PCI for LMCA lesions A Review of latest guidelines and relevant evidence

Transcription

1 HCS Working Group Seminars Met Hotel, Thursday 14 th February 2013 PCI for LMCA lesions A Review of latest guidelines and relevant evidence Vassilis Spanos Interventional Cardiologist, As. Director 3 rd Cardiology Clinic Euroclinic Hospital, Athens

2 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

3 ESC/EACTS (2010) ESC & EACTS Guidelines on Myocardial Revascularization Eur Heart J 2010; 31(20):

4 ACCF/AHA/SCAI (2011) Levine GN et.al. Guidelines for Percutaneous Coronary Interventions J Am Coll Cardiol, 2011; 68(24):

5 ACCF/SCAI/STS/AATS/AHA/ASNC/SCCT (2012) PCI CABG Patel M et.al: Appropriate Use Criteria for Coronary Revascularization Focused Update JACC 2012; 59(9):

6 LMCA subgroup in SYNTAX trial pts with PES vs. 348 pts with CABG 4 year results for Syntax in LM subsets CABG Taxus All LM only LM+1VD LM+2VD LM+3VD

7 LMCA subgroup in SYNTAX trial Pts with LMCA randomized in the SYNTAX trial 357 pts with PES vs. 348 pts with CABG 4 year results for Syntax score>32 (149 vs. 135pts) CABG Taxus stenting P Value Death CVA MI Death/CVA/MI Revascularization <0.001

8 LMCA subgroup in SYNTAX trial Pts with LMCA randomized in the SYNTAX trial 357 pts with PES vs. 348 pts with CABG 4 year results for Syntax score: 0-32 (196 vs. 221pts) CABG Taxus stenting P Value Death CVA MI Death/CVA/MI Revascularization

9 Morice MC

10 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

11 Clinical Trial: SES vs CABG 100 pts with SES vs. 101 pts with CABG Mean Syntax score 23.5 (30 in SYNTAX) Euroscore 2.5 (3.9- SYNTAX), 2 SES per patient 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

12 PRECOMBAT Clinical Trial 300 pts with SES vs. 300 pts with CABG Euroscore: 2.7, Syntax score: 25 Park SJ. et al. Randomized trial of stents versus bypass surgery for left main coronary artery disease N Engl J Med 2011;364:

13 1611 pts in 4 RCTs (SYNTAX, PRECOMBAT, LEMANS, Boudriot at al) 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):

14 MAIN-COMPARE Registry 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]: ) Seung K. et al. Stents versus Coronary-Artery Bypass Grafting for Left Main Coronary Artery Disease. N Engl J Meed 2008;358(17):

15 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 ;360: MACE in SYNTAX Trial Syntax score 22 Syntax score: 23-32

16 CABG Grafts: Failure rates

17 Zhao D. et al Routine Intraoperative Completion Angiography After Coronary Artery Bypass Grafting and 1-Stop Hybrid Revascularization J Am Coll Cardiol, 2009; 53: Routine intraoperative angiography 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%)

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

19 The SYNTAX LE MANS substudy Morice MC

20 Morice MC The SYNTAX LE MANS substudy Pts with LMCA randomized in the SYNTAX trial 156 pts with PES and 115 pts with CABG

21 Morice MC The SYNTAX LE MANS substudy Pts with LMCA randomized in the SYNTAX trial 156 pts with PES and 115 pts with CABG

22 The SYNTAX LE MANS substudy Pts with LMCA randomized in the SYNTAX trial 156 pts with PES and 115 pts with CABG Morice MC

23 The SYNTAX LE MANS substudy Pts with LMCA randomized in the SYNTAX trial 156 pts with PES and 115 pts with CABG Morice MC

24 Paclitaxel vs. Everolimus eluting stents 2 years follow up of the SPIRIT III Trial 669 lesions with EES vs. 333 with PES 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) Stone G. et al Randomized Comparison of Everolimus-Eluting and Paclitaxel-Eluting Stents. Circulation. 2009;119:

25 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: IVUS for ULMCA 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

26 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): Distal Left Main: The challenge 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.

27 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): Distal Left Main: How to treat? 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: ) 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: )

28 Distal LM: The approach in SYNTAX Morice MC

29 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

30 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!

31 CONCLUSIONS 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

32 Thank you for your attention!

33 ISAR-LEFT MAIN: Are DES equal? 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) Mehilli J. et al Paclitaxel- Versus Sirolimus-Eluting Stents for Unprotected Left Main Coronary Artery Disease. J Am Coll Cardiol, 2009; 53:

34 ULMCA restenosis: The FAILS Study 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% 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:

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

36 ULMCA subgroup in SYNTAX trial Pts with LMCA randomized in the SYNTAX trial 357 pts with PES vs. 348 pts with CABG 4 year results for Syntax score<23 (104 vs. 118pts) CABG Taxus stenting P Value Death CVA MI Death/CVA/MI Revascularization

37 ULMCA subgroup in SYNTAX trial Pts with LMCA randomized in the SYNTAX trial 357 pts with PES vs. 348 pts with CABG 4 year results for Syntax score: (92 vs.103pts) CABG Taxus stenting P Value Death CVA MI Death/CVA/MI Revascularization

38 Correlation of LM MLA < 5.9mm 2 with FFR Jasti V et al. Circulation 2004;110:

39 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): DES vs. BMS for ULMCA 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

40 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: Syntax score 33 Morice MC

41 Thank you for your attention!