Assadi-Schmidt Athena, Mohring Annemarie, Liebsch Eva, Dannenberg Lisa, Achilles Alina, Pöhl Martin, Afzal Shazia, Veulemans Verena, Horn Patrick, Sansone Roberto, Bönner Florian, Levkau Bodo, Kelm Malte, Zeus Tobias, Polzin Amin
Division of Cardiology, Pulmonology, and Vascular Medicine, Heinrich Heine University Medical Center Dusseldorf, Dusseldorf, Germany.
Institute of Pathophysiology, West German Heart and Vascular Center, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.
Int J Cardiol. 2017 Mar 15;231:68-72. doi: 10.1016/j.ijcard.2016.12.022. Epub 2016 Dec 13.
In-stent restenosis (ISR) is still a major concern in interventional cardiology. Drug coated balloon (DCB) angioplasty has been shown to be a promising option in treatment of ISR. However heterogeneity of different DCBs in suppression of neointimal growth has been described in a porcine model of coronary ISR. Therefore, in this registry analysis, we compared two frequently used paclitaxel eluting DCBs, the SeQuent Please and the Pantera Lux DCB.
571 patients were treated with DCB angioplasty at the Heinrich-Heine University Düsseldorf between 2009 and 2012. Follow-up was conducted during ambulatory care at our department. Major adverse cardiac events (death, myocardial infarction [MI] and target lesion revascularization) were registered during hospitalization and follow-up.
Patient characteristics, prior diseases, clinical presentation, ejection fraction, procedural success and lost-for-follow-up did not differ between patients treated with the SeQuent Please and. The Pantera Lux DCB. MACE during hospital course were similar as well (Pantera Lux: 6 patients [1.6%] vs. SeQuent®Please: 3 patients [1.5%], relative risk 1.06, 95% confidence interval 0.3-4.2, P=0.93). Event free survival was significantly longer in patients treated with the Pantera Lux DCB as compared to SeQuent Please DCB (Hazard ratio: 0.65, 95% confidence interval 0.43-0.98; P value of log-rank test: 0.0405).
MACE free survival was longer in Pantera Lux DCB treated patients as compared to SeQuent Please treated patients. This finding has to be confirmed in future clinical trials.
支架内再狭窄(ISR)仍是介入心脏病学中的一个主要问题。药物涂层球囊(DCB)血管成形术已被证明是治疗ISR的一个有前景的选择。然而,在冠状动脉ISR的猪模型中,不同DCB在抑制新生内膜生长方面存在异质性。因此,在本注册研究分析中,我们比较了两种常用的紫杉醇洗脱DCB,即SeQuent Please和Pantera Lux DCB。
2009年至2012年期间,571例患者在杜塞尔多夫海因里希-海涅大学接受了DCB血管成形术治疗。在我们科室的门诊护理期间进行随访。在住院期间和随访期间记录主要不良心脏事件(死亡、心肌梗死[MI]和靶病变血管重建)。
接受SeQuent Please和Pantera Lux DCB治疗的患者在患者特征、既往疾病、临床表现、射血分数、手术成功率和失访情况方面没有差异。住院期间的主要不良心脏事件也相似(Pantera Lux:6例患者[1.6%] vs. SeQuent®Please:3例患者[1.5%],相对风险1.06,95%置信区间0.3 - 4.2,P = 0.93)。与SeQuent Please DCB相比,接受Pantera Lux DCB治疗的患者无事件生存期显著更长(风险比:0.65,95%置信区间0.43 - 0.98;对数秩检验P值:0.0405)。
与接受SeQuent Please治疗的患者相比,接受Pantera Lux DCB治疗的患者无主要不良心脏事件生存期更长。这一发现有待未来临床试验证实。