SHA24/057005

Comparison of clinical outcomes of Percutaneous Coronary Intervention versus Bypass Grafting in patients with unprotected left main disease

K Naeem S Lawand N AlRuwaily H Obeid M Ibrahim

Prince Salman Heart Center KFMC, Riyadh

Left main: the anatomical challenges • LM PCI is attractive due to the proximal location and relatively large diameter.

• Up to 90% of stenoses are bifurcation lesions1,2 with high risk of restenosis.3,4,5 • About half the lesions have calcifications.6 • Up to 80% have MVD.7,8 5 deLezo AHJ 2004 Valgimigli JACC 2006 2 6 Ragosta CCI 2006 Park JACC 2005 3 7 Tanabe AJC 2004 Lee JACC 2006 4 Lemos Circulation 2004 8 Palmesini AJC 2006 1

Objective • To compare clinical characteristics and outcomes in left main disease patients who underwent percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).

Methods • Retrospective analysis of ‘all-comers’ with left main disease with or without multi-vessel disease who underwent PCI or CABG. • Ninety-one patients (49 CABG, 42 PCI).

• Since 2008 with 2 years follow-up.

• Seven patients in PCI group were declined CABG for co-morbidities/poor targets, while one refused surgery.

End-points Primary end-point: Major adverse cardiac or cerebrovascular events (all-cause death, stroke, myocardial infarction, repeat revascularization) Secondary end-point: Repeat hospitalization rate

Definitions Variable

Definition

Myocardial infarction <7 days after intervention: New Q waves and either peak CKMB/total CK >10% or plasma level of CKMB 5xULN. 7 days or more after New Q waves or peak CKMB/total CK >10% or plasma intervention : level of CKMB5xULN or plasma level of CK 5xULN. Stroke

Focal, central neurological deficit lasting >72 hrs which resulted in irreversible brain damage or body impairment.

TVR (Unplanned, not staged)

Repeat revascularization with either PCI or CABG performed in the treated vessel.

TLR (Unplanned, not staged)

Repeat revascularization with either PCI or CABG of the original target lesion defined as the area covered by the stent plus a 5mm margin proximal and distal to the edges of the stent.

Baseline characteristics: demographics Variables

CABG n=49 (%)

PCI n=42 (%)

P value

Age (years)

61 (39-81)

65 (32-92)

Men

39 (81%)

29 (69%)

0.162

Mean BMI (kg/m2)

28

27

0.724

DM

33 (67%)

27(64%)

0.759

Smoker

13 (27%)

7 (17%)

0.021

Prior MI

21 (43%)

25 (60%)

0.496

LVEF<30%

23 (48%)

18 (44%)

0.225

DLP

27 (55%)

12 (29%)

0.011

BP>130/85

30 (61%)

31 (74%)

0.20

Baseline characteristics: clinical variables Variables

CABG n=49 (%)

PCI n=42 (%)

P value

STEMI

16 (33%)

21 (50%)

0.09

NSTEMI

30 (61%)

13 (31%)

0.057

Unstable/Cardiogenic shock

10 (20%)

13 (31%)

0.249

Creatinine >200 umol/L

2 (4%)

6 (14%)

0.30

Mean euroSCORE (logistic)

2.8

6.6

0.006

Mean Syntax score

42

34

0.01

Unstable: Electrically, hemodynamically or recurrent chest pain.

Cardiogenic shock: BP <90/60 mmHg, MAP <60 mmHg, CI <2.5, or on inotropes.

Baseline characteristics: angiographic data Variables

CABG n=49 (%)

PCI % n=42 (%)

P value

Isolated LM

0 (0%)

6 (14%)

0.006

LM + 1VD

9 (18%)

3 (7%)

0.115

LM + 2VD

4 (8%)

11 (26%)

0.021

LM + 3VD

37 (76%)

31 (74%)

0.852

Ostial LM

38 (73%)

14 (27%)

0.0001

Shaft LM

30 (80%)

9 (20%)

0.0001

Distal LM

4 (8%)

14 (33%)

0.003

Both ostial and distal

1 (2%)

1 (2.3%)

0.912

Diffuse disease/small vessel disease

26 (53%)

22 (52%)

0.948

Baseline characteristics: angiographic data Bifurcation disease (Medina classification)

CABG % (n=49)

PCI % (n=42)

p value

1,0,0

1 (2%)

1 (2.4%)

0.912

0,1,0

1 (2%)

2 (5%)

0.465

1,1,0

9 (18%)

14 (33%)

0.101

1,1,1

2 (4)

2 (5%)

0.875

0,0,1

3 (6%)

3 (7%)

0.845

1,0,1

4 (7.5%)

4 (10%)

0.544

0,1,1

4 (8%)

4 (10%)

0.819

Results: Major adverse cardiac and cerebrovascular events (MACCE) (PCI n=42, CABG n=49)

P=0.001

Results: End-points (PCI n=42, CABG n=49) P=0.02 P=0.15

P=0.057

P=0.12 P=0.234

P=0.02

Results (PCI n=42, CABG n=49)

P=0.001

• 2 patients in PCI group had CABG post-PCI. • 2 patients in CABG group had PCI postCABG and 1 had graft failure treated medically.

Results: Sub-groups (PCI n=42, CABG n=49)

P=0.04

P=0.79

Results Endpoint

PCI % (n=42)

CABG % (n=49)

P value

MACCE

55% (23)

13% (6)

0.001

Cardiac death

12% (5)

4% (2)

0.15

Non-cardiac death

5% (2)

2% (1)

0.12

Myocardial infarction

12% (5)

4% (2)

0.057

Target vessel revascularization

10% (4)

0% (0)

0.02

Target lesion revascularization

14% (6)

2% (1)

0.02

Stroke

2.6% (1)

0% (0)

0.234

Repeat hospitalization

62% (26)

25% (12)

0.001

Summary • Retrospective analysis of patients undergoing unprotected LM revascularization in a tertiary care center.

• The population represents the sicker of the sickest: – Extremely high rate of DM (64% in PCI, 67% in CABG) which is much higher than the international rates.

– High number of TVD (74% in PCI, 76% in CABG).

– Significantly higher rate of distal LM involvement in the PCI group (33% in PCI, 8% in CABG, p=0.003).

– High proportion of patients presenting with recent or acute STEMI (50% in PCI, 33% in CABG, p=0.09).

– Very high Syntax scores in both groups (PCI 34, CABG 42), significantly more in CABG (p=0.01)

Conclusions • In this very sick cohort, as expected, significantly more repeat hospitalizations in the PCI group compared to CABG, driven mostly by need for repeat revascularization.

• Though not statistically different, more incidence of death, stroke and MI in the PCI group.

• In real life unprotected LM PCI when associated with such high risk determinants (DM, MVD, distal LM, high Syntax scores) should only be carried out when patients are not suitable for CABG (AHA guidelines 2011).