Giugliano Gregory R, Falcone M Wayne, Mego David, Ebersole Doug, Jenkins Steve, Das Tony, Barker Esmund, Ruggio Joseph M, Maini Brijeshwar, Bailey Steven R
Baystate Medical Center, 759 Chestnut St., Springfield, MA 01199, USA.
Cardiovasc Revasc Med. 2012 Mar-Apr;13(2):84-9. doi: 10.1016/j.carrev.2012.01.004. Epub 2012 Mar 7.
The primary aim of this study was to prospectively evaluate the safety and efficacy of Excimer laser atherectomy as a primary treatment strategy in consecutively eligible patients presenting for percutaneous coronary intervention (PCI) of degenerated saphenous vein graft (SVG) lesions using a multicenter registry. Prior single-center experience suggested that laser atherectomy may decrease acute procedural complications during treatment of degenerated SVGs, including lesions not amenable to distal protection devices (DPDs).
The COronary graft Results following Atherectomy with Laser investigators enrolled 98 patients at 18 centers between June 23, 2003, and October 4, 2004, with greater than 50% stenosis of an SVG who presented for PCI due to angina pectoris or objective evidence of myocardial ischemia in a concordant myocardial distribution. Laser atherectomy was planned. Patients were excluded if the operator planned to utilize a DPD. Inclusion and exclusion criteria were aligned to those in the Saphenous vein graft Angioplasty Free of Emboli Randomized (SAFER) trial.
The primary end point [30-day major adverse cardiac events (MACE)] occurred in 18/98 (18.4%) patients driven primarily by non-q-wave myocardial infarction. Major procedural complications included no reflow (n=5) and major dissection (n=1). No perforations occurred. Univariate predictors of 30-day MACE included lesion length, vessel angulation, plaque burden, SVG degeneracy score, number of laser pulses used, and larger-sized laser catheters.
This study demonstrated that Excimer laser atherectomy of diseased SVGs is feasible with results comparable to the 30-day MACE in the control population from the SAFER trial. Whether the addition of laser to embolic protection devices is of any clinical utility remains to be tested in future studies.
本研究的主要目的是通过多中心注册研究，前瞻性评估准分子激光消蚀术作为连续符合条件的患者原发性大隐静脉桥血管（SVG）病变经皮冠状动脉介入治疗（PCI）的主要治疗策略的安全性和有效性。先前的单中心经验表明，激光消蚀术可能会减少退化性SVG治疗期间的急性手术并发症，包括不适用于远端保护装置（DPD）的病变。
激光消蚀术后冠状动脉桥血管结果研究的研究者在2003年6月23日至2004年10月4日期间，在18个中心招募了98例SVG狭窄超过50%、因心绞痛或心肌缺血客观证据而接受PCI的患者，其心肌分布一致。计划进行激光消蚀术。如果操作者计划使用DPD，则将患者排除。纳入和排除标准与大隐静脉桥血管无栓子血管成形术随机试验（SAFER）中的标准一致。
主要终点[30天主要不良心脏事件（MACE）]发生在18/98（18.4%）的患者中，主要由非Q波心肌梗死引起。主要手术并发症包括无复流（n = 5）和严重夹层（n = 1）。未发生穿孔。30天MACE的单因素预测因素包括病变长度、血管角度、斑块负荷、SVG退化评分、使用的激光脉冲数和较大尺寸的激光导管。
本研究表明，对病变SVG进行准分子激光消蚀术是可行的，其结果与SAFER试验对照组人群的30天MACE相当。在未来的研究中，激光与栓塞保护装置联合使用是否具有任何临床实用性仍有待测试。
