Revascularization Procedures for Coronary Artery Disease

(RECHARGE:M Trial)

Recruiting at 13 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

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. It's best to discuss this with the trial coordinators or your doctor.

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

Research shows that for patients with multiple blocked heart arteries, coronary artery bypass grafting (CABG) often leads to better long-term survival compared to percutaneous coronary intervention (PCI), which includes procedures like stenting. ^{1 2 3 4 5}

Is coronary revascularization generally safe for humans?

Coronary revascularization procedures like coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) have been widely studied and are generally considered safe, though they can have some risks. Studies show that adverse events can occur, but these procedures are well-established for treating coronary artery disease and acute coronary syndromes. ^{6 7 8 9 10}

How is the treatment of coronary artery disease with CABG and PCI different from other treatments?

CABG (Coronary Artery Bypass Grafting) and PCI (Percutaneous Coronary Intervention) are unique because they are surgical procedures specifically designed to improve blood flow to the heart. CABG is often used for more complex cases involving multiple blocked arteries, while PCI is typically used for single blockages and involves less invasive techniques like stenting. These treatments are chosen based on the specific needs of the patient and the complexity of their coronary artery disease. ^{11 12 13 14 15}

What is the purpose of this trial?

This is a research study in minorities 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

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

Eligibility Criteria

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

I can sign consent and follow all study requirements.

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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 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 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 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 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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Composite outcomes in coronary bypass surgery versus percutaneous intervention. [2021]

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

Comparison of coronary-artery bypass surgery and stenting for the treatment of multivessel disease. [2010]

3. United States 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. [2010]

4. United States 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. [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. Netherlands 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. [2018]

7. United States 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). [2011]

8. Netherlands 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. [2017]

9. Poland 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]. [2010]

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

Adverse events after coronary revascularization procedures in California 2000 to 2010. [2013]

11. Belgium pubmed.ncbi.nlm.nih.gov

[Bypass surgery vs angioplasty for coronary artery disease]. [2015]

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

Robotic CABG and Hybrid Approaches: The Current Landscape. [2015]

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

Advances in the surgical treatment of coronary artery disease. [2005]

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

Newer surgical techniques in myocardial revascularization. [2004]

15. Germany pubmed.ncbi.nlm.nih.gov

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