PCI for LMCA lesions - Livemedia.gr · 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

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

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

ESC/EACTS (2010)

ESC & EACTS “Guidelines on Myocardial Revascularization” Eur Heart J 2010; 31(20): 2501-2555

Levine GN et.al. Guidelines for Percutaneous Coronary Interventions J Am Coll Cardiol, 2011; 68(24):2550-2583

ACCF/AHA/SCAI (2011)

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

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

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)

LMCA subgroup in SYNTAX trial Pts with LMCA randomized in the SYNTAX trial


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)

Morice MC http://www.tctmd.com/txshow.aspx?tid=938648&id=81242&trid=938634

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

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

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

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)

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)

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

CABG Grafts: Failure rates

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%)

Less revascularization, since we do not see results post CABG!

The SYNTAX – LE MANS substudy



The SYNTAX – LE MANS substudy Pts with LMCA randomized in the SYNTAX trial

156 pts with PES and 115 pts with CABG



Pts with LMCA randomized in the SYNTAX trial 156 pts with PES and 115 pts with CABG







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)

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

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.

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)

Distal LM: The approach in SYNTAX


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

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!

•  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

Thank you for your attention!

www.mathetinkardiasou.gr

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)

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%

Levine GN et.al. J Am Coll Cardiol, 2011; 68(24):2550-2583

ULMCA subgroup in SYNTAX trial Pts with LMCA randomized in the SYNTAX trial



4 year results for Syntax score<23 (104 vs. 118pts)

ULMCA subgroup in SYNTAX trial Pts with LMCA randomized in the SYNTAX trial



4 year results for Syntax score: 23-32 (92 vs.103pts)

Jasti V et al. Circulation 2004;110:2831-2836

Correlation of LM MLA < 5.9mm2 with FFR

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

LMCA subgroup in SYNTAX trial


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

Thank you for your attention!

Documents

PCI for LMCA lesions - Livemedia.gr · 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