← Back to Search

Procedure

Heart Surgery for Coronary Artery Disease

N/A

Recruiting

Led By Stephen Fremes, MD,MSc,FRCSC

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Prognostically important multivessel CAD (triple vessel CAD or double vessel disease including the left anterior descending (LAD) or LM). Significant coronary stenosis is defined as ≥ 70% based on coronary angiography, and/or fractional flow reserve (FFR) ≤0.80 or instantaneous wave-free ratio (iFR) ≤0.89. For LM disease, significant coronary stenosis is defined as >50% based on coronary angiography, intravascular ultrasound (IVUS) minimal luminal area (MLA) ≤6.0 mm2 (<4.5 mm2 Asian descent), or equivalent optical coherence tomography (OCT) measurements

Age >18 years

Must not have

Planned major concomitant surgical procedures (LAAO and AF ablation surgical procedures permitted)

Prohibitive bleeding risk mandating avoidance of dual antiplatelet therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up reported at 1 and 5 years and as a cumulative incidence.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether CABG is better than PCI for reducing death, stroke, heart attack, and heart failure readmission in patients with ischemic cardiomyopathy and coronary artery disease.

Who is the study for?

This trial is for adults over 18 with ischemic cardiomyopathy, specifically those with significant blockages in multiple heart arteries and reduced heart pump function. Participants must have been on guideline-directed medical therapy for at least a month and be deemed suitable for non-emergency artery-opening procedures by their Heart Team.

What is being tested?

The STICH3C trial compares two types of artery-opening procedures: PCI (using catheters to place stents) versus CABG (open-heart surgery to bypass blocked vessels), in patients with weak heart muscles due to blocked arteries. The goal is to see which method better reduces the risk of death, stroke, repeat procedures, or hospital readmission over five years.

What are the potential side effects?

Risks include bleeding, infection, reactions from anesthesia during surgery for CABG; while PCI may cause blood vessel damage or kidney problems related to contrast dye used during the procedure. Both can lead to irregular heartbeats or future blockages.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have severe blockage in multiple heart arteries.

Select...

I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not planning any major surgeries except for LAAO or AF ablation.

Select...

I cannot take certain blood thinners due to a high risk of bleeding.

Select...

I do not have severe organ failure or conditions reducing my life expectancy to under 5 years.

Select...

I had a major heart attack in the last 4 weeks.

Select...

I have been diagnosed with Takotsubo Cardiomyopathy.

Select...

I have a severe heart valve issue or similar condition needing surgery.

Select...

I have had heart surgery before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ reported at 1 and 5 years and as a cumulative incidence.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~reported at 1 and 5 years and as a cumulative incidence.

This trial's timeline: 3 weeks for screening, Varies for treatment, and reported at 1 and 5 years and as a cumulative incidence. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The is a Composite of all-cause mortality, stroke, spontaneous myocardial infarction, urgent repeat revascularization or heart failure readmission.

Secondary study objectives

Composite of death or cardiac hospitalization

Composite of death/stroke/spontaneous MI

Composite of death/stroke/spontaneous MI/RR

+10 more

Other study objectives

Composite of severe stroke/ventilator dependance/new onset or worsening heart failure/ nursing home admission/ or new onset dialysis

Composite of stroke, nursing home admission and 3 or more non-elective admissions per 12 months

Cost-effectiveness

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Revascularization by PCIExperimental Treatment1 Intervention

Revascularization will be attempted on/for significant lesions in major coronary vessels/side branches as planned by the local Heart Team, with the general recommendation of stenotic/occluded vessels with diameter \>2.0 mm for PCI. The Heart Team consists of a minimum of one heart failure cardiologist, one interventional cardiologist and one cardiac surgeon.

Group II: Revascularization by CABGExperimental Treatment1 Intervention

Revascularization will be attempted on/for significant lesions in major coronary vessels/side branches as planned by the local Heart Team, with the general recommendation of stenotic/occluded vessels with diameter \>1.5 mm for CABG. The Heart Team consists of a minimum of one heart failure cardiologist, one interventional cardiologist and one cardiac surgeon

0 / 9Eligibility criteria met