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The primary hypothesis of the ROMA trial is that in patients undergoing primary isolated non-emergent coronary artery bypass grafting, the use of 2 or more arterial grafts compared with a single arterial graft (SAG) is associated with a reduction in the composite outcome of death from any cause, any stroke, post-discharge myocardial infarction and/or repeat revascularization. The secondary hypothesis is that in these patients, the use of 2 or more arterial grafts compared with a SAG is associated with improved survival. The ROMA trial is a prospective, unblinded, randomized event-driven multicentre trial comprising at least 4300 subjects. Patients younger than 70 years with left main and/or multivessel disease will be randomized to a SAG or multiple arterial grafts to the left coronary system in a 1:1 fashion. Permuted block randomization stratified by the centre and the type of second arterial graft will be used. The primary outcome will be a composite of death from any cause, any stroke, post-discharge myocardial infarction and/or repeat revascularization. The secondary outcome will be all-cause mortality. The primary safety outcome will be a composite of death from any cause, any stroke and any myocardial infarction. In all patients, 1 internal thoracic artery will be anastomosed to the left anterior descending coronary artery. For patients randomized to the SAG group, saphenous vein grafts will be used for all non-left anterior descending target vessels. For patients randomized to the multiple arterial graft group, the main target vessel of the lateral wall will be grafted with either a radial artery or a second internal thoracic artery. Additional grafts for the multiple arterial graft group can be saphenous veins or supplemental arterial conduits. To detect a 20% relative reduction in the primary outcome, with 90% power at 5% alpha and assuming a time-to-event analysis, the sample size must include 845 events (and 3650 patients). To detect a 20% relative reduction in the secondary outcome, with 80% power at 5% alpha, the sample size must include 631 events (and 3650 patients). To be conservative, the sample size will be set at 4300 patients. The primary outcome will be tested according to the intention-to-treat principle. The primary analysis will be a Cox proportional hazards regression model, with the treatment arm included as a covariate. If non-proportional hazards are observed, alternatives to Cox proportional hazards regression will be explored. [ABSTRACT FROM AUTHOR]

Background: Diabetes predicts worse outcomes after coronary artery bypass grafting (CABG) We hypothesized that a strategy using radial artery (RA) conduit(s) would improve outcomes and long term survival for diabetic patients undergoing CABG with Left Internal Thoracic Artery (LITA) and RA grafts, with or without additional saphenous vein (SV) when compared with outcomes for patients bypassed with LITA and SV but no RA. Methods: A propensity matched study of long term survival in diabetic patients who had isolated first time CABG from January 1995 to June 2010 at an urban academic medical center in New York City. Our primary endpoint was all cause mortality determined from the Social Security Death Index in December 2010. Results: We compared our 15 year outcomes in diabetic patients after isolated, primary CABG: 642 patients received LITA + RA +/- SV (RA group) vs. 1201 patients who had LITA + SV only (SV group). Propensity scoring for multiple preoperative and operative variables matched 409 patients from each group: 68% were male with an average age of 61 years and ejection fraction averaged 47%. Average grafts per patient was 3.7 for both groups with 2.3 arterial grafts per patient for the RA group. Operative (30 day) mortality was 0.1% RA vs. 1.9% SV, (p<0.0001) For propensity matched patients, mortality was 0.25 RA vs 0.5% SV. (p<0.001) The incidence of major complications was similar in both groups. Kaplan Meier actuarial survival at 1, 5, 10 and 12 years was 98%, 89%, 77 and 70% for RA vs. 96%, 87%, 64% and 59% for SV (p<0.006.) By Cox multivariate analysis significant predictors of mortality were: age, stroke, peripheral vascular disease, COPD, creatinine > 2.5mg/dl and low ejection fraction but only RA use predicted better survival [HR 0.683, CI 0.507- 0.920, p=0.0122]. Conclusion: For diabetic patients having CABG with LITA, use of radial artery conduit adds a substantial and sustained survival advantage compared to LITA and vein. Optimal revascularization for diabetics with multi vessel disease is redefined. [ABSTRACT FROM AUTHOR]

Background--Radial artery (RA) grafts are an attractive second arterial conduit after the left internal thoracic artery (LITA) for coronary artery bypass graft (CABG) surgery. However, long-term outcomes and the need for subsequent reintervention have not been defined. Methods and Results--We performed a retrospective cohort study of our single institution's 16-year experience with 1851 consecutive patients (average age, 58 years; 82% men, 36% diabetic) undergoing primary, isolated CABG with the LITA, RA, and saphenous vein as needed. Average grafts per patient were 3.8, with 2.4 arterial grafts per patient. Survival was determined using the Social Security Death Index. Grafts were nonpatent if they had a >50% stenosis, a string sign, or were occluded. Five patients (0.3%) died in hospital and 0.8% had a myocardial infarction, 1.1% a stroke, and 0.6% renal failure. Kaplan-Meier-estimated 1-, 5-, 10-, and 15-year survival was 99%, 96%, 89%, and 75%, respectively. Of the cohort, 278 symptomatic patients underwent cardiac catheterization at our institution an average of 5.0±3.8 years (range, 0.1-12 years) after CABG. Overall RA (n=420 grafts) patency was 82% and SV (n=364 grafts) patency, 47% (P<0.0001). LITA (n=287 grafts including 9 sequential grafts) patency was 85% and right internal thoracic artery (n=15 grafts) patency was 80% (P=0.6). RA patency was not different from LITA patency (P=0.3). Overall freedom from catheterization, percutaneous coronary intervention, and CABG was 85%, 97%, and 99%, respectively. Conclusions--RA grafting is a highly effective revascularization strategy providing excellent short and long-term outcomes with very low rates of reintervention. RA patency is similar to LITA patency and is much better than S V patency. RA grafting should be more widely utilized in patients undergoing CABG. [ABSTRACT FROM AUTHOR]

Background: The second best conduit for coronary artery bypass graft surgery (CABG) is unclear. We sought to determine if the use of a second arterial conduit, the radial artery (RA), would improve long-term survival after CABG using the left internal thoracic artery (LITA) and saphenous vein (SV). Methods: We compared the 14-year outcomes in propensity-matched patients undergoing isolated, primary CABG using the LITA, RA, and SV versus CABG using the LITA and only SV. In all, 826 patients from each group had similar propensity-matched demographics and multiple variables. The primary endpoint was all-cause mortality obtained using the Social Security Death Index. Results: Perioperative outcomes including in hospital mortality (0.1% for the RA patients and 0.2% for the SV patients) were similar. Kaplan-Meier survival at 1, 5, and 10 years was 98.3%, 93.9%, and 83.1% for the RA group versus 97.2%, 88.7%, and 74.3% for the SV group (log rank, p = 0.0011). Cox proportional hazards models showed a lower all-cause mortality in the RA group (hazard ratio 0.72, confidence interval: 0.56 to 0.92, p = 0.0084). Ten-year survivals showed a 52% increased mortality for the SV patients (25.7%) versus the RA patients (16.9%; p = 0.0011). For symptomatic patients, RA patency was 80.7%, which was not different than the LITA patency rate of 86.4% but was superior to the SV patency rate of 46.7% (p < 0.001). Conclusions: Using the LITA, SV, and a RA conduit for CABG results in significantly improved long-term survival compared with using the LITA and SV. The use of two arterial conduits offers a clear and lasting survival advantage, likely due to the improved patency of RA grafts. We conclude that RA conduits should be more widely utilized during CABG. [ABSTRACT FROM AUTHOR]

Background: Treatment of multivessel coronary artery disease with traditional single-arterial coronary artery bypass graft (SA-CABG) has been associated with superior intermediate-term survival and reintervention compared with percutaneous coronary intervention (PCI) using either bare-metal stents (BMS) or drug-eluting stents (DES).Objectives: This study sought to investigate longer-term outcomes including the potential added advantage of multiarterial coronary artery bypass graft (MA-CABG).Methods: We studied 8,402 single-institution, primary revascularization, multivessel coronary artery disease patients: 2,207 BMS-PCI (age 66.6 ± 11.9 years); 2,381 DES-PCI (age 65.9 ± 11.7 years); 2,289 SA-CABG (age 69.3 ± 9.0 years); and 1,525 MA-CABG (age 58.3 ± 8.7 years). Patients with myocardial infarction within 24 h, shock, or left main stents were excluded. Kaplan-Meier analysis and Cox regression were used to separately compare 9-year all-cause mortality and unplanned reintervention for BMS-PCI and DES-PCI to respective propensity-matched SA-CABG and MA-CABG cohorts.Results: BMS-PCI was associated with worse survival than SA-CABG, especially from 0 to 7 years (p = 0.015) and to a greater extent than MA-CABG was (9-year follow-up: 76.3% vs. 86.9%; p < 0.001). The surgery-to-BMS-PCI hazard ratios (HR) were as follows: versus SA-CABG, HR: 0.87; and versus MA-CABG, HR: 0.38. DES-PCI showed similar survival to SA-CABG except for a modest 0 to 3 years surgery advantage (HR: 1.06; p = 0.615). Compared with MA-CABG, DES-PCI exhibited worse survival at 5 (86.3% vs. 95.6%) and 9 (82.8% vs. 89.8%) years (HR: 0.45; p <0.001). Reintervention was substantially worse with PCI for all comparisons (all p <0.001).Conclusions: Multiarterial surgical revascularization, compared with either BMS-PCI or DES-PCI, resulted in substantially enhanced death and reintervention-free survival. Accordingly, MA-CABG represents the optimal therapy for multivessel coronary artery disease and should be enthusiastically adopted by multidisciplinary heart teams as the best evidence-based therapy. [ABSTRACT FROM AUTHOR]