effectiveness of complete lesion coverage with sirolimus ...effectiveness of complete lesion...

Effectiveness of Complete Lesion Effectiveness of Complete Lesion Coverage with Coverage with SirolimusSirolimus--Eluting Eluting

StentStent for for OstialOstial Left Anterior Left Anterior Descending Artery Descending Artery StenosisStenosis

Ki-Bae Seung, M.D., Ph.D.

Division of Cardiovascular MedicineKang-Nam St. Mary’s Hospital

The Catholic University of Korea

Cardiovascular Research Foundation ANGIOPLASTY SUMMIT

• Stenting at ostial left anterior descending artery (LAD) remains challenging because :- The ostial lesion has prominent elastic recoil and rigidity- The frequent involvement of atherosclerotic lesion to the distal left main coronary

artery(LMCA)- Technical difficulties such as optimal stent deployment and the concern

of left circumflex artery (LCX) occlusion during procedure - Higher rate of in-stent restenosis compared to non-ostial lesion

• There was no published data regarding the results of sirolimus-eluting stent (SES) implantation for ostial LAD stenosis in spite of very promising results of SES implantation for simple coronary lesions.

BackgroundBackground

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• To evaluate the clinical and angiographic outcomes of SES implantation for ostialLAD lesions, compared to bare metal stent (BMS) implantation

ObjectiveObjective

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• From March 2003 to January 2004, SES was implanted for 68 consecutive patients with de novoostial LAD lesions in the three cardiac centers (SES group).

• The control group was composed of 77 patients with BMS during the preceding 2 years (BMS group), who had been included in a randomized study investigating the efficacy of debulking atherectomy before BMS stenting for ostial LAD stenosis.

PatientsPatients

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• Ischemic evidence of anterior myocardial ischemia

• De novo Lesions with diameter stenosis≥70%

• Lesions located ≤3 mm of the LAD ostium• Reference vessel diameter >2.5mm

Inclusion CriteriaInclusion Criteria

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• Contraindication to antiplatelet agents• Bailout stenting• Primary angioplasty in acute myocardial infarction• Left ventricular ejection fraction ≤ 40%• Previous bypass surgery• Involvement (≥50% of diameter stenosis by visual

estimation) of the LMCA or the ostium of the LCX• Chronic total occlusion • An inability to follow the protocol

Exclusion CriteriaExclusion Criteria

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Stenting Strategies for LAD OsStenting Strategies for LAD Os

• Precise location method

• Method covering distal part of LMCA

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Precise LocationPrecise LocationOstial LAD Lesion

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Precise LocationPrecise LocationIVUS Evaluation

Ostial LAD•Lumen CSA:2.86 mm2

•EEM CSA:14.38 mm2

•Plaque burden:80%

Distal LMCA•Lumen CSA: 16.28mm2

•EEM CSA: 17.89mm2

•Plaque burden:10%

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Precise Location MethodPrecise Location Method

Stenting and Final Result

Cypher 3.5×18 mm

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• All the BMS patients• SES patients with normal LMCA bifurcation• Debulking atherectomy was performed to

decrease plaque burden in suitable cases.

Stenting ProcedureStenting ProcedurePrecise Location Method

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Stenting Covering the Distal LMCAOstial LAD Lesion

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Stent Covering Stent Covering IVUS Evaluation

Ostial LAD•Lumen CSA: 2.23mm2

•EEM CSA: 14.35mm2

•Plaque burden: 85%

Distal LMCA•Lumen CSA: 8.27mm2

•EEM CSA: 17.17mm2

•Plaque burden: 52%

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Stenting Covering the Distal LMCA

Stenting and Final Result

Cypher 3.5×18 mm

Additional balloon

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• SES patients with insignificant mild narrowing at the LMCA bifurcation

• Definition of insignificant mild narrowing of the LMCA bifurcation by visual estimation

- Diameter stenosis ≥ 20%

- Plaque burden ≥ 40% by IVUS

Stenting ProcedureStenting ProcedureStenting Covering the Distal LMCA

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• Follow-up information was obtained by regular outpatient evaluation and by telephone contact.

• Angiographic follow-up was being routinely performed at six months or earlier if a patient showed symptoms of recurrence.

Follow-upFollow-up

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Antiplatelet RegimensAntiplatelet Regimens

• Aspirin 100 mg indefinitely • Clopidogrel 75 mg QD for 6 months

SES group

BMS group• Aspirin 100 mg indefinitely • Clopidogrel 75 mg QD for 1 month or• Ticlopidine 250mg BID for 1 month

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Baseline Demographics

0.318 62.9±9.9 61.3±8.7 Left ventricular EF, %0.120 37 (48.1) 24 (35.3) Current smoking

0.168 21 (27.3) 12 (17.6) Hypercholesterolemia (total cholesterol ≥ 200 mg/dL)

0.428 14 (18.2) 16 (23.5) Diabetes mellitus 0.201 26 (33.8) 30 (44.1) Hypertension0.163 62 (80.5) 48 (70.6) Male 0.756 57.8±7.9 58.2±9.0 Age, yr

77 68 Patients

PBMSSES

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Baseline Demographics

7768Patients

<0.0017 (9.1) 33 (48.5) Multivessel involvement6 (7.8) 4 (5.9) Acute MI

56 (72.7) 41 (60.3) Unstable angina15 (19.5) 23 (33.8) Stable angina

0.145 Clinical manifestation0.389 4 (5.2) 6 (8.8) Previous PCI

PBMSSES

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Baseline QCA Results

7768Patients

0.014 71.1±12.4 65.2±15.7 Diameter stenosis, %

0.143 1.04±0.48 0.92±0.53 MLD, mm

<0.00115.4±5.2 24.6±17.1 Lesion length, mm

<0.0013.61±0.54 2.86±0.51 Reference diameter, mm

PBMSSES

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Procedural Findings

7768Patients

1.0002 (2.6) 1 (1.5) GP IIb/IIIa inhibitor

0.03759 (76.6) 61 (89.7) IVUS guidance

<0.00138 (49.4) 1 (1.5) Debulking atherectomy

<0.0010 (0) 24 (35.3) Direct stenting

0.0037 (9.1) 19 (27.9) Multivessel PCI

PBMSSES

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Procedural Findings

7768Patients

0.00314 (5.2) 12 (17.6) Final kissing balloon

<0.00114.9±2.6 17.6±3.1 Inflation pressure, mm

0.0373.9±0.6 3.8±0.4Final balloon size, mm

<0.00116.6±5.2 31.2±19.3 Total stent length, mm

<0.0011.0±0.2 1.4±0.6 Stents per lesion

PBMSSES

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In-Hospital Outcomes

1.000TLR1.000Stent thrombosis

7768Patients

4 (5.2)5 (7.4)Non-Q MI00Q MI

0.5914 (5.2)5 (7.4)MI1.000Death1.077 (100)68 (100)Procedural success

PBMSSES

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Follow-up Follow-up

SES group: 59 patients (87 %)BMS group: 62 patients (81%)

Angiographic follow-up at 6 months

Clinical follow-up at 12 monthsAvailable in all patients

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QCA & IVUS After Procedure

<0.00147.5±6.7 53.0±6.0 Plaque burden, %<0.0019.57±2.04 7.39±1.40 Stent CSA, mm2

<0.00118.32±3.49 15.89±3.05 EEM CSA, mm2

QCA7768Patients

IVUS<0.0012.73±0.732.06±0.56Acute gain, mm0.027-3.3±11.80.8±15.1DS, %

<0.0014.08±0.573.36±0.47MLD, mm

PBMSSES

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QCA at Follow-up

6259Patients

<0.0011.60±0.81 0.22±0.52 Late loss, mm

<0.00140.9±25.6 -2.1±19.0 DS, %

<0.0012.13±0.91 2.77±0.56 MLD, mm

<0.0013.61±0.54 2.86±0.51 Reference, mm

PBMSSES

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Acute Gain & Late Loss

1.90

0.22

2.67

1.60

0

1

2

3

Acute gain Late loss

Cypher BMS

mm

P<0.001P<0.001

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Restenosis Rate at 6 Months

32.3

5.1

0

10

20

30

40

%

3/59 20/62SES BMS

P<0.001

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Clinical Outcomes at 12 Months

<0.00113 (16.9%)0MACE<0.00113 (16.9%)0TLR

7768Patients

1.000Stent thrombosis00Non-Q MI00Q MI

1.0MI1.000Death

PBMSSES

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LAD Os stenting with cypher stents

Covering LMCAVs

Precise Location

LAD Os stenting with cypher stents

Covering LMCAVs

Precise Location

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Restenosis Rate at 6 Months

7.9

0

0

2

4

6

8

10

%

0/21 3/38Covering

LMCAPrecise Location

P=0.546

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• Sirolimus-Eluting Stentings appear more effective in reducing restenosis and target lesion revascularization for ostial left anterior descending lesions, compared to bare metal stentimplantations.

• New strategy covering the distal left main coronary artery across left circumflex artery which was applied to the cases having insignificant mild narrowing at the distal left main coronary artery was safe and may lead to favorable clinical outcomes with complete lesion coverage.

ConclusionsConclusions