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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coronary Stent Occlusion

Intervention / Treatment
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* Device: Optical coherence tomography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Optical Coherence Tomography<br>Patients enrolled in the study will undergo optical coherence tomography to evaluate the extent of stent strut coverage. | Device: Optical coherence tomography<br>* 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.<br>* Other names: invasive intracoronary imaging;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug-eluting stents, noncardiac surgery