女性患者经桡动脉PCI安全可行

旧金山——一项纳入1,787例患者的随机研究显示，在接受经皮冠状动脉介入(PCI)治疗的女性患者中，采用桡动脉入路者的出血或血管并发症发生率比采用股动脉入路者降低了59%，不过这一差异并未达到统计学意义。

杜克大学的Sunil V. Rao医生在经导管心血管治疗(TCT)年会上报告称，在345例接受经桡动脉PCI和345例接受经股动脉PCI的女性患者中，分别有1.2%和2.9%在72 h内或出院时存在出血或血管并发症。

虽然针对实际接受了PCI 的患者的预设分析并未显示出统计学显著性差异，但在针对整个队列的分析中，随机分至桡动脉入路者的出血和血管并发症发生率显著低于股动脉入路组患者，无论她们接受的是PCI还是仅接受诊断性心导管术。桡动脉入路组和股动脉入路组的出血和血管并发症发生率分别为0.6%和1.7%。


Sunil V. Rao医生

在PCI队列和整个队列中，与股动脉入路组相比，桡动脉入路组均有明显更多的女性患者需要转为股动脉入路PCI。在PCI队列中，桡动脉入路组有6.1%的患者交叉到股动脉入路组，而股动脉入路组仅有1.7%交叉到桡动脉入路组。在整个队列中，上述比例分别为6.7%和1.9%。从桡动脉入路交叉至股动脉入路的主要原因是桡动脉痉挛(占43%)。

为优化女性PCI而评估入路研究(SAFE-PCI)利用了来自全国心血管数据注册CathPCI注册研究中60个中心对成年女性行择期或急诊PCI或诊断性血管造影以评价缺血症状的数据。主要终点指标是出血学术研究联盟(BARC)2、3或5型出血事件，以及需要干预的血管并发症。

研究人员曾计划招募3,000名女性以获得1,800例PCI患者数据，但在对1,120例患者进行随机化后进行的一项常规审查提示，由于出血发生率低于预期，这项试验可能规模过小而不足以显示出差异。由于在桡动脉入路或股动脉入路组均未发现伤害，研究人员继续招募患者直至足以开展生活质量亚研究，然后提前终止了这项试验。

桡动脉入路组的出血减少与既往研究结果相似。桡动脉入路组患者交叉到股动脉入路组的比例也与既往研究结果相似：2011年《柳叶刀》杂志发表的一项研究报告交叉率为7.6%(Lancet 2011;377:1409-20)。

与男性相比，女性因抗血栓治疗和股动脉入路PCI发生出血的风险更高。采用桡动脉入路可减少出血风险，但经桡动脉PCI在女性中不太常用，部分原因是女性的桡动脉相对较细。

本项试验结果提示，“对于接受心导管术或PCI的女性患者，初始采用桡动脉入路的策略是合理的，不过要注意的是，部分患者将需要转换为股动脉入路”。Rao医生补充道，在本项研究中，女性患者更愿意采用桡动脉入路而非股动脉入路。

在讨论中，西奈山医学院心血管介入研究所主任Roxana Mehran医生表示，上述结果可被看作一个装了半杯水的玻璃杯。Mehran医生曾在SAFE-PCI试验执行委员会中任职。

Mehran医生指出，在纯粹的统计学家眼中，上述结果并未展示出桡动脉入路可预防出血或血管并发症的明确证据。但从临床医生的角度来看，在整个队列和PCI队列中估计的桡动脉入路获益是相似的，均使出血减少了大约60%。“本研究提供了桡动脉入路对女性患者更有效的证据，尽管尚不具备决定性。”

从交叉率来看，桡动脉入路组每预防1例出血事件或血管并发症，就有3例患者交叉到股动脉入路组。“虽然从桡动脉入路交叉到股动脉入路的比例更高，但对女性患者初始采用桡动脉入路仍是合理和符合直觉的，尤其是对于那些出血风险高的女性。”

Rao医生是Medicines Co.和阿斯利康的顾问，Medicines Co.曾帮助该试验获得资金。Mehran医生报告称与这两家公司及雅培血管、第一三共/礼来有利益关系，后者也资助了本项试验。

本项研究的其他资助者包括Terumo医疗、美敦力、ACIST医疗系统和Guerbet。Mehran医生还报告称与另外9家医学公司有利益关系。

相关评论：有希望但尚未确证

从数据来看，我不认为这是一项阳性研究，也不认为应当基于这些结果而改变临床实践。这是一项不完整的研究，数据不充分。我们需要想一想，为什么没有达到预期的招募数量，以及为什么股动脉入路组的出血率低于预期。


Alice K. Jacobs医生

不过它也不完全是一项阴性试验。我们只是不确定桡动脉入路对于接受PCI的高危女性而言是否是更好的选择。桡动脉入路是有前途的，它的存在意义是由女性出血风险赋予的。

评论专家Alice K. Jacobs医生是波士顿大学心导管室和介入心脏病学主任。她在新闻发布会上作出了上述评论。Jacobs医生报告称无相关利益冲突。

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By: SHERRY BOSCHERT, Cardiology News Digital Network

SAN FRANCISCO – Rates of bleeding or vascular complications in women undergoing percutaneous coronary intervention were 59% lower using radial access, compared with femoral access, a difference that did not reach statistical significance in a randomized study of 1,787 patients.

Bleeding or vascular complications within 72 hours or at hospital discharge were seen in 1.2% of 345 women who had transradial percutaneous coronary intervention (PCI) and 2.9% of 345 women who had transfemoral PCI, Dr. Sunil V. Rao reported at the Transcatheter Cardiovascular Therapeutics annual meeting.

Although that difference was not statistically significant in this prespecified analysis of patients who actually underwent PCI, the rate of bleeding and vascular complications was significantly lower for the group randomized to radial access in an analysis of the whole cohort, regardless of whether they had PCI or just diagnostic catheterization.

Bleeding and vascular complication rates were 0.6% in those randomized to radial access and 1.7% in those randomized to femoral access,
 
In both the PCI cohort and the total cohort, significantly more women in the radial group needed to cross over to femoral access for PCI compared with the crossover rate in the femoral group. In the PCI cohort, 6.1% of the radial group crossed over, as did 1.7% of the femoral group.

In the total cohort, crossover was needed in 6.7% of the radial group and 1.9% of the femoral group, said Dr. Rao of Duke University, Durham, N.C. The main reason for crossover from radial to femoral access was radial artery spasm, in 43% of cases.

The Study of Access Site for Enhancement of PCI for Women (SAFE-PCI) leveraged data from the National Cardiovascular Data Registry’s CathPCI Registry from 60 institutions on adult women undergoing elective or urgent PCI or undergoing diagnostic angiography to evaluate ischemic symptoms with the possibility of PCI.

The primary outcome measure was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding events and vascular complications requiring intervention.

The investigators had planned to randomize 3,000 women to obtain 1,800 who underwent PCI, but a routine review after randomizing 1,120 patients suggested that the trial would be too small to show a difference because of lower-than-expected bleeding rates.

Because no harm was noted in either the radial or femoral group, the investigators continued until they had enough patients for a quality-of-life substudy, then prematurely discontinued the trial.

The reduction in bleeding with the radial approach was similar to reductions seen in previous studies, Dr. Rao said at the meeting, cosponsored by the American College of Cardiology.

The conversion rate from radial to femoral access was similar to the 7.6% rate reported in a prior trial (Lancet 2011;377:1409-20).

Compared with men, women have an increased risk for bleeding from antithrombotic therapy and from femoral access for PCI. Radial access can decrease bleeding risk, but transradial PCI has been less common in women, in part because they have smaller radial arteries.

The current trial’s results suggest that "an initial strategy of radial access is reasonable and may be preferred by some operators for women undergoing cardiac catheterization or PCI, with the recognition that a proportion of patients will require conversion to femoral access," he said.

Women preferred the radial approach over femoral access in the study, he added.

The results could be looked at as a glass half empty or half full, Dr. Roxana Mehran said as the discussant of the study at the meeting. She served on the executive committee of the SAFE-PCI trial.

In the eyes of a purist statistician, the results show no significant evidence that radial access prevents bleeding or vascular complications, the primary endpoint, said Dr. Mehran, professor of medicine and director of interventional cardiovascular research at Mount Sinai School of Medicine, New York.

From a clinician’s viewpoint, however, the estimates of benefit from radial access in the overall cohort and the PCI cohort were similar, yielding approximately a 60% reduction in bleeding with radial access, she noted. "The study provides evidence, albeit not conclusive, for greater efficacy with radial access in women," she said.

The crossover rates suggest that for every bleeding event or vascular complication prevented in the radial access group, three patients would cross over. "While there’s a higher crossover from [the] radial to the femoral approach, it’s reasonable and intuitive to begin with the radial approach in women," she said, "especially in those women at high risk for bleeding."

Dr. Rao has been a consultant for the Medicines Co., which helped fund the trial, and for AstraZeneca. Dr. Mehran reported financial associations with these companies and with Abbott Vascular and Daiichi-Sankyo/Eli Lilly & Co., which also funded the trial.

Other funders of the study included Terumo Medical, Medtronic, ACIST Medical Systems, and Guerbet. Dr. Mehran also reported financial associations with nine other medical companies.

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Promising, not proven

I don’t think we have the data to say that this is a positive study or that we should change our practice because of these results. It’s an incomplete study, so we really don’t have the data. We need to think about why we didn’t have the anticipated enrollment and why the bleeding rate was lower than expected in the femoral access group.

Those are the things that I think led to the futility. But it’s not really a negative trial. We simply don’t know whether radial access will be better in high-risk women undergoing PCI. It’s promising, and it makes all the sense in the world because of the bleeding risk in women.

Alice K. Jacobs, M.D., is a professor of medicine and director of the cardiac catheterization laboratory and interventional cardiology at Boston University. She gave these remarks at a press briefing. Dr. Jacobs reported having no relevant financial disclosures.