Trends in P2Y12 Inhibitor Use in Patients Referred for Invasive Evaluation of Coronary Artery Disease in Contemporary US Practice.

Practice in patients undergoing invasive evaluation for coronary artery disease is variable regarding choice of P2Y12 inhibitor and timing of treatment initiation and is usually dictated by institutional or even individual operator preference. Limited data are available on the actual patterns of P2Y12 inhibitor use in contemporary practice in the United States. We used electronic medical records from the Cerner "Health Facts" database of adults who underwent coronary angiography with or without percutaneous coronary intervention (PCI) from January 2008 to June 2013 and who received a loading dose of clopidogrel, prasugrel, or ticagrelor at any time from 48 hours before the start of procedure up to 6 hours after. Timing of P2Y12 inhibitor administration was categorized as >2 hours before, 0 to 2 hours before (pretreatment groups), or after the start of procedure. Results were also evaluated according to type of P2Y12 inhibitor and patient clinical presentation. A total of 37,964 patients underwent coronary angiography, and 28,306 proceeded to PCI. Pretreatment with a P2Y12 inhibitor was observed in 28% and 23% in the overall and PCI populations, respectively. Moderate variability of pretreatment rates was noted relative to clinical presentation and P2Y12 inhibitor type. Pretreatment rates remained fairly constant over time with the exception of a decreasing trend with prasugrel. In conclusion, among patients referred for invasive evaluation of coronary artery disease, P2Y12 inhibitor pretreatment was low in contemporary US practice, an observation consistent over time and for all available agents and clinical presentations.

Utilization of anticoagulants and outcomes in STEMI patients undergoing PPCI in the US hospitals: Bivalirudin, heparin plus GPI or heparin alone?

OBJECTIVE: Despite major trials showing the opposite, one of three small randomized trials conducted outside the US has raised questions about whether heparin alone is a viable antithrombotic strategy for primary percutaneous coronary interventions (PPCI). We determined the frequency and in-hospital outcomes of anticoagulation strategies in patients undergoing PPCI. METHODS: We analyzed records from 2008 through 2013 in the Premier Research Database of patients hospitalized with ST-segment elevation myocardial infarction (STEMI) undergoing PPCI. Patients were categorized into one of four anticoagulation strategies: bivalirudin alone, bivalirudin plus glycoprotein IIb/IIIa inhibitors (GPI), unfractionated or low-molecular-weight heparin alone or heparin plus GPI. In-hospital clinical outcomes were compared between treatment groups after propensity score matching. RESULTS: Among 114,134 eligible STEMI patients, heparin alone was the least frequent anticoagulation strategy, used in 14.4% to 18.1% of cases per year. Bivalirudin alone nearly tripled during the study period, from 12.7% to 37.8% and surpassed that of heparin plus GPI by 2013. Bivalirudin alone performed better than heparin alone for mortality (4.7% vs 5.3%, p = 0.010), clinically apparent bleeding (5.7% vs 6.7%, p < 0.001), transfusion rates (4.1% vs 4.8%, p = 0.003) and mean length of stay (4.1 vs 4.2 days, p < 0.001). The in-hospital death rate was lower with heparin plus GPI than with heparin alone (4.9% vs 5.9%, p < 0.001), but clinically apparent bleeding was higher in heparin plus GPI than in heparin alone (9.4% vs 7.1%, p < 0.001). CONCLUSION: In patients hospitalized for STEMI undergoing PPCI, heparin alone is not commonly used and is inferior to bivalirudin for mortality, bleeding and length of stay outcomes. Heparin is also inferior to heparin plus GPI for ischemic protection but associated with less bleeding.

Cost implications of intraprocedural thrombotic events during PCI.

OBJECTIVES: We sought to estimate the direct costs (in-hospital and 30-day) associated with an intraprocedural thrombotic event (IPTE) among patients with non-ST-segment elevation acute coronary syndromes (NSTEACS) undergoing percutaneous coronary intervention (PCI). BACKGROUND: Patients with IPTE have higher rates of in-hospital and 30-day major adverse cardiac events than patients without IPTE. The extent to which IPTE also add to medical costs is unknown. METHODS: Hospital costs for patients in the ACUITY Trial were compared between patients with and without IPTE. Adjusted comparisons were performed using generalized linear models (GLMs). All costs are reported in 2012 US dollars. RESULTS: A total of 1,307 patients with both core laboratory-based angiographic assessment and detailed economic data were included in the final study population. IPTE occurred in 52 patients (4.0%). Median in-hospital costs were higher in patients with IPTE than in those without IPTE ($23,719 vs. $18,419, P = 0.01). Thirty-day median costs were also higher for IPTE patients ($23,719 vs. $19,556, P = 0.05). After adjusting for baseline differences, IPTE was associated with 19.5% (95% CI: [2.8-38.8%], P = 0.02) and 18.9% (95% CI: [1.2-39.7%], P = 0.04) increases in in-hospital and 30-day costs, respectively. These relative differences represent median increases of $3,592 in initial hospital costs and $3,696 in 30-day costs. CONCLUSIONS: The occurrence of IPTE during the index PCI in patients with NSTEACS is associated with substantial increases in-hospital and 30-day costs. These findings suggest that strategies to prevent IPTE may be associated with important cost offsets as well as improved clinical outcomes.

Cost-effectiveness of bivalirudin versus heparin plus glycoprotein IIb/IIIa inhibitor in the treatment of acute ST-segment elevation myocardial infarction.

OBJECTIVE: To assess the cost-effectiveness of bivalirudin versus heparin and glycoprotein IIb/IIIa inhibitor (H-GPI) in patients undergoing primary percutaneous coronary intervention (PPCI) for acute ST-segment elevation myocardial infarction (STEMI), from a UK health service perspective. DESIGN: Cost-utility analysis with life-long time horizon. MAIN OUTCOME MEASURES: Costs, quality-adjusted life-years (QALYs) and incremental cost-effectiveness. METHODS: Event risks and medical resource use data derived from the HORIZONS-AMI trial were entered into a decision analytic model. Clinical events until the end of year 1 (main model) or year 3 (alternative model) were modelled in detail. Adjustments were applied to approximate UK routine practice characteristics. Life expectancy of 1-year or 3-year survivors, health-state utilities, initial hospitalisation length of stay in the comparator strategy and unit costs were based on UK sources. Costs and effects were discounted at 3.5%. RESULTS: The main model predicted bivalirudin and H-GPI patients to survive 11.52 and 11.35 (undiscounted) years on average, respectively, and to accrue 6.26 and 6.17 QALYs. Patient lifetime costs were £267 lower in the bivalirudin strategy (£12 843 vs £13 110). Extensive sensitivity and scenario analyses confirmed these results to be robust. In probabilistic analysis, quality-adjusted survival was higher and costs were lower with bivalirudin in 95.0% of simulation runs. In 99.2%, cost-effectiveness was better than £20 000 per QALY gained. Results from the alternative model were fully consistent. CONCLUSION: The use of bivalirudin instead of H-GPI in STEMI patients undergoing PPCI is cost-effective, and offers a high probability of dominance. Background treatment with aspirin and clopidogrel is assumed.

Economic impact of switching to bivalirudin for a primary percutaneous coronary intervention in a US hospital.

BACKGROUND: The addition of glycoprotein IIb/IIIa inhibitors (GPIs) to heparin in percutaneous coronary intervention (PCI) procedures has been demonstrated to reduce ischemic complications; however, GPI use is known to increase the risk of bleeding events, which are linked to increased mortality, longer hospital length of stay, greater medical resource utilization, and increased costs. New antithrombotic therapies have the potential to improve clinical outcomes and decrease costs. The Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) study of bivalirudin demonstrated significantly reduced clinical event rates (mortality and bleeding) compared with an unfractionated heparin (UFH)+GPI regimen. OBJECTIVE: The potential clinical and economic value of implementing a bivalirudin-based strategy for ST-segment elevation myocardial infarction (STEMI) patients receiving primary PCI (PPCI) is compared with current UFH+GPI-based practice from a US hospital perspective. METHODS: A budget impact model was developed to compare treatment of STEMI patients undergoing PPCI with a bivalirudin- or UFH+GPI-based strategy. Clinical data for the model were derived from the HORIZONS-AMI trial, and included 30-day event rates for major complications (eg, protocol bleeding, Q-wave MI, repeat PCI, and coronary artery bypass graft procedures). United States cost data and clinical practice data were derived from a Premier Perspective™ database analysis and published sources. RESULTS: Overall, average procedure costs per UFH+GPI-treated patient were $18,561. Treating patients with bivalirudin (incorporating 7.2% provisional GPI use per HORIZONS-AMI) may save $1690 per patient (average procedural cost, $16,872). In extrapolating these benefits to the American College of Cardiology/American Heart Association recommended institutional minimum of 36 PPCIs annually, 1 major bleeding event (3.7%) and 3 minor bleeding events (6.8%) could be averted with use of bivalirudin. In addition, introducing a bivalirudin-based strategy to treat a minimum cohort of 36 STEMI patients would save the hospital budget $60,807 (9%) per year. CONCLUSION: Using a bivalirudin-based strategy in STEMI patients undergoing PPCI is associated with favorable clinical and economic outcomes when compared with an UFH+GPI-based strategy in a US hospital setting.