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).