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The efficacy of bivalirudin that remains comparable with that of heparin plus Gp IIb/IIIa blockade over six months and one year are described. The result indicates that long-term clinical outcome with bivalirudin and provisional Gp IIb/IIa blockade is comparable with that of heparin plus planned Gp IIb/IIa inhibition during contemporary percutaneous coronary intervention.

The drug bivalirudin may be as effective as heparin when used to prevent complications from coronary angioplasty, according to a study of 6,010 patients. Bivalirudin is an anticoagulant drug that can prevent blood clots from forming during coronary angioplasty.

Context In the Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE)-2 trial, bivalirudin with provisional glycoprotein IIb/IIIa (Gp IIb/IIIa) inhibition was found to be noninferior to heparin plus planned Gp IIb/IIIa blockade in the prevention of acute ischemic end points and was associated with significantly less bleeding by 30 days after percutaneous coronary intervention (PCI). Objective To determine whether the efficacy of bivalirudin remains comparable with that of heparin plus Gp IIb/IIIa blockade over 6 months and 1 year. Design, Setting, and Participants Follow-up study to 1 year of a randomized, double-blind trial conducted among 6010 patients undergoing urgent or elective PCI at 233 community or referral hospitals in 9 countries from October 2001 through August 2002. Interventions Patients were randomly assigned to receive intravenously bivalirudin (0.75 mg/kg bolus, 1.75 mg/kg per hour for the duration of PCI), with provisional Gp IIb/IIIa inhibition, or to receive heparin (65 U/kg bolus), with planned Gp IIb/IIIa inhibition (abciximab or eptifibatide). Both groups received daily aspirin and a thienopyridine for at least 30 days after PCI. Main Outcome Measures Incidence of death, myocardial infarction, or repeat revascularization by 6 months and death by 12 months after enrollment. Results At 6 months, death occurred in 1.4% of patients in the heparin plus Gp IIb/IIIa group and in 1.0% of patients in the bivalirudin group (hazard ratio [HR], 0.70; 95% confidence interval [CI], 0.43-1.14; P = .15). Myocardial infarction occurred in 7.4% and 8.2% of patients, respectively (HR, 1.12; 95% CI, 0.93-1.34; P = .24), and repeat revascularization was required in 11.4% and 12.1% of patients, respectively (HR, 1.06; 95% CI, 0.91-1.23; P = .45). By 1 year, death occurred in 2.46% of patients treated with heparin plus Gp IIb/IIIa blockade and in 1.89% of patients treated with bivalirudin (HR, 0.78; 95% CI, 0.55-1.11; P = .16). Nonsign... [ABSTRACT FROM AUTHOR]

Importance: Advances in perioperative cardiac management and an increase in the number of endovascular procedures have made significant contributions to patients and postoperative myocardial infarction (POMI) risk following high-risk vascular procedures. Whether these changes have translated into real-world improvements in POMI incidence remain unknown., Objective: To examine the temporal trends of myocardial infarction (MI) following high-risk vascular procedures., Design, Setting, and Participants: A retrospective cohort study was performed using data collected from January 1, 2005, to December 31, 2013, in the American College of Surgeons National Surgery Quality Improvement Program database, to which participating hospitals across the United States report their preoperative, operative, and 30-day outcome data. A total of 90 303 adults who underwent a high-risk vascular procedure-open aortic surgery or infrainguinal bypass-during the study period were identified. Patients were divided into cohorts based on their year of operation, and their baseline cardiac risk factors and incidence of POMI were compared. Cases from 2005 to 2014 in the database were eligible for inclusion if one of their Current Procedural Terminology codes matched any of the operations identified as a high-risk vascular procedure. Data analysis took place from August 1, 2016, to November 15, 2016., Exposures: The main exposure was the year of the operation. Other variables of interest included demographics, comorbidities, and other risk factors for MI., Main Outcomes and Measures: Primary outcome of interest was the incidence of POMI., Results: Of the 90 303 patients included in the study, 22 836 (25.3%) had undergone open aortic surgery and 67 467 (74.7%) had had infrainguinal bypass. The open aortic cohort comprised 16 391 men (71.9%), had a mean (SD) age of 69.1 (11.5) years, and was predominantly white (18 440 patients [80.8%] self-identified as white race/ethnicity). The infrainguinal bypass cohort included 41 845 men (62.1%), had a mean (SD) age of 66.7 (11.7) years, and had 51 043 patients (75.7%) who self-identified as white race/ethnicity. During the study period, patients who underwent open aortic procedures were more likely to be classified as American Society of Anesthesiologists class IV (7426 patients [32.6%] vs 15 683 [23.3%] for the infrainguinal bypass cohort) or class V (1131 [5.0%] vs 206 [0.3%]; P < .001) and to undergo emergency procedures (4852 [21.3%] vs 4954 [7.3%]; P < .001). The open aortic procedure cohort also experienced significantly higher actual incidence of POMI (464 [3.0%] vs 1270 [1.9%]; P < .001). From 2009 to 2014, the incidence of POMI demonstrated no substantial temporal change (2.7% in 2009 to 3.1% in 2014; P = .64 for trend). Postoperative MI was consistently associated with poor prognosis, with a 3.62-fold (95% CI, 2.25-5.82) to 11.77-fold (95% CI, 6.10-22.72) increased odds of cardiac arrest and a 3.01-fold (95% CI, 2.08-4.36) to 6.66-fold (95% CI, 4.66-9.52) increased odds of mortality., Conclusions and Relevance: The incidence of MI did not significantly decrease in the past decade and has been consistently associated with worse clinical outcomes. Further inquiry into why advanced perioperative care did not reduce cardiac complications is important to quality improvement efforts.