PCI Revascularization Strategies for Coronary Artery Disease

Recruiting at 49 trial locations

Overseen By Jolanda Pol-van der Velde, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Diagram B.V.

Disqualifiers: CABG, Severe valvular disease, Renal insufficiency, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

1222 Participants Needed

Trial Summary

What is the purpose of this trial?

The COMBINE-INTERVENE Trial will investigate whether a PCI revascularization strategy based on combined FFR and OCT assessment is superior to a PCI revascularization strategy based on FFR-alone in patients with MVD with any presentation.

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

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What data supports the effectiveness of the PCI revascularization strategy based on FFR and OCT assessment for coronary artery disease?

Research shows that using fractional flow reserve (FFR) to guide PCI (a procedure to open blocked heart arteries) improves patient outcomes by accurately identifying which blockages need treatment. Optical coherence tomography (OCT) provides detailed images of the arteries, which can help in making more precise treatment decisions. ^{1 2 3 4 5}

Is PCI revascularization safe for humans?

Studies show that using FD-OCT and FFR in PCI procedures is generally safe, with no related cardiac adverse events reported during trials. These methods help guide treatment and improve outcomes by identifying issues like stent malapposition, which can be corrected during the procedure. ^{6 7 8 9 10}

How does the PCI revascularization strategy based on FFR and OCT differ from other treatments for coronary artery disease?

This treatment is unique because it combines FFR (fractional flow reserve), which measures blood flow to determine the significance of a coronary artery blockage, with OCT (optical coherence tomography), which provides detailed images of the artery's interior. This dual approach aims to improve the accuracy of identifying which blockages need treatment, potentially leading to better outcomes compared to using either method alone or traditional angiography. ^{1 3 11 12 13}

Research Team

Elvin Kedhi, Prof.dr.

Principal Investigator

Professor of Medicine McGill University; Director Intervention Cardiology, McGill University Health Center, Canada; Visiting Professor, Silesian Medical University Katowice, Poland

Eligibility Criteria

This trial is for individuals aged 30-80 with multiple vessel coronary artery disease who are undergoing PCI. They must have at least two new blockages in different arteries suitable for PCI, as determined by a heart team. The blockages should be significant but the blood flow through them must still be normal.

Inclusion Criteria

I. DS ≥ 50% on visual estimation II. de novo lesion located in native (non-grafted) vessel III. lesion reference diameter of ≥ 2.0 mm IV. Thrombolysis In Myocardial Infarction (TIMI) 3 flow in all vessels (with exclusion of culprit lesions if MI at presentation)

I am between 30 and 80 years old and am having a PCI procedure.

I have at least 2 target lesions or 1 culprit and 1 target lesion for FFR.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo PCI revascularization strategy based on combined FFR and OCT assessment or FFR-alone

12 weeks

Follow-up

Participants are monitored for cardiac death, myocardial infarction, or revascularization events

24 months

Treatment Details

Interventions

• PCI revascularization strategy based FFR assessment
• PCI revascularization strategy based on combined FFR and OCT assessment

Trial Overview The COMBINE-INTERVENE Trial is testing if using both FFR (a pressure wire test) and OCT (an imaging test) to guide where stents should go during PCI is better than just using FFR alone in patients with multiple blocked arteries.

Participant Groups

Group I: MVD > 2 50% angiographic stenosis PCI revascularization strategy based FFR and OCT assessment Experimental Treatment 1 Intervention

MVD \> 2 50% angiographic stenosis PCI revascularization strategy based FFR and OCT assessment

Group II: MVD > 2 50% angiographic stenosis PCI revascularization strategy based FFR assessment (and sham OCT) Placebo Group 1 Intervention

MVD \> 2 50% angiographic stenosis PCI revascularization strategy based FFR assessment (and sham OCT)

Who Is Running the Clinical Trial?

Diagram B.V.

Lead Sponsor

Trials

15

Recruited

8,800+

Abbott

Industry Sponsor

Trials

760

Recruited

489,000+

Dr. Etahn Korngold

Abbott

Chief Medical Officer

MD, Harvard Medical School

Robert B. Ford

Abbott

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Findings from Research

In a study of 562 patients with acute myocardial infarction and multivessel disease, 30% of those undergoing angiography-guided PCI received unnecessary treatment for non-infarct-related arteries (non-IRA) that had a quantitative flow ratio (QFR) greater than 0.80, indicating they did not need intervention.

Patients who underwent unnecessary PCI for non-IRA lesions had a significantly higher rate of major adverse cardiac events (MACEs) at 12.9% compared to just 3.1% in those who deferred treatment, highlighting the risks associated with unnecessary procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

QFR Assessment and Prognosis After Nonculprit PCI in Patients With Acute Myocardial Infarction. Lee, SH., Hong, D., Shin, D., et al.[2023]

References

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

Optical coherence tomography compared with fractional flow reserve guided approach in acute coronary syndromes: A propensity matched analysis. [2018]

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

Outcomes of Functionally Complete vs Incomplete Revascularization: Insights From the FAVOR III China Trial. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Myocardial fractional flow reserve. Its role in guiding PCI in stable coronary artery disease. [2021]

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

Projected costs and consequences of computed tomography-determined fractional flow reserve. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Fractional flow reserve (FFR) as a guide to treat coronary artery disease. [2018]

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

Unrestricted utilization of frequency domain optical coherence tomography in coronary interventions. [2021]

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

Very long-term clinical follow-up after fractional flow reserve-guided coronary revascularization. [2022]

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

Fractional flow reserve-guided coronary bypass surgery: should surgeons use it? [2022]

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

Fractional Flow Reserve following Percutaneous Coronary Intervention. [2020]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Prognostic Value of Post-PCI Angiography-Derived Fractional Flow Reserve: A Systematic Review and Meta-Analysis of Cohort Studies. [2023]

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

QFR Assessment and Prognosis After Nonculprit PCI in Patients With Acute Myocardial Infarction. [2023]

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

Long-term clinical outcome after fractional flow reserve- versus angio-guided percutaneous coronary intervention in patients with intermediate stenosis of coronary artery bypass grafts. [2016]

13. England pubmed.ncbi.nlm.nih.gov

Fractional flow reserve versus angiography for guiding percutaneous coronary intervention: a meta-analysis. [2018]