BACKGROUND:Complex percutaneous coronary intervention (PCI) in patients with severely impaired left ventricular function carries a high risk of death and complications. Whether percutaneous left ventricular unloading improves outcomes remains unclear. METHODS:We randomly assigned 300 patients with severe left ventricular dysfunction and extensive coronary artery disease in a 1:1 ratio to a strategy of elective unloading with a microaxial flow pump or to standard care during planned complex PCI. The primary outcome was a hierarchical composite that included death from any cause, disabling stroke, spontaneous myocardial infarction, hospitalization for cardiovascular causes, or periprocedural myocardial injury at a minimum of 12 months, as analyzed according to a win ratio. RESULTS:A total of 148 patients were assigned to receive a microaxial flow pump and 152 to receive standard care. At a median of 22 months (interquartile range, 16 to 30), 36.6% of pairwise comparisons favored the microaxial flow pump, and 43.0% favored standard care (win ratio, 0.85; 95% confidence interval [CI], 0.63 to 1.15; difference, -6.4 percentage points; P = 0.30). Death from any cause occurred in 47 patients in the microaxial-flow-pump group and 33 in the standard-care group (hazard ratio, 1.54; 95% CI, 0.99 to 2.41). There was no material between-group difference in the risk of bleeding or vascular complications. CONCLUSIONS:Among patients with severely impaired left ventricular function undergoing complex PCI, elective left ventricular unloading with a microaxial flow pump did not reduce the risk of major adverse clinical outcomes at a minimum of 12 months. (Funded by the U.K. National Institute for Health and Care Research; CHIP-BCIS3 ClinicalTrials.gov number, NCT05003817.).

Objectives: This trial aimed to compare conventional and haemostatic dressings in achieving rapid and effective radial artery haemostasis following coronary procedures. Background: In small studies, using a haemostatic dressing is associated with expedited haemostasis and a reduced duration of external radial compression. Methods: Patients were randomised to one of three compression strategies: 120-min (min) with conventional dressing (C2) vs 60-min with conventional dressing (C1) vs 60-min with haemostatic dressing (H1). The primary outcome was failure to achieve haemostasis at the planned time. The secondary outcomes included: total time-tofinal haemostasis (TTH); subsequent radial artery occlusion (RAO), puncture-related haematoma and vascular injury requiring repair; incidence of delayed discharge due to prolongation of radial access site care. Results: A total of 2114 patients were randomised. At the planned time, 62 % of patients in C1 and 50 % in C2 failed to achieve haemostasis vs 5.2 % in H1 (P < 0.001 for H1 vs C2 or C1). Median (IQR) TTH was 72 mins [68-81 min] in H1, 136 mins [80-189] in C1, and 166 min [133-213] in C2 (P < 0.001 for H1 vs C2 or C1). No significant differences were seen in access-site complications, with low rates of haematomas >5 cm and RAO. Overall, 16.2 % of patients in C2 and 15.8 % in C1 experienced delayed discharge exclusively due to prolonged radial care vs 2.0 % in H1 (P < 0.001 for H1 vs C2 or C1). Conclusions: The use of the haemostatic dressing allowed for more rapid, consistent and safe haemostasis, reducing nursing care requirements and incidence of delayed discharge.

BACKGROUND In the BRIGHT-4 (Bivalirudin With Prolonged Full-Dose Infusion During Primary PCI Versus Heparin Trial-4), anticoagulation with bivalirudin plus a 2- to 4-hour high-dose infusion after percutaneous coronary intervention (PCI) reduced all-cause mortality and bleeding without increasing reinfarction or stent thrombosis compared with heparin alone in patients with ST-segment elevation myocardial infarction (STEMI). These findings require external validation. OBJECTIVES This study sought to determine outcomes of bivalirudin vs heparin anticoagulation during PCI in STEMI. METHODS We performed an individual-patient-data meta-analysis of all large randomized trials of bivalirudin vs heparin in STEMI patients undergoing primary PCI performed before BRIGHT-4. The primary endpoint was all-cause mortality. RESULTS Six trials randomizing 15,254 patients were included. Pooled across all regimens of bivalirudin and glycoprotein IIb/IIIa inhibitor (GPI) use, bivalirudin reduced 30-day all-cause mortality (2.5% vs 2.9%; adjusted OR: 0.78; 95% CI: 0.620.99), cardiac mortality (adjusted OR: 0.69; 95% CI: 0.54-0.88), and major bleeding (adjusted OR: 0.53; 95% CI: 0.440.64) but increased reinfarction (adjusted OR: 1.30; 95% CI: 1.02-1.65) and stent thrombosis (adjusted OR: 1.43; 95% CI: 1.05-1.93) compared with heparin. In 4 trials in which 6,244 patients were randomized to bivalirudin plus a high-dose post-PCI infusion vs heparin without planned GPI use (the BRIGHT-4 regimens), 30-day all-cause mortality occurred in 1.8% vs 2.9% of patients, respectively (adjusted OR: 0.74; 95% CI: 0.48-1.12), and bivalirudin reduced cardiac mortality (adjusted OR: 0.62; 95% CI: 0.39-0.97) and major bleeding (adjusted OR: 0.49; 95% CI: 0.35-0.70), with similar rates of reinfarction (adjusted OR: 0.89; 95% CI: 0.58-1.38) and stent thrombosis (adjusted OR: 0.80; 95% CI: 0.41-1.57). CONCLUSIONS In STEMI patients undergoing primary PCI, bivalirudin with a 2- to 4-hour post-PCI high-dose infusion reduced cardiac mortality and major bleeding without an increase in ischemic events compared with heparin monotherapy with provisional GPI use, confirming the BRIGHT-4 results. (JACC. 2024;84:1512-1524) (c) 2024 by the American College of Cardiology Foundation.

Bivalirudin, a direct thrombin inhibitor, has been extensively studied as an alternative option for anticoagulation in patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI). Studies comparing bivalirudin to heparin yielded mixed results, with signals of concern about acute stent thrombosis; in addition, the perceived lower bleeding risk associated with bivalirudin has been attributed to the increased use of glycoprotein IIb/IIIa inhibitors (GPI) in heparin arms, suggesting potential bias in the comparison. Nevertheless, more recent trials and meta-analyses showed that bivalirudin was associated with similar or even lower risks of death and ischaemic events - including stent thrombosis - as well as less bleeding compared to heparin. In the light of accumulating evidence, whether bivalirudin should be considered as the preferred option for anticoagulation in ACS patients undergoing PCI is an area of ongoing debate.

Hypertrophic cardiomyopathy is a common inherited cardiac condition where the myocardium progressively thickens in the absence of abnormal loading conditions. Left ventricular hypertrophy often leads to outflow tract obstruction, and this confers significant mortality and morbidity implications. Septal reduction therapies aim to relieve the obstruction in an attempt to reduce the burden of symptoms and potentially improve prognosis. However, both surgical and catheter-based approaches to septal reduction carry risks. At present, international guidelines and expert consensus statements suggest surgical myomectomy is the gold-standard treatment. In this point-counterpoint review, we discuss why in our opinion this recommendation should be reconsidered. We hope to cover the history of catheter based septal reduction therapies and the significant advances made over the last two decades. We also hope to show why we believe the current evidence shows catheter-based alcohol septal ablation is superior to surgical myomectomy.

INTRODUCTION:Percutaneous coronary intervention for complex coronary disease is associated with a high risk of cardiogenic shock. This can cause harm and limit the quality of revascularization achieved, especially when left ventricular function is impaired at the outset. Elective percutaneous left ventricular unloading is increasingly used to mitigate adverse events in patients undergoing high-risk percutaneous coronary intervention, but this strategy has fiscal and clinical costs and is not supported by robust evidence.METHODS:CHIP-BCIS3 (Controlled Trial of High-Risk Coronary Intervention With Percutaneous Left Ventricular Unloading) is a prospective, multicenter, open-label randomized controlled trial that aims to determine whether a strategy of elective percutaneous left ventricular unloading is superior to standard care (no planned mechanical circulatory support) in patients undergoing nonemergent high-risk percutaneous coronary intervention. Patients are eligible for recruitment if they have severe left ventricular systolic dysfunction, extensive coronary artery disease, and are due to undergo complex percutaneous coronary intervention (to the left main stem with calcium modification or to a chronic total occlusion with a retrograde approach). Cardiogenic shock and acute ST-segment-elevation myocardial infarction are exclusions. The primary outcome is a hierarchical composite of all-cause death, stroke, spontaneous myocardial infarction, cardiovascular hospitalization, and periprocedural myocardial infarction, analyzed using the win ratio. Secondary outcomes include completeness of revascularization, major bleeding, vascular complications, health economic analyses, and health-related quality of life. A sample size of 250 patients will have in excess of 80% power to detect a hazard ratio of 0.62 at a minimum of 12 months, assuming 150 patients experience an event across all follow-up.CONCLUSIONS:To date, 169 patients have been recruited from 21 National Health Service hospitals in the United Kingdom, with recruitment expected to complete in 2024.REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT05003817.

Abstract Background Following the publication of international cardio-oncology (CO) imaging guidelines, standard echocardiographic monitoring parameters of left ventricular systolic function have been endorsed. Recommendations highlight that either two-dimensional (2D) or three-dimensional (3D) left ventricular ejection fraction (LVEF), alongside global longitudinal strain (GLS) should be routinely performed for surveillance of patients at risk of cancer therapy-related cardiac dysfunction (CTRCD). We studied the feasibility of 3D-LVEF, 2D-GLS and 2D-LVEF in a dedicated CO service. Methods This was a single-centre prospective analysis of consecutive all-comer patients (n = 105) referred to an NHS CO clinic. Using a dedicated Philips EPIQ CVx v7.0, with X5-1 3D-transducer and 3DQA software, we sought to acquire and analyse 2D- and 3D-LVEF and 2D-GLS, adhering to the British Society of Echocardiography (BSE) and British Cardio-Oncology Society (BCOS) transthoracic echocardiography protocol. Results A total of 105 patients were enrolled in the study; 5 were excluded due to carcinoid heart disease (n = 5). Calculation of 3D-LVEF was achieved in 40% (n = 40), 2D-GLS in 73% (n = 73), and 2D-LVEF in 81% (n = 81). LV quantification was not possible in 19% (n = 19) due to poor myocardial border definition. Strong correlation existed between 2D-LVEF and 3D-LVEF (r = 0.94, p < 0.0001). Bland–Altman plot demonstrated no statistical differences in that the mean deviation between 2D-LVEF and 3D-LVEF were consistent throughout a range of LVEF values. The most persistent obstacle to 3D-LVEF acquisition was insufficient myocardial border tracking (n = 30, 50%). Conclusion This study demonstrates the high feasibility of 2D-GLS and 2D-LVEF, even in those with challenging echocardiographic windows. The lower feasibility of 3D-LVEF limits its real-world clinical application, even though only a small difference in agreement with 2D-LVEF calculation was found when successfully performed.

BACKGROUND:In the BRIGHT-4 (Bivalirudin With Prolonged Full-Dose Infusion During Primary PCI Versus Heparin Trial-4), anticoagulation with bivalirudin plus a 2- to 4-hour high-dose infusion after percutaneous coronary intervention (PCI) reduced all-cause mortality and bleeding without increasing reinfarction or stent thrombosis compared with heparin alone in patients with ST-segment elevation myocardial infarction (STEMI). These findings require external validation. OBJECTIVES:This study sought to determine outcomes of bivalirudin vs heparin anticoagulation during PCI in STEMI. METHODS:We performed an individual-patient-data meta-analysis of all large randomized trials of bivalirudin vs heparin in STEMI patients undergoing primary PCI performed before BRIGHT-4. The primary endpoint was all-cause mortality. RESULTS:Six trials randomizing 15,254 patients were included. Pooled across all regimens of bivalirudin and glycoprotein IIb/IIIa inhibitor (GPI) use, bivalirudin reduced 30-day all-cause mortality (2.5% vs 2.9%; adjusted OR: 0.78; 95% CI: 0.62-0.99), cardiac mortality (adjusted OR: 0.69; 95% CI: 0.54-0.88), and major bleeding (adjusted OR: 0.53; 95% CI: 0.44-0.64) but increased reinfarction (adjusted OR: 1.30; 95% CI: 1.02-1.65) and stent thrombosis (adjusted OR: 1.43; 95% CI: 1.05-1.93) compared with heparin. In 4 trials in which 6,244 patients were randomized to bivalirudin plus a high-dose post-PCI infusion vs heparin without planned GPI use (the BRIGHT-4 regimens), 30-day all-cause mortality occurred in 1.8% vs 2.9% of patients, respectively (adjusted OR: 0.74; 95% CI: 0.48-1.12), and bivalirudin reduced cardiac mortality (adjusted OR: 0.62; 95% CI: 0.39-0.97) and major bleeding (adjusted OR: 0.49; 95% CI: 0.35-0.70), with similar rates of reinfarction (adjusted OR: 0.89; 95% CI: 0.58-1.38) and stent thrombosis (adjusted OR: 0.80; 95% CI: 0.41-1.57). CONCLUSIONS:In STEMI patients undergoing primary PCI, bivalirudin with a 2- to 4-hour post-PCI high-dose infusion reduced cardiac mortality and major bleeding without an increase in ischemic events compared with heparin monotherapy with provisional GPI use, confirming the BRIGHT-4 results.

BACKGROUND: The benefit:risk profile of bivalirudin versus heparin anticoagulation in patients with non–ST-segment–elevation myocardial infarction undergoing percutaneous coronary intervention (PCI) is uncertain. Study-level meta-analyses lack granularity to provide conclusive answers. We sought to compare the outcomes of bivalirudin and heparin in patients with non–ST-segment–elevation myocardial infarction undergoing PCI. METHODS: We performed an individual patient data meta-analysis of patients with non–ST-segment–elevation myocardial infarction in all 5 trials that randomized ≥1000 patients with any myocardial infarction undergoing PCI to bivalirudin versus heparin (MATRIX [Minimizing Adverse Hemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox], VALIDATE-SWEDEHEART [Bivalirudin Versus Heparin in ST-Segment and Non–ST-Segment Elevation Myocardial Infarction in Patients on Modern Antiplatelet Therapy in the Swedish Web System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies Registry Trial], ISAR-REACT 4 [Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment 4], ACUITY [Acute Catheterization and Urgent Intervention Triage Strategy], and BRIGHT [Bivalirudin in Acute Myocardial Infarction vs Heparin and GPI Plus Heparin Trial]). The primary effectiveness and safety end points were 30-day all-cause mortality and serious bleeding. RESULTS: A total of 12 155 patients were randomized: 6040 to bivalirudin (52.3% with a post-PCI bivalirudin infusion), and 6115 to heparin (53.2% with planned glycoprotein IIb/IIIa inhibitor use). Thirty-day mortality was not significantly different between bivalirudin and heparin (1.2% versus 1.1%; adjusted odds ratio, 1.24 [95% CI, 0.86–1.79]; P =0.25). Cardiac mortality, reinfarction, and stent thrombosis rates were also not significantly different. Bivalirudin reduced serious bleeding (both access site–related and non—access site–related) compared with heparin (3.3% versus 5.5%; adjusted odds ratio, 0.59; 95% CI, 0.48–0.72; P <0.0001). Outcomes were consistent regardless of use of a post-PCI bivalirudin infusion or routine lycoprotein IIb/IIIa inhibitor use with heparin and during 1-year follow-up. CONCLUSIONS: In patients with non–ST-segment–elevation myocardial infarction undergoing PCI, procedural anticoagulation with bivalirudin and heparin did not result in significantly different rates of mortality or ischemic events, including stent thrombosis and reinfarction. Bivalirudin reduced serious bleeding compared with heparin arising both from the access site and nonaccess sites.

Background/Aim: The value of androgen receptor (AR) in breast cancer has gained renewed interest as a prognostic and treatment predictive biomarker. The aims of this work were to study the associations and the prognostic value of AR in patients from two clinical cohorts. Materials and Methods: Cohort 1 included 208 premenopausal, node-negative patients of whom 87% had received no adjuvant medical treatment; cohort 2 consisted of 263 patients with stage II disease who had all received 2 years of adjuvant tamoxifen. A semi-quantitative assessment of nuclear AR expression divided into five groups (0-1%, 2-10%, 11-50%, 51-75%, and 76-100%) was performed. Survival analyses, stratified by cohort, were performed using both a trend-test and a cut-off of >10% for positivity. Results: A total of 76% of all patients were AR+, and 89%, 48%, and 23% of the estrogen receptor-positive, negative, and triple-negative, respectively. In Cox regression, stratified by cohort, AR divided into five groups was a prognostic factor for 5-year distant disease-free survival with a hazard ratio of 0.86 per step in fraction score (p=0.018). With a predefined cut-off at 10%, moderate evidence of an effect remained (Hazard Ratio=0.67, p=0.077). In multivariable analysis, AR did not retain an independent prognostic value. Conclusion: AR is a weak, however, not independent prognostic factor for distant metastasis. Although the prognostic value of AR may be questionable, the study identified a subset of AR-positive triple-negative patients as being potential candidates for AR-directed therapy for which further studies are warranted.

Background: Measurement of fractional flow reserve (FFR) has an established role in guiding percutaneous coronary intervention. We tested the hypothesis that, at the stage of diagnostic invasive coronary angiography, systematic FFR-guided assessment of coronary artery disease would be superior, in terms of resource use and quality of life, to assessment by angiography alone. Methods: We performed an open-label, randomized, controlled trial in 17 UK centers, recruiting 1100 patients undergoing invasive coronary angiography for the investigation of stable angina or non–ST-segment–elevation myocardial infarction. Patients were randomized to either angiography alone (angiography) or angiography with systematic pressure wire assessment of all epicardial vessels >2.25 mm in diameter (angiography+FFR). The coprimary outcomes assessed at 1 year were National Health Service hospital costs and quality of life. Prespecified secondary outcomes included clinical events. Results: In the angiography+FFR arm, the median number of vessels examined was 4 (interquartile range, 3–5). The median hospital costs were similar: angiography, £4136 (interquartile range, £2613–£7015); and angiography+FFR, £4510 (£2721–£7415; P =0.137). There was no difference in median quality of life using the visual analog scale of the EuroQol EQ-5D-5L: angiography, 75 (interquartile range, 60–87); and angiography+FFR, 75 (interquartile range, 60–90; P =0.88). The number of clinical events was as follows: deaths, 5 versus 8; strokes, 3 versus 4; myocardial infarctions, 23 versus 22; and unplanned revascularizations, 26 versus 33, with a composite hierarchical event rate of 8.7% (48 of 552) for angiography versus 9.5% (52 of 548) for angiography+FFR ( P =0.64). Conclusions: A strategy of systematic FFR assessment compared with angiography alone did not result in a significant reduction in cost or improvement in quality of life. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01070771.

Background: Whether there are treatment tradeoffs between bivalirudin and heparin in patients with NSTEMI undergoing PCI is controversial. Study-level meta-analyses lack granularity to provide conclusive answers or assess subgroups. Methods: We performed an individual-patient-data pooled analysis from all 5 large (n >1000) RCTs of bivalirudin vs heparin in NSTEMI patients undergoing PCI (MATRIX, VALIDATE-SWEDEHEART, ISAR-REACT 4, ACUITY, BRIGHT). The primary efficacy outcome was the 30-day rate of all-cause mortality. Other prespecified outcomes included 30-day serious bleeding, 1-year mortality, and 30-day and 1-year MACCE, and net adverse clinical events (NACE). Subgroup analyses were performed according to access site and post-PCI bivalirudin infusion. Results: A total of 12,155 patients with NSTEMI undergoing PCI were randomized to bivalirudin alone (n=6,040, 52.3% with a post-PCI infusion) or to heparin (n=6,115, 53.2% with planned use of a GPIIb/IIIa inhibitor). Thirty-day mortality was not significantly different between bivalirudin vs heparin (aHR: 1.21; 95% CI: 0.84-1.73). There was a lower risk of 30-day serious bleeding with bivalirudin vs heparin (aHR: 0.63; 95% CI: 0.52, 0.76). At 1-year follow-up, there was no significant difference between bivalirudin and heparin for all-cause mortality (aHR: 0.97; 95% CI: 0.79, 1.19), MACCE (aHR: 1.03; 95% CI: 0.94, 1.13) or NACE (aHR: 0.92 0.84, 1.00). There were no significant differences between bivalirudin or heparin in the rates of MI or stent thrombosis (Table). Findings were consistent irrespective of access site (femoral vs radial), and post-PCI infusion of bivalirudin. Conclusions: In patients with NSTEMI undergoing PCI, procedural anticoagulation with bivalirudin was not associated with improvements in 30-day or 1-year mortality or MACCE compared with heparin with or without GPIIb/IIIa inhibitor, although serious bleeding was reduced. Full analyses will be presented at AHA 2022.

This case highlights 2 important issues: the immediate management of large intracoronary thrombus in the ST-segment elevation myocardial infarction setting with TIMI 3 flow, and the risks/benefits associated with sealing a plaque in an unobstructed artery by stenting. Potent antithrombotic therapy with a view to subsequent intracoronary imaging to define etiology and plaque morphology appears to be a reasonable initial strategy in this specific population. Furthermore, for patients with acute coronary syndromes diagnosed with plaque erosion by optical coherence tomography and residual diameter stenosis <70%, deferred stenting appears a viable option.

Background: The RIPCORD 2 trial randomized patients undergoing coronary angiography to strategy of routine measurement of fractional flow reserve (FFR) in all vessels or to angiography alone. Objectives: We compared, for the randomized groups, the catheter laboratory procedure costs to diagnosis. Methods: This is a sub-study of the RIPCORD2 trial. We excluded patients with follow-on PCI to better reflect procedural costs of the diagnostic phase. We compared resource utilization and, from this, derived an estimated procedure cost for UK practice. We examined the association between cost and the number of vessels examined with pressure wire (PW) technology. Results: We included 249/552 (45%) patients randomized to angiography and 261/548 (48%) patients to systematic FFR measurement. The median (IQR) procedure cost was higher in the FFR group £1392 (1126 – 1686) versus £411 (308 – 586); P < 0.001. In the FFR group, 86.6% of procedures were completed with a single pressure wire; two and three PWs were used in 10.7% and 1.5% of cases respectively. The procedure duration (median, IQR; mins) was longer in the FFR group; 52 (39 – 66) versus 20 (15 – 30) as was the use of radiographic contrast (median, IQR; mls); 140 (110 – 189) versus 70 (60 – 94). In the FFR group, it seems that the additional cost was associated with the cost of the PW and laboratory set up for the performance of FFR measurement; the incremental cost of examining additional vessels, beyond the first, was modest. Conclusion: The procedural cost associated with a strategy of systematic measurement of FFR in all vessels is higher than that of angiography alone.

Background: Given differences in prior trial designs, the treatment tradeoffs between bivalirudin and heparin in patients with STEMI undergoing PCI remain uncertain. Study-level meta-analyses lack granularity to provide conclusive answers or assess subgroups. Methods: We performed an individual-patient-data pooled analysis from all 6 large (n>1000) RCTs of bivalirudin vs heparin in STEMI pts undergoing PCI (BRIGHT, EUROMAX, HEAT-PPCI, HORIZONS-AMI, MATRIX, and VALIDATE-SWEDEHEART). The primary efficacy outcome was the 30-day rate of all-cause mortality. Subgroup analyses were performed according to planned use of glycoprotein IIb/IIIa inhibitors (GPI), and administration of a post-PCI bivalirudin infusion. Results: A total of 15,254 patients with STEMI undergoing PCI were included (7,306 randomized to bivalirudin and 7,948 to heparin [43.6% with planned GPI use]). Thirty-day mortality was not significantly different between bivalirudin vs heparin (aHR: 0.80; 95% CI: 0.64, 1.01); 30-day cardiac mortality was reduced with bivalirudin (aHR: 0.72; 95% CI: 0.57, 0.91). There was a higher risk of 30-day MI (aHR: 1.29, 95% CI: 1.02, 1.64) and stent thrombosis (aHR: 1.42; 95 % CI: 1.05, 1.91) but lower risk of serious bleeding (aHR: 0.57 (0.47, 0.68) with bivalirudin vs heparin. At 1 year, net adverse clinical events were reduced with bivalirudin (aHR: 0.84; 95% CI: 0.77, 0.93) (Table). All-cause mortality was reduced with bivalirudin when a post-PCI infusion was used. A high-dose post-PCI infusion mitigated the 30-day MI and ST risks, irrespective of planned GPI use with heparin. Conclusions: In patients with STEMI undergoing PCI, procedural anticoagulation with bivalirudin did not reduce all-cause mortality. Cardiac mortality and serious bleeding were reduced with bivalirudin at the cost of increased rates of MI and ST. Full analyses will be presented at AHA 2022.

AIMS:Post-infarction ventricular septal defect (PIVSD) is a mechanical complication of acute myocardial infarction (AMI) with a poor prognosis. Surgical repair is the mainstay of treatment, although percutaneous closure is increasingly undertaken.METHODS AND RESUTS:Patients treated with surgical or percutaneous repair of PIVSD (2010-2021) were identified at 16 UK centres. Case note review was undertaken. The primary outcome was long-term mortality. Patient groups were allocated based upon initial management (percutaneous or surgical). Three-hundred sixty-two patients received 416 procedures (131 percutaneous, 231 surgery). 16.1% of percutaneous patients subsequently had surgery. 7.8% of surgical patients subsequently had percutaneous treatment. Times from AMI to treatment were similar [percutaneous 9 (6-14) vs. surgical 9 (4-22) days, P = 0.18]. Surgical patients were more likely to have cardiogenic shock (62.8% vs. 51.9%, P = 0.044). Percutaneous patients were substantially older [72 (64-77) vs. 67 (61-73) years, P < 0.001] and more likely to be discussed in a heart team setting. There was no difference in long-term mortality between patients (61.1% vs. 53.7%, P = 0.17). In-hospital mortality was lower in the surgical group (55.0% vs. 44.2%, P = 0.048) with no difference in mortality after hospital discharge (P = 0.65). Cardiogenic shock [adjusted hazard ratio (aHR) 1.97 (95% confidence interval 1.37-2.84), P < 0.001), percutaneous approach [aHR 1.44 (1.01-2.05), P = 0.042], and number of vessels with coronary artery disease [aHR 1.22 (1.01-1.47), P = 0.043] were independently associated with long-term mortality.CONCLUSION:Surgical and percutaneous repair are viable options for management of PIVSD. There was no difference in post-discharge long-term mortality between patients, although in-hospital mortality was lower for surgery.

BACKGROUND:There is ongoing uncertainty regarding the safety and efficacy of unfractionated heparin and bivalirudin when used for systemic anticoagulation in patients undergoing primary percutaneous coronary intervention (PPCI). This paper reports 12-month mortality from the HEAT-PPCI randomised trial.METHODS:In this open-label, randomised controlled trial (RCT) we enrolled consecutive adults with suspected ST-elevation myocardial infarction (STEMI). Patients were randomised to heparin (bolus 70 U/kg) or bivalirudin (bolus 0.75 mg/kg followed by an infusion 1.75 mg/kg/h for the duration of the procedure). We report the pre-specified secondary outcome of all-cause mortality at 12 months. Mortality was classified as cardiovascular or not, blinded to treatment allocation. Deaths in the first 28 days were classified by formal event adjudication and later events classified from death certificates.RESULTS:Mortality status at 12 months was obtained for 1805/1812 = 99.6% of participants. Overall mortality was 160/1812 = 8.9%. There were more deaths in those randomised to bivalirudin (95/902 = 10.5% vs 65/903 = 7.2%; HR 1.48; 95% CI 1.08 to 2.03; p = 0.015). Most deaths were classified as cardiovascular (71/902 = 7.9% in the bivalirudin group and 53/904 = 5.9% in the heparin group). The difference between the rates of cardiovascular deaths in each treatment group did not reach statistical significance: HR 1.35; 95% CI 0.95 to 1.93; p = 0.095.CONCLUSIONS:At 12 months, treatment with bivalirudin, rather than heparin, was associated with a higher rate of all-cause mortality. Cardiovascular mortality was higher with bivalirudin although this difference was not statistically significant.

AIMS We aimed to examine the relative performance of the new COMET wire from Boston Scientific (BS), and the established technology from St. Jude/Abbott Vascular (SJ). METHODS AND RESULTS We compared simultaneous readings from pairs of wires. Patients were randomised to one of three groups: BS/BS, SJ/SJ, or SJ/BS. The last group was sub-randomised to specify the type of wire that would be passed first. After pressure equalisation at the guide catheter, we recorded paired observations in sequence: (a) distal to proximal pressure ratio at baseline, (b) FFR at maximum hyperaemia, and (c) pressure on withdrawal into the guide catheter to quantify "drift". We randomised 106 patients, yielding 288 sets of paired recordings (BS/BS=90; SJ/SJ=90; SJ/BS=108). Drift was recorded from 208 vessels (BS=105; SJ=103). All wires were successfully advanced to their desired positions in the coronary vasculature. The mean (±SD) differences for the randomised pairs were similar: BS/BS=0.0016 (0.023); SJ/SJ=0.002 (0.03); SJ/BS=0.0013 (0.028). The primary outcome tested the hypothesis that the absolute magnitude of the difference (irrespective of sign) observed in the SJ/BS pairing would be similar to that in the SJ/SJ group. The median (IQR) values were SJ/BS=0.015 (0.01-0.03); SJ/SJ=0.01 (0.00-0.03); p=0.61. The drift, expressed as the median (IQR) difference in Pd/Pa from 1.0 (irrespective of sign), was similar: BS=0.02 (0.01-0.05); SJ=0.02 (0.01-0.04); p=0.14. CONCLUSIONS We found no significant difference between these wires in terms of safety and performance.