Five-Year Follow-Up After Intracoronary Gamma Radiation Therapy for In-Stent Restenosis
Five-Year Follow-Up After Intracoronary Gamma Radiation Therapy for In-Stent Restenosis
复制标题
冠状动脉内伽玛放射治疗支架内再狭窄后的五年随访
作者：
R. Waksman;A. Ajani;Roger L. White;R. Chan;B. Bass;A. Pichard;L. Satler;K. Kent;R. Torguson;R. Deible;E. Pinnow;J. Lindsay
华盛顿放射治疗支架内再狭窄试验是一项评价冠状动脉内放射治疗(IRT)对支架内再狭窄(ISR)患者疗效的双盲随机研究。方法和结果：130例ISR患者(100例天然冠状动脉和30例静脉移植)接受了经皮冠状动脉腔内成形术、激光消融、旋转性动脉粥样硬化切除术或附加支架(占病变的36%)。患者被随机分为192-Ir-IRT组和安慰剂组，处方剂量为15Gy至源中心2 mm的径向距离。接受介入治疗的患者在6个月后血管造影再狭窄(27%比56%，P=0.002)和靶血管再血管化(26%比68%，P<；0.001)都减少了。在6-60个月期间，与安慰剂相比，接受IRT治疗的患者有更多的靶病变血管重建(IRT，21.6%比安慰剂组，4.7%；P=0.04)和靶血管再血管化(IRT，21.5%比安慰剂组，6.1%；P=0.03)。5年时，IRT组的主要心脏不良事件发生率显著降低(46.2%比69.2%，P=0.008)。结论：在华盛顿放射治疗支架内再狭窄试验中，使用192-Iridium进行IRT治疗的ISR患者在6个月和5年内减少了重复靶点损伤和血管重建的需要。
Background—The Washington Radiation for In-Stent Restenosis Trial is a double-blinded randomized study evaluating the effects of intracoronary radiation therapy (IRT) in patients with in-stent restenosis (ISR). Methods and Results—One hundred thirty patients with ISR (100 native coronary and 30 vein grafts) underwent percutaneous transluminal coronary angioplasty, laser ablation, rotational atherectomy, or additional stenting (36% of lesions). Patients were randomized to either 192-Iridium IRT or placebo, with a prescribed dose of 15 Gy to a 2-mm radial distance from the center of the source. Angiographic restenosis (27% versus 56%, P =0.002) and target vessel revascularization (26% versus 68%, P <0.001) were reduced at 6 months in patients treated with IRT. Between 6 and 60 months, patients treated with IRT compared with placebo had more target lesion revascularization (IRT, 21.6% versus placebo, 4.7%; P =0.04) and target vessel revascularization (IRT, 21.5% versus placebo, 6.1%; P =0.03). At 5 years, the major adverse cardiac event rate was significantly reduced with IRT (46.2% versus 69.2%, P =0.008). Conclusions—In the Washington Radiation for In-Stent Restenosis Trial, patients with ISR treated with IRT using 192-Iridium had a reduction in the need for repeat target lesion and vessel revascularization at 6 months and 5 years.