technical feasibility, safety, and clinical outcome of ... · disastrous clinical events. it has...

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Technical Feasibility, Safety, and Clinical Outcome of Stenting of Unprotected Left Main Coronary Artery Bifurcation Narrowing Technical Feasibility, Safety, and Technical Feasibility, Safety, and Clinical Outcome of Clinical Outcome of Stenting Stenting of of Unprotected Left Main Coronary Unprotected Left Main Coronary Artery Bifurcation Narrowing Artery Bifurcation Narrowing Seung-Jung Park, MD, PhD, FACC Seung Seung - - Jung Park, MD, PhD, FACC Jung Park, MD, PhD, FACC Cardiovascular Center, Asan Medical Center University of Ulsan, Seoul, Korea Cardiovascular Center, Cardiovascular Center, Asan Asan Medical Center Medical Center University of University of Ulsan Ulsan , , Seoul, Korea Seoul, Korea Seung-Jung Park Am J Cardiol 2002;104:1609-1614

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Page 1: Technical Feasibility, Safety, and Clinical Outcome of ... · disastrous clinical events. It has been regarded as absolute contraindication of PCI because the occlusion of side branches

Technical Feasibility, Safety, and Clinical Outcome of Stenting of Unprotected Left Main Coronary Artery Bifurcation Narrowing

Technical Feasibility, Safety, and Technical Feasibility, Safety, and Clinical Outcome of Clinical Outcome of Stenting Stenting of of Unprotected Left Main Coronary Unprotected Left Main Coronary Artery Bifurcation NarrowingArtery Bifurcation Narrowing

Seung-Jung Park, MD, PhD, FACCSeungSeung--Jung Park, MD, PhD, FACCJung Park, MD, PhD, FACC

Cardiovascular Center, Asan Medical Center University of Ulsan, Seoul, Korea

Cardiovascular Center, Cardiovascular Center, AsanAsan Medical Center Medical Center University of University of UlsanUlsan, , Seoul, KoreaSeoul, Korea

Seung-Jung Park Am J Cardiol 2002;104:1609-1614

Page 2: Technical Feasibility, Safety, and Clinical Outcome of ... · disastrous clinical events. It has been regarded as absolute contraindication of PCI because the occlusion of side branches

PCI for LMCA Narrowing

Advances in techniques and equipment make it possible to expand the use of angioplasty to unprotected LMCA stenosis.

Advances in techniques and Advances in techniques and equipment make it possible to expand equipment make it possible to expand the use of angioplasty to unprotected the use of angioplasty to unprotected LMCA LMCA stenosisstenosis..

Seung-Jung Park Am J Cardiol 2002;104:1609-1614

Page 3: Technical Feasibility, Safety, and Clinical Outcome of ... · disastrous clinical events. It has been regarded as absolute contraindication of PCI because the occlusion of side branches

LMCA Bifurcation NarrowingLMCA Bifurcation Narrowing

•It has been regarded as absolute contraindication of PCI because the occlusion of side branches could lead to disastrous clinical events.

••It has been regarded as absolute It has been regarded as absolute contraindication of PCI because the contraindication of PCI because the occlusion of side branches could lead to occlusion of side branches could lead to disastrous clinical events.disastrous clinical events.

Seung-Jung Park Am J Cardiol 2002;104:1609-1614

Page 4: Technical Feasibility, Safety, and Clinical Outcome of ... · disastrous clinical events. It has been regarded as absolute contraindication of PCI because the occlusion of side branches

LMCA Bifurcation NarrowingLMCA Bifurcation Narrowing

•But, stenting was supposed to be safe and effective treatment in selected group of patients who have normal LV function and lesions confined to distal left main with large reference size.

••But,But, stentingstenting was supposed to be safe and was supposed to be safe and effective treatment in selected group of effective treatment in selected group of patients who have normal LV function patients who have normal LV function and lesions confined to distal left main and lesions confined to distal left main with large reference size.with large reference size.

Seung-Jung Park Am J Cardiol 2002;104:1609-1614

Page 5: Technical Feasibility, Safety, and Clinical Outcome of ... · disastrous clinical events. It has been regarded as absolute contraindication of PCI because the occlusion of side branches

PurposePurpose

•This study was performed to evaluate the acute and long-term clinical results of stenting for unprotected LMCA lesions.

••This study was performed to evaluate the This study was performed to evaluate the acute and longacute and long--term clinical results of term clinical results of stenting stenting for unprotected LMCA lesions.for unprotected LMCA lesions.

Seung-Jung Park Am J Cardiol 2002;104:1609-1614

Page 6: Technical Feasibility, Safety, and Clinical Outcome of ... · disastrous clinical events. It has been regarded as absolute contraindication of PCI because the occlusion of side branches

SubjectsSubjects

•From Nov 1995 to Nov 2001, 63 consecutive patients with unprotected LMCA bifurcation lesions who underwent stenting with (n=32) or without debulkingatherectomy (n=31).

••From Nov 1995 to Nov 2001, 63 From Nov 1995 to Nov 2001, 63 consecutive patients with unprotected consecutive patients with unprotected LMCA bifurcation lesions who underwent LMCA bifurcation lesions who underwent stenting stenting with (n=32) or without with (n=32) or without debulkingdebulkingatherectomyatherectomy (n=31). (n=31).

Seung-Jung Park Am J Cardiol 2002;104:1609-1614

Page 7: Technical Feasibility, Safety, and Clinical Outcome of ... · disastrous clinical events. It has been regarded as absolute contraindication of PCI because the occlusion of side branches

Inclusion CriteriaInclusion CriteriaInclusion Criteria

Good Candidate for SurgeryGood Candidate for Surgery(Diameter (Diameter stenosis stenosis >> 50% involving both a 50% involving both a LMCA and/or the LMCA and/or the ostium ostium of LAD or LCX of LAD or LCX with Objective with Objective IschemiaIschemia))

•• Normal LV functionNormal LV function

Seung-Jung Park Am J Cardiol 2002;104:1609-1614

Page 8: Technical Feasibility, Safety, and Clinical Outcome of ... · disastrous clinical events. It has been regarded as absolute contraindication of PCI because the occlusion of side branches

Bifurcation Types

Type 1 Type 2 Type 3

Lefevre T. Cathet Cardiovasc Intervent 2000;49:274-83

Page 9: Technical Feasibility, Safety, and Clinical Outcome of ... · disastrous clinical events. It has been regarded as absolute contraindication of PCI because the occlusion of side branches

PCI Strategy for Bifurcation lesion

PCI Strategy for Bifurcation lesion

Stenting with or without debulkingStenting cross over LCX with

optional kissing balloon inflationT(Y)-stent techniqueKissing stent techniqueBifurcation stent (SLK-View stent)

StentingStenting with or without with or without debulkingdebulkingStenting Stenting cross over LCX with cross over LCX with

optional kissing balloon inflationoptional kissing balloon inflationT(Y)T(Y)--stent stent techniquetechniqueKissing Kissing stent stent techniquetechniqueBifurcation Bifurcation stent stent (SLK(SLK--View View stentstent))

Seung-Jung Park Am J Cardiol 2002;104:1609-1614

Page 10: Technical Feasibility, Safety, and Clinical Outcome of ... · disastrous clinical events. It has been regarded as absolute contraindication of PCI because the occlusion of side branches

Stenting Cross Over Tube stenting cross over LCX with optional kissing balloon dilatation

LMCA

LAD

LMCA

LAD

LCX LCX

Seung-Jung Park Am J Cardiol 2002;104:1609-1614

Page 11: Technical Feasibility, Safety, and Clinical Outcome of ... · disastrous clinical events. It has been regarded as absolute contraindication of PCI because the occlusion of side branches

Stenting Cross Over Tube stenting cross over LCX with optional kissing balloon dilatation

LMCA

LAD

LMCA

LAD

LCX LCX

Seung-Jung Park Am J Cardiol 2002;104:1609-1614

Page 12: Technical Feasibility, Safety, and Clinical Outcome of ... · disastrous clinical events. It has been regarded as absolute contraindication of PCI because the occlusion of side branches

T Stenting

LMCA

LAD

LMCA

LAD

LCXLCX

Seung-Jung Park Am J Cardiol 2002;104:1609-1614

Page 13: Technical Feasibility, Safety, and Clinical Outcome of ... · disastrous clinical events. It has been regarded as absolute contraindication of PCI because the occlusion of side branches

T Stenting

LMCA

LAD

LMCA

LAD

LCXLCX

Seung-Jung Park Am J Cardiol 2002;104:1609-1614

Page 14: Technical Feasibility, Safety, and Clinical Outcome of ... · disastrous clinical events. It has been regarded as absolute contraindication of PCI because the occlusion of side branches

T Stenting

LMCA

LCX

LAD

LMCA

LAD

LCX

Seung-Jung Park Am J Cardiol 2002;104:1609-1614

Page 15: Technical Feasibility, Safety, and Clinical Outcome of ... · disastrous clinical events. It has been regarded as absolute contraindication of PCI because the occlusion of side branches

Y (Culotte) Stenting

LMCA

LAD

LMCA

LAD

LCXLCX

Seung-Jung Park Am J Cardiol 2002;104:1609-1614

Page 16: Technical Feasibility, Safety, and Clinical Outcome of ... · disastrous clinical events. It has been regarded as absolute contraindication of PCI because the occlusion of side branches

Y (Culotte) Stenting

LMCA

LAD

LMCA

LAD

LCXLCX

Seung-Jung Park Am J Cardiol 2002;104:1609-1614

Page 17: Technical Feasibility, Safety, and Clinical Outcome of ... · disastrous clinical events. It has been regarded as absolute contraindication of PCI because the occlusion of side branches

Y (Culotte) Stenting

LMCA

LAD

LCX

Seung-Jung Park Am J Cardiol 2002;104:1609-1614

Page 18: Technical Feasibility, Safety, and Clinical Outcome of ... · disastrous clinical events. It has been regarded as absolute contraindication of PCI because the occlusion of side branches

Kissing Stenting

Kissing stents with optional stent on the Main

LMCA

LAD

LMCA

LAD

LCXLCX

Seung-Jung Park Am J Cardiol 2002;104:1609-1614

Page 19: Technical Feasibility, Safety, and Clinical Outcome of ... · disastrous clinical events. It has been regarded as absolute contraindication of PCI because the occlusion of side branches

Kissing Stenting

Kissing stents with optional stent on the Main

LMCA

LCX

LAD

LMCA

LAD

Seung-Jung Park Am J Cardiol 2002;104:1609-1614

LCX

Page 20: Technical Feasibility, Safety, and Clinical Outcome of ... · disastrous clinical events. It has been regarded as absolute contraindication of PCI because the occlusion of side branches

Bifurcation StentSLK-View Stent

Side holeSeung-Jung Park Am J Cardiol 2002;104:1609-1614

Page 21: Technical Feasibility, Safety, and Clinical Outcome of ... · disastrous clinical events. It has been regarded as absolute contraindication of PCI because the occlusion of side branches

Initial OutcomesInitial Outcomes

Procedural Success Rate:Procedural Success Rate:

InIn--Hospital Clinical ComplicationsHospital Clinical ComplicationsDeathDeathStentStent thrombosis thrombosis Q wave myocardial infarctionQ wave myocardial infarctionEmergency CABGEmergency CABG

100 %

0%0%0%0%

Seung-Jung Park Am J Cardiol 2002;104:1609-1614

Page 22: Technical Feasibility, Safety, and Clinical Outcome of ... · disastrous clinical events. It has been regarded as absolute contraindication of PCI because the occlusion of side branches

Clinical CharacteristicsClinical Characteristics

41 (65%)Unstable angina pectoris31 (49%)Current smoker28 (44%)Total cholesterol > 200mg/dL14 (22%)Diabetes mellitus20 (33%)Systemic hypertension

53 / 10Male / women58 ± 10Age

Seung-Jung Park Am J Cardiol 2002;104:1609-1614

Page 23: Technical Feasibility, Safety, and Clinical Outcome of ... · disastrous clinical events. It has been regarded as absolute contraindication of PCI because the occlusion of side branches

Angiographic Angiographic CharacteristicsCharacteristics

7 (11%)Type 329 (46%)Type 227 (43%)Type 1

Bifurcation types20 (33%)left main and RCA

53 / 10Left main onlyExtent of coronary disease

Seung-Jung Park Am J Cardiol 2002;104:1609-1614

Page 24: Technical Feasibility, Safety, and Clinical Outcome of ... · disastrous clinical events. It has been regarded as absolute contraindication of PCI because the occlusion of side branches

Angiographic Angiographic CharacteristicsCharacteristicsSide branchSide branchParent vesselParent vessel((mm)mm)

2.8 2.8 ±± 1.01.04.1 4.1 ±± 0.70.71.1 1.1 ±± 0.5 0.5

3.3 3.3 ±± 0.70.73.8 3.8 ±± 0.6 0.6 4.4 4.4 ±± 0.70.7

1.9 1.9 ±± 0.90.9FollowFollow--upup2.7 2.7 ±± 0.80.8FinalFinal2.0 2.0 ±± 1.01.0BaselineBaseline

MLDMLDMeanMean

3.0 3.0 ±± 0.80.8DistalDistalProximalProximal

Reference artery Reference artery

Seung-Jung Park Am J Cardiol 2002;104:1609-1614

Page 25: Technical Feasibility, Safety, and Clinical Outcome of ... · disastrous clinical events. It has been regarded as absolute contraindication of PCI because the occlusion of side branches

Angiographic Angiographic CharacteristicsCharacteristics

Side branchParent vessel(%)

26.4 ± 25.9-8.6 ± 15.8 70.9 ± 12.7

36.9 ± 26.5Follow-up9.9 ± 19.5Final33.8 ± 27.6Baseline

Diameter stenosis

Seung-Jung Park Am J Cardiol 2002;104:1609-1614

Page 26: Technical Feasibility, Safety, and Clinical Outcome of ... · disastrous clinical events. It has been regarded as absolute contraindication of PCI because the occlusion of side branches

Procedural DataProcedural Data

Side branchParent vessel

32 (51%)

63 (100%)

15.0 ± 2.5

6 (10%)Debulking procedure

22 (35%)Stent use

Maximum pressure (atm)

Seung-Jung Park Am J Cardiol 2002;104:1609-1614

Page 27: Technical Feasibility, Safety, and Clinical Outcome of ... · disastrous clinical events. It has been regarded as absolute contraindication of PCI because the occlusion of side branches

0

10

20

30

40

50

60

70

Stentingcross over

T- Stent Kissing stent

SLK-View stent

34 (54%)34 (54%)

14 (22%)14 (22%)

6 (10%)6 (10%) 9 (14%)9 (14%)

Different Technique Different Technique Different Technique

Seung-Jung Park Am J Cardiol 2002;104:1609-1614

Page 28: Technical Feasibility, Safety, and Clinical Outcome of ... · disastrous clinical events. It has been regarded as absolute contraindication of PCI because the occlusion of side branches

Angiographic RestenosisAngiographic Restenosis

6-Month follow-up rate : 86% (43 / 50 eligible patients)

Parent vessel only : 14%Side branch only : 9%Both restenosis : 5%Overall Overall restenosis restenosis : 28%: 28%

Seung-Jung Park Am J Cardiol 2002;104:1609-1614

Page 29: Technical Feasibility, Safety, and Clinical Outcome of ... · disastrous clinical events. It has been regarded as absolute contraindication of PCI because the occlusion of side branches

Predictors of Predictors of RestenosisRestenosis

0.560.230.96

0.032

pNo restenosis(n=35)

Restenosis(n=8)

03 (18%)5 (23%)

3.9 ± 0.71.0 ± 0.8

3.4 ± 0.6

4 (100%)Type 314 (82%)Type 217 (77%)Type 1

Bifurcation types4.3 ± 0.7Final1.1 ± 0.5Baseline

MLD (mm)3.9 ± 0.6Reference vs (mm)

Seung-Jung Park Am J Cardiol 2002;104:1609-1614

Page 30: Technical Feasibility, Safety, and Clinical Outcome of ... · disastrous clinical events. It has been regarded as absolute contraindication of PCI because the occlusion of side branches

6 month Angiographic Restenosis 6 6 month month Angiographic Restenosis Angiographic Restenosis

%

0

10

20

30

Stenting cross overStenting cross over

T(Y) or Kissing stent

T(Y) or Kissing stent

17%17%

4 / 24

4 / 19

21%21%

SLK-View stentSLK-View stent

??

P = 0.7P = 0.7

Seung-Jung Park Am J Cardiol 2002;104:1609-1614

Page 31: Technical Feasibility, Safety, and Clinical Outcome of ... · disastrous clinical events. It has been regarded as absolute contraindication of PCI because the occlusion of side branches

Effect of DebulkingRestenosis Rate of Parent Vessel

0

10

20

30

40

(%)

33%

7 / 14

Non-DebulkingDebulking

1 / 26

5%

P = 0.02

Seung-Jung Park Am J Cardiol 2002;104:1609-1614

Page 32: Technical Feasibility, Safety, and Clinical Outcome of ... · disastrous clinical events. It has been regarded as absolute contraindication of PCI because the occlusion of side branches

Protective Factor of RestenosisBy multivariate analysis

Debulking procedure

Odds ratio ; 0.1095% CI ; 0.01 to 0.91P =0.04

Seung-Jung Park Am J Cardiol 2002;104:1609-1614

Page 33: Technical Feasibility, Safety, and Clinical Outcome of ... · disastrous clinical events. It has been regarded as absolute contraindication of PCI because the occlusion of side branches

Two-year MACE-Free SurvivalTwo-year MACE-Free Survival% 100

P = NS 89.2 ± 5.9 %90

80 84.1 ± 7.3 %

Stenting with debulking70

Stenting only 60

0 6 12 18 24

Duration of Follow-Up (month)Seung-Jung Park Am J Cardiol 2002;104:1609-1614

Page 34: Technical Feasibility, Safety, and Clinical Outcome of ... · disastrous clinical events. It has been regarded as absolute contraindication of PCI because the occlusion of side branches

ConclusionsConclusions

•• StentingStenting with or without with or without debulkingdebulkingatherectomyatherectomy is technically feasible and is technically feasible and may be an effective strategy for treatment may be an effective strategy for treatment of unprotected LMCA bifurcation lesions. of unprotected LMCA bifurcation lesions.

•• Furthermore, Furthermore, debulkingdebulking atherectomyatherectomybefore before stentingstenting might reduce the late might reduce the late restenosis, providing new insight in the restenosis, providing new insight in the approach.approach.