Randomized Comparison of the Effects of PLatinum Chromium Everolimus-eluting Stent vs. cobAlT Chromium Everolimus-eluting Stent on inFlammatOry maRkers and Endothelial daMage - The PLATFORM Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Post-PCI changes in markers of endothelial damage
研究概览
简要总结
Percutaneous coronary intervention (PCI) with stenting may induce endothelial damage/dysfunction and inflammatory reactions, which in turn delay healing and endothelialization and may lead to restenosis and atherosclerosis within the stented segments. Drugs and polymers are considered the protagonists of these pathophysiologic processes whereas the role of stent platforms remains poorly defined.It remains unknown, conversely, if stent platforms affect the extent of post-PCI endothelial damage and inflammation.
详细描述
Percutaneous coronary intervention (PCI) with stenting may induce endothelial damage/dysfunction and inflammatory reactions, which in turn delay healing and endothelialization and may lead to restenosis and atherosclerosis within the stented segments.
Drugs and polymers are considered the protagonists of these pathophysiologic processes whereas the role of stent platforms remains poorly defined.
Due to advances in stent technology, stent platforms have evolved from the cobalt-chromium (CoCr) to the platinum-chromium (PtCr) stent series. At present, the PROMUS Element stent (which uses the PtCr platform) employs an identical polymer, drug, drug formulation and dose density to the CoCr XIENCE V stent.
The PLATINUM WH trial is the only randomized trial comparing the PROMUS Element stent with the XIENCE V stent in a total of 1,530 patients. The study met its primary end-point demonstrating that the PROMUS Element stent is non-inferior to the XIENCE V stent. The 12-month rare of target lesion failure was 3.4% in the PROMUS Element stent and 2.9% in the XIENCE V stent.
Pre-clinical animal studies, however, suggest that the PtCr platform might have important advantages over the CrCo platform, as improved vascular compatibility and early and late healing for PtCr devices compared with CoCr stents have been demonstrated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A de novo native coronary artery lesions (reference vessel diameter:2.5-3.75 mm)
- •Class I indication to elective percutaneous coronary intervention
- •Stable conditions and no recent acute coronary syndromes
- •Normal baseline values of markers of myocardial damage (creatine kinase, creatine kinase-MB, myoglobin, and troponin I)
- •Able to understand and willing to sign the informed CF
排除标准
- •Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT
结局指标
主要结局
Post-PCI changes in markers of endothelial damage
时间窗: Baseline and 24 hours after PCI
Changes 24 hours after PCI in the following indexes of endothelial damage: 1. von Willebrand Factor (vWF) 2. sE-selectin 3. Vascular cell adhesion molecule (sVCAM-1) 4. Intercellular adhesion molecule (sICAM-1)
Post-PCI changes in markers of inflammation
时间窗: Baseline and 24 hours after PCI
Changes 24 hours after PCI in the following inflammatory markers: 1. C-reactive protein (CPR) 2. Fibrinogen 3. Plasminogen activator inhibitor (PAI-1) 4. Interleukin-6 (IL-6)
次要结局
- 12-month rate of MACE(Up to 12 months)
研究者
Francesco Pelliccia
Assistant Professor
University of Roma La Sapienza