CABG vs PCI for Coronary Artery Disease in Women
(RECHARGE:W Trial)
Recruiting in Palo Alto (17 mi)
+14 other locations
Overseen byMario Gaudino, MD, PhD, MSCE, FEBCTS, FACC
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Weill Medical College of Cornell University
Must be taking: Dual antiplatelet
Disqualifiers: Recent MI, Cardiogenic shock, Pregnancy, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
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.
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.
12345Is 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.
24678How 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.
1491011Eligibility 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.
I am 18 years old or older.
Ability to provide written informed consent and comply with all follow-up procedures, including QOL questionnaires
+1 more
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.
+8 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: RECHARGE:Women - PCIExperimental Treatment1 Intervention
Group II: RECHARGE:Women - CABGExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Emory UniversityAtlanta, GA
Ascension St. Vincent Cardiovascular Research InstituteCarmel, IN
Massachusetts General HospitalBoston, MA
Englewood HospitalEnglewood, NJ
More Trial Locations
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Who Is Running the Clinical Trial?
Weill Medical College of Cornell UniversityLead Sponsor
Patient-Centered Outcomes Research InstituteCollaborator
Icahn School of Medicine at Mount SinaiCollaborator
References
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]Information on the relative benefit of coronary artery bypass grafting (CABG) versus stent-assisted percutaneous coronary intervention (PCI) for improvement of cardiac-related health status in women and how it compares with men is limited. The Stent or Surgery trial compared randomly assigned CABG and stent-assisted PCI in 206 women and 782 men with multivessel disease. We examined longitudinal changes at 6 and 12 months from baseline by gender and treatment in 3 subscales of the Seattle Angina Questionnaire (SAQ): physical limitation, angina frequency, and quality of life. At the time of revascularization, women were older, more severely ill, and tended to have lower SAQ scores than men. At 6 months, SAQ scores after both procedures improved significantly in both genders, with greater improvement achieved with CABG. After adjustment for other factors, in men, CABG was associated with a 54.7% greater improvement in physical limitation compared with PCI, 31.3% greater improvement in angina frequency, and 18.3% greater improvement in quality of life. In women, these relative differences were 11.6%, 43.2%, and 39.3%, respectively. At 1 year, men continued to show greater improvement with CABG in all 3 dimensions (50.6%, 19.7%, and 15.3%, respectively), but in women the relative differences decreased substantially (1.6%, 11.1%, and 0.6%, respectively) due to a greater later improvement after PCI (p = 0.049 for the interaction among treatment, gender, and follow-up for the quality of life domain). Although CABG may be superior to PCI in men, in women, at 1 year after intervention, both procedures appear equally effective.
Coronary bypass versus percutaneous intervention: sex matters. The impact of gender on long-term outcomes of coronary revascularization. [2018]Women have a higher mortality than men following coronary artery bypass grafting (CABG). The influence of patient sex on outcomes of percutaneous coronary interventions (PCI) is controversial. Since patient selection for randomized clinical trials may not reflect clinical practice, we investigated the impact of sex on outcomes of CABG versus PCI in a comprehensive registry of coronary revascularization (CR).
Do women benefit more than men from off-pump coronary artery bypass grafting? [2021]Outcomes after coronary artery bypass grafting (CABG) are worse in women than in men. This study aims to investigate whether off-pump coronary artery bypass (OPCAB) surgery improves the outcomes in women by comparing different outcome measures in both genders.
Bilateral internal mammary artery grafting reverses the negative influence of gender on outcomes of coronary artery bypass grafting surgery. [2022]Coronary artery bypass grafting (CABG) has historically demonstrated higher hospital mortality in women compared with men. The influence of gender on long-term outcomes has not been clearly defined.
Systematic review: the comparative effectiveness of percutaneous coronary interventions and coronary artery bypass graft surgery. [2022]The comparative effectiveness of coronary artery bypass graft (CABG) surgery and percutaneous coronary intervention (PCI) for patients in whom both procedures are feasible remains poorly understood.
Independent predictors of early mortality after coronary artery bypass grafting in a single centre experience--does gender matter? [2022]It is commonly believed that women undergoing isolated coronary artery bypass graft surgery (CABG) are subject to a higher risk of perioperative complications and death.
The Effect of Female Sex on Short-Term Outcomes of Patients Undergoing Off-Pump Versus On-Pump Coronary Artery Bypass Grafting. [2023]According to the American Heart Association guideline for coronary artery bypass grafting (CABG), female patients undergoing on-pump CABG (ONCAB) are at higher risk of short-term adverse outcomes than male patients. However, whether off-pump CABG (OPCAB) can improve the short-term outcome of female patients compared to ONCAB remains unclear.
Myocardium at risk is associated with adverse clinical events in women but not in men, after coronary artery bypass grafting. [2016]Women undergoing coronary artery bypass grafting (CABG) are at increased risk for morbidity and mortality. Factors responsible for this observation include smaller coronary size and delayed presentation. To date, no studies have examined the effect of the degree of myocardium at risk (MAR) on the relationship between female sex and adverse postoperative events.
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]Age and sex are important considerations in the choice between percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) in daily clinical practice.
Unique Coronary Artery Disease Differences in Women as Related to Revascularization. [2019]There are significant differences in coronary heart disease (CHD) in women whenever a comparison is made to men and these carry over to revascularization procedures including percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) surgery. The coronary arteries of women are smaller, which presents additional challenges for PCI and CABG procedures. Unique atypical symptomatology in response to acute coronary syndrome (ACS) in women can confound diagnosis, women notoriously delay seeking medical help for ACS, and physicians and other caregivers have had a tendency to minimize the significance of these symptoms, contributing further to a delay in necessary care. There also appears to be an increased association of inflammation and CHD in women. The younger the female patient with CHD, the higher the mortality and that mortality clearly exceeds that of comparable male patients. For cardiovascular (CV) risk prevention in women, statins have had controversy associated with their use but overall, the proof of beneficial outcomes results from statins is also valid in women. An increased rate of adverse outcomes has been reported in women after PCI and CABG surgery. These worse clinical outcomes have persisted in contemporary years but lessened due to advancement in invasive techniques. Nevertheless, PCI that could improve clinical outcomes in women who have high-risk ACS is, unfortunately, performed on a less frequent basis and, in addition, there are greater delays involving women as compared to men. With increased clinical comorbidity associated with complex CHD in women, a lower anatomical SYNTAX score (from: SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery [SYNTAX] trial) appears necessary in order for women to achieve a similar long-term mortality benefit from CABG surgery as compared to PCI.
Early results of coronary artery bypass graft surgery in women. [2010]Coronary artery disease is one of the leading causes of death among women in developed countries all over the world. Coronary artery bypass grafting (CABG) is a well established therapeutic modality to treat diffuse coronary artery atherosclerosis.