Acute Coronary Syndrome, Coronary Stent Occlusion, Surgery
Conditions
Keywords
Coronary Stent, BMS stent, DES stent, Date of stent implantation, cardiac event, neurovascular event, Bleeding, transfusion
Brief summary
The purpose of this study is to evaluate and monitor perioperative management of patients with coronary stents undergoing noncardiac surgery. Objectives: * To describe the incidence and severity of adverse cardiovascular events in patients with coronary stents undergoing noncardiac surgery with admission. * To assess the following-up of the guidelines about the perioperative management of antiplatelet therapy in these patients. * To assess the relationship between the incidence of cardiac or neurovascular events, as well as bleeding complications with the perioperative management of antiplatelet therapy. * Number of Participants with Adverse Events as a Measure of Safety
Detailed description
(Not desired)
Interventions
None listed
Sponsors
Corporacion Parc Tauli
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \> 18 years old, with coronary stents * American Society of Anaesthesia physical status II-V * noncardiac surgery wiht admission * informed consent
Exclusion criteria
* \< 18 years old * American Society of Anaesthesia physical status I * ambulatory surgery * pregnancy * obstetric anaesthesia * endoscopic procedures * cardiac surgery * not informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiac and Cerebrovascular Events (MACCEs) | up to 90 days after surgery | Cardiac Mortality, Myocardial Infarction, Angina Pectoris, new arrythmia, Congestive Heart Failure, Stroke, Cardiac Arrest |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Haemorrhagic Events | up to 90 days after surgery | Transfusion \> = 2 red blood cells Units, haemoglobin descent \>= 20 gr/dL, intracerebral haemorrhage |
| Number of Patients With Adverse Events Related With Antiplatelet Therapy Management | 90 days after surgery | Perioperative withdrawal antiplatelet therapy is defined with \> or = 5 days without therapy We create 3 categories: 1. Not withdrawal 2. Complete withdrawal (5 or \> days without antiplatelet drugs , mono or dual therapy) 3. Incomplete withdrawal: patients under dual antiplatelet therapy, who maintain aspirin and stopped clopidogrel =/ \> 5 days |
Countries
Spain
Participant flow
Recruitment details
Observational, multicenter and prospective study, approved by the Ethics Committee. All patients with coronary stents undergoing noncardiac surgery with admission from February 2010 to April 2012 were the basis of the study.
Pre-assignment details
Patients scheduled for noncardiac surgery with admission
Participants by arm
| Arm | Count |
|---|---|
| Coronary Stent Patients with coronary Bare Metal Stent (BMS) or Drug Eluting Stent (DES) undergoing noncardiac surgery | 432 |
| Total | 432 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 51 |
Baseline characteristics
| Characteristic | Coronary Stent |
|---|---|
| Age, Customized >70 years | 213 participants |
| Age, Customized Between 18 and 70 years | 219 participants |
| Antiplatelet Therapy Antiplatelet therapy | 412 participants |
| Antiplatelet Therapy Not antiplatelet therapy | 20 participants |
| Body Mass Index | 27.9 Kgm^2 |
| Region of Enrollment Spain | 432 participants |
| Sex: Female, Male Female | 72 Participants |
| Sex: Female, Male Male | 360 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 432 |
| serious Total, serious adverse events | 61 / 432 |
Outcome results
Primary
Major Adverse Cardiac and Cerebrovascular Events (MACCEs)
Cardiac Mortality, Myocardial Infarction, Angina Pectoris, new arrythmia, Congestive Heart Failure, Stroke, Cardiac Arrest
Time frame: up to 90 days after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Coronary Stent | Major Adverse Cardiac and Cerebrovascular Events (MACCEs) | 63 participants |
Secondary
Major Haemorrhagic Events
Transfusion \> = 2 red blood cells Units, haemoglobin descent \>= 20 gr/dL, intracerebral haemorrhage
Time frame: up to 90 days after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Coronary Stent | Major Haemorrhagic Events | 161 participants |
Secondary
Number of Patients With Adverse Events Related With Antiplatelet Therapy Management
Perioperative withdrawal antiplatelet therapy is defined with \> or = 5 days without therapy We create 3 categories: 1. Not withdrawal 2. Complete withdrawal (5 or \> days without antiplatelet drugs , mono or dual therapy) 3. Incomplete withdrawal: patients under dual antiplatelet therapy, who maintain aspirin and stopped clopidogrel =/ \> 5 days
Time frame: 90 days after surgery
Population: MACCEs
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Coronary Stent | Number of Patients With Adverse Events Related With Antiplatelet Therapy Management | 38 participants |
| Incomplete Withdrawal (Mantaining ASA, Clopidogrel Withdrawn) | Number of Patients With Adverse Events Related With Antiplatelet Therapy Management | 10 participants |
| Complete Withdrawal | Number of Patients With Adverse Events Related With Antiplatelet Therapy Management | 9 participants |
Comparison: Reference group were patients who maintained antiplatelet drugs (aspirin and/or clopidogrel) during the 4 days before surgeryp-value: 0.47995% CI: [0.513, 2.299]Chi-squared
p-value: 0.47995% CI: [0.733, 3.662]Chi-squared