Management of Antiplatelet Regimen During Surgical Procedures (MARS)

Description

1. Registry infrastructure: The proposed registry is a multicenter prospective registry that is designed to capture perioperative DAPT management strategies in patients undergoing NCS or CS post-PCI. It will be adjudicated and monitored for data accuracy and completeness. The registry will be de-identified and compliant with HIPPA regulations and will be located on secure servers of the University of Texas Southwestern Medical Center (UTSW). Full-time staff that includes an information technology officer and data programmer manages the registry servers professionally. The servers are backed up daily and provide on-line secure access to site investigators and coordinators. The current registry structure is already in use for a national peripheral artery disease registry and can be viewed at www.XLPAD.org. The MARS registry will include two separate registry arms to capture data on two distinct cohorts: (i) NCS and (ii) CS.
2. Hypothesis: This observational registry is designed to test whether 30-day NACE associated with IV APT bridging is ≥6%.
3. Study period: period of 14 days prior to surgery to 30 days post-surgery.
4. Study eligible NCS or CS :
   • Study eligible non-cardiac surgeries and procedures:
     1. Intra-abdominal surgery (e.g., bowel or visceral organ resection) *
     2. Intra-thoracic surgery (e.g., lung resection) *
     3. Major orthopedic surgery (e.g., hip or knee replacement)
     4. Peripheral arterial revascularization (e.g., aortic aneurysm repair, vascular bypass, carotid surgery)
     5. Urologic surgery (e.g., prostatectomy*, bladder tumor resection);
     6. Major procedure (e.g., renal, lung or liver transplants, biopsy of lung, head and neck surgery)
     7. Breast and other surgeries or procedures requiring DAPT interruption as per the clinical team *High-risk NCS, remaining classified as low-intermediate
   • Study eligible cardiac surgeries and procedures
     1. Coronary artery bypass graft (CABG)
     2. Cardiac valve repair or replacement with or without CABG
     3. Surgical arrhythmia treatment (MAZE procedure)
     4. Pericardial procedures
     5. Thoracoscopic procedures
     6. Other cardiothoracic procedures (please contact study tem)
     7. Study population: Post-PCI patients on DAPT undergoing NCS and CS. Patients will be asked to sign an informed consent form (ICF) or ICF deferred based on the mandate of their respective institutional review boards (IRB).
     8. Registry data collection: The registry will be built on the NHLBI's REDCap data collection portal that is available to UTSW under an Academic Information Systems NIH grant UL1-RR024982. The proposed MARS Registry data collection portal. The data collection portal has been designed to facilitate comprehensive data collection from 2 weeks prior to surgery to 30±7 days post-surgery and includes demographics, laboratory, coronary revascularization, medication and clinical outcome information. Baseline information will include demographic, relevant medical history, preoperative medications and laboratory values and any preoperative clinical events during the study period. Procedure related data will include surgical procedure details, intraoperative medications and medications, laboratory values and clinical outcomes from the day of surgery till hospital discharge. Postoperative data collection will include medications, laboratory values and clinical events between hospital discharge and 30 days post-discharge. Data will be entered into a secure and HIPPA compliant online REDCap data collection portal. No study related procedures, interventions or follow-ups are required. Each site staff will enter data based on electronic health records (EHR), which wills serve as the primary data source. Out of hospital medical records will need to be incorporated or documented as part of a given participants' source data. All participants will be given the opportunity to re-evaluate their decisions regarding participation in the MARS Registry. The MARS registry will include two separate arms of the registry to capture data on two distinct cohorts: (i) NCS and (ii) CS.

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