CABG vs PCI for Coronary Artery Disease in Women

(RECHARGE:W Trial)

Recruiting at 14 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

Trial Summary

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.

What data supports the effectiveness of the treatment for coronary artery disease in women?

Research shows that both coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) improve heart-related health in women with coronary artery disease. At one year after treatment, both procedures appear equally effective in women, with CABG showing slightly better early improvements in some areas. ^{1 2 3 4 5}

Is coronary artery bypass grafting (CABG) safe for women?

Research indicates that women undergoing coronary artery bypass grafting (CABG) may face higher risks of complications and mortality compared to men. Factors such as smaller coronary size and delayed presentation contribute to these risks. ^{2 4 6 7 8}

How do CABG and PCI treatments differ for coronary artery disease in women?

CABG (Coronary Artery Bypass Grafting) and PCI (Percutaneous Coronary Intervention) are both treatments for coronary artery disease, but they differ in approach. CABG involves surgery to create a new path for blood flow around blocked arteries, while PCI uses a catheter to place a stent and open up the artery. In women, both treatments show similar effectiveness after one year, although CABG may initially offer greater improvement in symptoms. ^{1 4 9 10 11}

What is the purpose of this trial?

This is a research study in women to compare the outcomes of two procedures that restore blood flow to the arteries of the heart. In one procedure the blockages are ballooned and then stented with a small wire mesh tube through a small incision in the wrist or the groin. The other procedure is an open-heart operation in which healthy blood vessels from inside the chest, leg, and/or forearm are used to "bypass" the blockages (like a detour). Outcomes will be measured by comparing survival and improvement in quality-of-life.

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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 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 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 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 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 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]

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 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]

References

1. United States 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). [2010]

2. Germany pubmed.ncbi.nlm.nih.gov

Coronary bypass versus percutaneous intervention: sex matters. The impact of gender on long-term outcomes of coronary revascularization. [2018]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Do women benefit more than men from off-pump coronary artery bypass grafting? [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

Bilateral internal mammary artery grafting reverses the negative influence of gender on outcomes of coronary artery bypass grafting surgery. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Systematic review: the comparative effectiveness of percutaneous coronary interventions and coronary artery bypass graft surgery. [2022]

6. Poland pubmed.ncbi.nlm.nih.gov

Independent predictors of early mortality after coronary artery bypass grafting in a single centre experience--does gender matter? [2022]

7. Brazil 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. [2023]

8. England 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. [2016]

9. United States 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. [2017]

10. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Unique Coronary Artery Disease Differences in Women as Related to Revascularization. [2019]

11. Poland pubmed.ncbi.nlm.nih.gov

Early results of coronary artery bypass graft surgery in women. [2010]