Asymptomatic Carotid Surgery TrialACST-2

Collaborators Meeting 2014Pembroke College,

Oxford

Is recent coronary stenting a problem (or an opportunity) for enrolling the patient in the

trial?

Valerio Tolva MD, PhDIstituto Auxologico Italiano IRCCS

Deparment of SurgeryVascular 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. 2010

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?

Unprotected Protected

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 PCISolid line: CAS with PCI

Tomai et al.2011. 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?

NOYES

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