BACKGROUND Patients with peripheral artery disease have an increased risk of cardiovascular morbidity and mortality. Antiplatelet agents are widely used to reduce these complications. METHODS This was a multicentre, double-blind, randomised placebo-controlled trial for which patients were recruited at 602 hospitals, clinics, or community practices from 33 countries across six continents. Eligible patients had a history of peripheral artery disease of the lower extremities (previous peripheral bypass surgery or angioplasty, limb or foot amputation, intermittent claudication with objective evidence of peripheral artery disease), of the carotid arteries (previous carotid artery revascularisation or asymptomatic carotid artery stenosis of at least 50%), or coronary artery disease with an ankle-brachial index of less than 0·90. After a 30-day run-in period, patients were randomly assigned (1:1:1) to receive oral rivaroxaban (2·5 mg twice a day) plus aspirin (100 mg once a day), rivaroxaban twice a day (5 mg with aspirin placebo once a day), or to aspirin once a day (100 mg and rivaroxaban placebo twice a day). Randomisation was computer generated. Each treatment group was double dummy, and the patient, investigators, and central study staff were masked to treatment allocation. The primary outcome was cardiovascular death, myocardial infarction or stroke; the primary peripheral artery disease outcome was major adverse limb events including major amputation. This trial is registered with ClinicalTrials.gov, number NCT01776424, and is closed to new participants. FINDINGS Between March 12, 2013, and May 10, 2016, we ; HR 0·67, 95% CI 0·45-1·00, p=0·05). The median duration of treatment was 21 months. The use of the rivaroxaban plus aspirin combination increased major bleeding compared with the aspirin alone group (77 [3%] of 2492 vs 48 [2%] of 2504; HR 1·61, 95% CI 1·12-2·31, p=0·0089), which was mainly gastrointestinal. Similarly, major bleeding occurred in 79 (3%) of 2474 patients with rivaroxaban 5 mg, and in 48 (2%) of 2504 in the aspirin alone group (HR 1·68, 95% CI 1·17-2·40; p=0·0043). INTERPRETATION Low-dose rivaroxaban taken twice a day plus aspirin once a day reduced major adverse cardiovascular and limb events when compared with aspirin alone. Although major bleeding was increased, fatal or critical organ bleeding was not. This combination therapy represents an important advance in the management of patients with peripheral artery disease. Rivaroxaban alone did not significantly reduce major adverse cardiovascular events compared with asprin alone, but reduced major adverse limb events and increased major bleeding. FUNDING Bayer AG. Methods This was a multicentre, double-blind, randomised placebo-controlled trial for which patients were recruited at 602 hospitals, clinics, or community practices from 33 countries across six continents. Eligible patients had a history of peripheral artery disease of the lower extremities (previous peripheral bypass surgery or angioplasty, limb or foot amputation, i...
There 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 perioperative bleeding, respiratory complications, and acute kidney injury but also resulted in an increased risk of early revascularization. (Funded by the Canadian Institutes of Health Research; CORONARY ClinicalTrials.gov number, NCT00463294.).
In our trial, the rate of the composite outcome of death, stroke, myocardial infarction, renal failure, or repeat revascularization at 5 years of follow-up was similar among patients who underwent off-pump CABG and those who underwent on-pump CABG. (Funded by the Canadian Institutes of Health Research; CORONARY ClinicalTrials.gov number, NCT00463294 .).
C oronary artery bypass grafting (CABG) can be performed on-pump (use of cardiopulmonary bypass [CPB]) or with the technique of operating on a beating heart (off-pump) to decrease the perioperative complications associated with CPB and cross-clamping of the aorta. This randomized controlled trial was designed to compare off-pump and on-pump CABG in patients undergoing isolated CABG surgery to ascertain the relative benefits and risks of the 2 techniques.The study was conducted at 79 centers in 19 countries. Patients (n = 4752) were randomly assigned to either off-or onpump CABG; all patients and investigators were aware of the patient's study-group assignment. Coronary artery bypass grafting was performed using a standard median sternotomy in all patients. Crossovers from the assigned procedure were recorded as were the reasons for and timing of the crossovers. Patients were seen at 30 days for short-term follow-up. Subsequent follow-up, still ongoing, will include clinic visits at 1 and 5 years and telephone follow-up at 6 months and 2, 3, and 4 years. 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. The second coprimary outcome was the first plus repeat coronary revascularization at a mean of 5 years. Secondary outcomes included rates of blood transfusion, recurrent angina, and death from cardiovascular causes. All deaths in the first 30 days were considered the result of cardiovascular causes. All analyses by a blinded adjudication committee were conducted on an intention-to-treat basis. Cox regression was used to report the 30-day outcomes. Comparisons between the study groups were assessed using the log-rank test.Of the 4752 patients, 2375 were assigned to off-pump and 2377 to on-pump CABG. Eighty-one percent of the patients were men (mean age, 68 years), and 33% of the patients had had a previous myocardial infarction. Other baseline clinical and demographic characteristics were similar. Thirty-four patients did not undergo surgery, including 6 patients who died. For crossovers, 184 (7.9%) of 2332 patients who were assigned to the off-pump CABG underwent on-pump surgery; 150 (6.4%) of 2333 patients assigned for on-pump surgery underwent offpump surgery. In the off-pump group, 3.0 grafts were performed compared with 3.2 in the on-pump group. The respective rates of incomplete revascularization were 11.8% and 10.0%. The rates for transfusion were 50.7% in the off-pump group compared with 63.3% in the on-pump group. Perioperative repeat operations for bleeding were necessary in 34 patients (1.4%) in the off-pump group compared with 56 (2.4%) in the on-pump group. The primary outcome at 30 days occurred in 233 patients (9.8%) in the off-pump group and 245 (10.3%) in the on-pump group (hazard ratio for the off-pump group, 0.95). The individual components of the composite did not differ between the groups. No interactions were seen between the effects of the procedures and any of the subgr...
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