Adelman A G, Cohen E A, Kimball B P, Bonan R, Ricci D R, Webb J G, Laramee L, Barbeau G, Traboulsi M, Corbett B N
Cardiovascular Clinical Research Laboratory, Mount Sinai Hospital, Toronto, ON, Canada.
N Engl J Med. 1993 Jul 22;329(4):228-33. doi: 10.1056/NEJM199307223290402.
Restenosis is a major limitation of coronary angioplasty. Directional coronary atherectomy was developed with the expectation that it would provide better results than angioplasty, including a lower rate of restenosis. We undertook a randomized, multicenter trial to compare the rates of restenosis for atherectomy and angioplasty when used to treat lesions of the proximal left anterior descending coronary artery.
Of 274 patients referred for first-time, non-surgical revascularization of lesions of the proximal left anterior descending coronary artery, 138 were randomly assigned to undergo atherectomy and 136 to undergo angioplasty; 257 of 265 eligible patients (97 percent) underwent follow-up angiography at a median of 5.9 months. Computer-assisted quantitative measurements of luminal dimensions were determined from the angiograms obtained before and immediately after the procedure and at follow-up. The primary end point of restenosis was defined as stenosis of more than 50 percent of the vessel's diameter at follow-up.
Quantitative analysis showed that the procedural success rate was higher in patients who underwent atherectomy than in those who had angioplasty (94 percent vs. 88 percent, P = 0.061); there was no significant difference in the frequency of major in-hospital complications (5 percent vs. 6 percent). At follow-up, the rate of restenosis was 46 percent after atherectomy and 43 percent after angioplasty (P = 0.71). Despite a larger initial gain in the minimal luminal diameter with atherectomy (mean [+/- SD], 1.45 +/- 0.47 vs. 1.16 +/- 0.44 mm; P < 0.001), there was a larger late loss (0.79 +/- 0.61 vs. 0.47 +/- 0.64 mm; P < 0.001), resulting in a similar minimal luminal diameter in the two groups at follow-up (1.55 +/- 0.60 vs. 1.61 +/- 0.68, P = 0.44). The clinical outcomes at six months were not significantly different between the two groups.
The role of atherectomy in percutaneous coronary revascularization remains to be fully defined. However, as compared with angioplasty, atherectomy did not result in better late angiographic or clinical outcomes in patients with lesions of the proximal left anterior descending coronary artery.
再狭窄是冠状动脉血管成形术的主要局限性。定向冠状动脉斑块旋切术的研发旨在期望其能比血管成形术取得更好的效果，包括更低的再狭窄率。我们开展了一项随机、多中心试验，以比较斑块旋切术和血管成形术用于治疗左前降支近端冠状动脉病变时的再狭窄率。
在274例因首次非手术方式对左前降支近端冠状动脉病变进行血运重建的患者中，138例被随机分配接受斑块旋切术，136例接受血管成形术；265例符合条件的患者中有257例（97%）在中位时间5.9个月时接受了随访血管造影。通过计算机辅助对术前、术后即刻及随访时获得的血管造影图像进行管腔尺寸的定量测量。再狭窄的主要终点定义为随访时血管直径狭窄超过50%。
定量分析显示，接受斑块旋切术的患者手术成功率高于接受血管成形术的患者（94%对88%，P = 0.061）；住院期间主要并发症的发生率无显著差异（5%对6%）。随访时，斑块旋切术后再狭窄率为46%，血管成形术后为43%（P = 0.71）。尽管斑块旋切术最初使最小管腔直径增加幅度更大（均值[±标准差]，1.45±0.47对1.16±0.44 mm；P < 0.001），但后期损失更大（0.79±0.61对0.47±0.64 mm；P < 0.001），导致两组随访时最小管腔直径相似（1.55±0.60对1.61±0.68，P = 0.44）。两组六个月时的临床结局无显著差异。
斑块旋切术在经皮冠状动脉血运重建中的作用仍有待充分明确。然而，与血管成形术相比，对于左前降支近端冠状动脉病变患者，斑块旋切术并未带来更好的后期血管造影或临床结局。
