Revascularization Procedures for Coronary Artery Disease

(RECHARGE:M Trial)

Recruiting at 17 trial locations

Overseen By Gregg Stone, MD, FACC, MSCAI

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Weill Medical College of Cornell University

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: 32

Duration: 1 month

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods to improve blood flow in individuals with coronary artery disease, a condition where the heart's arteries are blocked. One method, percutaneous coronary intervention (PCI), involves inserting a small tube through the wrist or groin to clear and support the artery. The other method, coronary artery bypass grafting (CABG) or open-heart surgery, involves bypassing the blockage using healthy blood vessels from other parts of the body. The study aims to determine which method helps people live longer and feel better. This trial may be suitable for minorities with multiple blocked heart arteries who have not recently undergone major heart procedures. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to important research that could enhance treatment options.

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 coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) have specific safety profiles.

For CABG, studies indicate it is generally safe, with less than 2.1% of patients experiencing in-hospital death. However, about 14% of patients may have complications within 30 days, with higher risks for certain groups, such as Black patients and those from low-income areas.

For PCI, research highlights its widespread use but also certain risks. Over time, more PCI patients tend to face issues compared to those who have CABG. Specifically, one study found that more PCI patients died from any cause over five years than those who had CABG (13% vs. 9.9%).

Both procedures are common and have been used for many years, each with its own risks and benefits. Discussing with a doctor can help determine which option might be best based on individual health and needs. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these revascularization procedures because they focus on tailoring treatment for coronary artery disease in minority populations, which have historically been underrepresented in clinical trials. Coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) are well-established treatments, but this trial aims to explore their effectiveness and outcomes specifically within diverse groups. By understanding how these procedures affect different demographics, researchers hope to optimize treatment plans and improve outcomes for all patients, addressing potential disparities in cardiac care.

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

This trial will compare coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) for coronary artery disease. Studies have shown that CABG can help people with blocked heart arteries live longer and feel better, often resulting in better long-term survival compared to other treatments. Evidence indicates that PCI can lower the risk of dying from heart problems and reduce the chance of a heart attack after treatment. Both treatments aim to improve blood flow to the heart and have proven effective, each with its own strengths. CABG usually offers better results for complicated cases, while PCI is less invasive and can be a good choice for some patients. Participants in this trial will receive either the CABG or PCI treatment to evaluate these outcomes. ^{2 3 6 7 8}

Who Is on the Research Team?

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

Principal Investigator

Weill Medical College of Cornell University

Gregg Stone, MD, FACC, MSCAI

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

The RECHARGE trial is for minority individuals at least 18 years old with multivessel or left main coronary artery disease (CAD), where a heart team believes both stenting and bypass surgery could work. Participants must be able to give consent and complete quality-of-life questionnaires.

Inclusion Criteria

I identify as a member of a minority group.

I can sign consent and follow all study requirements.

I have been diagnosed with severe coronary artery disease and am considered for surgery or stenting.

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

5-10 years

Telephone follow-up at 30 days, 3 months, 6 months, and every 6 months through 36 months, then annually

Annual Assessment

Annual assessments including echocardiogram and blood tests for serum creatinine, hemoglobin, and lipids

Annually

1 visit (in-person or outpatient)

What Are the Treatments Tested in This Trial?

Interventions

• Coronary artery bypass grafting
• Percutaneous coronary intervention

Trial Overview This study compares two heart procedures in minorities: one uses stents to open blockages via an incision in the wrist or groin, while the other is open-heart surgery using vessels from elsewhere in the body to bypass blockages.

How Is the Trial Designed?

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

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

Coronary artery bypass grafting is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:

Approved in United States as CABG for:

• Coronary artery disease
• Heart failure
• Angina pectoris

Approved in European Union as CABG for:

• Coronary artery disease
• Heart failure
• Angina pectoris

Approved in Canada as CABG for:

• Coronary artery disease
• Heart failure
• Angina pectoris

Approved in Japan as CABG for:

• Coronary artery disease
• Heart failure
• Angina pectoris

Approved in China as CABG for:

• Coronary artery disease
• Heart failure
• Angina pectoris

Approved in Switzerland as CABG for:

• Coronary artery disease
• Heart failure
• Angina pectoris

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

After the introduction of public reporting and drug-eluting stents in 2003, in-hospital mortality and 1-year mortality rates for coronary artery bypass grafting (CABG) decreased, while mortality rates after percutaneous coronary intervention (PCI) remained unchanged.

Overall, the volume of coronary interventions in California decreased significantly, but the rates of adverse cardiovascular and cerebral events also declined, leading to an estimated reduction of over 6,000 adverse events annually by the end of the decade.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events after coronary revascularization procedures in California 2000 to 2010. Rudersdorf, PD., Abolhoda, A., Carey, JS., et al.[2013]

New surgical techniques for coronary artery disease revascularization aim to reduce the negative effects linked to traditional bypass surgery and cardiopulmonary bypass, enhancing patient safety.

The article discusses various innovative methods, such as minimally invasive direct coronary artery bypass and transmyocardial revascularization, while also highlighting important nursing considerations for each approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in the surgical treatment of coronary artery disease. Acorda, R., Kraus, T., Casey, PE.[2005]

In a study of 361 patients with acute coronary syndromes, those who underwent percutaneous coronary intervention (PCI) had a lower overall mortality rate (3.5%) compared to those who had coronary artery bypass grafting (CABG) (9.1%), indicating PCI may be a safer option for these patients.

While CABG patients experienced fewer episodes of unstable angina and required less repeat revascularization, PCI patients had a higher rate of cardiovascular hospitalizations, suggesting that while PCI may be safer in terms of mortality, CABG may offer better long-term stability in certain cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Percutaneous and surgical revascularization in acute coronary syndromes without persistent ST segment elevation. One-year outcome of 361 patients assigned to early invasive strategy]. Szyguła-Jurkiewicz, B., Wilczek, K., Przybylski, R., et al.[2010]

Coronary stenting and bypass surgery provide similar protection against major adverse cardiac events (like death, stroke, and heart attacks) after one year, based on a study of 1205 patients.

While stenting is initially less expensive and has similar outcomes, it leads to a higher rate of repeat procedures (16.8% for stenting vs. 3.5% for surgery), which can increase overall costs over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of coronary-artery bypass surgery and stenting for the treatment of multivessel disease. Serruys, PW., Unger, F., Sousa, JE., et al.[2010]

In a study of 583 patients with left main coronary artery disease and acute coronary syndromes, those treated with percutaneous coronary intervention (PCI) experienced significantly higher rates of major adverse cardiac events (MACEs) at 1 year compared to those treated with coronary artery bypass grafting (CABG) (14.4% vs 5.3%).

The increased risk of MACEs in the PCI group was primarily due to a higher rate of target lesion revascularization (8.1% vs 1.7%), while no significant differences were found in mortality or myocardial infarction rates between the two treatment methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of one-year outcomes of percutaneous coronary intervention versus coronary artery bypass grafting in patients with unprotected left main coronary artery disease and acute coronary syndromes (from the CUSTOMIZE Registry). Caggegi, A., Capodanno, D., Capranzano, P., et al.[2011]

In a study of 1680 patients with multivessel coronary artery disease, coronary artery bypass grafting (CABG) significantly reduced the rate of major adverse cardiovascular and cerebrovascular events compared to percutaneous coronary intervention (PCI) with drug-eluting stents, especially in patients with diabetes.

CABG showed a lower unadjusted event rate of 9.7% for 2-vessel disease and 10.8% for 3-vessel disease, compared to 21.2% and 28.4% for PCI, respectively, suggesting that CABG may be the preferred treatment for diabetic patients with multivessel disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of coronary artery bypass grafting versus percutaneous coronary intervention with drug-eluting stents for patients with multivessel coronary artery disease. Javaid, A., Steinberg, DH., Buch, AN., et al.[2010]

In a study of 220 patients with prior coronary artery bypass graft (CABG) surgery, those who underwent secondary percutaneous coronary intervention (PCI) on graft vessels (GV) experienced significantly higher rates of target vessel revascularization (12.5%) compared to those treated on native vessels (NV) (3.6%), indicating worse long-term outcomes for GV PCI.

The median survival time was lower for patients undergoing PCI on graft vessels (315 months) compared to those on native vessels (372 months), suggesting that targeting native vessels may be a safer and more effective strategy for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Superior long term outcome associated with native vessel versus graft vessel PCI following secondary PCI in patients with prior CABG. Mavroudis, CA., Kotecha, T., Chehab, O., et al.[2017]

In a meta-analysis of over 2,000 patients, both minimally invasive direct coronary artery bypass graft surgery (MIDCABG) and percutaneous coronary intervention (PCI) showed comparable midterm mortality rates, indicating similar safety profiles for both procedures.

However, MIDCABG resulted in significantly lower rates of angina recurrence and the need for target vessel reinterventions compared to PCI, even when using drug-eluting stents, suggesting that MIDCABG may offer better long-term efficacy for patients with proximal LAD disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimally invasive direct coronary artery bypass graft surgery or percutaneous coronary intervention for proximal left anterior descending artery stenosis: a meta-analysis. Deo, SV., Sharma, V., Shah, IK., et al.[2018]

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]

Coronary angioplasty is preferred for treating single coronary lesions, while coronary artery bypass surgery is the best option for multivessel disease, although there are specific cases where bypass is favored, such as proximal left anterior descending lesions.

The choice between angioplasty and bypass surgery is based on a combination of clinical, anatomical, and physiological factors, highlighting the importance of a collaborative approach between medical and surgical teams.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Bypass surgery vs angioplasty for coronary artery disease]. Legrand, V., Martinez, C.[2015]

Modern treatment of coronary artery disease (CAD) emphasizes a patient-centered approach, incorporating new technologies and techniques to improve safety and efficacy in surgical interventions.

Innovative methods such as off-pump coronary artery bypass grafting, minimally invasive procedures, and robotic revascularization are being explored, with ongoing discussions about their effectiveness and future challenges in the field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic CABG and Hybrid Approaches: The Current Landscape. Ejiofor, JI., Leacche, M., Byrne, JG.[2015]

Recent changes in the patient population undergoing coronary artery bypass surgery have led to a greater focus on using arterial grafts, which may offer better long-term outcomes compared to traditional vein grafts.

Surgeons are increasingly employing endarterectomy techniques to revascularize vessels with extensive distal disease, aiming for more comprehensive and durable revascularization in patients with coronary artery disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Newer surgical techniques in myocardial revascularization. Everson, CT., Mills, NL.[2004]

The paper outlines various surgical techniques for treating coronary heart disease, emphasizing the importance of selecting appropriate bypass materials and surgical instruments for successful outcomes.

It also discusses critical aspects of the surgery, such as intraoperative monitoring and management of complications like myocardial infarction, which are essential for ensuring patient safety and improving recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Surgical treatment in coronary heart disease (author's transl)]. Dittrich, H.[2019]

In a study of over 189,000 Medicare patients with stable multivessel coronary disease, coronary artery bypass grafting (CABG) showed a lower risk of myocardial infarction (MI) at 4 years (3.2% for CABG vs. 6.6% for PCI), indicating better long-term heart health outcomes with CABG.

While CABG had a higher 30-day stroke rate, leading to an overall higher stroke incidence (4.5% for CABG vs. 3.1% for PCI), the composite risk of death, MI, or stroke was lower for CABG (21.6%) compared to PCI (26.7%), suggesting CABG may be the preferred option for long-term survival despite the initial stroke risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Composite outcomes in coronary bypass surgery versus percutaneous intervention. Edwards, FH., Shahian, DM., Grau-Sepulveda, MV., et al.[2021]

In a study of 4616 patients with multivessel disease and severe left ventricular systolic dysfunction, PCI with everolimus-eluting stents showed similar long-term survival rates compared to CABG, indicating its efficacy as a treatment option.

While PCI had a lower risk of stroke in the short term, it was associated with a higher risk of myocardial infarction and repeat revascularization in the long term, especially in cases of incomplete revascularization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Revascularization in Patients With Multivessel Coronary Artery Disease and Severe Left Ventricular Systolic Dysfunction: Everolimus-Eluting Stents Versus Coronary Artery Bypass Graft Surgery. Bangalore, S., Guo, Y., Samadashvili, Z., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1994021/

Outcomes of coronary artery bypass graft surgery - PMC The overall 5-year cumulative survival rates in the medically assigned group (92%) and the surgically assigned group (95%) were similar. No significant ...

2. ccjm.org ccjm.org/content/92/3/181

Coronary artery bypass grafting: Practice trends and ... Coronary artery bypass grafting (CABG) is performed in patients with ischemic heart disease to improve symptoms, quality of life, and life expectancy.

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.124.068312

Coronary Artery Bypass Grafting: Past and Future Coronary artery bypass grafting (CABG) improves survival relative to medical therapy and percutaneous coronary intervention (PCI) in stable ...

4. annalscts.com annalscts.com/article/view/17136/html

The outcomes of robotic-assisted coronary artery bypass ... Actuarial survival at yearly assessment from 12- to 60-month intervals was determined to be 95%, 94%, 92%, 90%, and 88%, respectively.

5. nature.com nature.com/articles/s41598-023-49069-2

Comparing outcomes between coronary artery bypass ... CABG appears superior to PCI over time in octogenarians with complex CAD. This survival advantage is associated with fewer events of MI and RR.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11591588/

Investigating outcomes of coronary artery bypass graft (CABG ... Still, CABG is a high-risk procedure with a 30-day morbidity rate of 14%. Almost 14% of Medicare post-CABG patients are readmitted within 30 ...

7. opencardiovascularmedicinejournal.com opencardiovascularmedicinejournal.com/VOLUME/18/ELOCATOR/e18741924331868/FULLTEXT/

Long-term Outcomes of Coronary Artery Bypass Grafting ... This study aims to compare the efficacy and safety of surgical myocardial revascularization using CABG vs. staged HCR.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11696952/

Outcomes among patients with coronary artery bypass ... The group treated with redo-CABG demonstrated 13% mortality in the first year; however, for those who survived this initial postoperative period ...