Percutaneous Coronary Intervention vs CABG for Diabetes and Coronary Artery Disease

(DEFINE-DM Trial)

Recruiting at 32 trial locations

Overseen By Jung-hee Ham, Project manager

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duk-Woo Park, MD

Must be taking: Insulin, Oral hypoglycemics

Must not be taking: Aspirin, P2Y12 inhibitors

Disqualifiers: Left main disease, Recent MI, Shock, others

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

Compensation: Varies

Number of Visits: 1

Duration: 7 days

1500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which treatment is more effective for individuals with type 2 diabetes and significant three-vessel coronary artery disease (CAD), characterized by severe narrowing in three major heart arteries. The two treatments being compared are percutaneous coronary intervention (PCI), a less invasive procedure using a small tube to open blocked arteries, and coronary artery bypass grafting (CABG), a surgical procedure to bypass blocked arteries. The trial seeks participants with type 2 diabetes who experience chest pain or symptoms of heart issues and have been diagnosed with major blockages in their heart arteries. As an unphased trial, it offers participants the chance to contribute to important research that could enhance treatment options for others with similar health conditions.

Do I need to stop my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

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

Research has shown that people with diabetes and multiple blocked heart vessels (coronary artery disease, or CAD) experience mixed results after percutaneous coronary intervention (PCI). In PCI, doctors use a small tube to open blocked heart vessels. Studies have found that people with diabetes often achieve better outcomes with coronary artery bypass grafting (CABG), a type of heart surgery, compared to PCI.

For instance, one study found that CABG reduced the risk of death by 30% more than PCI. Another study showed that people who underwent CABG lived slightly longer on average than those who had PCI. While PCI is generally safe, evidence suggests that CABG might be more effective in lowering long-term risks for people with diabetes and multiple blocked vessels.

Regarding safety, PCI is usually well-tolerated, but the long-term benefits might not be as strong as with CABG for this group of patients. Patients should consult their doctor to determine the best treatment option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Imaging- and Physiology-Guided State-of-the-Art Percutaneous Coronary Intervention (PCI) for diabetes and coronary artery disease because it offers a more personalized approach to treatment. Unlike the standard Coronary-Artery Bypass Grafting (CABG), which is a more invasive surgery, this new PCI method uses advanced imaging and physiological measurements to precisely target and treat blockages in coronary arteries. This tailored approach could mean less recovery time and potentially fewer complications for patients. By focusing on individual patient anatomy and physiology, this treatment aims to improve outcomes, especially for those with complex conditions like diabetes.

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

This trial will compare two treatment options for individuals with diabetes and severe heart disease affecting three major arteries: Imaging- and Physiology-Guided State-of-the-Art Percutaneous Coronary Intervention (PCI) and Coronary-Artery Bypass Grafting (CABG). Studies have shown that for individuals with diabetes and severe heart disease, heart bypass surgery (CABG) usually yields better outcomes than PCI. Research indicates that diabetic patients undergoing bypass surgery generally have a longer lifespan over five years compared to those undergoing PCI. Additionally, individuals who undergo PCI often require more follow-up procedures than those who have bypass surgery. While PCI is less invasive, for those with diabetes and complex heart issues, bypass surgery may provide better long-term benefits. ^{1 4 5 6 7}

Who Is on the Research Team?

Seung-jung Park, MD

Principal Investigator

Asan Medical Center

Are You a Good Fit for This Trial?

This trial is for people over 20 with type 2 diabetes and multivessel coronary artery disease, who experience angina or signs of reduced blood flow to the heart. They must have a significant narrowing of major heart arteries suitable for both PCI and CABG treatments as assessed by medical experts. Participants need to consent to follow-up checks.

Inclusion Criteria

I am 20 or older with chest pain or signs of heart strain.

I have type 2 diabetes and need medication or have high blood sugar levels.

I have severe blockage in my heart's major arteries, including the LAD, that can be treated with 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 imaging- and physiology-guided percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)

7 days

In-hospital stay for procedure

Follow-up

Participants are monitored for major adverse cardiac or cerebrovascular events and other outcomes

5 years

Regular follow-up visits at 1, 6, 12, 18, 24, 36, 60 months

What Are the Treatments Tested in This Trial?

Interventions

• Standard CABG
• State-of-the-Art Percutaneous Coronary Intervention

Trial Overview The study compares two ways to improve blood flow in the heart's arteries in diabetic patients: state-of-the-art PCI, which involves placing stents without surgery, and standard CABG, which is open-heart surgery to bypass blocked vessels.

How Is the Trial Designed?

Group I: Imaging- and Physiology-Guided State-of-the-Art Percutaneous Coronary Intervention Experimental Treatment 1 Intervention

Group II: Coronary-Artery Bypass Grafting Active Control 1 Intervention

Who Is Running the Clinical Trial?

Duk-Woo Park, MD

Lead Sponsor

Trials

14

Recruited

22,600+

CardioVascular Research Foundation, Korea

Collaborator

Trials

107

Recruited

235,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22513345/

Percutaneous coronary intervention (PCI) versus ... Results showed that five-year mortality was significantly higher in diabetic patients after PCI than after CABG (risk difference (RD) of 7%; P<0.001); repeated ...

2. ahajournals.org ahajournals.org/doi/10.1161/JAHA.124.039663

Percutaneous Coronary Intervention Versus ... Robust literature has identified improved outcomes in patients with 3‐vessel CAD and diabetes undergoing CABG compared with PCI in the short ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11261656/

Current status of percutaneous coronary interventions ... - PMC The study population included 1,900 patients with diabetes and angiographically confirmed multivessel CAD, with stenosis of more than 70% in two or more major ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1109966616302433

Percutaneous coronary intervention vs. cardiac surgery in ... Several studies have compared outcomes in diabetic patients with stable CAD following myocardial revascularization with 1st and 2nd generation drug-eluting ...

5. bmccardiovascdisord.biomedcentral.com bmccardiovascdisord.biomedcentral.com/articles/10.1186/s12872-020-01447-8

Percutaneous coronary intervention in diabetic versus non ... The target of this study was to explore the outcomes of percutaneous coronary intervention (PCI) in diabetic versus non-diabetic patients with prior coronary ...

6. ahajournals.org ahajournals.org/doi/10.1161/circinterventions.114.001944

Percutaneous Coronary Interventions in the Diabetic Patient Patients with diabetes mellitus (DM) have suboptimal outcomes after percutaneous coronary interventions (PCIs).

7. academic.oup.com academic.oup.com/eurheartj/article/43/1/56/6353625

Ten-year all-cause death after percutaneous or surgical ... The mean restricted life expectancy for diabetic patients treated with CABG and PCI was, respectively, 8.41 and 8.08 years (P = 0.551). The treatment effect of ...