Clinical trial NCT03184805: STOPping Versus Continuing Antiplatelet Therapy During Noncardiac Surgery and Procedures After Next Generation Drug-eluting Stent Implantation
Official title: Randomized Controlled Comparison: STOPping Versus Continuing Antiplatelet Therapy During Noncardiac Surgery and Procedures After Next Generation Drug-eluting Stent Implantation (STOP-ASP Trial)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 140
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

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

Primary outcomes:
measure: A composite of cardiac death
timeFrame: 1 day after discharging from the hospital
measure: nonfatal myocardial infarction (MI)
timeFrame: 1 day after discharging from the hospital
measure: cerebrovascular accident
timeFrame: 1 day after discharging from the hospital
measure: definite or probable stent thrombosis
timeFrame: 1 day after discharging from the hospital
measure: any revascularization and BARC(Bleeding Academic Research Consortium) ≥3 bleeding during index hospitalization for surgery or procedure
timeFrame: 1 day after discharging from the hospital
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine
Study officials:
References: