A multicentre, randomised controlled clinical study of drug-coated balloons for the treatment of coronary in-stent restenosis.
- 作者列表："Hamm CW","Dörr O","Woehrle J","Krackhardt F","Ince H","Zeus T","Berland J","Piot C","Roubille F","Schult I","Allocco DJ","Nef H
AIMS:Treatment of in-stent restenosis of coronary stents is challenging. The use of drug-coated balloons (DCB) is a promising technique to treat in-stent restenosis without adding another metal layer. The aim of the AGENT ISR randomised trial is to evaluate angiographic and clinical outcomes in patients with ISR of a previously treated lesion who were treated with either a DCB with a new coating formulation (Agent) or a standard DCB (SeQuent Please). METHODS AND RESULTS:AGENT ISR is a multicentre, randomised, open-label, non-inferiority study comparing the Agent and SeQuent Please DCB. A total of 125 patients (mean age ~68 years, 18% female) with in-stent restenosis of a previously treated lesion <28 mm in length were randomised at 11 sites in Europe to Agent (n=65) or SeQuent Please (n=60). The primary endpoint, six-month in-stent late lumen loss, in the Agent group (0.397±0.43 mm [n=51]) was non-inferior to that of the SeQuent Please group (0.393±0.536 mm [n=49]), as the two-sided upper 95% confidence boundary for the difference between groups was less than the pre-specified non-inferiority margin of 0.20 (difference 0.004, 95% CI [-0.189, 0.196]; pnon-inferiority=0.046). At one year, mortality was 3.1% in Agent and 1.7% in SeQuent Please patients (p>0.99), target lesion revascularisation 7.7% versus 10.0% (p=0.89), and stent thrombosis 0% versus 3.3% (p=0.44). Similar improvements in quality of life were seen in the two groups. CONCLUSIONS:In this head-to-head comparison of two DCB, Agent proved to be non-inferior to SeQuent Please for in-stent late lumen loss at six months. CLINICAL TRIALS REGISTRATION:NCT02151812 (http://clinicaltrials.gov/).
目的: 冠状动脉支架内再狭窄的治疗具有挑战性。药物涂层球囊 (DCB) 的使用是一种有前途的技术，用于治疗支架内再狭窄而不添加另一金属层。代理ISR随机试验的目的是评估先前治疗的病变的ISR患者的血管造影和临床结果，这些患者使用新的涂层制剂 (药剂) 或标准DCB (请随后) 治疗DCB。 方法和结果: AGENT ISR是一项多中心、随机、开放标签、非劣效性研究，比较了Agent和SeQuent Please DCB。共有125名患者 (平均年龄 ~ 68岁，18% 为女性) 在欧洲11个地点接受治疗，既往治疗的病变长度 <28毫米cm，支架内再狭窄患者被随机分组，接受药物治疗 (n = 65) 或后续治疗 (n = 60)。主要终点，6个月支架内晚期管腔丢失，在药剂组 (0.397 ± 0.43毫米 [n = 51]) 不劣于后续请组 (0.393 ± 0.536毫米 [n = 49])，由于组间差异的双侧上95% 置信边界小于预先规定的非劣效性界值0.20 (差异0.004，95% CI [-0.189，0.196]; 非劣效性 = 0.046)。1年时，Agent的死亡率为3.1%，SeQuent Please患者的死亡率为1.7% (p>0.99)，靶病变血管重建为7.7% 对10.0% (p = 0.89)，支架内血栓形成为0% 对3.3% (p = 0.44)。在两组中观察到类似的生活质量改善。 结论: 在两种DCB的头对头比较中，对于6个月的支架内晚期管腔丢失，证明药剂不劣于SeQuent Please。 临床试验注册: NCT02151812 (http://clinicaltrials.gov/)。
METHODS::We present the case of a 61-year-old woman with a large tumoral infiltration extending from the pelvis throughout the inferior vena cava inferior to the right atrium, protruding into the right ventricle and right ventricular outflow tract. She had been treated 10 years before for low-grade endometrial stromal sarcoma by hysterectomy and adnexectomy followed by hormone- and radio-therapy. Due to cancer recurrence, she underwent peritonectomy, appendectomy, and resection of terminal ileum.
METHODS:AIMS:Significant platelet activation after long stented coronary segments has been associated with periprocedural microvascular impairment and myonecrosis. In long lesions treated either with an everolimus-eluting bioresorbable vascular scaffold (BVS) or an everolimus-eluting stent (EES), we aimed to investigate (a) procedure-related microvascular impairment, and (b) the relationship of platelet activation with microvascular function and related myonecrosis. METHODS AND RESULTS:Patients (n=66) undergoing elective percutaneous coronary intervention (PCI) in long lesions were randomised 1:1 to either BVS or EES. The primary endpoint was the difference between groups in changes of pressure-derived corrected index of microvascular resistance (cIMR) after PCI. Periprocedural myonecrosis was assessed by high-sensitivity cardiac troponin T (hs-cTnT), platelet reactivity by high-sensitivity adenosine diphosphate (hs-ADP)-induced platelet reactivity with the Multiplate Analyzer. Post-dilatation was more frequent in the BVS group, with consequent longer procedure time. A significant difference was observed between the two groups in the primary endpoint of ΔcIMR (p=0.04). hs-ADP was not different between the groups at different time points. hs-cTnT significantly increased after PCI, without difference between the groups. CONCLUSIONS:In long lesions, BVS implantation is associated with significant acute reduction in IMR as compared with EES, with no significant interaction with platelet reactivity or periprocedural myonecrosis.
METHODS:BACKGROUND:Aortopulmonary window is an uncommon congenital heart disease, with untreated cases not surviving beyond childhood. However, very rarely it can present in adult patients with features of pulmonary hypertension. Clinically these patients cannot be differentiated from other more common conditions with left to right shunt. Transthoracic echocardiography if performed meticulously, can depict the defect in aortopulmonary septum. RESULTS:We report a case of large unrepaired aortopulmonary window in a 23 years old patient, diagnosed on transthoracic echocardiography.