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

Phase 4

Terminated

• Conditions: Coronary Stent Occlusion
• Interventions: Device: Optical coherence tomography

• Registration Number: NCT01288105
• Lead Sponsor: North Texas Veterans Healthcare System

Brief Summary

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.

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 Timeline

• Status Verified: 2010-12
• Study Start: 2011-01
• Study First Submitted: 2011-01-20
• Study First Submitted QC: 2011-01-31
• Study First Posted: 2011-02-02
• Last Update Submitted: 2011-12-27
• Last Update Posted: 2011-12-28
• Primary Completion: 2014-01
• Study Completion: 2014-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 107

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Optical Coherence Tomography	Optical coherence tomography	Patients enrolled in the study will undergo optical coherence tomography to evaluate the extent of stent strut coverage.

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac events	30-days post surgery	composite of cardiac death, myocardial infarction, coronary revascularization

Trial Locations

Locations (1)

VA North Texas Healthcare System; 🇺🇸 Dallas, Texas, United States