Transcript Follow-up

Multi-vessel disease…
Le Mans implications
Oxford
The John Radcliffe Hospital
Dr Adrian Banning
Multi-vessel disease…
Le Mans - implications ?
• Lemans trial
J Am Coll Cardiol 2008
– Small randomised trial of CABG vs PCI for patients
with left main disease
• Syntax Lemans
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Subset of the Syntax trial
patients with left main disease
follow up angios at 15 months (both surgical and PCI)
To be reported at PCR 09
Why is the Left Main important?
It supplies at least 2/3 of the blood to the heart!!!
Why is the left main special?
• Large vessel
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Prone to calcification
Large volume of plaque required to cause stenosis
Intubated by the diagnostic catheter –ostium?
By definition terminates in a bifurcation – at least
• Untreated LMS stenosis > 20% mortality at 1yr
Results of initial intervention on the
LMS- the early years
• 1980s Hartzler using POBA
– 10% procedural mortality in hospital
– 64% 3yr mortality
• Early 1993-8 ULTIMA
– 279 pts unprotected LMS
– 14% procedural mortality in hospital
– 25% mortality at one year
– NB if 46% inoperable are excluded –
• 97% 1yr survival in these low risk pts
Can we predict risk when stenting the LMS?
Stent the LMS with BMS safe,
but high rate of MACE due to restenosis
Am J Cardiol. 2003;91:12-6.
A Randomized Comparison of Paclitaxel-Eluting
Stents Versus Bare-Metal Stents for Treatment
of Unprotected Left Main Coronary Artery Stenosis
• 103 patients
• BMS (n 50) or PES (n 53).
• All IVUS guidance and Cutting balloon pretreatment x 3 to cover
entire lesion
• Ostium and body were treated with a single stent
Single stent 49/50 and 52/53
Final kissing balloon dilation was performed only in cases with
suboptimal result at the LCX ostium (6% and 19%)
• Follow-up: 6 months angio and IVUS
• No “late” stent thrombosis in either group
Erglis et al JACC 2007
A Randomized Comparison of Paclitaxel-Eluting
Stents Versus Bare-Metal Stents for Treatment
of Unprotected Left Main Coronary Artery Stenosis
Erglis et al JACC 2007
A Randomized Comparison of Paclitaxel-Eluting
Stents Versus Bare-Metal Stents for Treatment
of Unprotected Left Main Coronary Artery Stenosis
Erglis et al JACC 2007
A Randomized Comparison of Paclitaxel-Eluting
Stents Versus Bare-Metal Stents for Treatment
of Unprotected Left Main Coronary Artery Stenosis
Erglis et al JACC 2007
A Randomized Comparison of Paclitaxel-Eluting
Stents Versus Bare-Metal Stents for Treatment
of Unprotected Left Main Coronary Artery Stenosis
Erglis et al JACC 2007
Location matters
Ostium
Distal- bifurcation
Shaft
What makes the left main special?
• Anatomy matters
– Ostial
Needs 1 stent
– Body
Needs 1 stent
– Bifurcation Usually >1 stent, 2 wires, >6F
Preliminary DES in LMS disease?
Long-Term Outcome After DES
in Nonbifurcation Lesions that involve Unprotected LMS
• Population: 147 pts
• elective (only) consecutive pts SES or PES in 5 centers
• - stenosis in the ostium and/or the mid-shaft of an
unprotected LMCA
• PCI instead of surgery was considered either
(1) suitable anatomy for stenting and preference patient
and physician
(2) suitable anatomy for stenting and EuroSCORE 6
and/or Parsonnet score 13 and/or prior bypass surgery
with failure of all conduits (n=2).
Chieffo et al Circulation
2007
Favorable Long-Term Outcome After Drug-Eluting Stent
Implantation in Nonbifurcation Lesions That Involve
Unprotected Left Main Coronary
• Medications:
• IIb/IIIa inhibitors at the discretion of the operator.
• Dual antiplatelet therapy for at least 6 months after. All patients were
advised to maintain lifelong use of aspirin (100 mg/d).
• Clinical follow-up: at 1, 6, 12, and 24 months.
• Patients eligible for longer clinical follow-up were contacted at 36
and 48 months.
• Angio follow-up: 4 and 9 months or earlier if neccesary
• Total follow up mean 886 days
Chieffo et al Circulation
2007
Favorable Long-Term Outcome After Drug-Eluting Stent
Implantation in Nonbifurcation Lesions That Involve
Unprotected Left Main Coronary
Chieffo et al Circulation 2007
Favorable Long-Term Outcome After Drug-Eluting Stent
Implantation in Nonbifurcation Lesions That Involve
Unprotected Left Main Coronary
Chieffo et al Circulation 2007
Favorable Long-Term Outcome After Drug-Eluting Stent
Implantation in Nonbifurcation Lesions That Involve
Unprotected Left Main Coronary
Chieffo et al Circulation 2007
Favorable Long-Term Outcome After Drug-Eluting Stent
Implantation in Nonbifurcation Lesions That Involve
Unprotected Left Main Coronary
Chieffo et al Circulation 2007
Favorable Long-Term Outcome After Drug-Eluting Stent
Implantation in Nonbifurcation Lesions That Involve
Unprotected Left Main Coronary
No proven late stent thrombosis
4 unexpected deaths
Chieffo et al Circulation 2007
Favorable Long-Term Outcome After Drug-Eluting Stent
Implantation in Nonbifurcation Lesions That Involve
Unprotected Left Main Coronary
Chieffo et al Circulation 2007
What about late stent thrombosis in
LMS disease?
• Specific worries
– Late thrombosis for all DES >BMS
– Late thrombosis higher off label
– Higher risk of incomplete expansion?
– Left main occlusion will be fatal
• Reassurances
– Big vessel
Late and very late stent thrombosis following
DES in ULM. Chieffo et al, EHJ Sept 2008.
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Multicentre registry of 731 pts with
Elective DES stenting of ULM disease.
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Definite ST
4 pts (0.5%). 3 early (≤30d), 1 late (≤ 1 yr). No VLST.
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Probable ST = 3 pts. All early (≤30d)
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Definite or probable ST = 7 / 731 = 0.95%
All were on dual AP Rx.
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Possible ST
(8 late, 12 very late) in 20 (2.7%) pts.
Late and very late stent thrombosis following
DES in ULM. Chieffo et al, EHJ Sept 2008.
• Outcomes after 29.5±13.7 months follow up:
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Death:
6.2%
(n=45).
Cardiac death:
4.2%
(n=31)
TVR:
12.9% (n=95)
TLR:
10.9% (n=76)
Restenosis rate:
14.1% on angiographic follow-up of 548 pts.
(NB: 76% of lesions involved the distal LM.)
• Predictors of ST at logistic analysis:
– Euroscore
– LVEF
• Consistent with general PCI population.
• No unique ST predictor among ULM pts identified in this analysis.
• Conclusion: Elective DES stenting of ULM is safe - low rates of ST.
358 consecutive patients
7 centres
All DES
Elective
Urgent
MACE free
74%
68%
Mortality
6%
21%
Reinfarction
8%
10%
TLR
7%
3%
TVR
16%
7%
Delft
J Am Coll Cardiol 2008 ; 51 2212-9
So can stents replace surgery
in left main disease?
Unprotected left main
stenting vs CABG
Seung et al, NEJM April 2008.
• Long term follow up of 1102 patients
stenting for ULM disease,
• vs propensity-matched cohort of
CABG patients
• No significant difference in the risk
of death and the composite
outcome of death, Q-wave MI, or
stroke between the two groups.
• TVR higher in the stents group,
even with DES.
Seung KB et al. N Engl J Med 2008;358:1781-1792
Study of unprotected LEft MAiN Stenting versus bypass
surgery
J Am Coll Cardiol 2008; 51: 538-45
Lemans study design
PCI technique
Direct stenting preferred
if not poss predil with 2 or 2.5
Bifurcation technique
Initial stent to LAD then
Cullotte or Prov T if necessary
No crush stenting
IVUS advised
DES if diameter < 3.8mm (35%)
LeMans study 2008
Improved EF with PCI
ETT similar by 12 months
more angina PCI initially
Lemans trial 2008
LeMans survival
SYNTAX Eligible Patients
De novo disease
Limited Exclusion Criteria
Previous interventions
Acute MI with CPK>2x
Concomitant cardiac surgery
Left Main Disease
(isolated, +1, +2 or +3 vessels)
3 Vessel Disease
(revasc all 3 vascular territories)
Syntax Lemans (reports PCR 09)
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All left main pts in the randomised Syntax n=710
Follow up angio at 15 months
Asses late angio outcomes with clinical outcomes
Asses utility of angio follow up
• Stats
– Surgery occlusion rate rate 5-12%
• 100 surgery pts 95% confidence interval (+/-0.043) if occlusion is
5% or (+/-0.043) if occlusion is 12%
– PCI Expected Patency rate 74-97%
• 100 PCI pts 95% confidence interval (+/-0.078) if patency is 80%
– Expected attrition 30%
12 Month LM Subgroup MACCE Rates
CABG
TAXUS
Left Main Isolated
Left Main + 3VD
N=91
Patients (%)
(13%)
N=258
N=138
(37%)
(20%)
N=218
(31%)
All LM
N=705
Left Main + 1VD
Left Main + 2VD
12 Month Subgroup MACCE Rates
TAXUS
Patients (%)
CABG
All LM
N=705
LM isolated LM+1VD
N=91
N=138
LM+2VD
N=218
LM+3VD
N=258
3VD (All)
N=1095
So why is the left main special?
• The left main is unforgiving during PCI
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Because large volumes of myocardium are at risk
Large volumes of plaque may move
Calcification is restrictive to stent expansion
loss of “branches” will have immediate and profound
haemodynamic consequences
• The left main is unforgiving in the long term
– All ostial disease has a very high restenosis
rate (particularly if the stent is incompletely
expanded).
What do we know about left main
PCI?
• Procedural risk fallen from 10-20% to <1%
(in all but shock cases)
• Ostial and shaft disease is different to
terminal disease of the main
• Left main PCI should be definitely
considered in all emergency cases and
many urgent cases
What do we know about left main
PCI in 2008?
• DES are almost certainly better than BMS
• Risks of treating left main disease with PCI
or surgery are probably the same
• Long term results of DES in elective ostial
and shaft disease are very encouraging
– Those cases treatable with one properly
expanded stent
What do we know about left main
PCI in 2008?
• However
– How do we treat distal bifurcation disease
best?
• Perhaps the cullotte? Not the crush for me
• LMS + 2VD / 3VD
– surgery still has lower rates of TVR
particularly in diabetics
Isolated left main stenting in 2008…
OSTIUM
CABG
UNSUITABLE
URGENT
ELECTIVE
BODY
DISTAL
1 STENT
DISTAL
2 STENT