Hybrid Coronary Revascularization Trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Hybrid Coronary Revascularization, Coronary Artery Bypass Grafting, Percutaneous Coronary Intervention Read More

Inclusion Criteria:

• Signed informed consent, inclusive of release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation (US sites)
• Age ≥ 18 years
• Clinical indication for coronary revascularization

• Coronary anatomy requiring revascularization as follows(2)

  • Multivessel CAD involving the LAD (proximal or mid) and/or LM (ostial, mid-shaft or distal) with at least 1 other epicardial coronary artery requiring treatment (LCX or RCA), OR
  • Single vessel disease involving the LAD and a major diagonal, with both requiring independent revascularization with at least one stent if randomized to HCR and stents for both the LAD and diagonal if randomized to multivessel PCI Note: If the patient qualifies based only on a LM lesion, then there must be involvement of the distal bifurcation (Medina 1,1,1) intended for treatment with a 2-stent approach (separate stents into the LAD and LCX) if randomized to PCI. However, if the patient also has non-LM disease in the RCA and/or non-ostial LAD and/or non-ostial LCX that requires separate treatment, any LM lesion is a valid criterion for enrollment, whether LM ostial, shaft or distal bifurcation disease, and any strategy of treating the LM may be employed, including not treating the ostial LCX, a provisional approach or a planned 2-stent strategy as appropriate. Similarly, if the patient qualifies based only on LAD-Dg disease, whether a bifurcation lesion or separate lesions in the LAD and Dg, without RCA or LCX disease, then both the LAD and Dg must be true lesions intended for stents (planned 2-stent approach). However, if the patient has LAD-Dg disease and a lesion in the RCA or LCX that also requires treatment, the LAD-Dg disease can then be treated in any fashion (2-stents, a provisional approach, or the Dg not even dilated if it is small), according to operator preference
• Suitable candidate for both PCI with metallic DES and HCR as determined by clinical assessment and angiogram review by an interventional cardiologist and a cardiac surgeon at the enrolling clinical site
• Ability to tolerate and no plans to interrupt dual anti-platelet therapy for ≥ 6 months if presentation with stable CAD, or ≥ 12 months if presentation with biomarker positive acute coronary syndrome (ACS)
• Willing to comply with all protocol required follow-up

Exclusion Criteria:

• Previous cardiac surgery of any kind, including CABG
• Previous thoracic surgery involving the left pleural space
• Previous LM or LAD stent (a) with evidence of in-stent restenosis or (b) within 1 cm of a qualifying lesion
• Previous PCI of the LM and/or LAD within 12 months prior to randomization
• PCI with bare metal stent (BMS) within 12 months prior to randomization
• Any complication or unsuccessful revascularization with PCI within 30 days prior to randomization.

Note: A patient may be considered eligible for enrollment if PCI with DES in non-LM and non-LAD territory was performed within 30 days prior to randomization, as long as revascularization was successful and uncomplicated, or has been performed more than 30 days prior even if unsuccessful or complicated

• Planned treatment with bioresorbable vascular scaffold(s) after randomization
• Total occlusion (TIMI 0 or 1 flow) of the LM, LAD or LCX.
• Cardiogenic shock at time of screening
• STEMI within 72 hours prior to randomization
• Need for concomitant vascular or other cardiac surgery during the index hospitalization (including, but not limited to, valve surgery, aortic resection, left ventricular aneurysmectomy, and carotid endarterectomy or stenting)
• Indication for chronic oral anticoagulation therapy at the time of randomization
• Any prior lung resection
• ESRD on dialysis
• Patients who could not be switched from prasugrel or ticagrelor to clopidogrel, should that be needed prior to a CABG, during reverse HCR
• Extra-cardiac illness that is expected to limit survival to less than 5 years
• Allergy or hypersensitivity to any of the study drugs or devices used in the trial
• Therapy with an investigational drug, device or biologic within 1 year prior to randomization, or plan to enroll patient in additional investigational study during participation in this trial
• Unable to give informed consent or potential for noncompliance with the study protocol in the judgment of the investigator
• Pregnant at time of screening or unwilling to use effective birth control measures while dual antiplatelet therapy is required.