Scoring balloon predilation before bioresorbable vascular scaffold implantation in patients with in-stent restenosis: the RIBS VI 'scoring' study.
支架内再狭窄患者生物可吸收血管支架植入前的评分球囊预扩张: 肋骨 VI '评分' 研究。
- 作者列表："Alfonso F","Cuesta J","García Del Blanco B","Bosa F","Pérez de Prado A","Masotti M","Trillo R","Rumoroso JR","Moreno R","Cequier A","Gutiérrez H","García Touchard A","López-Mínguez JR","Zueco J","Serra A","Velázquez M","Morís C","Bastante T","García-Guimaraes M","Rivero F","Fernández-Pérez C","Restenosis Intrastent: Bioresorbable Vascular Scaffolds Treatment with Scoring Balloon Pre-dilatation (RIBS VI ‘Scoring’) Study Investigators (under the auspices of the Interventional Cardiology Working Group of the Spanish Society of Cardiology).
BACKGROUND:Currently drug-eluting stents (DESs) and drug-eluting balloons are recommended in patients with in-stent restenosis (ISR). However, the efficacy of bioresorbable vascular scaffolds (BVS) after scoring balloon (SCB) predilation in these patients is unknown. METHODS:RIBS VI (NCT02672878) and RIBS VI 'Scoring' (NCT03069066) are prospective multicentre studies assessing the value of BVS in patients with ISR. Inclusion and exclusion criteria were identical in both studies. Results of conventional BVS implantation (112 patients) were compared with those obtained with systematic SCB therapy before BVS (108 patients). Angiographic follow-up was scheduled for all patients. RESULTS:On late angiography (93% of eligible patients) the in-segment minimal lumen diameter (primary end-point) (1.88 ± 0.5 vs. 1.90 ± 0.4 mm, P = 0.81), % diameter stenosis (28 ± 17 vs. 29 ± 15%), late lumen loss (0.23 ± 0.4 vs. 0.22 ± 0.4 mm) and binary restenosis rate (8.5 vs. 9.3%) were similar in the conventional BVS and SCB + BVS groups, respectively. At 1-year follow-up (100% of patients) target lesion revascularization (TLR) requirement (9.8 vs. 11.1%) was similar with the two strategies. Freedom from cardiac death, myocardial infarction and TLR was 88% and 87%, respectively. Results remained unchanged after adjusting for potential baseline confounders and were consistent in 10 prespecified subgroups. CONCLUSION:This study suggests that results of conventional BVS implantation in patients with ISR are not improved by systematic predilation with SCB. ClinicalTrials.gov ID: NCT02672878 (RIBS VI) and NCT03069066 (RIBS VI 'Scoring').
背景: 目前药物洗脱支架 (DESs) 和药物洗脱球囊被推荐用于支架内再狭窄 (ISR) 患者。然而，评分球囊 (SCB) 预扩张后生物可吸收血管支架 (BVS) 在这些患者中的疗效尚不清楚。 方法: 肋骨 VI (NCT02672878) 和肋骨 VI '评分' (NCT03069066) 是评估 BVS 在 ISR 患者中的价值的前瞻性多中心研究。两项研究的纳入和排除标准相同。常规 BVS 植入的结果 (112 例患者) 与 BVS 前系统 SCB 治疗获得的结果 (108 例患者) 进行比较。对所有患者进行了血管造影随访。 结果: 在晚期血管造影 (93% 的合格患者) 中，段内最小管腔直径 (主要终点) (1.88 ± 0.5 vs. 1.90 ± 0.4毫米，P = 0.81)，% 直径狭窄 (28 ± 17 vs. 29 ± 15%)，晚期管腔丢失 (0.23 ± 0.4 vs. 0.22 ± 0.4毫米)常规 BVS 组和 SCB + BVS 组的再狭窄率相似 (分别为 8.5 和 9.3%)。在 1 年随访时 (100% 的患者)，两种策略的靶病变血运重建 (TLR) 要求 (9.8 vs. 11.1%) 相似。无心源性死亡、心肌梗死和 TLR 分别为 88% 和 87%。校正潜在的基线混杂因素后，结果保持不变，在 10 个预先设定的亚组中一致。 结论: 本研究提示 ISR 患者常规 BVS 植入的结果不能通过 SCB 系统预扩张得到改善。ClinicalTrials.gov ID: NCT02672878 (肋骨 VI) 和 NCT03069066 (肋骨 VI '分数')。
METHODS:Aims : We sought to investigate the thrombogenicity of different DES and BMS in an in vitro system of stent perfusion. Material and Methods: The experimental model consisted of a peristaltic pump connected to 4 parallel silicone tubes in which different stents were deployed. Blood was drawn from healthy volunteers and the amount of stent surfaced -induced thrombus deposition was determined using 125 I -fibrinogen. Results: Compared to Resolute, Biomatrix and Vision, Xience was associated with the lowest amount of stent surface -induced thrombus formation, with a significant difference compared to Vision (125 I -fibrinogen median value deposition [IQ range]: 50 ng [25 -98] versus 560 ng [320 - 1,520], respectively, p<0.05), but not to other DES. In the second set of experiments Fluoropolymer -coated BMS not eluting drug was associated with a significant 3 -fold reduction in 125 I -fibrinogen deposition (245 ng [80 -300]) compared to Vision (625 ng [320 -760], p<0.05), but a 7 -fold increase compared to Xience (35 ng [20 -60], p<0.05). Finally Xience was associated with a significantly greater absorption of albumin compared to BMS. Conclusions: In an in vitro system of stent perfusion, Xience was associated with the lowest amount of stent surface -induced thrombus formation compared with Resolute, Biomatrix and Vision, with a noted synergistic effect between the fluoropolymer and the drug.
METHODS::Fibronectin-splice variant containing extra domain A (Fn-EDA) is associated with smooth muscle cells (SMCs) following vascular injury. The role of SMC-derived Fn-EDA in SMC phenotypic switching or its implication in neointimal hyperplasia remains unclear. Herein, using human coronary artery sections with a bare metal stent, we demonstrate the expression of Fn-EDA in the vicinity of SMC-rich neointima and peri-strut areas. In mice, Fn-EDA colocalizes with SMCs in the neointima of injured carotid arteries and promotes neointima formation in the comorbid condition of hyperlipidemia by potentiating SMC proliferation and migration. No sex-based differences were observed. Mechanistic studies suggested that Fn-EDA mediates integrin- and TLR4-dependent proliferation and migration through activation of FAK/Src and Akt1/mTOR signaling, respectively. Specific deletion of Fn-EDA in SMCs, but not in endothelial cells, reduced intimal hyperplasia and suppressed the SMC synthetic phenotype concomitant with decreased Akt1/mTOR signaling. Targeting Fn-EDA in human aortic SMCs suppressed the synthetic phenotype and downregulated Akt1/mTOR signaling. These results reveal that SMC-derived Fn-EDA potentiates phenotypic switching in human and mouse aortic SMCs and neointimal hyperplasia in the mouse. We suggest that targeting Fn-EDA could be explored as a potential therapeutic strategy to reduce neointimal hyperplasia.
METHODS:OBJECTIVE:The goal of this study was to determine the impact of late-acquired stent malapposition (LASM) on long-term clinical outcomes in patients treated with coronary stent implantation. Approach and Results: We investigated major adverse cardiac event during 10 years after 6-month intravascular ultrasound examination using our previous studies database. A total of 732 patients treated with bare-metal stent (54 LASM versus 678 non-LASM) and 529 patients treated with first-generation drug-eluting stent (82 LASM versus 447 non-LASM), who did not have clinical event or censoring at the time of follow-up intravascular ultrasound, were included for the present analysis. major adverse cardiac event was defined as the composite of cardiac death, target vessel-related myocardial infarction, target lesion revascularization and stent thrombosis. Multivariable adjustment and inverse probability weight were performed to consider baseline differences. After multivariable adjustment, LASM was related to a greater risk of major adverse cardiac event (hazard ratio, 1.666 [95% CI, 1.041-2.665]; P=0.0333) and very-late stent thrombosis (hazard ratio, 3.529 [95% CI, 1.153-10.798]; P=0.0271) than non-LASM in patients treated with first-generation drug-eluting stent, but not in those treated with bare-metal stent. Results were consistent after inverse probability weight. Among patients with LASM of first-generation drug-eluting stent, no late stent thrombosis occurred in patients who continued to receive dual antiplatelet therapy. CONCLUSIONS:The relationship between LASM and major adverse cardiac event might depend on the type of implanted stents during the long-term follow-up, highlighting the clinical significance of polymers and drugs in drug-eluting stent system.