Eurointervention最新文献

Background: Percutaneous large-bore arteriotomy closure devices are either suture- or plug-based. The comparative efficacy and safety of both techniques and optimal patient selection remain controversial.

Aims: We aimed to conduct a patient-level meta-analysis of randomised trials comparing suture-based ProGlide versus plug-based MANTA large-bore vascular closure devices (VCDs).

Methods: We searched PubMed, the Cochrane Central Register of Controlled Trials, and Google Scholar for randomised controlled trials comparing vascular closure with the ProGlide-based and the MANTA-based technique. The primary endpoint of this analysis was access site-related vascular complications defined according to the Valve Academic Research Consortium-3 criteria.

Results: We identified 2 trials that enrolled a total of 722 patients undergoing transcatheter aortic valve implantation. The primary endpoint was significantly less common after vascular closure with the ProGlide-based technique (odds ratio [OR] 0.54, 95% confidence interval [CI]: 0.35-0.82). Access site-related bleeding events were also less common with the ProGlide-based technique (OR 0.41, 95% CI: 0.18-0.94). Prespecified subgroup analyses did not reveal any subgroup favouring the plug-based technique. Clinical outcomes with the MANTA-based technique were better in larger-sized vessels. Patients who received the ProGlide-based technique were less likely to undergo endovascular stenting or vascular surgery (OR 0.22, 95% CI: 0.06-0.79).

Conclusions: In this patient-level meta-analysis of randomised trials, the ProGlide-based technique for large-bore arterial access was superior to the MANTA-based technique in terms of vascular and bleeding complications.

Background: The drug delivery eï¬ciency of drug-coated balloons (DCBs) in de novo coronary artery disease is correlated with atherosclerotic plaque characteristics. It remains to be elucidated whether plaque composition and vulnerability can affect the efficacy of DCBs.

Aims: This study aimed to explore the association between a novel angiography-based radial wall strain (RWS) measurement for plaque vulnerability and DCB efficacy in de novo small vessel disease (SVD).

Methods: This study is a post hoc analysis of 266 SVD lesions in 260 patients treated with a paclitaxelâcoated balloon or plain old balloon angioplasty (POBA) from the PEPCAD China SVD study. The baseline maximum RWS (RWS_max) ≥13% was selected as the cutoff value for vulnerable plaques. The primary outcome was in-segment late lumen loss (LLL) at 9-month follow-up.

Results: A total of 152 and 72 lesions in the DCB and POBA groups, respectively, completed the 9-month angiographic follow-up. In the DCB group, lesions with RWS_max ≥13% had higher in-segment LLL (0.24±0.53 mm vs 0.05±0.16 mm; p=0.0009), greater binary restenosis (14.9% vs 1.9%; p=0.0040) and more target lesion failure (10.2% vs 1.6%; p=0.022) than those with RWS_max <13%. Among all the lesions with RWS_max ≥13%, no significant difference was observed in in-segment LLL (0.24±0.53 mm vs 0.32±0.48 mm; p=0.49) between the DCB and POBA groups.

Conclusions: Angiographically derived RWS has the potential to predict the angiographic and clinical outcomes of DCB treatment for de novo SVD (PEPCAD China SVD study; ClinicalTrials.gov: NCT03625830).

Background: High-risk coronary plaques (HRPs) are associated with adverse cardiovascular outcomes. However, the clinical practicality of HRP identification is challenged by their modest prevalence and low positive predictive value.

Aims: We aimed to evaluate the association between clinical risk factors and HRPs, as well as the clinical impact of HRPs across different clinical risk profiles.

Methods: This is a pooled analysis of individual patient data from the prospective observational COMBINE (OCT-FFR) and PECTUS-obs studies. A modified version of the Thrombolysis in Myocardial Infarction Risk Score for Secondary Prevention (TRS-2P) was used for risk stratification. The composite endpoint of major adverse cardiovascular events (MACE) was evaluated on a patient level, and target lesion failure (TLF), also a composite endpoint, was evaluated on a lesion level.

Results: Among 810 patients, 311, 265, and 234 were at low (TRS-2P 0-1), intermediate (TRS-2P 2), and high risk (TRS-2P ≥3), respectively. The modified TRS-2P had no discriminative value for the identification of patients with an HRP (area under the receiver operating characteristic curve 0.51, 95% confidence interval [CI]: 0.47-0.56). A consistent trend towards worse clinical outcome in the presence of an HRP was observed across different clinical risk profiles (p_interaction=0.539 for MACE and 0.337 for TLF). For TLF, the highest event rate per 100 lesion-years was observed in high-risk patients with HRPs (6.28, 95% CI: 3.52-10.36; 13.6% absolute risk at 2 years).

Conclusions: HRPs are associated with a negative clinical outcome, without apparent differences between clinical risk profiles. This highlights the independent value of optical coherence tomography for prognostication beyond clinical risk factors. The high event rates in high-risk patients with HRPs necessitate the search for additional therapeutic strategies to mitigate this risk.