Identification and management of patients at high bleeding risk undergoing percutaneous coronary intervention are of major importance, but a lack of standardization in defining this population limits ...trial design, data interpretation, and clinical decision-making. The Academic Research Consortium for High Bleeding Risk (ARC-HBR) is a collaboration among leading research organizations, regulatory authorities, and physician-scientists from the United States, Asia, and Europe focusing on percutaneous coronary intervention-related bleeding. Two meetings of the 31-member consortium were held in Washington, DC, in April 2018 and in Paris, France, in October 2018. These meetings were organized by the Cardiovascular European Research Center on behalf of the ARC-HBR group and included representatives of the US Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency, as well as observers from the pharmaceutical and medical device industries. A consensus definition of patients at high bleeding risk was developed that was based on review of the available evidence. The definition is intended to provide consistency in defining this population for clinical trials and to complement clinical decision-making and regulatory review. The proposed ARC-HBR consensus document represents the first pragmatic approach to a consistent definition of high bleeding risk in clinical trials evaluating the safety and effectiveness of devices and drug regimens for patients undergoing percutaneous coronary intervention.
Bleeding following percutaneous coronary intervention has important prognostic implications. The Academic Research Consortium (ARC) recently proposed a list of clinical criteria to define patients at ...high bleeding risk (HBR).
This study sought to validate the ARC definition for HBR patients in a contemporary real-world cohort.
Patients undergoing coronary stenting between 2014 and 2017 at a tertiary-care center were defined as HBR if they met at least 1 major or 2 minor ARC-HBR criteria. To account for the presence of multiple criteria, patients were further stratified by the number of times they fulfilled the ARC-HBR definition. The primary endpoint was a composite of peri-procedural in-hospital or post-discharge bleeding at 1 year. Secondary endpoints included individual components of the primary bleeding endpoint, myocardial infarction, and all-cause mortality.
Among 9,623 patients, 4,278 (44.4%) qualified as HBR. Moderate or severe anemia was the most common major criterion (33.2%); age ≥75 years was the most frequent minor criterion and the most common overall (46.8%). The rate of the primary bleeding endpoint at 1 year was 9.1% in HBR patients compared with 3.2% in non-HBR patients (p < 0.001), with a stepwise increase in bleeding risk corresponding to the number of times the ARC-HBR definition was fulfilled. HBR patients also experienced significantly higher rates of all secondary endpoints.
This study validates the ARC-HBR definition in a contemporary group of patients who underwent percutaneous coronary intervention. The ARC-HBR definition identified patients at increased risk not only for bleeding but also for thrombotic events, including all-cause mortality. Coexistence of multiple ARC-HBR criteria showed additive prognostic value.
To validate the set of clinical and biochemical criteria proposed by consensus by the Academic Research Consortium (ARC) for High Bleeding Risk (HBR) for the identification of HBR patients. These ...criteria were categorized into major and minor, if expected to carry in isolation, respectively, ≥4% and <4% Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding risk within 1-year after percutaneous coronary intervention (PCI). High bleeding risk patients are those meeting at least 1 major or 2 minor criteria.
All patients undergoing PCI at Bern University Hospital, between February 2009 and September 2018 were prospectively entered into the Bern PCI Registry (NCT02241291). Age, haemoglobin, platelet count, creatinine, and use of oral anticoagulation were prospectively collected, while the remaining HBR criteria except for planned surgery were retrospectively adjudicated. A total of 16 580 participants with complete ARC-HBR criteria were included. After assigning 1 point to each major and 0.5 point to each minor criterion, we observed for every 0.5 score increase a step-wise augmentation of BARC 3 or 5 bleeding rates at 1 year ranging from 1.90% among patients fulfilling no criterion, through 4.01%, 5.98%, 7.42%, 8.60%, 12.21%, 12.29%, and 17.64%. All major and five out of six minor criteria, conferred in isolation a risk for BARC 3 or 5 bleeding at 1 year exceeding 4% at the upper limit of the 95% confidence intervals.
All major and the majority of minor ARC-HBR criteria identify in isolation patients at HBR.
Abstract Anemia is common amongst patients undergoing percutaneous coronary intervention (PCI) and current guidelines fail to offer recommendations for its management. This review aims to examine the ...relationship between baseline anemia and mortality, Major Adverse Cardiovascular Events (MACE) and major bleeding in patients undergoing PCI. We searched MEDLINE and EMBASE for studies that evaluated mortality and adverse outcomes in anemic and non-anemic patients who underwent PCI. Data were collected on study design, participant characteristics, definition of anemia, follow up and adverse outcomes. Random effects meta-analysis of risk ratios was performed using inverse variance method. A total of 44 studies were included in the review with 230,795 participants. The prevalence of baseline anemia was 26,514/170,914 (16%). There was an elevated risk of mortality and MACE with anemia compared to no anemia pooled RR 2.39 (2.02-2.83), p<0.001 and RR 1.51 (1.34-1.71), p<0.001, respectively. The risk of myocardial infarction and bleeding with anemia compared to no anemia was elevated, pooled RR 1.33 (1.07-1.65), p=0.01 and RR 1.97 (1.03-3.77), p<0.001, respectively. The risk of mortality per unit incremental decrease in hemoglobin(g/dl) was RR 1.19 (1.09-1.30), p<0.001 and the risk of mortality, MACE and re-infarction per 1 unit incremental decrease in hematocrit(%) was RR 1.07 (1.05-1.10), p=0.04, RR 1.09 (1.08-1.10) and RR 1.06 (1.03-1.10), respectively. The prevalence of anemia in contemporary cohorts of patients undergoing PCI is significant and is associated with significant increases in post procedural mortality, MACE, re-infarction and bleeding. The optimal strategy for the management of anemia in such patients remains uncertain.
Objective
Catecholamines have been the mainstay of pharmacological treatment of cardiogenic shock (CS). Recently, use of epinephrine has been associated with detrimental outcomes. In the present ...study we aimed to evaluate the association between epinephrine use and short-term mortality in all-cause CS patients.
Design
We performed a meta-analysis of individual data with prespecified inclusion criteria: (1) patients in non-surgical CS treated with inotropes and/or vasopressors and (2) at least 15% of patients treated with epinephrine administrated alone or in association with other inotropes/vasopressors. The primary outcome was short-term mortality.
Measurements and results
Fourteen published cohorts and two unpublished data sets were included. We studied 2583 patients. Across all cohorts of patients, the incidence of epinephrine use was 37% (17–76%) and short-term mortality rate was 49% (21–69%). A positive correlation was found between percentages of epinephrine use and short-term mortality in the CS cohort. The risk of death was higher in epinephrine-treated CS patients (OR CI = 3.3 2.8–3.9) compared to patients treated with other drug regimens. Adjusted mortality risk remained striking in epinephrine-treated patients (
n
= 1227) (adjusted OR = 4.7 3.4–6.4). After propensity score matching, two sets of 338 matched patients were identified and epinephrine use remained associated with a strong detrimental impact on short-term mortality (OR = 4.2 3.0–6.0).
Conclusions
In this very large cohort, epinephrine use for hemodynamic management of CS patients is associated with a threefold increase of risk of death.
A 1-year follow-up, polymer-free metallic stent coated with biolimus-A9 followed by 1-month dual antiplatelet therapy is safer and more effective than a bare-metal stent (BMS) for patients with high ...risk of bleeding.
This study analyzed 2-year outcomes to determine whether these benefits are maintained.
In a prospective, multicenter, double-blind trial, we randomized 2,466 high bleeding risk patients to receive a drug-coated stent (DCS) or a BMS followed by 1-month dual antiplatelet therapy. The primary safety endpoint was a composite of cardiac death, myocardial infarction, or stent thrombosis. The primary efficacy endpoint was clinically driven target lesion revascularization.
At 2 years, the primary safety endpoint had occurred in 147 DCS and 180 BMS patients (15.3%) (hazard ratio: 0.80; 95% confidence interval: 0.64 to 0.99; p = 0.039). Clinically driven target lesion revascularization occurred for 77 DCS and 136 BMS patients (12.0%) (hazard ratio: 0.54; 95% confidence interval: 0.41 to 0.72; p < 0.0001). Major bleeding occurred in 8.9% of DCS and 9.2% of BMS patients (p = 0.95), and a coronary thrombotic event (myocardial infarction and/or stent thrombosis) occurred in 8.2% of DCS and 10.6% of BMS patients (p = 0.045). One-year mortality was 27.1% for a major bleed and 26.3% for a thrombotic event. At 2 years, multivariate correlates of major bleeding were age >75 years, anemia, raised plasma creatinine, and planned long-term anticoagulation. Correlates of the primary safety endpoint were age, anemia, congestive heart failure, multivessel disease, number of stents implanted, and use of a BMS rather than a DCS.
Safety and efficacy benefits of DCS over BMS were maintained for 2 years in high bleeding risk patients. Rates of major bleeding and coronary thrombotic events were no different and were associated with a substantial and comparable mortality risk. (A Prospective Randomized Comparison of the BioFreedom Biolimus A9 Drug Coated Stent Versus the Gazelle Bare Metal Stent in Patients With High Risk of Bleeding LEADERS FREE; NCT01623180)
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Few studies describe recent changes in the incidence, treatment, and outcomes of cardiogenic shock.
To examine temporal trends in the incidence, therapeutic management, and mortality rates of ...patients with the acute coronary syndrome (ACS) and cardiogenic shock, and to assess associations of therapeutic management with death and cardiogenic shock developing during hospitalization.
Analysis of registry data collected among patients admitted to hospitals between 1997 and 2006.
70 of the 106 acute cardiac care hospitals in Switzerland.
23 696 adults with ACS enrolled in the AMIS (Acute Myocardial Infarction in Switzerland) Plus Registry.
Cardiogenic shock incidence; treatment, including rates of percutaneous coronary intervention; and in-hospital mortality rates.
Rates of overall cardiogenic shock (8.3% of patients with ACS) and cardiogenic shock developing during hospitalization (6.0% of patients with ACS and 71.5% of patients with cardiogenic shock) decreased during the past decade (P < 0.001 for temporal trend), whereas rates of cardiogenic shock on admission remained constant (2.3% of patients with ACS and 28.5% of patients with cardiogenic shock). Rates of percutaneous coronary intervention increased among patients with cardiogenic shock (7.6% to 65.9%; P = 0.010), whereas in-hospital mortality decreased (62.8% to 47.7%; P = 0.010). Percutaneous coronary intervention was independently associated with lower risk for both in-hospital mortality in all patients with ACS (odds ratio, 0.47 95% CI, 0.30 to 0.73; P = 0.001) and cardiogenic shock development during hospitalization in patients with ACS but without cardiogenic shock on admission (odds ratio, 0.59 CI, 0.39 to 0.89; P = 0.012).
There was no central review of cardiogenic shock diagnoses, and follow-up duration was confined to the hospital stay. Unmeasured or inaccurately measured characteristics may have confounded observed associations of treatment with outcomes.
Over the past decade, rates of cardiogenic shock developing during hospitalization and in-hospital mortality decreased among patients with ACS. Increased percutaneous coronary intervention rates were associated with decreased mortality among patients with cardiogenic shock and with decreased development of cardiogenic shock during hospitalization.
Abstract Background Stent thrombosis remains among the most feared complications of percutaneous coronary intervention (PCI) with stenting. However, data on its incidence and predictors are sparse ...and conflicting. We thus aimed to perform a collaborative systematic review on incidence and predictors of stent thrombosis. Methods PubMed was systematically searched for eligible studies from the drug-eluting stent (DES) era (1/2002–12/2010). Studies were selected if including ≥ 2000 patients undergoing stenting or reporting on ≥ 25 thromboses. Study features, patient characteristics, and incidence of stent thrombosis were abstracted and pooled, when appropriate, with random-effect methods (point estimate 95% confidence intervals), and consistency of predictors was formally appraised. Results A total of 30 studies were identified (221,066 patients, 4276 thromboses), with DES used in 87%. After a median of 22 months, definite, probable, or possible stent thrombosis had occurred in 2.4% (2.0%; 2.9%), with acute in 0.4% (0.2%; 0.6%), subacute in 1.1% (1.0%; 1.3%), late in 0.5% (0.4%; 0.6%), and very late in 0.6% (0.4%; 0.8%). Similar figures were computed for studies reporting only on DES. From a total of 47 candidate variables, definite/probable stent thrombosis was more commonly and consistently predicted by early antiplatelet therapy discontinuation, extent of coronary disease, and stent number/length, with acute coronary syndrome at admission, diabetes, smoking status, and bifurcation/ostial disease also proving frequent predictors, but less consistently. Conclusions Despite numerous possible risk factors, the most common and consistent predictors of stent thrombosis are early antiplatelet therapy discontinuation, extent of coronary disease, and stent number/length.
Why Are We Still Using Coronary Bare-Metal Stents? Morice, Marie-Claude, MD; Urban, Philip, MD; Greene, Samantha, BA ...
Journal of the American College of Cardiology,
03/2013, Volume:
61, Issue:
10
Journal Article
Peer reviewed
Open access
Eight indications for using BMS were identified: large vessel diameter, 241 (32.4%); ST-segment elevation myocardial infarction, 132 (17.7%); reimbursement/regulatory/other reasons, 70 (9,4%); ...advanced age, 92 (12.4%); concomitant oral anticoagulant treatment, 84 (11.3%); increased bleeding risk, cancer, or anemia, 71 (9.5%); planned noncardiac surgery within the next year, 41 (5.5%); and anticipated poor DAPT compliance, 13 (1.7%).
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