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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
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
• To evaluate the clinical and angiographic outcomes of SES implantation for ostialLAD lesions, compared to bare metal stent (BMS) implantation
ObjectiveObjective
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
• 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
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
• 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
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
• 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
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
Stenting Strategies for LAD OsStenting Strategies for LAD Os
• Precise location method
• Method covering distal part of LMCA
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
Precise LocationPrecise LocationOstial LAD Lesion
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
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%
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
Precise Location MethodPrecise Location Method
Stenting and Final Result
Cypher 3.5×18 mm
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
• 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
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
Stenting Covering the Distal LMCAOstial LAD Lesion
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
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%
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
Stenting Covering the Distal LMCA
Stenting and Final Result
Cypher 3.5×18 mm
Additional balloon
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
• 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
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
• 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
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
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
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
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
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
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
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
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
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
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
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
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
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
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
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
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
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
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
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
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
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
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
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
Restenosis Rate at 6 Months
32.3
5.1
0
10
20
30
40
%
3/59 20/62SES BMS
P<0.001
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
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
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
LAD Os stenting with cypher stents
Covering LMCAVs
Precise Location
LAD Os stenting with cypher stents
Covering LMCAVs
Precise Location
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
Restenosis Rate at 6 Months
7.9
0
0
2
4
6
8
10
%
0/21 3/38Covering
LMCAPrecise Location
P=0.546
Cardiovascular Research Foundation ANGIOPLASTY SUMMIT
• 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