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Off Pump Versus On Pump Coronary Artery Bypass Grafting in Frailty Patients (FRAGILE)

Information source: University of Sao Paulo General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Coronary Artery Disease; Complications Due to Coronary Artery Bypass Graft; Fragility

Intervention: OPCAB (Procedure); CABG (Procedure)

Phase: N/A

Status: Not yet recruiting

Sponsored by: University of Sao Paulo General Hospital

Official(s) and/or principal investigator(s):
Luis Alberto O Dallan, MD, PhD, Study Chair, Affiliation: Heart Institute of São Paulo Medical School

Overall contact:
Omar Mejia, MD, Phone: 55-11-26615000, Ext: 5014, Email: omarvmejia@gmail.com

Summary

The purpose of this study is to determine whether off-pump coronary artery bypass graft (OPCAB) surgery is superior to conventional on-pump coronary artery bypass graft (CABG) surgery in the treatment of Pre-frailty and Frailty patients

Clinical Details

Official title: Off Pump Versus On Pump Coronary Artery Bypass Grafting in Frailty Patients: A National, Multicenter, Prospective, Randomized Clinical Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The primary purpose of this study is to compare adverse cardiac and cerebrovascular events after OPCAB and CABG in pre-frailty and frailty patients

Secondary outcome:

Major Adverse Cardiac and Cerebrovascular events after OPCAB and CABG in pre-frailty and frailty patients

Major Adverse Cardiac and Cerebrovascular events after OPCAB and CABG in pre-frailty and frailty patients

Major Adverse Cardiac and Cerebrovascular events after OPCAB and CABG in pre-frailty and frailty patients

Operative Time

Mechanical Ventilation Time

Hyperdynamic Shock

New Onset of Atrial Fibrillation

Need for Pacing >24 hours

Renal Replacement Therapy

Reoperation for Bleeding

Pneumonia

Length of Stay in Intensive Care Unit

Length of Stay in Hospital

Transfusion Requirement

Graft Patency

Clinical and Angiographic Scores Correlation with Prognostic

Recurrence of Angina

Rate of Complete Revascularization

Detailed description: One of the most controversial areas of cardiac surgery has been whether off-pump coronary artery bypass graft (OPCAB) surgery is superior to conventional on-pump coronary artery bypass graft (CABG) surgery. There is an ongoing debate about the benefits and disadvantage of OPCAB. Initial trials have shown that OPCAB is feasible in selected low-risk patients and offers results similar to CABG. In institutions with experience in OPCAB, the rate of major adverse events and the rates of complete revascularization and graft patency have been similar to those with CABG. These positive results have been called into question by reports of inferior graft patency and higher rates of repeat target-vessel revascularization associated with OPCAB. The Randomized On/Off Bypass (ROOBY) trial showed that among low-risk patients, the rate of death or major adverse events at 30 days after surgery was similar with OPCAB and CABG, but OPCAB was associated with a higher rate of incomplete revascularization at 1 year. Short-term mortality and morbidity after OPCAB and CABG were similar in a recent trial involving 4752 patients with a mixed operative-risk profile in the CABG Off or On Pump Revascularization Study (CORONARY). The German Off-Pump Coronary Artery Bypass Grafting in Elderly Patients (GOPCABE) study focused exclusively on patients ≥ 75 years. However, this trial wouldn't elucidate the potential benefit of OPCAB in high-risk patients because of this specific group of Germans patients were moderate-risk patients. The results of the Best Bypass Surgery Trial (BBS), performed on 341 high-risk patients (European system for cardiac operative risk evaluation "EuroSCORE" >5) undergoing CABG or OPCAB, report no significant differences in the composite of adverse cardiac and cerebrovascular events or in any of the following outcomes: All-cause mortality, acute myocardial infarction, cardiac arrest, low cardiac output/cardiogenic shock, stroke, and coronary re-intervention. However, in our opinion, the definition of high-risk patient should be interpreted carefully. Although the EuroSCORE identifies patients based on 18 independent variables, many of which were not considered in the study. Risk factors such as previous cardiac surgery, critical preoperative state, emergency operation, and poor left ventricular dysfunction were excluded. In the real world, with more than 1500 patients, Heart Institute researchers at the University of São Paulo, showed lower mortality among patients operated OPCAB. So, after a certain cutoff EuroSCORE > 4. 5 or 2000 Bernstein-Parsonnet score >17. 75, OPCAB significantly reduces the chances of operative mortality. Indeed, numerous large retrospective studies and meta-analyses have shown significant short-term improvements after OPCAB and comparable long-term outcomes. A recent risk-adjusted analysis of the national Society of Thoracic Surgeons database assessing 876081 patients demonstrated a significant reduction in death and stroke (11% and 34% reduction, respectively) after OPCAB. After that, it is important to reconsider the best approach for patients with higher surgical risk for CABG. Clearly a base is being built with strong scientific evidence that this is the group that experiments the most benefit from OPCAB. This could change the focus in relation to the use of cardiopulmonary bypass in coronary artery bypass surgery, as well as the preference for complete revascularization and the use of arterial grafts, especially in extremely high risk patients. Really, randomized, controlled trials have failed to demonstrate a significant mortality benefit for OPCAB. However, the available randomized, controlled trials were underpowered to detect significant differences between rarely events such as stroke or death and can suffer from high selection and exclusion of biases. Even more important is the fact that available randomized, controlled trials so far have primarily focused only on low-risk (ROOBY, CORONARY), elevated-risk (GOPCABE) or high-risk patients (BBS) but not frailty patients in whom the benefits of OPCAB should be well defined. Investigators believe that avoiding cardiopulmonary bypass should be viewed primarily as a step toward avoiding aortic manipulation. Despite the long-term benefits of surgery, some patients may choose percutaneous coronary intervention for the treatment of complex multivessel disease to avoid the morbidity associated with CABG, of which stroke is the most feared. Expert OPCAB surgeons can offer equivalent durability of graft patency as in CABG, with a lower rate of stroke if aortic manipulation is avoided. Cardiac Risk Scores, including EuroSCORE and STS, have been developed to predict the risk of adverse outcomes following surgery. Frailty, an independent predictor of mortality and complications, is not included in these risk algorithms. Emerging evidence suggests that frailty is a better marker of biological age and more important than chronological age. Afilalo et al. determined that patients with slow preoperative gait speed (≥6 s to walk 5 m) had a 2 to 3 fold increased risk of mortality and major morbidity for any given level of STS-Predicted Risk of Mortality or Major Morbidity (PROM) compared with normal speed. Lee et al. performed a retrospective review of a large cardiac registry, comparing outcomes between non-frail and frail individuals. Frailty was an independent risk factor for in-hospital mortality (risk-adjusted odds ratio [OR] 1. 8; 95% confidence interval [CI] 1. 1-3. 0; P = 0. 03) and mortality at 2 years (risk-adjusted hazards ratio [HR] 1. 5, 95% CI 1. 1-2. 2; P = 0. 01). The benefits of coronary artery bypass grafting without cardiopulmonary bypass in Pre-frailty and Frailty patients are still undetermined. Investigators believe OPCAB remains an important technique for the improvement of coronary surgery. The question right now is: Pre-frailty and Frailty patients will benefit more from OPCAB or CABG? The aim of this paper was clarify the potential benefit of OPCAB in Pre-frailty and Frailty patients, Investigators conducted a national, multicenter, controlled, randomized clinical trial comparing OPCAB versus CABG in FRAGIL trial.

Eligibility

Minimum age: 65 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients who will be scheduled for isolated, first-time CABG must be eligible if they

will be at least 65 years of age and should be pre-frailty or frailty status according the Fried Frailty Criteria Exclusion Criteria:

- Any additional cardiovascular disease necessitating concomitant surgery, previous

pericardiotomy, any condition requiring immediate surgery (i. e., within 24 hours after hospital admission), planned minimally invasive direct coronary-artery bypass procedure (CABG with the use of left anterior thoracotomy), and the inability or unwillingness of the patient to provide consent.

Locations and Contacts

Omar Mejia, MD, Phone: 55-11-26615000, Ext: 5014, Email: omarvmejia@gmail.com

USP Heart Institute, São Paulo, Brazil; Not yet recruiting
Omar AV Mejia, MD, Phone: 11-996862043, Email: omarvmejia@gmail.com
Luiz AF Lisboa, MD, PhD, Phone: 11-994445829, Email: luiz.lisboa@incor.usp.br
Omar Asdrúbal V Mejía, MD, Principal Investigator
Luiz Augusto F Lisboa, MD, PhD, Principal Investigator
Fabio B Jatene, MD, PhD, Principal Investigator
Luís Roberto P Dallan, MD, Sub-Investigator
Fernando A Atik, MD, PhD, Sub-Investigator
Orlando Petrucci Junior, MD, PhD, Sub-Investigator
Walter Gomes, MD, PhD, Sub-Investigator
Marco Antonio P Oliveira, MD, Sub-Investigator
Ricardo C Lima, MD, PhD, Sub-Investigator
Rodrigo C Segalote, MD, Sub-Investigator
Rodrigo M Milani, MD, Sub-Investigator
Alexandre C Hueb, MD, PhD, Sub-Investigator
Maurilio O Deininger, MD, PhD, Principal Investigator
Gustavo CA Ribeiro, MD, PhD, Sub-Investigator
Marcelo M Cascudo, MD, Sub-Investigator
Roberto Rocha e Silva, MD, PhD, Sub-Investigator
Ludhmila A Hajjar, MD, PhD, Sub-Investigator
Filomena Regina G Galas, MD, PhD, Sub-Investigator
Luiz Antonio M César, MD, PhD, Sub-Investigator
José C Nicolau, MD, PhD, Sub-Investigator
Humberto Pierri, MD, PhD, Sub-Investigator
Roberto Kalil Filho, MD, PhD, Sub-Investigator
Leandro Batisti de Faria, MD, Sub-Investigator
Additional Information

Foundation for Research Support of the State of São Paulo

Zerbini Foundation

Brazilian Cardiovascular Society

Starting date: August 2015
Last updated: April 10, 2015

Page last updated: August 23, 2015

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