Villanueva E V, Wasiak J, Petherick E S
Monash Institute of Health Services Research, Monash University, 246 Clayton Road, Clayton, Victoria, Australia, 3168.
Cochrane Database Syst Rev. 2003(4):CD003334. doi: 10.1002/14651858.CD003334.
Percutaneous transluminal coronary rotational atherectomy (PTCRA) debulks atherosclerotic plaque from coronary arteries using an abrasive burr. On rotation, the burr selectively removes hard tissue.
To assess the effects of PTCRA for coronary artery disease in patients with non-complex and complex lesions (e.g., ostial, long, or diffuse lesions or those arising from in-stent restenosis) of the coronary arteries.
We searched the Heart Group specialised register, the Cochrane Library to Issue 2, 2001, and MEDLINE, CINAHL, EMBASE and Current Contents to December 2002 and reviewed reference lists for relevant articles.
We included randomised and quasi-randomised controlled trials of PTCRA compared with placebo, no treatment or another intervention and excluded cross-over trials.
Data were extracted independently by two authors. We asked authors of trials to provide information when missing data was encountered. Statistical summaries used risk ratios (RR) and weighted mean differences.
We included 9 trials enrolling 3,066 patients. There was no evidence of the effectiveness of PTCRA in non-complex lesions. In complex lesions, there were no statistically significant differences in restenosis rates at 6 months (relative risk 1.00; 95% confidence interval 0.83 to 1.20) and 1 year (relative risk 1.21; 95% confidence interval =0.95 to 1.55) in those receiving PTCRA with adjunctive PTCA (PTCRA/PTCA) compared to those receiving PTCA alone. Morphological characteristics distinguishing complex lesions have not been examined in parallel-arm randomised controlled trials. There is equivocal evidence of the effectiveness of PTCRA in in-stent restenosis. Compared to angioplasty alone, PTCRA/PTCA did not result in a statistically significant increase in the risk of major adverse cardiac events (myocardial infarction, emergency cardiac surgery or death) during the in-hospital period (relative risk 1.19; 95% confidence interval =0.78 to 1.83). Compared to angioplasty, PTCRA was associated with 9 times the risk of an angiographically-detectable vascular spasm (relative risk 9.23; 95% confidence interval 4.61 to 18.47), 4 times the risk of perforation (relative risk 3.87; 95% confidence interval 0.82 to 18.21) and about 2 times the risk of transient vessel occlusions (relative risk 2.28; 95% confidence interval 1.00, 5.19) while angiographic dissections (relative risk 0.49; 95% confidence interval 0.33 to 0.75) and stents used as a bailout procedure (relative risk 0.38; 95% confidence interval 0.22 to 0.65) were less common.
REVIEWER'S CONCLUSIONS: When conventional PTCA is feasible, PTCRA appears to confer no additional benefits. There is limited published evidence and no long-term data to support the routine use of PTCRA in in-stent restenosis. In certain circumstances (e.g., patients ineligible for cardiac surgery, those with architecturally complex lesions, or those with lesions that fail PTCA), PTCRA may achieve satisfactory revascularisation in subsequent procedures.
经皮腔内冠状动脉旋磨术(PTCRA)使用磨蚀性磨头去除冠状动脉粥样硬化斑块。旋转时,磨头选择性地去除硬组织。
评估PTCRA对冠状动脉非复杂病变和复杂病变(如开口处、长段或弥漫性病变或支架内再狭窄所致病变)患者冠心病的治疗效果。
我们检索了心脏组专业注册库、截至2001年第2期的Cochrane图书馆,以及截至2002年12月的MEDLINE、CINAHL、EMBASE和《现刊目次》,并查阅了相关文章的参考文献列表。
我们纳入了将PTCRA与安慰剂、未治疗或其他干预措施进行比较的随机和半随机对照试验,排除了交叉试验。
由两位作者独立提取数据。遇到缺失数据时,我们要求试验作者提供信息。统计汇总采用风险比(RR)和加权均数差。
我们纳入了9项试验,共3066例患者。没有证据表明PTCRA对非复杂病变有效。在复杂病变中,接受PTCRA联合PTCA(PTCRA/PTCA)的患者与仅接受PTCA的患者相比,6个月时再狭窄率(相对风险1.00;95%置信区间0.83至1.20)和一年时再狭窄率(相对风险1.21;95%置信区间0.95至1.55)无统计学显著差异。在平行组随机对照试验中尚未对区分复杂病变的形态学特征进行研究。关于PTCRA对支架内再狭窄疗效的证据尚不明确。与单纯血管成形术相比,PTCRA/PTCA在住院期间并未导致主要不良心脏事件(心肌梗死、急诊心脏手术或死亡)风险有统计学显著增加(相对风险1.19;95%置信区间0.78至1.83)。与血管成形术相比,PTCRA与血管造影可检测到的血管痉挛风险增加9倍(相对风险9.23;95%置信区间4.61至18.47)、穿孔风险增加4倍(相对风险3.87;95%置信区间0.82至18.21)以及短暂血管闭塞风险增加约2倍(相对风险2.28;95%置信区间1.00至5.19)相关,而血管造影夹层(相对风险0.49;95%置信区间0.33至0.75)和作为补救措施使用的支架(相对风险0.38;95%置信区间0.22至0.65)则较少见。
当常规PTCA可行时,PTCRA似乎并无额外益处。关于在支架内再狭窄中常规使用PTCRA,已发表的证据有限且无长期数据支持。在某些情况下(如不符合心脏手术条件的患者、具有复杂结构病变的患者或PTCA失败的病变患者),PTCRA可能在后续手术中实现令人满意的血管重建。