REGULATE-PCI解读：新型抗凝剂REG1与比伐卢定的心血管获益比较

主要疗效终点 主要安全终点
次要终点
事件终点
(在3天和30天评估)
• 3天时死亡 • 非致死性心梗 • 非致死性卒中 • 紧急TLR
Steering Committee: A. Levinson (USA), R. Becker (USA), V. Hasselblad (USA), K. Huber (Austria, P.R. Sinnaeve (Belgium), M. Aschermann (Czech Republic), P. Laanmets (Estonia), B. Merkely (Hungary), V. Guetta (Israel), M. Valgimigli (Italy), J.H. Cornel (Netherlands), J.D. Kasprzak (Poland), J. Morais (Portugal), B. Alekyan (Russia), V. Fridrich (Slovakia), J. Lopez/Sendon (Spain), R. Stables (UK), M. G. Cohen (USA), T. Povsic (USA)
背景
• 新型抗栓药物在PCI中表现并不完美。GP IIb/IIIa抑 制剂可以很好的抑制血小板，但出血事件更多。虽然 比伐卢定的出血风险较小，但有支架内血栓形成的风 险
• 之前RADAR 2期研究显示，REG1治疗组的30天死亡率、 非致死性心梗、目标血管紧急血运重建（TLR）或目 标血管复发缺血事件发生率低于肝素治疗组
inhibition with Pegnivacogin during PCI would provide a greater reduction in ischemic events than bivalirudin without increased bleeding as a result of anticoagulant reversal with Anivamersen.
陈灿 教授 2015.07.16
新型抗凝剂REG1（REG1 Anticoagulation System）与 比伐卢定（Bivalirudin）的心血管
获益比较
The REGULATE-PCI Randomized Clinical Trial
试验主要参与组织
Leabharlann Baidu
Academic Leadership
What would be an ideal antithrombotic Regimen for PCI?
Rapid Onset of Action（速效） Predictable Dose-Response（精准剂量反应） High Anti-Thrombotic Efficacy（高抗血栓效应） Quick Reversibility or Titratability（快速可逆）
The REGULATE-PCI Randomized Clinical Trial
• Randomized, open-label, active-controlled, superiority, • phase 3 trial to test the hypothesis that near complete FIXa
Factor IXa
特异性结合 IXa因子anivamersen 中和pegnivacogin
31 nucleotides
(RB007) 15 nucleotides
+ 40 kDa PEG
t1/2 < 5 min
t1/2 > 24hr tmax < 5 min
+
tmax ~ immediate
该研究注册情况：
背景
The REG1 Anti-Coagulation System
• REG-1 由pegnivacogin 和拮抗剂 anivamersen组成 REG1是一种快速起效、可预测剂量反应、高效的抗凝剂
pegnivacogin
anivamersen
pegnivacogin (RB006)
研究设计
经CAG后需要 PCI患者
REG1组
Pegnivacogin Anivamersen
1 mg/kg
0.5 mg/kg
随机分组
剂量
PCI
PCI 术后
鞘管拔出后
Bival 药丸
Bival 输注
Bivalirudin 组
最初结局 (Day 3)
随访评估 4-10d
随访 30 d
纳入标准
• 经PCI治疗的CAD患者（分为以下三个亚组）
Executive Committee •John Alexander (co-PI) •Michael Lincoff (co-PI) •Roxana Mehran (co-PI) •Paul Armstrong •Gabriel Steg •Christoph Bode •Steve Zelenkofske (Regado)
Operations
Project Management: DCRI, C5R, Regado, PAREXEL US Site Management: DCRI, C5R CN Site Management: CVC ROW Site Management: PAREXEL Data Management: DCRI Statistics: DCRI Safety: DCRI Clinical Event Committee: DCRI IXRS: ClinPhone Perceptive Informatics) Study Drug: Catalent / PAREXEL DSMB: Stanford U. – Robert Harrington (chair)
• Subgroup A: 心梗后7日之内无发作，心肌标志物阴性 • Subgroup B: 患者至少以下一种危险因素: ACS 患者7天后
心肌标志物阴性; 不稳定性心绞痛患者; 年龄> 70; 糖尿病; 慢性肾脏病; 计划行多血管PCI; 准备进行 CABG; 外周血管 疾病; • Subgroup C: A、B组以外的CAD患者