Karjalainen Pasi P, Ylitalo Antti, Airaksinen Juhani K E
Satakunta Central Hospital, Sairaalatie 3, Pori, 28100, Finland.
J Invasive Cardiol. 2006 Oct;18(10):462-8.
The aim of this study was to compare clinical outcome of a stainless-steel stent coated with titanium nitride oxide (TITANOX) and a paclitaxel-eluting stent (PES) in routine clinical practice represented by two prospective registries including all patients with de novo coronary artery disease treated exclusively with a TITANOX stent (n = 201) or with a PES (n = 204) between May 2003 and November 2004 (63% of all PCI patients). The primary endpoint of the study was major adverse cardiac events (MACE) at 30 days and 12 months. The TITANOX stent patients were more frequently (p = 0.011) treated for acute myocardial infarction and had more complex B- and C-type lesions (p = 0.004). The PES patients had longer (p < 0.001) total stent length. At 30 days, the rate of MACE was 0% and 4.9% for the TITANOX stent and PES groups, respectively (p = 0.001). A significant difference in target vessel revascularization (TVR) was seen in favor of the TITANOX stent (0% vs. 2.9% for PES; p = 0.014). This was mainly driven by stent thrombosis (n = 7). At 12 months, the difference in MACE was no longer significant (10.9% vs. 13.7%; p = 0.40), but the rate of myocardial infarction was lower in the TITANOX stent group (4.5% vs. 10.3%; p = 0.025). The rate of TVR (8% vs. 6.9%; p = 0.67) was similar between the two groups. In conclusion, both the TITANOX-coated stent and PES resulted in good clinical outcome with infrequent need for repeat interventions in the real-world setting of high-risk patients and complex coronary lesions.
本研究旨在比较氮化钛氧化物涂层不锈钢支架（TITANOX）与紫杉醇洗脱支架（PES）在常规临床实践中的临床疗效，该研究以两个前瞻性注册研究为代表，纳入了2003年5月至2004年11月期间所有仅接受TITANOX支架（n = 201）或PES（n = 204）治疗的初发冠心病患者（占所有PCI患者的63%）。研究的主要终点是30天和12个月时的主要不良心脏事件（MACE）。TITANOX支架组患者因急性心肌梗死接受治疗的频率更高（p = 0.011），且B型和C型病变更复杂（p = 0.004）。PES组患者的支架总长度更长（p < 0.001）。30天时，TITANOX支架组和PES组的MACE发生率分别为0%和4.9%（p = 0.001）。在靶血管重建（TVR）方面，TITANOX支架组有显著优势（PES组为0%，TITANOX支架组为2.9%；p = 0.014）。这主要是由支架血栓形成（n = 7）导致的。12个月时，MACE差异不再显著（10.9%对13.7%；p = 0.40），但TITANOX支架组的心肌梗死发生率较低（4.5%对10.3%；p = 0.025）。两组的TVR发生率相似（8%对6.9%；p = 0.67）。总之，在高危患者和复杂冠状动脉病变的实际临床环境中，TITANOX涂层支架和PES均取得了良好的临床疗效，重复干预需求较少。
