Coronary Stenting and Coronary Bypass Grafting at the Same Time in a Specialty Built Operating Room
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      This study will combine coronary stenting with minimally invasive robotic coronary bypass
      surgery, accomplished with the use of the da Vinci robot, to restore blood flow to occluded
      coronary arteries. Two previously approved and commonly performed procedures used to treat
      coronary artery disease(coronary stenting and robotic bypass surgery) are being combined into
      a hybrid surgery in a specialty built operating room. Patients with low risk coronary lesions
      will undergo cardiac hybrid revascularization using stenting and LIMA to LAD robotic bypass
      concomitantly. Patients' postoperative bleeding rates, angiographs and complication free
      rates will be recorded.
    

Detailed description: 
      Coronary artery disease (CAD) is the leading cause of death in the United States and becomes
      more common as the population ages (American Heart Association, 2003). The symptoms of CAD
      may not become perceptible until the condition has advanced to a severe and serious stage,
      which might explain the large mortality and morbidity rates associated with heart disease.

      At this point there are many procedures available to treat CAD all of which aim to improve
      myocardial blood flow, stop angina, increase exercise ability and ultimately free patients
      from medications and improve their quality of life. Medications are used to reduce blood
      pressure and relieve strain on the heart. Cardiologists use angioplasty, which compresses
      plaque deposits, and stenting, in which a small wire mesh tube is inserted into the diseased
      artery to revascularize the heart muscle. On-pump coronary artery bypass grafting (CABG)
      redirects blood flow around clogged vessels of the heart and is commonly used by cardiac
      surgeons to treat CAD because it has been proven to yield the lowest restenosis rate of all
      revascularization techniques (Cisowski, 2002). CABG is an effective yet painful and traumatic
      intervention.

      The desire to discover a less distressing approach to coronary artery revascularization has
      led to a fairly new cardiac hybrid procedure that involves stenting followed by a minimally
      invasive left internal mammary artery (LIMA) to left anterior descending artery (LAD) bypass
      graft (Amodeo, 2002). The hybrid procedure for revascularization carries a lower morbidity
      than does on-pump CABG and is also quickly gaining acceptance in the surgical community (de
      Canniere et al, 2001). The two procedures of hybrid revascularization are currently performed
      within 24 to 48 hours of each other with little collaboration between cardiac surgeons and
      cardiologist.

      This study will asses the efficacy and safety of cardiac hybrid surgery that combines
      stenting and robotic LIMA to LAD grafting in the same procedure in a specialty built
      operating room. Long term use of the antiplatelet inhibitor, clopidogrel, to be taken by
      patients in this study, was proven to significantly reduce the risk of adverse ischemic
      events after percutaneous coronary interventions (Steinhubl, 2002). In addition, the
      application of Bivalirudin (Direct Thrombin Inhibitor) will be assessed in this integrated
      myocardial revascularization scenario. The many attractive aspects of robotic hybrid bypass
      include the avoidance of the procedural phases (arrested heart, blood transfusion, median
      sternotomy and cardiopulmonary bypass) of on-pump CABG. Robotic LIMA to LAD bypass and
      stenting in the same procedure will allow cardiac surgeons and cardiologists to work together
      to help patients obtain safe and effective coronary artery revascularization.
    

Intervention name(s): Robotic-assisted Coronary Surgical Revascularization; PCI- Drug Eluting Stents
Intervention type(s): Procedure; Procedure
Intervention description(s): Robotic assistance of coronary artery bypass grafting using the DaVinci surgical robotic console; Drug eluting stents performed by cardiologist within the same operating theatre following robotic assisted coronary artery bypass surgery
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Coronary Artery Disease; PCI; Drug eluting stents; Coronary Hybrid Revascularization; Robotic CABG