Faculty Bibliography

BACKGROUND:Prior studies have suggested that blacks with acute ST-segment-elevation myocardial infarction have increased bleeding risks with fibrinolysis relative to whites, yet these data were quite limited. Additionally, it is unknown whether there are racial differences in bleeding risks among patients with ST-segment-elevation myocardial infarction receiving primary percutaneous coronary intervention. METHODS AND RESULTS/RESULTS:We evaluated data on blacks and whites with ST-segment-elevation myocardial infarction treated with either fibrinolysis or primary percutaneous coronary intervention from the National Registry of Myocardial Infarction (NRMI)-4 and 5 participating centers between July 2000 and December 2006. We compared differences between the 2 groups in rates of in-hospital major bleeding and mortality, adjusted with logistic regression analyses. In fibrinolytic-treated patients with ST-segment-elevation myocardial infarction, the bleeding rates were higher among blacks (n=2283) than whites (n=42 243; 10.9% versus 10.3%; adjusted odds ratio, 1.21; 95% confidence interval, 1.02-1.43). Similarly, in patients receiving primary percutaneous coronary intervention, the bleeding rates were higher in blacks (n=2826) than in whites (n=46 332; 10.3% versus 7.8%; adjusted odds ratio, 1.33; 95% confidence interval, 1.13-1.56). Bleeding was associated with higher risk of death in both ethnic groups. However, there was no overall racial difference in in-hospital mortality among those with bleeding or without bleeding treated with either fibrinolysis or primary percutaneous coronary intervention. CONCLUSIONS:Blacks with ST-segment-elevation myocardial infarction treated with either fibrinolysis or primary percutaneous coronary intervention had a higher risk of bleeding events than their white counterparts. Bleeding was associated with a similar increased risk of death in both ethnic groups treated by either reperfusion strategy.

The adoption of transradial coronary angiography and coronary intervention is growing because of emerging data on its potential advantages over the femoral approach. As the adoption of radial procedures increases, it is important to understand the remaining challenges of both the technique and its implementation. In this review, we discuss four important issues related to transradial procedures--radial access site bleeding, radial artery injury and occlusion, radiation exposure, and implementation of a successful transradial primary percutaneous coronary intervention (PCI) programme. Although the radial artery is superficial and haemostasis can be achieved readily, access site bleeding can occur that, if left unchecked, can lead to forearm haematoma and, rarely, to compartment syndrome. Radial artery injury and occlusion are consequences of radial access, and randomized trials show that use of smaller diameter sheaths, adequate anticoagulation, and post-procedure 'patent' haemostasis reduce the risk of occlusion. The published literature demonstrates an association between transradial procedures and increased radiation exposure; therefore, reduction of radiation dosing during transradial procedures should be a priority for operators and catheterization laboratories. The potential reduction in mortality seen with transradial primary PCI must be balanced against the clinical imperative of timely reperfusion. Operators and catheterization laboratories should not begin a transradial primary PCI programme until sufficient radial experience has been gained in the elective setting. In addition, a protocol for femoral bailout should be considered to maintain door-to-reperfusion metrics.

DESCRIPTION/METHODS:Although approximately 85 million units of red blood cells (RBCs) are transfused annually worldwide, transfusion practices vary widely. The AABB (formerly, the American Association of Blood Banks) developed this guideline to provide clinical recommendations about hemoglobin concentration thresholds and other clinical variables that trigger RBC transfusions in hemodynamically stable adults and children. METHODS:These guidelines are based on a systematic review of randomized clinical trials evaluating transfusion thresholds. We performed a literature search from 1950 to February 2011 with no language restrictions. We examined the proportion of patients who received any RBC transfusion and the number of RBC units transfused to describe the effect of restrictive transfusion strategies on RBC use. To determine the clinical consequences of restrictive transfusion strategies, we examined overall mortality, nonfatal myocardial infarction, cardiac events, pulmonary edema, stroke, thromboembolism, renal failure, infection, hemorrhage, mental confusion, functional recovery, and length of hospital stay. RECOMMENDATION 1: The AABB recommends adhering to a restrictive transfusion strategy (7 to 8 g/dL) in hospitalized, stable patients (Grade: strong recommendation; high-quality evidence). RECOMMENDATION 2: The AABB suggests adhering to a restrictive strategy in hospitalized patients with preexisting cardiovascular disease and considering transfusion for patients with symptoms or a hemoglobin level of 8 g/dL or less (Grade: weak recommendation; moderate-quality evidence). RECOMMENDATION 3: The AABB cannot recommend for or against a liberal or restrictive transfusion threshold for hospitalized, hemodynamically stable patients with the acute coronary syndrome (Grade: uncertain recommendation; very low-quality evidence). RECOMMENDATION 4: The AABB suggests that transfusion decisions be influenced by symptoms as well as hemoglobin concentration (Grade: weak recommendation; low-quality evidence).

OBJECTIVES/OBJECTIVE:The authors sought to describe the association between post-procedural bleeding and long-term recurrent bleeding, major adverse cardiac events (MACE), and mortality among older patients undergoing percutaneous coronary intervention (PCI). BACKGROUND:Bleeding complications after PCI are associated with an increased risk for acute morbidity and long-term mortality, but the association of these bleeding complications with other events is unknown. METHODS:Patients entered into the National Cardiovascular Data Registry (NCDR) CathPCI Registry (n = 461,311; 946 sites) from January 2004 to December 2008 were linked with claims from the Centers for Medicare & Medicaid Services and grouped according to in-hospital post-PCI bleeding. The association between post-PCI bleeding and 1-, 12-, and 30-month readmission for bleeding, MACE, and all-cause mortality was examined with Cox regression that included patient and procedural characteristics using no bleeding as the reference. RESULTS:Overall, 3.1% (n = 14,107) of patients experienced post-PCI bleeding. Patients who bled were older, more often female, had more medical comorbidities, less often received bivalirudin, and more often underwent PCI via the femoral approach. After adjustment, bleeding after the index procedure was significantly associated with readmission for bleeding (adjusted hazard ratios [95% confidence interval]: 1 month, 1.54 [1.42 to 1.67]; 12 months, 1.52 [1.40 to 1.66]; 30 months, 1.29 [1.11 to 1.50]), MACE (1 month, 1.11 [1.07 to 1.15]; 12 months, 1.17 [1.13 to 1.21]; 30 months, 1.12 [1.06 to 1.19]) and all-cause mortality (1 month, 1.32 [1.26 to 1.38]; 12 months, 1.33 [1.27 to 1.40]); 30 months, 1.22 [1.15 to 1.30]). CONCLUSIONS:Post-PCI bleeding complications are associated with an increased risk for short- and long-term recurrent bleeding, MACE, and all-cause mortality. These data underscore the prognostic importance of periprocedural bleeding and the need for identifying strategies to reduce long-term bleeding risk among patients undergoing PCI.

AIMS/OBJECTIVE:Fondaparinux is an indirect, Factor Xa inhibitor that requires co-administration of another anticoagulant with anti-Factor IIa activity for percutaneous coronary intervention (PCI) per guideline recommendations. In this setting, the use of bivalirudin, a direct Factor IIa inhibitor, is not well established. METHODS AND RESULTS/RESULTS:Using the Premier hospital database, we identified 971 patients who underwent elective or urgent PCI after receiving fondaparinux as the initial anticoagulant. They were treated with either bivalirudin ± glycoprotein IIb/IIIa inhibitor (GPI) (Group A=618) or unfractionated heparin (UFH) ± GPI (Group B=353) during PCI. A 2:1 propensity score matching (PSM) process was performed to control for patient and hospital level characteristics. The primary endpoints were to determine in-hospital death, bleeding and post-PCI length of stay (LOS) between treatment groups. After PSM, 512 matched patients were analysed (Group A=348 and Group B=174). In-hospital death was 1.4% in Group A vs. 2.9% in Group B (p=0.26). Clinically apparent bleeding occurred in 4.0% of Group A vs. 9.2% of Group B patients (p<0.02). Clinically apparent bleeding requiring transfusion was lower in Group A patients (0.6% vs. 2.9%; p=0.04). Post-PCI LOS was 1.9 ± 3.8 days for Group A and 2.4 ± 5.8 days for Group B (p=0.36). GPI use during PCI occurred in 9.2% of Group A vs. 44.8% of Group B patients (p<0.0001). CONCLUSIONS:After initial administration of fondaparinux, a bivalirudin-based strategy for PCI is associated with significantly reduced bleeding, with similar mortality and post-PCI LOS when compared with an UFH-based strategy.

Since its advent over two decades ago, transradial access for cardiac catheterization and percutaneous intervention has evolved into a versatile and evidence-based approach for containing the risks of access-site bleeding and vascular complications without compromising the technical range or success associated with contemporary percutaneous coronary intervention (PCI). Early studies demonstrated reduced rates of vascular complications and access-site bleeding with radial-access catheterization but at the cost of increased access-site crossover and reduced procedural success. Contemporary data demonstrate that while the rates of major bleeding with femoral-access PCI in standard-risk cohorts have declined significantly over time, the transradial approach still retains significant advantages by way of reductions in vascular complications, length of stay, and enhanced patient comfort and patient preference over the femoral approach, while maintaining procedural success. Major adverse cardiovascular events and bleeding are lowest with the transradial approach when procedures are performed at high-volume radial centers, by experienced radial operators, or in the context of ST-segment elevation myocardial infarction. Choice of procedural anticoagulation appears to differentially impact access-site bleeding in transradial versus transfemoral PCI; however, non-access site bleeding remains a significant contributor to major bleeding in both groups. Despite abundant supporting data, adoption of transradial technique as the default strategy in cardiac catheterization in the United States has lagged behind many other countries. However, recent trends suggest that interest and adoption of the technique in the United States is growing at a brisker pace than previously observed.

OBJECTIVES/OBJECTIVE:The purpose of this study was to examine temporal trends in post-percutaneous coronary intervention (PCI) bleeding among patients with elective PCI, unstable angina (UA)/non-ST-segment elevation myocardial infarction (NSTEMI), and ST-segment elevation myocardial infarction (STEMI). BACKGROUND:The impact of bleeding avoidance strategies on post-PCI bleeding rates over time is unknown. METHODS:Using the CathPCI Registry, we examined temporal trends in post-PCI bleeding from 2005 to 2009 among patients with elective PCI (n = 599,524), UA/NSTEMI (n = 836,103), and STEMI (n = 267,632). We quantified the linear time trend in bleeding using 3 sequential logistic regression models: 1) clinical factors; 2) clinical + vascular access strategies (femoral vs. radial, use of closure devices); and 3) clinical, vascular strategies + antithrombotic treatments (anticoagulant ± glycoprotein IIb/IIIa inhibitor [GPI]). Changes in the odds ratio for time trend in bleeding were compared using bootstrapping and converted to risk ratio. RESULTS:An approximate 20% reduction in post-PCI bleeding was seen (elective PCI: 1.4% to 1.1%; UA/NSTEMI: 2.3% to 1.8; STEMI: 4.9% to 4.5%). Radial approach remained low (<3%), and closure device use increased marginally from 44% to 49%. Bivalirudin use increased (17% to 30%), whereas any heparin + GPI decreased (41% to 28%). There was a significant 6% to 8% per year reduction in annual bleeding risk in UA/NSTEMI and elective PCI, but not in STEMI. Antithrombotic strategies were associated with roughly half of the reduction in annual bleeding risk: change in risk ratio from 7.5% to 4% for elective PCI, and 5.7% to 2.8% for UA/NSTEMI (both p <0.001). CONCLUSIONS:The nearly 20% reduction in post-PCI bleeding over time was largely due to temporal changes in antithrombotic strategies. Further reductions in bleeding complications may be possible as bleeding avoidance strategies evolve, especially in STEMI.

BACKGROUND:Conflicting evidence exists on sex-based outcomes after coronary stenting. METHODS AND RESULTS/RESULTS:Data on 426 996 patients ≥65 years old (42.3% women) from the National Cardiovascular Data Registry CathPCI Registry (2004-2008) were linked to Medicare inpatient claims to compare in-hospital outcomes by sex and long-term outcomes by sex and stent type. In-hospital complications were more frequent in women than in men: death (3869 [2.2%] versus 3737 [1.6%]; adjusted odds ratio, 1.41; 95% confidence interval [CI], 1.33-1.49), myocardial infarction (2365 [1.3%] versus 2858 [1.2%]; odds ratio, 1.19; 95% CI, 1.11-1.27), bleeding (7860 [4.4%] versus 5627 [2.3%]; odds ratio, 1.86; 95% CI, 1.79-1.93), and vascular complications (2381 [1.3%] versus 1648 [0.7%]; odds ratio, 1.85; 95% CI, 1.73-1.99). At 20.4 months, women had a lower adjusted risk of death (hazard ratio [HR], 0.92; 95% CI, 0.90-0.94) but similar rates of myocardial infarction, revascularization, and bleeding. Relative to bare metal stent use, drug-eluting stent use was associated with similar improved long-term outcomes in both sexes: death (women: adjusted HR, 0.78; 95% CI, 0.76-0.81; men: HR, 0.77; 95% CI, 0.74-0.79), myocardial infarction (women: HR, 0.79; 95% CI, 0.74-0.84; men: HR, 0.81; 95% CI, 0.77-0.85), and revascularization (women: HR, 0.93; 95% CI, 0.90-0.97; men: HR, 0.91; 95% CI, 0.88-0.94). There was no interaction between sex and stent type for long-term outcomes. CONCLUSIONS:In contemporary coronary stenting, women have a slightly higher procedural risk than men but have better long-term survival. In both sexes, use of a drug-eluting stent is associated with lower long-term likelihood for death, myocardial infarction, and revascularization.