Off-pump vs On-pump Surgery for Coronary Artery Disease

(FRAGILE Trial)

Not currently recruiting at 11 trial locations

Overseen By Bianca C Meneghini, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Sao Paulo General Hospital

Disqualifiers: Angioplasty, Emergency operation, Previous surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Surgical procedure duration up to 600 minutes

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two types of heart surgery to determine which is better for frail individuals. One surgery uses a heart-lung machine (on-pump coronary-artery bypass grafting), while the other does not (off-pump coronary-artery bypass grafting). The goal is to identify which method is safer and more effective for patients with coronary artery disease who struggle with stress, such as surgery. Individuals aged 60 or older who have been advised to undergo heart surgery and feel frail or easily tired might be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance heart surgery outcomes for frail patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both off-pump and on-pump coronary artery bypass surgeries offer similar safety in terms of survival rates. Studies have found that off-pump surgery can cause less surgical trauma and lead to quicker recovery compared to on-pump surgery, often resulting in fewer complications. The risk of perioperative mortality is about 2% for both types, though off-pump surgery carries a slightly lower risk of death during the operation.

Conversely, on-pump surgery has a slightly higher chance of causing a short-term stroke compared to off-pump surgery. Despite this, research suggests that on-pump surgery might lead to fewer repeat procedures in the years following the surgery.

In summary, both surgeries are generally safe with low risks of death, but they differ in recovery time and long-term outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these surgical techniques for coronary artery disease because they offer different approaches to bypass surgery. On-pump coronary-artery bypass grafting (CABG) uses a heart-lung machine to circulate blood during surgery, which allows the heart to be stopped for a more controlled operation. In contrast, off-pump coronary-artery bypass grafting (OPCAB) is performed while the heart is still beating, potentially reducing complications related to the heart-lung machine. These approaches are being explored to see which is safer and more effective for patients, especially those who are frail, and could lead to improved outcomes and recovery times.

What evidence suggests that this trial's treatments could be effective for coronary artery disease?

This trial will compare off-pump and on-pump coronary artery bypass surgeries. Studies have shown that both methods offer similar survival rates shortly after and long after surgery. Participants in the off-pump arm will undergo surgery without a heart-lung machine, potentially reducing complications from stopping the heart. However, this approach may increase the likelihood of needing another surgery and a higher long-term risk of death. Participants in the on-pump arm will receive the standard treatment, which can improve symptoms and life expectancy for heart disease patients. Research generally indicates no significant difference in safety or effectiveness between the two methods over time. ^{1 2 6 7 8}

Who Is on the Research Team?

Omar AV Mejia, MD, PhD

Principal Investigator

InCor Heart Institute

Fábio B Jatene, MD, PhD

Principal Investigator

InCor Heart Institute

Are You a Good Fit for This Trial?

This trial is for patients aged 60 or older who need heart surgery to improve blood flow and meet at least two frailty criteria. It's not specified who can't join, but typically those with conditions making surgery too risky are excluded.

Inclusion Criteria

I am 60 or older, considered frail by specific criteria, and can have heart bypass surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either off-pump or on-pump coronary artery bypass grafting surgery

Surgical procedure duration up to 600 minutes

1 visit (in-person for surgery)

Immediate Postoperative Monitoring

Participants are monitored for major adverse cardiac and cerebrovascular events, mechanical ventilation time, and other immediate postoperative outcomes

30 days

Inpatient stay including ICU monitoring

Follow-up

Participants are monitored for frailty status, neurobehavioral outcomes, graft patency, and quality of life

12 months

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Off-pump coronary-artery bypass grafting
• On-pump coronary-artery bypass grafting

Trial Overview The study compares two types of heart bypass surgery in frail elderly patients: one without stopping the heart (off-pump) and one with stopping the heart (on-pump). The goal is to see which method is better for these high-risk patients.

How Is the Trial Designed?

Group I: On-pump coronary-artery bypass grafting - CABG Active Control 1 Intervention

Pre-frail and frail patients will be randomly assigned to CABG after the evaluation of the target vessels by an internet-based, password protected database program. The surgery will be performed as described in the "intervention" section and the patients will be followed up for two years.

Group II: Off-pump coronary-artery bypass grafting - OPCAB Active Control 1 Intervention

Pre-frail and frail patients will be randomly assigned to OPCAB after the evaluation of the target vessels by an internet-based, password protected database program. The surgery will be performed as described in the "intervention" section and the patients will be followed up for two years.

Who Is Running the Clinical Trial?

University of Sao Paulo General Hospital

Lead Sponsor

Trials

567

Recruited

218,000+

Beneficência Portuguesa de São Paulo

Collaborator

Trials

20

Recruited

34,100+

Hospital das Clínicas Samuel Libânio

Collaborator

Trials

1

Recruited

440+

Clinical Hospital Samuel Libânio of Pouso Alegre

Collaborator

Trials

1

Recruited

440+

Hospital do Coração de Messejana Dr. Carlos Alberto Studart

Collaborator

Trials

1

Recruited

440+

Instituto Nacional de Cardiologia de Laranjeiras

Collaborator

Trials

14

Recruited

3,600+

Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina de São Paulo

Collaborator

Trials

1

Recruited

440+

Hospital Alberto Urquiza Wanderley

Collaborator

Trials

1

Recruited

440+

Hospital Samaritano Campinas

Collaborator

Trials

1

Recruited

440+

Mount Sinai Hospital, New York

Collaborator

Trials

37

Recruited

892,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10720830/

Comparative efficacy on outcomes of C-CABG, OPCAB, and ... Off-pump CABG (OPCAB) avoids CPB and cardioplegic arrest, with less aortic manipulation, which could eliminate the complications caused by CPB and heart arrest.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5124584/

Current outcomes of off-pump versus on-pump coronary ... The current evidence synthesised from RCTs demonstrates comparable early and late survival for both off-pump and conventional coronary artery bypass grafting.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772993125002840

A 27-Year Comparative Analysis of Off-Pump and On- ... Off-pump coronary artery bypass reduces 30-day mortality in octogenarians compared with on-pump coronary artery bypass, but long-term survival ...

4. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2789138

Ten-Year Outcomes of Off-Pump vs On-Pump Coronary ... For nonconverted patients, the 10-year composite outcome rates were 49.0% (474 of 967) for the off-pump group and 44.6% (472 of 1059) for the on ...

5. jacc.org jacc.org/doi/10.1016/j.jacc.2018.07.029

Long-Term Outcomes After Off-Pump Versus On- ... Off-pump was associated with increased incomplete revascularization, repeat revascularization, and mortality at 10 years compared with on-pump CABG.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40821072/

Off pump method of coronary artery bypass grafting ... Conclusion: Off-pump CABG reduces surgical trauma, shortens recovery time, lowers complication rates, and improves QoL compared to conventional ...

7. nejm.org nejm.org/doi/full/10.1056/NEJMoa1601564

Five-Year Outcomes after Off-Pump or On-Pump Coronary- ... With this approach, perioperative mortality is approximately 2%, with an additional 5 to 9% of patients having myocardial infarction, stroke, or ...

8. jtd.amegroups.org jtd.amegroups.org/article/view/10291/html

Current outcomes of off-pump coronary artery bypass grafting The overall propensity-adjusted operative mortality (PAOMR) was significantly lower in patients undergoing off-pump (2.59%) than on-pump CABG (3.22%) (OR 0.8; P ...