Closure Devices Reduce Major Bleeding Compared with Manual Compression

Download this article's Factoid (PDF & PPT for Gold Subscribers)

Arterial closure devices reduce major bleeding compared with manual compression in patients following percutaneous coronary intervention (PCI), with those at highest risk benefiting the most, according to findings from a propensity-matched cohort published online March 21, 2011, ahead of print in the American Journal of Cardiology.

Researchers led by David M. Safley, MD, of Saint Luke’s Mid America Heart and Vascular Institute (Kansas City, MO), looked at over 5,000 PCI patients from 4 centers within the Saint Luke’s Health System. The investigators used propensity scoring to match 1,162 pairs of patients who achieved hemostasis after receiving either a closure device or manual compression following the procedure.

All patients underwent PCI via femoral access from January 1, 2006, to June 30, 2009. Baseline characteristics were well matched between the 2 groups. More than two-thirds of all patients (67.9%) presented with ACS, and most patients (approximately 80%) underwent single-vessel PCI.

The primary endpoint of major bleeding (defined by National Cardiovascular Data Registry [NCDR] criteria) was lower in the closure device group than in the manual compression group, as was entry site bleeding, other/unknown bleeding, stroke, and pseudoaneurysm, with a trend for reduced in-hospital mortality (table 1).

Table 1. Procedural Outcomes and Complications

 

Other endpoints including MI and renal failure, as well as retroperitoneal, GI, and genital/urinary bleeding, were equivalent between groups. Length of stay, meanwhile, was shorter in the closure device group (1.9 ± 1.9 days vs. 2.3 ± 5.3 days; P = 0.007).

Patients classified as NCDR-high risk for major bleeding had the biggest reduction (70%) in that endpoint with arterial closure devices (3.1% vs. 10.3%; P < 0.001). Low- and moderate-risk patients also showed lower rates of major bleeding with closure devices (relative reductions of 61% and 34%, respectively), but the differences were not statistically significant.

Not All Devices Made the Same

When separated by device type, both suture-based closure devices (1.4% vs. 6.5%; P < 0.01) and collagen plug-based closure devices (3.4% vs. 6.5%; P = 0.003) reduced the composite endpoint (major bleeding, vascular occlusion, significant dissection, pseudoaneurysm, or arteriovenous fistula at the access site and peripheral embolization) compared with manual compression. However, when compared with each other, suture-based devices were more effective than collagen plug devices in this regard (1.4% vs. 3.4%; P = 0.048).

“The use of [arterial closure devices] after PCI is associated with lower rates of NCDR major bleeding, shorter hospital length of stay, and fewer pseudoaneurysms,” the researchers conclude. “Although a numerically lower rate of complications is noted regardless of baseline bleeding risk, the greatest benefit in reducing major bleeds occurs in PCI patients at high risk for complications from the procedure.”

Dr. Safley and colleagues note that the lower rate of stroke and in-hospital mortality found with closure devices was unexpected but could be related to the reductions in major bleeding. They stress that the study was not powered to detect a mortality benefit. Reductions in both bleeding and pseudoaneurysms have been found in previous studies evaluating closure devices. However, meta-analyses have consistently demonstrated no benefit compared with manual closure, the researchers note.

Old Data vs. New

“The limited benefit in meta-analyses may be a function of bleeding definitions that differ among the studies being analyzed,” they write. “Additionally, the disparate results in benefit may also be a function of device improvement over the years.”

However, until there is another randomized trial, “in aggregate, the data suggest that there is, at best, no benefit of vascular closure devices,” said Sunil V. Rao, MD, of Duke University Medical Center (Durham, NC) in a telephone interview with TCTMD. “And they may be worse, associated with more vascular complications.”

Dr. Rao acknowledged that many criticize reliance on the previous meta-analyses because they use older data with first-generation devices. “What’s interesting is that since that time, there’ve been a series of observational studies trying to refute those findings,” he noted. “And if the criticism is that the meta-analyses used old devices, then let’s do a meta-analysis with the new devices.”

Can I Get an Amen?

To that suggestion, Robert J. Applegate, MD, of Wake Forest University School of Medicine (Winston-Salem, NC), said, “Amen!”

Regarding Dr. Rao’s argument, though, “I honestly don’t agree with that interpretation,” Dr. Applegate told TCTMD in a telephone interview. “The absence of a randomized clinical trial does not mean there are no data relevant to contemporary medicine. There have been over 5 observational studies with more than 10,000 patients. Each of them consistently indicates there’s an association. I’m not saying they’re causal, but there’s an association with reduced bleeding from closure devices. I don’t dismiss new information because it’s not a randomized trial and go back to older data and say, ‘See what they found?’”

Dr. Rao pointed out that despite the lack of more recent randomized data, closure devices “are outrageously popular in the United States. In the NCDR, they account for more than 60% of femoral cases.”

This may be counterintuitive, he noted. “I think people use them because they let the patient get up faster,” he said. “Well, you can get the patient up faster if you just use the radial approach, but that’s not very popular in the United States.”

Plausible or Unconvincing?

Nevertheless, Dr. Applegate maintained that the current study adds to the weight of evidence supporting closure devices, especially in higher risk patients. “If we’re doing such a good job with manual compression and there’s a problem with closure devices, why in the world would you have a decrease in bleeding?” he said. “To me, this study shows that when there’s a high likelihood you’re going to bleed, the closure device actively reduces the likelihood of that happening. This is a very plausible and expected outcome.”

But Dr. Rao maintained that the study does not address the one factor that could make a difference in determining the effectiveness of closure devices.

“It looks like centers and operators that are very experienced and are used to a high volume with closure devices have better outcomes with them than with manual compression,” he said. “I never use vascular closure devices, and I probably shouldn’t start using them because in my hands the outcomes are going to be bad, at least for the first several ones I do. There is a learning curve associated with these. This study is very good, but it doesn’t really speak directly to the volume issue. It adds to the observational literature on closure devices, but it’s hard to be convincing when there hasn’t been a randomization. Does it convince the skeptic? I’m not convinced it’s going to do that.”

 

---

Source:
Allen DS, Marso SP, Lindsey JB, et al. Comparison of bleeding complications using arterial closure device versus manual compression by propensity matching in patients undergoing percutaneous coronary intervention. Am J Cardiol. 2011;Epub ahead of print.

 

 

Related Stories:

• AHA Statement Offers Guidance on Arterial Closure Device Use
• Closure Devices, Bivalirudin a Powerful Duo Against Access Site Bleeding
• Closure Device Failures Rare, Cause Serious Vascular Complications