9.60 (3.85 – 23.95) < 0.001 < 0.001

(RE) PTCA(RE) PTCA 105 (21.5)105 (21.5) 41 (8.1)41 (8.1) 2.67 (1.90 – 3.75)2.67 (1.90 – 3.75) < 0.001 < 0.001

ANY REVASC-ANY REVASC- 134 (27.5)134 (27.5) 43 (8.4)43 (8.4) 3.25 (2.36 – 4.48)3.25 (2.36 – 4.48) < 0.001 < 0.001

ULARISATIONULARISATION

ANY MACCEANY MACCE 189 (38.7)189 (38.7) 108 (21.2)108 (21.2) 1.83 (1.49 – 2.23)1.83 (1.49 – 2.23) < 0.001 < 0.001 P. W. SERRUYSJACC 2005www.cardiositeindia.com

ARTS II : Summary• Among patients with multivessel coronary lesions, patients

treated with sirolimus eluting stents had significantly lower rates of MACCE compared with a historical registry of similar patients treated with bare metal stents and rates of MACCE statistically equivalent to patients from the same registry treated with CABG.

• The majority of the differnce in MACCE between the ARTS II and ARTS I BMS groups was driven by the increased need for repeat revascularization in the bare metal stent group. The ARTS II group had equal rates of revascularization to the ARTS I CABG group, despite having increased length and complexity of lesions.

• While this historical registry comparison is promising and statistical measures were used to adjust for co-founding variables, a randomized trial is needed to adequately determine the superiority of one therapy over another.


Short & Long Term Results After Short & Long Term Results After Multivessel Stenting In Diabetic Multivessel Stenting In Diabetic PatientsPatients


Short & Long Term Results After Short & Long Term Results After Multivessel Stenting In Diabetic PatientsMultivessel Stenting In Diabetic Patients• Prospective data base of CRF 1993-1999Prospective data base of CRF 1993-1999

• 689 consecutive patients689 consecutive patients

• 1639 stents1639 stents

• 501 (1200 lesions) – no DM501 (1200 lesions) – no DM

• 102 (235 lesions) oral agents102 (235 lesions) oral agents

• 86 (204 lesions) insulin86 (204 lesions) insulin

R. MEHRANJACC 2004www.cardiositeindia.com

MULTISTENTING IN DIABETICSIN-HOSPITAL OUTCOMES OF PATIENTS / LESIONS NO DM NIDDM IDDM

(N= 560/1428) (N = 114/284) (N = 81/213)p VALUE

ANGIOGRAPHIC

SUCCESS (%) 99.8 99.0 100 0.47

ABRUPT

CLOSURE (%) 1.3 0.4 0 0.13

QMI (%) 0 0 0 NA

NON QMI (%) 27 28 21 0.51R. MEHRAN

JACC 2004www.cardiositeindia.com

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1.0

0 100 200 300 400

TIME IN DAYS

SU

RVIV

AL

P < 0.001No DM

DM treated with oral agent

DM treated with Insulin

MULTIVESSEL STENTING IN DIABETICSMULTIVESSEL STENTING IN DIABETICS

R. MEHRAN ET ALJACC 2004, 43, 1348www.cardiositeindia.com

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1.0

0 100 200 300 400

TIME IN DAYS

EV

EN

T F

RE

E S

UR

VIV

AL

P < 0.001No DM

DM treated with oral agent

DM treated with Insulin

MULTIVESSEL STENTING IN DIABETICSMULTIVESSEL STENTING IN DIABETICS

R. MEHRAN ET ALJACC 2004, 43, 1348www.cardiositeindia.com

Comparison of Outcome Using Sirolimus-Eluting Stenting in Diabetic Versus Non

diabetic Patients With Comparison of Insulin Versus Non-Insulin Therapy in

the Diabetic PatientsRamon Kumar, MDa, Tobias T. Lee, MDa, Allen Jeremias, MDa, Christopher P. Ruisi, MDa, Brett Sylvia, BSa, Jorge Magallon, MDa,

Ajay J. Kirtane, MDa, Brian Bigelow, MDa, Martin Abrahamson, MDb, Duane S. Pinto, MDa, Kalon K.L. Ho, MD MSca, David J.

Cohen, MD, MSca, Joseph P. Carrozza, Jr., MDa, and Donald E. Cutlip, MDa

Am J. Cardiol 2007;100:1187www.cardiositeindia.com

Comparison of Sirolimus Stent in DM Vs NDM - Insulin VS Non Insulin

Therapy

• 297 pts. With DM297 pts. With DM• 115 on Insulin115 on Insulin• 541 Non DM541 Non DM• All received Sirolimus StentAll received Sirolimus Stent

Am.J.Card.2007


CAD / Insulin TREATED & Siro Stent OutcomeNine-month clinical events :

diabetic versus non diabetic patients

0.800.80 6 (1.2 %)6 (1.2 %) 5 (1.8 %)5 (1.8 %)Cardiac deathCardiac death

0.0020.00228 (5.6 %)28 (5.6 %)33 (11.8 %)33 (11.8 %)MACEsMACEs

NoNo(n = 541)(n = 541)

YesYes(n = 297)(n = 297)

P P ValueValueDiabetes MellitusDiabetes MellitusEventsEvents


CAD / Insulin Treated & Siro Stent OutcomeNine-month clinical events : insulin-treated patients versus

others

0.570.57 3 (1.7 %) 3 (1.7 %) 3 (2.6 %)3 (2.6 %)Stent ThrombosisStent Thrombosis

0.040.0412 (7.1 %)12 (7.1 %)14 (13.3 %)14 (13.3 %)TLRTLR

0.010.01 9 (5.2 %)9 (5.2 %)11 (10.1 %)11 (10.1 %)Cardiac death or MICardiac death or MI

0.060.06 8 (4.6 %)8 (4.6 %) 9 (8.2 %)9 (8.2 %)MIMI

0.0060.006 1 (0.6 %)1 (0.6 %) 4 (3.7 %)4 (3.7 %)Cardiac deathCardiac death

0.0010.00114 (8.2 %)14 (8.2 %)19 (17.5 %)19 (17.5 %)MACEsMACEs

NoNo(n = 182)(n = 182)

YesYes(n = 115)(n = 115)

P ValueP ValueInsulin TherapyInsulin TherapyEventsEvents


Influence of DM on Outcomes-ST in Asian Patients

856 with DM

2295 no DM

All received DES

Death, Non fatal MI,TVR

Park et al Am.J.Card.2009,103,2079


0

10

20

30

40

0

1

2

4

0 365 730 1095

No. at RiskDiabetes 865 730 457 195 Non-diabetes 2295 2057 1339 561

0 365 730 1095

No. at RiskDiabetes 865 842 560 247 Non-diabetes 2295 22487 1520 674

Even

t rat

es (%

)

Even

t rat

es (%

)

Follow-up (days) Follow-up (days)

Log Rank P=0.34 Log Rank P=0.34

DiabetesNon-diabetes

DiabetesNon-diabetes

Kaplan-Meir survival curve of primary composite end point and stent thrombosis

(definite or probable)

Park et al Am J. Cardiol 2009, 103;646www.cardiositeindia.com

Adjusted hazard ratios for clinical outcomes and stent thrombosis in diabetic patients who do (A) and do not (B) require insulin therapy versus

non-diabetic patientsPark et al Am j. Cardiol 2009, 103;646

Death

MI

TLR

TVR

Death or MI

Death, MI or TVR

ST (decline or probable

ST (any ARC criteria)

2.77 (1.55-4.95)

1.01 (0.54-1.89)

1.36 (0.77-2.39)

1.72 (1.02-2.88)

1.66 (1.09-2.53)

1.65 (1.17-2.32)

0.99 (0.20-4.92)

1.75 (0.77-3.96)

0.001

0.97

0.29

0.04

0.02

0.004

0.99

0.20

Non-diabetics vs. insulin-treated diabetesAdjusted HR (95 % CI) P value

Adjusted Hazard Ratio (95 % CI) 0.1 1 10

A


Adjusted hazard ratios for clinical outcomes and stent thrombosis in diabetic patients who do (A) and do not (B) require insulin therapy versus

non-diabetic patientsPark et al Am j. Cardiol 2009, 103;646

Death

MI

TLR

TVR

Death or MI

Death, MI or TVR

ST (decline or probable

ST (any ARC criteria)

0.66 (0.52-1.45)

1.05 (0.74-1.49)

0.94 (0.67-1.32)

1.23 (0.91-1.67)

0.99 (0.74-1.31)

1.08 (0.87-1.35)

0.62 (0.21-1.88)

0.74 (0.36-1.52)

0.58

0.79

0.72

0.18

0.92

0.47

0.40

0.41

Non-diabetics vs. Non insulin-treated diabetesAdjusted HR (95 % CI) P value

Adjusted Hazard Ratio (95 % CI) 0.1 1 10

B


ENDEAVOR IV - DM


ENDEAVOR IV: Diabetics ENDEAVOR IV: Diabetics Baseline CharacteristicsBaseline Characteristics

Endeavor (241)

Taxus (236)

P value

Age (yrs) 64.2 63.8 0.679

Male (%) 59.8 61.0 0.780

History of Smoking (%) 54.4 53.8 0.926

Family History CAD (%) 43.9 42.1 0.917

Diabetes (%) 100.0 100.0 N/A

IDDM (%) 33.2 27.1 0.163

Hypertension (%) 90.5 90.7 1.000

Hyperlipidemia (%) 83.8 90.3 0.041


ENDEAVOR IV - DM

JACC Intv. 2009, 2, 967www.cardiositeindia.com

Endeavor Clinical program

• Endeavor shows remarkable consistency in clinical outcomes

9 month results

EI n=100 EII n=591 EIICA n=289

EIII n= 316

Combined N=1296

MACE (%) 2.0 7.3 10.4 7.6 7.6

TLR (%) 2.0 4.6 4.8 6.3 4.9

TVF (%) 2.0 8.0 13.1 12.0 9.7


www.cardiositeindia.comwww.cardiositeindia.com

ENDEAVOR IV: Diabetics vs Non-diabetics ENDEAVOR IV: Diabetics vs Non-diabetics Clinical Results to 12 monthsClinical Results to 12 months

Diabetes(477)

Non Diabetes(1071) P value

Death (all) - % (#) 0.4% 1.4% 0.171

Cardiac 0.4% 0.6% 1.000

MI (all) - % 0.9% 2.6% 0.030

Q Wave 0.0% 0.3% 0.557

Non Q Wave 0.9% 2.3% 0.063

Cardiac Death + All MI, % 1.3% 3.2% 0.035

Stent Thrombosis (all), % 0.7% 0.4% 0.444

TLR - % 6.4% 2.8% 0.002

TVR - % 9.0% 5.4% 0.012

MACE - % 7.0% 6.4% 0.651

TVF - % 9.6% 8.1% 0.367www.cardiositeindia.com

7.4% 6.9%

3.5%

10.8%

8.9%

5.8%

2.1%

8.6%

Rat

e

20/233 24/223 16/233 13/223

DiabeticsDiabetics

P P =0.53=0.53

P P =0.70=0.70

TVF TLR

Endeavor

Taxus

Non-diabeticsNon-diabetics

38/516 46/518

P P =0.43=0.43

P P =0.19=0.19

18/516 11/518

DiabeticsDiabetics Non-diabeticsNon-diabetics

477 diabetics (30.8% of E IV patients)477 diabetics (30.8% of E IV patients)

ENDEAVOR IV: Diabetics TVF and TLR at 12 months


DDENDEAVOR IV: ENDEAVOR IV: Demographics: Diabetics vs Non DiabeticsDemographics: Diabetics vs Non Diabetics

Diabetics (773)

Non-Diabetics (775)

P value

Age (yrs) 64.0 63.3 0.225

Male (%) 60.4 71.0 <0.001

History of Smoking (%) 54.1 64.8 <0.001

Family History CAD (%) 43.3 42.6 0.851

Diabetes (%) 100.0 0.0 N/A

IRDM (%) 30.2 0.0 <0.001

Hypertension (%) 90.6 76.8 <0.001

Hyperlipidemia (%) 87.0 81.3 0.007


1. The Endeavor stent is safe and effective in diabetic

patients with “workhorse lesions” (i.e., moderate lesion

complexity) compared to patients treated with the

TAXUS stent

2. Very long term safety surveillance will determine

whether very late stent thrombosis has been reduced

with the use of the Endeavor


ThankThank You!!You!!


Diabetes Mellitus & Multi vessel disease-part 1

Health & Medicine

Transcript of Diabetes Mellitus & Multi vessel disease-part 1