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

Coronary Stent Occlusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01288105
• Other study ID #: 10-106
• Status: Terminated
• Phase: Phase 4
• First received: January 20, 2011
• Last updated: December 27, 2011
• Start date: January 2011
• Est. completion date: February 2014

Study information

• Verified date: December 2010
• Source: North Texas Veterans Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 107
• Est. completion date: February 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coronary Stent Occlusion

Intervention

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.

Locations

Country	Name	City	State
United States	VA North Texas Healthcare System	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
North Texas Veterans Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac events	composite of cardiac death, myocardial infarction, coronary revascularization	30-days post surgery	Yes