Hoberg E, Dietz R, Frees U, Katus H A, Rauch B, Schömig A, Schuler G, Schwarz F, Tillmanns H, Niebauer J
Abteilung Kardiologie, Angiologie, Pulmologie, Universität Heidelberg, Germany.
Br Heart J. 1994 Mar;71(3):254-60. doi: 10.1136/hrt.71.3.254.
To evaluate the efficacy of high-dose verapamil treatment (240 mg twice daily) in the prevention of angiographic restenosis after primary successful coronary angioplasty in patients at high risk of recurrent obstruction.
A placebo controlled, double blind trial in which patients with stable angina pectoris and patients with unstable angina or non-Q wave infarction treated with 330 mg aspirin and 75 mg dipyridamole twice daily were randomised to a verapamil group or a control group. Follow up angiography was performed 6 months after angioplasty or sooner if signs of recurrent ischaemia developed.
University department of cardiology.
196 consecutive patients undergoing coronary angioplasty from the beginning of April 1987 to the end of March 1989 and meeting the selection criteria that included the presence of at least one of six predefined risk factors for restenosis. At the time of coronary angioplasty 113 patients had unstable angina or non-Q wave infarction and 83 had stable angina pectoris.
In 89 (91%) patients in the verapamil group and in 83 (85%) control patients follow up angiograms were available. The restenosis rate was lower in the verapamil group (48.3%) than in the placebo group (62.7%) (odds ratio 0.56, 95% confidence interval (CI) 0.303 to 1.025 p = 0.059). Of the 172 patients in whom follow up angiograms were available, 24 (13 taking verapamil and 11 taking placebo) did not comply with the trial for more than 40 (34) days (mean (1 SD)). For the remaining 148 patients the restenosis rate was 47.4% in the verapamil group and 63.9% in the placebo group (odds ratio 0.52, 95% CI 0.271 to 0.993, p = 0.046). In the 97 patients with unstable angina or non-Q wave infarction the restenosis rate was not significantly influenced by verapamil (55.8% with verapamil v 62.2% with placebo, odds ratio 0.77, 95% CI 0.339 to 1.728, p = 0.520). In the 75 patients with stable angina pectoris the restenosis rate dropped from 63.2% with placebo to 37.8% with verapamil (odds ratio 0.36, 95% CI 0.137 to 0.917, p = 0.038).
The observed beneficial effect of high-dose verapamil treatment on the angiographic restenosis rate in patients with stable angina pectoris and at increased risk of recurrent obstruction requires confirmation in further prospective studies.
评估大剂量维拉帕米治疗（每日两次，每次240毫克）对复发梗阻高危患者首次成功冠状动脉血管成形术后血管造影再狭窄的预防效果。
一项安慰剂对照、双盲试验，将每日两次服用330毫克阿司匹林和75毫克双嘧达莫治疗的稳定型心绞痛患者以及不稳定型心绞痛或非Q波梗死患者随机分为维拉帕米组或对照组。血管成形术后6个月进行随访血管造影，若出现复发缺血迹象则提前进行。
大学心脏病学系。
1987年4月初至1989年3月底连续196例接受冠状动脉血管成形术且符合入选标准的患者，入选标准包括存在六种预先定义的再狭窄危险因素中的至少一种。冠状动脉血管成形术时，113例患者患有不稳定型心绞痛或非Q波梗死，83例患有稳定型心绞痛。
维拉帕米组89例（91%）患者和对照组83例（85%）患者有随访血管造影结果。维拉帕米组的再狭窄率（48.3%）低于安慰剂组（62.7%）（优势比0.56，95%置信区间（CI）0.303至1.025，p = 0.059）。在有随访血管造影结果的172例患者中，24例（13例服用维拉帕米，11例服用安慰剂）不符合试验要求超过40（34）天（均值（标准差））。对于其余148例患者，维拉帕米组的再狭窄率为47.4%，安慰剂组为63.9%（优势比0.52，95%CI 0.271至0.993，p = 0.046）。在97例不稳定型心绞痛或非Q波梗死患者中，维拉帕米对再狭窄率无显著影响（维拉帕米组为55.8%，安慰剂组为62.2%，优势比0.77，95%CI 0.339至1.728，p = 0.520）。在75例稳定型心绞痛患者中，再狭窄率从安慰剂组的63.2%降至维拉帕米组的37.8%（优势比0.36，95%CI 0.137至0.917，p = 0.038）。
大剂量维拉帕米治疗对稳定型心绞痛且复发梗阻风险增加患者的血管造影再狭窄率的观察到的有益效果需要在进一步的前瞻性研究中得到证实。
