HYbrid CoronAry Revascularization in DiabeticS
HYbrid CoronAry Revascularization in DiabeticS
To evaluate whether an HCR strategy is more or less effective than conventional coronary
 artery bypass grafting (cCABG), in diabetic patients with multivessel CAD involving the left
 anterior descending artery (LAD), who do not present in the context of acute ST-elevation
 myocardial infarction (STEMI).
Globally, diabetes mellitus has become a major threat to human health. An increase in the
 prevalence of diabetes has been observed, which in part can be attributed to the aging of the
 population, as well as to an increase in the rate of obesity and sedentary lifestyle in
 Canada and the United States.1 Diabetes mellitus is an emerging epidemic with an estimate,
 currently, of almost 18 million confirmed cases and another 20 million patients with impaired
 glucose tolerance at risk to diabetes, in the United States alone.2,3

 Diabetes mellitus, either Type-I or Type-II, is a very strong risk factor for the development
 of coronary artery disease (CAD) and stroke. Eighty percent of all deaths among diabetic
 patients are due to atherosclerosis, compared to about 30% among non-diabetic patients.2 A
 large NIH cohort study, the First National Health and Nutrition Examination Survey, revealed
 that heart disease mortality in the general population is declining at a much greater rate
 than in diabetic patients. In fact, diabetic women suffered an increase in heart disease
 mortality over the same time period.4,5 Furthermore, despite recent reductions in
 cardiovascular events amongst adults with diabetes, the absolute risk of cardiovascular
 events remains 2- fold greater than amongst non-diabetic individuals.6

 There are various methods by which we can treat multivessel CAD in diabetic patients.
 Although conventional bypass (cCABG) is more beneficial than percutaneous coronary
 intervention (PCI) with drug eluting stents (DES) for myocardial revascularization in
 diabetics with multivessel CAD, diabetics are also the patients who experience the most
 complications, infections, and highest costs with cCABG through a sternotomy. Recently, we
 developed and diffused MICS CABG, which can be combined with PCI/DES to vessels other than
 the one at the front of the heart in order to constitute hybrid coronary revascularization
 (HCR). The safety and efficacy of MICS CABG was recently validated in a multicentre study
 from our research team, with 100% patency of the left internal thoracic artery (LITA)-LAD
 axis on angiography7. Potential advantages of an HCR approach in diabetics include the
 avoidance of a sternotomy and the potential for earlier recovery, less bleeding and
 transfusions, fewer infections, decreased costs, increased patient acceptance, while
 potentially maintaining the benefits of cCABG due to the LITA-LAD axis in a diabetic
 population.

 Despite HCR's theoretical advantages as outlined above, it is a novel innovative approach
 that has not been studied in a randomized setting, nor in the context of diabetic patients.
 Its rationale and main research question stem from MICS CABG work by the principal
 investigator, as well as his recent, collaborative Lancet meta-analysis which revealed that
 diabetic patients with multivessel coronary disease (CAD) have better much survival with
 bypass surgery than with stents8. However, diabetics are also the patients who experience the
 most complications and infections from cCABG with incision of the breastbone. The
 investigators main hypothesis is therefore that a HCR strategy in diabetics with multivessel
 CAD will combine the benefits of bypass surgery on the artery at the front of the heart (the
 LAD), nearly eliminate the risk of complications and wound infection, and allow for faster
 recovery and improved quality of life when compared to cCABG. Other blockages would be
 treated with a PCI/DES to reduce the invasiveness of the procedure.

 Overall, the investigators believe that the equipoise as to whether HCR is better than cCABG
 in diabetic patients with multivessel CAD constitutes the next important question in the
 diabetes/CAD field. The investigators propose to evaluate the feasibility of a definitive
 trial examining this question by conducting the present pilot trial.

 Upon study approval, the time frame will be one year of recruitment, followed by 1 year of
 follow-up. Since this is a pilot trial, the investigators are assessing the feasibility of
 conducting this trial on diabetic patients with multivessel coronary artery disease. Should
 this trial be feasible, the investigators will extend the study to a full-scale study. At
 that time, an application will be submitted to conduct the study.
Inclusion Criteria:

 1. Male or Female, aged 18 years or older;

 2. Diabetes Mellitus (Type 1 or Type 2) undergoing treatment;

 3. Multivessel disease involving the LAD + at least one other coronary territory
 (stenosis ≥ 70% in a 1.5 mm artery) in a patient referred for cCABG;

 4. Angiographic lesion characteristics amenable to both PCI/DES and MICS CABG;

 5. Indication for revascularization based upon objective ischemia.

 Exclusion Criteria:

 1. Severe congestive heart failure (class III or IV NYHA) at enrollment;

 2. Left ventricular ejection fraction less than 20%;

 3. Prior CABG surgery;

 4. Prior heart valve surgery;

 5. Prior PCI within the previous 6 months;

 6. Previous tuberculosis or trauma to the chest that may have caused adhesions or LITA
 damage;

 7. Previous stroke within 6 months or patients with stroke at more than 6 months with
 significant residual neurologic involvement, as reflected by a Rankin Score > 1;

 8. Prior history of significant bleeding that might be expected to recur with MICS CABG
 or PCI/DES related anticoagulation;

 9. STEMI or Q-wave MI within 72 hours prior to enrollment;

 10. Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g.
 valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stenting);

 11. Contraindication to either cCABG, MICS CABG, or PCI/DES because of a coexisting
 clinical condition;

 12. Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding
 diathesis;

 13. Intolerance or contraindication to aspirin or both clopidogrel and ticagrelor;

 14. Dementia with a Mini Mental Status Examination (MMSE) score of < 20;

 15. Extra-cardiac illness that is expected to limit survival to less than 5 years;

 16. Suspected pregnancy. A pregnancy test (urine or serum) will be administered to all
 women not clearly menopausal;

 17. Concurrent enrollment in another clinical trial;

 18. Geographic inaccessibility for the follow-up visits required by protocol.