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 Vascular Surgery (Head: Renato Casana MD) Milan, Italy

Handling a patient with recent coronary stenting and carotid stenosis is like a sailing race: You can head straight forcing the upwind : with double therapy perform CAS You can run on a beam wind and then upwind : stop double therapy and perform CEA Crews have guidelines for the right approach to a race… can we create guidelines using the data of the Trial?

“the prevalence of severe carotid disease (>80% stenosis of ICA) among patients undergoing Percutaneous Coronary Intervention (PCI)/Open Heart Surgery (OHS) is estimated to be 6% to 12%.” “…optimal treatment of patients with concurrent carotid and coronary artery disease remains unresolved despite >110 publications during 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 Vasc Surg 2009

Coronary revascularization before non cardiac surgery is believed to decrease the peri- and post-operative risk in selected patients Fleisher LA et al. ACC/AHA 2007 Guidelines on perioperative cardiovascular evaluation. J Am Coll Cardiol 2007 The frequency of major non cardiac surgery in the year after Drug Eluting Stent placement is >4-5% Berger et al. Pre-Operative DES in EVENT Registry. J Am Coll Cardiol Intv Van Kuijk et al. Timing of non cardiac surgery after coronary artery stenting. Am J Cardiol 2009

Do PCI/Open Heart Surgery affect the rate of Major Adverse Cardiovascular Events in patient with carotid artery stenosis? UnprotectedProtected Shishehbor et al. JACC. 2013

Do PCI affect the rate of Major Adverse Cardiovascular Events in patients with carotid artery stenosis? Dashed line: CAS without PCI Solid line: CAS with PCI Tomai et al JACC:Cardiovasc Interv

Why do we consider Percutaneous Coronary Intervention a bias? CEA without Double AntiPlatelet Therapy RELATED COMPLICATIONS: death, MI, stent thrombosis Van Kuijk et al. Am.J.Cardiol, 2009

Suspension of Double AntiPlatelet Therapy after Percutaneous Coronary Intervention (PCI) is associated with the risk of peri- operative Major Adverse Cardiovascular Events due to stent thrombosis Stent thrombosis is a multifactorial process Surface coating: Drug Eluting Stents (DES), Bare Metal Stents (BMS) Stent diameter Stent length Vessel diameter Left ventricular ejection fraction Metabolic syndrome

Stent-related decision making: 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 patients scheduled for carotid or aortic surgery can save 6-9 months. The cardiovascular crew

Why do we consider PCI a bias? CEA with Double AntiPlatelet Therapy RELATED COMPLICATIONS: Severe bleeding (life-threatening, requiring surgical intervention, transfusion)

Bleeding and Double AntiPlatelet Therapy Bleeding and hematoma of the neck are the leading causes of in-hospital morbidity after carotid surgery Major Adverse Cardiovascular Events and bleeding are the main predictors for unplanned hospital readmission within 30 days of CEA Ho KJ et al. Predictors and consequences of unplanned hospital readmission. J Vasc Surg 2014

A decision-making flowchart? Enrollable carotid stenosis Is DAPT still running? NO YES ENROLL THE PATIENT BMS Wait 3 months from PCI DES Symptoms? Unstable instrumental findings? CAS Wait 9 months Recent PCI (< 3 months)

The cut off for enrolling the patient is 3 months. In asymptomatic patients, cardiac timing is the leading priority regarding carotid stenosis Carotid endarterectomy is the bias for enrollment if the patient is taking double therapy As DES and BMS have different safety periods, a tailored stenting in patients with tandem lesions (coronary and carotid) must be considered. Recruitment Centers with CathLab can enroll 6-12% of patients after PCI (30-60 pts/year) Should we look at this subgroup or will the trial give the answers? Key points

Before making a mistake… …Join the Trial and choose the best route