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4 th European Bifurcation Club 26-27 September 2008 - PRAGUE

4 th European Bifurcation Club 26-27 September 2008 - PRAGUE. A comprehensive meta-analysis on drug-eluting stenting for unprotected left main disease. Background. Cardiac surgery is the gold standard revascularization means for unprotected left main disease (ULM).

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4 th European Bifurcation Club 26-27 September 2008 - PRAGUE

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  1. 4th European Bifurcation Club 26-27 September 2008 - PRAGUE A comprehensive meta-analysis on drug-eluting stenting for unprotected left main disease

  2. Background • Cardiac surgery is the gold standard revascularization means for unprotected left main disease (ULM). • Percutaneous drug-eluting stent (DES) implantation has been recently reported in patients with ULM, but with unclear results. • Moreover, predictors of adverse events after DES implantation in ULM are still under investigation.

  3. Aims • To perform a systematic review of the outcomes of DES implantation in patients with ULM coronary disease. • To pool major outcomes with meta-analytic techniques. • To identify predictors of adverse events by means of meta-regression analysis.

  4. Methods • Several databases (BioMedCentral, clinicaltrials.gov, Google Scholar, and PubMed) were systematically searched for pertinent clinical studies • Major selection criteria were: enrolment of at least 20 patients, follow-up for at least 6 months, and full text publication (thus excluding abstracts) • Pre-specified subgroup analyses were performed according to ostial ULM, and non-high-risk features (defined by means of Parsonnet or EuroSCORE systems) • Generic-inverse-variance random-effect methods were used to pool incidence rates and adjusted risk estimates (odds ratios [OR], with 95% confidence intervals) of death, myocardial infarction (MI), target vessel revascularization (TVR), or their composite, ie major adverse cardiovascular events (MACE)

  5. Methods • Several databases (BioMedCentral, clinicaltrials.gov, Google Scholar, and PubMed) were systematically searched • Major selection criteria were: enrolment of at least 20 patients, follow-up for at least 6 months, and full text publication (thus excluding abstracts) • Pre-specified subgroup analyses were performed according to ostial ULM, and non-high-risk features (defined by means of Parsonnet or EuroSCORE systems) • Generic-inverse-variance random-effect methods were used to pool incidence rates and adjusted risk estimates (odds ratios [OR], with 95% confidence intervals) of death, myocardial infarction (MI), target vessel revascularization (TVR), or their composite, ie major adverse cardiovascular events (MACE) • Meta-regression was performed to identify regression coefficients (with 95% confidence intervals) for event predictors

  6. Review profile 823 hits retrieved from extensive database search 774 titles/abstracts excluded because non-relevant 49 articles assessed according to inclusion/exclusion criteria 32 articles excluded according to selection criteria 7 duplicate publications 4 enrolling <20 patients 9 ongoing 7 unpublished 5 using BMS only 17 studies (16 original cohorts) included in the review

  7. Includedstudies

  8. Major excludedstudies

  9. Characteristics of includedstudies

  10. Unadjustedclinicaloutcomes

  11. Results • After excluding 806 non-pertinent citations, we finally included 16 original studies (1274 patients, median follow-up 9 months [range 6-24]) • There were 8 uncontrolled reports on DES, 5 non-randomized comparison between DES and bare-metal stents (BMS), and 3 between DES and CABG • Overall, 31% of patients had non-bifurcational ULM and 59.5% had high-risk features at EuroSCORE or Parsonnet

  12. Results • Mid-term MACE occurred in 18.2%, mid-term death in 4.4%, and repeat revascularization in 7.4% • Meta-regression showed that location of disease was the most significant predictor of mid-term MACE (p=0.001) as well as of TVR (p=0.050) • On the other hand, high-risk features at EuroSCORE or Parsonnet were the most significant predictor of mid-term death (p=0.027) • Stenting technique was also significantly associated with MACE rate (p=0.050)

  13. Risk of in-hospital death Agostoni et al (2005, 58 pts) 1,7 Carriè et al (2006, 120 pts) 4,2 Chieffo et al (2005, 85 pts) 0,0 Christiansen et al (2006, 42 pts) 2,4 0,0 de Lezo et al (2004, 52 pts) KOMATE (2005, 54 pts) 1,9 Lee et al (2006, 50 pts) 2,0 Lozano et al (2005, 42 pts) 9,5 Study Migliorini et al (2006, 156 pts) 7,1 0,0 Park et al (2005, 102 pts) Price et al (2006, 50 pts) 0,0 Sheiban et al (2006, 85 pts) 2,8 Wood et al (2006, 100 pts) 2,0 2,3 (1,1-3,4) Overall estimate (95%CI) 0 3 6 9 12 15 Rate of in-hospital death (%)

  14. Risk of in-hospital MI Agostoni et al (2005, 58 pts) 3,5 Carriè et al (2006, 120 pts) 2,5 Chieffo et al (2005, 85 pts) 5,9 Christiansen et al (2006, 42 pts) 0,0 3,9 de Lezo et al (2004, 52 pts) KOMATE (2005, 54 pts) 0,0 Lee et al (2006, 50 pts) 0,0 Study Lozano et al (2005, 42 pts) 0,0 Migliorini et al (2006, 156 pts) 0,6 6,9 Park et al (2005, 102 pts) Price et al (2006, 50 pts) 8,0 Sheiban et al (2006, 85 pts) 2,6 Wood et al (2006, 100 pts) 3,0 2,5 (1,2-3,8) Overall estimate (95%CI) 0 3 6 9 12 15 Rate of in-hospital myocardial infarction (%)

  15. Risk of MACE at follow-up Agostoni et al (2005, 58 pts) 15,5 12.5 Carriè et al (2006, 120 pts) Chieffo et al (2005, 85 pts) 32,7 7,1 Christiansen et al (2006, 42 pts) de Lezo et al (2004, 52 pts) 5,8 14,3 Dudek et al (2006, 28 pts) Han et al (2006, 138 pts) 10,9 4,6 KOMATE (2005, 54 pts) Lee et al (2006, 50 pts) 10,6 Study 26,2 Lozano et al (2005, 42 pts) Migliorini et al (2006, 156 pts) 23,7 25,5 Palmerini et al (2006, 94 pts) Park et al (2005, 102 pts) 8,8 54,0 Price et al (2006, 50 pts) Sheiban et al (2006, 85 pts) 9,1 19,0 Wood et al (2006, 100 pts) 16,5 (11,7-21,3) Overall estimate (95%CI) 0 15 30 45 60 Rate of mid-term MACE (%)

  16. Risk of death at follow-up Agostoni et al (2005, 58 pts) 5,2 10,0 Carriè et al (2006, 120 pts) Chieffo et al (2005, 85 pts) 2,8 Christiansen et al (2006, 42 pts) 4,8 0,0 de Lezo et al (2004, 52 pts) Han et al (2006, 138 pts) 5,1 KOMATE (2005, 54 pts) 1,9 Lee et al (2006, 50 pts) 4,0 Study Lozano et al (2005, 42 pts) 19,1 10,9 Migliorini et al (2006, 156 pts) Palmerini et al (2006, 94 pts) 13,8 0,0 Park et al (2005, 102 pts) Price et al (2006, 50 pts) 10,0 Sheiban et al (2006, 85 pts) 2,6 8,0 Wood et al (2006, 100 pts) Overall estimate (95%CI) 5,5 (3,4-7,7) 0 15 30 45 60 Rate of mid-term death (%)

  17. Risk of TVR at follow-up Agostoni et al (2005, 58 pts) 6,9 Carriè et al (2006, 120 pts) 1,7 Chieffo et al (2005, 85 pts) 18,8 Christiansen et al (2006, 42 pts) 4,8 1,9 de Lezo et al (2004, 52 pts) Dudek et al (2006, 28 pts) 0,0 Han et al (2006, 138 pts) 7,3 KOMATE (2005, 54 pts) 2,3 Study Lee et al (2006, 50 pts) 6,3 2,4 Lozano et al (2005, 42 pts) Migliorini et al (2006, 156 pts) 12,1 2,0 Park et al (2005, 102 pts) Price et al (2006, 50 pts) 44,0 Sheiban et al (2006, 85 pts) 3,9 8,0 Wood et al (2006, 100 pts) Overall estimate (95%CI) 6,5 (3,7-9,2) 0 15 30 45 60 Rate of mid-term TVR (%)

  18. Surgical risk and death rate -,6 P=0.027 Lozano -,8 Palmerini Migliorini -1,0 Price Risk of death at follow-up (Log10 of the actual rate) Patients at high surgical risk are significantly more likely to die during follow-up ←Lower risk Higher risk→ -1,2 Christiansen Lee -1,4 Chieffo -1,6 Sheiban 30 40 50 60 70 80 90 100 Prevalence of high-risk clinical features (%)

  19. Stenosis location and MACE rate -,2 P=0.001 Price Patients with high distal ULM are significantly more likely to have MACE -,4 Chieffo Palmerini Lozano -,6 Migliorini Wood Risk of MACE at follow-up (Log10 of the actual rate) Agostoni -,8 ←Lower risk Higher risk→ Carrié Lee Han -1,0 Sheiban Park Christiansen De Lezo -1,2 Komate -1,4 0 10 20 30 40 50 60 70 Prevalence of non-bifurcational disease (%)

  20. Stenting technique and MACE rate -,2 P=0.050 Price -,4 Chieffo Palmerini -,6 Migliorini Risk of MACE at follow-up (Log10 of the actual rate) Dudek -,8 ←Lower risk Higher risk→ Agostoni Patients treated with 2 stents are significantly more likely to have MACE Carrié Lee -1,0 Han Park Sheiban Christiansen -1,2 De Lezo -1,4 0 20 40 60 80 100 Rate of complex stenting technique (%)

  21. Stenosis location and TVR rate -,2 P=0.050 Price Patients with high distal ULM are significantly more likely to have TVR -,4 -,6 Chieffo -,8 Migliorini Risk of TVR at follow-up (Log10 of the actual rate) ←Lower risk Higher risk→ -1,0 Wood Agostoni Lee Han -1,2 Christiansen Sheiban -1,4 Lozano Komate -1,6 Carrié Park De Lezo -1,8 0 10 20 30 40 50 60 70 Prevalence of non-bifurcational disease (%)

  22. Conclusions • The largest cohort reported to date of patients with ULM treated with DES provides encouraging mid-term follow-up data, at least in selected patients • Analysis of the largest cohort to date of patients treated with DES for ULM shows that risk-stratification should be based in these patients on location of disease and overall risk features • Event-free survival is excellent in low-risk patients with non-bifurcational ULM, while a high case fatality can be expected in high-risk subjects, irrespective of disease location

  23. Forfurtherslides on thesetopicspleasefeel free tovisit the metcardio.org website:http://www.metcardio.org/slides.html

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