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作为杂交慢性完全闭塞血运重建策略的一部分的顺行夹层和再进入:RECHARGE 注册研究(法国、荷兰、比利时和英国的 CrossBoss 和杂交手术注册研究)的一个亚组分析。

Antegrade Dissection and Reentry as Part of the Hybrid Chronic Total Occlusion Revascularization Strategy: A Subanalysis of the RECHARGE Registry (Registry of CrossBoss and Hybrid Procedures in France, the Netherlands, Belgium and United Kingdom).

机构信息

From the Faculty of Medicine and Life Sciences, Universiteit Hasselt, Belgium (J.M., J.D.); Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium (J.M., J.D.); Department of Cardiology, Forth Valley Royal Hospital, Edinburgh, United Kingdom (J.C.S., W.W., S.W.); Department of Cardiology, Freeman Hospital, Newcastle upon Tyne, United Kingdom (A.J.B., M.E.); Institute of Cellular Medicine, Newcastle University, United Kingdom (A.J.B., M.E.); Department of Cardiology, VU University Medical Center, Amsterdam, the Netherlands (W.S., A.N., P.K.); Department of Cardiology, Universitair Medisch Centrum Utrecht, the Netherlands (P.A.); Department of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands (P.A.); Department of Cardiology, Belfast City Hospital, United Kingdom (C.G.H., S.W.); Department of Cardiology, Groupe Hospitalier Mutualiste, Grenoble, France (B.F.); Department of Cardiology, Clinique de Marignane, France (A.A.); and Department of Cardiology, Nouvelles Cliniques Nantaises, Nantes, France (E.B.).

出版信息

Circ Cardiovasc Interv. 2017 Jun;10(6). doi: 10.1161/CIRCINTERVENTIONS.116.004791.

DOI:10.1161/CIRCINTERVENTIONS.116.004791
PMID:28625964
Abstract

BACKGROUND

Development of the CrossBoss and Stingray devices for antegrade dissection and reentry (ADR) of chronic total occlusions has improved historically suboptimal outcomes. However, the outcomes, safety, and failure modes of the technique have to be studied in a larger patient cohort. This preplanned substudy of the RECHARGE registry (Registry of CrossBoss and Hybrid Procedures in France, the Netherlands, Belgium and United Kingdom) aims to evaluate the value and use of ADR and determine its future position in contemporary chronic total occlusion intervention.

METHODS AND RESULTS

Patients were selected if an ADR strategy was applied. Outcomes, safety, and failure modes of the technique were assessed. The ADR technique was used in 23% (n=292/1253) of the RECHARGE registry and was mainly applied for complex lesions (Japanese chronic total occlusion score=2.7±1.1). ADR was the primary strategy in 30% (n=88/292), of which 67% were successful. Bail-out ADR strategies were successful in 63% (n=133/210). The Controlled ADR (ie, combined CrossBoss-Stingray) subtype was applied most frequently (32%; n=93/292) and successfully (81%; n=75/93). Overall per-lesion success rate was 78% (n=229/292), after use of additional bail-out strategies. The inability to reach the distal target zone (n=48/100) or to reenter (n=43/100) most commonly led to failure. ADR-associated major events occurred in 3.4% (n=10/292).

CONCLUSIONS

Although mostly applied as a bail-out strategy for complex lesions, the frequency, outcomes, and low complication rate of the ADR technique and its subtypes confirm the benefit and value of the technique in hybrid chronic total occlusion percutaneous coronary intervention, especially when antegrade wiring or retrograde approaches are not feasible.

CLINICAL TRIAL REGISTRATION

URL: http://www.clinicaltrials.gov. Unique identifier: NCT02075372.

摘要

背景

CrossBoss 和 Stingray 装置的发展用于慢性完全闭塞的顺行夹层和再进入(ADR),提高了既往不尽人意的结果。然而,该技术的结果、安全性和失败模式需要在更大的患者队列中进行研究。这项 RECHARGE 注册研究(法国、荷兰、比利时和英国的 CrossBoss 和杂交手术注册研究)的预先计划的子研究旨在评估 ADR 的价值和用途,并确定其在当代慢性完全闭塞介入治疗中的未来地位。

方法和结果

如果应用 ADR 策略,则选择患者。评估技术的结果、安全性和失败模式。ADR 技术在 RECHARGE 注册研究的 23%(n=292/1253)中使用,主要应用于复杂病变(日本慢性完全闭塞评分=2.7±1.1)。ADR 是主要策略的 30%(n=88/292),其中 67%成功。133/210 例(63%) bailout ADR 策略成功。控制性 ADR(即 CrossBoss-Stingray 联合)亚组应用最频繁(32%;n=93/292),成功率为 81%(n=75/93)。使用额外的 bailout 策略后,整体每例病变成功率为 78%(n=229/292)。最常见的失败原因是无法到达远端靶区(n=48/100)或无法再进入(n=43/100)。ADR 相关的主要事件发生率为 3.4%(n=10/292)。

结论

尽管主要作为复杂病变的 bailout 策略应用,但 ADR 技术及其亚型的频率、结果和低并发症发生率证实了该技术在杂交慢性完全闭塞经皮冠状动脉介入治疗中的益处和价值,尤其是在前向导线或逆行方法不可行时。

临床试验注册

网址:http://www.clinicaltrials.gov。唯一标识符:NCT02075372。

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