Vascular Surgery
Conditions
Keywords
vascular surgery, aspirin resistance, MINS
Brief summary
The aim of our study is to investigate the association between perioperative aspirin resistance and Myocardial Injury after Non-cardiac Surgery (MINS) in patients undergoing vascular surgery.
Detailed description
Because of new surgical techniques, advanced monitoring modalities and improvements in perioperative care, perioperative mortality and morbidity have been significantly reduced in the last decades; however, patients still suffer from high perioperative mortality and morbidity, especially those with pre-existing cardiovascular diseases. Not only perioperative myocardial infarction but also myocardial injury after non-cardiac surgery, which presents without clinical symptoms, is associated with an adverse outcome. Possibilities to preoperatively identify patients at cardiovascular risk are limited and prophylactic interventions are not yet established or controversial. Aspirin is used for primary and secondary prevention in cardiovascular diseases. New-onset increased platelet function on aspirin treatment (aspirin resistance) has been demonstrated in cardiac and vascular surgery. Yet, it has not been investigated whether a new perioperative aspirin resistance is associated with higher risk of myocardial injury after non-cardiac surgery (MINS) and cardiovascular events. The aim of this study is to evaluate a potential association between new-onset aspirin resistance and MINS in patients undergoing vascular surgery. If there is an association of perioperative aspirin resistance and MINS during vascular surgery, the detection of perioperative aspirin resistance could be used as perioperative risk stratification tool in order to improve clinical risk stratification and reduce perioperative morbidity and mortality. Therefore, 220 patients treated with aspirin and scheduled for vascular surgery will be recruited. Blood will be drawn at predefined time points before surgery and up to three days postoperatively. Aspirin resistance will be measured by Multiplate Analyzer prior to surgery, one hour after skin-incision, four hours after surgery and on post-OP days one and two. Adverse cardiovascular events will be recorded until 30 days post-OP. ECGs will be recorded preoperatively and on post-OP day 3. High-sensitive cardiac Troponin T will be measured prior to surgery and on post-OP days one to three. Patient charts will be screened and a telephone interview will be performed to detect cardiovascular events after discharge until post-OP day 30.
Interventions
None listed
Sponsors
University Hospital Heidelberg
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 or older * Preoperative aspirin treatment at least 14 days prior to surgery * Elective vascular surgery * In-patient treatment * Informed consent
Exclusion criteria
* 17 years of age or younger * Known pregnancy or breastfeeding * Missing informed consent * Ambulatory or day-case surgery * Emergency surgery * Current clopidogrel or non-steroidal anti-inflammatory drug treatment * Preoperative aspirin resistance * Current thrombocytopenia (\<100000 platelet/µl) * Liver or renal failure (GOT/GPT and/or creatinine increased \>2-fold) * Entity which is part of the composite endpoint diagnosed within past 28 days * Angiography without surgical intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial Injury after Non-cardiac Surgery | 30 days postoperative | Number of participants with MINS defined as raise in postoperative hs-cTNT (high sensitivity cardiac troponin T) judged due to myocardial ischemia detected at postoperative visits, documented in patient chart or detected during telephone interview after 30 postoperative days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peripheral vascular occlusion | 30 days postoperative | Diagnosed by a radiologist based on the results of duplex ultrasonography, angiography or CT-angiography. |
| Mesenteric ischemia | 30 days postoperative | Diagnosed by a radiologist based on the results of angiography or CT-angiography. |
| New-onset atrial fibrillation | 30 days postoperative | Number of participants with new electrocardiographic detection of atrial fibrillation in postoperative ECG and/or documented in patient chart |
| Congestive heart failure | 30 days postoperative | Number of participants with congestive heart failure according to European Perioperative Clinical Outcome (EPCO) definitions |
| Cardiac death | 30 days postoperative | Number of participants with cardiac death defined as death due to new myocardial infarction or ischemia, or atrial or ventricular arrhythmias, or cardiogenic pulmonary edema, or pulmonary embolism detected at postoperative visits, documented in patient chart or detected during telephone interview after 30 postoperative days |
| Composite of Cardiovascular Events | 30 days postoperative | Number of participants with Cardiovascular Events defined as occurrence of Cardiac Death and/or Myocardial Ischemia and/or Myocardial Infarction and/or Embolic Stroke and/or Thrombotic Stroke recorded until postoperative day 30. Definitions according to European Perioperative Clinical Outcome-(EPCO) detected at postoperative visits, documented in patient chart or detected during telephone interview after 30 postoperative days |
| Myocardial Infarction | 30 days postoperative | Number of participants with myocardial infarction defined as an increase in serum cardiac biomarker values in combination with symptoms of ischemia or new/presumed new significant ST segment or T wave ECG changes or new left bundle branch block or development of pathological Q waves on ECG. Definition according to European Perioperative Clinical Outcome-(EPCO) detected at postoperative visits, postoperative blood analyses, documented in patient chart or detected during telephone interview after 30 postoperative days |
| Stroke | 30 days postoperative | Number of participants with embolic or thrombotic stroke defined as cerebral event with persistent residual motor, sensory or cognitive dysfunction detected at postoperative visits, documented in patient chart or detected during telephone interview after 30 postoperative days. |
| Length of hospital stay | 30 days postoperative | Documented in patient charts. |
| Length of intensive care unit stay | 30 days postoperative | Documented in patient charts. |
| Myocardial Ischemia | 30 days postoperative | Number of participants with myocardial ischemia defined as new electrocardiographic detection of myocardial ischemia in ECG and/or documented in patient charts which will be screened up to 30 postoperative days and/or detected during telephone interview after 30 postoperative days |
Countries
Germany
Contacts
Primary ContactJan Larmann, MD PhD
Outcome results
None listed