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Asymptomatic Carotid Surgery Trial ACST-2. Collaborators Meeting 2014 Pembroke College, Oxford Is recent coronary stenting a problem (or an opportunity ) for enrolling the patient in the trial? Valerio Tolva MD, PhD Istituto Auxologico Italiano IRCCS Deparment of Surgery
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AsymptomaticCarotidSurgery TrialACST-2 Collaborators Meeting 2014 Pembroke College, Oxford Isrecentcoronarystenting a problem (or an opportunity) for enrolling the patient in the trial? Valerio Tolva MD, PhD Istituto Auxologico Italiano IRCCS Deparment of Surgery VascularSurgery (Head: Renato Casana MD) Milan, Italy
Handling a patient with recentcoronarystenting and carotidstenosisislike a sailing race: You can head straight forcing the upwind : with double therapyperform CAS You can run on a beamwind and thenupwind : stop double therapy and performCEA Crewshaveguidelines for the right approach to a race… can we create guidelinesusing the data of the Trial?
“the prevalence of severe carotiddisease (>80%% stenosis of ICA) amongpatientsundergoingPercutaneousCoronary Intervention (PCI)/Open HeartSurgery (OHS) isestimated to be 6% to 12%.” “…optimal treatment of patients with concurrentcarotid and coronaryarterydiseaseremainsunresolveddespite >110 publicationsduring the last 30 years reporting results in 9,000 patients.” Overview of the Nationwide Inpatient Sample (NIS) of the Healthcare Cost and Utilization Project (HCUP), from Timaran et al. J VascSurg 2009
Coronaryrevascularizationbefore non cardiacsurgeryisbelievedtodecrease the peri- and post-operative risk in selectedpatients Fleisher LA et al. ACC/AHA 2007 Guidelines on perioperativecardiovascularevaluation. J Am CollCardiol 2007 The frequency of major non cardiacsurgery in the yearafterDrugElutingStentplacementis >4-5% Berger et al. Pre-Operative DES in EVENT Registry. J AmCollCardiolIntv. 2010 Van Kuijk et al. Timing of non cardiacsurgeryaftercoronaryarterystenting. Am J Cardiol 2009
UnprotectedProtected Do PCI/Open HeartSurgeryaffect the rate of Major AdverseCardiovascularEvents in patient with carotidarterystenosis? Shishehbor et al. JACC. 2013
Dashed line: CAS without PCI Solid line: CAS with PCI Tomai et al. 2011. JACC:CardiovascInterv Do PCI affect the rate of Major AdverseCardiovascularEvents in patients with carotidarterystenosis?
Why do weconsiderPercutaneousCoronaryIntervention a bias? CEA withoutDoubleAntiPlateletTherapy RELATED COMPLICATIONS: death, MI, stentthrombosis Van Kuijk et al. Am.J.Cardiol, 2009
SuspensionofDoubleAntiPlateletTherapyafterPercutaneousCoronaryIntervention (PCI) isassociated with the risk of peri-operative Major AdverseCardiovascularEvents due to stentthrombosis Stentthrombosisis a multifactorialprocess Surfacecoating: DrugElutingStents (DES), Bare Metal Stents (BMS) Stentdiameter Stentlength Vessel diameter Left ventricularejectionfraction Metabolicsyndrome
Stent-relateddecisionmaking: PCI with BMS: The European Society of Cardiology + ACC/AHA recommends DAPT for a minimum of 6 weeks after PCI PCI with DES: The European Society of Cardiology + ACC/AHA recommends DAPT for a minimum of 1 year Always consider the time interval in patients with coronary and carotid lesions Avoiding DES in patientsscheduled for carotid or aorticsurgery can save 6-9 months. The cardiovascular crew
Why do weconsider PCI a bias? CEA withDoubleAntiPlateletTherapy RELATED COMPLICATIONS: Severe bleeding (life-threatening, requiring surgical intervention, transfusion)
Bleeding and DoubleAntiPlateletTherapy Bleeding and hematoma of the neck are the leadingcauses of in-hospital morbidityaftercarotidsurgery Major AdverseCardiovascularEvents and bleeding are the mainpredictors for unplanned hospital readmissionwithin 30 days of CEA Ho KJ et al. Predictors and consequences of unplanned hospital readmission. J VascSurg 2014
Enrollablecarotidstenosis Recent PCI (< 3 months) Is DAPT stillrunning? A decision-making flowchart? YES NO BMS DES Symptoms? Unstableinstrumentalfindings? Wait 9 months Wait 3 months from PCI ENROLL THE PATIENT CAS
Keypoints • The cut off for enrolling the patientis 3 months. • In asymptomaticpatients, cardiac timing is the leadingpriorityregardingcarotidstenosis • Carotidendarterectomyis the bias for enrollmentif the patientistaking double therapy • As DES and BMS havedifferentsafetyperiods, a tailoredstenting in patients with tandem lesions (coronary and carotid) must be considered. • RecruitmentCenters with CathLab can enroll 6-12% of patientsafter PCI (30-60 pts/year) • Shouldwe look at thissubgroupor will the trial give the answers?
Before making a mistake… …Join the Trial and choose the best route