CABG vs PCI for Coronary Artery Disease in Women

(RECHARGE:W Trial)

Recruiting at 18 trial locations

Overseen By Gregg Stone, MD, FACC, MSCAI

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Weill Medical College of Cornell University

Must be taking: Dual antiplatelet

Disqualifiers: Recent MI, Cardiogenic shock, Pregnancy, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 month

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two methods to improve blood flow to the heart in women with coronary artery disease. The first method, percutaneous coronary intervention (PCI), uses small tubes called stents to keep arteries open. The second method, coronary artery bypass grafting (CABG), involves surgery to create a new pathway around blocked arteries. The researchers aim to determine which approach leads to better survival and quality of life. Women with multiple blocked heart arteries considering treatment might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you must be able to tolerate and comply with dual antiplatelet therapy for at least 3 to 6 months, depending on your condition.

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

Research has shown that coronary artery bypass grafting (CABG) carries certain risks for women. Studies indicate that women might face a higher chance of short-term complications, such as stroke, compared to men. However, in the long term, CABG can lower the risk of major heart issues and death.

For percutaneous coronary intervention (PCI), research has found that women may have a higher risk of heart attacks during the procedure than men. Despite this, women often experience longer survival after undergoing PCI.

Both treatments present specific risks and benefits for women. These factors are important to consider when deciding to join a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about comparing coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) for coronary artery disease in women because these approaches could offer distinct benefits over standard treatments. CABG is unique because it involves creating a new route for blood flow around a blocked artery, which can provide long-term relief and improve heart function. On the other hand, PCI is a less invasive procedure that uses a balloon and stent to open up blood vessels, offering a quicker recovery time and fewer surgical risks. By directly comparing these two methods specifically in women, researchers hope to better understand which treatment offers the best outcomes in terms of effectiveness and safety for this population.

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

This trial will compare coronary artery bypass grafting (CABG) with percutaneous coronary intervention (PCI) for women with coronary artery disease. Research has shown that women often experience worse outcomes than men after CABG, with studies finding a higher likelihood of complications like stroke and an increased risk of death shortly after surgery. In contrast, women undergoing PCI, where a stent opens blocked arteries, face slightly higher procedural risks but tend to live longer than men afterward. However, some evidence suggests that women might still encounter more issues, such as heart attacks, during follow-up after PCI. Overall, both treatments present distinct risks and benefits for women with heart disease, and this trial aims to evaluate these differences. ^{3 6 7 8 9}

Who Is on the Research Team?

Gregg S Stone, MD, FACC, MSCAI

Principal Investigator

Icahn School of Medicine at Mount Sinai

Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This clinical trial is for women with coronary artery disease. It's designed to compare two different heart procedures: one that uses a small tube to open blockages and another that creates a detour around the blockage using healthy blood vessels.

Inclusion Criteria

I am female.

Ability to provide written informed consent and comply with all follow-up procedures, including QOL questionnaires

My heart condition requires surgery, and doctors are deciding between two types.

Exclusion Criteria

I am scheduled for a procedure to open one blocked heart artery.

I am scheduled for a combined heart bypass and stent procedure.

I have experienced a severe heart condition that suddenly reduced blood flow.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either CABG or PCI procedures to restore blood flow to the heart

1 month

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up assessments at 30 days, 3 months, 6 months, and every 6 months through 36 months, then annually up to 10 years

5-10 years

Telephone follow-ups and annual in-person visits

What Are the Treatments Tested in This Trial?

Interventions

• Coronary artery bypass grafting (CABG)
• Percutaneous coronary intervention (PCI)

Trial Overview The study tests two treatments for blocked heart arteries in women: Percutaneous coronary intervention (PCI), where blockages are opened with a stent, and Coronary artery bypass grafting (CABG), an open-heart surgery for creating bypasses around blockages.

How Is the Trial Designed?

Group I: RECHARGE:Women - PCI Experimental Treatment 1 Intervention

Group II: RECHARGE:Women - CABG Experimental Treatment 1 Intervention

Coronary artery bypass grafting (CABG) is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Coronary artery bypass grafting for:

• Coronary artery disease
• Heart failure
• Angina

Approved in Canada as Coronary artery bypass grafting for:

• Coronary artery disease
• Heart failure
• Angina

Approved in European Union as Coronary artery bypass grafting for:

• Coronary artery disease
• Heart failure
• Angina

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Icahn School of Medicine at Mount Sinai

Collaborator

Trials

933

Recruited

579,000+

Published Research Related to This Trial

In a study of 2,194 patients undergoing isolated coronary artery bypass graft surgery (CABG), women had a significantly higher 30-day mortality rate (7.6%) compared to men (2.8%), indicating that female sex is an independent risk factor for death after this procedure.

Women were generally older and had more comorbidities, such as diabetes and impaired renal function, which may contribute to their increased risk of postoperative complications, including a higher incidence of recent myocardial infarction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Independent predictors of early mortality after coronary artery bypass grafting in a single centre experience--does gender matter? Miśkowiec, DŁ., Walczak, A., Jaszewski, R., et al.[2022]

In a study of 2881 patients undergoing coronary artery bypass grafting (CABG), women experienced significantly higher rates of complications, including left ventricular failure and perioperative myocardial infarction, compared to men (22.1% vs. 16.1% and 5.5% vs. 2.9%, respectively).

The early postoperative mortality rate was also higher in women at 3.6%, compared to 1.6% in men, indicating that women may face greater risks and complications following CABG surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early results of coronary artery bypass graft surgery in women. Czech, B., Kucewicz-Czech, E., Pacholewicz, J., et al.[2010]

Women with coronary heart disease (CHD) face unique challenges, including smaller coronary arteries and atypical symptoms, which can lead to delays in diagnosis and treatment compared to men.

Despite advancements in techniques, women experience higher rates of adverse outcomes after procedures like PCI and CABG, and these interventions are performed less frequently on women, particularly those with high-risk acute coronary syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unique Coronary Artery Disease Differences in Women as Related to Revascularization. Whayne, TF., Mukherjee, D.[2019]

In a study of 17,052 patients, including 3,684 women, it was found that women who underwent off-pump coronary artery bypass (OPCAB) surgery had significantly lower 120-day mortality rates compared to those who had on-pump surgery (ONCAB), suggesting a potential benefit of OPCAB for women.

Both men and women experienced fewer blood transfusions and higher postoperative hemoglobin levels after OPCAB, but the significant reduction in 120-day mortality was unique to women, indicating that OPCAB may be a safer option for female patients undergoing coronary artery bypass grafting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do women benefit more than men from off-pump coronary artery bypass grafting? Ter Woorst, JF., Hoff, AHT., Haanschoten, MC., et al.[2021]

In a study of 5,651 patients with triple-vessel coronary artery disease, older patients (≥74 years) showed a significantly higher mortality risk when undergoing percutaneous coronary intervention (PCI) compared to coronary artery bypass grafting (CABG), with a hazard ratio of 1.40.

The study found no significant difference in mortality risk between PCI and CABG for younger patients (≤65 years) and no notable sex-related differences in outcomes, indicating that age is a critical factor in treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Age and Sex on Clinical Outcomes After Percutaneous Coronary Intervention Relative to Coronary Artery Bypass Grafting in Patients With Triple-Vessel Coronary Artery Disease. Yamaji, K., Shiomi, H., Morimoto, T., et al.[2017]

In a study of 4584 CABG patients, women showed higher hospital mortality rates compared to men, particularly in those receiving single internal mammary artery (SIMA) grafts, but this difference was less pronounced in those receiving bilateral internal mammary artery (BIMA) grafts.

When matched for baseline risk factors, female patients with SIMA grafts had better long-term survival rates than their male counterparts, while long-term survival rates were similar between matched male and female patients with BIMA grafts, suggesting that BIMA grafting may improve outcomes for both genders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral internal mammary artery grafting reverses the negative influence of gender on outcomes of coronary artery bypass grafting surgery. Kurlansky, PA., Traad, EA., Dorman, MJ., et al.[2022]

In a study of 3,153 patients undergoing coronary revascularization, men showed significantly better survival rates and fewer major adverse cardiac events (MACE) with coronary artery bypass grafting (CABG) compared to percutaneous coronary interventions (PCI), while women had similar outcomes with both procedures.

The findings highlight that while men benefit more from CABG over PCI, women's outcomes are generally worse than men's and do not significantly differ between the two procedures, underscoring the need to consider sex differences in treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coronary bypass versus percutaneous intervention: sex matters. The impact of gender on long-term outcomes of coronary revascularization. Kurlansky, P., Herbert, M., Prince, S., et al.[2018]

In a study of 3741 patients undergoing coronary artery bypass grafting (CABG), women were found to have a significantly higher risk of adverse postoperative events, particularly when the myocardium at risk (MAR) was high, with an odds ratio of 1.9.

The severity of MAR was identified as an independent predictor of adverse events specifically in women, indicating that the degree of heart muscle at risk plays a crucial role in the outcomes of female patients undergoing CABG.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Myocardium at risk is associated with adverse clinical events in women but not in men, after coronary artery bypass grafting. Ouzounian, M., Currie, ME., Buth, KJ., et al.[2016]

In a review of 23 randomized controlled trials involving over 10,000 patients, coronary artery bypass graft (CABG) surgery was found to be more effective than percutaneous coronary intervention (PCI) in relieving angina and resulted in fewer repeated revascularization procedures, although it had a higher risk of procedural strokes (1.2% for CABG vs. 0.6% for PCI).

Survival rates after 10 years were similar for both CABG and PCI, with less than a 1% difference, indicating that while CABG may provide better symptom relief, both procedures offer comparable long-term survival outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review: the comparative effectiveness of percutaneous coronary interventions and coronary artery bypass graft surgery. Bravata, DM., Gienger, AL., McDonald, KM., et al.[2022]

In a meta-analysis of 31,115 patients, female patients undergoing off-pump coronary artery bypass grafting (OPCAB) had significantly lower in-hospital mortality rates compared to those undergoing on-pump CABG (ONCAB), with rates of 2.7% versus 3.4%.

The incidence of postoperative stroke was also lower in the OPCAB group (1.2%) compared to the ONCAB group (2.1%), although this difference was not significant after adjusting for cardiovascular risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Female Sex on Short-Term Outcomes of Patients Undergoing Off-Pump Versus On-Pump Coronary Artery Bypass Grafting. Fan, J., Luo, SL., Pan, YC., et al.[2023]

In a study involving 988 participants (206 women and 782 men), coronary artery bypass grafting (CABG) showed greater improvements in cardiac-related health status compared to stent-assisted PCI, particularly in men, at both 6 and 12 months post-procedure.

While CABG was more effective for men in improving physical limitation, angina frequency, and quality of life, the differences in outcomes between CABG and PCI for women diminished significantly by 1 year, suggesting that both procedures may be equally effective for women in the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relative benefit of coronary artery bypass grafting versus stent-assisted percutaneous coronary intervention for angina pectoris and multivessel coronary disease in women versus men (one-year results from the Stent or Surgery trial). Zhang, Z., Weintraub, WS., Mahoney, EM., et al.[2010]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38960512/

Coronary Artery Bypass Graft Failure in Women Women have worse outcomes after coronary artery bypass surgery (CABG) than men. Objectives: This study aimed to determine the incidence of ...

2. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2802105

Operative Outcomes of Women Undergoing Coronary ... Women remain at significantly higher risk for adverse outcomes following coronary artery bypass grafting and no significant improvement has been seen over the ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S277299312300284X

Two Decades of Coronary Artery Bypass Grafting in Women Studies have shown that women have worse outcomes after coronary artery bypass grafting (CABG); it is unclear whether this knowledge has led to improved ...

4. nature.com nature.com/articles/s41598-024-71414-2

A systematic review and meta-analysis of differences ... The short-term mortality risk after CABG is higher in women, compared to men. Women are at higher risk of postoperative stroke.

5. jcvaonline.com jcvaonline.com/article/S1053-0770(24)00831-0/abstract

Outcomes in Women Undergoing Coronary Artery Bypass ... Although evidence has long suggested that women seem to be at significantly increased risk of adverse perioperative outcomes and worse long-term ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39547868/

Outcomes in Women Undergoing Coronary Artery Bypass ... Although evidence has long suggested that women seem to be at significantly increased risk of adverse perioperative outcomes and worse long-term outcomes, ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0735109724072127

Coronary Artery Bypass Graft Failure in Women The majority of the available evidence shows that women have worse outcomes after CABG than men,, and that the excess risk in women has persisted over the past ...

8. academic.oup.com academic.oup.com/eurheartj/article/45/Supplement_1/ehae666.1446/7837518

Long-term outcomes of percutaneous coronary intervention ... In women with severe CAD, CABG appears to be associated with a long-term reduction in MACCE and mortality compared with PCI. Our findings ...

9. jacc.org jacc.org/doi/abs/10.1016/j.jacc.2024.04.046

Coronary Artery Bypass Graft Failure in Women This study aimed to determine the incidence of CABG graft failure in women, its association with cardiac events, and whether it contributes to sex-related ...