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BACKGROUND: Radial artery access for coronary angiography or percutaneous coronary intervention (PCI) reduces the risk of death, bleeding, and vascular complications and is preferred over femoral artery access, leading to a class 1 indication by clinical practice guidelines. However, alternate upper extremity access such as distal radial and ulnar access are not mentioned in the guidelines despite randomized trials. We aimed to evaluate procedural outcomes with femoral, radial, distal radial, and ulnar access sites in patients undergoing coronary angiography or PCI. METHODS: PubMed, EMBASE, and clinicaltrials.gov databases were searched for randomized clinical trials that compared at least 2 of the 4 access sites in patients undergoing PCI or angiography. Primary outcomes were major bleeding and access site hematoma. Intention-to-treat mixed treatment comparison meta-analysis was performed. RESULTS: From 47 randomized clinical trials that randomized 38 924 patients undergoing coronary angiography or PCI, when compared with femoral access, there was a lower risk of major bleeding with radial access (odds ratio [OR], 0.46 [95% CI, 0.35--0.59]) and lower risk of access site hematoma with radial (OR, 0.34 [95% CI, 0.24--0.48]), distal radial (OR, 0.33 [95% CI, 0.20--0.56]), and ulnar (OR, 0.50 [95% CI, 0.31--0.83]) access. However, when compared with radial access, there was higher risk of hematoma with ulnar access (OR, 1.48 [95% CI, 1.03--2.14]). CONCLUSIONS: Data from randomized trials support guideline recommendation of class 1 for the preference of radial access over femoral access in patients undergoing coronary angiography or PCI. Moreover, distal radial and ulnar access can be considered as a default secondary access site before considering femoral access. REGISTRATION: URL: https://www.crd.york.ac.uk/PROSPERO/; Unique identifier: 42024512365. GRAPHIC ABSTRACT: A graphic abstract is available for this article. [ABSTRACT FROM AUTHOR]

BACKGROUND: Transradial percutaneous coronary intervention (PCI; TRI) reduces adverse outcomes when compared with transfemoral PCI (TFI). However, TRI is also used less in high-risk patients. It remains unknown how baseline patient risk influences access-site choice among PCI operators and whether the absolute benefit of TRI is greater among patients at high risk for bleeding, acute kidney injury (AKI), and death. METHODS: We analyzed 28 005 PCIs performed in a 7-hospital system between July, 01, 2009 and April 30, 2018, to assess the choice of access-site (TRI versus TFI) as a function of baseline risk for bleeding, AKI, and death, and examined whether the association between TRI use (versus TFI) and in-hospital outcomes is influenced by baseline risk. RESULTS: Among 28 005 PCIs, over a 9-year period, TRI increased over time, however, a risk-treatment paradox for TRI use was observed not only for bleeding risk, but also AKI, and mortality risks, where TRI use was lower in those at highest risk. Operator variability with TRI was large. The incidences of bleeding, AKI, and death were higher with TFI versus TRI. The absolute risk difference between TRI and TFI increased with increasing baseline risk. The number needed to treat to prevent one adverse event with TRI (versus TFI) in low-, moderate- and high-risk groups, respectively, was 259, 82, and 32 for bleeding; 194, 53, and 40 for AKI; and 957, 78, and 18 for death. CONCLUSIONS: This analysis of a large multicenter cohort of patients with PCI demonstrates a risk-treatment paradox for TRI use, not only for bleeding, but also for AKI and death. Despite this, a greater absolute risk difference favoring TRI was observed among patients with the highest baseline risk. Addressing the risk-treatment paradox by preferentially selecting TRI across the spectrum of risk, but especially high-risk cases, may be an important potential strategy for improving outcomes with PCI. [ABSTRACT FROM AUTHOR]

Background: This study was designed to estimate the costs of index hospitalizations after cardiac arrest in the United States.Methods and Results: We used the US Nationwide Inpatient Sample (2003-2012) to identify patients with cardiac arrest. Log transformation of inflation-adjusted cost was determined for care to patient outcomes. Overall, an estimated 1 387 396 patients were hospitalized after cardiac arrest. The mean age of the cohort was 66 years, 45% were women, and the majority were white. Inpatient procedures included coronary angiography (15%), percutaneous coronary intervention (7%), intra-aortic balloon pump (4.4%), therapeutic hypothermia (1.1%), and mechanical circulatory support (0.1%). The rates of therapeutic hypothermia increased from zero in 2003 to 2.7% in 2012 (P<0.001). Both hospital charges and inflation-adjusted cost increased linearly over time. In a multivariate analysis, predictors of inflation-adjusted cost included large hospital size, urban teaching hospital, and length of stay. Among comorbidities, atrial fibrillation or fluid and electrolytes imbalance was most associated with cost. Among selected interventions, the cost was significantly increased with automatic implantable cardioverter defibrillators (odds ratio, 1.83; P<0.001), intra-aortic balloon pump (odds ratio, 1.50; P<0.001), hypothermia (odds ratio, 1.28; P<0.001), and extracorporeal membrane oxygenation (odds ratio, 2.38; P<0.001).Conclusions: In the period between 2003 and 2012, postcardiac arrest hospitalizations resulted in a steady rise in associated health care cost, likely related to increased length of stay, medical procedures, and systems of care. Although targeted cost containment for postarrest interventions may reduce the finance burden, there is an increasing need for funding research into prediction and prevention of cardiac arrest, which offers greater societal benefit. [ABSTRACT FROM AUTHOR]

Background: Restricting transcatheter aortic valve replacement (TAVR) to centers based on volume thresholds alone can potentially create unintended disparities in healthcare access. We aimed to compare the influence of population density in state of Florida in regard to access to TAVR, TAVR utilization rates, and in-hospital mortality.Methods and Results: From 2011 to 2016, we used data from the Agency for Health Care Administration to calculate travel time and distance for each TAVR patient by comparing their home address to their TAVR facility ZIP code. Travel time and distance, TAVR rates, and mortality were compared across categories of low to high population density (population per square miles of land). Of the 6531 patients included, the mean (SD) age was 82 (9) years, 43% were female and 91% were White. Patients residing in the lowest category (<50/square miles) were younger, more likely to be men, and less likely to be a racial minority. Those residing in the lowest category density faced a longer unadjusted driving distances and times to their TAVR center (mean extra distance [miles]=43.5 [95% CI, 35.6-51.4]; P<0.001; mean extra time (minutes)=45.6 [95% CI, 38.3-52.9], P<0.001). This association persisted regardless of the methods used to determine population density. Excluding uninhabitable land, there was a 7-fold difference in TAVR utilization rates in the lowest versus highest population density regions (7 versus 45 per 100 000, P-for-pairwise-comparisons <0.001) and increase in TAVR in-hospital mortality (adjusted OR, 6.13 [95% CI, 1.97-19.1]; P<0.001).Conclusions: Older patients living in rural counties in Florida face (1) significantly longer travel distances and times for TAVR, (2) lower TAVR utilization rates, and (3) higher adjusted TAVR mortality. These findings suggest that there are trade-offs between access to TAVR, its rate of utilization, and procedural mortality, all of which are important considerations when defining institutional and operator requirements for TAVR across the country. [ABSTRACT FROM AUTHOR]

Supplemental Digital Content is available in the text. [ABSTRACT FROM AUTHOR]

Background: Percutaneous coronary intervention with drug-eluting stents (DES) has been increasingly used for revascularization of saphenous vein graft stenosis without strong clinical evidence favoring their use. Randomized controlled trials comparing DES versus bare-metal stents (BMS) in saphenous vein graft–percutaneous coronary intervention have been inconclusive. Methods and Results: We performed a comprehensive literature search through May 15, 2018, for all eligible studies comparing DES versus BMS in patients with saphenous vein graft stenosis in PubMed, EMBASE, SCOPUS, Google Scholar, and ClinicalTrials.gov. Clinical outcomes included all-cause mortality, cardiovascular mortality, major adverse cardiovascular events, myocardial infarction, stent thrombosis, and target vessel revascularization. Six randomized controlled trials were eligible and included 1582 patients, of whom 797 received DES and 785 received BMS. The follow-up period ranged from 18 months to 60 months. There was no statistically significant difference between DES and BMS for all-cause mortality (risk ratio [RR],1.11; 95% CI, 0.0.77–1.62; P =0.57), cardiovascular mortality (RR, 1.00; 95% CI, 0.64–1.57; P =0.99), major adverse cardiovascular events (RR, 0.83; 95% CI, 0.63–1.10; P =20), target vessel revascularization (RR, 0.73; 95% CI, 0.48–1.11; P =0.14), myocardial infarction (RR, 0.74; 95% CI, 0.48–1.16; P =0.19), or stent thrombosis (RR, 1.06; 95% CI, 0.42–2.65; P =0.90). Conclusions: In patients undergoing percutaneous coronary intervention for saphenous vein graft lesions, our results showed that there was no significant difference between DES and BMS for mortality, major adverse cardiovascular events, target vessel revascularization, myocardial infarction, or stent thrombosis. [ABSTRACT FROM AUTHOR]

Supplemental Digital Content is available in the text. Transradial artery access for percutaneous coronary intervention is associated with lower bleeding and vascular complications than transfemoral artery access, especially in patients with acute coronary syndromes. A growing body of evidence supports adoption of transradial artery access to improve acute coronary syndrome–related outcomes, to improve healthcare quality, and to reduce cost. The purpose of this scientific statement is to propose and support a "radial-first" strategy in the United States for patients with acute coronary syndromes. This document also provides an update to previously published statements on transradial artery access technique and best practices, particularly as they relate to the management of patients with acute coronary syndromes. [ABSTRACT FROM AUTHOR]

Background: The relationship between operator or institutional volume and outcomes among patients undergoing percutaneous coronary interventions (PCI) is unclear., Methods and Results: Cross-sectional study based on the Healthcare Cost and Utilization Project's Nationwide Inpatient Sample between 2005 to 2009. Subjects were identified by International Classification of Diseases, 9(th) Revision, Clinical Modification procedure code, 36.06 and 36.07. Annual operator and institutional volumes were calculated using unique identification numbers and then divided into quartiles. Three-level hierarchical multivariate mixed models were created. The primary outcome was in-hospital mortality; secondary outcome was a composite of in-hospital mortality and peri-procedural complications. A total of 457,498 PCIs were identified representing a total of 2,243,209 PCIs performed in the United States during the study period. In-hospital, all-cause mortality was 1.08%, and the overall complication rate was 7.10%. The primary and secondary outcomes of procedures performed by operators in 4(th) [annual procedural volume; primary and secondary outcomes] [>100; 0.59% and 5.51%], 3(rd) [45-100; 0.87% and 6.40%], and 2(nd) quartile [16-44; 1.15% and 7.75%] were significantly less (P<0.001) when compared with those by operators in the 1(st) quartile [≤15; 1.68% and 10.91%]. Spline analysis also showed significant operator and institutional volume outcome relationship. Similarly operators in the higher quartiles witnessed a significant reduction in length of hospital stay and cost of hospitalization (P<0.001)., Conclusions: Overall in-hospital mortality after PCI was low. An increase in operator and institutional volume of PCI was found to be associated with a decrease in adverse outcomes, length of hospital stay, and cost of hospitalization., (© 2014 American Heart Association, Inc.)

Background: The ideal anticoagulant should prevent ischemic complications without increasing the risk of bleeding. Controlled anticoagulation is possible with the REG1 system, an RNA aptamer pair comprising the direct factor IXa inhibitor RB006 and its active control agent RB007., Methods and Results: This phase 2a study included a roll-in group (n=2) treated with REG1 plus glycoprotein IIb/IIIa inhibitors followed by 2 groups randomized 5:1 to REG1 or unfractionated heparin. In group 1 (n=12), RB006 was partially reversed with RB007 after percutaneous coronary intervention and fully reversed 4 hours later. In group 2 (n=12), RB006 was fully reversed with RB007 immediately after percutaneous coronary intervention. Femoral sheaths were removed after complete reversal. Patients were pretreated with aspirin and clopidogrel. End points included major bleeding within 48 hours; composite of death, myocardial infarction, or urgent target vessel revascularization within 14 days; and pharmacodynamic measures. All cases were successful, with final Thrombolysis in Myocardial Infarction grade 3 flow and no angiographic thrombotic complications. There were 2 ischemic end points in the REG1 group and 1 in the unfractionated heparin group, with 1 major bleed in the unfractionated heparin group. Median activated clotting time values rose from 151 to 236 seconds after RB006. Administration of the partial RB007 dose reversed anticoagulation to an intermediate activated clotting time value of 186 seconds. Complete reversal with RB007 returned the median activated clotting time value to 144 seconds. Both reversal strategies enabled scheduled femoral sheath removal., Conclusions: This study demonstrates the clinical translation of a novel platform of anticoagulation targeting factor IXa and its active reversal to percutaneous coronary intervention and provides the basis for further investigation., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00715455.

Background: Racial/ethnic differences in cardiovascular care have been well documented. We sought to determine whether racial/ethnic differences in evidence-based acute myocardial infarction care persist among hospitals participating in a national quality improvement program., Methods and Results: We analyzed 142 593 acute myocardial infarction patients (121 528 whites, 10 882 blacks, and 10 183 Hispanics) at 443 hospitals participating in the Get With the Guidelines-Coronary Artery Disease (GWTG-CAD) program between January 2002 and June 2007. We examined individual and overall composite rates of defect-free care, defined as the proportion of patients receiving all eligible performance measures. In addition, we examined temporal trends in use of performance measures according to race/ethnicity by calendar quarter. Overall, individual performance measure use was high, ranging from 78% for use of angiotensin-converting enzyme inhibitors to 96% for use of aspirin at discharge. Use of each of these improved significantly over the 5 years of study. Overall, defect-free care was 80.9% for whites, 79.5% for Hispanics (adjusted odds ratio versus whites 1.00, 95% confidence interval 0.94 to 1.06, P=0.94), and 77.7% for blacks (adjusted odds ratio versus whites 0.93, 95% confidence interval 0.87 to 0.98, P=0.01). A significant gap in defect-free care was observed for blacks mostly during the first half of the study, which was no longer present during the remainder of the study. Overall, progressive improvements in defect-free care were observed regardless of race/ethnic groups., Conclusions: Among hospitals engaged in a national quality monitoring and improvement program, evidence-based care for acute myocardial infarction appeared to improve over time for patients irrespective of race/ethnicity, and differences in care by race/ethnicity care were reduced or eliminated.

Background: Whether selective factor IXa inhibition produces an appropriate anticoagulant effect when combined with platelet-directed therapy in patients with stable coronary artery disease is unknown. REG1 consists of RB006 (drug), an injectable RNA aptamer that specifically binds and inhibits factor IXa, and RB007 (antidote), the complementary oligonucleotide that neutralizes its anti-IXa activity., Methods and Results: We evaluated the safety, tolerability, and pharmacodynamic profile of REG1 in a randomized, double-blind, placebo-controlled study, assigning 50 subjects with coronary artery disease taking aspirin and/or clopidogrel to 4 dose levels of RB006 (15, 30, 50, and 75 mg) and RB007 (30, 60, 100, and 150 mg). The median age was 61 years (25th and 75th percentiles, 56 and 68 years), and 80% of patients were male. RB006 increased the activated partial thromboplastin time dose dependently; the median activated partial thromboplastin time at 10 minutes after a single intravenous bolus of 15, 30, 50, and 75 mg RB006 was 29.2 seconds (25th and 75th percentiles, 28.1 and 29.8 seconds), 34.6 seconds (25th and 75th percentiles, 30.9 and 40.0 seconds), 46.9 seconds (25th and 75th percentiles, 40.3 and 51.1 seconds), and 52.2 seconds (25th and 75th percentiles, 46.3 and 58.6) (P<0.0001; normal 25th and 75th percentiles, 27 and 40 seconds). RB007 reversed the activated partial thromboplastin time to baseline levels within a median of 1 minute (25th and 75th percentiles, 1 and 2 minutes) with no rebound increase through 7 days. No major bleeding or other serious adverse events occurred., Conclusions: This is the first experience of an RNA aptamer drug-antidote pair achieving inhibition and active restoration of factor IXa activity in combination with platelet-directed therapy in stable coronary artery disease. The preliminary clinical safety and predictable pharmacodynamic effects form the basis for ongoing studies in patients undergoing elective revascularization procedures.

Background: Black patients with acute myocardial infarction are less likely than whites to receive coronary interventions. It is unknown whether racial disparities exist for other treatments for non-ST-segment elevation acute coronary syndromes (NSTE ACS) and how different treatments affect outcomes., Methods and Results: Using data from 400 US hospitals participating in the CRUSADE (Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the ACC/AHA Guidelines?) National Quality Improvement Initiative, we identified black and white patients with high-risk NSTE ACS (positive cardiac markers and/or ischemic ST-segment changes). After adjustment for demographics and medical comorbidity, we compared the use of therapies recommended by the American College of Cardiology/American Heart Association guidelines for NSTE ACS and outcomes by race. Our study included 37,813 (87.3%) white and 5504 (12.7%) black patients. Black patients were younger; were more likely to have hypertension, diabetes, heart failure, and renal insufficiency; and were less likely to have insurance coverage or primary cardiology care. Black patients had a similar or higher likelihood than whites of receiving older ACS treatments such as aspirin, beta-blockers, or ACE inhibitors but were significantly less likely to receive newer ACS therapies, including acute glycoprotein IIb/IIIa inhibitors, acute and discharge clopidogrel, and statin therapy at discharge. Blacks were also less likely to receive cardiac catheterization, revascularization procedures, or smoking cessation counseling. Acute risk-adjusted outcomes were similar between black and white patients., Conclusions: Black patients with NSTE ACS were less likely than whites to receive many evidence-based treatments, particularly those that are costly or newer. Longitudinal studies are needed to assess the long-term impact of these treatment disparities on clinical outcomes.