Is the Surgeon Obsolete?

Keith G Oldroyd

Clinical Director

Department of Cardiology

West of Scotland Regional Heart & Lung Centre

Golden Jubilee National Hospital

Is the Surgeon Obsolete?

Not quite yet…………?

“Surgery is the best intervention for severe coronary artery

disease”

DP Taggart. BMJ 2005; 330: 785-86

“The current tendency of some cardiologists to abandon the traditional multidisciplinary approach to multi-vessel coronary artery disease

effectively denies some patients the option of surgery and

consequently falls far short of best practice”

DP Taggart. Lancet 2006; 367: 1313

                    

 

                                                                              

1964

1977

PCI vs Isolated CABG1991 to 2006

0

10000

20000

30000

40000

50000

60000

70000

800001

99

1

19

92

19

93

19

94

19

95

19

96

19

97

19

98

19

99

20

00

20

01

20

02

20

03

20

04

20

05

20

06

PCICABG

CABG data for financial year: all PCI v NHS CABG

2006 data: Ludman

PCI Rate PMP(2000 to 2006)

1211 1263

1559

943

0

200

400

600

800

1000

1200

1400

1600

1800

England Scotland N. Ireland Wales

2000200120022003200420052006

2006 data: Ludman

Nombres de PCI dans certains pays EuropéensNombres de PCI dans certains pays Européens

0

500

1000

1500

2000

2500

3000

3500

4000

1997 1998 1999 2000 2001 2002 2003 2004 2005 2006

Par 106

habitantsGEGE

BEBE

UKUK

Bernard De Bruyne, Aalst, Belgium

74.1

21.6

3.8

0

20

40

60

80

100

% of all PCIs

1 2 3

Vessels Treated per case

2006 data: Ludman

Multi-vessel TreatmentMean = 1.28 vessels per case

CCAD E&W

Year%

ProcedureSuccess

% QMI % NQMI(stable)

% Em. CABGMortality

(%)

1997 92 1.2 1.1 0.89

1998 92 0.8 0.7 0.80

1999 90 0.57 0.48 0.61

2000 92 0.6 0.4 0.64

2001 94 0.5 0.4 0.75

2002 92(51 of 64)

0.57(49 of 64)

0.28(53 of 64)

0.54(53 of 64)

2003 92(62 of 73)

0.36(56 of 73)

0.29(64 of 73)

0.53(64 of 73)

2004 93.5(63 of 78)

0.30(57 of 78)

0.21(64 of 78)

0.56(66 of 78)

2005 90.2 0.24 0.12 0.59

2006 95.5 0.15 0.74 0.09 0.74

MACE - All PCIsAll Data from CCAD + Scotland

2006 data: Ludman

UK PCI Outcomes (all indications)

0.0

0.5

1.0

1.5

2.0

2.5

3.0

'91 '92 '93 '94 '95 '96 '97 '98 '99 '00 '01 '02 '03 '04 '05 '06

%Mortality

em CABG

2006 data: Ludman

STEMI - LMS occlusion

All as % No. SuccessPartial

successFail no comp

Re-PCI

QMIEm

CABGDeath

NSTEMI / UA no shock 13667 93.5 2.7 3.0 0.3 0.2 0.09 0.62

All STEMI

no shock3656 93.0 2.0 2.4 0.6 0.14 2.5

Primary PCI 2549 90.4 2.2 2.7 0.5 0.2 4.6

Rescue PCI 1187 91.1 1.9 2.6 0.4 0 4.8

Shock 430 65.6 4.1 2.2 0.5 0.93 30.2

PCI Outcomes 2006CCAD data only

2006 data: Ludman

Unprotected LMS(In hospital outcome)

2006 data: Ludman

All as % No. SuccessPartial

successFail no comp

Re-PCI

QMI Em CABG

Death

Unprotected LMS 583 86.8 4.5 0.9 0.3 0.51 0.17 7.0

All clinical presentations(including shock)

SIGN Guideline 96Management of stable angina

• Who is supposed to have CABG?– “Significant” LMS “should undergo CABG– 3 vessel disease “ should be considered for CABG to

improve prognosis, but where unsuitable be offered PCI”

• What is 3 vessel PCI– Single vessel PCI x 3

• What dictates suitability for CABG– Lesion morphology – NO!– Distal vessels – YES!– Co-morbidity – YES!– LV function – YES!

PCI vs CABG Trials

• 1205

•998

•450

•454

•611

•1829

•1052

•127

•1011

•392

•531

•Randomized

•n/a

•n/a

•1076

•2431

•611

•4100

•23,047

•302

•1011

•1033

•531

•Screen 1: Clinical Criteria

•7.3•2076•MASS-2

•9.0• 127•1409•ERACI

•3.6•27,975•RITA

• n/a

•~3-6

•8.0

•2.0

•7.3

•2.7

•7.7

•4.0

•% Original Pool

Randomized

•454

•392

•359

•Screen 3: Patient

Consent

• 450

•781

•842

•Screen 2: Physician Agreement

•n/a•ARTS

•17-30K•SoS

•5619•ERACI-2

•22,621•AWESOME

•25,200

•42,580

•5118

•8981

•Original Pool

•BARI

•CABRI

•EAST

•GABI

•Trial

No stents used Stents used

Meta-analysis of BMS vs CABG1 year follow-up

Meta-analysis of BMS vs CABG1 year follow-up

• No difference in death

• No difference in death/MI

• No difference in death/MI/stroke

8.7% after PCI vs 9.1% after CABG

• Repeat revasc more frequent after PCI

18.0% vs 4.4%; p < 0.001

Meta-analysis of BMS vs CABG at 1 year (ARTS, SOS, ERACI 2, MASS 2)

Good LV

function

SIGN Guideline 96Management of stable angina

• Who is supposed to have CABG?– “Significant” LMS “should undergo CABG

– 3 vessel disease “ should be considered for CABG to improve prognosis, but where unsuitable be offered PCI”

• What is 3 vessel PCI– Single vessel PCI x 3

• What dictates suitability for CABG– Lesion morphology – NO!– Distal vessels – YES!– Co-morbidity – YES!– LV function – YES!

ERACI II - Freedom from anginaCABG (solid bars) vs PCI (gray bars)

ARTS I – 5 year outcomes

Good LV

function

Ad

vers

e E

ven

ts (

%)

Ad

vers

e E

ven

ts (

%)

TAXUS II, IV, V, VI* (N=3,445)TAXUS II, IV, V, VI* (N=3,445)

BenefitBenefitRiskRisk

Stent Thrombosis

All Death

CardiacDeath

Q-WaveMI

Death or QWMI

TLR

TAXUS® Stent 4-Year Meta-AnalysisBottom bar: 3 year; Top Bar: 4-year

*TAXUS Stent 4-year meta-analysis includes TAXUS II (4 yr), IV (4 yr), V (2 yr), VI (3 yr) (N=3,445).*TAXUS Stent 4-year meta-analysis includes TAXUS II (4 yr), IV (4 yr), V (2 yr), VI (3 yr) (N=3,445).

0.90.9 1.31.3

7.07.06.46.4

3.13.1 2.62.61.21.2 1.51.5

8.18.1 7.67.6

20.420.4

10.510.5

p=0.55p=0.55 p=0.53p=0.53 p=0.40p=0.40 p=0.80p=0.80 p<0.0001p<0.0001p=0.29p=0.29

0.80.8 1.31.3 4.34.3 4.64.6 2.02.0 2.12.1 1.11.1 1.31.3 5.35.3 5.75.7 19.819.8 9.39.3

Bare Metal Stent (N=1,727)Bare Metal Stent (N=1,727) TAXUSTAXUS®® Express Stent (N=1,718) Express Stent (N=1,718)

The safety and effectiveness of the TAXUS Express Stent has not been established longer than twelve months.

TAXUS® Stent 4-Year Meta-AnalysisAll Diabetes

Bare Metal Stent (N=415)Bare Metal Stent (N=415) TAXUSTAXUS®® Express Stent (N=399) Express Stent (N=399)

Ad

vers

e E

ven

ts (

%)

Ad

vers

e E

ven

ts (

%)

TAXUS II, IV, V, VI (N=814)TAXUS II, IV, V, VI (N=814)

BenefitBenefitRiskRisk

Stent Thrombosis

All Death

CardiacDeath

Q-WaveMI

Death or QWMI

TLR

1.21.2 1.41.4

11.011.09.19.1

3.83.8 4.64.61.71.7

0.50.5

12.612.6

9.69.6

25.525.5

13.113.1

p=0.58p=0.58 p=0.75p=0.75 p=0.18p=0.18 p=0.31p=0.31 p<0.0001p<0.0001p=0.80p=0.80

TAXUS® Stent 4-Year Meta-AnalysisInsulin-Requiring Diabetes

Bare Metal Stent (N=136)Bare Metal Stent (N=136) TAXUSTAXUS®® Express Stent (N=120) Express Stent (N=120)

Ad

vers

e E

ven

ts (

%)

Ad

vers

e E

ven

ts (

%)

TAXUS II, IV, V, VI (N=256)TAXUS II, IV, V, VI (N=256)

BenefitBenefitRiskRisk

Stent Thrombosis

All Death

CardiacDeath

Q-WaveMI

Death or QWMI

TLR

0.70.73.03.0

15.715.7 14.614.6

7.17.1 6.86.8

00 0.80.8

15.715.7 15.415.4

24.124.1

13.713.7

p=0.97p=0.97 p=1.00p=1.00 p=0.29p=0.29 p=0.86p=0.86 p=0.0133p=0.0133p=0.49p=0.49

TAXUS® Stent 4-Year Meta-AnalysisSmall Vessels (RVD≤2.5mm)

Bare Metal Stent (N=588)Bare Metal Stent (N=588) TAXUSTAXUS®® Express Stent (N=578) Express Stent (N=578)

Ad

vers

e E

ven

ts (

%)

Ad

vers

e E

ven

ts (

%)

TAXUS II, IV, V, VI (N=1,166)TAXUS II, IV, V, VI (N=1,166)

BenefitBenefitRiskRisk

Stent Thrombosis

All Death

CardiacDeath

Q-WaveMI

Death or QWMI

TLR

0.90.9 1.61.6

7.07.0 7.27.2

3.93.9 3.53.50.90.9 1.51.5

7.77.7 8.48.4

28.028.0

13.513.5

p=0.71p=0.71 p=0.92p=0.92 p=0.54p=0.54 p=0.55p=0.55 p<0.0001p<0.0001p=0.54p=0.54

TAXUS® Stent 4-Year Meta-AnalysisLong Lesions (>26mm)

Bare Metal Stent (N=154)Bare Metal Stent (N=154) TAXUSTAXUS®® Express Stent (N=175) Express Stent (N=175)

Ad

vers

e E

ven

ts (

%)

Ad

vers

e E

ven

ts (

%)

TAXUS II, IV, V, VI (N=329)TAXUS II, IV, V, VI (N=329)

BenefitBenefitRiskRisk

Stent Thrombosis

All Death

CardiacDeath

Q-WaveMI

Death or QWMI

TLR

002.42.4

5.05.02.92.9

0.70.72.32.3

00

4.14.1 5.05.06.46.4

27.227.2

12.912.9

p=0.85p=0.85 p=0.23p=0.23 p=0.0121p=0.0121 p=0.10p=0.10 p=0.0022p=0.0022p=0.06p=0.06

A Brief History of (early) Stent Thrombosis

0

2

4

6

8

10

12

14

16

PS 1991 STRESS 1993 Colombo 1996 ISAR 1996 STARS 1997

% S

tent

Thr

ombo

sis

HPD + dualAPT (IVUS)

Warfarin

Safety and Efficacy of Sirolimus Eluting Stents (NEJM 2007; 356: 998-1008)

Safety and Efficacy of Paclitaxel Eluting Stents (NEJM 2007; 356: 998-1008)

95

96

97

98

99

100

95

96

97

98

99

100

Time after Initial Procedure (years)Time after Initial Procedure (years)

00 11 22 33 44

Time after Initial Procedure (years)Time after Initial Procedure (years)

TAXUS I, II, IV, V, VITAXUS I, II, IV, V, VI(n=3,506)(n=3,506)

RAVEL, SIRIUS, E-SIRIUS, and C-SIRIUSRAVEL, SIRIUS, E-SIRIUS, and C-SIRIUS(n=1,748)(n=1,748)

CYPHER stent (n=870) Bare metal stent (n=878)

NEJM 2007; 356: 998-1008 (data contained in Table 3)

00 11 22 33 44

95

96

97

98

99

100

95

96

97

98

99

100

TAXUS stent (n=1,749) Bare metal stent (n=1,757)

Freedom From Stent Thrombosis (Protocol defined)in Cypher and Taxus RCT’s

P=0.2099.4% (5)98.8% (10)

P=0.2999.1% (14)98.7% (20)

5 vs. 0, P=0.025After 1 yearAfter 1 year

9 vs. 2, P=0.033After 1 yearAfter 1 year

0 1 2 3 4

0.0

00

.05

0.1

00

.15

0.2

00

.25

2004 landmark

Time (years)

Cu

mu

lativ

e r

isk

of d

ea

th o

r M

I

BMSDES

BMS 6737 6228 6090 5983 5883 3143 3 0 0DES 3880 3638 3550 3468 3388 1523 2 0 0

RR: 0.98 (0.83, 1.17)

RR: 1.22 (1.05, 1.43)

0 1 2 3 40

.00

0.0

50

.10

0.1

50

.20

0.2

5

2005 landmark

Time (years)

Cu

mu

lativ

e r

isk

of d

ea

th o

r M

I

BMSDES

BMS 5584 5061 4949 2611 0 0 0 0 0DES 6336 5963 5809 2573 0 0 0 0 0

RR: 0.69 (0.59, 0.81)

RR: 0.93 (0.76, 1.13)

0 1 2 3 4

0.0

00

.05

0.1

00

.15

0.2

00

.25

2003 landmark

Time (years)

Cu

mu

lativ

e r

isk

of d

ea

th o

r M

I

BMSDES

BMS 6448 6037 5918 5820 5713 5612 5520 2934 7DES 1799 1685 1644 1607 1568 1539 1496 535 0

RR: 1.06 (0.86, 1.32)

RR: 1.31 (1.12, 1.53)

SCAAR Registry2004

2005

2003

21.8% DES

36.5% DES

53.1% DES

SCAAR Data , Dr. S. James, ESC 2007.

p<0.001

All

Cau

se M

ort

alit

y R

ate

(%)

p=0.052 p=NR p<0.001p<0.0001 p<0.001 p=0.004N

=3,

160

N=

4,06

1

N=

483

N=

871

N=

5,71

9

N=

5,39

9

N=

6,38

4

N=

7,83

4

N=

3,75

1

N=

3,75

1

N=

5,99

6

N=

1,35

9

N=

3,54

8

N=

8,84

7

BMSDES

3-year 3-year 2-year 2-year 3-year 2-year

2-year

DES vs. BMS Registries at TCT 07All Cause Mortality

ASAN registry presented by Dr SJ Park, TCT 2007. GHOST registry presented by Dr Harjai, TCT 2007. MIDAS registry presented by Dr Vagonescu, TCT 2007. NY State registry presented by Dr Hannan, TCT 2007. Ontario registry presented by Dr Ko, TCT 2007. SCAAR registry presented by Dr Wallentin, TCT 2007. S.T.E.N.T. registry presented by Dr Brodie, TCT 2007. Western Denmark registry presented by Dr Jensen, TCT 2007. *Adjusted for baseline characteristics, Crude or unadjusted for baseline characteristics

0 1 2 3 4

0.0

00

.05

0.1

00

.15

0.2

00

.25

2004 landmark

Time (years)

Cu

mu

lativ

e r

isk

of d

ea

th o

r M

I

BMSDES

BMS 6737 6228 6090 5983 5883 3143 3 0 0DES 3880 3638 3550 3468 3388 1523 2 0 0

RR: 0.98 (0.83, 1.17)

RR: 1.22 (1.05, 1.43)

0 1 2 3 40

.00

0.0

50

.10

0.1

50

.20

0.2

5

2005 landmark

Time (years)

Cu

mu

lativ

e r

isk

of d

ea

th o

r M

I

BMSDES

BMS 5584 5061 4949 2611 0 0 0 0 0DES 6336 5963 5809 2573 0 0 0 0 0

RR: 0.69 (0.59, 0.81)

RR: 0.93 (0.76, 1.13)

0 1 2 3 4

0.0

00

.05

0.1

00

.15

0.2

00

.25

2003 landmark

Time (years)

Cu

mu

lativ

e r

isk

of d

ea

th o

r M

I

BMSDES

BMS 6448 6037 5918 5820 5713 5612 5520 2934 7DES 1799 1685 1644 1607 1568 1539 1496 535 0

RR: 1.06 (0.86, 1.32)

RR: 1.31 (1.12, 1.53)

SCAAR Registry2004

2005

2003

21.8% DES

36.5% DES

53.1% DES

SCAAR Data , Dr. S. James, ESC 2007.

29

8.7

5.53.5 3.2 2.6

1.3

0

5

10

15

20

25

30

Prematurewithdrawal

of APT

Prior BrachyRx

Renal failure

Bifns ULM DM UA

Predictors of Thrombosis in DESIakovou et al. JAMA 2005; 293: 2196-30. Milan and Siegburg.

%

5/17; 4 both drugs, 1 only clopidogrel

2/23

8/127

18/507

Year Study n F/U CABG MACCE (%)

2001-02 French LM 230 12M 40% AR 23.8

2001-03 Buszman 61 12M 47% LIMA 26.0

Mortality* (%)

1999-03 Ehara 183 9M On pump 8.6

1997-03 Lu 1197 12M On/off pump 5.0

1999-02 Beauford 234 12M On pump 14.0

1999-02 Beauford 420 12M Off pump 6.0

1996-00 Yeatman 312 24M On pump 5.9

1996-00 Yeatman 75 24M Off pump 2.3

1998-99 Mack 273 1M Off pump 2.6

1998-99 Mack 1163 1M On pump 4.5

*: Events other than death often not reported

CABG for LMS Disease

Bologna LM Registry(median follow-up 430 days)

CABG

n=154

PCI

n=157

p value

DES 94 (60%)

Death (%) 12.3 13.4 ns

MI (%) 4.5 8.3 ns

TLR (%) 2.6 25.5 0.0001

MVA – age> 70; NYHA 3/4; ACS; PVD

AJC 2006; 98: 54-9.

SYNTAX

Not treatable by eitherCABG or PCI

TAXUS CABG

Patients with de novo 3V and/or left main disease

Heart Team Meeting – SYNTAX Score/EuroScore(surgeon and interventionist)

Randomisation

Registries

Treatable by eitherCABG or PCI

RCT

CABG RegistryPCI Registry

Glasgow SYNTAX CohortPCI patients 1-12

S0

20

40

60

80

100

120

Flouro time (mins) Dose (Gy/cm2x10)

S S

Glasgow SYNTAX CohortPCI patients 1-12

020406080

100120140160

8 6 4 4 1 5 2 4 6 4 5 4

DES (n); mean = 4.4

Total Length(mm)

SYNTAX # 7

SYNTAX # 7

SYNTAX # 9

SYNTAX # 9 (Provisional T)

SYNTAX # 9 (Culotte)

SYNTAX # 19

Syntax # 19

SYNTAX # 19

SYNTAX # 19

IVUS to both limbs of bifurcation – 4mm Quantum to both limbs required for optimisation

CoreValve

CAROTID STENTING

CAROTID STENTING

Heart Team

ARTS II - (Sub)acute occlusions (per patient)

0.50.8

0.2 0.2

2.52.8

0

5

10

Discharge 30 Days

Pe

rce

nta

ge

(%

)

ARTS II ARTS I - CABG ARTS I - PCI

Meta-analysis of BMS vs CABG1 year follow-up

http://www.tctmd.com/display/expert/slides/52205/

Meta-analysis of BMS vs CABG1 year follow-up

ERACI II – 5 year outcomes

Arterial Revascularisation Trial (ART)

A randomised trial to compare survival following bilateral vs single internal

mammary grafting in coronary revascularisation

3000 patientsBHF/MRC

Effects of Off-Pump Versus On-Pump Coronary Surgery on Reversible and Irreversible Myocardial Injury: A Randomized Trial Using Cardiovascular Magnetic Resonance Imaging and Biochemical Markers

Selvanayagam, Joseph B. MBBS, FRACP; Petersen, Steffen E. MD; Francis, Jane M. DCRR, DNM; Robson, Matthew D. PhD; Kardos, Attila MD, PhD; Neubauer, Stefan MD, FRCP; Taggart, David P. MD, PhD

Circ 2004; 109(3): 345-350

DP TaggartPrimary CABG 2002-05

n=656In-hospital mortality 2.74%

SYNTAX• Inclusions

– 3 vessel and/or left main disease – CTO without time limitation– Previous cerebrovascular events >1 months – Any degree of renal and respiratory insufficiency– Any LVEF– Myocardial ischemia (unstable-silent-stable)– Patients with cardiac or extra-cardiac comorbidities

• Exclusions– Prior CABG or PCI procedure– AMI with CK (>2xCK upper limit of normal) – Planned need for major surgery

SYNTAX score

• What’s the potential value of validating this “new” angiographic score?

– General prognostic value• Quantification of the disease

– Set the threshold for PCI vs Surgery• Guide to appropriate referral

– Trial outcome data will be used to optimise the score (weighting)

The TAXUS® Express® Stent

• Binds tubulin• Stabilises

microtubules• Suppresses

migration and proliferation at low concentrations

• Biostable and biocompatible polymer

• Controlled release from drug/polymer matrix

•Paclitaxel•TransluteTM

• Stainless steel• Maverick Balloon

Catheter • Flexible• Deliverable

•Express® Stent

•paclitaxel

ARTS I – 5 year outcomes in diabetes

BMS; n = 112 CABG; n = 96 RR (95% CI) p value

Death 15 (13.4) 8 (8.3) 1.61 (0.71–3.63) 0.27

CVA 7 (6.3) 7 (7.3) 0.86 (0.31–2.36) 0.79

MI 12 (10.7) 7 (7.3) 1.47 (0.60–3.59) 0.47

 Q-wave MI 9 (8.0) 4 (4.2) 1.93 (0.61–6.07) 0.39

 Non–Q-wave MI 3 (2.7) 3 (3.1) 0.86 (0.18–4.15) 1.00

Composite death/CVA/MI

28 (25.0) 19 (19.8) 1.26 (0.76–2.11) 0.41

(re) CABG 17 (15.2) 2 (2.1) 7.29 (1.73–30.7) 0.001

(re) PTCA 34 (30.4) 9 (9.4) 3.24 (1.64–6.41) <0.001

Any revascularization

48 (42.9) 10 (10.4) 4.11 (2.20–7.68) <0.001

Any MACCE 61 (54.5) 24 (25.0) 2.18 (1.48–3.20) <0.001

Glasgow ARTS II CohortDemographics

• 17 patients (9 male/8 female)• Mean age 60 (range 47-74)• 9 – 2VD; 8 – 3VD• Risk factors

– Diabetes 24%– Current smokers 71%– Hypertension 69%– Statins 88%– Mean BMI 29 (range 21-36)

Glasgow ARTS II CohortProcedural data

17 patients; 9 – 2VD, 8 – 3VD

No of lesions (median + range) 4 (2-6)

No of stents (median + range) 4 (2-6)

Total stent length (mean) 72mm

Procedure time (mean) 109 mins

GP2b3a 7/19 (37%)

Procedural success/lesion 92%

Hospital stay (median + range) 1 (1-3)

Glasgow ARTS II CohortOutcomes

In-hospital events1 coronary perforation Asymptomatic

1 NSTEMI Side branch occlusion

1 Access site complication Radial artery perforation

6 month follow-upNo deaths/MI/revascularisation

1 readmission Epistaxis

1 re-angio No restenosis

ARTS IILesion characteristics ARTS II

Cypher Stent %

ARTS I Bypass

%

ARTS I Crown Stent

% Lesion Type

Type A Type B1 Type B2 Type C

6.8 23.4 55.9 13.9

6.8 31.3 54.0 7.9

5.9 26.4 59.7 7.5

Calcification Moderate to heavy

31.2

14.8

17.5

Occlusions Total,< 3 months old

Total,> 3 months old

0.1 2.3

4.1 1.3

3.1 0.6

Side branch involvement 33.9 31.8 34.5

ARTS II – Stented length per patient

0.5

24.7

16

0.55.7

58.4

0

31.426.9 27.1

2.66.2

0

10

20

30

40

50

60

0-25 26-50 51-75 76-100 100-200 > 200

Total stent length ranges (mm)

% o

f p

atie

nts

ARTS II ARTS I - PCI

Average stent length: ARTS II – 72.5; ARTS I – 47.6

ARTS II - Hierarchical MACCE (per patient)

From procedure until 30 days post-procedure

0 0.2 0.3

1.3 1

2.8

1.3 1

3.2

0.3 0.5

6.3

1.7

0.8

2.72 2

9.2

0

10

Death CVA MI CABG rePCI AnyMACCE

Pe

rce

nta

ge

(%

)

ARTS II ARTS I - CABG ARTS I - PCI

**) ARTS II versus ARTS I-CABG, p = 0.004

ARTS II versus ARTS I - PCI, p < 0.0001

ARTS I - PCI versus ARTS I-CABG, p = 0.07

**

ARTS II - Maximum CKMBpost-procedure

0.3 1.5

7.1

12.6

4.36.1

1.5

41

20.5

0

5

10

15

20

25

30

35

40

45

1-3 ULN 3-5 ULN > 5 ULN

Per

cen

tag

e (%

)

ARTS II

ARTS I-Bypass

ARTS I - PCI

LMS - PCI

• 1980’s - POBA– 19 unprotected LMS– No procedural mortality– 1 emergency CABG– Mean follow-up 41

months– 7 patients restenosed all

referred for CABG

• Stertzer and Myler

• 1980’s - POBA– Protected (n = 85)– Mortality

• Procedural - 2.4%• 3 year - 10%

– Unprotected (n = 42)– Mortality

• Procedural - 9.1%• 3 year - 64%• 3 year ( 9 AMI) - 78%

• O’Keefe & Hartzler

LMS - PCI

• Early 1990’s - stents– Palmaz-Schatz– Multicentre Registry

• ~ 90% procedural success

• 10% SAT/bleeding

• Stent jail

• 8/9 deaths were in stented patients

• Late 1990’s - stents– Post-Colombian– 2nd/3rd generation

• ~ 100% procedural success

• < 1% SAT/bleeding

• Bifurcation stenting

• IVUS optimisation

Emergency Unprotected LMS - PCI

Year n Indication In-hospital

mortality

Chauhan 1997 6 AMI +/- shock 80%

Ellis 1997 16 AMI 69%

Laruelle 1998 8 AMI/NSTEACS 25%

Kosuga 1999 14

10

AMI

Shock

36%

40%

Marco 1999 40 AMI 55%

Elective Unprotected LMS - PCIYear n Stent

%Risk(n)

LVEF In hosp mortality

1 yearMortality

Ellis 1997 91 50 High 47Low 44

<40%>40%

38%2%

73%13%

Karam 1998 39* 100 High* N/D 8% 23%

Wong 1999 55 100 Low >45% 0% 2%

Silvestri 2000 140 100 High 47Low 93

<35%>35%

9%0%

11%3%

Park 2001 127 100 Low Normal 0% 2%

Glasgow SYNTAX PCI Cohort• 41 patient randomised

– 19 to PCI

• Mean age 61 (range 45-80); 15 male– 3 diabetics; 9 previous MI

• Euroscore 3.6 (0-7)• Syntax score 26 (12-43)• Target segments 3.2 (2-5)

• LMS 2• LMS + 3VD 3• LMS + 2VD 5• LMS + 1VD 1• 3VD 8

Glasgow SYNTAX PCI Cohort

Staged procedure 2Radial 12No of DES 4.2 (1-8)Stent length 80mm (12-156)GPI 13CK-MB elevation2Days in hospital 16 x 1 day

3 x 2 days

LE MANS

PCI

N=52

CABG

N=53

35% DES 79% LIMA

LVEF 5% No change p<0.05

Angina status No difference

ETT No difference

MAE < 30/7 35.8% 5.8% p<0.0001

MACE 30/7 to 12/12 20% 21% ns

Buszman; TCT 2005

ARTS II CYPHER

N=607

ARTS I

CABG

N= 605

BMS

N= 600

R

Patient characteristics ARTS II Cypher Stent

%

ARTS I Bypass

%

ARTS I Crown Stent

% Risk factors

Diabetes mellitus - insulin dependent - non insulin dependent Hypertension Hypercholesterolemia Family history History of CVA Previous smoker Current smoker Peripheral vascular disease COPD Ejection fraction

26.2 4.6 21.6 67.3 74.0 36.0 0.8 40.9 19.3 6.9 3.6

60.3 11.5

15.9 2.6

13.2 45.0 57.6 42.0 1.0

46.6 25.8 5.1 4.8

60.3 13.2

18.7 3.8

14.8 44.7 58.0 39.2 0.8

43.8 27.9 5.5 5.0

60.9 12.3

ARTS II

ARTS IIProcedure ARTS II

Cypher Stent %

ARTS I Bypass

%

ARTS I Crown Stent

%

# Diseased vessels 2.5 0.5 2.3 0.5 2.2 0.5

# Diseased lesions 3.6 1.3 2.8 1.0 2.8 1.0

# Stented lesions/ anastomosed segments

3.2 1.1 2.6 1.0 2.5 1.0

# stents implanted 3.7 1.5 2.8 1.3

Days to procedure since randomization

0.1 1.1 26.9 38.5 10.8 16.4

Duration procedure (minutes)

85.0 43.2 193.3 66.6 98.7 50.0

IIb/IIIa inhibitors 36%