无保护左主干时生物可吸收 vs 持久聚合物药物洗脱支架比较（来自 RAIN-CARDIOGROUP VII 研究）。
Comparison of bioresorbable vs durable polymer drug-eluting stents in unprotected left main (from the RAIN-CARDIOGROUP VII Study).
机构信息
Division of Cardiology, SS. Annunziata Hospital, ASL CN1, Savigliano, Italy.
Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan.
出版信息
BMC Cardiovasc Disord. 2020 May 15;20(1):225. doi: 10.1186/s12872-020-01420-5.
BACKGROUND
There are limited data regarding the impact of bioresorbable polymer drug eluting stent (BP-DES) compared to durable polymer drug eluting stent (DP-DES) in patients treated with percutaneous coronary intervention using ultrathin stents in left main or bifurcations.
METHODS
In the RAIN registry (ClinicalTrials NCT03544294, june 2018 retrospectively registered) patients with a ULM or bifurcation stenosis treated with PCI using ultrathin stents (struts thinner than 81 μm) were enrolled. The primary endpoint was the rate of target lesion revascularization (TLR); major adverse cardiovascular events (MACE, a composite of all-cause death, myocardial infarction, TLR and stent thrombosis) and its components, along with target vessel revascularization (TVR) were the secondary ones. A propensity score with matching analysis to compare patients treated with BP-DES versus DP-DES was also assessed.
RESULTS
From 3001 enrolled patients, after propensity score analysis 1400 patients (700 for each group) were selected. Among them, 352 had ULM disease and 1048 had non-LM bifurcations. At 16 months (12-22), rates of TLR (3.7% vs 2.9%, p = 0.22) and MACE were similar (12.3% vs. 11.6%, p = 0.74) as well as for the other endpoints. Sensitivity analysis of outcomes after a two-stents strategy, showed better outcome in term of MACE (20.4% vs 10%, p = 0.03) and TVR (12% vs 4.6%, p = 0.05) and a trend towards lower TLR in patients treated with BP-DES.
CONCLUSION
In patients with bifurcations or ULM treated with ultrathin stents BP-DES seems to perform similarly to DP-DES: the trends toward improved clinical outcomes in patients treated with the BP-DES might potentially be of value for speculating the stent choice in selected high-risk subgroups of patients at increased risk of ischemic events.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT03544294. Retrospectively registered June 1, 2018.
背景
在使用超薄支架进行经皮冠状动脉介入治疗（支架厚度小于 81μm）的左主干或分叉病变患者中，与耐用聚合物药物洗脱支架（DP-DES）相比，生物可吸收聚合物药物洗脱支架（BP-DES）的影响数据有限。
方法
在 RAIN 登记研究（ClinicalTrials NCT03544294，2018 年 6 月回顾性注册）中，纳入了使用超薄支架治疗的左主干或分叉狭窄的患者。主要终点是靶病变血运重建（TLR）的发生率；主要不良心血管事件（MACE，包括全因死亡、心肌梗死、TLR 和支架血栓形成）及其组成部分以及靶血管血运重建（TVR）是次要终点。还评估了使用 BP-DES 与 DP-DES 治疗的患者的倾向评分匹配分析。
结果
在纳入的 3001 例患者中，经倾向评分分析后，选择了 1400 例患者（每组 700 例）。其中，352 例患者有左主干病变，1048 例患者有非左主干分叉病变。在 16 个月（12-22 个月）时，TLR 发生率（3.7% vs 2.9%，p=0.22）和 MACE 相似（12.3% vs. 11.6%，p=0.74），其他终点也相似。两支架策略治疗后结局的敏感性分析显示，BP-DES 治疗组在 MACE（20.4% vs 10%，p=0.03）和 TVR（12% vs 4.6%，p=0.05）方面的结果更好，且 TLR 趋势较低。
结论
在使用超薄支架治疗的分叉病变或左主干病变患者中，BP-DES 似乎与 DP-DES 表现相似：BP-DES 治疗患者的临床结局改善趋势可能对推测特定高危亚组患者的支架选择具有价值，这些患者发生缺血事件的风险增加。
试验注册
ClinicalTrials.gov 标识符：NCT03544294。2018 年 6 月 1 日回顾性注册。
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