Clinical Outcome of Coronary Artery Bypass Graft Surgery Versus Percutaneous Coronary Intervention in Patients With Severe Left Ventricular Disfunction (CROWN) (CROWN)
Clinical Outcome of Coronary Artery Bypass Graft Surgery Versus Percutaneous Coronary Intervention in Patients With Severe Left Ventricular Disfunction: the CROWN Study.
The objective of this study is to evaluate the best treatment strategy in patients with critical coronary artery disease and severe left ventricular dysfunction.
In details, main goal of the study is to compare the clinical outcomes of patients with critical coronary artery disease and severe left ventricular dysfunction undergoing surgical coronary artery bypass grafting with those of patients treated by percutaneous coronary intervention.
Studieoversigt
Status
Detaljeret beskrivelse
Despite CABG being increasingly performed in patients with reduced EF, the literature lacks of data directly comparing the clinical outcomes of surgical versus percutaneous revascularization in patients with left ventricular dysfunction.
The goal of this study is to compare the clinical outcomes of patients with critical coronary artery disease and severe left ventricular dysfunction undergoing surgical coronary artery bypass grafting with those of patients treated by percutaneous coronary intervention (PCI).
All patients affected by coronary artery disease who underwent surgical treatment (coronary artery bypass grafting, CABG) or percutaneous treatment (percutaneous coronary intervention, PCI) between January 2019 and December 2023, and who meet the inclusion and exclusion criteria, will be included in the study. Each patient will be enrolled following an interview and the subsequent signing of the informed consent form. Data will then be recorded in a dedicated database. In detail, the following information will be collected: anamnestic data, description of the performed procedure, preoperative and postoperative laboratory test results, preoperative, intraoperative, and postoperative echocardiographic parameters (including follow-up visits up to 2 years after the procedure), length of stay in the Intensive Care Unit and in the general ward, and data regarding any intraoperative and postoperative complications (death, shock, pericardial effusion, stroke, myocardial infarction, need for postoperative PCI, rehospitalization, heart failure). All data recorded in the database are routinely collected for all patients undergoing this type of intervention, and no additional examinations will be performed on patients included in the study.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiesteder
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Roma, Italien, 00168
- Fondazione Policlinico Universitario A Gemelli IRCCS
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Age >= 18 years old;
- Written informed consent;
- Indication to CABG surgery (both "on-pump" and "off-pump") or to PCI;
- Preoperative EF ≤35%.
Exclusion Criteria:
- Inability to give written informed consent;
- Emergency surgery;
- Combined cardiac surgical procedures;
- Previous cardiac surgery.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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CABG
Patients with critical coronary artery disease and severe left ventricular disfunction treated with coronary artery bypass graft surgery
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PCI
Patients with critical coronary artery disease and severe left ventricular disfunction treated with percutaneous coronary intervention
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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All-cause mortality
Tidsramme: through study completion, an average of 1 year
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Number of patients who died for any cause after CABG or PCI
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through study completion, an average of 1 year
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Mortality from cardiovascular causes
Tidsramme: through study completion, an average of 1 year
|
Number of patients who died for cardiovascolar causes after CABG or PCI
|
through study completion, an average of 1 year
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Acute myocardial infarction
Tidsramme: through study completion, an average of 1 year
|
Number of patients who experienced myocardial infarction after CABG or PCI
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through study completion, an average of 1 year
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Rehospitalization from cardiovascular reasons
Tidsramme: through study completion, an average of 1 year
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Number of patients who needed rehospitalization after being discharged
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through study completion, an average of 1 year
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Repeated revascularization
Tidsramme: through study completion, an average of 1 year
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Number of patients who needed repeated revascularization after CABG or PCI
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through study completion, an average of 1 year
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Stroke
Tidsramme: through study completion, an average of 1 year
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Number of patients who had stroke after CABG or PCI
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through study completion, an average of 1 year
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Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Generelle publikationer
- Maron DJ, Hochman JS, Reynolds HR, Bangalore S, O'Brien SM, Boden WE, Chaitman BR, Senior R, Lopez-Sendon J, Alexander KP, Lopes RD, Shaw LJ, Berger JS, Newman JD, Sidhu MS, Goodman SG, Ruzyllo W, Gosselin G, Maggioni AP, White HD, Bhargava B, Min JK, Mancini GBJ, Berman DS, Picard MH, Kwong RY, Ali ZA, Mark DB, Spertus JA, Krishnan MN, Elghamaz A, Moorthy N, Hueb WA, Demkow M, Mavromatis K, Bockeria O, Peteiro J, Miller TD, Szwed H, Doerr R, Keltai M, Selvanayagam JB, Steg PG, Held C, Kohsaka S, Mavromichalis S, Kirby R, Jeffries NO, Harrell FE Jr, Rockhold FW, Broderick S, Ferguson TB Jr, Williams DO, Harrington RA, Stone GW, Rosenberg Y; ISCHEMIA Research Group. Initial Invasive or Conservative Strategy for Stable Coronary Disease. N Engl J Med. 2020 Apr 9;382(15):1395-1407. doi: 10.1056/NEJMoa1915922. Epub 2020 Mar 30.
- Coronary artery surgery study (CASS): a randomized trial of coronary artery bypass surgery. Survival data. Circulation. 1983 Nov;68(5):939-50. doi: 10.1161/01.cir.68.5.939.
- Velazquez EJ, Lee KL, Deja MA, Jain A, Sopko G, Marchenko A, Ali IS, Pohost G, Gradinac S, Abraham WT, Yii M, Prabhakaran D, Szwed H, Ferrazzi P, Petrie MC, O'Connor CM, Panchavinnin P, She L, Bonow RO, Rankin GR, Jones RH, Rouleau JL; STICH Investigators. Coronary-artery bypass surgery in patients with left ventricular dysfunction. N Engl J Med. 2011 Apr 28;364(17):1607-16. doi: 10.1056/NEJMoa1100356. Epub 2011 Apr 4.
- Christiaan Vrints, Felicita Andreotti, Konstantinos C Koskinas, Xavier Rossello, Marianna Adamo, James Ainslie, Adrian Paul Banning, Andrzej Budaj, Ronny R Buechel, Giovanni Alfonso Chiariello, Alaide Chieffo, Ruxandra Maria Christodorescu, Christi Deaton, Torsten Doenst, Hywel W Jones, Vijay Kunadian, Julinda Mehilli, Milan Milojevic, Jan J Piek, Francesca Pugliese, Andrea Rubboli, Anne Grete Semb, Roxy Senior, Jurrien M ten Berg, Eric Van Belle, Emeline M Van Craenenbroeck, Rafael Vidal-Perez, Simon Winther, ESC Scientific Document Group , 2024 ESC Guidelines for the management of chronic coronary syndromes: Developed by the task force for the management of chronic coronary syndromes of the European Society of Cardiology (ESC) Endorsed by the European Association for Cardio-Thoracic Surgery (EACTS), European Heart Journal, Volume 45, Issue 36, 21 September 2024, Pages 3415-3537, https://doi.org/10.1093/eurheartj/ehae177
- Morgan H, Nazir MS, Li Kam Wa ME, McCann GP, Greenwood JP, McDiarmid AK, Dodd M, Ryan M, Perera D, Chiribiri A. Prognostic impact of inducible ischaemia in ischaemic left ventricular dysfunction: the REVIVED-BCIS2 trial. Eur Heart J. 2025 Feb 3;46(5):487-490. doi: 10.1093/eurheartj/ehae844. No abstract available.
- Shaw LJ, Weintraub WS, Maron DJ, Hartigan PM, Hachamovitch R, Min JK, Dada M, Mancini GB, Hayes SW, O'Rourke RA, Spertus JA, Kostuk W, Gosselin G, Chaitman BR, Knudtson M, Friedman J, Slomka P, Germano G, Bates ER, Teo KK, Boden WE, Berman DS. Baseline stress myocardial perfusion imaging results and outcomes in patients with stable ischemic heart disease randomized to optimal medical therapy with or without percutaneous coronary intervention. Am Heart J. 2012 Aug;164(2):243-50. doi: 10.1016/j.ahj.2012.05.018.
- Chareonthaitawee P, Gersh BJ, Araoz PA, Gibbons RJ. Revascularization in severe left ventricular dysfunction: the role of viability testing. J Am Coll Cardiol. 2005 Aug 16;46(4):567-74. doi: 10.1016/j.jacc.2005.03.072.
- Cleland JG, Calvert M, Freemantle N, Arrow Y, Ball SG, Bonser RS, Chattopadhyay S, Norell MS, Pennell DJ, Senior R. The Heart Failure Revascularisation Trial (HEART). Eur J Heart Fail. 2011 Feb;13(2):227-33. doi: 10.1093/eurjhf/hfq230. Epub 2010 Dec 13.
- Varnauskas E. Twelve-year follow-up of survival in the randomized European Coronary Surgery Study. N Engl J Med. 1988 Aug 11;319(6):332-7. doi: 10.1056/NEJM198808113190603.
- Veterans Administration Coronary Artery Bypass Surgery Cooperative Study Group. Eleven-year survival in the Veterans Administration randomized trial of coronary bypass surgery for stable angina. N Engl J Med. 1984 Nov 22;311(21):1333-9. doi: 10.1056/NEJM198411223112102.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
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