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

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02941588
Collaborator
(none)
1,582
1
19
83.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Non-cardiac surgery

Detailed Description

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.

The aim of our study was (1) to determine independent risk factors for postoperative adverse events and the strength of their association, (2) to assess the incidences of postoperative morbidities including major adverse cardiovascular and cerebral event as a function of time between PCI and surgery and (3) to compare bleeding amount and transfusion requirements between different intervals from PCI to surgery and durations of antiplatelet agent administration prior to surgery. To achieve this aim, we undertook a retrospective cohort study of the patients who underwent noncardiac surgery after PCI with DES.

Study Design

Study Type:
Observational
Actual Enrollment :
1582 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
The Impact of Early Surgery and Maintenance of Antiplatelet Therapy on Intraoperative Bleeding and Major Adverse Cardiovascular Event After Percutaneous Coronary Intervention
Actual Study Start Date :
Apr 1, 2016
Actual Primary Completion Date :
Nov 1, 2017
Actual Study Completion Date :
Nov 1, 2017

Arms and Interventions

Arm Intervention/Treatment
non-cardiac surgery after DES

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

Procedure: Non-cardiac surgery
Any surgery with general anesthesia except cardiac surgery

Outcome Measures

Primary Outcome Measures

  1. Major adverse cardiovascular and cerebral event [during postoperative 30 days]

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

Secondary Outcome Measures

  1. Composite morbidity [during postoperative 30 days]

    composite of overall postoperative morbidity, including Major adverse cardiovascular and cerebral event and all respiratory, cardiac, renal and other complications during postoperative 30 days.

  2. Major bleeding event [during the 24 hours from the surgery]

    a bleeding event with any one of the following (1) A preoperative hematocrit ≤ 30% or a drop of hematocrit ≥10% as well as transfusion of ≥2 units of RBC during the surgery, or (2) the patient received a transfusion of ≥4 units of red blood cells within a 24 hour period, or (3) any one of the following interventions (i.e., embolization, superficial vascular repair, nasal packing); or retroperitoneal, intraspinal or intraocular bleeding (confirmed clinically or on imaging).

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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
Exclusion Criteria:
  • Patients who underwent percutaneous coronary intervention with balloon angioplasty or bare metal stent

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Hospital Seoul Korea, Republic of 03080

Sponsors and Collaborators

  • Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Won Ho Kim, MD, Clinical Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT02941588
Other Study ID Numbers:
  • 1604-023-753
First Posted:
Oct 21, 2016
Last Update Posted:
Nov 8, 2017
Last Verified:
Nov 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 8, 2017