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Impact of Kissing Balloon in Patients Treated With Ultrathin Stents for Left Main Lesions and Bifurcations: An Analysis From the RAIN-CARDIOGROUP VII Study.
Circulation: Cardiovascular Interventions ( IF 5.6 ) Pub Date : 2020-02-27 , DOI: 10.1161/circinterventions.119.008325
Luca Gaido 1 , Fabrizio D'Ascenzo 2 , Yoichi Imori 3 , Wojciech Wojakowski 4 , Andrea Saglietto , Filippo Figini 2 , Alessio Mattesini 5 , Daniela Trabattoni 6 , Andrea Rognoni 7 , Francesco Tomassini 8, 9 , Alessandro Bernardi 10 , Nicola Ryan 11 , Saverio Muscoli 12 , Gerard Helft 13 , Ovidio De Filippo , Radoslaw Parma 14 , Leonardo De Luca 15 , Fabrizio Ugo 10 , Enrico Cerrato 8, 9 , Antonio Montefusco 2 , Mauro Pennacchi 15 , Wojciech Wańha 4 , Grzegorz Smolka 4 , Giulia de Lio 2 , Francesco Bruno 2 , Zenon Huczek 14 , Giacomo Boccuzzi 10 , Bernardo Cortese 16 , Davide Capodanno 17 , Pierluigi Omedè 2 , Massimo Mancone 18 , Ivan Nuñez-Gil 11 , Francesco Romeo 12 , Ferdiando Varbella 8, 9 , Mauro Rinaldi 2 , Javier Escaned 11 , Federico Conrotto 2 , Francesco Burzotta 19 , Alaide Chieffo 20 , Leor Perl 21 , Maurizio D'Amico 2 , Carlo di Mario 5 , Imad Sheiban 22 , Andrea Gagnor 1 , Massimo Giammaria 1 , Gaetano Maria De Ferrari 2
Affiliation  

BACKGROUND There are limited data regarding the impact of final kissing balloon (FKI) in patients treated with percutaneous coronary intervention using ultrathin stents in left main or bifurcations. METHODS All patients undergoing left main or bifurcations percutaneous coronary intervention enrolled in the RAIN registry (Very Thin Stents for Patients With MAIN or BiF in Real Life: The RAIN, a Multicenter Study) evaluating ultrathin stents were included. Major adverse cardiac event (a composite of all-cause death, myocardial infarction, target lesion revascularization, and stent thrombosis) was the primary end point, while its components, along with target vessel revascularization, were the secondary end points. The main analysis was performed comparing patients with and without FKI after adjustment with inverse probability of treatment weighting. Subgroup analyses were performed according to FKI (short [<3 mm] versus long overlap), strategy (provisional versus 2-stent), routine versus bail-out FKI, and the use of imaging and proximal optimization technique. RESULTS Two thousand seven hundred forty-two patients were included. At 16 months (8-20) follow-up, inverse probability of treatment weighting adjusted rates of major adverse cardiac event were similar between FKI and no-FKI group (15.1% versus 15.5%; P=0.967), this result did not change with use of imaging, proximal optimization technique, or routine versus bail-out FKI. In the 2-stent subgroup, FKI was associated with lower rates of target vessel revascularization (7.8% versus 15.9%; P=0.030) and target lesion revascularization (7.3% versus 15.2%; P=0.032). Short overlap FKI was associated with a lower rate of target lesion revascularization compared with no FKI (2.6% versus 5.4%; P=0.034), while long overlap was not (6.8% versus 5.4%; P=0.567). CONCLUSIONS In patients with bifurcations or unprotected left main treated with ultrathin stents, short overlap FKI is associated with less restenosis. In a 2-stent strategy, FKI was associated with less target vessel revascularization and restenosis. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03544294.

中文翻译:

接吻球囊对超薄支架治疗左主要病变和分叉的患者的影响:来自RAIN-CARDIOGROUP VII研究的分析。

背景技术关于最终吻接球囊(FKI)对在左主干或分叉中使用超薄支架经皮冠状动脉介入治疗的患者的影响的数据有限。方法纳入所有接受过左主干或分叉经皮冠状动脉介入治疗的患者,这些患者均纳入了评估超薄支架的RAIN登记册(在现实生活中对MAIN或BiF患者使用非常薄的支架:RAIN,一项多中心研究)。主要的不良心脏事件(全因死亡,心肌梗塞,目标病变血运重建和支架血栓形成的综合因素)是主要终点,而其主要组成部分以及目标血管血运重建是次要终点。进行了主要分析,将调整后有或没有FKI的患者与治疗权重的倒数进行比较。根据FKI(短[<3 mm]与长重叠),策略(临时与2支架),常规与纾困FKI以及使用成像和近端优化技术进行亚组分析。结果纳入274例患者。在16个月(8-20)的随访中,FKI组和非FKI组之间的​​治疗加权加权重大不良心脏事件发生率的逆概率相似(15.1%对15.5%; P = 0.967)。使用成像,近端优化技术或常规与救助FKI。在2个支架亚组中,FKI与靶血管血运重建率较低(7.8%对15.9%; P = 0.030)和靶病变血运重建率较低(7.3%对15.2%; P = 0.032)相关。与没有FKI相比,短重叠FKI与目标病变血运重建率较低相关(2.6%对5.4%; P = 0.034),而长重叠则不相关(6.8%对5.4%; P = 0.567)。结论对于分叉或无保护的左主干接受超薄支架治疗的患者,较短的FKI重叠可减少再狭窄。在2支架策略中,FKI与较少的靶血管血运重建和再狭窄相关。注册:URL:https://www.clinicaltrials.gov;唯一标识符:NCT03544294。FKI与较少的靶血管血运重建和再狭窄相关。注册:URL:https://www.clinicaltrials.gov;唯一标识符:NCT03544294。FKI与较少的靶血管血运重建和再狭窄相关。注册:URL:https://www.clinicaltrials.gov;唯一标识符:NCT03544294。
更新日期:2020-02-27
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