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BACKGROUND: Complete revascularization improves cardiovascular outcomes compared with culprit-only revascularization in patients with acute myocardial infarction ([MI]; ST-segment-elevation MI or non-ST-segment-elevation MI) and multivessel coronary artery disease. However, the timing of complete revascularization (single-setting versus staged revascularization) is uncertain. The aim was to compare the outcomes of single-setting complete, staged complete, and culprit vessel-only revascularization in patients with acute MI and multivessel disease. METHODS: PubMed, EMBASE, and clinicaltrials.gov databases were searched for randomized controlled trials that compared 3 revascularization strategies. RESULTS: From 16 randomized controlled trials that randomized 11 876 patients with acute MI and multivessel disease, both single-setting complete and staged complete revascularization reduced primary outcome (cardiovascular mortality/MI; odds ratio [OR], 0.52 [95% CI, 0.41-0.65]; OR, 0.74 [95% CI, 0.62-0.88]), composite of all-cause mortality/MI (OR, 0.52 [95% CI, 0.40-0.67]; OR, 0.78 [95% CI, 0.67-0.91]), major adverse cardiovascular event (OR, 0.42 [95% CI, 0.32-0.56]; OR, 0.62 [95% CI, 0.47-0.82]), MI (OR, 0.39 [95% CI, 0.26-0.57]; OR, 0.73 [95% CI, 0.59-0.90]), and repeat revascularization (OR, 0.30 [95% CI, 0.18-0.47]; OR, 0.46 [95% CI, 0.30-0.71]) compared with culprit-only revascularization. Single-setting complete revascularization reduced cardiovascular mortality/MI (OR, 0.70 [95% CI, 0.55-0.91]), major adverse cardiovascular event (OR, 0.67 [95% CI, 0.50-0.91]), and all-cause mortality/MI driven by a lower risk of MI (OR, 0.53 [95% CI, 0.36-0.77]) compared with staged complete revascularization. Single-setting complete revascularization ranked number 1, followed by staged complete revascularization (number 2) and culprit-only revascularization (number 3) for all outcomes. The results were largely consistent in subgroup analysis comparing ST-segment-elevation MI versus non-ST-segment-elevation MI cohorts. CONCLUSIONS: Single-setting complete revascularization may offer the greatest reductions in cardiovascular events in patients with acute MI and multivessel disease. A large-scale randomized trial of single-setting complete versus staged complete revascularization is warranted to evaluate the optimal timing of complete revascularization. [ABSTRACT FROM AUTHOR]

BACKGROUND: The American College of Cardiology Reduce the Risk: PCI Bleed Campaign was a hospital-based quality improvement campaign designed to reduce post-percutaneous coronary intervention (PCI) bleeding events. The aim of the campaign was to provide actionable evidence-based tools for participants to review, adapt, and adopt, depending upon hospital resources and engagement. METHODS: We used data from 8 757 737 procedures in the National Cardiovascular Data Registry between 2015 and 2021 to compare patient and hospital characteristics and bleeding outcomes among campaign participants (n=195 hospitals) and noncampaign participants (n=1384). Post-PCI bleeding risk was compared before and after campaign participation. Multivariable hierarchical logistic regression was used to determine the adjusted association between campaign participation and post-PCI bleeding events. Prespecified subgroups were examined. RESULTS: Campaign hospitals were more often higher volume teaching facilities located in urban or suburban locations. After adjustment, campaign participation was associated with a significant reduction in the rate of bleeding (bleeding: adjusted odds ratio, 0.61 [95% CI, 0.53-0.71]). Campaign hospitals had a greater decrease in bleeding events than noncampaign hospitals. In a subgroup analysis, the reduction in bleeding was noted in non-ST-segment-elevation acute coronary syndrome and ST-segment-elevation myocardial infarction patients, but no significant reduction was seen in patients without acute coronary syndrome. CONCLUSIONS: Participation in the American College of Cardiology Reduce the Risk: PCI Bleed Campaign was associated with a significant reduction in post-PCI bleeding. Our results underscore that national quality improvement efforts can be associated with a significant impact on PCI outcomes. [ABSTRACT FROM AUTHOR]

BACKGROUND: In the COMPLETE trial (Complete Versus Culprit-Only Revascularization to Treat Multivessel Disease After Early PCI for STEMI), a strategy of complete revascularization reduced the risk of major cardiovascular events compared with culprit-lesion-only percutaneous coronary intervention in patients presenting with ST-segment--elevation myocardial infarction (STEMI) and multivessel coronary artery disease. Patients with diabetes have a worse prognosis following STEMI. We evaluated the consistency of the effects of complete revascularization in patients with and without diabetes. METHODS: The COMPLETE trial randomized a strategy of complete revascularization, consisting of angiography-guided percutaneous coronary intervention of all suitable nonculprit lesions, versus a strategy of culprit-lesion-only percutaneous coronary intervention (guideline-directed medical therapy alone). In prespecified analyses, treatment effects were determined in patients with and without diabetes on the first coprimary outcome of cardiovascular death or new myocardial infarction and the second coprimary outcome of cardiovascular death, new myocardial infarction, or ischemia-driven revascularization. Interaction P values were calculated to evaluate whether there was a differential treatment effect in patients with and without diabetes. RESULTS: Of the 4041 patients enrolled in the COMPLETE trial, 787 patients (19.5%) had diabetes. The median HbA1c (glycated hemoglobin) was 7.7% in the diabetes group and 5.7% in the nondiabetes group. Complete revascularization consistently reduced the first coprimary outcome in patients with diabetes (hazard ratio, 0.87 [95% CI, 0.59--1.29]) and without diabetes (hazard ratio, 0.70 [95% CI, 0.55--0.90]), with no evidence of a differential treatment effect (interaction P=0.36). Similarly, for the second coprimary outcome, no differential treatment effect (interaction P=0.27) of complete revascularization was found in patients with diabetes (hazard ratio, 0.61 [95% CI, 0.43--0.87]) and without diabetes (hazard ratio, 0.48 [95% CI, 0.39--0.60]). CONCLUSIONS: Among patients presenting with STEMI and multivessel disease, the benefit of complete revascularization over a culprit-lesion-only percutaneous coronary intervention strategy was consistent regardless of the presence or absence of diabetes. GRAPHIC ABSTRACT: A graphic abstract is available for this article. [ABSTRACT FROM AUTHOR]

The outcomes of chronic total occlusion percutaneous coronary intervention have considerably improved during the last decade with continued emphasis on improving procedural safety. Vascular access site bleeding remains one of the most frequent complications. Several procedural strategies have been implemented to reduce the rate of vascular access site complications. This state-of-the-art review summarizes and describes the current evidence on optimal vascular access strategies for chronic total occlusion percutaneous coronary intervention. [ABSTRACT FROM AUTHOR]

BACKGROUND: In patients with tricuspid valve infective endocarditis, percutaneous debulking is a treatment option. However, the outcomes of this approach are less well known. METHODS: We performed a retrospective analysis of all patients who underwent percutaneous vegetation debulking for tricuspid valve infective endocarditis from August 2020 to November 2022 at a large academic tertiary care public hospital. The primary efficacy outcome was procedural success defined by clearance of blood cultures. The primary safety outcome was any procedural complication. For the composite outcome of in-hospital mortality or heart block, outcomes were compared (sequential noninferiority and superiority) with published surgical outcomes data. RESULTS: Of the 29 patients with tricuspid valve infective endocarditis who underwent percutaneous debulking, the average age was 41.3±10.1 years, all patients had septic pulmonary emboli with 27 (93.1%) patients having cavitary lung lesions before the procedure. For the efficacy outcomes, 28 patients (96.6%) had clearance of cultures after their procedure, mean white blood cell count significantly decreased from 16.8±1.4×103 to 12.6±1.0×103 per µL (P<0.01), and mean body temperature significantly decreased from 99.8F ±0.30 to 98.3F ±0.20 (P<0.001) post-procedure. For safety outcomes, there were no procedural complications (0%). Two patients (6.9%) died during the follow-up period, both during the index hospitalization due to severe necrotizing pneumonia. When compared with published data on surgical outcomes, percutaneous debulking was noninferior and superior for the composite of in-hospital death or heart block (noninferiority, P<0.001; superiority, P=0.016). CONCLUSIONS: Percutaneous debulking is feasible, effective, and safe in treating patients with tricuspid valve infective endocarditis refractory to medical therapy. [ABSTRACT FROM AUTHOR]

Background: Oral activated factor XI (FXIa) inhibitors may modulate coagulation to prevent thromboembolic events without substantially increasing bleeding. We explored the pharmacodynamics, safety, and efficacy of the oral FXIa inhibitor asundexian for secondary prevention after acute myocardial infarction (MI).Methods: We randomized 1601 patients with recent acute MI to oral asundexian 10, 20, or 50 mg or placebo once daily for 6 to 12 months in a double-blind, placebo-controlled, phase 2, dose-ranging trial. Patients were randomized within 5 days of their qualifying MI and received dual antiplatelet therapy with aspirin plus a P2Y12 inhibitor. The effect of asundexian on FXIa inhibition was assessed at 4 weeks. The prespecified main safety outcome was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding comparing all pooled asundexian doses with placebo. The prespecified efficacy outcome was a composite of cardiovascular death, MI, stroke, or stent thrombosis comparing pooled asundexian 20 and 50 mg doses with placebo.Results: The median age was 68 years, 23% of participants were women, 51% had ST-segment-elevation MI, 80% were treated with aspirin plus ticagrelor or prasugrel, and 99% underwent percutaneous coronary intervention before randomization. Asundexian caused dose-related inhibition of FXIa activity, with 50 mg resulting in >90% inhibition. Over a median follow-up of 368 days, the main safety outcome occurred in 30 (7.6%), 32 (8.1%), 42 (10.5%), and 36 (9.0%) patients receiving asundexian 10 mg, 20 mg, or 50 mg, or placebo, respectively (pooled asundexian versus placebo: hazard ratio, 0.98 [90% CI, 0.71-1.35]). The efficacy outcome occurred in 27 (6.8%), 24 (6.0%), 22 (5.5%), and 22 (5.5%) patients assigned asundexian 10 mg, 20 mg, or 50 mg, or placebo, respectively (pooled asundexian 20 and 50 mg versus placebo: hazard ratio, 1.05 [90% CI, 0.69-1.61]).Conclusions: In patients with recent acute MI, 3 doses of asundexian, when added to aspirin plus a P2Y12 inhibitor, resulted in dose-dependent, near-complete inhibition of FXIa activity without a significant increase in bleeding and a low rate of ischemic events. These data support the investigation of asundexian at a dose of 50 mg daily in an adequately powered clinical trial of patients who experienced acute MI.Registration: URL: https://www.Clinicaltrials: gov; Unique identifier: NCT04304534; URL: https://www.clinicaltrialsregister.eu/ctr-search/search; Unique identifier: 2019-003244-79. [ABSTRACT FROM AUTHOR]

BACKGROUND: The SVELTE fixed-wire and rapid exchange bioresorbable-polymer sirolimus-eluting coronary stent systems (SVELTE sirolimus-eluting stent [SES]) are novel, low-profile devices designed to facilitate direct stenting, transradial access, and enhance procedural efficiencies. METHODS: Eligible subjects (N=1639) scheduled to undergo percutaneous coronary intervention for non-ST-segment-elevation myocardial infarction or stable coronary artery disease were randomly assigned (1:1) to treatment with either SVELTE SES or a control durable polymer everolimus-eluting coronary stent. The primary end point was 12-month target lesion failure and a noninferiority margin was specified as 3.58% with an expected event rate of 6.5%. RESULTS: Target lesion failure was observed in 10.3% of SVELTE SES and 9.5% of control everolimus-eluting stent subjects under intention to treat analysis (difference=0.8%; PNI=0.034). Clinically indicated target lesion revascularization and stent thrombosis were observed in 1.5% versus 1.9% (P=0.57) and 0.38% versus 0.51% (P=0.72) of SVELTE SES versus control everolimus-eluting stent-treated subjects, respectively. Protocol-defined target vessel myocardial infarction (9.4% versus 8.2%) was higher than anticipated and more frequent at sites that utilized troponin versus creatine kinase myocardial band assays. CONCLUSIONS: The SVELTE SES did not meet the prespecified threshold for noninferiority. Unexpectedly, high rates of target vessel myocardial infarction in both treatment groups contributed to higher than expected rates of target lesion failure, effectively underpowering the study. No differences between the SVELTE SES and control everolimus-eluting stent were observed for primary clinical or angiographic end point events. [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]

Optimal treatment of stable ischemic heart disease for those in the transportation industry is considered in the context of the individual's health, as well as with the perspective that sudden impairment could have catastrophic consequences for others. This article focuses on two high risk occupations that one may encounter in practice: commercial motor vehicle drivers and commercial pilots. This article discusses coronary heart disease in patients in high risk occupations and covers current guideline recommendations for screening, treatment, and secondary prevention. The importance of the complimentary perspectives of the regulatory agency, medical examiners, physicians, and pilot or driver are considered in this narrative review, as are considerations for future guideline updates. [ABSTRACT FROM AUTHOR]

BACKGROUND: Advances in chronic total occlusion percutaneous coronary intervention (CTO PCI) techniques have led to increased procedural success rates among operators. While utilization of CTO PCI has disseminated widely, the learning curve for new operators has not been well-defined. METHODS: Between July 2009 and December 2015, 93 875 CTO PCI cases were extracted from the CathPCI Registry. We delineated a cohort of new CTO operators performing <10 CTO PCI cases per given year. In-hospital outcomes for subsequent CTO PCIs were stratified by the number of prior cases accrued by each operator. Multivariable regression models were used to estimate differences in outcomes with increasing experience. The primary outcome was major adverse cardiovascular events defined as the composite of death, myocardial infarction, stroke, tamponade, or urgent coronary artery bypass grafting. RESULTS: Among 70 916 cases performed by 7251 new operators, procedure success rate was 61.4% and major adverse cardiovascular event rate was 4.2%. Meanwhile, the rate of major bleeding was 4.0%, myocardial infarction 2.0%, mortality 0.6%, tamponade 0.3%, and renal failure 0.2%. Adjusted regression models demonstrated piecewise linear improvements in guidewire crossing, stent placement, and procedure success with accrued volume, albeit with increased contrast use, fluoroscopy time, and bleeding. Major adverse cardiovascular event rates were stable beyond the 12th case (odds ratio per 5 case increase 1.00; 95% CI, 0.98-1.03, P=0.7980). CONCLUSIONS: Among a large number of new CTO PCI operators in the United States, there exists an experiential learning curve for procedural success. However, there were higher rates of bleeding despite case experience, while major adverse cardiovascular events remained relatively unchanged after initiation. [ABSTRACT FROM AUTHOR]

Background--Patients with end-stage renal disease undergoing percutaneous coronary intervention (PCI) have largely been excluded from trials of antithrombotic therapies leaving little data to guide agent choice in this population. Methods and Results--The National Cardiovascular Data Registry CathPCI Registry was used to identify patients with end-stage renal disease undergoing PCI who received monotherapy with either bivalirudin or unfractionated heparin (UFH) (n=71 675). In hospital bleeding and mortality were compared and adjusted using the CathPCI Registry logistic regression models with generalized estimating equations with UFH as the reference. Bivalirudin was used in 51.3% of patients versus 48.7% for UFH. The use of bivalirudin decreased over time, and in 2014, UFH became the most frequently used. Patients receiving UFH were more likely to have an acute coronary syndrome presentation (37.8% versus 27.4%) or have cardiogenic shock (3.74% versus 1.98%). The observed rates for in hospital bleeding (7.0% versus 9.5%; adjusted odds ratio,0.82; 95% confidence interval, 0.76-0.87) and mortality (2.6% versus 4.2%; adjusted odds ratio, 0.87; 95% confidence interval, 0.78-0.97) were lower for patients receiving bivalirudin compared with those receiving UFH. Conclusions--In patients with end-stage renal disease undergoing PCI, bivalirudin and UFH were used with similar frequency although the patterns of use changed over the enrollment period. Patients with end-stage renal disease undergoing PCI had a lower adjusted risk of in hospital outcomes with bivalirudin; however, given the observational nature of this analysis, a randomized trial is warranted. [ABSTRACT FROM AUTHOR]

Background--Current guidelines give a class I recommendation to use of embolic protection devices (EPD) for saphenous vein graft (SVG) intervention; however, studies have shown conflicting results. The objective of this meta-analysis is to compare all-cause mortality, major adverse cardiovascular events, myocardial infarction (MI), or target vessel revascularization in SVG intervention with and without EPD. Methods and Results--Literature was searched through October 2016. Eight studies (n=52 893) comparing SVG intervention performed with EPD (n=11 506) and without EPD (n=41 387) were included. There was no significant difference in allcause mortality (odds ratio [OR], 0.79; confidence interval [CI], 0.55-1.12; P=0.19), major adverse cardiovascular events (OR, 0.73, CI, 0.51-1.05; P=0.09), target vessel revascularization (OR, 1.0; CI, 0.95-1.05; P=0.94), periprocedural MI (OR, 1.12; CI, 0.65-1.90, P=0.69), and late MI (OR, 0.80; CI, 0.52-1.23; P=0.30) between the 2 groups. Sensitivity analysis excluding CathPCI Registry study showed no difference in periprocedural MI, late MI, and target vessel revascularization; however, it favored EPD use in all-cause mortality and major adverse cardiovascular events. Further sensitivity analysis including only observational studies revealed no difference in all-cause mortality, major adverse cardiovascular events, target vessel revascularization, and late MI. Additional analysis after excluding CathPCI Registry study revealed no difference in outcomes. Conclusions--This study including 52 893 patients suggests no apparent benefit in routine use of EPD during SVG intervention in the contemporary real-world practice. Further randomized clinical trials are needed in current era to evaluate long-term outcomes in routine use of EPD, and meanwhile, current guideline recommendations on EPD use should be revisited. [ABSTRACT FROM AUTHOR]

Background: Morbidity and mortality conference is a common educational and quality improvement activity performed in cardiac catheterization laboratories, but best practices for case selection and for maximizing the effectiveness of peer review have not been determined.Methods and Results: We reviewed the 10-year percutaneous coronary intervention morbidity and mortality conference experience of an academic medical center. Cases were triggered for review by the occurrence of prespecified procedural events. Summary reports from morbidity and mortality conference discussions were linked to clinical data from the Duke Databank for Cardiovascular Disease to compare baseline and procedural characteristics and to assess postdischarge outcomes. Of 11 786 procedures, from 2004 to 2013, 157 (1.3%) were triggered for review. The most frequent triggering events were cardioversion/defibrillation (72, 0.6%), unplanned use of mechanical circulatory support (64, 0.5%), and major dissection (41, 0.3%). Selected procedures were more likely to include high-risk features, such as ST-segment-elevation myocardial infarction, cardiogenic shock, and multivessel disease, and were associated with higher mortality at 30 days. Only a minority of triggering events were caused by controversial or unacceptable physician behavior.Conclusions: This 10-year experience outlines the processes for conduct of an effective percutaneous coronary intervention morbidity and mortality conference, including a novel approach to case selection and structured peer review leading to actionable quality interventions. The prespecified clinical triggers, captured in the natural workflow by laboratory staff, identified complex cases that were associated with poor patient outcomes. [ABSTRACT FROM AUTHOR]

Despite a high rate of early revascularization and use of intra-aortic balloon pump counterpulsation therapy, the prognosis of patients with cardiogenic shock has remained poor. In the hopes of improving outcomes, clinicians are increasingly turning to percutaneous left and right mechanical circulatory support devices. Until recently, the evidence base for these devices had consisted only of observational data, meta-analyses, and small feasibility trials. In this article, we describe the contemporary outcomes of patients with cardiogenic shock, the hemodynamics of cardiogenic shock, and hemodynamic effects of percutaneous mechanical circulatory support devices. We then use this discussion to provide clinicians with a useful framework for understanding when selecting between or while managing patients with a percutaneous mechanical circulatory support devices. We critically review the recently published data for and against the use of commercially available devices--the intra-aortic balloon pump counterpulsation, the Impella system, the TandemHeart, and venous--arterial extracorporeal membrane oxygenation--and highlight gaps in our understanding. Given such gaps, a consensus multidisciplinary approach that combines expertise from interventional cardiologists, heart failure specialists, cardiac surgeons, and cardiac anesthesiologists may help pair the right patient with the right device at the right time. [ABSTRACT FROM AUTHOR]

Background: The optimal duration of hemostatic compression post transradial access is controversial. Longer duration increases the risk of radial artery occlusion (RAO) while shorter duration increases the risk of access site bleeding or hematoma. As such, a target of 2 hours is typically used. Whether a shorter or longer duration is better is not known. Methods: A PubMed, EMBASE, and clinicaltrials.gov databases were searched for randomized clinical trials of different duration (<90 minutes, 90 minutes, 2 hours, and 2–4 hours) of hemostasis banding. The efficacy outcome was RAO, primary safety outcome was access site hematoma, and secondary safety outcome was access site rebleeding. Primary analysis compared the effect of various duration in reference to the 2 hours duration using a mixed treatment comparison meta-analysis. Results: Of the 10 randomized clinical trials included with 4911 patients, when compared to the 2-hour reference duration, there was a significantly higher risk of access site hematoma with 90 minutes (odds ratio, 2.39 [95% CI, 1.40–4.06]) and <90 minutes (odds ratio, 3.61 [95% CI, 1.79–7.29]) but not with the 2 to 4 hours duration. When compared with the 2-hour reference, there was no significant difference in access site rebleeding or RAO with shorter or longer duration but the point estimates favored longer duration for access site rebleeding and shorter duration for RAO. Duration of <90 minutes and 90 minutes ranked 1 and duration of 2 hours ranked 2 as the most efficacious duration whereas duration of 2 hours ranked 1 and 2 to 4 hours ranked 2 as the safest duration. Conclusions: In patients undergoing transradial access for coronary angiography or intervention, a hemostasis duration of 2 hours offers the best balance for efficacy (prevention of RAO) and safety (prevention of access site hematoma/rebleeding). [ABSTRACT FROM AUTHOR]

Background--Acute kidney injury (AKI) complicating percutaneous coronary intervention (PCI) is associated with adverse clinical outcomes. To date, no studies have evaluated the association of blood transfusion with AKI in patients undergoing PCI. Methods and Results--We used a retrospective cohort study of all patients with acute coronary syndrome undergoing PCI from CathPCI Registry (n=1 756 864). The primary outcome was AKI defined as the rise in serum creatinine post procedure ≥0.5 mg/dL or ≥25% above baseline values. AKI developed in 9.0% of study sample. Patients with AKI were older, more often women, and had high prevalence of comorbidities, including diabetes mellitus, hypertension, and advanced stages of chronic kidney disease at baseline. Blood transfusion was utilized in 2.2% of patients. In the overall sample, AKI developed in 35.1% of patients who received transfusion versus 8.4% of patients without transfusion (adjusted odds ratio, 4.87 [4.71-5.04]). In the subgroup of patients who sustained bleeding event and received transfusion, the rate of AKI was significantly increased across all preprocedure hemoglobin levels versus no blood transfusion. Similar findings were seen in the subgroup of patients with no bleeding event. Conclusions--Blood transfusion is strongly associated with AKI in patients with acute coronary syndrome undergoing PCI. Further investigation is needed to determine whether a restrictive blood transfusion strategy might improve PCI outcomes by reducing the risk of AKI. [ABSTRACT FROM AUTHOR]

Background--Because of recent changes in criteria for coverage for inpatient hospital stays, most nonacute percutaneous coronary intervention (PCI) procedures are reimbursed on an outpatient basis regardless of underlying patient risk. Downstream effects of these changes on the risk profile of patients undergoing outpatient PCI have not been evaluated. Methods and Results--Using the American College of Cardiology National Cardiovascular Data Registry's CathPCI Registry, we assessed temporal trends in risk profiles and rates of hospital admission among 999 279 patients undergoing PCI qualifying for outpatient reimbursement. We estimated mortality and bleeding risk using validated models from the registry. From 2009 to 2014, the proportion of outpatients not admitted to a hospital after PCI increased from 32.8% to 66.3% (P<0.001). Patients who were admitted after PCI were older, had greater comorbidities, and experienced more post-PCI complications (all P<0.001). Among those not admitted, the proportion of patients at high risk for predicted mortality increased significantly from 17.0% to 19.8% during the study period (P<0.001). In contrast, 16.7% of patients admitted after PCI were at low risk for mortality. Conclusions--Among patients undergoing PCI procedures that qualify for outpatient reimbursement, there has been a temporal decrease in postprocedure hospital admission. Concomitantly, the proportion of these outpatients at high risk for mortality has significantly increased over time. These data suggest that current reimbursement classification could be improved by incorporating patient risk to appropriately match the necessary resources to the needed level of care. [ABSTRACT FROM AUTHOR]

Background: Women with coronary artery disease are shown to have worse outcomes after percutaneous coronary intervention compared with men; however, less is known about sex-based outcomes following lower extremity peripheral vascular intervention (PVI) for symptomatic peripheral artery disease. The study aims to assess whether female sex is independently associated with periprocedural complications in patients undergoing PVI. Methods: Analysis includes patients undergoing lower extremity PVI from September 2016 to March 2020 from the Vascular Quality Initiative registry. Multivariate logistic regression was used to assess the independent association of female sex with post-PVI complications. Results: Of the 119 620 patients included, 47 316 (39.6%) were women. Analysis reflected that women were at higher risk of developing access site complications, including any hematoma (odds ratio [OR], 1.45 [1.35–1.57]), hematoma requiring transfusion (OR, 2.24 [1.82–2.76]; P <0.001), hematoma requiring surgery (OR, 1.49 [1.19–1.86]; P <0.001), pseudoaneurysm (OR, 1.69 [1.39–2.05]; P <0.001), and access site occlusion (OR, 1.89 [1.15–3.08]; P <0.001). Women also faced higher risks of target lesion dissection (OR, 1.36 [1.26–1.46]; P <0.001), above-knee amputation (OR, 1.37 [1.18–1.58]; P <0.001), and in-hospital mortality (OR, 1.21 [1.07–1.38]; P =0.003). Conclusions: In a contemporary cohort, women undergoing lower extremity PVI for symptomatic peripheral artery disease were at higher risk than men of developing periprocedural complications, including moderate or severe access site bleeding, above-knee amputation, and in-hospital mortality. This increased risk persisted despite adjustment for differences in baseline patient or procedural characteristics and warrants further investigation. [ABSTRACT FROM AUTHOR]

Background: Prior studies of radial access for cardiac catheterization have focused on early adopters of the technique, and some have described a risk/treatment paradox of low radial access use among high bleeding risk patients. This study aimed to determine (1) trends in radial access use over time, (2) if increasing use of radial access is driven by new invasive and interventional cardiologists (operators) or existing operators changing their practice, and (3) if increasing radial rates are associated with lower bleeding rates and elimination of the risk/treatment paradox.Methods: In this cross-sectional study using data from the Clinical Assessment, Reporting, and Tracking Program, we calculated radial access rates and risk-adjusted postprocedural bleeding rates of patients undergoing diagnostic angiography or percutaneous coronary intervention (PCI) between 2011 and 2018 in Veterans Affairs hospitals. We used separate bleeding risk models for diagnostic angiography and PCI and assessed temporal trends with the Kendall Tau-b test.Results: Among 253 179 diagnostic angiograms and 93 614 PCIs, radial access rates increased over time for both diagnostic (17.5%-60.4%; P<0.01)) and PCI procedures (14.0%-51.8%; P<0.01). Existing operators and new operators increased their use at similar rates, but new operators entered practice with higher baseline rates. Nearly all operators used radial access at least once in 2018. Overall adjusted rates of bleeding declined, a trend that was significant for diagnostic angiography (2.4%-1.4%, P=0.02) but not PCI (3.4%-2.5%, P=0.20). Femoral access patients had a higher predicted risk for bleeding.Conclusions: A steady rise in radial access for diagnostic angiography and PCI was driven by increasing use among existing operators and high use by new operators. While this was associated with decreasing bleeding rates, a risk/treatment paradox for access site selection persists; patients at higher bleeding risk were still more likely to receive femoral access. [ABSTRACT FROM AUTHOR]

Background: Mechanical circulatory support (MCS) devices can be used in high-risk percutaneous coronary intervention (PCI). Our objective was to describe trends and outcomes of prophylactic MCS use in elective PCI for patients with stable coronary artery disease in the American College of Cardiology National Cardiovascular Data Registry's CathPCI registry. Methods: Among 2 108 715 consecutive patients with stable coronary artery disease undergoing elective PCI in the CathPCI registry between 2009 and 2018, we examined patterns of prophylactic use of MCS. Propensity score models with inverse probability of treatment weighting compared effectiveness (in-hospital death, cardiogenic shock, or new heart failure) and safety (stroke, tamponade, major bleeding, or vascular complication requiring treatment) between patients treated with intra-aortic balloon pump versus other MCS (Impella or extracorporeal membrane oxygenation). Results: Overall, 6905 (0.3%) patients underwent elective PCI with prophylactic MCS. MCS use trended up from 0.2% of elective PCIs in 2009 to 0.6% in 2018 (P <0.0001), driven by other MCS (P <0.0001), whereas intra-aortic balloon pump use remained low and constant (P =0.12). In-hospital major adverse cardiac events and cardiovascular complications occurred in 7.1% and 18.8% of elective PCI patients with prophylactic MCS use and 0.5% and 2.3% of patients without prophylactic MCS use. Intra-aortic balloon pump use was associated with a higher risk of major adverse cardiac events (9.6% versus 6.0%, adjusted odds ratio, 1.59 [95% CI, 1.32–1.91]) but lower risk of complications (18.2% versus 19.1%, adjusted odds ratio, 0.88 [95% CI, 0.77–0.99]) than use of other MCS. Conclusions: The use of prophylactic MCS has increased over time for elective PCI in patients with stable coronary artery disease. Intra-aortic balloon pump was associated with higher major adverse cardiac events but lower risk of procedural complications compared with other MCS. [ABSTRACT FROM AUTHOR]

Background: Whether increasing use of radial access has improved percutaneous coronary intervention outcomes remains unknown. We sought to determine the relationship between increasing facility-level use of transradial percutaneous coronary intervention (TRI) and periprocedural outcomes.Methods and Results: Within the National Cardiovascular Data Registry CathPCI Registry, we estimated the risk-adjusted association between hospital category of change in TRI use (during the 3-year period from 2009 to 2012) and trends in access site and overall bleeding, fluoroscopy time, and contrast use among 818 facilities with low baseline TRI use. There were 4 categories of hospital change in TRI use: very low (baseline, 0.2% increasing to 1.8% at the end of 3 years), low (0.9% increasing to 8.9%), moderate (1.6% increasing to 27.2%), and high (1.0% increasing to 45.1%). Risk-adjusted access site bleeding decreased over time for all hospital categories; however, the rate of decline varied across hospital categories (P for interaction, <0.001). The decrease in access site bleeding was significantly greater for hospitals with moderate or high increases in TRI use (relative risk, 0.45, 95% confidence interval, 0.36-0.56) when compared with that of very low or low hospitals (relative risk, 0.65; 95% confidence interval, 0.58-0.74; P for comparison, 0.002). Similar findings were observed for overall bleeding. An increase in fluoroscopy time (≈1.3 minutes) was noted at hospitals with moderate and high use of TRI (P=0.01). Trends in contrast use were similar across hospital categories.Conclusions: In a national sample of hospitals performing percutaneous coronary intervention, bleeding rates decreased over time for all hospital categories of change in TRI use. The decline in bleeding outcomes was larger at hospitals with increased adoption of TRI when compared with hospitals with minimal or no change in TRI use. [ABSTRACT FROM AUTHOR]

Transradial percutaneous coronary intervention (PCI [TRI]) does not involve catheter manipulation in the descending aorta, whereas transfemoral PCI (TFI) does. Therefore, the risk of acute kidney injury (AKI) after PCI might be influenced by vascular access site. We compared risks of AKI and nephropathy requiring dialysis (NRD) among patients treated with TRI and TFI.We included patients across 47 hospitals in Michigan. Primary end point was AKI (serum creatinine increase ≥0.5 mg/dL). Secondary end points were NRD and postprocedural bleeding. Odds ratios (OR) for study end points were calculated for the entire and propensity-matched population, reported as crude, and values adjusted for preprocedural calculated AKI risk. Between 2010 and 2012, a total of 82 225 PCI procedures were performed, of which 8915 were TRI. After adjustment, TRI was associated with a reduction in AKI (OR, 0.76, 95% confidence intervals [0.62-0.92]) and bleeding with a trend toward lower NRD risk. The propensity-matched population consisted of 8857 procedures per group. In this population, TRI was associated with lower adjusted odds of AKI (OR, 0.74; 95% confidence intervals [0.58-0.96]), and bleeding (OR, 0.47; 95% confidence intervals [0.36-0.63]), but no difference in NRD was observed. Although postprocedural bleeding was independently associated with AKI (OR, 2.86; 95% confidence intervals [1.75-4.66]) in the propensity-matched population, the lower odds of AKI was not mediated by a reduction in bleeding with TRI. Sensitivity analysis demonstrated that the observed association between access site and AKI could potentially be explained by a moderately strong unknown confounder.The risk of AKI was significantly lower after TRI compared with TFI. This finding needs to be evaluated in randomized controlled trials. [ABSTRACT FROM AUTHOR]

Background: Percutaneous coronary intervention is performed by operators with differing experience, technique, and case mix. It is unknown if operator practice patterns impact patient outcomes. We sought to determine if a cluster algorithm can identify distinct profiles of percutaneous coronary intervention operators and if these profiles are associated with patient outcomes. Methods: Operators performing at least 25 annual procedures between 2014 and 2018 were clustered using an agglomerative hierarchical clustering algorithm. Risk-adjusted in-hospital mortality was compared between clusters. Results: We identified 4 practice profiles among 7706 operators performing 2 937 419 procedures. Cluster 1 (n=3345) demonstrated case mix and practice patterns similar to the national median. Cluster 2 (n=1993) treated patients with lower clinical acuity and were less likely to use intracoronary diagnostics, atherectomy, and radial access. Cluster 3 (n=1513) had the lowest case volume, were more likely to work at rural hospitals, and cared for a higher proportion of patients with ST-segment-elevation myocardial infarction and cardiogenic shock. Cluster 4 (n=855) had the highest case volume, were most likely to treat patients with high anatomic complexity and use atherectomy, intracoronary diagnostics, and mechanical support. Compared with cluster 1, adjusted in-hospital mortality was similar for cluster 2 (estimated difference, -0.03 [95% CI, -0.10 to 0.04]), higher for cluster 3 (0.14 [0.07-0.22]), and lower for cluster 4 (-0.15 [-0.24 to -0.06]). Conclusions: Distinct percutaneous coronary intervention operator profiles are differentially associated with patient outcomes. A phenotypic approach to physician assessment may provide actionable feedback for quality improvement. * Practice patterns of percutaneous coronary intervention operators in the United States vary regarding case mix and use of contemporary procedural techniques. * Differences in patient outcomes may be associated with operator factors such as case volume. * A novel machine-learning algorithm clusters percutaneous coronary intervention operators into 4 distinct profiles that differ by patient case mix and use of procedural techniques. * The cluster that most closely corresponds to proposed standards for optimal percutaneous coronary intervention practice-high annual volume, frequent use of contemporary procedural techniques, high clinical, and anatomic complexity-had the lowest adjusted in-hospital mortality rates. [ABSTRACT FROM AUTHOR]

Bleeding is a common, noncardiac, preventable complication of percutaneous coronary intervention. We compared the relative safety of radial access and bivalirudin in percutaneous coronary intervention.From CathPCI Registry, we determined the association between the site of arterial access, bivalirudin, and periprocedural bleeding rates in 501 017 patients. Radial access patients receiving heparin (radial group) were compared with those receiving bivalirudin (radial combination group). Femoral access patients who had bivalirudin and a vascular closure device served as a reference group (femoral group). An inverse probability weighting analysis incorporating propensity scores was used to compare groups. The overall rate of bleeding was 2.59%. It was 2.71% in the femoral group, 2.5% in the radial group, and 1.82% in the radial combination groups (P<0.001). When compared with femoral group, the adjusted odds ratio for bleeding was significantly lower for patients with radial combination group (odds ratio, 0.79; 95% confidence interval, 0.72-0.86), but not for radial group (odds ratio, 0.96; 95% confidence interval, 0.88-1.05), unless patients treated with IIb/IIIa were excluded (radial group-IIb/IIIa odds ratio, 0.84; 95% confidence interval, 0.75-0.94).The number needed to treat to prevent 1 bleeding event with radial combination group was 138, whereas the number needed to treat to prevent 1 bleeding event in high-bleeding risk patients was 68.In this observational analysis, the combination of bivalirudin and radial access was associated with reduced bleeding event rate. This benefit was present across the entire spectrum of preprocedural risk of bleeding, with or without exposure to IIb/IIIa inhibitors. These data support an adequately powered randomized trial comparing bleeding avoidance strategies. [ABSTRACT FROM AUTHOR]

Studies examining the association between radial approach and post-percutaneous coronary intervention (PCI) bleeding and mortality have reached conflicting conclusions. There are no current data about the use and outcomes of transradial PCI (r-PCI) in the Veterans Affairs system.Consecutive veterans (n=24 143 patients) undergoing PCI in the Veterans Affairs between 2007 and 2010 were examined. On the basis of propensity to undergo r-PCI, 3 cohorts matched with veterans undergoing transfemoral access were constructed among sites performing ≥1 r-PCI, ≥50 r-PCI (high volume), and <50 r-PCI (low volume). Cox proportional hazard models were used to determine the association between PCI access site, blood transfusion, and mortality. The prevalence of r-PCI increased over time (2007=2.1%; 2010=8.8%). Overall, there was no difference in procedure success between matched groups (r-PCI 97.3% versus transfemoral PCI 96.6%; P=0.182), or in the risk of postprocedure transfusion or mortality. Among matched patients treated at high r-PCI volume sites, radial access was associated with a decreased risk of post-PCI blood transfusion (hazard ratio, 0.4; 95% confidence interval, 0.3-0.7; P<0.001), and no significant difference in the risk of mortality (hazard ratio, 0.7; 95% confidence interval, 0.4-1.3; P=0.279).Within the Veterans Affairs, the use of r-PCI increased over time. r-PCI may be associated with a significant decreased risk of post-PCI blood transfusion among higher volume r-PCI sites. These data demonstrate that potential benefits of r-PCI in terms of reduced post-PCI blood transfusions may be more pronounced at sites that routinely use radial access. [ABSTRACT FROM AUTHOR]

The article discusses a study which aimed to determine imaging for identifying patients with non-ST-segment elevation (NSTE) acute coronary syndromes (ACS), encompassing NSTE myocardial infarction (NSTEMI) and unstable angina. It also discusses current diagnosis and risk stratification in NSTE-ACS. It suggests further study on management of high-risk features to be able to predict, prevent and reduce the economic and social burden of NSTE-ACS.

The article presents a study which explored elinogrel's pharmacodynamic (PD) and pharmacokinetic (PK) effects. Participants included a subset of randomized patients in the Intravenous and Oral Administration of Elinogrel to Evaluate Tolerability and Efficacy in Nonurgent Percutaneous Coronary Intervention Patients (INNOVATE-PCI) trial. Results found no differences in PK and Pd effects between two dosing regimens of elinogrel.

The article discusses a study which investigated the tolerability, efficacy, and safety of elinogrel in patients who underwent nonurgent percutaneous coronary intervention (PCI). The patients were given either 600 or 300 milligrams (mg) clopidogrel followed with 75, 80, or 120 mg IV elinogrel daily and then 50, 100, or 150 mg oral elinogrel two times daily. Compared with clopidogrel, oral and intravenous elinogrel did not increase thrombolysis in myocardial infarction minor or major bleeding.

The article focuses on bleeding complications, which are associated with stent thrombosis and death, in patients undergoing percutaneous coronary intervention as well as in the long term antithrombotic setting. It states balancing the anti-ischemic benefits against the bleeding risk of antithrombotic agents is of paramount importance in assessing new therapies. It states bleeding events have been identified as a crucial point for assessment of safety of drugs during clinical trials.