Eurointervention最新文献

Background: The optimal strategy to treat coronary bifurcation lesions (CBL) has been a long-debated topic. The combination of a stent in the main vessel (MV) and a drug-coated balloon (DCB) in the side branch (SB) seems promising, but the evidence is limited.

Aims: This study aims to investigate a novel sirolimus-coated balloon in the treatment of non-left main CBL compared with a paclitaxel-coated balloon.

Methods: The SPACIOUS trial is a prospective, non-inferiority, multicentre trial. A total of 230 patients were randomised to the sirolimus DCB or the paclitaxel DCB group in a 1:1 ratio. Angiographic and clinical follow-ups were planned at 9 months and 1 year, respectively. The primary endpoint was diameter stenosis (DS) in the SB at 9 months.

Results: At 9 months, DS in the sirolimus group was 30.5±16.1% compared with 33.5±16.2% in the paclitaxel group (difference -2.94%; 95% confidence interval: -7.62% to 1.74%; p for non-inferiority<0.01). The incidence of binary restenosis was significantly lower in the sirolimus group compared to the paclitaxel group (4.4% vs 12.8%; p=0.043). Secondary angiographic endpoints, including late lumen loss and net lumen gain, and 1-year clinical outcomes were not significantly different between groups.

Conclusions: In de novo non-left main CBL treatment, MV stenting accompanied by SB dilation with the sirolimus DCB was non-inferior to the paclitaxel DCB.

Background: The prognostic significance of the Coronary Vasomotor Disorders International Study Group (COVADIS) criteria during acetylcholine (ACh) provocation testing is uncertain.

Aims: The aim of this study was to assess the prognostic impact of COVADIS criteria in patients with myocardial ischaemia (INOCA) or myocardial infarction (MINOCA) and non-obstructive coronary arteries undergoing ACh provocation testing.

Methods: We enrolled consecutive INOCA and MINOCA patients undergoing ACh provocation testing. The occurrence of each COVADIS criterion was recorded. The primary outcome was the incidence of major adverse cardiovascular and cerebrovascular events (MACCE) at follow-up.

Results: Among 519 patients (346 [66.7%] INOCA and 173 [33.3%] MINOCA), 274 (52.8%) exhibited a positive ACh test. Over a median 22-month follow-up, the highest incidence of MACCE occurred in patients with 3 positive criteria (15.4%), followed by those with 2 (10.3%) and 1 (9.2%), while the lowest incidence occurred in patients with 0 (3.1%; p=0.004). Patients with ≥1 positive criteria had significantly higher MACCE rates than those with 0 (12.5% vs 3.1%; p=0.003). MACCE-free survival differed significantly among the four groups, with the best survival for 0 criteria and the worst for 3 (p=0.004). Epicardial coronary diameter reduction ≥90% and MINOCA were independent MACCE predictors. Among patients with a negative test, an epicardial coronary diameter reduction ≥90% was the only independent predictor of MACCE, and the presence of ≥1 criteria in this group was associated with a significantly higher MACCE rate compared to patients without any criteria.

Conclusions: Our findings challenge the binary stratification (positive vs negative) of COVADIS criteria, suggesting an added value of a comprehensive analysis of their components to provide prognostic stratification and personalised treatment.

Background: The impact of final kissing balloon inflation (FKB) in patients treated with an upfront provisional strategy for coronary bifurcation lesions is controversial.

Aims: We aimed to assess the impact of FKB on patient- and lesion-oriented outcomes in a large real-world cohort.

Methods: The ULTRA-BIFURCAT registry was obtained by patient-level merging the BIFURCAT and ULTRA registries. Pairs of patients were generated with propensity score matching (PSM). The primary outcome of interest was major adverse cardiac events (MACE) - a composite of all-cause death, myocardial infarction (MI), target lesion revascularisation (TLR) or stent thrombosis. A lesion-oriented composite outcome (LOCO) - a composite of target vessel MI (TVMI) or TLR - along with each single component of MACE represented the secondary outcomes. Subgroup analyses included the site of bifurcation (unprotected left main [ULM] vs non-ULM), side branch involvement (true bifurcation vs non-true bifurcation), side branch diameter and lesion length. Follow-up was censored at 800 days.

Results: A total of 5,607 patients undergoing a provisional stenting technique were selected for the present analysis. PSM generated 1,784 pairs. Between the matched patients with FKB versus no FKB, no significant difference in MACE was observed (9.0% vs 8.6%; p=0.68). FKB was associated with a lower rate of the LOCO (1.9% vs 2.9%; p=0.04) compared to the no FKB group, driven by lower rates of TVMI (0.2% vs 0.5%; p=0.03) and TLR (1.8% vs 2.6%; p=0.14). These results were confirmed in the subgroups of patients treated for bifurcations with side branches with a diameter >2.5 mm and for true coronary bifurcation lesions.

Conclusions: Among patients treated for coronary bifurcation lesions with provisional stenting, FKB had no significant impact on MACE but was associated with a mild reduction in the incidence of the LOCO.

Background: Transcatheter edge-to-edge repair (TEER) using the TriClip tricuspid valve repair system has emerged as a therapy for tricuspid regurgitation (TR). Patients with TR undergoing TEER commonly present with an endocardial lead across the tricuspid valve (TV).

Aims: We sought to examine the effectiveness and safety of tricuspid TEER (T-TEER) in subjects with endocardial leads in the bRIGHT EU Post-Approval Study (PAS).

Methods: The bRIGHT EU PAS is a prospective, single-arm, open-label, multicentre, post-market registry conducted at 26 sites in Europe. Echocardiographic assessments of endocardial lead placement, interaction, and TR grade were performed at a core laboratory.

Results: Of the 511 enrolled subjects, a total of 110 had an endocardial lead, and in 80.7% of these subjects, TR was at least partially related to the lead. At 30 days, 71% of subjects with endocardial leads had TR of moderate or less. The percentage of subjects with endocardial leads categorised as New York Heart Association Functional Class I-II increased from 17% at baseline to 75% at 30 days (p<0.0001), and quality of life with the Kansas City Cardiomyopathy Questionnaire showed a mean improvement of 20±24 points from baseline to 30 days (p<0.0001). T-TEER was safe in subjects with endocardial leads, with similar rates of events, including TV reintervention/reoperation and TV surgery, to those in subjects without leads. No reports of lead malfunction were reported.

Conclusions: In the bRIGHT EU PAS, T-TEER using the TriClip system was safe and effective in severe TR subjects with an endocardial lead across the TV.