Eurointervention最新文献

Background: There are limited head-to-head randomised trials comparing the performance of different transcatheter heart valves (THVs).

Aims: We aimed to evaluate the non-inferiority of the balloon-expandable Myval THV series compared to the balloon-expandable SAPIEN THV series or the self-expanding Evolut THV series.

Methods: The LANDMARK trial randomised 768 patients in a 1:1 ratio, (Myval THV series [n=384] vs contemporary series with 50% SAPIEN THV series [n=192] and 50% Evolut THV series [n=192]). The non-inferiority of Myval over the SAPIEN or Evolut THV series in terms of the 30-day primary composite safety and effectiveness endpoint as per the third Valve Academic Research Consortium (VARC-3) was tested in an intention-to-treat population with a predefined statistical power of 80% (1-sided alpha of 5%) for a non-inferiority margin of 10.44%.

Results: The Myval THV series achieved non-inferiority for the primary composite endpoint over the SAPIEN THV series (24.7% vs 24.1%, risk difference [95% confidence interval {CI}]: 0.6% [not applicable {NA} to 8.0]; p=0.0033) and the Evolut THV series (24.7% vs 30.0%, risk difference [95% CI]: -5.3% [NA to 2.5]; p<0.0001). The incidences of pacemaker implantation were comparable (Myval THV series: 15.0%, SAPIEN THV series: 17.3%, Evolut THV series: 16.8%). At 30 days, the mean pressure gradient and effective orifice area were significantly better with the Myval THV series compared to the SAPIEN THV series (p<0.0001) and better with the Evolut THV series than with the Myval THV series (p<0.0001). At 30 days, the proportion of moderate to severe prosthetic valve regurgitation was numerically higher with the Evolut THV series compared to the Myval THV series (7.4% vs 3.4%; p=0.06), while not significantly different between the Myval THV series and the SAPIEN THV series (3.4% vs 1.6%; p=0.32).

Conclusions: The Myval THV series is non-inferior to the SAPIEN THV series and the Evolut THV series in terms of the primary composite endpoint at 30 days.

Clinical trial registration: ClinicalTrials.gov: NCT04275726; EudraCT number 2020-000,137-40.

Background: Few data are available on polymer-free drug-eluting stents in patients undergoing percutaneous coronary intervention (PCI).

Aims: We aimed to determine the efficacy and safety of a polymer-free amphilimus-eluting stent (AES), using a reservoir-based technology for drug delivery, compared with a biodegradable-polymer everolimus-eluting stent (EES).

Methods: This was a randomised, investigator-initiated, assessor-blind, non-inferiority trial conducted at 14 hospitals in Italy (ClinicalTrials.gov: NCT04135989). All-comer patients undergoing PCI were randomly assigned to either polymer-free AES or biodegradable-polymer EES. The primary endpoint was a device-oriented composite endpoint, including cardiovascular death, target vessel myocardial infarction, or target lesion revascularisation at 1-year follow-up.

Results: Between January 2020 and June 2022, a total of 2,107 patients with 3,042 coronary lesions were randomised to polymer-free AES (1,051 patients) or biodegradable-polymer EES (1,056 patients). At 1-year follow-up, the primary endpoint occurred in 86 (8.2%) patients randomised to polymer-free AES and 76 (7.2%) patients randomised to biodegradable-polymer EES (risk difference 1%, upper limit of the 1-sided 95% confidence interval [CI] of 2.9%; p for non-inferiority=0.041). There were no significant differences in the incidence of the components of the primary endpoint between groups. However, definite or probable stent thrombosis occurred more frequently in patients randomised to polymer-free stents (1.0% vs 0.3%; hazard ratio 3.72, 95% CI: 1.04-13.33; p=0.044) due to an increased risk of early stent thrombosis within 30 day Conclusions: In all-comer patients undergoing PCI, polymer-free AES were non-inferior to biodegradable-polymer EES at 1-year follow-up in terms of a device-oriented composite endpoint despite being associated with an increased risk of early stent thrombosis.

Background: Microvascular angina (MVA) is an important contributor to morbidity and mortality in patients with non-obstructive coronary artery disease. Despite improvements in its recognition and diagnosis, uncertainty remains around the most effective treatment strategy, and more data are needed.

Aims: We aimed to evaluate the quality of patient selection in treatment studies of MVA and provide a contemporary overview of the evidence base for the treatment of MVA.

Methods: PubMed, the Cochrane Library and Google Scholar were searched from inception to 4 November 2023 for all treatment studies in patients with angina and non-obstructive coronary artery disease or coronary microvascular dysfunction. Populations with acute coronary syndrome were excluded (PROSPERO: CRD42023383075).

Results: Forty-three studies were included. By contemporary definitions of MVA according to the Coronary Vasomotor Disorders International Study Group criteria, 11 (26%) studies enrolled patients with "definitive" MVA, 24 (56%) with "suspected" MVA, and 8 (19%) did not enrol patients who met the diagnostic criteria. A total of 24 unique treatment interventions were investigated. Most studies were observational and single armed (12/24, 50%) or had a single randomised study (9/24, 38%). Ranolazine is the most well-studied intervention drug. Double-blind randomised controlled trials of ranolazine (n=6) have shown inconsistent improvements in Seattle Angina Questionnaire scores and coronary flow reserve with short-term follow-up.

Conclusions: Treatment studies of MVA enrolled a heterogeneous population, with only a quarter meeting contemporary diagnostic criteria for definitive MVA. There is a paucity of high quality, randomised data to support any specific treatment intervention. Larger studies with robust selection criteria, blinded patient-reported outcomes, and long-term follow-up are needed.

Background: Coronary computed tomography angiography (CCTA) and fractional flow reserve (FFR) derived from CCTA (FFR-CT) may provide a means of reducing unnecessary invasive coronary angiography (ICA) in patients with suspected non-ST-elevation acute coronary syndromes (NSTE-ACS).

Aims: The aim of this study was to evaluate the capacity of FFR-CT and CCTA to rule out significant lesions in high-risk NSTE-ACS patients, using ICA with invasive FFR as the gold standard.

Methods: High-risk NSTE-ACS patients admitted to 4 European centres were enrolled in this single-arm, prospective core lab-adjudicated study. Patients underwent CCTA with FFR-CT analysis, followed by ICA with invasive FFR.

Results: Out of the 250 initially planned NSTE-ACS patients, 168 were included, of whom 151 (92%) had sufficient CCTA image quality to undergo CCTA and FFR-CT analysis. The median high-sensitivity troponin T level at 1 hour post-hospitalisation was 5.3 (interquartile range: 1.8-18.6) times the upper reference limit. At the patient level, the diagnostic performance of FFR-CT was numerically higher as compared to CCTA though not statistically significant (sensitivity: 94% vs 93%, specificity: 63% vs 54%, positive predictive value: 83% vs 79%, negative predictive value: 85% vs 80% and accuracy: 83% vs 79%; p=0.58), suggesting an enhanced capability to avoid unnecessary ICA. At the lesion level, the ability of FFR-CT to detect significant lesions was significantly better than that of CCTA (receiver operating characteristic curves: 0.84 vs 0.65 respectively; p<0.01).

Conclusions: In patients with high-risk NSTE-ACS, FFR-CT offers better diagnostic accuracy - though not statistically significant - and a higher ability to rule out haemodynamically significant stenoses as compared to CCTA. This indicates that FFR-CT can reduce unnecessary invasive procedures by more accurately identifying patients requiring further intervention.

Background: The role of direct oral anticoagulants (DOACs) in the treatment of left ventricular thrombus (LVT) after ST-elevation myocardial infarction (STEMI) remains uncertain.

Aims: We aimed to compare the effect of rivaroxaban versus warfarin in patients with STEMI complicated by LVT.

Methods: Adult patients with STEMI and two-dimensional transthoracic echocardiography showing LVT were assigned to rivaroxaban (15 mg once daily) or warfarin (international normalised ratio goal of 2.0-2.5) in an open-label, randomised clinical trial (RCT). A prospective pooled analysis was planned comparing DOAC- versus warfarin-based anticoagulation for the same indication. The main outcome of the RCT was complete LVT resolution at 3 months, determined by a blinded imaging core laboratory. Complete LVT resolution and bleeding were investigated in the pooled analysis.

Results: A total of 50 patients (median age: 55 years, 18% females) were enrolled from June 2020 to November 2022. Three-month complete LVT resolution occurred in 19/25 (76.0%) patients assigned to rivaroxaban and 13/24 (54.2%) assigned to warfarin (relative risk [RR] 1.40, 95% confidence interval [CI]: 0.91-2.15; p=0.12) with no thrombotic or major bleeding events. Pooled analysis showed numerically better complete LVT resolution with DOACs (rivaroxaban and apixaban; 93/115 [80.8%] vs 79/112 [70.5%], RR 1.14, 95% CI: 0.98-1.32; p=0.08) and less major bleeding (2/116 [1.7%] and 9/112 [8.0%], risk difference -0.06, 95% CI: -0.12 to 0.00; p=0.05) than with warfarin.

Conclusions: Although the findings are limited by a small sample size, the results suggest that DOACs are safe with at least similar outcomes concerning LVT resolution and major bleeding compared with warfarin. (ClinicalTrials.gov: NCT05705089).