Karjalainen Pasi P, Ylitalo Antti S, Juhani Airaksinen K E
Satakunta Central Hospital, Division of Cardiology, Pori, Finland.
EuroIntervention. 2006 Aug;2(2):187-91.
The aim of the Titan PORI Registry was to evaluate the safety and efficacy of a stainless steel stent coated with titanium nitride oxide (Titan(R), Hexacath, France) in routine clinical practice.
We report a prospective single-centre experience in treating patients with the Titan(R) stent. All consecutive patients receiving Titan(R) stent(s) were enrolled. The choice of a stent was at the discretion of the operator with no exclusion criteria. The primary end point of the registry was Major Adverse Cardiac Events (MACE) at 6 and 9 months. A total of 210 lesions were treated in 193 enrolled patients (mean age 67+/-10; men 71%; diabetes 17%). Lesions were of type B in 64% and type C in 23%. The indications for PCI were unstable angina or non-Q-wave MI in 36% and acute STEMI in 30% of the patients. Mean reference diameter was 2.9+/-0.3 mm and mean lesion length 12.9+/-3.0 mm. Mean stent size was 2.98 mm (range 2-3.5 mm) and length 15.5 mm (range 7-28 mm). Stent delivery was successful in all cases (23% direct stenting). Complete follow-up of all 193 patients was obtained up to 9 months. There were no in-hospital or 30-day MACE observed. At 270 days, the MACE rate was 10.4% (MI 4.1%, cardiac death 0%, TVR 8.3%). There were no cases with stent thrombosis.
These medium term data confirm good safety profile of Titan(R) stent even in high risk patients and complex coronary lesions in routine clinical use.
Titan PORI注册研究的目的是评估在常规临床实践中，涂有氮氧化钛的不锈钢支架（Titan®，Hexacath，法国）的安全性和有效性。
我们报告了使用Titan®支架治疗患者的前瞻性单中心经验。纳入所有连续接受Titan®支架治疗的患者。支架的选择由操作者自行决定，无排除标准。注册研究的主要终点是6个月和9个月时的主要不良心脏事件（MACE）。共纳入193例患者，治疗了210处病变（平均年龄67±10岁；男性71%；糖尿病17%）。64%的病变为B型，23%为C型。36%的患者PCI适应证为不稳定型心绞痛或非Q波心肌梗死，30%为急性ST段抬高型心肌梗死。平均参考直径为2.9±0.3mm，平均病变长度为12.9±3.0mm。平均支架尺寸为2.98mm（范围2 - 3.5mm），长度为15.5mm（范围7 - 28mm）。所有病例支架置入均成功（23%直接支架置入）。对所有193例患者进行了长达9个月的完整随访。未观察到院内或30天的MACE。在270天时，MACE发生率为10.4%（心肌梗死4.1%，心源性死亡0%，靶病变血管重建8.3%）。无支架血栓形成病例。
这些中期数据证实，即使在常规临床使用的高危患者和复杂冠状动脉病变中，Titan®支架也具有良好的安全性。
