Use of Optical Coherence Tomography to Determine the Optimal Management of Patients With Drug-eluting Stents Who Need Non-cardiac Surgery

The specific aim of this proposal is to examine the impact of OCT and IVUS-guided management of patients with prior DES implantation who need major non-cardiac surgery and discontinuation of dual antiplatelet therapy on the perioperative (1 week prior to surgery until 30 days post surgery) incidence of major adverse cardiac events.

Study Overview

• Status: Terminated
• Conditions: Coronary Stent Occlusion
• Intervention / Treatment: Device: Optical coherence tomography

Detailed Description

Patients who receive drug-eluting stents (DES) and subsequently require non-cardiac surgery have increased risk for perioperative stent thrombosis, especially when antiplatelet therapy discontinuation is required. Perioperative administration of a glycoprotein IIb/IIIa inhibitor may decrease the stent thrombosis risk, but it is cumbersome and carries high cost. Stents that have been endothelialized by optical coherence tomography (OCT) are likely to have low risk for perioperative stent thrombosis and therefore intensive management strategies, such as "bridging with a glycoprotein IIb/IIIa inhibitor" would not be required. The current study will assess whether OCT utilization can help optimize the preoperative management of DES patients requiring major non-cardiac surgery.

The specific aim of this proposal is to examine the impact of OCT and IVUS-guided management of patients with prior DES implantation who need major non-cardiac surgery and discontinuation of dual antiplatelet therapy on the perioperative (1 week prior to surgery until 30 days post surgery) incidence of major adverse cardiac events.

The hypothesis is that OCT and IVUS-guided treatment will have low incidence (≤10%) of perioperative major adverse cardiac events.

The specific aim of this proposal is to examine the impact of OCT and IVUS-guided management of patients with prior DES implantation who need major non-cardiac surgery and discontinuation of dual antiplatelet therapy on the perioperative (1 week prior to surgery until 30 days post surgery) incidence of major adverse cardiac events.

The hypothesis is that OCT and IVUS-guided treatment will have low incidence (≤10%) of perioperative major adverse cardiac events.

• Study Type: Interventional
• Enrollment (Anticipated): 107
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75216
      • VA North Texas Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 years or older
• Need for major non-cardiac surgery requiring discontinuation of dual antiplatelet therapy
• Agree to participate and provide informed consent

Exclusion Criteria:

• Patients who have a creatinine above 2.5 mg/dL (unless they require hemodialysis, in which case they are eligible to participate)
• Challenging vascular access
• History of an allergic reaction to glycoprotein IIb/IIIa inhibitors

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Optical Coherence Tomography; Patients enrolled in the study will undergo optical coherence tomography to evaluate the extent of stent strut coverage.	Device: Optical coherence tomography; Optical coherence tomography will be performed to determine the stent strut coverage. Patients in whom >95% of stent struts are covered will not receive perioperative bridging with a glycoprotein IIb/IIIa inhibitors, whereas those with <95% stent strut coverage will receive perioperative bridging.; Other Names: invasive intracoronary imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiac events	composite of cardiac death, myocardial infarction, coronary revascularization	30-days post surgery

Collaborators and Investigators

• Sponsor: North Texas Veterans Healthcare System
• Investigators: Principal Investigator: Emmanouil S Brilakis, MD, PhD, North Texas Veterans Healthcare System

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): January 1, 2014
• Study Completion (Anticipated): February 1, 2014

Study Registration Dates

• First Submitted: January 20, 2011
• First Submitted That Met QC Criteria: January 31, 2011
• First Posted (Estimate): February 2, 2011

Study Record Updates

• Last Update Posted (Estimate): December 28, 2011
• Last Update Submitted That Met QC Criteria: December 27, 2011
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: noncardiac surgery; drug-eluting stents
• Other Study ID Numbers: 10-106