Long-term Outcomes Following DES Implantation for UPLM stenosis

Alaide Chieffo, MD

San Raffaele Scientific Institute

Milan, Italy

Single-stent Crossover Technique ULMCA/LCx

The Milan Registry

•Naganuma et al. Catheter Cardiovasc Interv. 2013 May 15.

3-Y MACE TLR (Overall) TLR (Stented Branch)

Single-stenting with DES for ULMCA performed in 584 patients.

31 patients underwent LMCA–LCx stenting, 553 underwent LMCA–LAD stenting.

Five-year MACE of ULMCA Stenting: One versus

Two-Stent Techniques Versus DK Crush Technique

The Chinese Experience

Chen et al. EuroIntervention. 2012;8:803-14

1 Stent vs 2 Stents One stent vs DK Crush 1 Stent vs 2 Stents

Double Kissing Crush Versus Culotte Stenting

for Unprotected Distal Left Main Bifurcation Lesions

DKCRUSH-III

Chen et al. J Am Coll Cardiol. 2013;61:1482-8

• Compared to the DK crush, Culotte stenting was associated with significantly increased MACEs at 12 months

• DK crush was associated with • less in-stent restenosis of SB • less TLR/TVR

5-Year Outcomes of First-Generation DES

The Japanese (N=582) and French (N=291) Registries

•J-CYPHER •JACC Cardiovasc Interv. 2013;6:654-63.

•FLM-TAXUS •EuroIntervention. 2012;8:970-81

Second- vs. First-generation DES

1-year MACE P=0.01

FLORENCE (N=390)

J Am Coll Cardiol. 2012;60:1217-22

3-year MACE P=0.60

ESTROFA-LM (N=770)

J Am J Cardiol. 2013;111:676-83

EXCELLENT (N=275) Int J Cardiol.

2013 Apr 24. AOP

1-year MACE P=0.12

2-year TLF P=0.01

FML-T/LEMAX (N=344)

EuroIntervention. 2013;9:452-62.

Adj. HR (EES): 0.42, 95% CI 0.19-0.92, P=0.03

Adj. HR (PES): 2.36, 95% CI 1.16-4.82, P=0.02

Propensity adjusted 166 matched pairs

Propensity adjusted 200 matched pairs

Capodanno et al. Int J Cardiol 2013 3 Apr 30.

Second- vs. First-Generation DES Meta-Analysis Of 2,231 Patients from

4 Adjusted/Matched OSs

Studies N Random effects

P Fixed

effects P I2, % P

Systematic bias, P

Death 3 1,461 1.04

(0.69-1.58) 0.25

1.04 (0.69-1.58)

0.25 0 0.48 0.12

Non fatal MI

3 1,461 0.58

(0.22-1.53) 0.27

0.60 (0.27-1.32)

0.21 32 0.23 0.60

TVF/TLR 4 2,231 0.78

(0.41-1.49) 0.45

0.85 (0.61-1.17)

0.31 73 0.01 1.00

ST 4 2,231 0.51

(0.22-1.15) 0.11

0.51 (0.22-1.15)

0.11 0 0.40 0.50

Buchanan, Chieffo et al Eurointerv 2013 in press

DELTA Study Population

April 2002 April 2006

ALL consecutive patients with de novo ULMCA disease

PCI with DES n=1874

CABG n=901

Chieffo et al JACC Cardiovasc Interv. 2012 Jul;5(7):718-27

DELTA Registry (N = 2775)

Patients treated with PCI (N = 1874)

Patients treated with CABG were excluded (N = 901)

Patients treated with bifurcation stenting were

excluded (N = 262)

Distal bifurcation lesion

(N = 1130)

Ostial/midshaft ULMCA PCI group (N = 482)

Ostial/midshaft lesion

(N = 744)

Distal ULMCA PCI group

(N = 1130) Study population (N = 1612)

Naganuma T, Chieffo A, et al. JACC Cardiovasc Interv. in press.

P value HR 95% CI

MACE* Unadjusted <0.001 1.57 1.28 to 1.93

PS adjusted 0.001 1.48 1.16 to 1.89

PS matched 0.006 1.48 1.12 to 1.95

All-cause death Unadjusted 0.074 1.31 0.97 to 1.77

PS adjusted 0.057 1.45 0.99 to 2.14

PS matched 0.230 1.32 0.84 to 2.08

Death/MI Unadjusted 0.018 1.36 1.05 to 1.74

PS adjusted 0.050 1.37 1.00 to 1.86

PS matched 0.188 1.28 0.89 to 1.84

TVR Unadjusted <0.001 1.97 1.44 to 2.68

PS adjusted 0.003 1.68 1.19 to 2.38

PS matched 0.003 1.82 1.23 to 2.69

TLR Unadjusted <0.001 2.29 1.53 to 3.41

PS adjusted 0.002 2.00 1.29 to 3.10

PS matched 0.001 2.32 1.41 to 3.82

DELTA Study endpoints

Propensity score matched analysis

Naganuma T, Chieffo A, et al. JACC Cardiovasc Interv. in press.

DELTA Registry (N = 2775)

Patients with ostial/midshaft lesion (N = 1118)

Patients with distal bifurcation lesion were excluded (N = 1657)

Patients treated with bifurcation stenting were

excluded (N = 262)

Treated with CABG (N = 374)

PCI group (N = 482)

Treated with PCI (N = 744)

CABG group (N = 374)

Study population (N = 856)

P value HR 95% CI

MACCE Unadjusted 0.059 1.33 0.99-1.78

PS adjusted 0.113 1.34 0.93-1.93

PS matched 0.104 1.40 0.93-2.10

All-cause death Unadjusted 0.307 1.24 0.82-1.88

PS adjusted 0.255 1.35 0.80-2.27

PS matched 0.348 1.31 0.74-2.32

Death/MI Unadjusted 0.623 1.09 0.76-1.57

PS adjusted 0.235 1.33 0.83-2.12

PS matched 0.220 1.38 0.82-2.31

Death/MI/CVA Unadjusted 0.793 1.05 0.75-1.46

PS adjusted 0.372 1.21 0.79-1.86

PS matched 0.350 1.25 0.78-2.01

TVR Unadjusted 0.009 2.15 1.21-3.80

PS adjusted 0.039 1.94 1.03-3.64

PS matched 0.060 1.97 0.97-4.00

TLR Unadjusted 0.057 2.03 0.98-4.21

PS adjusted 0.090 2.00 0.90-4.45

PS matched 0.073 2.23 0.93-5.37

DELTA Study endpoints

Propensity score matched analysis

P 0.006

•Mohr, et al. Lancet 2013;381:629–38

SYNTAX – Final 5-Year Results

Left Main Cohort (N=705)

Re-Assessing the Comparative Effectiveness of CABG vs PCI vs Medical Therapy in Left Main Disease A Bayesian Cross-Design And Network Approach

• Bittl et al. Circulation. 2013;127:2177-2185

PCI

vs C

AB

G

RC

Ts

SYNTAX LM

LEMANS

Boudriot et al.

PRECOMBAT

PCI v

s CA

BG

O

Ss

White et al.

MAIN COMPARE

Wu et al.

Brener et al.

Chieffo et al.

Makikallio et al.

Palmerini et al.

Sanmartin et al.

CA

BG

vs

MT

2

RC

T, 5

OS

s

Takaro et al.

Chaitman et al.

Oberman et al.

Cohen et al.

Talano et al.

ECCS

APPROACH

Evidence for the ACCF/AHA Class IIa recommendation for PCI to

improve survival in patients with ULMCAD

Knowledge base to show that CABG confers a survival advantage

over MT in patients with ULMCAD

2013 ESC Guidelines For Stable CAD

•Montalescot et al. Eur Heart J 2013 Ahead Of Print

a50% stenosis and proof of ischaemia, >70% stenosis in two angiographic views, or fractional fow reserve <0.80. bPreferred option in general.