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NCT03089398

Hybrid Coronary Revascularization Trial

Completed NA Results posted Last updated 23 May 2025
What this trial tests

NA trial testing Hybrid Coronary Revascularization (isolated LIMA-LAD) in Coronary Artery Disease in 200 participants. Completed in 30 September 2021.

Timeline
9 October 2017
Primary endpoint
31 March 2021
30 September 2021

Quick facts

Lead sponsorEmilia Bagiella
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment200
Start date9 October 2017
Primary completion31 March 2021
Estimated completion30 September 2021
Sites46 locations across Canada, United States

Drugs / interventions tested

Conditions studied

Sponsor

Emilia Bagiella

Who can join

18 and older, any sex, with Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Major Adverse Coronary and Cerebrovascular Events (MACCE) Primary · Up to 24 months

The current sample size of 200 patients will not provide sufficient power to test the original null hypothesis of the trial. However, it will allow for an estimate of the MACCE rate in the two groups. A 2-year follow-up will be used to capture and understand the difference in MACCE between the two procedures. This reasoning is based on the NHLBI-funded Hybrid Revascularization Observational Study (ClinicalTrials.gov Identifier NCT01121263), which enrolled 200 HCR and 98 multi-vessel PCI with drug-eluting stent (DES) patients, and demonstrated similar risk-adjusted MACCE rates over the first 12

GroupValue95% CI
Hybrid Coronary Revascularization Group0.1300.080 – 0.211
Percutaneous Coronary Intervention0.1110.073 – 0.167
Hemoglobin Levels Secondary · Up to 90 days post-randomization

For HCR patients, lab values are pre- and post-CABG. For PCI patients, lab values are pre- and post- the last PCI.

Pre-Procedure
GroupValue95% CI
Hybrid Coronary Revascularization Group13.9512.80 – 15.20
Percutaneous Coronary Intervention13.4012.20 – 14.70
Post-Procedure
GroupValue95% CI
Hybrid Coronary Revascularization Group10.959.90 – 12.30
Percutaneous Coronary Intervention12.9011.80 – 14.10
Creatinine Levels Secondary · Up to 90 days post-randomization

For HCR patients, lab values are pre- and post-CABG. For PCI patients, lab values are pre- and post- the last PCI.

Pre-Procedure
GroupValue95% CI
Hybrid Coronary Revascularization Group0.950.82 – 1.14
Percutaneous Coronary Intervention0.950.81 – 1.11
Post-Procedure
GroupValue95% CI
Hybrid Coronary Revascularization Group1.030.89 – 1.22
Percutaneous Coronary Intervention0.930.80 – 1.17
CK-MB Levels (ng/dL) Secondary · Up to 90 days post-randomization

For HCR patients, lab values are pre- and post-CABG. For PCI patients, lab values are pre- and post- the last PCI.

Pre-Procedure
GroupValue95% CI
Hybrid Coronary Revascularization Group0.900.50 – 1.20
Percutaneous Coronary Intervention1.801.15 – 3.15
Post-Procedure
GroupValue95% CI
Hybrid Coronary Revascularization Group2.792.20 – 4.90
Percutaneous Coronary Intervention3.752.60 – 8.30
CK-MB Levels (IU/L) Secondary · Up to 90 days post-randomization

For HCR patients, lab values are pre- and post-CABG. For PCI patients, lab values are pre- and post- the last PCI.

Pre-Procedure
GroupValue95% CI
Hybrid Coronary Revascularization Group72.0039.00 – 118.00
Percutaneous Coronary Intervention62.0033.00 – 96.50
Post-Procedure
GroupValue95% CI
Hybrid Coronary Revascularization Group311.0062.55 – 1045.00
Percutaneous Coronary Intervention77.0044.00 – 119.50
Troponin Levels Secondary · Up to 90 days post-randomization

For HCR patients, lab values are pre- and post-CABG. For PCI patients, lab values are pre- and post- the last PCI.

Pre-Procedure Troponin I
GroupValue95% CI
Hybrid Coronary Revascularization Group0.030.01 – 0.18
Percutaneous Coronary Intervention0.030.01 – 0.12
Post-Procedure Troponin I
GroupValue95% CI
Hybrid Coronary Revascularization Group0.300.13 – 0.97
Percutaneous Coronary Intervention0.170.03 – 0.81
Pre-Procedure Troponin T
GroupValue95% CI
Hybrid Coronary Revascularization Group0.030.02 – 0.31
Percutaneous Coronary Intervention0.010.01 – 0.03
Post-Procedure Troponin T
GroupValue95% CI
Hybrid Coronary Revascularization Group0.050.01 – 0.34
Percutaneous Coronary Intervention0.010.01 – 0.35
Number of Participants Requiring Medications Secondary · 24 Hours Prior to, During, and Within 24 Hours of the Procedure

For HCR patients, medications are prior/during/after CABG. For PCI patients, medications are prior/during/after the last PCI. Number of participants requiring medications at any time 24 Hours Prior to, During, and Within 24 Hours of the Procedure. Procedures can occur up to 90 days after randomization.

Antiplatelets
GroupValue95% CI
Hybrid Coronary Revascularization Group74
Percutaneous Coronary Intervention101
Anticoagulants
GroupValue95% CI
Hybrid Coronary Revascularization Group53
Percutaneous Coronary Intervention66
Beta Blockers
GroupValue95% CI
Hybrid Coronary Revascularization Group73
Percutaneous Coronary Intervention65
ACE Inhibitors or ARBs
GroupValue95% CI
Hybrid Coronary Revascularization Group22
Percutaneous Coronary Intervention37
Diuretics
GroupValue95% CI
Hybrid Coronary Revascularization Group25
Percutaneous Coronary Intervention18
Statins
GroupValue95% CI
Hybrid Coronary Revascularization Group71
Percutaneous Coronary Intervention79
Number of Participants Requiring Transfusion Secondary · Up to 90 days post-randomization

Number of participants requiring transfusion during procedure and after procedure

Transfusion Intra-Procedure
GroupValue95% CI
Hybrid Coronary Revascularization Group3
Percutaneous Coronary Intervention1
Transfusion Post-Procedure
GroupValue95% CI
Hybrid Coronary Revascularization Group6
Percutaneous Coronary Intervention1
Length of Stay Secondary · Up to 90 days post-randomization

Length of stay for all study procedures combined, beginning at date of procedure

GroupValue95% CI
Hybrid Coronary Revascularization Group7.006.00 – 9.00
Percutaneous Coronary Intervention2.002.00 – 4.00
Discharge Disposition Secondary · Up to 90 days post-randomization

Discharge disposition is for the last study procedure

Home
GroupValue95% CI
Hybrid Coronary Revascularization Group76
Percutaneous Coronary Intervention105
Extended Care/Transitional Care Unit/Rehab
GroupValue95% CI
Hybrid Coronary Revascularization Group5
Percutaneous Coronary Intervention3
Other Acute Care Hospital
GroupValue95% CI
Hybrid Coronary Revascularization Group0
Percutaneous Coronary Intervention1
Nursing Home
GroupValue95% CI
Hybrid Coronary Revascularization Group1
Percutaneous Coronary Intervention0
Other
GroupValue95% CI
Hybrid Coronary Revascularization Group1
Percutaneous Coronary Intervention0

Adverse events — posted to ClinicalTrials.gov

Time frame: 24 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Hybrid Coronary Revascularization Group
Serious: 20/88 (23%)
Deaths: 4/88
Percutaneous Coronary Intervention
Serious: 11/112 (10%)
Deaths: 9/112

Serious adverse events (14 terms)

ReactionSystemHybrid Coronary Revascular…Percutaneous Coronary Inte…
Unplanned Repeat RevascularizationSurgical and medical procedures——
Infection Requiring AntibioticsInfections and infestations——
Myocardial InfarctionCardiac disorders——
Atrial FibrillationCardiac disorders——
Post-Pericardiotomy SyndromeCardiac disorders——
Stent ThrombosisCardiac disorders——
Graft Stenosis or OcclusionCardiac disorders——
Renal FailureRenal and urinary disorders——
BleedingBlood and lymphatic system disorders——
Gastrointestinal BleedingGastrointestinal disorders——
Ischemic StrokeNervous system disorders——
Other BleedingNervous system disorders——
Renal and Urinary BleedingRenal and urinary disorders——
Respiratory FailureRespiratory, thoracic and mediastinal disorders——
Other adverse events (12 terms — click to expand)

ReactionSystemHybrid Coronary Revascular…Percutaneous Coronary Inte…
Atrial FibrillationCardiac disorders——
Post-Pericardiotomy SyndromeCardiac disorders——
Unplanned Repeat RevascularizationSurgical and medical procedures——
Gastrointestinal BleedingGastrointestinal disorders——
BleedingBlood and lymphatic system disorders——
Myocardial InfarctionCardiac disorders——
Renal FailureRenal and urinary disorders——
Mediastinal BleedingRespiratory, thoracic and mediastinal disorders——
Vascular BleedingVascular disorders——
Ischemic StrokeNervous system disorders——
Unknown Etiology StrokeNervous system disorders——
Renal and Urinary BleedingRenal and urinary disorders——

Most-reported serious reactions: Unplanned Repeat Revascularization, Infection Requiring Antibiotics, Myocardial Infarction, Atrial Fibrillation, Post-Pericardiotomy Syndrome, Stent Thrombosis, Graft Stenosis or Occlusion, Renal Failure.

Data from ClinicalTrials.gov NCT03089398 adverse events section.

Sponsor's own description

The purpose of the study is to learn which treatment option is better for patients who have multi-vessel coronary artery disease (blockages in more than one vessel supplying blood to the heart muscle). The treatment options this study will compare are: (1) Hybrid Coronary Revascularization \[HCR\] (a combination of surgery and catheter procedures to open up clogged heart arteries) and (2) Percutaneous Coronary Intervention \[PCI\] (catheter procedures alone to open up clogged heart arteries). There are no new or "experimental" procedures being tested in this study: both HCR and PCI are well-established procedures and are regularly performed in patients who have coronary artery disease. But, the FDA has not approved the drug-eluting stents used in PCI for all types of coronary artery disease. We have received an Investigational Device Exemption from the FDA to use the drug-eluting stents in this trial in the same way that they are used in clinical practice. The study being proposed here will use rigorous scientific methods and should result in a very high level of certainty about which procedure is best for patients with coronary artery disease.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Management of Left Main Coronary Artery Disease.
    Ramadan R, Boden WE, Kinlay S. · · 2018 · cited 59× · PMID 29605817 · DOI 10.1161/jaha.117.008151
  2. Randomized Clinical Trial of Surgical vs. Percutaneous vs. Hybrid Revascularization in Multivessel Coronary Artery Disease: Residual Myocardial Ischemia and Clinical Outcomes at One Year-Hybrid coronary REvascularization Versus Stenting or Surgery (HREVS).
    Ganyukov V, Kochergin N, Shilov A, Tarasov R, et al · · 2020 · cited 38× · PMID 31969796 · DOI 10.1155/2020/5458064
  3. Review of Contemporary Techniques for Minimally Invasive Coronary Revascularization.
    Fatehi Hassanabad A, Kang J, Maitland A, Adams C, et al · · 2021 · cited 14× · PMID 34081874 · DOI 10.1177/15569845211010767
  4. Hybrid coronary revascularization versus percutaneous coronary intervention: A systematic review and meta-analysis.
    Van den Eynde J, Sá MP, De Groote S, Amabile A, et al · · 2021 · cited 9× · PMID 34917749 · DOI 10.1016/j.ijcha.2021.100916
  5. Hybrid coronary revascularization <i>vs</i>. percutaneous coronary interventions for multivessel coronary artery disease.
    Hannan EL, Wu YF, Cozzens K, Tamis-Holland J, et al · · 2021 · cited 6× · PMID 33907545 · DOI 10.11909/j.issn.1671-5411.2021.03.003
  6. Hybrid Coronary Revascularisation: Indications, Techniques, and Outcomes.
    Fazmin IT, Ali JM. · · 2025 · cited 5× · PMID 39941551 · DOI 10.3390/jcm14030880
  7. Combining Surgical and Percutaneous Revascularization for Multivessel Coronary Artery Disease: The Case for a Hybrid Approach.
    Heuts S, van der Harst P, Nodin E, Frederiksen JG, et al · · 2025 · PMID 41370637 · DOI 10.1093/ejcts/ezaf406

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