Contemporary coronary intervention trialconduct : addressing the 4P's: Patency, Perfusion, Performance and Prevention

The concern about how the effects of pharmacologic as well as device therapies are understood in clinical practice requires attention to the methods of randomized clinical trials, including the selection of meaningful clinical endpoints

Combined anatomical and clinical factors for the long-term risk stratification of patients undergoing percutaneous coronary intervention: the Logistic Clinical SYNTAX score

Background The SYNTAX score (SXscore), an anatomical-based scoring tool reflecting the complexity of coronary anatomy, has established itself as an important long-term prognostic factor in patients undergoing percutaneous coronary intervention (PCI). The incorporation of clinical factors may further augment the utility of the SXscore to longer-term risk stratify the individual patient for clinical outcomes. Methods and results Patient-level merged data from >6000 patients in seven contemporary coronary stent trials was used to develop a logistic regression model—the Logistic Clinical SXscore—to predict 1-year risk for all-cause death and major adverse cardiac events (MACE). A core model (composed of the SXscore, age, creatinine clearance, and left ventricular ejection fraction) and an extended model [incorporating the core model and six additional (best performing) clinical variables] were developed and validated in a cross-validation procedure. The core model demonstrated a substantial improvement in predictive ability for 1-year all-cause death compared with the SXscore in isolation [area under the receiver operator curve (AUC): core model: 0.753, SXscore: 0.660]. A minor incremental benefit of the extended model was shown (AUC: 0.791). Consequently the core model alone was retained in the final the Logistic Clinical SXscore model. Validation plots confirmed the model predictions to be well calibrated. For 1-year MACE, the addition of clinical variables did not improve the predictive ability of the SXscore, secondary to the SXscore being the predominant determinant of all-cause revascularization. Conclusion The Logistic Clinical SXscore substantially enhances the prediction of 1-year mortality after PCI compared with the SXscore, and allows for an accurate personalized assessment of patient ris

Safety and efficacy outcomes of double vs. triple antithrombotic therapy in patients with atrial fibrillation following percutaneous coronary intervention: a systematic review and meta-analysis of non-vitamin K antagonist oral anticoagulant-based randomized clinical trials.

Abstract Aims To investigate the safety and efficacy of double vs. triple antithrombotic therapy (DAT vs. TAT) in patients with atrial fibrillation (AF) and acute coronary syndrome or who underwent percutaneous coronary intervention (PCI). Methods and results A systematic review and meta-analysis was performed using PubMed to search for non-vitamin K antagonist oral anticoagulant (NOAC)-based randomized clinical trials comparing DAT vs. TAT in AF patients undergoing PCI. Four trials encompassing 10 234 patients (DAT = 5496 vs. TAT = 4738) were included. The primary safety endpoint (ISTH major or clinically relevant non-major bleeding) was significantly lower with DAT compared with TAT [risk ratio (RR) 0.66, 95% confidence interval (CI) 0.56–0.78; P < 0.0001; I2 = 69%], which was consistent across all available bleeding definitions. This benefit was counterbalanced by a significant increase of stent thrombosis (RR 1.59, 95% CI 1.01–2.50; P = 0.04; I2 = 0%) and a trend towards higher risk of myocardial infarction with DAT. There were no significant differences in all-cause and cardiovascular death, stroke and major adverse cardiovascular events. The comparison of NOAC-based DAT vs. vitamin K antagonist (VKA)-TAT yielded consistent results and a significant reduction of intracranial haemorrhage (RR 0.33, 95% CI 0.17–0.65; P = 0.001; I2 = 0%). Conclusion Double antithrombotic therapy, particularly if consisting of a NOAC instead of VKA and a P2Y12 inhibitor, is associated with a reduction of bleeding, including major and intracranial haemorrhages. This benefit is however counterbalanced by a higher risk of cardiac—mainly stent-related—but not cerebrovascular ischaemic occurrences

Safety and efficacy of double vs. triple antithrombotic therapy in patients with atrial fibrillation with or without acute coronary syndrome undergoing percutaneous coronary intervention: a collaborative meta-analysis of non-vitamin K antagonist oral anticoagulant-based randomized clinical trials.

AIMS Safety and efficacy of antithrombotic regimens in patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) may differ based on clinical presentation. We sought to compare double vs. triple antithrombotic therapy (DAT vs. TAT) in AF patients with or without acute coronary syndrome (ACS) undergoing PCI. METHODS AND RESULTS A systematic review and meta-analysis was performed using PubMed to search for non-vitamin K antagonist oral anticoagulant (NOAC)-based randomized clinical trials. Data on subgroups of ACS or elective PCI were obtained by published reports or trial investigators. A total of 10 193 patients from four NOAC trials were analysed, of whom 5675 presenting with ACS (DAT = 3063 vs. TAT = 2612) and 4518 with stable coronary artery disease (SCAD; DAT = 2421 vs. TAT = 2097). The primary safety endpoint of ISTH major bleeding or clinically relevant non-major bleeding was reduced with DAT compared with TAT in both ACS (12.2% vs. 19.4%; RR 0.63, 95% CI 0.56-0.71; P < 0.0001; I2 = 0%) and SCAD (14.6% vs. 22.0%; RR 0.68, 95% CI 0.55-0.85; P = 0.0008; I2 = 66%), without interaction (P-int = 0.54). Findings were consistent for secondary bleeding endpoints, including intra-cranial haemorrhage. In both subgroups, there was no difference between DAT and TAT for all-cause death, major adverse cardiovascular events, or stroke. Myocardial infarction and stent thrombosis were numerically higher with DAT vs. TAT consistently in ACS and SCAD (P-int = 0.60 and 0.86, respectively). Findings were confirmed by multiple sensitivity analyses, including a separate analysis on dabigatran regimens and a restriction to PCI population. CONCLUSIONS DAT, compared with TAT, is associated with lower bleeding risks, including intra-cranial haemorrhage, and a small non-significant excess of cardiac ischaemic events in both patients with or without ACS

Anticoagulation for Percutaneous Ventricular Assist Device-Supported Cardiogenic Shock JACC Review Topic of the Week

© 2022 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY-NC-ND License. https://creativecommons.org/licenses/by-nc-nd/4.0/Interest in the use of mechanical circulatory support for patients presenting with cardiogenic shock is growing rapidly. The Impella (Abiomed Inc), a microaxial, continuous-flow, short-term, ventricular assist device (VAD), requires meticulous postimplantation management. Because systemic anticoagulation is needed to prevent pump thrombosis, patients are exposed to increased bleeding risk, further aggravated by sepsis, thrombocytopenia, and high shear stress–induced acquired von Willebrand syndrome. The precarious balance between bleeding and thrombosis in percutaneous VAD–supported cardiogenic shock patients is often the main reason that patient outcomes are jeopardized, and there is a lack of data addressing optimal anticoagulation management strategies during percutaneous VAD support. Here, we present a parallel anti-Factor Xa/activated partial thromboplastin time-guided anticoagulation algorithm and discuss pitfalls of heparin monitoring in critically ill patients. This review will guide physicians toward a more standardized (anti)coagulation approach to tackle device-related morbidity and mortality in this critically ill patient group.Peer reviewe

Physical fitness affects the quality of single operator cardiocerebral resuscitation in healthcare professionals

Objective Sustained external chest compressions during cardiocerebral resuscitation (CCR) are physically demanding. It might be hypothesized that a high cardiopulmonary exercise capacity and/or muscle strength delays the development of physical fatigue and, consequently, preserves CCR quality. We intended to assess the impact of cardiopulmonary exercise capacity and muscle strength on CCR quality. Methods Fifteen healthcare professionals (10 men and five women, mean age 34± 9 years) performed a 15-min hands-on CCR session on an adult training manikin. CCR compression depth (from which CCR quality was calculated) and frequency were monitored. During CCR we assessed serial blood lactate concentrations, and provided continuous heart rate monitoring. Relationships were examined between participant characteristics, peak cardiopulmonary exercise capacity, ventilatory threshold, maximal muscle strength, muscle strength endurance and CCR quality. Results Significant univariate correlations were found between 15-min CCR quality and body height (r =0.53), ventilatory threshold (r =0.67), peak oxygen uptake capacity (r =0.54), peak cycling power output (r= 0.54), and maximal isometric elbow extension strength (r= 0.55) (P < 0.05). CCR quality was significantly lower in females, when compared with males (P < 0.05). Within different timeframes, CCR quality was mainly related to the ventilatory threshold up to the first 5 min (P < 0.05), whereas CCR quality was mainly related to maximal isometric elbow extension strength after 5 min (P <0.05). Conclusion In healthcare professionals, the ventilatory threshold is significantly related to CCR quality during the first few min. Healthcare professionals who are regularly involved in CCR should therefore aim to achieve/sustain a high aerobic exercise capacity.Jessa Hosp, Heart Ctr Hasselt, Diepenbeek, BelgiumHOSPITAL CARDIAC-ARREST; CARDIOPULMONARY-RESUSCITATION; CHEST COMPRESSIONS; REFERENCE VALUES; PERFORMANCE; THRESHOLD; RESCUER; MIN; exercise tolerance; quality; resuscitatio

Antithrombotic therapy in patients with acute coronary syndrome complicated by cardiogenic shock or out-of-hospital cardiac arrest: a Joint Position Paper from the European Society of Cardiology (ESC) Working Group on Thrombosis, in association with the Acute Cardiovascular Care Association (ACCA) and European Association of Percutaneous Cardiovascular Interventions (EAPCI)

© The Author 2020. This is a pre-copyedited, author-produced version of an article accepted for publication in European Heart Journal - Cardiovascular Pharmacotherapy following peer review. The version of record [Gorog et al., Antithrombotic therapy in patients with acute coronary syndrome complicated by cardiogenic shock or out-of-hospital cardiac arrest: a Joint Position Paper from the European Society of Cardiology (ESC) Working Group on Thrombosis, in association with the Acute Cardiovascular Care Association (ACCA) and European Association of Percutaneous Cardiovascular Interventions (EAPCI), European Heart Journal - Cardiovascular Pharmacotherapy, pvaa009] is available online at: https://doi.org/10.1093/ehjcvp/pvaa009.Peer reviewedFinal Accepted Versio

Efficacy and Safety of Ticagrelor Monotherapy by Clinical Presentation: Pre-Specified Analysis of the GLOBAL LEADERS Trial.

Background The optimal duration of dual antiplatelet therapy after coronary drug-eluting stent placement in adults with stable coronary artery disease (SCAD) versus acute coronary syndromes (ACS) remains uncertain. Methods and Results This was a prespecified subgroup analysis of the GLOBAL LEADERS trial. Participants were randomly assigned 1:1 to the experimental or reference strategy, stratified by ACS (experimental, n=3750; reference, n=3737) versus SCAD (experimental, n=4230; reference, n=4251). The experimental strategy was 75 to 100 mg aspirin daily plus 90 mg ticagrelor twice daily for 1 month, followed by 23 months of ticagrelor monotherapy. The reference strategy was 75 to 100 mg aspirin daily plus either 75 mg clopidogrel daily (for SCAD) or 90 mg ticagrelor twice daily (for ACS) for 12 months, followed by aspirin monotherapy for 12 months. The primary end point at 2 years was a composite of all-cause mortality or non-fatal centrally adjudicated new Q-wave myocardial infarction. The key secondary safety end point was site-reported Bleeding Academic Research Consortium grade 3 or 5 bleeding. The primary end point occurred in 147 (3.92%) versus 169 (4.52%) patients with ACS (rate ratio [RR], 0.86; 95% CI, 0.69-1.08; P=0.189), and in 157 (3.71%) versus 180 (4.23%) patients with SCAD (RR, 0.87; 95% CI, 0.71-1.08; P=0.221) with experimental and reference strategy, respectively (P-interaction=0.926). Bleeding Academic Research Consortium grade 3 or 5 bleeding occurred in 73 (1.95%) versus 100 (2.68%) patients with ACS (RR, 0.73; 95% CI, 0.54-0.98; P=0.037), and in 90 (2.13%) versus 69 (1.62%) patients with SCAD (RR, 1.32; 95% CI, 0.97-1.81; P=0.081; P-interaction=0.007). Conclusions While there was no evidence for differences in efficacy between treatment strategies by subgroup, the experimental strategy appeared to reduce bleeding risk in patients with ACS but not in patients with SCAD. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01813435