Rationale, design and baseline characteristics of participants in the cardiovascular outcomes for people using anticoagulation strategies (COMPASS) trial

BACKGROUND: Long-term aspirin prevents vascular events but is only modestly effective. Rivaroxaban alone or in combination with aspirin might be more effective than aspirin alone for vascular prevention in patients with stable coronary artery disease (CAD) or peripheral artery disease (PAD). Rivaroxaban as well as aspirin increase upper gastrointestinal (GI) bleeding and this might be prevented by proton pump inhibitor therapy. METHODS: Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) is a double-blind superiority trial comparing rivaroxaban 2.5 mg twice daily combined with aspirin 100 mg once daily or rivaroxaban 5 mg twice daily vs aspirin 100 mg once daily for prevention of myocardial infarction, stroke, or cardiovascular death in patients with stable CAD or PAD. Patients not taking a proton pump inhibitor were also randomized, using a partial factorial design, to pantoprazole 40 mg once daily or placebo. The trial was designed to have at least 90% power to detect a 20% reduction in each of the rivaroxaban treatment arms compared with aspirin and to detect a 50% reduction in upper GI complications with pantoprazole compared with placebo...

Conversion after off-pump coronary artery bypass grafting: the CORONARY trial experience

OBJECTIVES: Emergent and late conversions form OFF-to-ON pump coronary artery bypass grafting (CABG) have been associated with worse outcomes, however, it remains unclear as to which risk factors are associated with conversion and how to prevent them. METHODS: Among 4718 patients who randomly underwent off- or on-pump CABG, the incidence of off-pump to on-pump cross-over, or 'OFF-to-ON conversion', was 7.9% (186/2356). The primary outcome was a composite of death, stroke, myocardial infarction, or new renal failure requiring dialysis. We assessed the risk factors and outcomes of converted patients. RESULTS: Emergent OFF-to-ON conversions, defined as conversions for hypotension or ischaemia, were required for 3.2% of patients ( n  = 75), while most elective conversions were due to small or intramuscular coronaries ( n  = 83). OFF-to-ON converted patients required increased surgery time, blood transfusions, intensive care unit stay, and presented a higher incidence at 1 year of the composite outcome compared with non-converted off-pump patients (all P < 0.01), especially if the conversion was emergent. Conversely, elective conversions outcomes were no different compared with non-converted off-pump patients ( P  = 0.35). Independent predictors of emergent conversions included higher heart rate or chronic atrial fibrillation, urgent surgery, more grafts planned and surgeon experience with off-pump CABG...

Five-year outcomes after off-pump or on-pump coronary-artery bypass grafting

BACKGROUND: We previously reported that there was no significant difference at 30 days or at 1 year in the rate of the composite outcome of death, stroke, myocardial infarction, or renal failure between patients who underwent coronary-artery bypass grafting (CABG) performed with a beating-heart technique (off-pump) and those who underwent CABG performed with cardiopulmonary bypass (on-pump). We now report the results at 5 years (the end of the trial). METHODS: A total of 4752 patients (from 19 countries) who had coronary artery disease were randomly assigned to undergo off-pump or on-pump CABG. For this report, we analyzed a composite outcome of death, stroke, myocardial infarction, renal failure, or repeat coronary revascularization (either CABG or percutaneous coronary intervention). The mean follow-up period was 4.8 years. RESULTS: There were no significant differences between the off-pump group and the on-pump group in the rate of the composite outcome (23.1% and 23.6%, respectively; hazard ratio with off-pump CABG, 0.98; 95% confidence interval [CI], 0.87 to 1.10; P=0.72) or in the rates of the components of the outcome, including repeat coronary revascularization, which was performed in 2.8% of the patients in the off-pump group and in 2.3% of the patients in the on-pump group (hazard ratio, 1.21; 95% CI, 0.85 to 1.73; P=0.29)...

Methylprednisolone in patients undergoing cardiopulmonary bypass (SIRS): a randomised, double-blind, placebo-controlled trial

BACKGROUND:Cardiopulmonary bypass initiates a systemic inflammatory response syndrome that is associated with postoperative morbidity and mortality. Steroids suppress inflammatory responses and might improve outcomes in patients at high risk of morbidity and mortality undergoing cardiopulmonary bypass. We aimed to assess the effects of steroids in patients at high risk of morbidity and mortality undergoing cardiopulmonary bypass.METHODS:The Steroids In caRdiac Surgery (SIRS) study is a double-blind, randomised, controlled trial. We used a central computerised phone or interactive web system to randomly assign (1:1) patients at high risk of morbidity and mortality from 80 hospital or cardiac surgery centres in 18 countries undergoing cardiac surgery with the use of cardiopulmonary bypass to receive either methylprednisolone (250 mg at anaesthetic induction and 250 mg at initiation of cardiopulmonary bypass) or placebo. Patients were assigned with block randomisation with random block sizes of 2, 4, or 6 and stratified by centre. Patients aged 18 years or older were eligible if they had a European System for Cardiac Operative Risk Evaluation of at least 6. Patients were excluded if they were taking or expected to receive systemic steroids in the immediate postoperative period or had a history of bacterial or fungal infection in the preceding 30 days. Patients, caregivers, and those assessing outcomes were masked to allocation. The primary outcomes were 30-day mortality and a composite of death and major morbidity (ie, myocardial injury, stroke, renal failure, or respiratory failure) within 30 days, both analysed by intention to treat. Safety outcomes were also analysed by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00427388...

Rationale and design of the steroids in cardiac surgery trial

Background Steroids may improve outcomes in high-risk patients undergoing cardiac surgery with the use of cardiopulmonarybypass (CBP). There is a need for a large randomized controlled trial to clarify the effect of steroids in such patients.Methods We plan to randomize 7,500 patients with elevated European System for Cardiac Operative Risk Evaluation whoare undergoing cardiac surgery with the use of CBP to methylprednisolone or placebo. The first coprimary outcome is 30-day allcausemortality, and the most second coprimary outcome is a composite of death, MI, stroke, renal failure, or respiratory failurewithin 30 days. Other outcomes include a composite of MI or mortality at 30 days, new onset atrial fibrillation, bleeding andtransfusion requirements, length of intensive care unit stay and hospital stay, infection, stroke, wound complications,gastrointestinal complications, delirium, postoperative insulin use and peak blood glucose, and all-cause mortality at 6 months.Results As of October 22, 2013, 7,034 patients have been recruited into SIRS in 82 centers from 18 countries. Patient’smean age is 67.3 years, and 60.4% are male. The average European System for Cardiac Operative Risk Evaluation is 7.0with 22.1% having an isolated coronary artery bypass graft procedure, and 66.1% having a valve procedure.Conclusions SIRS will lead to a better understanding of the safety and efficacy of prophylactic steroids for cardiacsurgery requiring CBP. (Am Heart J 2014;167:660-5.)BackgroundWorldwide, N2 million patients undergo cardiacsurgery annually. Most cardiac surgeries use cardiopulmonarybypass (CPB). Although CPB serves an importantrole, it.

Off-pump or on-pump coronary-arterybypass grafting at 30 days

BackgroundThe relative benefits and risks of performing coronary-artery bypass grafting (CABG) with a beating-heart technique (off-pump CABG), as compared with cardiopulmonarybypass (on-pump CABG), are not clearly established.MethodsAt 79 centers in 19 countries, we randomly assigned 4752 patients in whom CABG was planned to undergo the procedure off-pump or on-pump. The first coprimary outcome was a composite of death, nonfatal stroke, nonfatal myocardial infarction, or new renal failure requiring dialysis at 30 days after randomization.ResultsThere was no significant difference in the rate of the primary composite outcomebetween off-pump and on-pump CABG (9.8% vs. 10.3%; hazard ratio for the offpump group, 0.95; 95% confidence interval [CI], 0.79 to 1.14; P = 0.59) or in any of its individual components. The use of off-pump CABG, as compared with on-pump CABG, significantly reduced the rates of blood-product transfusion (50.7% vs. 63.3%; relative risk, 0.80; 95% CI, 0.75 to 0.85; P<0.001), reoperation for perioperative bleeding(1.4% vs. 2.4%; relative risk, 0.61; 95% CI, 0.40 to 0.93; P = 0.02), acute kidney injury (28.0% vs. 32.1%; relative risk, 0.87; 95% CI, 0.80 to 0.96; P = 0.01), and respiratorycomplications (5.9% vs. 7.5%; relative risk, 0.79; 95% CI, 0.63 to 0.98; P = 0.03) but increased the rate of early repeat revascularizations (0.7% vs. 0.2%; hazard ratio, 4.01; 95% CI, 1.34 to 12.0; P = 0.01).ConclusionsThere was no significant difference between off-pump and on-pump CABG with respect to the 30-day rate of death, myocardial infarction, stroke, or renal failure requiring dialysis. The use of off-pump CABG resulted in reduced rates of transfusion, reoperation for erioperative bleeding, respiratory complications, and acute kidney injury but also resulted in an increased risk of early revascularization. (Funded by theCanadian Institutes of Health Research; CORONARY ClinicalTrials.gov number,NCT00463294.)

Rationale and design of the coronary artery bypass grafting surgery off or on pump revascularization study: a large international randomized trial in cardiac surgery

Background Uncertainty remains regarding the benefits and risks of the technique of operating on a beating heart(off pump) for coronary artery bypass grafting (CABG) surgery versus on-pump CABG. Prior trials had few events and relativelyshort follow-up. There is a need for a large randomized, controlled trial with long-term follow-up to inform both the short- andlong-term impact of the 2 approaches to CABG.Methods We plan to randomize 4,700 patients in whom CABG is planned to undergo the procedure on pump or offpump. The coprimary outcomes are a composite of total mortality, myocardial infarction (MI), stroke, and renal failure at30 days and a composite of total mortality, MI, stroke, renal failure, and repeat revascularization at 5 years. We will alsoundertake a cost-effectiveness analysis at 30 days and 5 years after CABG surgery. Other outcomes include neurocognitivedysfunction, recurrence of angina, cardiovascular mortality, blood transfusions, and quality of life.Results As of May 3, 2011, CORONARY has recruited N3,884 patients from 79 centers in 19 countries. Currently,patient's mean age is 67.6 years, 80.7% are men, 47.0% have a history of diabetes, 51.4% have a history of smoking, and34.4% had a previous MI. In addition, 20.9% of patients have a left main disease, and 96.6% have double or triplevessel disease.Conclusions CORONARY is the largest trial yet conducted comparing off-pump CABG to on-pump CABG. Its resultswill lead to a better understanding of the safety and efficacy of off-pump CABG. (Am Heart J 2012;163:1-6.)