Ventricular septal rupture after delayed STEMI: A modern management approach.

BACKGROUND: Myocardial infarction associated ventricular septal rupture (VSR) is a potentially catastrophic complication. Though surgical repair remains the definitive treatment, outcomes are poor with high mortality rates.Case and Management: We present the case of a 62-year-old male who presented with a delayed STEMI leading to a VSR and cardiogenic shock. His management strategy included early percutaneous VSR closure and use of an intra-aortic balloon pump and inotropes. This served as a bridge to definitive surgical VSR patch repair while allowing hemodynamic stabilization, end-organ recovery, and myocardial tissue stabilization. CONCLUSION: Mechanical support devices such as intra-aortic balloon pump and Impella combined with percutaneous closure options can serve as a bridge to definitive surgery for VSR. This requires rapid mobilization of a multi-disciplinary structural heart team including advanced imagers, structural interventionalists, and surgeons.

Evaluation of the Benefit of Extended Catheter-Directed Thrombolysis with Serial Angiography for Acute Pulmonary Embolism.

PURPOSE: To evaluate whether extended catheter-directed thrombolysis (CDT) with repeat visits to the angiography suite provide added benefit in treatment of acute pulmonary embolism (PE). MATERIALS AND METHODS: This was a retrospective review of CDT procedures performed for acute PE in 156 patients (age 56.1 y ± 15.3, 46.2% women) between 2009 and 2019. All patients underwent at least 1 follow-up visit to the angiography suite for evaluation of pulmonary artery pressure (PAP) and thrombus burden (Miller score) before termination (111/156, 71.2%) or continuation of CDT (45/156, 28.8%). RESULTS: Patients who had CDT extended beyond the first follow-up visit required a higher total dose of tissue plasminogen activator (40.7 mg ± 14.3 vs 22.6 mg ± 9.9, P < .001) to achieve a similar final Miller score (6.4 ± 3.8 vs 7.6 ± 3.9, P = .1) and a similar reduction in systolic PAP (-14.4 mm Hg ± 10.2 vs -12.6 mm Hg ± 11.9, P = .6). The initial Miller scores were similar in both groups (19.7 ± 5.8 vs 19 ± 4, P = .4) but were significantly higher during the first follow-up visit (after 18 hours ± 5.5 vs 20 hours ± 4.8, P = .06) in patients requiring multiple follow-up visits (12.2 ± 5 vs 7.6 ± 3.9, P < .001). Multiple regression analyses identified heart rate > 100 beats/min and systolic PAP > 55 mm Hg as associated with the need for extended CDT. Extended CDT did not result in a higher hemorrhagic complication rate (1/45 vs 6/111, P = .7). CONCLUSIONS: Patients presenting with higher heart rates and systolic PAP may benefit from extended CDT to achieve similar reductions in PAP and thrombus burden, without clear added risk of hemorrhage.

Utilization of an ICU Severity of Illness Scoring System to Triage Patients With ST-Elevation Myocardial Infarction.

OBJECTIVE: To subjectively identify low-risk ST-elevation myocardial infarction (STEMI) patients and triage this low-risk population to an intermediate level of care. BACKGROUND: Many patients with STEMI are admitted to the intensive care unit (ICU), however, a large portion do not merit ICU admission. We sought to examine whether, among post-STEMI patients admitted to the ICU, if an easily obtainable subjective scoring system could predict low-risk patients and safely triage them to an intermediate level of care. METHODS: Retrospective observational study at Christiana Hospital, a 900-bed regional referral center. Data were defined by the ACTION Registry and CathPCI Registry. Acute Physiology and Chronic Health Evaluation (APACHE) predictions were retrieved for all patients with STEMI and were analyzed for complications, length of stay, and inhospital mortality. We then examined subjective criteria to triage patients with STEMI out of the ICU. RESULTS: Among 253 patients with STEMI, 179 (70.75%) were classified as low risk (intermediate level care appropriate) and 74 (29.25%) were classified as high risk (ICU appropriate). The mean age was 64.95 years. The APACHE III score was right skewed with a mean of 36.97 and a median of 31. There was a significant difference between the APACHE III score of low-risk patients and the APACHE III score of high-risk patients (P < .001). CONCLUSION: In conclusion, patients characterized as low risk, as defined by our criteria, had low APACHE III scores and a low likelihood of complications post-STEMI. This low-risk population could potentially be admitted to an intermediate level of care, avoiding the ICU altogether.

Large-Bore Aspiration Thrombectomy versus Catheter-Directed Thrombolysis for Acute Pulmonary Embolism: A Propensity Score-Matched Comparison.

PURPOSE: To compare effectiveness and safety of large-bore aspiration thrombectomy (LBAT) with catheter-directed thrombolysis (CDT) for treatment of acute massive and submassive pulmonary embolism (PE). MATERIALS AND METHODS: This retrospective review included patients with acute PE treated with LBAT or CDT using tissue plasminogen activator (tPA) between December 2009 and May 2020. A propensity score based on Pulmonary Embolism Severity Index class and PE severity (massive vs submassive) was calculated, and 26 LBAT cases (age 60.2 y ± 17.1, 14/26 women) were matched with 26 CDT cases (age 59.7 y ± 14.2, 14/26 women). RESULTS: The CDT group had 22.1 mg ± 8.1 tPA infused over 21.2 h ± 6.6. Both groups demonstrated similar initial and final systolic pulmonary artery pressure (PAP) (LBAT: 54.5 mm Hg ± 12.9 vs CDT: 54.5 mm Hg ± 16.3, P = .8, and LBAT: 42.5 mm Hg ± 14.1 vs CDT: 42.6 mm Hg ± 12.1, P = .8, respectively) and similar reductions in heart rate (LBAT: -5.4 beats/min ± 19.2 vs CDT: -9.6 beats/min ± 15.8, P = .4). CDT demonstrated a higher reduction in Miller score (-10.1 ± 3.9 vs -7.5 ± 3.8, P = .02). LBAT resulted in 1 minor hemorrhagic complication and 2 procedure-related mortalities, and CDT resulted in 1 minor and 1 major hemorrhagic complication. CONCLUSIONS: LBAT and CDT resulted in similar reductions of PAP and heart rate when used to treat acute PE. CDT reduced thrombus burden to a greater degree. Although hemorrhagic complications rates were not significantly different, the LBAT group demonstrated a higher rate of procedure-related mortality. Larger studies are needed to compare the safety of these techniques.

Long-term outcomes in patients with acute coronary syndromes related to prolonging dual antiplatelet therapy more than 12 months after coronary stenting.

OBJECTIVES: To assess the impact of stent type on the risk of death or myocardial infarction (MI) related to dual antiplatelet therapy (DAPT) more than 12 months (prolonged DAPT) versus 12 or less months after PCI for an acute coronary syndrome (ACS). BACKGROUND: The recent DAPT study reported lower recurrent ischemic events from prolonged DAPT in patients treated with PCI for an ACS, but was underpowered to determine the impact of stent type. METHODS: We determined clinical outcomes after PCI for an ACS (median follow-up: DES = 26 months, BMS = 46 months) in 18,484 patients in the Veterans Affairs system treated with first generation drug-eluting stents (DES) or bare-metal stents (BMS). We used landmark analyses starting 1 year after the index PCI to assess the risk of prolonged DAPT on the primary endpoint of death or MI. Multivariable and propensity models adjusted for confounding. RESULTS: There was a significant interaction between stent type and prolonged DAPT for death and MI (P = 0.0036), death (P = 0.054), and major bleeding (P = 0.0013). Patients treated with prolonged DAPT had lower risks of death or MI (HR = 0.71, 95% CI = 0.61, 0.82) and death (HR = 0.74, 95%CI = 0.62, 0.89) with DES, but not BMS, and higher risks of major bleeding, particularly with BMS (HR = 1.67, P < 0.001) than DES (HR = 1.24, p = 0.01). CONCLUSIONS: Prolonging DAPT more than 12 months after PCI for ACS only associated with a lower risk of ischemic events in the 1-4 years after PCI in those receiving first generation DES. Stent type may influence the benefit of prolonged DAPT. © 2016 Wiley Periodicals, Inc.

2017 ISHNE-HRS expert consensus statement on ambulatory ECG and external cardiac monitoring/telemetry.

Ambulatory ECG (AECG) is very commonly employed in a variety of clinical contexts to detect cardiac arrhythmias and/or arrhythmia patterns which are not readily obtained from the standard ECG. Accurate and timely characterization of arrhythmias is crucial to direct therapies that can have an important impact on diagnosis, prognosis or patient symptom status. The rhythm information derived from the large variety of AECG recording systems can often lead to appropriate and patient-specific medical and interventional management. The details in this document provide background and framework from which to apply AECG techniques in clinical practice, as well as clinical research.

Assessing the cost burden of United States FDA-mandated post-approval studies for medical devices.

Approved medical devices frequently undergo FDA mandated post-approval studies (PAS). However, there is uncertainty as to the value of PAS in assessing the safety of medical devices and the cost of these studies to the healthcare system is unknown. Since PAS costs are funded through device manufacturers who do not share the costs with regulators, we sought to estimate the total PAS costs through interviews with a panel of experts in medical device clinical trial design in order to design a general cost model for PAS which was then applied to the FDA PAS. A total of 277 PAS were initiated between 3/1/05 through 6/30/13 and demonstrated a median cost of $2.16 million per study and an overall cost of $1.22 billion over the 8.25 years of study. While these costs are funded through manufacturers, the ultimate cost is borne by the healthcare system through the medical device costs. Given concerns regarding the informational value of PAS, the resources used to support mandated PAS may be better allocated to other approaches to assure safety.

Renal Denervation: Where to Now?

Resistant hypertension remains a growing problem worldwide. Renal sympathetic denervation was thought to be a new method for the treatment for resistant hypertension. Early studies demonstrated a marked benefit in patients who underwent renal denervation procedures, but the pivotal SYMPLICITY 3-HTN trial, the only sham-controlled randomized trial performed, did not show a benefit for patients treated with the procedure compared to sham. There is still much to learn about the physiology and anatomy of renal sympathetic pathways as well as careful attention to medication adherence in order to understand the role of renal sympathetic denervation in treating hypertensive patients. While renal denervation technology remains available in clinical practice outside of the USA, we expect further development of this technology in the upcoming years and the continued evaluation of this technology in patients with hypertension as well as other disease states to fully understand its role.

Abdominal aorta as an alternative access route for transcatheter aortic valve replacement.

A variety of access routes have been employed for transcatheter aortic valve replacement (TAVR). We report a TAVR case using the abdominal aorta as the direct access route when other approaches are not feasible.

Delay in reperfusion with transradial percutaneous coronary intervention for ST-elevation myocardial infarction: Might some delays be acceptable?

BACKGROUND: Randomized clinical trials (RCTs) suggest benefits for the transradial approach to percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI). However, transradial PCI may delay reperfusion, leading to its avoidance. We sought to quantify the delay in reperfusion from transradial PCI ("transradial delay") that would need to be introduced to offset the potential mortality benefit of transradial PCI, compared with transfemoral, observed in RCTs. METHODS: We developed a decision-analytic model to compare transfemoral and transradial PCI in STEMI. Thirty-day mortality rates were estimated by pooling STEMI patients from 2 RCTs comparing transfemoral and transradial PCI. We projected the impact of transradial delay using estimates of the increase in mortality associated with door-to-balloon time delays. Sensitivity analyses were performed to understand the impact of uncertainty in assumptions. RESULTS: In the base case, a transradial delay of 83.0 minutes was needed to offset the mortality benefit of transradial PCI. When the mortality benefit of transradial PCI was one-quarter that observed in RCTs, the delay associated with equivalent mortality was 20.9 minutes. In probabilistic sensitivity analyses, transradial PCI was preferred over transfemoral PCI in 97.5% of simulations when transradial delay was 30 minutes and in 79.0% of simulations when delay was 60 minutes. CONCLUSIONS: A substantial transradial delay is required to eliminate even a fraction of the mortality benefit observed with transradial PCI in RCTs. Results were robust to changing multiple assumptions and have implications for operators reluctant to transition to transradial PCI in STEMI because of concern for delaying reperfusion.

Impact of ACIST CVi contrast delivery system on iodinated contrast media administration and waste.

The COVID-19 pandemic led to disruptions in iodinated contrast media (ICM) production and produced a global product shortage in the spring of 2022. The ACIST CVi system is an automated contrast injector system approved by the FDA for multi-patient dosing of ICM from a single container. A transition from the traditional manifold system for contrast injection to the ACIST CVi automated injector system in our cardiac angiographic labs during the COVID-19 pandemic led to reductions in contrast waste and cost while limiting patient exposure to ICM.

Liberal versus restrictive transfusion thresholds for patients with symptomatic coronary artery disease.

BACKGROUND: Prior trials suggest it is safe to defer transfusion at hemoglobin levels above 7 to 8 g/dL in most patients. Patients with acute coronary syndrome may benefit from higher hemoglobin levels. METHODS: We performed a pilot trial in 110 patients with acute coronary syndrome or stable angina undergoing cardiac catheterization and a hemoglobin <10 g/dL. Patients in the liberal transfusion strategy received one or more units of blood to raise the hemoglobin level ≥10 g/dL. Patients in the restrictive transfusion strategy were permitted to receive blood for symptoms from anemia or for a hemoglobin <8 g/dL. The predefined primary outcome was the composite of death, myocardial infarction, or unscheduled revascularization 30 days post randomization. RESULTS: Baseline characteristics were similar between groups except age (liberal, 67.3; restrictive, 74.3). The mean number of units transfused was 1.6 in the liberal group and 0.6 in the restrictive group. The primary outcome occurred in 6 patients (10.9%) in the liberal group and 14 (25.5%) in the restrictive group (risk difference = 15.0%; 95% confidence interval of difference 0.7% to 29.3%; P = .054 and adjusted for age P = .076). Death at 30 days was less frequent in liberal group (n = 1, 1.8%) compared to restrictive group (n = 7, 13.0%; P = .032). CONCLUSIONS: The liberal transfusion strategy was associated with a trend for fewer major cardiac events and deaths than a more restrictive strategy. These results support the feasibility of and the need for a definitive trial.

Anti-anginal and anti-ischemic effects of late sodium current inhibition.

The effective treatment of coronary artery disease targets two distinct goals, controlling symptomatic angina and decreasing the adverse events associated with ischemia. Traditional anti-anginal and anti-ischemic drugs function by altering the determinants of myocardial oxygen supply or demand, usually by altering loading conditions, changing the heart rate, or impacting contractility. Blockade of the late inward sodium current, late I(Na), offers another target for the treatment of ischemia. Blockade of late I(Na) reduces the sodium and calcium overload that follows ischemia. This improves myocardial relaxation and reduces left ventricular diastolic stiffness, in turn enhancing myocardial contractility and perfusion. Ranolazine, a late I(Na) inhibitor, has been shown to provide both anti-anginal and anti-ischemic benefits without significant alterations in the heart rate and blood pressure in patients with stable coronary artery disease. When evaluated in patients with acute coronary syndrome, ranolazine has been shown to decrease recurrent ischemia, but not significantly reduce the risk of death or myocardial infarction. This review will address the rationale that inhibition of the late sodium current is beneficial in reducing cardiac dysfunction during ischemia, and discuss the clinical studies supporting the use of ranolazine for its anti-anginal and anti-ischemic effects.

Risk prediction for adverse events after carotid artery stenting in higher surgical risk patients.

BACKGROUND AND PURPOSE: The goal of carotid artery stenting is to decrease the risk of stroke or other adverse events from carotid artery disease. Choosing a treatment strategy requires patient-specific information regarding periprocedural risk of adverse neurologic events. The aim of this study was to predict individual patient risk after carotid artery stenting in patients at higher risk for carotid endarterectomy. METHODS: Subjects enrolled in the Stenting and Angioplasty with Protection in Patients at High-Risk for Endarterectomy (SAPPHIRE) worldwide study underwent carotid artery stenting with distal protection. Only patients with at least 1 anatomic or comorbid factor associated with elevated surgical risk were included. Preprocedural factors were used to develop a model and integer-based risk score predicting stroke or death within 30 days. The model was calibrated and internally validated using bootstrap resampling. RESULTS: Ten thousand one hundred eighty-six patients were included in the analysis. The overall rate of stroke or death was 3.6% at 30 days after carotid artery stenting. Independent predictors of adverse outcomes were increased age (P=0.006), history of stroke (P<0.001), history of transient ischemic attack presentation (P=0.001), recent (<4 weeks) myocardial infarction (P=0.006), dialysis treatment (P=0.007), need for cardiac surgery in addition to carotid revascularization (P=0.005), a right-sided carotid stenosis (P=0.006), a longer carotid plaque (P=0.012), the presence of a Type II or III aortic arch (P=0.035), and a tortuous carotid arterial system (P=0.004). The optimism-adjusted C-statistic was 0.691. CONCLUSIONS: Commonly collected clinical and anatomic variables can identify patients at high and low risk for stroke or death after carotid artery stenting.

Outcomes With Early Cardiac Catheterization in Out of Hospital Cardiac Arrest Survivors and Utility of a Prognostic Scoring System.

Objectives A retrospective study in patients presenting out of hospital cardiac arrest (OHCA) to assess the impact of early cardiac catheterization on survival and cerebral performance category (CPC) on discharge. Background The role of early coronary angiography in OHCA patients remains controversial. The cardiac arrest hospital prognosis (CAHP) scoring system has not been validated in the US population. Methods Inclusion criteria were OHCA patients with a sustained return of spontaneous circulation (ROSC), presumed cardiac cause of arrest, and elements to calculate CAHP score. We compared in-hospital mortality rates and final inpatient CPC in patients who underwent early cardiac catheterization to those with delayed or no cardiac catheterization. We assessed the performance of the CAHP score in the entire OHCA population using receiver-operator curve (ROC) analysis. Results A hundred and fifty-eight patients were included, of which 39 underwent early cardiac catheterization. The mortality rate of the early catheterization group was lower than the delayed or no catheterization group (41% vs 61.3%, p=0.02); the Early cardiac catheterization group had more favorable final hospital CPC scores overall (53.8% vs 24.3%, p<0.001). However, when risk-adjusted, there was no benefit in early catheterization for mortality or CPC level in any of the CAHP score subgroups. CAHP scores showed good discrimination with c-statistics of 0.85 for mortality and 0.90 for the CPC category. Conclusion Early use of cardiac catheterization in OHCA patients with sustained ROSC was not associated with lower mortality rates or higher rates of favorable neurologic recovery when adjusted for baseline risk factors in each of the different CAHP score-based sub-groups. This was despite a higher proportion of patients with STEMI in the early catheterization group. We demonstrated a good fit between observed outcomes and outcomes predicted by the CAHP scoring system.

An examination of cardiovascular intensive care unit mortality based on admission day and time.

BACKGROUND: Recent interest in the 'weekend effect' has been expanded to cardiovascular intensive care units, yet the impact of off-hours admission on mortality and cardiovascular ICU (CICU) length of stay remains uncertain. OBJECTIVES: We examine the association between CICU admission day and time with mortality. Additionally, length-of-stay was also evaluated in relation to admission time. METHODS: A single-center, retrospective cohort study was conducted including 10,638 adult patients admitted to a CICU in a tertiary-care academic medical center from July 1, 2012 to June 30, 2019. ICU mortality and length-of-stay were assessed by admission day and time adjusting for comorbid conditions and other clinical variables. We used logistic regression models to evaluate the factors associated with mortality and a generalized linear model (GLM) with log link function and gamma distribution was used to evaluate the factors associated with ICU length of stay. RESULTS: Compared to weekday-day admissions, we observed an increased mortality for weekend-day for all admissions (6.5 vs 9.6%, Adjusted OR: 1.32 (1.03-1.72)), and for medical CICU admissions (7.6 vs 9.9%, Adjusted OR: 1.35 (1.02-1.79)). Additionally, compared to weekday-day, weekday-night admission was associated with 7% longer ICU length of stay in surgical ICU patients, 7% shorter length of stay in medical ICU patients. CONCLUSION: Admission to this open-model CICU during weekend hours (Saturday 08:00-Sunday 17:59) versus nights or weekdays is associated with increased mortality. ICU staffing care models should not significantly change based on the day of the week.

Temporal Analysis of Tachycardia During Catheter Directed Thrombolysis for Acute Pulmonary Embolism.

PURPOSE: To evaluate the effect of catheter directed thrombolysis (CDT) on heart rate (HR) in patients with sinus tachycardia and acute pulmonary embolism (PE). METHODS: A retrospective chart review was performed for patients who underwent CDT with tPA for acute massive or submassive PE between 12/2009 and 2/2020. Included were patients who presented with tachycardia at the time of initiation of CDT. Patients with chronic PE, atrial fibrillation, beta blocker therapy, adjunctive endovascular therapy, systemic thrombolysis, or who expired before conclusion of CDT were excluded. HR was measured approximately every hour during CDT. Graphs were plotted of HR as a function of CDT duration. Two interventional radiologists identified the point of plateau (POP) on the graph where CDT had maximized its benefit in decreasing the patient's HR. Discrepancies were adjudicated by a third interventional radiologist and the median of the 3 measurements was selected. The primary endpoint was the duration of CDT from initiation until the POP. RESULTS: 48 patients were included (52.5 ± 14.7 years, 56.3% female). The POP occurred after 13.1 ± 6.1 hours, by which point HR had been reduced from 110 ± 9.2 bpm to 88 ± 10.6 bpm. Sinus tachycardia was not resolved in 10 patients even though they achieved maximal improvement in HR after 11.3 ± 6.7 hours. CONCLUSION: Patients presenting with sinus tachycardia related to acute PE achieved maximal, sustained reduction in heart rate from CDT, after approximately 13 hours of infusion. Patients who did not resolve their tachycardia by that point in time were unlikely to resolve it by the conclusion of CDT.

Comparison of pulse wave analysis between persons with white coat hypertension and normotensive persons.

White coat hypertension (WCH) is considered by some but not all investigators to be a benign condition without increased cardiovascular risk. Pulse wave analysis is a noninvasive method to measure how the reflected pressure wave interacts with central aortic blood pressure (BP) and to assess how it is related to vascular stiffness. The purpose of the study was to compare central aortic BP in normotensive and WCH participants. WCH participants were identified after ambulatory BP monitoring. Normotensive participants served as controls. Using radial artery applanation tonometry, aortic pulse wave analysis was performed. Augmentation index (AI), AI75, and differences in systolic BP between central aortic and peripheral vasculatures were calculated. Results show a difference in AI, AI75, (AI standardized to a heart rate of 75 beats per minute), and central aortic systolic pressures between WCH and normotensive participants. The WCH group had significantly higher systolic BP and pulse pressure; however, these were still within the normal range. In summary, WCH participants had increased central aortic pressures compared with normotensives, supporting the potential for increased cardiovascular risk in WCH.

Practice Patterns and In-Hospital Outcomes Associated With Bivalirudin Use Among Patients With Non-ST-Segment-Elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention in the United States.

BACKGROUND: Practice patterns in anticoagulant strategies used during percutaneous coronary intervention (PCI) in the United States for patients with non-ST-segment-elevation myocardial infarction and the comparative outcomes between bivalirudin and unfractionated heparin (UFH) have not been well described. METHODS AND RESULTS: Trends in anticoagulant use were examined among 553 562 PCIs performed by 9254 operators at 1538 hospitals for non-ST-segment-elevation myocardial infarction from 2009 to 2014 within the CathPCI Registry. To compare bivalirudin with UFH, propensity score matching and instrumental variable (IV) methods with operator preference for bivalirudin as the instrument were used. To determine whether differences in outcomes were because of differences in glycoprotein IIb/IIIa inhibitor (GPI) use, a test of mediation was performed using the IV. Outcomes were in-hospital bleeding and mortality. Bivalirudin use increased from 2009 to 2013 but declined during 2014. GPI use was 50.5% during UFH PCIs and 12.0% during bivalirudin PCIs. Before GPI adjustment, bleeding reductions with bivalirudin ranged from 2.04% (IV: 95% confidence interval [CI]: 1.81%, 2.27%) to 2.29% (propensity score: 95% CI: 2.14%, 2.44%) and mortality reductions ranged from 0.16% (IV: 95% CI: 0.03%, 0.28%) to 0.25% (propensity score: 95% CI: 0.17%, 0.33%). After GPI adjustment in the IV, more than half the bleeding reduction with bivalirudin was because of the lower use of GPIs (risk difference, -0.84%; 95% CI: -1.11%, -0.57%), and no survival benefit was apparent (risk difference, -0.10%; 95% CI: -0.24%, 0.05%). Bleeding reductions with bivalirudin were largest for transfemoral PCI (GPI-adjusted risk difference, -1.11%; 95% CI: -1.43%, -0.80%) and negligible for transradial PCI (GPI-adjusted risk difference, 0.09%; 95% CI: -0.32%, 0.50%). CONCLUSIONS: In the largest comparative analysis of bivalirudin versus UFH for non-ST-segment-elevation myocardial infarction to date, bivalirudin was associated with lower in-hospital bleeding and mortality given current practices with respect to GPI use and access site. Bleeding differences were, in part, explained by the greater use of GPIs with UFH. Reductions in bleeding were largest among those undergoing transfemoral PCI, whereas no bleeding benefit was observed for those treated with transradial PCI.