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GENNARO SARDELLA MD, FACC ,FESC

TRIAL. SMILE. Featured Clinical Research II. Impact of one S tage compared with M ultistaged percutaneous complete coronary revascular I zation on c L inical outcome in multivessel NSTEMI pati E nts. ( NCT01478984). On behalf of SMILE TRIAL investigators.

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GENNARO SARDELLA MD, FACC ,FESC

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  1. TRIAL SMILE Featured Clinical Research II Impact of one Stage compared with Multistaged percutaneous complete coronary revascularIzation on cLinical outcome in multivessel NSTEMI patiEnts. (NCT01478984) On behalf of SMILE TRIAL investigators GENNARO SARDELLA MD, FACC ,FESC O.U. of Interventional Cardiology Dept. of Cardiovascular and Pulmonary Sciences Policlinico Umberto I “Sapienza “ University of ROME rino.sardella@uniroma1.it

  2. Grant/Research Support Consulting Fees/Honoraria Major Stock Shareholder/Equity Royalty Income Ownership/Founder Intellectual Property Rights Other Financial Benefit None Boston Scientific, Astra Zeneca,Alvimedica,Biosensors,Terumo None None None None None Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Company

  3. Multi-vessel Disease in the setting of ACS SMILE TRIAL • 30-40% in the setting of STEMI Muller DW, et al Multivessel coronary artery disease: a key predictor of short-term prognosis after reperfusion therapy for acute myocardial infarction. Thrombolysis and Angioplasty in Myocardial Infarction (TAMI) Study Group. Am Heart J 1991;121:1042-9 Toma M,, et al. Non-culprit coronary artery percutaneous coronary intervention during acute ST-segment elevation myocardial infarction: insights from the APEX-AMI trial. European Heart Journal 2010;31:1701-7 • 44-60% in the setting of NSTEMI Effects of tissue plasminogen activator and a comparison of early invasive and conservative strategies in unstable angina and non-Q-wave myocardial infarction. Results of the TIMI IIIB Trial. Thrombolysis in Myocardial Ischemia. Circulation 1994;89:1545–1556. Invasive compared with non-invasive treatment in unstable coronary-artery disease: FRISC II prospective randomised multicentre study. FRagmin and Fast Revascularisation during InStability in Coronary artery disease Investigators. Lancet 1999;354:708–715.

  4. Multi-vessel Disease in the setting of ACS SMILE TRIAL Culptit lesion uncertain and misleading

  5. Guidelines and Multi-Vessels NSTEMI Patients No suggestions • The strategy of multivesselstenting for suitablesignificantstenosesratherthanstenting the culpritlesiononlyhasnotbeenevaluatedappropriatelyin a randomized fashion No References

  6. Impact of one Stage compared with Multistaged percutaneous complete coronary revascularIzation on cLinical outcome in multivessel NSTEMI patiEnts. Complete coronary revascularization, in multivessel NSTEMI patients, is superior to ad hoc culprit lesion PCI OBJECTIVE:The aim of our study is to compare one stage (S-PCI) vs multi-staged (MS-PCI) complete coronary revascularization during the index hospitalization in NSTEMI patients with > 1 vessel > 70% angiographically. HYPOTHESIS:

  7. Statistical Analysis • On the basis of a two-sided test size of 5% and a power of 80%, it was calculated that a minimum of 247 patients would need to be recruited in each group to detect a difference in the incidence of MACCE at one year of 9%. . • Expected MACCE at 1 year * ** • Multi-staged = 9% • One Staged = 18% • Applying the Pocock group sequential design for a trial with two planned analyses (the first after half the number of patients were recruited) would assume P<0.029 as a stopping rule at each analysis for a treatment difference. *Shishehbor MH, et al. J Am Coll Cardiol 2007;49:849–854. **Kornowski R, Mehran R, Dangas G, et al. JACC 2011; 58 (7): 704-11

  8. Study Design 500 NSTEMI pts • DESIGN: Prospective, randomized, open label,double-arm, multi-center study • Primary Endpoint: Incidence of major adverse cardiac and cerebrovascular events (MACCE) defined as cardiac or non-cardiac death, re-infarction, re-hospitalization for acute coronary syndrome,repeat coronary revascularization and stroke 1 year. • Secondary endpoint : Incidence of Bleedings at 30 days, 6 months and 1 year Early Invasive Strategy (within 24 hrs) Angio > 1 vessel with > 70% DS 1:1 Randomization Multi- stage PCI revascularization n= 247 SINGLE stage PCI revascularization n= 253 Clinical Follow-Up (1 -6 -12Months)

  9. S.Giovanni Bosco Hospital Turin P.I. : Gennaro Sardella MD Steering Committe: M.Mancone,R.Garbo L.Lucisano, M.Pennacchi Safety Committee: U.Fabrizio,G.Boccuzzi R.Garbo MD F.Ugo MD G.Boccuzzi MD G.Sardella MD M.Mancone MD M.Pennacchi MD L.Lucisano MD Policlinico Umberto I Rome

  10. METHODS Exclusion Criteria Inclusion Criteria • age ≥ 18 years, • diagnosis of NSTEMI according to current guidelines • MV disease at angio (> 1 vessel with • > 70% stenosis) • The unculprit vessel should be a major (>2mm) epicardial coronary artery or branch (>2mm) and be suitable for stent implantation. • signed informed consent. • cardiogenic shockor any condition • requesting an Urgent Invasive Strategy • (< 2hrs) • left main coronary artery disease, • CTO • Syntax Score > 32 • previous coronary artery bypass grafting surgery, • candidate to by-pass surgery, • severe valvular heart disease • kidney impairment

  11. FLOW-Chart • 476 pts excluded : • 143 ptssuitable for EIS (< 2hrs) • 30pts previous coronary artery • bypass grafting surgery • 303 pts with a single lesion Between September 2011 and August 2013 1091 pts with diagnosed NSTEMI were scheduled. 615 Multivessel pts (56,3%) • 73 pts excluded : • 5 pts left main coronary artery disease, • 55 Syntax Score >32and/or indication to CABG revascularization • 3 pts severe valvular heart disease • 10 refused consent 542 pts randomized • 27 unsuccessful complete coronary revascularization • 15 pts were lost to the follow-up Multi- stage PCI revascularization n= 247 MACCE at 12 months analyzed SINGLE stage PCI revascularization n= 253 MACCE at 12 months analyzed

  12. Baseline Characteristics

  13. Anti-aggregation therapy at Hospitalization

  14. Artery access site

  15. Procedural characteristics

  16. Myocardial Enzymes p<0.001 p=ns p=ns

  17. In-Hospital Clinical Events * Excluded peri-procedural MI

  18. 1 month Clinical Events *According to BARC Criteria * Mehran R,Circulation. 2011;123:2736-2747.

  19. 6 months Clinical Events

  20. 12 months Clinical Events

  21. 12 months follow-up Survival Analysis MACCE One-stage rev. Multi-stage rev. Cum MACCE p log rank =0.004 Time (days)

  22. 12 months follow-up Survival Analysis Non- Cardiac Death One-stage rev. Multi-stage rev. Cum Non-Cardiac Death p log rank =0.021 Time (days)

  23. 12 months follow-up Survival Analysis Target Vessel Revascularization One-stage rev. Multi-stage rev. Cum TVR p log rank =0.045 Time (days)

  24. 12 months follow-up Survival Analysis Cardiac Death One-stage rev. Multi-stage rev. Cum Cardiac Death p log rank =0.361 Time (days)

  25. 12 months follow-up Survival Analysis MACCE (cardiac death only) One-stage rev. Multi-stage rev. Cardiac death p log rank =0.060 Time (days)

  26. Conclusions • One staged complete coronary revascularization is associated: • to less minor bleeding • a rapid decrease of myocardial enzymes in particular troponin • to minor incidence of MACCE • The superiority of one staged complete coronary revascularization in terms of MACCE is mainly due to the unexplained higher incidence of non cardiac death. • One staged revascularization is associated to a lower TVR rate.

  27. Positive Features of SMILE TRIAL Limitations of SMILE TRIAL

  28. Thank you

  29. 12 months follow-up: Survival Analysis non-Q MI One-stage population Multi-stage population Cum non-Q MI p log rank =0.734 Time (days)

  30. 12 months follow-up Survival Analysis Q MI One-stage population Multi-stage population Cum Q MI p log rank =0.636 Time (days)

  31. 12 months follow-up Survival Analysis STROKE One-stage population Multi-stage population Cum STROKE p log rank =0.550 Time (days)

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