AsiaIntervention最新文献

Background: The efficacy and safety of the ultrathin BioMime sirolimus-eluting coronary stent (SES) system in treating single or multiple de novo native coronary lesions, in-stent restenosis, and bifurcation lesions have been evidenced at 1 year.

Aims: We sought to investigate the long-term safety and efficacy of the BioMime SES in a real-world population with obstructive coronary artery disease (CAD).

Methods: The prospective, single-arm, multicentre meriT-2 trial enrolled 250 patients from 11 sites across India. The safety endpoint was the cumulative frequency of major adverse cardiovascular events (MACE) at 5 years, defined as a composite of cardiac death, myocardial infarction (MI), emergent coronary artery bypass grafting or clinically indicated target lesion revascularisation (CI-TLR). Stent thrombosis (ST) was evaluated according to the Academic Research Consortium definitions.

Results: A total of 214 (85.6%) subjects completed the 5-year follow-up. The mean age of patients was 57.44±10.75 years, and 82.71% were males. A total of 308 lesions were treated with BioMime SES. Most of the lesions were localised in the left anterior descending artery (45.46%) and were type B2 lesions (44.81%). The cumulative MACE rate at 5 years was 8.9% (n=19), including 0.9% cardiac deaths, 1.9% MI and 6.1% CI-TLR. The rate of ST was only 0.5%. The Kaplan-Meier survivor analysis revealed actuarial survivorship of 95.6% for the intention-to-treat population (n=250) over 5 years.

Conclusions: The long-term clinical outcomes of the meriT-2 trial established the safety and efficacy of the ultrathin-strut biodegradable-polymer-based BioMime SES with satisfactory clinical outcomes at 5 years.

Background: The hybrid strategy of drug-eluting stent (DES) and drug-coated balloon (DCB) has been increasingly accepted for the treatment of de novo coronary artery disease. However, data regarding the clinical outcome of this practice in a Southeast Asian population are limited.

Aims: We aimed to investigate the safety and clinical outcome of this hybrid strategy (DES and DCB) in the treatment of de novo coronary artery disease. The primary endpoint was target lesion failure (TLF) in the DES/DCB-treated segment at 12 months. TLF is defined as the composite of cardiac death, target vessel myocardial infarction (TVMI) and ischaemia-driven target lesion revascularisation (ID-TLR) in the DES- and/or DCB-treated segment.

Methods: A total of 401 patients with 458 lesions were treated with the hybrid strategy at the National Heart Institute (IJN), Kuala Lumpur, Malaysia, from 1 July 2021 to 30 June 2022, were retrospectively enrolled in the study. A total of 38 patients (9.5%) were lost to subsequent follow-up, and the remaining 363 patients (90.5%) were included in the outcome analysis. Clinical outcomes at 1 year were analysed.

Results: In all, 219 lesions (47.8%) involved the left anterior descending artery, 146 lesions (31.9%) involved the right coronary artery, and 57 lesions (12.4%) involved the left circumflex artery. In all, 87 lesions (19%) were bifurcation lesions. A total of 8 patients (2.2%) had TLF, of whom 3 patients (0.83%) had TVMI, 3 patients (0.83%) had ID-TLR, and 2 patients (0.6%) experienced cardiac death. Four patients died of a non-cardiac cause at 1-year follow-up.

Conclusions: A hybrid strategy of DES and DCB for the treatment of de novo coronary artery lesions appears to be feasible and clinically safe according to the 1-year outcomes.

Background: Coronary endarteritis and stent abscess following percutaneous coronary intervention (PCI) are rare and challenging conditions with no clear treatment guidelines available.

Aims: This retrospective study aims to present the clinical features, patient and procedural factors, management strategies, and outcomes in 11 consecutive cases referred between 2018 and 2022.

Methods: We retrospectively analysed 11 cases of coronary endarteritis and stent abscess post-PCI that were referred from various centres. We recorded clinical features, patient demographics, procedural factors, and management approaches, and evaluated treatment outcomes.

Results: Among the 11 patients, 7 (63.6%) were male. PCIs had been performed in the right coronary artery (6, 54.5%), left anterior descending artery (3, 27.3%), and circumflex artery (2, 18.2%). The presenting symptoms included fever, pericarditis with effusion, tamponade, and postinterventional angina due to stent occlusion. Fever occurred in 10 (90.9%) patients, and the majority (70%) of patients experienced fever within one week of PCI. Staphylococcus aureus was the predominant organism (54.5%), followed by Pseudomonas aeruginosa. Transthoracic echocardiography revealed abscess cavities in 10 patients. All patients received vancomycin and piperacillin-tazobactam. Surgery was considered in 7 cases with abscesses >2 cm; one patient refused and responded to antibiotics for 4 weeks. Possible risk factors included repeated use of local sites, reuse of hardware, multiple guidewire manipulations, prolonged catheterisation, inadequate sterility, and diabetes.

Conclusions: This study provides insights into coronary endarteritis and stent abscess following PCI. The lack of clear treatment guidelines highlights the challenges in managing this condition. Identifying risk factors may aid in preventive strategies. Further research is needed to develop standardised approaches for effective management.

Background: Radiation injury is an important concern for interventional cardiologists and needs to be addressed. RADPAD is a radiation protection drape that has been shown to reduce the radiation exposure of the primary operator (PO). While Indian data on radiation exposure of the PO in the cath lab are scarce, the exposure of the secondary operator (SO) is even less well studied.

Aims: The aim of this study was to evaluate the efficacy of RADPAD drapes in reducing radiation doses in the cath lab for the primary as well as the secondary operator.

Methods: A total of 160 patients (40 patients each with single vessel disease [SVD], double vessel disease [DVD] and triple vessel disease [TVD] undergoing coronary angioplasty, and 40 patients undergoing balloon mitral valvuloplasty [BMV]) were randomised in a 1:1 pattern to undergo a procedure with or without the use of RADPAD.

Results: For patients with SVD, DVD and TVD undergoing percutaneous coronary intervention (PCI) and those undergoing BMV, the % reduction with the use of RADPAD reduced the PO's received dose (in mrem) by 65%, 54%, 28% and 67%, respectively, as compared to without RADPAD. The % reduction in relative operator exposure for the PO for the 4 groups was 55%, 34%, 18% and 75%, respectively, with the use of RADPAD. The corresponding % reduction for the SO's received dose (in mrem) was 80%, 63%, 33% and 69% and for relative operator exposure was 74%, 46%, 23% and 76% in the 4 groups, respectively.

Conclusions: RADPAD significantly reduces the radiation exposure of the primary and secondary operator during prolonged complex PCI and BMV procedures.

Diabetes mellitus (DM) and coronary artery disease (CAD) are the leading causes of death in the world. Over the last two decades, clinical trials have indicated that DM patients with CAD have poorer cardiac outcomes than non-diabetic patients with CAD. The pivotal findings of the FREEDOM trial greatly impacted the way clinicians approached revascularisation in diabetic patients with multivessel disease (MVD). However, since the publication of the FREEDOM trial, much has changed both in percutaneous coronary intervention (PCI) technology, as well as in the management of diabetes. This review provides insights into advancements in stent technology, enhanced patient management strategies, improved clinical outcomes with newer hypoglycaemic agents, current approaches to antiplatelet therapy, and advances in lipid management in diabetic patients. The influence of patient-specific factors such as comorbidities and anatomical complexities on treatment decisions in diabetic patients with MVD is also discussed. The ongoing TUXEDO-2 India trial was designed to primarily compare the clinical outcomes of PCI with the new-generation ultrathin-strut Supraflex Cruz stent, compared to the second-generation XIENCE stent in the setting of contemporary optimal medical therapy in Indian diabetic patients with MVD. The secondary objective of this study is to compare clinical outcomes in the combined group from both study arms against a performance goal derived from the coronary artery bypass grafting (CABG) arm of the FREEDOM trial (historical cohort). The tertiary objective is to compare the efficacy and safety of ticagrelor versus prasugrel in diabetic patients with MVD. In view of recent advances in PCI and medical therapy since the FREEDOM trial, now is an appropriate time to revisit the results of CABG versus PCI in diabetic patients with MVD.

Background: Drug-coated balloon (DCB) angioplasty has emerged as an effective treatment option for de novo coronary artery lesions; however, the chronic-phase angiographic patterns after DCB angioplasty for de novo lesions have not yet been described.

Aims: The aim of the present study was to evaluate chronic-phase angiographic classification after DCB angioplasty.

Methods: This was a single-centre, retrospective, observational study. From June 2016 to August 2022, 708 lesions (670 patients) underwent DCB angioplasty for de novo coronary lesions. Successful DCB angioplasty was defined as a non-flow-limiting dissection, with residual stenosis ≤30% and absence of a bailout stent. A total of 337 lesions (318 patients) were enrolled in this study.

Results: Of the 337 lesions analysed, 91.1% (n=307) were in the non-restenosis group, and 8.9% (n=30) were in the restenosis group. The non-restenosis group was classified into non-restenosis (45.1%; n=152) and lumen enlargement (46.0%; n=155). The restenosis group was classified into focal restenosis (5.0%; n=17), diffuse restenosis (3.6%; n=12), and occlusive restenosis (0.3%; n=1). There were no aneurysms, and plaque cavities were often observed (8.0%). During the chronic phase, residual dissection was seen in only one case (0.3%).

Conclusions: This report demonstrates for the first time the angiographic classification after DCB angioplasty for de novo coronary lesions. Restenosis patterns were seen in 8.9% of lesions, and half of the restenosis patterns presented a focal restenosis pattern. Late lumen enlargement was observed in 46% of the treated lesions.