Hizoh Istvan, Majoros Zsuzsanna, Major Laszlo, Gulyas Zalan, Szabo Gabor, Kerecsen Gabor, Korda Andras, Molnar Ferenc, Kiss Robert Gabor
Department of Cardiology, Military Hospital, Budapest, Hungary.
J Am Heart Assoc. 2014 Apr 14;3(2):e000588. doi: 10.1161/JAHA.113.000588.
Verapamil is traditionally applied prophylactically in transradial procedures to prevent radial artery spasm. However, verapamil may have side effects and is contraindicated in some clinical settings.
During an investigator-initiated, randomized, double-blind trial, we evaluated the need for preventive verapamil administration. After vascular access was established, patients received either 5 mg verapamil (n=297) or placebo (n=294). We compared the rate of access site conversions as primary end point using a superiority margin of 5%. Occurrence of code breaks (composite of conversions and unplanned use of verapamil), overall verapamil use, procedural and fluoroscopic times, contrast volume, and subjective pain were investigated as secondary end points. The rate of access site conversions was not different in the 2 arms (placebo 1.7% versus verapamil 0.7%, P=0.28, difference 1.0%, 95% CI for the difference -1.1% to 3.3%). Proportion of code breaks was similar in the 2 groups (3.4% versus 1.3%, P=0.11), whereas overall verapamil use was markedly lower in the placebo arm (2.0% versus 100%, P<0.0001). Procedural time (median [IQR] 16.0 minutes [9.0 to 30.0 minutes] versus 17.0 minutes [10.0 to 31.0 minutes], P=0.37), fluoroscopic time (4.4 minutes [2.1 to 9.6 minutes] versus 4.8 minutes [2.4 to 10.7 minutes], P=0.28), contrast volume (72.5 mL [48.0 to 146.0 mL] versus 75.5 mL [47.0 to 156.5 mL], P=0.74), and pain score (P for trend=0.12) were comparable in the 2 groups.
The preventive use of verapamil may be unnecessary for transradial procedures. The omission of prophylactic verapamil may not only reduce the rate of potential complications related to the drug but also allow the safe extension of the transradial method to those with contraindications to verapamil.
http://www.clinicaltrials.gov. Unique identifier: NCT01402427.
传统上，维拉帕米在经桡动脉手术中预防性应用以预防桡动脉痉挛。然而，维拉帕米可能有副作用，且在某些临床情况下是禁忌的。
在一项研究者发起的随机双盲试验中，我们评估了预防性应用维拉帕米的必要性。建立血管通路后，患者分别接受5毫克维拉帕米（n = 297）或安慰剂（n = 294）。我们将通路部位转换率作为主要终点进行比较，优效性界值为5%。将破盲情况（转换和未计划使用维拉帕米的综合情况）、维拉帕米的总体使用情况、手术时间和透视时间、造影剂用量以及主观疼痛作为次要终点进行研究。两组的通路部位转换率无差异（安慰剂组为1.7%，维拉帕米组为0.7%，P = 0.28，差异为1.0%，差异的95%CI为 -1.1%至3.3%）。两组的破盲比例相似（3.4%对1.3%，P = 0.11），而安慰剂组维拉帕米的总体使用明显更低（2.0%对100%，P < 0.0001）。两组的手术时间（中位数[IQR] 16.0分钟[9.0至30.0分钟]对17.0分钟[10.0至31.0分钟]，P = 0.37）、透视时间（4.4分钟[2.1至9.6分钟]对4.8分钟[2.4至10.7分钟]，P = 0.28）、造影剂用量（72.5毫升[48.0至146.0毫升]对75.5毫升[47.0至156.5毫升]，P = 0.74）和疼痛评分（趋势P = 0.12）相当。
经桡动脉手术可能无需预防性使用维拉帕米。省略预防性维拉帕米不仅可降低与该药物相关的潜在并发症发生率，还可使经桡动脉方法安全地扩展至维拉帕米禁忌患者。
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