rino.sardella@uniroma 1.it GENNARO SARDELLA MD, FACC ,FESC O.U. of Interventional Cardiology Dept. of Cardiovascular and Pulmonary Sciences Policlinico Umberto I “Sapienza “ University of ROME [email protected]On behalf of SMILE TRIAL investigators Impact of one Stage compared with Multistaged percutaneous complete coronary revascularIzation on cLinical outcome in multivessel NSTEMI patiEnts. (NCT01478984) Featured Clinical Research II
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[email protected] GENNARO SARDELLA MD, FACC,FESC O.U. of Interventional Cardiology Dept. of Cardiovascular and Pulmonary Sciences Policlinico Umberto.
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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.
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.
Impact of one Stage compared with Multistaged percutaneous complete coronary revascularIzation on cLinical outcome in
multivessel NSTEMI patiEnts.
HYPOTHESIS: HYPOTHESIS: Complete coronary revascularization, in multivessel Complete coronary revascularization, in multivessel NSTEMI patients, is superior to NSTEMI patients, is superior to ad hoc ad hoc culprit lesion PCIculprit lesion PCI
• 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
• 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
• 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.
•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.