STOPping Versus Continuing Antiplatelet Therapy During Noncardiac Surgery and Procedures After Next Generation Drug-eluting Stent Implantation

Not Applicable

Terminated

• Conditions: Coronary Artery Disease
• Interventions: Drug: Continuing aspirin; Drug: Stopping aspirin

• Registration Number: NCT03184805
• Lead Sponsor: Yonsei University

Brief Summary

Most previous trials support the absolute increase in bleeding risk with perioperative administration of antiplatelet. Furthermore, recent studies demonstrated that perioperative major bleeding may be related to increase cardiovascular risk. The investigators will compare the efficacy and safety of continuing versus stopping antiplatelet therapy during perioperative period in patients underwent PCI(Percutaneous Coronary Intervention) with next generation DES(Drug Eluting Stent).

Detailed Description

Most current guidelines recommend to focus on continuing antiplatelet therapy (mostly with aspirin) during noncardiac surgery if possible. Although previous study showed efficacy of continuous antiplatelet therapy in reducing perioperative ischemic cardiovascular events, its effectiveness is still not clear between perioperative bleeding and ischemic risk. Most previous trials support the absolute increase in bleeding risk with perioperative administration of antiplatelet. Furthermore, recent studies demonstrated that perioperative major bleeding may be related to increase cardiovascular risk. The investigators will compare the efficacy and safety of continuing versus stopping antiplatelet therapy during perioperative period in patients underwent PCI(Percutaneous Coronary Intervention) with next generation DES(Drug Eluting Stent).

Study Timeline

• Study First Submitted: 2017-06-07
• Study First Submitted QC: 2017-06-08
• Study First Posted: 2017-06-14
• Study Start: 2017-06-23
• Primary Completion: 2018-04-09
• Study Completion: 2018-04-09
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-17
• Last Update Posted: 2018-05-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Age 19-85 years
• Planning of elective noncardiac surgery or invasive procedure
• At least 1 year interval between the surgery or procedure and last PCI with next generation DES
• Currently on antiplatelet therapy

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Exclusion Criteria

• PCI with BMS(bare metal stent), 1st generation DES or bioresorbable vascular scaffold
• Total length of inserted DES in the 3 vessels >60 mm
• History of stent thrombosis
• History of coronary artery bypass grafting surgery
• Planned surgery or procedure with high bleeding risk including followings: intracranial neurosurgery, spinal canal surgery, and eye posterior chamber surgery, endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), ampullary resection, endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic sphincterotomy plus large-balloon papillary dilation, endoscopic ultrasonography-guided fine-needle aspiration (EUS-FNA) of cystic lesions
• Left ventricular ejection fraction <40%
• Myocardial infarction within 6 months
• Any overt thromboembolism requiring medical surveillance and/or treatment
• Any clinically overt sign of hemorrhage within 3 months
• Anticoagulant therapy for any reason
• Need of continuation or discontinuation of antiplatelet therapy during surgery or procedure at the discretion of cardiologist or operator
• Any contraindication, adverse drug reaction or hypersensitivity to aspirin
• Pregnant women or women with potential childbearing
• Inability to understand or read the informed content

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuing aspirin	Continuing aspirin	Patients in the group may continue the administration of aspirin during perioperative period.
Stopping aspirin	Stopping aspirin	Patients in the group may stop medication of antiplatelet drugs during perioperative period.

Primary Outcome Measures

Name	Time	Method
A composite of cardiac death	1 day after discharging from the hospital	A composite of major perioperative adverse events
cerebrovascular accident	1 day after discharging from the hospital	A composite of major perioperative adverse events
nonfatal myocardial infarction (MI)	1 day after discharging from the hospital	A composite of major perioperative adverse events
definite or probable stent thrombosis	1 day after discharging from the hospital	A composite of major perioperative adverse events
any revascularization and BARC(Bleeding Academic Research Consortium) ≥3 bleeding during index hospitalization for surgery or procedure	1 day after discharging from the hospital	A composite of major perioperative adverse events

Trial Locations

Locations (1)

Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of