聚合物涂层药物洗脱冠脉支架在高出血风险糖尿病患者中的应用：LEADERS FREE 试验的预先设定亚组研究。
Polymer-free drug-coated coronary stents in diabetic patients at high bleeding risk: a pre-specified sub-study of the LEADERS FREE trial.
机构信息
Heart Center, Segeberger Kliniken GmbH, Am Kurpark 1, 23795, Bad Segeberg, Germany.
Clinique Axium, Aix-en-Provence, France.
出版信息
Clin Res Cardiol. 2019 Jan;108(1):31-38. doi: 10.1007/s00392-018-1308-1. Epub 2018 Jun 27.
OBJECTIVE
Diabetics are at increased risk after stent implantation and potentially sensitive to the type of stent and dual anti-platelet therapy (DAPT). The randomized, double-blind LEADERS FREE trial compared 2432 patients at high bleeding risk (HBR) receiving either a polymer-free BA9-coated stent (DCS) or a bare metal stent (BMS) with 1 month of DAPT, and showed superior safety and efficacy of the DCS at 2 years. We report outcomes at 2 years of the pre-specified diabetic subgroup.
METHODS AND RESULTS
The diabetic sub-group comprised 805 (33.1%) patients; 262 (10.8%) were insulin-dependent (IDDM). Compared to non-diabetics, diabetics were younger and had more risk factors and multi-vessel disease. They suffered higher rates of death (15.6 vs. 12.2%, p = 0.01), cardiac death (8.3 vs. 5.9%, p = 0.02), myocardial infarction (MI) (11.1 vs. 7.8%, p = 0.009) and definite/probable stent thrombosis (3.1 vs. 1.7%, p = 0.01), but rates of clinically-indicated TLR (9.1 vs. 9.5%, p = 0.93) and BARC 3-5 bleeding (10.2 vs. 8.4%, p = 0.20) were comparable. Compared to diabetic patients treated with a BMS, diabetic DCS recipients required less clinically driven TLR (6.3 vs. 12.2%, p = 0.006). The primary safety endpoint (cardiac death, MI, definite/probable stent thrombosis) occurred numerically less frequently in the DCS group (14.9 vs. 19.7%, p = 0.10), and was significantly lower in IDDM patients (13.8 vs. 25.4%, p = 0.03). BARC 3-5 was similar for patients treated with DCS (9.9%) and BMS (10.5%, p = 0.84).
CONCLUSIONS
In diabetic HBR patients, DCS significantly reduced re-intervention rates over BMS, and showed a strong trend towards a safety benefit at 2 years.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov number: NCT01623180.
目的
支架植入术后糖尿病患者风险增加，且可能对支架类型和双联抗血小板治疗（DAPT）敏感。这项随机、双盲 LEADERS FREE 试验比较了 2432 例高出血风险（HBR）患者，分别接受无聚合物涂层的 BA9 涂层支架（DCS）或裸金属支架（BMS）治疗，并使用 1 个月的 DAPT，结果显示 DCS 在 2 年时具有更好的安全性和疗效。我们报告了预先指定的糖尿病亚组 2 年的结果。
方法和结果
糖尿病亚组包括 805 例（33.1%）患者；262 例（10.8%）为胰岛素依赖型（IDDM）。与非糖尿病患者相比，糖尿病患者更年轻，且有更多的危险因素和多血管疾病。他们的死亡率（15.6%比 12.2%，p=0.01）、心脏死亡率（8.3%比 5.9%，p=0.02）、心肌梗死（MI）（11.1%比 7.8%，p=0.009）和明确/可能的支架血栓形成（3.1%比 1.7%，p=0.01）更高，但临床指示性 TLR（9.1%比 9.5%，p=0.93）和 BARC 3-5 出血（10.2%比 8.4%，p=0.20）的发生率相似。与接受 BMS 治疗的糖尿病患者相比，接受 DCS 治疗的糖尿病患者需要较少的临床驱动 TLR（6.3%比 12.2%，p=0.006）。主要安全性终点（心脏死亡、MI、明确/可能的支架血栓形成）在 DCS 组的发生率较低（14.9%比 19.7%，p=0.10），在 IDDM 患者中显著降低（13.8%比 25.4%，p=0.03）。DCS（9.9%）和 BMS（10.5%）治疗的患者的 BARC 3-5 相似（p=0.84）。
结论
在 HBR 的糖尿病患者中，DCS 显著降低了与 BMS 相比的再介入率，并在 2 年时显示出安全性获益的强烈趋势。
临床试验注册
ClinicalTrials.gov 编号：NCT01623180。
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