BACKGROUND:Whether anticoagulation alone is an adequate treatment for acute, intermediate-risk pulmonary embolism is uncertain. METHODS:We conducted a multinational, adaptive-design trial with blinded outcome adjudication. Patients with intermediate-risk pulmonary embolism (with a ratio of right ventricular end-diastolic diameter to left ventricular end-diastolic diameter of ≥1.0 and an elevated troponin level) were eligible if they had at least two indicators of cardiorespiratory distress (systolic blood pressure of ≤110 mm Hg, a heart rate of ≥100 beats per minute, or a respiratory rate of >20 breaths per minute). Patients were randomly assigned to undergo ultrasound-facilitated, catheter-directed fibrinolysis with alteplase plus anticoagulation (the intervention group) or anticoagulation alone (the control group) according to prespecified treatment protocols. The primary outcome was a composite of pulmonary embolism-related death, cardiorespiratory decompensation or collapse, or symptomatic recurrence of pulmonary embolism within 7 days. RESULTS:The intention-to-treat population comprised 544 patients: 273 in the intervention group and 271 in the control group. The mean (±SD) age was 58.2±13.5 years, and 42.6% of the patients were women. A primary-outcome event occurred in 11 patients (4.0%; 95% confidence interval [CI], 2.3 to 7.1) in the intervention group and 28 (10.3%; 95% CI, 7.2 to 14.5) in the control group (relative risk, 0.39; 95% CI, 0.20 to 0.77; P = 0.005). The effect was driven primarily by a lower risk of cardiorespiratory decompensation or collapse in the intervention group. Major bleeding occurred within 7 days after randomization in 11 patients (4.1%) in the intervention group and 6 (2.2%) in the control group (P = 0.32); major bleeding occurred within 30 days in 11 patients (4.1%) and 8 patients (3.0%), respectively (P = 0.64). No substantial between-group differences in the incidence of other serious adverse events were observed up to 30 days after randomization; no intracranial hemorrhage occurred. CONCLUSIONS:In patients with acute, intermediate-risk pulmonary embolism, ultrasound-facilitated, catheter-directed fibrinolysis plus anticoagulation led to a lower risk of the composite of pulmonary embolism-related death, cardiopulmonary decompensation or collapse, or symptomatic recurrence of pulmonary embolism within 7 days than anticoagulation alone. (Funded by Boston Scientific; HI-PEITHO ClinicalTrials.gov number, NCT04790370.).
Following the recently upgraded recommendations for intravascular imaging use from the European Society of Cardiology and the American Heart Association, we present a UK consensus statement on the use of intravascular ultrasound (IVUS) in percutaneous coronary intervention. Developed by 26 senior interventional cardiologists across a range of UK centres, this statement reflects growing evidence and changing expectations for IVUS use. We discuss the indications for IVUS, the current patterns of use in the UK, anticipated future standards and the need for broader adoption. We propose a standardised workflow and recommend routine documentation of a core IVUS dataset to support quality and as a mechanism for improvement. Persistent barriers, such as perceived cost, training variability and procedural integration, are addressed with practical solutions, including the introduction of national training curricula incorporating intravascular imaging accreditation for operators and targeted education for allied health professionals. Our goal is to support clinicians, catheter lab teams and service leads in embedding IVUS more consistently into practice to optimise patient outcomes.
Background Left ventricular diastolic function as assessed by tissue Doppler echocardiography predicts cardiovascular event rates at 4 years of follow-up in patients with hypertension. Our aim was to evaluate whether this extends to predicting cardiovascular mortality after 20 years of follow-up.Methods Conventional (E) and tissue Doppler (e′) echocardiography was performed on hypertensive participants in the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) with long-term follow-up ascertained via linkage to the Office of National Statistics. Cardiovascular mortality was defined as death from coronary heart disease, stroke and other cardiovascular aetiology such as heart failure or peripheral vascular disease. Unadjusted and adjusted Cox regression survival models were constructed to investigate the association between tissue Doppler echocardiography measurements and long-term cardiovascular mortality.Results Among 506 hypertensive patients (median age 64, interquartile range (58, 69), 87% male), there were 200 (40%) deaths over a 20-year follow-up period. 60 deaths (12%) were cardiovascular-related.A reduction in e′ was independently associated with increased cardiovascular mortality, after adjusting for the ACC/AHA Atherosclerotic Cardiovascular Disease (ASCVD) risk score, with an inverse HR of 1.22 per 1 cm/s decrease (95% CI 1.04–1.43). A higher E/e′ ratio was independently associated with increased cardiovascular mortality, after adjusting for the ASCVD risk score, with an HR of 1.12 per 1-unit increase (95% CI, 1.02 to 1.23).Conclusions Impaired left ventricular diastolic function, measured using tissue Doppler echocardiography through e′ and E/e′, independently predicts increased cardiovascular mortality over 20 years in hypertensive patients, highlighting its long-term prognostic significance.
BACKGROUND:Catheter-directed therapies are increasingly used to treat acute pulmonary embolism (PE). However, randomized data on reperfusion treatments, including large-bore mechanical thrombectomy (LBMT), for patients with High-Risk PE are lacking. METHODS:PERSEVERE (NCT06588634) is a multinational randomized controlled trial comparing the FlowTriever LBMT system vs. standard of care (SoC) in patients with High-Risk PE, with the modified intention-to-treat population planned for 200 patients from 40 sites in Europe and the US. Patients are randomized 1:1 to LBMT or SoC (systemic thrombolysis [ST], surgical embolectomy, extracorporeal membrane oxygenation [ECMO], or anticoagulation alone). Key inclusion criteria are the presence of proximal pulmonary thrombus on computed tomography plus ≥1 of the following: (1) systolic hypotension or need for vasopressors, (2) venous lactate ≥4 mmol/L with clinical signs suggesting obstructive shock, (3) need for mechanical circulatory support, (4) resuscitated cardiac arrest. Exclusion criteria include known chronic thromboembolic pulmonary hypertension and key absolute contraindications to ST. Patients are followed for 3 months. The primary endpoint is a composite of events through hospital discharge or 7 days post randomization, whichever occurs first: (1) all-cause death, (2) cardiac arrest requiring cardiopulmonary resuscitation, (3) bailout to rescue treatment, (4) major bleeding, and (5) ECMO in place on day 7. Secondary endpoints include a broad spectrum of functional and patient-reported outcomes (quality of life, functional status and healthcare resource utilization) at 3 months. The trial is funded by Inari. CONCLUSION:The PERSEVERE study will assess the potential superiority of LBMT over SoC for the treatment of High-Risk PE. CLINICALTRIALS:gov Identifier: NCT06588634.