predictors of outcome after the treatment of des restenosis in … · 2020. 4. 6. · the milan and...

Welcome to the 8th European Bifurcation Club

12-13 October 2012 - Barcelona

Predictors of Outcome after the Treatment of DES restenosis in the

Distal UPLM (MITO)

Kensuke Takagi MD, Alaide Chieffo MD Antonio Colombo MD

Sunao Nakamura MD,

Sunao Nakamura FACC, FAHA, FESC, FSCAI

The MIlan and New-TOkyo (MITO) Registry

From 2005 April 2002 April

Milan n=385

New-Tokyo n=635

MITO Registry Total 1020 patients

Between April 2002 and April 2011, patient cohort includes 1020 patients with LMT stenosis in our data-base, treated with Drug-eluting stent.


① DES Restenosis in the Unprotected Distal Left Main Stem Circ cardiovasc interv. 2012

② Predictors of Main Branch Restenosis in the Unprotected Distal Left Main Bifurcation Coronary Lesions

Euro PCR 2012

③ Impact of Residual CTO of Right Coronary Artery on the Long Term Outcome in Patients treated for Unprotected Left Main Disease

ESC2012. Circ cardiovasc interv. Under revision

Background

  Aside from the use of DES, there is no consensual agreement regarding the optimal PCI strategy for ULM stenosis, particularly when the distal bifurcation is involved. Moreover, there is little data available on the treatment of ISR in this region.

  The aim of this study was to evaluate the optimal PCI strategy for patients with UDLM DES-ISR, and to determine whether the initial strategy impacts upon the outcome of TLR for the ISR.

575 patients undergoing first PCI with DES for unprotected LM disease

Between April 2002 and December 2008

8 patients underwent CABG

84 patients underwent repeat PCI (43 POBA and 41 DES)

10 patients lost at follow-up

within 6months

565 patients with clinical or routine

angiographic follow-up

91 patients with non-Bifurcation ULM

474 patients with Distal Bifurcation ULM

(1-stent 280patients, 2-stent 194 patients)

7 ISR of non-Bifurcation ULM 92 ISR of Distal Bifurcation ULM

7 patients underwent PCI

Study population

Endpoint

•  Primary outcome

•  Secondary outcome

Composite of MACE (all-cause death, MI and TLR) during follow-up period (median 24 months)

All the individual components of the primary outcome: Death, MI, TLR and ST

Patients: n (%)

UDLM DES-ISR underwent PCI

84 (91.3)

UDLM DES-ISR treated with POBA

43 (51.2)

UDLM DES-ISR treated with DES

41 (48.8) p-value

LM +3 VD 33 (39.3) 10 (23.3) 23 (56.1) 0.01 True-Bifurcation

Medina 111,101,011 64 (76.2) 30 (69.8) 34 (82.9) 0.20

Syntax score 31.30±9.82 30.39±9.62 32.36±10.09 0.39

IABP 10 (11.9) 1 (2.3) 9 (22.0) 0.01

IVUS 41 (48.8) 25 (58.1) 16 (39.0) 0.09

Rota 8 (9.5) 5 (11.6) 3 (7.3) 0.71

Bif-2 stent 49 (58.3) 30 (69.8) 19 (46.3) 0.05 Number of stents/

patient 1.49±0.50 1.60±0.50 1.37±0.49 0.03

Total stent length/patient, mm 30.55±12.70 31.84±11.90 29.20±13.51 0.34

Maximum stent diameter, mm 3.24±0.31 3.26±0.32 3.22±0.30 0.59

Maximum balloon diameter, mm 3.53±0.60 3.60±0.63 3.46±0.56 0.36

Maximum dilation pressure, atm 18.73±3.76 18.67±3.68 18.77±3.86 0.92

Lesion characteristics 1

Patients: n (%)

UDLM DES-ISR underwent PCI

84 (91.3)

UDLM DES-ISR treated with POBA

43 (51.2)

UDLM DES-ISR treated with DES

41 (48.8) p-value

Isolated Ostial LAD 8 (9.5) 5 (11.6) 3 (7.3)

0.001

Isolated Ostial LCx 41 (48.8) 28 (65.1) 13 (31.7)

Both ostial LAD and LCx 7 (8.3) 4 (9.3) 3 (7.3)

LAD or LCx 6 (7.2) 3 (7.0) 3 (7.3)

Left main stem 5 (6.0) 0 5 (12.2)Diffuse

restenosis 17 (20.2) 3 (7.0) 14 (34.1)

Lesion characteristics 2 -Type of restenosis-

Outcome Rates (%) at 2-years Cox regression

Patients: n (%) POBA(n=43) DES

(n=41) Hazard Ratio (95% CI) p-value

MACE (Cardiac death, MI and

TLR) 51.3±7.6 23.7±7.0 2.75 (1.26-5.98) 0.011

Cardiac death 4.8±3.3 5.5±3.8 0.91 (0.13-6.46) 0.91 Cardiac death +

MI 7.8±4.3 5.9±4.1 1.29 (0.22-7.78) 0.78

TLR 47.6±7.7 20.8±6.6 2.79 (1.23-6.34) 0.014

Clinical Results

Log Rank P=0.078

DES implantation N=41 POBA alone N=43

DES 94.1% at 2-yearsPOBA 92.2% at 2-years

(A) Cardiac-death + MI

Log Rank P=0.01

POBA 52.4% at 2-years

DES 76.3% at 2-years

(B) MACE

Log Rank P=0.01

POBA 48.7% at 2-years

DES 79.2% at 2-years

(C) TLR



follow-up months follow-up months follow-up months

Even

t fre

e su

rviv

al (%

) 100

80

60

40

20

0

100

80

60

40

20

0

100

80

60

40

20

0

Risk at No DES

POBA

2-years 30 35

1-year 36 39

Risk at No DES

POBA

2-years 26 20

1-year 29 22

Risk at No DES

POBA

2-years 26 20

1-year 29 22

Cumulative events according to the treatment (POBA vs DES) in Pts with UDLM-ISR

Univariable Hazard ratio P Value Cox regression adjusted

Hazard ratio P Value

POBA vs. DES 2.79 (1.23-6.34) 0.014 3.29 (1.41-7.69) 0.006

EuroScore >6 1.89 (0.80-4.44) 0.147 2.53 (1.02-6.28) 0.045

DM 1.80 (0.85-3.81) 0.126 1.79 (0.83-3.86) 0.14

High EF 1.05 (1.00-1.11) 0.059

Older age 1.03 (0.99-1.07) 0.13

Estimated GFR 0.99 (0.97-1.01) 0.19

The use ofa 2-stent strategy 1.27 (0.59-2.75) 0.55

The pattern of ISR(focal or diffuse) 0.58 (0.22-1.53) 0.27

Predictors of Repeat TLR in Pts Treated with PCI for UDLM-ISR (n=84)

Cumulative TLR events according to the treatment (POBA vs. DES) in patients with UDLM-ISR at LCx-ostial

100

80

60

40

20

0

DES implantation N=13

Log Rank P=0.06

POBA alone N=28

More complex lesion were observed in patients with 2-stent strategy

Patients: n (%) All patients(n=474) 1-Stent Strategy

(n=280) 2-Stent Strategy

(n=194) p-value

LM+ 3VD 191 (40.3) 98 (35.0) 93 (47.9) 0.006

Stenosis of LCx >75% 171 (36.1)

67 (23.9) 104 (53.6) 0.001

Stenosis Length of LCx >10mm 94 (19.8) 36 (12.9) 58 (29.9) 0.001

True-Bifurcation(Medina 111, 101, 011) 292 (61.6) 133 (47.5) 159 (82.0) 0.001

IABP 71 (15.0) 27 (9.6) 44 (22.7) 0.001

Angiographic follow-up 416 (87.8) 244 (87.1) 172 (88.7) 0.67

Baseline Angiographic and Procedural Characteristics in Patients Treated for UDLM According to

Original 1-Stent Strategy or 2-Stent Strategy

Outcome Rates (%) at 2-years Cox regression

Patients: n (%) 1-Stent Strategy(n=280) 2-Stent Strategy

(n=194) Hazard Ratio (95% CI) p-value

Cardiac death, MI and TLR 16.6±0.2 30.3±0.3 1.641 (1.168-2.304) 0.004

Cardiac death 3.7±0.1 2.6±0.1 0.664 (0.330-1.338) 0.25

Cardiac death + MI 4.0±0.1 3.6±0.1 0.715 (0.371-1.378) 0.32

TLR 13.5±0.2 28.2±0.3 2.012 (1.368-2.961) 0.001

TLR (any TLR involving Side

branch) 9.3±0.2 23.7±0.3 2.511 (1.590-3.967) 0.001

Clinical Outcome in Patients Treated for UDLM According to Original 1-Stent Strategy or 2-Stent Strategy

TLR for side branch occurred more frequently in patients with 2-SS despite similar result of main branch-TLR

and cardiac mortality compared to 1-SS.

  On Cox regression analysis, the independent predictors of repeat-TLR were treatment with POBA (HR 3.29, 95% CI 1.41-7.69; p=0.006) and EuroScore>6 (HR 2.53, 95% CI 1.02-6.28; p=0.045).

  MACE at 2-years were observed in 31 (36.9%) of the PCI group. TLR was observed in 28 (33.3. The incidence of repeat-TLR was higher following PCI with POBA than with DES (HR 2.79, 95% CI 1.23-6.34, p=0.014). MI was observed in 2.3% following POBA compared with 2.4% following DES, whilst cardiac-death was observed in 4.7% and 4.9%, respectively

  More complex lesions requiring the use of a 2-Stent strategy (2-SS) were associated with a higher incidence of restenosis at the LCx ostium (LCx-ISR) as well as recurrent LCx-ISR (HR 4.32 95% CI 0.97-19.20, p=0.05), compared to a 1-SS. No cardiac-death at 2-years occurred in these restenosis.

Summary

  Complex lesions requiring a 2-SS were associated with a higher risk of initial DES-ISR as well as recurrent DES-ISR in the region of the LCx ostium following TLR. .

Conclusions   This study suggests that patients with DES-ISR in the

UDLM derive greater benefit from further DES implantation than from POBA even if the restenosis is focal.

  Given that the majority of patients with focal DES-ISR at the ostium of the LCx are asymptomatic, it remains to be seen whether these lesions, often found at follow-up angiography, should be treated.




Euro PCR 2012



468 patients undergoing PCI with SES for de novo ULM

between April 2002 and December 2008

379 patients with

Distal Bifurcation ULM disease Following SES implantation

11 MI 7 patients lost at 12 months F/U 22 patients no available baseline

angiographic analysis (These patients had 2TLR,2 non-cardiac death)

49 patients with ostial/body ULM

Study population

Log rank P=0.001 N0-‐ISR (n=245)

SB-‐ISR alone (n=45)

MB-‐ISR alone (n=13)

Both MB and SB ISR (n=20)

Days Since PCI

Cum

ulat

ive

Eve

nt R

ate

(%)

Cardiac-death according to ISR type in patients with f/u angiography

N0-ISR (n=245)

SB-ISR alone

(n=45)

MB-ISR alone

(n=13) MB and SB ISR (n=20)

  MB-ISR was associated with increased risk of subsequent cardiac-death as compared to SB-ISR alone in patients treated with SES for ULM distal Bifurcation Lesions.


Euro PCR 2012 Kensuke Takagi, Antonio Colombo et al

Full cover approach (Ostial LM cover)

FCA strategy: 252 patients No FCA strategy: 127patients

Overall MB-ISR 4.8% in FCA vs. 12.6% in no FCA MB ostial ISR 0.4% in FCA vs. 6.4% in no FCA

  Full Cover Approach for Distal Left Main Bifurcation Lesion was associated with the low occurrence of Main-Branch Restenosis.

Definition of FCA: coverage of the entire ULM, including the ostium, irrespective of whether the ostium was diseased.



Age

DM

Dialysis

EuroScore (standard)

True Bifurcation

Calcification

1 3 5 7 9 0.33 0.2 0.5 0.1

Overall-‐ISR MB-‐ISR

Protec4ve for restenosis

EuroPCR. 2012

Predictors of MB-ISR from Characteristics

HR (CI)

1 stent strategy

2 stent strategy

“early” crush

“modern” mini crush

KBT

Full Cover Approach -LM ostium-

After 2007

1 3 5 7 9 0.33 0.2 0.5 0.1

Overall-‐ISR MB-‐ISR

HR (CI)

EuroPCR. 2012

Predictors of MB-ISR from technical Issues

Protec4ve for restenosis

HR (95% CI) p-value

Calcification 7.989 (1.804-35.372) 0.006

Early crush stenting 4.243 (1.553-11.595) 0.005

Full cover approach 0.292 (0.129-0.662) 0.003

The Independent Predictors of MB-ISR on Multivariable Analysis

  Presence of calcification and “early period” crush-stenting (not modern mini-crush) were associated with increasing risk of Main-Branch Restenosis following UDLM intervention.






Euro PCR 2012



46 patients with ULM disease

and residual CTO-RCA

Exclusion criteria Acute MI, ISR, dissection

494 patients with

ULM and no CTO-RCA

95.1% with 36-month FU and 89.5% with　angiography

7 patients failed PCI 39 no attempt


and successfully treated CTO-RCA


and initial CTO-RCA

568 patients undergoing first PCI for ULM Between 2002.4 and 2008.12

523 patients with ULM

and open RCA

Study population

Log Rank P=0.001

(1) ULM without residual CTO-RCA (ULM with no CTO-RCA + ULM with treated CTO-RCA ) n=522 (2) ULM with residual CTO-RCA n=46

6.2% at 5-years

20.8% at 5-years

Cumulative events according to residual CTO-RCA in all ULM

(A) Cardiac-death

Log Rank P

Log Rank P=0.010

0% at 5-years

22.7% at 5-years

(A) Cardiac-death

Log Rank P=0.010

0% at 5-years

22.7% at 5-years

(B) Cardiac-death + MI

Log Rank P=0.175

16.3% at 5-years

30.0% at 5-years

(C) MACE

No at Risk (1) (2)

3-years 21 33

5-years 7

18

1-year 26 42

Patients with ULM with treated CTO-RCA n=29 Patients with ULM with residual CTO-RCA n=46

No at Risk (1) (2)

3-years 24 36

5-years 11 21

1-year 27 44

No at Risk (1) (2)

3-years 24 36

5-years 11 21

1-year 27 44

Cumulative events according to residual CTO-RCA in Pts with ULM + initial CTO-RCA

Treated CTO-RCA

With residual CTO-RCA

  Following PCI of ULM, cardiac-death occurred more frequently in patients with residual CTO-RCA, while no cardiac death occurred in patients without residual CTO-RCA.

③  Impact of Residual CTO of Right Coronary Artery on the Long Term Outcome in Patients treated for Unprotected Left Main

DiseaseESC2012. Circ cardiovasc interv. Under revision

Kensuke Takagi , Antonio Colombo et al

  These findings may suggest that recanalization of CTO-RCA may impact on the long-term cardiac mortality in patients with ULM-PCI.

*Univariable Hazard

ratio(Confidence Interval)

P Value Cox regression adjusted

Hazard ratio(Confidence Interval)

P Value

estimated GFR 0.961 (0.948-0.974) 0.001 0.972 (0.962-0.992) 0.003

Diabetes Mellitus 3.328 (1.774-6.242) 0.001 2.277 (1.190-4.355) 0.013

EuroScore 1.335 (1.208-1.475) 0.001 1.146 (1.017-1.291) 0.026 Residual CTO-

RCA 3.759 (1.831-7.713) 0.001 2.277 (1.190-4.355) 0.031

Ejection Fraction 0.938 (0.915-0.961) 0.001 0.972 (0.944-1.000) 0.050 Untreated CTO-

LAD 5.506 (1.694-17.899) 0.005

IABP 2.645 (1.370-5.107) 0.004 Three vessel

disease 2.062 (1.113-3.822) 0.022

Calcification 2.341 (1.111-4.932) 0.025

True-bifurcation 2.013 (1.009-4.007) 0.047

Male 0.531 (0.279-1.013) 0.055

Predictors of Cardiac Death during F/U (n=41) in Pts treated PCI forULM

  In patients with ULM disease, the independent predictors of cardiac-death were; low estimated GFR, DM, residual CTO-RCA, high EuroScore and low EF.

③  Impact of Residual CTO of Right Coronary Artery on the Long Term Outcome in Patients treated for Unprotected Left Main

DiseaseESC2012. Circ cardiovasc interv. Under revision

Kensuke Takagi , Antonio Colombo et al

Thank you☺ very much for your attentions And I appreciate for

this wonderful opportunities for collaborations

predictors of outcome after the treatment of des restenosis in … · 2020. 4. 6. · the milan and...

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