The Impact of Early Surgery and Maintenance of Antiplatelet Therapy on Intraoperative Bleeding and Major Adverse Cardiovascular Event After Percutaneous Coronary Intervention

NCT02941588 | Completed

• 1 other identifier: 1604-023-753
• Study Type: observational
• Target: 1,582
• Locations: 1 country
• Sites: 1

Brief Summary

Recent guidelines of the ACC/AHA suggest that elective non-cardiac surgery (NCS) should optimally be delayed one year after percutaneous coronary intervention (PCI) with drug-eluting stent (DES). Regarding the antiplatelet agents, dual antiplatelet therapy, or at least aspirin is recommended to be continued considering the relative risk of bleeding and stent thrombosis especially during the first 4 to 6 weeks after DES implantation. However, these recommendations are based upon insufficient and conflicting evidences.

Conditions

Acute Coronary Syndrome; Drug-eluting Stent; Aspirin

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiovascular and cerebral event

  a composite of non-fatal myocardial infarction, coronary revascularization, pulmonary embolism and stroke

  during postoperative 30 days

Secondary Outcomes (2)

• Composite morbidity

  during postoperative 30 days

• Major bleeding event

  during the 24 hours from the surgery

Study Arms (1)

non-cardiac surgery after DES

The patients who underwent non-cardiac surgery after percutaneous coronary intervention with drug-eluting stent

Procedure: Non-cardiac surgery

Interventions

Non-cardiac surgery PROCEDURE

Any surgery with general anesthesia except cardiac surgery

non-cardiac surgery after DES

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients who underwent non-cardiac surgery within 5 years after percutaneous coronary intervention with drug-eluting stent at Seoul National University Hospital between April 2004 and August 2017

You may qualify if:

• Adult patients who underwent non-cardiac surgery within 5 years after percutaneous coronary intervention with drug-eluting stent at Seoul National University Hospital between April 2004 and August 2017

You may not qualify if:

• Patients who underwent percutaneous coronary intervention with balloon angioplasty or bare metal stent

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: October 20, 2016
• First Posted: October 21, 2016
• Study Start: April 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 8, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)