Sirnes P A, Golf S, Myreng Y, Mølstad P, Emanuelsson H, Albertsson P, Brekke M, Mangschau A, Endresen K, Kjekshus J
Feiring Heart Clinic, Norway.
J Am Coll Cardiol. 1996 Nov 15;28(6):1444-51. doi: 10.1016/s0735-1097(96)00349-x.
This study investigated whether stenting improves long-term results after recanalization of chronic coronary occlusions.
Restenosis is common after percutaneous transluminal coronary angioplasty (PTCA) of chronic coronary occlusions. Stenting has been suggested as a means of improving results, but its use has not previously been investigated in a randomized trial.
We randomly assigned 119 patients with a satisfactory result after successful recanalization by PTCA of a chronic coronary occlusion to 1) a control (PTCA) group with no other intervention, or 2) a group in which PTCA was followed by implantation of Palmaz-Schatz stents with full anticoagulation. Coronary angiography was performed before randomization, after stenting and at 6-month follow-up.
Inguinal bleeding was more frequent in the stent group. There were no deaths. One patient with stenting had a myocardial infarction. Subacute occlusion within 2 weeks occurred in four patients in the stent group and in three in the PTCA group. At follow-up, 57% of patients with stenting were free from angina compared with 24% of patients with PTCA only (p < 0.001). Angiographic follow-up data were available in 114 patients. Restenosis (> or = 50% diameter stenosis) developed in 32% of patients with stenting and in 74% of patients with PTCA only (p < 0.001); reocclusion occurred in 12% and 26%, respectively (p = 0.058). Minimal lumen diameter (mean +/- SD) at follow-up was 1.92 +/- 0.95 mm and 1.11 +/- 0.78 mm, respectively (p < 0.001). Target lesion revascularization within 300 days was less frequent in patients with stenting than in patients with PTCA only (22% vs. 42%, p = 0.025).
Stent implantation improved long-term angiographic and clinical results after PTCA of chronic coronary occlusions and is thus recommended regardless of the primary PTCA result.
本研究调查了支架置入术是否能改善慢性冠状动脉闭塞再通后的长期效果。
慢性冠状动脉闭塞经皮腔内冠状动脉成形术（PTCA）后再狭窄很常见。有人提出支架置入术作为改善治疗效果的一种方法，但此前尚未在随机试验中对其应用进行研究。
我们将119例经PTCA成功再通慢性冠状动脉闭塞且效果满意的患者随机分为两组：1）对照组（PTCA组），不进行其他干预；2）PTCA后植入帕尔马兹 - 施查茨支架并进行充分抗凝的组。在随机分组前、支架置入后及6个月随访时进行冠状动脉造影。
支架组腹股沟出血更频繁。无死亡病例。1例接受支架置入术的患者发生心肌梗死。支架组4例患者和PTCA组3例患者在2周内发生亚急性闭塞。随访时，接受支架置入术的患者中57%无心绞痛，而仅接受PTCA的患者中这一比例为24%（p < 0.001）。114例患者有血管造影随访数据。支架置入组32%的患者出现再狭窄（直径狭窄≥50%），仅接受PTCA组为74%（p < 0.001）；再闭塞发生率分别为12%和26%（p = 0.058）。随访时最小管腔直径（均值±标准差）分别为1.92±0.95 mm和1.11±0.78 mm（p < 0.001）。支架置入组患者300天内靶病变血管重建术的发生率低于仅接受PTCA的患者（22%对42%，p = 0.025）。
慢性冠状动脉闭塞PTCA后植入支架可改善长期血管造影和临床效果，因此无论初始PTCA结果如何均推荐使用。
