Ambrose J A, Torre S R, Sharma S K, Israel D H, Monsen C E, Weiss M, Untereker W, Grunwald A, Moses J, Marshall J
Department of Medicine, Mount Sinai Medical Center, New York, New York 10029.
J Am Coll Cardiol. 1992 Nov 1;20(5):1197-204. doi: 10.1016/0735-1097(92)90378-z.
A multicenter pilot study was instituted to assess the role of intracoronary thrombolytic therapy during angioplasty for ischemic rest angina.
Acute thrombotic coronary occlusion is increased during angioplasty for unstable angina, and intracoronary thrombolytic agents have been used to maintain patency. Prophylactic use of intracoronary thrombolytic agents has been advocated in certain high risk subgroups, although no studies have randomized therapy.
Ninety-three patients with either unstable angina and pain at rest (trial A, 66 patients) or postinfarction pain at rest (trial B, 27 patients) were randomized in double-blind fashion to administration of either intracoronary urokinase, 150,000 U, or saline solution placebo given immediately before angioplasty. Cineangiograms of the culprit lesion were recorded and analyzed in blinded fashion by a core laboratory for definite or possible (haziness) filling defects 15 min after angioplasty or after acute closure.
Urokinase decreased filling defects at 15 min after angioplasty in comparison with placebo (14% vs. 29%, respectively, p = 0.08). Four patients in each treatment group developed acute vessel closure. However, although urokinase significantly reduced the incidence of filling defects in trial A (3% vs. 23%, p = 0.03), the drug had no effect at the selected dose in trial B (42% vs. 43%, respectively). Acute vessel closure occurred significantly more frequently in trial B than in trial A, and urokinase at the selected dose also had no effect. Ischemic events after angioplasty appeared to be related more to dissection than to thrombosis, although redilation, which was more frequent after placebo administration, may have reduced their incidence as well as that of acute closure.
These data suggest a possible role for intracoronary urokinase during angioplasty for unstable angina. The lack of effect after infarction may represent a greater thrombus burden or degree of plaque disruption. A trial utilizing higher doses of urokinase in a larger patient group is in progress.
开展一项多中心试点研究，以评估冠状动脉内溶栓治疗在缺血性静息性心绞痛血管成形术期间的作用。
不稳定型心绞痛血管成形术期间急性血栓性冠状动脉闭塞增加，冠状动脉内溶栓剂已被用于维持血管通畅。尽管尚无研究对治疗进行随机分组，但已有人主张在某些高危亚组中预防性使用冠状动脉内溶栓剂。
93例不稳定型心绞痛伴静息痛患者（试验A，66例）或心肌梗死后静息痛患者（试验B，27例）以双盲方式随机分为两组，分别在血管成形术前即刻给予冠状动脉内尿激酶150,000单位或生理盐水安慰剂。由核心实验室以盲法记录并分析罪犯病变的血管造影片，观察血管成形术后15分钟或急性闭塞后是否存在明确或可能（模糊）的充盈缺损。
与安慰剂相比，尿激酶使血管成形术后15分钟时的充盈缺损减少（分别为14%和29%，p = 0.08）。每个治疗组均有4例患者发生急性血管闭塞。然而，尽管尿激酶在试验A中显著降低了充盈缺损的发生率（3%对23%，p = 0.03），但在试验B中该剂量的药物无效（分别为42%和43%）。试验B中急性血管闭塞的发生频率显著高于试验A，所选剂量的尿激酶同样无效。血管成形术后的缺血事件似乎与夹层的关系比与血栓形成的关系更大，尽管安慰剂给药后再扩张更频繁，这可能也降低了缺血事件和急性闭塞的发生率。
这些数据提示冠状动脉内尿激酶在不稳定型心绞痛血管成形术期间可能发挥作用。心肌梗死后无效可能代表血栓负荷更大或斑块破裂程度更高。一项在更大患者群体中使用更高剂量尿激酶的试验正在进行中。
