临时边支支架置入术与双支架策略治疗累及大边支的真性冠状动脉分叉病变的随机对照研究：北欧-波罗的海分叉研究IV
Randomised comparison of provisional side branch stenting versus a two-stent strategy for treatment of true coronary bifurcation lesions involving a large side branch: the Nordic-Baltic Bifurcation Study IV.
作者信息
Kumsars Indulis, Holm Niels Ramsing, Niemelä Matti, Erglis Andrejs, Kervinen Kari, Christiansen Evald Høj, Maeng Michael, Dombrovskis Andis, Abraitis Vytautas, Kibarskis Aleksandras, Trovik Thor, Latkovskis Gustavs, Sondore Dace, Narbute Inga, Terkelsen Christian Juhl, Eskola Markku, Romppanen Hannu, Laine Mika, Jensen Lisette Okkels, Pietila Mikko, Gunnes Pål, Hebsgaard Lasse, Frobert Ole, Calais Fredrik, Hartikainen Juha, Aarøe Jens, Ravkilde Jan, Engstrøm Thomas, Steigen Terje K, Thuesen Leif, Lassen Jens F
机构信息
Department of Cardiology, Latvia Center of Cardiology, Paul Stradins Clinical University Hospital, Riga, Latvia.
Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
出版信息
Open Heart. 2020 Jan 19;7(1):e000947. doi: 10.1136/openhrt-2018-000947. eCollection 2020.
BACKGROUND
It is still uncertain whether coronary bifurcations with lesions involving a large side branch (SB) should be treated by stenting the main vessel and provisional stenting of the SB (simple) or by routine two-stent techniques (complex). We aimed to compare clinical outcome after treatment of lesions in large bifurcations by simple or complex stent implantation.
METHODS
The study was a randomised, superiority trial. Enrolment required a SB≥2.75 mm, ≥50% diameter stenosis in both vessels, and allowed SB lesion length up to 15 mm. The primary endpoint was a composite of cardiac death, non-procedural myocardial infarction and target lesion revascularisation at 6 months. Two-year clinical follow-up was included in this primary reporting due to lower than expected event rates.
RESULTS
A total of 450 patients were assigned to simple stenting (n=221) or complex stenting (n=229) in 14 Nordic and Baltic centres. Two-year follow-up was available in 218 (98.6%) and 228 (99.5%) patients, respectively. The primary endpoint of major adverse cardiac events (MACE) at 6 months was 5.5% vs 2.2% (risk differences 3.2%, 95% CI -0.2 to 6.8, p=0.07) and at 2 years 12.9% vs 8.4% (HR 0.63, 95% CI 0.35 to 1.13, p=0.12) after simple versus complex treatment. In the subgroup treated by newer generation drug-eluting stents, MACE was 12.0% vs 5.6% (HR 0.45, 95% CI 0.17 to 1.17, p=0.10) after simple versus complex treatment.
CONCLUSION
In the treatment of bifurcation lesions involving a large SB with ostial stenosis, routine two-stent techniques did not improve outcome significantly compared with treatment by the simpler main vessel stenting technique after 2 years.
TRIAL REGISTRATION NUMBER
NCT01496638.
背景
对于病变累及大分支血管（SB）的冠状动脉分叉病变，究竟应采用主支血管支架置入并对分支血管进行临时支架置入（简单术式）还是常规双支架技术（复杂术式）进行治疗仍不明确。我们旨在比较简单或复杂支架植入治疗大分叉病变后的临床结局。
方法
本研究为一项随机优效性试验。入组要求分支血管≥2.75毫米，两支血管直径狭窄均≥50%，且分支血管病变长度可达15毫米。主要终点为6个月时的心源性死亡、非手术相关心肌梗死和靶病变血运重建的复合终点。由于事件发生率低于预期，本次主要报告纳入了两年的临床随访。
结果
在14个北欧和波罗的海中心，共有450例患者被分配至简单支架置入组（n = 221）或复杂支架置入组（n = 229）。分别有218例（98.6%）和228例（99.5%）患者有两年的随访数据。简单治疗与复杂治疗后，6个月时主要不良心血管事件（MACE）的主要终点分别为5.5%和2.2%（风险差异3.2%，95%CI -0.2至6.8，p = 0.07），两年时分别为12.9%和8.4%（HR 0.63，95%CI 0.35至1.13，p = 0.12）。在接受新一代药物洗脱支架治疗的亚组中，简单治疗与复杂治疗后MACE分别为12.0%和5.6%（HR 0.45，95%CI 0.17至1.17，p = 0.10）。
结论
在治疗伴有开口狭窄的大分支血管分叉病变时，与采用更简单的主支血管支架置入技术治疗相比，常规双支架技术在两年后并未显著改善结局。
试验注册号
NCT01496638。
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