pci for lmca lesions - livemedia.gr · boudriot e. et al. randomized comparison of pci with...
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PCI for LMCA lesions A Review of latest guidelines and
relevant evidence
HCS Working Group Seminars Met Hotel, Thursday 14th February 2013
Vassilis Spanos Interventional Cardiologist, As. Director 3rd Cardiology Clinic
Euroclinic Hospital, Athens
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There is no financial relation/conflict of interest with any of the following:
ABBOTT LABORATORIES HELLAS ACTELION ASTRAZENECA BAYER HELLAS BOEHRINGER ELPEN GALENICA MENARINI HELLAS PFIZER HELLAS PLUSMEDICA SANOFI SPECIFAR ΦΑΡΜΑΣΕΡΒ ΛΙΛΛΥ WINMEDICA RAFARM GE HEALTHCARE NOVARTIS HELLAS MEDWORKS ΙΠΠΟΚΡΑΤΗΣ ΙΑΤΡΙΚΑ ΜHXANHMATA
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ESC/EACTS (2010)
ESC & EACTS “Guidelines on Myocardial Revascularization” Eur Heart J 2010; 31(20): 2501-2555
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Levine GN et.al. Guidelines for Percutaneous Coronary Interventions J Am Coll Cardiol, 2011; 68(24):2550-2583
ACCF/AHA/SCAI (2011)
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ACCF/SCAI/STS/AATS/AHA/ASNC/SCCT (2012)
Patel M et.al: “Appropriate Use Criteria for Coronary Revascularization Focused Update” JACC 2012; 59(9): 857–881
PCI CABG
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LMCA subgroup in SYNTAX trial
0
5
10
15
20
25
30
35
40
45
All LM only LM+1VD LM+2VD LM+3VD
CABG Taxus
33.2
27.8
19.1 14.3
31.5
26.9
29.7
39.2
27.4
37.3
357 pts with PES vs. 348 pts with CABG 4 year results for Syntax in LM subsets
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LMCA subgroup in SYNTAX trial Pts with LMCA randomized in the SYNTAX trial
357 pts with PES vs. 348 pts with CABG
CABG Taxus stenting P Value Death 10.5 17.9 0.06 CVA 4.9 1.6 0.14 MI 6.1 10.9 0.18 Death/CVA/MI 18.5 23.1 0.33 Revascularization 11.8 31.3 <0.001
4 year results for Syntax score>32 (149 vs. 135pts)
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LMCA subgroup in SYNTAX trial Pts with LMCA randomized in the SYNTAX trial
357 pts with PES vs. 348 pts with CABG
CABG Taxus stenting P Value Death 11.8 7.5 0.12 CVA 3.9 1.4 0.11 MI 3.8 5.1 0.55 Death/CVA/MI 17.1 13.5 0.25 Revascularization 16.9 19.1 0.57
4 year results for Syntax score: 0-32 (196 vs. 221pts)
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Morice MC http://www.tctmd.com/txshow.aspx?tid=938648&id=81242&trid=938634
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LE MANS Clinical Trial
Buszman P. et al. Acute and late outcomes of unprotected left main stenting in comparison with surgical revascularization. J Am Coll Cardiol 2008;51:538-45
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Boudriot E. et al. Randomized comparison of PCI with sirolimus-eluting stents versus CABG in ULM stenosis”. J Am Coll Cardiol 2011;57:538-45
• Mean Syntax score 23.5 (30 in SYNTAX) Euroscore 2.5 (3.9- SYNTAX), 2 SES per patient
Clinical Trial: SES vs CABG 100 pts with SES vs. 101 pts with CABG
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PRECOMBAT Clinical Trial
Park SJ. et al. Randomized trial of stents versus bypass surgery for left main coronary artery disease” N Engl J Med 2011;364:1718-27
300 pts with SES vs. 300 pts with CABG Euroscore: 2.7, Syntax score: 25
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Capodanno D.. et al: Percutaneous Coronary Intervention Versus Coronary Artery Bypass Graft Surgery in Left Main Coronary Artery Disease : A Meta-Analysis of Randomized Clinical Data. JACC 2011;58(14):1426-1432
1611 pts in 4 RCTs (SYNTAX, PRECOMBAT, LEMANS, Boudriot at al)
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MAIN-COMPARE Registry
Seung K. et al. Stents versus Coronary-Artery Bypass Grafting for Left Main Coronary Artery Disease. N Engl J Meed 2008;358(17):1781-92
Consecutive pts from 12 centers in Korea with ULMCA between Jan 2000-June 2006
Propensity score matching (542 matched pairs) 1,102 pts with DES/BMS vs. 1,138pts with CABG
• No difference in the risk of death, Q-wave MI or stroke during the 3-year follow-up
period
• Increased risk of TLR in the PCI group (hazard ratio:2.72; 95% CI]:1.51 - 4.91)
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MACE in SYNTAX Trial
Syntax score ≤ 22
Syntax score: 23-32
Syntax score ≥ 33 Serruys P. et al. Percutaneous coronary intervention versus coronary artery bypass grafting for severe coronary artery disease. N Engl J Med March 5 2009;360:961-972
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CABG Grafts: Failure rates
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Routine intraoperative angiography
Zhao D. et al Routine Intraoperative Completion Angiography After Coronary Artery Bypass Grafting and 1-Stop Hybrid Revascularization J Am Coll Cardiol, 2009; 53:232-241
366 consecutive CABG pts (112 hybrid procedures, 45 unplanned) underwent completion angiography before chest closure
• From 796 grafts 97 (12%) had angiographic defects
• 22 cases were repaired with minor
graft adjustment (2.8%)
• 48 with open chest PCI (6%)
• 27 with surgical revision (3.4%)
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Less revascularization, since we do not see results post CABG!
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The SYNTAX – LE MANS substudy
Morice MC http://www.tctmd.com/txshow.aspx?tid=938648&id=81242&trid=938634
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Morice MC http://www.tctmd.com/txshow.aspx?tid=938648&id=81242&trid=938634
The SYNTAX – LE MANS substudy Pts with LMCA randomized in the SYNTAX trial
156 pts with PES and 115 pts with CABG
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The SYNTAX – LE MANS substudy
Morice MC http://www.tctmd.com/txshow.aspx?tid=938648&id=81242&trid=938634
Pts with LMCA randomized in the SYNTAX trial 156 pts with PES and 115 pts with CABG
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The SYNTAX – LE MANS substudy
Morice MC http://www.tctmd.com/txshow.aspx?tid=938648&id=81242&trid=938634
Pts with LMCA randomized in the SYNTAX trial 156 pts with PES and 115 pts with CABG
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The SYNTAX – LE MANS substudy
Morice MC http://www.tctmd.com/txshow.aspx?tid=938648&id=81242&trid=938634
Pts with LMCA randomized in the SYNTAX trial 156 pts with PES and 115 pts with CABG
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Paclitaxel vs. Everolimus eluting stents 2 years follow up of the SPIRIT III Trial
669 lesions with EES vs. 333 with PES
Stone G. et al Randomized Comparison of Everolimus-Eluting and Paclitaxel-Eluting Stents. Circulation. 2009;119:680-686
Treatment with Everolimus stent resulted in a trend toward fewer re-interventions (TLR), fewer MIs and reduction in the composite of death/MI (4.8% vs. 8.1%, relative risk: 0.60,
95% CI: 0.36 to 0.99, p=0.055)
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IVUS for ULMCA
Park SJT. et al Impact of Intravascular Ultrasound Guidance on Long-Term Mortality in Stenting for Unprotected Left Main Coronary Artery Stenosis. Circulation: Cardiovascular Interventions. 2009;2:167-177
3 year follow up of the MAIN-COMPARE Registry 756 pts with IVUS guidance vs. 219 pts without
• in 145 matched pairs of patients with DES the mortality was lower with IVUS
guidance as compared with angiography
guidance (4.7% versus 16.0%, log-rank p=0.048; hazard ratio, 0.39; 95% CI, 0.15
to 1.02; Cox model p=0.055)
• The risk of MI or TVR was not associated with the use of IVUS guidance
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Distal Left Main: The challenge
Palmerini T. et al Ostial and midshaft lesions vs. bifurcation lesions in 1111 patients with unprotected left main coronary artery stenosis treated with drug-eluting stents: results of the survey from the Italian Society of Invasive Cardiology. Eur Heart J 2009; 30(17):2087-94
Registry involving 19 centres in Italy at 2 year follow-up 777 pts with distal LMCA vs. 334 pts without
• Survival free from MACE was 72% in distal LMCA group vs. 80% (p=0.03), due to higher TLR rate (19% in distal LMCA
vs. 8%, p=0.0003)
• 5 patients had a definite stent thrombosis (4 had distal LMCA lesion), 4 were
subacute and 1 late.
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Distal Left Main: How to treat?
Palmerini T. et al Ostial and midshaft lesions vs. bifurcation lesions in 1111 patients with unprotected left main coronary artery stenosis treated with drug-eluting stents: results of the survey from the Italian Society of Invasive Cardiology. Eur Heart J 2009; 30(17):2087-94
Registry involving 19 centres in Italy at 2 year follow-up 456 pts treated with 1 stent vs. 317 pts wuth 2 stents
• The propensity adjusted hazard ratio for 2 year risk of MACE was 0.53
(95% CI: 0.37-0.76) in favor of the 1 stent group
• The propensity adjusted hazard ratio for 2 year risk of cardiac mortality + MI was also in favor of the 1 stent group: 0.38 (95% CI: 0.17-0.85)
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Distal LM: The approach in SYNTAX
Morice MC http://www.tctmd.com/txshow.aspx?tid=938648&id=81242&trid=938634
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Registry involving 19 centres in Italy at 2 year follow-up 128 pts treated with T stenting vs. 121 with Crush vs. 60 with V stenting
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The EXCEL Trial (Xience Prime stent vs. CABG)
• Pts with LMCA disease and Syntax score <33
• Primary end point: Death/MI/CVA (2600 pts/3 years fu/124 centres in 17 countries)
• IVUS strongly encouraged
• Direct stenting discouraged
• Provisional SB stenting encouraged
• Angiographic fu NOT permitted!
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• First generation DES are at least as effective as CABG for LMCA disease with low/intermediate Syntax scores
• Practice Guidelines both in Europe and USA have evolved to incorporate the new data
• There are still technical issues to be answered, especially
in distal LMCA involvement
CONCLUSIONS
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Thank you for your attention!
www.mathetinkardiasou.gr
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ISAR-LEFT MAIN: Are DES equal?
Mehilli J. et al Paclitaxel- Versus Sirolimus-Eluting Stents for Unprotected Left Main Coronary Artery Disease. J Am Coll Cardiol, 2009; 53:1760-1768
Pts with LMCA randomized to either stent 302 pts with PES vs. 305 pts with SES
• At 1 year the primary end point of death, MI, and TLR was 13.6% in the PES and
15.8% in the SES group
• Restenosis was 16.0% in the PES and
19.4% in the SES group (localized in the distal part of the left main area in all but 1
patient)
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ULMCA restenosis: The FAILS Study
Sheiban I. et al Incidence and Management of Restenosis After Treatment of Unprotected Left Main Disease With Drug-Eluting Stents. J Am Coll Cardiol, 2009; 54:1131-1136
70 Restenotic Cases From a Cohort of 718 Patients Follow up of 25.6 ± 16.5 months
• MACE occurred cumulatively in 18 (25.7%) patients, with death in 4 (5.7%), MI in 2 (2.9%), and TLR in 15 (21.4%)
• Patients treated with medical, interventional, and surgical therapy had the following MACE rates, respectively: 50%,
25.4%, and 14.3%
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Levine GN et.al. J Am Coll Cardiol, 2011; 68(24):2550-2583
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ULMCA subgroup in SYNTAX trial Pts with LMCA randomized in the SYNTAX trial
357 pts with PES vs. 348 pts with CABG
CABG Taxus stenting P Value Death 9.2 7.1 0.54 CVA 4.1 1.8 0.28 MI 3.1 4.3 0.64 Death/CVA/MI 14.2 12.3 0.60 Revascularization 16.8 18.2 0.64
4 year results for Syntax score<23 (104 vs. 118pts)
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ULMCA subgroup in SYNTAX trial Pts with LMCA randomized in the SYNTAX trial
357 pts with PES vs. 348 pts with CABG
CABG Taxus stenting P Value Death 14.7 8.0 0.12 CVA 3.6 1.0 0.23 MI 4.6 6.0 0.71 Death/CVA/MI 20.3 14.8 0.28 Revascularization 17.0 20.2 0.60
4 year results for Syntax score: 23-32 (92 vs.103pts)
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Jasti V et al. Circulation 2004;110:2831-2836
Correlation of LM MLA < 5.9mm2 with FFR
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DES vs. BMS for ULMCA
Palmerini T. et al. Two year clinical outcome with drug-eluting stents versus bare metal stents in a real world registry of unprotected left main coronary artery stenosis from the Italian Society of Invasive cardiology. Am J Cardiol 2008;102(11):1463-8
All patients with unprotected LM treated between Jan 2002-Dec 2006 in 19 centers in Italy – 2 years follow-up
1,111 pts with DES vs. 342pts with BMS
• Survival free from cardiac death was higher in patients treated with DES (propensity adjusted hazard ratio: 0.49, 95% confidence intervals:
0.32 to 0.77).
• The benefit of DES was established in the period from 3 to 6 months post procedure and maintained up to 2 years
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LMCA subgroup in SYNTAX trial
Morice MC http://www.tctmd.com/txshow.aspx?tid=938648&id=81242&trid=938634
Pts with LMCA randomized in the SYNTAX trial 357 pts with PES vs. 348 pts with CABG
Syntax score ≤ 22 Syntax score: 23-32 Syntax score ≥ 33
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Thank you for your attention!