Management of Antiplatelet Regimen During Surgical Procedures

Surgery Clinical Trial

— MARS  

Official title:

Management of Antiplatelet Regimen During Surgical Procedures (MARS Registry)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03981835
• Other study ID #: STU-2018-0398
• Status: Recruiting
• Start date: August 1, 2019
• Est. completion date: March 19, 2025

Study information

• Verified date: December 2023
• Source: Baylor Research Institute
• Contact: Subhash Banerjee, MD
• Phone: 469-800-7400
• Email: subhash.banerjee[@]bswhealth.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

There are key differences today in clinical practice regarding perioperative management of post-PCI patients on DAPT undergoing NCS. Moreover, there are significant differences between bridging agents, and improved safety of current-generation DES. Given the significant limitations of current studies a well-designed registry to study current U.S. practice patterns and the bleeding or ischemic risks associated with the various perioperative DAPT management strategies including bridging and no bridging will significantly add to the understanding of the current problem and associated risks of patients. These data could form the basis for conducting future randomized clinical trials (RCTs) in this area. NCS in post-PCI patients on chronic DAPT presents a complex interaction of both ischemic and bleeding risks.

The MARS registry will study the area of perioperative antiplatelet therapy management through a multicenter observational national registry designed to collect pre-operative, intra-operative and post-operative clinical strategies, therapeutic interventions and outcomes data. This proposal outlines the role of a highly experienced clinical trial team to conduct a multicenter prospective registry. This question is highly relevant to a diverse group of medical providers and millions of patients in the US and around the world; this will be the first such U.S. registry to address this critically important public health issue.

Study objectives:

i. To collect data on contemporary clinical practice in the U.S. on managing post percutaneous coronary intervention (PCI) DAPT in patients scheduled to undergo NCS and CS.

ii. To assess ischemic and bleeding endpoints in this group of patients during the study period.

iii. To generate initial data to plan for future large-scale randomized clinical trials on perioperative management of DAPT.

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)

5. 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).

6. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1492
• Est. completion date: March 19, 2025
• Est. primary completion date: March 19, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with PCI within the past 2 years who: a. Are currently on DAPT, OR b. Have a current indication for DAPT

• Scheduled for NCS or CS.

• Willing and able to provide an informed consent (if needed based on institutional IRB requirements).

Exclusion Criteria:

• Emergent (6 hours) surgery post-PCI on DAPT that precludes a thorough informed consent process.

Related Conditions & MeSH terms

• Cardiac Surgery
• Percutaneous Coronary Intervention
• Surgery
• Surgery--Complications

Locations

Country	Name	City	State
United States	Baylor Scott & White Research Institute	Dallas	Texas
United States	Dallas VA Medical Center	Dallas	Texas
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Mary Washington Hospital	Fredericksburg	Virginia
United States	University of Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (43)

Alshawabkeh LI, Prasad A, Lenkovsky F, Makary LF, Kandil ES, Weideman RA, Kelly KC, Rangan BV, Banerjee S, Brilakis ES. Outcomes of a preoperative "bridging" strategy with glycoprotein IIb/IIIa inhibitors to prevent perioperative stent thrombosis in patients with drug-eluting stents who undergo surgery necessitating interruption of thienopyridine administration. EuroIntervention. 2013 Jun 22;9(2):204-11. doi: 10.4244/EIJV9I2A35. — View Citation

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Brilakis ES, Banerjee S. Patient with coronary stents needs surgery: what to do? JAMA. 2013 Oct 9;310(14):1451-2. doi: 10.1001/jama.2013.279123. No abstract available. — View Citation

Brilakis ES, Banerjee S. Perioperative management of drug-eluting stents: the Achilles heel of bridging. Catheter Cardiovasc Interv. 2013 Dec 1;82(7):1113-4. doi: 10.1002/ccd.25243. No abstract available. — View Citation

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Capodanno D, Musumeci G, Lettieri C, Limbruno U, Senni M, Guagliumi G, Valsecchi O, Angiolillo DJ, Rossini R. Impact of bridging with perioperative low-molecular-weight heparin on cardiac and bleeding outcomes of stented patients undergoing non-cardiac surgery. Thromb Haemost. 2015 Aug;114(2):423-31. doi: 10.1160/TH14-12-1057. Epub 2015 May 28. — View Citation

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Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):399-410. doi: 10.1161/01.cir.0000442015.53336.12. No abstract available. — View Citation

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Hawn MT, Graham LA, Richman JS, Itani KM, Henderson WG, Maddox TM. Risk of major adverse cardiac events following noncardiac surgery in patients with coronary stents. JAMA. 2013 Oct 9;310(14):1462-72. doi: 10.1001/jama.2013.278787. Erratum In: JAMA. 2014 Feb 5;311(5):528. — View Citation

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Luckie M, Khattar RS, Fraser D. Non-cardiac surgery and antiplatelet therapy following coronary artery stenting. Heart. 2009 Aug;95(16):1303-8. doi: 10.1136/hrt.2008.161273. Epub 2009 Feb 12. — View Citation

McFadden EP, Stabile E, Regar E, Cheneau E, Ong AT, Kinnaird T, Suddath WO, Weissman NJ, Torguson R, Kent KM, Pichard AD, Satler LF, Waksman R, Serruys PW. Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet. 2004 Oct 23-29;364(9444):1519-21. doi: 10.1016/S0140-6736(04)17275-9. — View Citation

Mehran R, Baber U, Steg PG, Ariti C, Weisz G, Witzenbichler B, Henry TD, Kini AS, Stuckey T, Cohen DJ, Berger PB, Iakovou I, Dangas G, Waksman R, Antoniucci D, Sartori S, Krucoff MW, Hermiller JB, Shawl F, Gibson CM, Chieffo A, Alu M, Moliterno DJ, Colombo A, Pocock S. Cessation of dual antiplatelet treatment and cardiac events after percutaneous coronary intervention (PARIS): 2 year results from a prospective observational study. Lancet. 2013 Nov 23;382(9906):1714-22. doi: 10.1016/S0140-6736(13)61720-1. Epub 2013 Sep 1. — View Citation

Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available. — View Citation

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Ong AT, Hoye A, Aoki J, van Mieghem CA, Rodriguez Granillo GA, Sonnenschein K, Regar E, McFadden EP, Sianos G, van der Giessen WJ, de Jaegere PP, de Feyter P, van Domburg RT, Serruys PW. Thirty-day incidence and six-month clinical outcome of thrombotic stent occlusion after bare-metal, sirolimus, or paclitaxel stent implantation. J Am Coll Cardiol. 2005 Mar 15;45(6):947-53. doi: 10.1016/j.jacc.2004.09.079. — View Citation

Palmerini T, Biondi-Zoccai G, Della Riva D, Mariani A, Genereux P, Branzi A, Stone GW. Stent thrombosis with drug-eluting stents: is the paradigm shifting? J Am Coll Cardiol. 2013 Nov 19;62(21):1915-1921. doi: 10.1016/j.jacc.2013.08.725. Epub 2013 Sep 11. — View Citation

Rassi AN, Blackstone E, Militello MA, Theodos G, Cavender MA, Sun Z, Ellis SG, Cho L. Safety of "bridging" with eptifibatide for patients with coronary stents before cardiac and non-cardiac surgery. Am J Cardiol. 2012 Aug 15;110(4):485-90. doi: 10.1016/j.amjcard.2012.04.016. Epub 2012 May 15. — View Citation

Regar E, Lemos PA, Saia F, Degertekin M, Tanabe K, Lee CH, Arampatzis CA, Hoye A, Sianos G, de Feyter P, van der Giessen WJ, Smits PC, van Domburg RT, Serruys PW. Incidence of thrombotic stent occlusion during the first three months after sirolimus-eluting stent implantation in 500 consecutive patients. Am J Cardiol. 2004 May 15;93(10):1271-5. doi: 10.1016/j.amjcard.2004.02.013. — View Citation

Rossini R, Capodanno D, Lettieri C, Musumeci G, Nijaradze T, Romano M, Lortkipanidze N, Cicorella N, Biondi Zoccai G, Sirbu V, Izzo A, Guagliumi G, Valsecchi O, Gavazzi A, Angiolillo DJ. Prevalence, predictors, and long-term prognosis of premature discontinuation of oral antiplatelet therapy after drug eluting stent implantation. Am J Cardiol. 2011 Jan 15;107(2):186-94. doi: 10.1016/j.amjcard.2010.08.067. — View Citation

Rossini R, Musumeci G, Capodanno D, Lettieri C, Limbruno U, Tarantini G, Russo N, Calabria P, Romano M, Inashvili A, Sirbu V, Guagliumi G, Valsecchi O, Senni M, Gavazzi A, Angiolillo DJ. Perioperative management of oral antiplatelet therapy and clinical outcomes in coronary stent patients undergoing surgery. Results of a multicentre registry. Thromb Haemost. 2015 Feb;113(2):272-82. doi: 10.1160/TH14-05-0436. Epub 2014 Oct 2. — View Citation

Rossini R, Musumeci G, Visconti LO, Bramucci E, Castiglioni B, De Servi S, Lettieri C, Lettino M, Piccaluga E, Savonitto S, Trabattoni D, Capodanno D, Buffoli F, Parolari A, Dionigi G, Boni L, Biglioli F, Valdatta L, Droghetti A, Bozzani A, Setacci C, Ravelli P, Crescini C, Staurenghi G, Scarone P, Francetti L, D'Angelo F, Gadda F, Comel A, Salvi L, Lorini L, Antonelli M, Bovenzi F, Cremonesi A, Angiolillo DJ, Guagliumi G; Italian Society of Invasive Cardiology (SICI-GISE); Italian Association of Hospital Cardiologists (ANMCO); Italian Society for Cardiac Surgery (SICCH); Italian Society of Vascular and Endovascular Surgery (SICVE); Italian Association of Hospital Surgeons (ACOI); Italian Society of Surgery (SIC); Italian Society of Anaesthesia and Intensive Care Medicine (SIAARTI); Lombard Society of Surgery (SLC); Italian Society of Maxillofacial Surgery (SICMF); Italian Society of Reconstructive Plastic Surgery and Aesthetics (SICPRE); Italian Society of Thoracic Surgeons (SICT); Italian Society of Urology (SIU); Italian Society of Orthopaedics and Traumatology (SIOT); Italian Society of Periodontology (SIdP); Italian Federation of Scientific Societies of Digestive System Diseases Lombardia (FISMAD); Association of Obstetricians Gynaecologists Italian Hospital Lombardia (AOGOI); Society of Ophthalmology Lombardia (SOL). Perioperative management of antiplatelet therapy in patients with coronary stents undergoing cardiac and non-cardiac surgery: a consensus document from Italian cardiological, surgical and anaesthesiological societies. EuroIntervention. 2014 May;10(1):38-46. doi: 10.4244/EIJV10I1A8. — View Citation

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* Note: There are 43 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Net adverse cardiovascular events (NACE) over the study period	A composite of cardiovascular (CV) death, non-fatal myocardial infarction (MI), ischemic stroke, need for urgent coronary revascularization (UCR) or Bleeding Academic Research Consortium (BARC) =3 bleeding during the study period.	2 weeks prior to surgery to up to 30 days post-surgery
Secondary	Incidence of individual components of NACE over the study period	Incidence of cardiovascular (CV) death, non-fatal myocardial infarction (MI), ischemic stroke, need for urgent coronary revascularization (UCR) or Bleeding Academic Research Consortium (BARC) =3 bleeding during the study period.	2 weeks prior to surgery to up to 30 days post-surgery
Secondary	Incidence of IV antiplatelet (APT) bridging and comparison of IV APT bridging and no bridging strategies.	Incidence of IV antiplatelet (APT) bridging and comparison of IV APT bridging and no bridging strategies.	2 weeks prior to surgery to up to 30 days post-surgery
Secondary	Time to NACE	Time to NACE	2 weeks prior to surgery to up to 30 days post-surgery
Secondary	All-cause mortality	All-cause mortality	2 weeks prior to surgery to up to 30 days post-surgery
Secondary	Incidence of definite and probable stent thrombosis (ST).	Incidence of definite and probable stent thrombosis (ST).	2 weeks prior to surgery to up to 30 days post-surgery
Secondary	Length of hospital stay (LOS).	Length of hospital stay (LOS).	2 weeks prior to surgery to up to 30 days post-surgery
Secondary	Health economic analysis comparing cost-effectiveness of IV APT bridging and no bridging strategies.	Health economic analysis comparing cost-effectiveness of IV APT bridging and no bridging strategies.	2 weeks prior to surgery to up to 30 days post-surgery