Left Main Disease: Why I Do It

How I Do It

Jeffrey W. Moses, MD
John and Myrna Daniels Professor of
Cardiology
Director, Interventional Cardiac Therapeutics
Columbia University Medical Center
Director Complex Coronary Interventions
St. Francis Hospital, Roslyn, LI
Disclosure Statement of Financial Interest

Within the past 12 months, I Jeffrey Moses have had a financial

interest/arrangement or affiliation with the organization(s) listed below.
• None
Recommendations for LM Revascularization
United States Europe

PCI CABG PCI CABG

Low Low
SxScore 0-22 IIa B IB SxScore 0-22 IB IB
Intermediate Intermediate
SxScore 23-32 IIb B IB SxScore 23-32 IIa B IB
High High
SxScore >32 III B IB SxScore >32 III B IB

Levine G, et al. J Am Coll Cardiol. 2011;58:44-122

Windecker S, et al. Eur Heart J. 2014;35:2541-619
 MACCE to 5 Years by SYNTAX Score Tercile
LM Subset Low Scores 0-22
CABG (N=104)
TAXUS (N=118) CABG PCI P value
LM Disease
50 Death 11.3% 7.0% 0.28
Cumulative Event Rate (%)

P=0.74
CVA 4.1% 1.8% 0.28
31.5%
30.4% MI 3.1% 6.2% 0.32
25

Death,
CVA or 15.2% 13.9% 0.71
MI

0 Revasc. 20.3% 23.0% 0.65

0 12 24 36 48 60
Months Since Allocation

Serruys PW. TCT2012

 MACCE to 5 Years by SYNTAX Score Tercile
LM Subset Intermediate Scores 23-32
CABG (N=92)
TAXUS (N=103) CABG PCI P value
LM Disease
50 Death 19.3% 8.9% 0.04
Cumulative Event Rate (%)

P=0.88
CVA 3.6% 1.0% 0.23
32.7%
32.3%
MI 4.6% 6.0% 0.71
25

Death,
CVA or 24.9% 15.7% 0.11
MI

0 Revasc. 16.6% 22.2% 0.40

0 12 24 36 48 60
Months Since Allocation

Serruys PW. TCT2012

 MACCE to 5 Years by SYNTAX Score Tercile
LM Subset High Scores ≥33
CABG (N=149)
TAXUS (N=135)
CABG PCI P value
LM Disease
50 P=0.003 Death 14.1% 20.9% 0.11
46.5%
Cumulative Event Rate (%)

CVA 4.9% 1.6% 0.13

29.7%
MI 6.1% 11.7% 0.13
25

Death,
CVA or 22.1% 26.1% 0.40
MI

0 Revasc. 11.6% 34.1% <0.001

0 12 24 36 48 60
Months Since Allocation

Serruys PW. TCT2012

 SYNTAX Score II
CABG vs PCI Interactions in LM Cohort

3
CABG Favored
Overall 50.1%
2 >95% CI 11.5%
Log Hazard PCI

1
PCI Favored
0
Overall 49.9%
>95% CI 8.8%
-1

79.7% lie within 95% CI

-2

-3
-3 -2 -1 0 1 2 3
Log hazard CABG

Farooq, Serruys, et al. Lancet 2013

 Why New Trials

• In SYNTAX, left main disease was just a

subgroup i.e., hypothesis generating
• First-generation drug-eluting stents were
used (and a bad one at that!)
• Our approach to revascularization has
evolved over a decade (i.e., CTO Rx,
image guidance, FFR/iFR etc)
 New Left Main Trials in Perspective
SYNTAX EXCEL NOBLE
All-comers Yes No No

Patient population LM/3VD LM LM

SYNTAX score Any ≤ 32 Lesion Based

Primary endpoint* Death/MI/CVA/TVR Death/MI/CVA Death/MI/CVA/TVR

Follow up 1 year 3 year (median) 3 year (median)

IVUS Infrequent Recommended Recommended

FFR guidance Infrequent Recommended Recommended

Stent PES EES BES recommended

Angio FU At discretion Not recommended Not recommended

* The definition of MI in EXCEL included large periprocedural MI. NOBLE did not include periprocedural MI in the primary endpoint

Capodanno D, et al. Int J Cardiol.

2012;156:1-3
 EXCEL and NOBLE – Study Features
EXCEL NOBLE
Randomized pts, centers, 1,905 pts at 126 sites in 1,201 pts at 36 sites in 9
countries, geographies 17 countries (US, EU) countries (EU)
Recruitment period 2010-2014 2008-2015
Age* 66 years (mean) 66 years (mean)
Diabetes mellitus* 30% 15%
LVEF* 57% (mean) 60% (mean)
Acute coronary syndrome* 24% 18%
SYNTAX score* (Core-lab) 27 (mean) 23 (mean)
Distal location* 82% 81%
IVUS use* 77% 74%
Off-Pump CABG 29% 16%
Arterial conduits used 99% 95%
Only arterial conduits used 25% 14%
* Data are shown for the PCI cohort
Stone GW, et al. NEJM 2016;
Christiansen EH, et al. Lancet 2016
 Registry (n=1,000)
Major reasons for exclusion Treatment
from randomization of registry patients
50-<70% LM stenosis
which did not meet
29.9%
criteria for hemodynamic
significance

Site-assessed SYNTAX
38.1%
score ≥33 33.1%
64.8%

Heart team consensus of

36.0%
ineligibility for PCI

Heart team consensus of 2.1%

17.1%
ineligibility for CABG
CABG PCI No revasc
0% 10% 20% 30% 40% 50%

Of the 1747 pts enrolled during the registry period, 62% were eligible for PCI
(1078; 331 reg + 747 rand), and 80% were eligible for CABG
(1395; 648 reg + 747 rand)
 Primary Endpoint
Death, Stroke or MI at 4 Years
25%
CABG (n=957)
PCI (n=948)
Death, Stroke or MI (%)

20%
18.6%
16.7%
15%

10%

HR [95%CI] =
1.10 [95% CI: 0.88, 1.36]
5%
P = 0.40

0%

01 6 12 24 36 48

No. at Risk:
Months
PCI 948 896 874 854 809 744 682
CABG 957 864 832 818 788 760 687
 EXCEL: Study Results
PCI CABG Diff [upper
(n=948) (n=957) confidence limit] PNI HR [95%CI] PSup
Primary endpoint

Death, stroke or MI
15.4% 14.7% 0.7% [4.0%]† 0.018 - -
at 3 years

Secondary endpoints

Death, stroke or MI
4.9% 7.9% -3.1% [-1.2%]†† <0.001 - -
at 30 days

Death, stroke, MI or
ischemia-driven revasc 23.1% 19.1% 4.0% [7.2%]†† 0.01 - -
at 3 years

Death, stroke or MI
at 3 years
15.4% 14.7% - - 1.00 [0.79, 1.26] 0.98

Stone GW, et al. NEJM 2016

 EXCEL: Landmark Analysis

From randomization to 30 days From 30 days to 3 years

PCI CABG P PCI CABG P

HR [95%CI] HR [95%CI]
(n=948) (n=957) value (n=939) (n=947) value

Death, stroke or
4.9% 7.9% 0.61 [0.42, 0.88] 0.008 11.5% 7.9% 1.44 [1.06, 1.96] 0.02
MI

Death 1.0% 1.1% 0.90 [0.37, 2.22] 0.82 7.3% 4.9% 1.44 [0.98, 2.13] 0.06

Stroke 0.6% 1.3% 0.50 [0.19, 1.33] 0.15 1.8% 1.8% 1.00 [0.49, 2.05] 1.00

MI 3.9% 6.2% 0.63 [0.42, 0.95] 0.02 4.2% 2.5% 1.71 [1.00, 2.93] 0.05

Stone GW, et al. NEJM 2016

 4-Year Death, Stroke or MI
PCI CABG Favors Favors
Subgroup (N=948) (N=957) HR [95% CI] PCI CABG P (Int)
All patients 18.6% 16.7% 1.10 [0.88, 1.36]
Age (median cutoff)
- ≥67 years 22.7% 17.4% 1.31 [0.98, 1.76]
0.09
- <67 years 14.8% 15.9% 0.89 [0.64, 1.23]
Sex
- Male 17.3% 16.5% 1.01 [0.78, 1.30]
0.20
- Female 23.0% 17.3% 1.40 [0.91, 2.16]
Diabetes mellitus
- Yes 24.4% 21.7% 1.10 [0.76, 1.59]
0.98
- No 16.5% 14.8% 1.09 [0.83, 1.43]
Chronic kidney disease
- eGFR ≤60 ml/min 28.1% 22.0% 1.30 [0.82, 2.08]
0.42
- eGFR >60 ml/min 16.7% 15.5% 1.05 [0.81, 1.34]
Geographic location
- North America 20.3% 14.6% 1.40 [0.99, 2.00]
- Europe 18.0% 17.6% 1.00 [0.75, 1.33] 0.30
- Other 9.6% 22.2% 0.37 [0.08, 1.21]
0.1 0.5 0.8 1 1.5 2 5
Hazard Ratio [95% CI]
 4-Year Death, Stroke or MI
PCI CABG Favors Favors
Subgroup (N=948) (N=957) HR [95% CI] PCI CABG P (Int)
All patients 18.6% 16.7% 1.10 [0.88, 1.36]
Left ventricular ejection fraction
- ≥50% 17.6% 16.1% 1.07 [0.84, 1.37]
0.92
- <50% 25.5% 22.2% 1.10 [0.64, 1.92]
Non-LM diseased coronary arteries
-0 18.1% 14.4% 1.23 [0.71, 2.15]
-1 16.7% 17.6% 0.91 [0.61, 1.35]
0.91
-2 22.2% 16.3% 1.38 [0.95, 2.01]
-3 16.1% 17.9% 0.87 [0.51, 1.45]
LM bifurcation or trifurcation stenosis ≥50%
- Yes 18.6% 16.7% 1.09 [0.86, 1.39]
0.90
- No 19.3% 16.7% 1.13 [0.69, 1.86]
Syntax score (site reported)
- ≤22 18.6% 16.7% 1.09 [0.77, 1.55] 0.98
- 23 - 32 18.7% 16.7% 1.10 [0.83, 1.45]
Syntax score (core lab assessment)
- ≤22 15.0% 15.5% 0.92 [0.62, 1.38]
- 23 - 32 19.9% 17.5% 1.13 [0.80, 1.58] 0.89
- ≥33 20.5% 17.2% 1.18 [0.77, 1.84]
0.1 0.5 0.8 1 1.5 2 5
Hazard Ratio [95% CI]
 NOBLE:
Primary Endpoint: MACCE

35
CABG PCI
30
HR 1.48 (1.11–1.96); p=0.0066 28.9%
25

20
19.1%
15

10

0
0 1 2 3 4 5
No. at risk: Analysis Time (Years)
PCI 592 539 442 313 227 127
CABG 592 PCI did
536 not show
440 non-inferiority
319 219 129
and CABG was superior to PCI
 NOBLE: Study Results

PCI* CABG*
(n=592) (n=592) HR [95%CI] PSup

MACCE 29% 19% 1.48 (1.11-1.96) 0.007

Death 12% 9% 1.07 (0.67-1.72) 0.77

Non-procedural MI 7% 2% 2.88 (1.40-5.90) 0.004

Stroke 5% 2% 2.25 (0.93-5.48) 0.07

Repeat revascularization 16% 10% 1.50 (1.04-2.17) 0.032

* Data are shown as 5-year K-M estimates

Christiansen EH, et al.

Lancet 2016
 Death in EXCEL and NOBLE
All-cause death Cardiovascular death*

P=0.11 P=0.77 P=0.71 P=0.84

12.0%
9.0%
8.2%
5.9%
3.7% 3.4% 3.0% 3.0%

EXCEL NOBLE EXCEL NOBLE

PCI CABG PCI CABG

* Definitions may vary across trials. K-M estimates are calculated at 3 years for EXCEL and 5 years
for NOBLE
Stone GW, et al. NEJM 2016;
Christiansen EH, et al. Lancet 2016
Myocardial Infarction in EXCEL and NOBLE
Periprocedural* Non-periprocedural*

P=0.03 P=0.52 P=0.07 P=0.004

7.0% 6.9%
6.0%
5.0% 4.3%
3.8%
2.7%
1.9%

EXCEL NOBLE EXCEL NOBLE

PCI CABG PCI CABG

* Definitions varied across trials. K-M estimates are calculated at 3 years for EXCEL and 5 years for
NOBLE
Stone GW, et al. NEJM 2016;
Christiansen EH, et al. Lancet 2016
 Other Endpoints in EXCEL and NOBLE
Stroke Def ST / SGO Revascularization

P=0.37 P=0.07 P<0.001 P=0.22 P<0.001 P=0.03

16.2%

12.9%
10.4%

7.6%

5.0% 5.4%
4.0%
3.0%
2.3%2.9% 2.0%
0.7%

EXCEL NOBLE EXCEL NOBLE EXCEL NOBLE

PCI CABG PCI CABG PCI CABG

* Definitions varied across trials. K-M estimates are calculated at 3 years for EXCEL and 5 years for
NOBLE
Stone GW, et al. NEJM 2016;
Christiansen EH, et al. Lancet 2016
Can We Trust the SYNTAX Score Anymore?

EXCEL NOBLE
P for interaction = 0.49
33%
30%
27%
24%
22%
18% 17% 17% 16%
13% 14%
10%

0-22 23-32 >32 0-22 23-32 >32

PCI CABG PCI CABG

* Percentages K-M estimates at 3 years (EXCEL) or 5 years (NOBLE)

Stone GW, et al. NEJM 2016;
Christiansen EH, et al. Lancet 2016
 Diabetic Subgroup
PCI CABG
(n=286) (n=268) HR [95%CI] P value
Death, stroke or MI (1˚ endpoint) 20.3% 19.6% 0.99 [0.68, 1.45] 0.95

- Death 13.6% 8.1%% 1.64 [0.96, 2.81] 0.07

- Definite cardiovascular 5.6% 4.7% 1.18 [0.55, 2.53] 0.66

- Definite non-cardiovascular 7.1% 2.7% 2.46 [1.03, 5.88] 0.04

- Undetermined cause 1.4% 0.8% 0.67

- Stroke

- MI 10.2% 10.9% 0.68

- Peri-procedural 3.5% 6.0% 0.17

- Spontaneous 7.1% 5.7% 0.59

- STEMI 2.9% 2.7% 0.90

- Non-STEMI 7.7% 9.1% 0.49

 NOBLE:
MACCE Diabetes

35
CABG PCI
33%
30
29%
25

20

15

10

5
HR 1.20, CI 0.64-2.25 p=0.58
0
0 1 2 3 4 5
No. at risk: Analysis Time (Years)
PCI 89 78 60 46 30 22
CABG 94 84 63 44 33 17
 Individual-patient-data Analysis from 11 PCI vs. CABG Trials
11,518 randomized pts; 4,478 (38.9%) with Left Main DS
All-cause Mortality (Left Main)
15 Mean follow-up 3.8 ± 1.4 years
PCI (n=2233)
CABG (n=2245)
10.7%
Mortality (%)

10 10.5%

HR 1.07 (95% CI 0.87-1.33)

P=0.52
0
0 1 2 3 4 5
Number at risk Follow-up (Years)
CABG (LM) 2245 2086 1903 932 804 406
PCI (LM 2233 2120 1946 978 849 478

Head SJ et al. Lancet 2018:on-line

 SYNTAXES: Left Main (LM)

50
HR: 0.89, 95%CI [0.66-1.19], P = 0.43
40
Mortality (%)

30 31.9% PCI
29.7% CABG
20

10

0
0 1 2 3 4 5 6 7 8 9 10
Follow-up (years)
Numbers at risk
CABG 348 330 319 309 300 245 183 171 161 155 145
PCI 357 343 338 331 316 265 190 183 176 164 154
Two Very Different Procedures…
 EXCEL: Periprocedural Events
PCI CABG
(n=948) (n=957) RR [95%CI] P value
30-Day peri-procedural MAE, any 8.1% 23.0% 0.35 [0.28, 0.45] <0.001
- Death* 0.9% 1.0% 0.91 [0.39, 2.23] 0.83
- Stroke* 0.6% 1.3% 0.50 [0.19, 1.34] 0.16
- Myocardial infarction* 3.9% 6.2% 0.63 [0.42, 0.95] 0.02
- Ischemia-driven revascularization* 0.6% 1.4% 0.47 [0.18, 1.22] 0.11
- TIMI major/minor bleeding 3.7% 8.9% 0.42 [0.28, 0.61] <0.001
- Transfusion ≥2 units 4.0% 17.0% 0.24 [0.17, 0.33] <0.001
- Major arrhythmia** 2.0% 15.8% 0.13 [0.08, 0.20] <0.001
- Surgery/radiologic procedure 1.1% 4.0% 0.27 [0.13, 0.53] <0.001
- Renal failure† 0.5% 2.4% 0.22 [0.08, 0.57] <0.001
- Sternal wound dehiscence 0.0% 1.9% 0.03 [0.00, 0.45] <0.001
- Infection requiring antibiotics 2.3% 13.6% 0.17 [0.11, 0.27] <0.001
- Prolonged intubation (>48 hours) 0.4% 2.9% 0.14 [0.05, 0.41] <0.001
- Post-pericardiotomy syndrome 0.0% 0.4% 0.11 [0.01, 2.08] 0.12
*Adjudicated events; others are site-reported. **SVT requiring cardioversion, VT or VF requiring treatment, or bradyarrhythmia
requiring temporary or permanent pacemaker. †Serum creatinine increased by ≥0.5 mg/dL from baseline or need for dialysis.

Stone GW, et al. NEJM 2016

Operator Volume and Outcomes
in LM PCI
Outcomes at 30 Days
High-volume Operator (n=1,422) Low-volume Operator (n=526)
10

p=0.17 p=0.11
30-day Event Rates (%)

8
7.0
6.5

6
4.9 5.1

4 p=0.008 p=0.002
p=0.43 p=0.10
2.1 2.1
2 p=1.00
1.1 0.6 1.1
0.6 0.5
0.1 0.4
0.0
0
Death Cardiac Stroke MI TVR Death/ Def/Prob
Death Stroke/MI ST

Xu et al, J Am Coll Cardiol Intv 2016;9:2086-93

 Operator Volume and Outcomes
in LM PCI
Subgroup Analyses: Primary Endpoint at 3 Years

Hazard Ratio P for

(95% CI) Interaction
IVUS used 0.42 (0.14, 1.22)
0.47
IVUS not used 0.53 (0.29, 0.97)

Non-bifurcation 0.50 (0.27, 0.90)

0.93
Bifurcation 0.45 (0.13, 1.53)

Two-stent 0.14 (0.03, 0.82)

0.39
One-stent 0.56 (0.29, 1.08)
0.0 1.0 2.0

Favors High-volume Favors Low-volume

Xu et al, J Am Coll Cardiol Intv 2016;9:2086-93

 EXCEL: Radial v Femoral
• 30-day major bleeding 2.4% (TRA) vs.
3.8% (TFA), p=0.30
• 3-year death/MI/stroke rates similar
15.7% (TRA) vs. 14.8% (TFA)

Chen et al. EuroIntervention, 2018

 New Ground Rules in 2019?

• No Difference between PCI and CABG

Diabetes
Renal disease
SYNTAX score
How to Implement the EXCEL Results
• Use best in class DES

• IVUS/FFR to assess the intermediate LM LSN

• FFR to avoid unnecessary stenting, but also to

ensure complete ischemic revascularization

• IVUS-guided LM stenting • 1- vs 2-stent techniques

• Optimal LM stent technique
• Optimal pharmacotherapy
• Debulking
• Hemodynamic support
• Staging
• No routine angio FU
• Thienopyridine pre-loading
• Statin pre-loading
• GDMT
 LM PCI in the US (NCDR)
3,342,162 Patients 33,128 LM

Valle et al, JAMA Cardiol. 2019;4:100-109

 Mean Annual LM PCI Volume US

• Operators 0.5/yr
• Facilities 3.2/yr
• 46% hospitals 84% operators,
<1 yr

Valle et al, JAMA Cardiol. 2019;4:100-109

 AUC in Left Main Coronary Artery Stenosis
Asymptomatic Ischemic Symptoms
Not on AA
Therapy or with Not on AA On 1 AA Drug
AA Therapy Therapy (BB Preferred) On ≥2 AA Drugs
Indication PCI CABG PCI CABG PCI CABG PCI CABG
• Isolated LMCA disease
M (6) A (8) A (7) A (8) A (7) A (9) A (7) A (9)
• Ostial or midshaft stenosis
• Isolated LMCA disease
M (5) A (8) M (5) A (8) M (5) A (9) M (6) A (9)
• Bifurcation involvement
• LMCA disease
• Ostial or midshaft stenosis
• Concurrent multivessel disease M (6) A (8) M (6) A (9) A (7) A (9) A (7) A (9)
• Low disease burden (e.g., 1-2 additional focal
stenoses, SYNTAX score ≤22)
• Ostial or midshaft stenosis
• Concurrent multivessel disease
• Intermediate or high disease burden (e.g., 1-2 M (4) A (9) M (4) A (9) M (4) A (9) M (4) A (9)
additional bifurcation stenosis, long stenoses,
SYNTAX score >22)
• LMCA disease
• Bifurcation involvement
M (4) A (8) M (5) A (8) M (5) A (9) M (6) A (9)
• Low disease burden in other vessels (e.g., 1-2
additional focal stenosis, SYNTAX score ≤22)
• LMCA disease
• Bifurcation involvement
• Intermediate or high disease burden in other vessels R (3) A (8) R (3) A (9) R (3) A (9) R (3) A (9)
(e.g., 1-2 additional bifurcation stenosis, long stenoses,
SYNTAX score >22)

Patel et al, J of Am Coll.of Cardiology. 2017 in press

Unprotected Left Main; Keys to Success

Is it really left main?

IVUS is key: especially in Ostial
Lesions
And while we’re at it: use it in all
phases of the case
0 1.0 4.0mm
IVUS in Intermediate Left Main Lesions

n=115
QCA – 38%
Plaque Burden – 63%
MLA <6.0 – 46%

Sano AHJ 2007;154:983

FFR vs. IVUS in LM and non-LM Lesions
Much Better Correlation in LM
Use of IVUS During LM Stenting Associated
with Trend towards Decreased Mortality
Hazard Ratio: 0.54 (95% CI 0.28-1.03, p=0.06
201 Pairs of Propensity-matched Patients
40
Angiography guidance
Cumulative Mortality (%)

30 IVUS guidance

P=0.063
20

13.6% (8.0-19.24%)
10
6.0% (2.5-9.4%)

0
0 180 360 540 720 900 1080
Patients at risk Days
Angiography guidance 201 194 143 88
IVUS guidance 201 191 138 64
Park SJ. et al. Circulation Cardiovascular Interventions 2010
 IVUS-guided PCI was
Performed in 690/935 Pts (74%)
Change in LM stenting by IVUS
• Used larger balloon: 30% (107)
• Post-dilated: 29% (102)
NO YES • Used higher pressure: 17% (62)
48.3% 51.7% • Treated stent under-expansion:
N=333 N=357 16% (57)
• Led to provisional 1 stent strategy
rather than planned 2 stents: 11%
(41)
• Led to planned 2 stent strategy
rather than provisional 1 stent:
9% (33)
Maehara A. TCT 2016
 Criteria for Stent Underexpansion at the
Distal LMCA Bifurcation (n=403)

• MACE-free survival was lower

in pts with underexpansion vs
LM Proximal those without underexpansion
to the POC (89.4% vs 98.1%)
LCX • TLR-free survival was lower in
ostium pts with underexpansion vs
POC
no underexpansion
(90.9% vs 98.5%)
LAD • Although acute malapposition
ostium was observed in 28 pts,
malapposition was not related
to MACE at follow-up

Kang et al. Circulation Cardiovasc Interv.

2011;4:562-9
 3-Year Outcomes by LM MSA
Low: Inter: High:
IVUS MSA tertiles
4.4-8.7 8.8-10.9 11.0-17.8 P P
(range)
(n=172) (n=169) (n=163) L vs I L vs H
Death/MI/stroke 19.4% (32) 16.1% (26) 9.6% (15) 0.45 0.01
Death/MI/stroke/IDR* 26.6% (44) 23.8% (39) 18.3% (29) 0.66 0.08
All-cause death 13.8% (22) 10.0% (16) 5.2% (8) 0.34 0.01
Cardiovascular death 7.4% (12) 4.8% (8) 4.0% (6) 0.39 0.16
MI 10.5% (17) 8.2% (13) 3.7% (6) 0.49 0.02
Stroke 1.8% (3) 1.2% (2) 2.1% (3) 0.66 0.98
Stent thrombosis (D/P) 3.1% (5) 1.2% (2) 0.0% (0) 0.26 0.03
Left main IDR 12.0% (19) 8.3% (13) 8.8% (14) 0.30 0.41
Non-TV IDR 1.9% (3) 3.3% (5) 1.3% (2) 0.48 0.65
* IDR: ischemia driven revascularization
Maehara A. TCT 2016
Unprotected Left Main Keys To Success

Completely revascularize!
 Incomplete Revascularization after LM PCI
is Associated with Worse Cardiac Survival
Italian CUSTOMIZE Registry of 400 patients undergoing LM PCI
Residual SYNTAX Score >0 is a marker of Incomplete Revascularization
Cumulative Cardiac Mortality Rate (%)

CR (rSS=0)
Low rSS (rSS 1-8)
40 High rSS (rSS > 8)
Log rank P<0.001
30 Residual SYNTAX score (rSS) =
(SYNTAX score Pre-PCI) –
High rSS 19.8%
20 (SYNTAX Score post-PCI)

10
Low rSS 4.5%

0 CR 3.5%
0 180 360 540 720
Time (Days)

Capodanno et al. Catheterization and Cardiovascular Interventions 2012

 Unprotected Left Main Pearls of
Wisdom for Success
Optimize lesion preparation
LM has a higher propensity for
calcification
Think
Angiosculpt/CB/Chocolate
Roto/OA
? Shockwave
Why “Prepare” a Left Main Lesion?

• To enhance stent delivery

and expansion
• To avoid side branch compromise
• To avoid abrupt closure and
hemodynamic compromise
• To treat side branch (i.e., circumflex)
stenosis to maximize the success of a
crossover single stent strategy
MLA / PB = 5.94mm2 / 73%
ANGIOSCULPT 3.5x10mm to 12 atm
Xience V 4.0x12mm 14 atm
Final Result

MLA = 13mm2
MLA / PB = 13mm2 / 34%
Unprotected Left Main Keys to Success

Rational Use of
Hemodynamic Support
 When Do I Consider Support?

• Last Remaining Vessel

• Severe LV dysfunction: support for
ischemic stress and contrast load
• LV dysfunction with prospect of
uncontrolled interruption of coronary flow
 Difficult wiring
 Difficult stent delivery
 High risk of no reflow (i.e., SVGs,
Roto, thrombus)
 Comparison of Support Devices
Impella
IABP ECMO TandemHeart CP
Catheter Size 7.5-9.0 21/18 21/17/15 9
Cannula Size 8.5-10 21/18 21/17/15 13
# Insertion Sites 1 2 2 1
Anticoagulation + +++ ++/+++ +
Transeptal No No Yes No
Limb ischemia + +++ +++ +
Priming volume No Yes Yes No
Unloads Directly LV No No No Yes
Requires stable Yes No No No
rhythm
Improve + +++ +++ ++/+++
hemodynamics
Unprotected Left Main Keys to Success

• Crossover is best but use 2

stents if you must
(severe 1,1,1)
• Size to Distal Vessel, POT
proximally tobifurcation
The Visible Heart®: General Procedures
Paul Iaizzo, PhD Francesco Burzotta, MD
• Cardioplegia
• Removal, w/ great vessels
• Cannulation
• Langendorff Perfusion / 4 Chamber modes
• Visualization of anatomy and/or devices
Chinchoy E, Soule CL, Houlton AJ, Callagher WJ, Hjelle MA, Laske TG, Morissette
J, Iaizzo PA. Isolated four-chamber working swine heart model. Ann Thorac Surg.
2000; 70(5):1607-14.
Coles JA Jr, Sigg DC, Iaizzo PA: The potential benefits of 1.5% hetastarch as a
cardioplegia additive. Biochemical Pharmacology 69: 1553-1558, 2005.
 Reperfusion In Vitro: Defibrillation

Sigg, DC, Coles JA Jr, Gallagher WJ, Oeltgen PR, Iaizzo PA: Opioid preconditioining: myocardial function and
energy metabolism. The Annals of Thoracic Surgery, 72: 1576-1582, 2001.

Sigg DC, Iaizzo PA: In vivo versus in vitro comparison of swine cardiac performance: Induction of
cardiodepression with halothane. European Journal of Pharmacology, 543:97-107, 2006. .
 Provisional Stenting – Step-by-Step
“Optimized” Provisional
When SB intervention is
needed

MV sizing POT
according to
DISTAL MV
Distal Kissing
Rewiring
Provisional Stenting – Wire
Both Branches
Provisional Stenting – Main Vessel Stent
Provisional Stenting – POT
Proximal Optimization Technique (POT)

• Proximal optimization seems to reduce the number of

cells covering the side branch ostium
• It also enlarges these cells, possible facilitating side
branch access
• The location where the guidewire goes into the side
branch is indicated with the red circle

From J. Wentzel, P. Mortier: Finite Element Simulation

Provisional Stenting – POT Importance
Provisional Stenting – Distal Rewiring
Pullback Technique

Distal
Rewiring
Provisional Stenting – Distal Rewiring
Pullback Technique

Jailed Wire

Rewiring Wire
Provisional Stenting – Kissing Balloons
& Final Result
What about Side-branch Stenting when
Needed after a Provisional Approach?
TAP (T-and Protrusion)

Final kissing balloon inflation

with the SB stent balloon and
the MV balloon
What about Side-branch Stenting when
Needed? TAP

SB Stent Positioning SB Stent Inflation Final Kissing

(intentional minimal with MV Balloon with SB Stent
protrusion) with MV Uninflated Balloon and MV
Balloon ready for Balloon
Kissing
What about Side-branch Stenting when
Needed? TAP Final Result
 Culotte Stenting Technique
1. Wire both branches and predilate if 2. Leave the wire in the more straight branch
needed (MB) and deploy a stent in the more angulated
branch (SB)

3. Rewire the unstented branch and dilate the 4. Place a second stent into the unstented
stent struts to unjail the branch (MB) branch (MB) and expand the stent leaving
some proximal overlap

5. Re-cross the 2nd stent’s (MB) struts into the 1st stent
(SB) with a wire and perform kissing balloon inflation.
Culotte Stenting – MV Stent
Culotte Stenting – SB Dilation
Culotte Stenting – SB Stent Deployed
Culotte Stenting – MB Rewiring
 Kissing Balloons & Final Culotte

Pre

Post
 DK Crush Illustration

E
• 1-2 mm of SB stent positioned in MV (proximal SB stent marker on
MB wire or SB just covers proximal edge of ostim)
• The SB stent is deployed & stent balloon withdrawn slightly with high
RBP inflation (flares proximal stent) – then angiogram to make sure
no distal dissection
• The SB is crushed by a MV balloon then rewire and kiss (extra kiss)

c/o J. Hermiller, adapted from Ormiston JACC Intv 2008

 DK Crush Illustration

• Deploy Main Branch Stent

• Rewire SB (for 2nd kiss)
• SB – high pressure dilatation NC balloon (1st step of
kissing balloon inflation)
• Final kissing balloon inflation

c/o J. Hermiller, adapted from Ormiston JACC Intv 2008

SB Stent Deployment
Crush
1st Kiss Inflation
MB Stent Deployment
Re-wiring SB
2nd Kissing
Final DK Crush Result
 Provisional 1-Stent vs. Planned 2-Stents
For LM Distal Bifurcation Disease (n=529)
HR [95% CI =
Provisional 1-stent and 0-1 SB with DS ≥50%
0.56 [0.32, 0.99]
Planned 2-stents and 0-1 SB with DS ≥50% P = 0.04
30
Provisional 1-stent and 2 SBs with DS ≥50% HR [95% CI =
Death, stroke or MI (%)

0.71 [0.34, 1.48]

25 Planned 2-stents and 2 SBs with DS ≥50%
P = 0.36
23.3%

20 19.2%

15 14.3%
13.8%
10

0
0 6 12 18 24 30 36
Time (Months)
Number at risk:
77 73 72 69 67 67 64
264 246 242 238 233 227 218
105 90 88 86 85 83 82
78 70 69 64 61 60 55

Kandzari DE et al. Submitted

 DKCRUSH-III: 3-Year MACE
863 pts from 18 centers in 4 countries with ULMCA distal
bifurcation lesions randomized to Culotte vs. DK Crushs
1.0 DK crush, 91.8%
Survival free from MACE

0.8

Culotte stenting, 76.3%

at 3-year FU

0.6
P<0.001
0.4

0.2

0.0

0 200 400 600 800 1000 1200

No. Pts at risk Time from Stenting Procedure (days)
DK 208 196 193 193 193 192 191
Culotte 207 194 173 164 160 158 158

Chen SL et al. JACC Int 2015;8:1335-42

 DKCRUSH-III: 3-Year Follow-up
DK Crush Culotte
(n=208) (n=207) P
Composite MACE, n (%) 17 (8.2) 49 (23.7) <0.001
- Cardiac death 3 (1.4) 6 (2.9) 0.34
- MI 7 (3.4) 17 (8.2) 0.04
- TLR 8 (3.8) 29 (14.0) <0.001
- TVR 12 (5.8) 39 (18.8) <0.001
- CABG 2 (1.0) 1 (0.5) 0.57
Stent thrombosis, n (%) 1 (0.5) 8 (3.9) 0.02
- Definite 0 7 (3.4) 0.007
- Probable 0 1 (0.5) 0.50
- Possible 1 (0.5) 0 0.32

Chen
Chen SLSL
etetal.al.JACC
JACC Int
Int 2015;8:1335–42
2015;8:1335-42
 DKCRUSH V: 12-month TLF
Simple vs. Complex Bifurcation Lesions

Chen SL et al. JACC 2017;70:2605-17

 EBC MAIN

• The European Bifurcation Club Left

Main Coronary Study – a randomised
comparison of Single versus Dual
Stenting for True Bifurcation Left Main
Coronary Lesions
EBC Main: LM x,1,1: Prov vs 2 Stent

• Multicentre
• Prospective
• Randomised
• 450 patients
• 30 centres
• 10 countries
 Inclusive of UK
 Inclusive of Catalonia
Unprotected Left Main Keys to Success

• If 2 stents used IVUS

is mandatory!
 Relationship Between Stent
Underexpansion and Restenosis
Two-Stent Techniques (n=114) One-stent Cross-over (n=289)
40
Underexpansion
35
ISR
30
25
20
15
10
5
0
LM POC LAD LCX LM POC LAD Unstented
LCX

Kang et al. Circulation Cardiovasc Interv.

2011;4:562-9
 Unprotected Left Main Keys
to Success

In tenuous situations stabilize

left main first
• V stent for x,1,1
• “Bang Bang” for crossover
 An approach for bifurcational lesions
when using 2 stents as intention to treat

Bifurcational lesion with Bifurcational lesion with

Bifurcational lesion with
main branch disease main branch disease
no disease proximal to
extending proximal to the extending proximal to the
the bifurcation or very
bifurcation and side bifurcation and side branch
short left main
branch which has origin which ha origin with about
with about 90° angle 60° angle
V-Stent
T-Stent Short-Mini Crush/culotte

Pre Post Pre Post Pre Post

Cross Section
 What is “Bang Bang”?
• 7-8F Guide
• Two wires down LAD ,one in circumflex
• NC Balloon on one LAD wire (Min 3mm)
• Stent on second
• Both placed at distal guide with 2
inflation devices
• Dilate balloon for 5 seconds at high
pressure and isure full inflation
• Pull balloon and wire back ,quick angio
• Place and deploy stent at high pressure
• DONE!!!!!
 Conclusions
• We are at equipoise for the majority of
Left Main Patients
• Further follow up will reinforce or
undermine this statement esp re long
term CV mortality
• Many old assumptions need to be
re-evaluated (DM, CKD, SYNTAX Score)
• In fairness to your patients You need to
be comfortable with LM intervention
(or know someone who is!)