A topical hemostatic patch placed under a standard air-bladder bracelet reduces the time to hemostasis after transradial cardiac catheterization without increasing complications, according to results from the STAT2 trial.
The average time to successful hemostasis fell from 113 minutes with the air-bladder bracelet alone (TR Band, Terumo) to 66 minutes when coupled with the StatSeal (Biolife) hemostatic patch (P < .001).
“On average, most people take about 2 hours with the TR Band alone to provide hemostasis, instead you have this oozing and rebleeding,” study author Arnold Seto, MD, MPA, said at the Society for Cardiovascular Angiography and Interventions (SCAI) 2021 Scientific Sessions.
There was no rebleeding requiring reinflation among patients treated with the patch, whereas 67.3% of those treated with the band alone required reinflation an average of 2.3 times because of bleeding at 60 minutes.
Potential implications of the findings are earlier discharge after catheterization, especially after percutaneous coronary intervention (PCI); reduced nursing burden, time, and costs; and reduced heparin doses below the usual 5000 recommended units, said Seto, from the Long Beach VA Medical Center, California.
He noted that there is no standardized protocol for compression with the TR Band, with wide variances in clinical practice. Previous studies have shown that longer hemostasis time predicts radial artery occlusion. Shorter compression times may reduce radial artery occlusion but, if too short, can result in more rebleeding and repeat band reinflation.
The StatSeal patch contains a hydrophilic polymer that dehydrates blood solids and potassium ferrate that clumps the blood solids and proteins together to form a seal, Seto explained.
Overcoming the Pilot Trial
In a pilot study, adjunctive use of the patch significantly cut the time to TR Band deflation from 160 to 43 minutes. The protocol, however, allowed the TR Band-alone group to begin deflation after 120 minutes, compared with 40 minutes for the patch, which “potentially biased the results,” Seto said. Also, the patch was associated with a numeric increase in hematomas and radial artery occlusion.
To address this in the investigator-initiated, multicenter STAT2 study, full deflation of the TR Band was at 60 minutes for all patients and the deflated band left in place for 30 minutes to avoid disrupting the clot.
Use of unfractionated heparin was left to operator preference vs a minimum of 5000 units in the pilot study. Also, a larger version of the patch, Statseal Advanced RAD, was used in 77% of patients and intravenous glycoprotein inhibitors and cangrelor, a source of hematomas in the pilot study, were excluded.
Among the 443 patients undergoing diagnostic catheterization and PCI, 223 were randomized to the patch plus TR Band and 220 to the TR Band alone. Most patients underwent diagnostic catheterization (73% vs 71.8%) and had unfractionated heparin (mean, 5608 vs 5555 units).
The average time to deflate the TR Band was shorter with the StatSeal, a difference that was even more pronounced in the PCI subgroup, despite receiving higher doses of heparin (mean, 68 vs 138 minutes; P < .001), Seto noted.
Overall complications were numerically lower with in the StatSeal group than in the TR Band-alone group (4.5% vs 8.6%; P = .08) but significantly lower in the PCI subgroup (10.0% vs 24.2%; P = .04).
The StatSeal group had lower rates of hematomas less than 5 cm (3.1% vs 5.5%) and larger than 5 cm (0.9% vs 1.4%). Radial artery occlusion was low in both groups (0.4% vs 0.9%), despite 41% of patients having fewer than 5000 units of unfractionated heparin, he said.
During a press briefing highlighting the results, study coauthor Jordan Safirstein, MD, Morristown Medical Center, New Jersey, said the hemostatic patch costs only about $20 to $30 but by decreasing complications likely saves costs on the back end.
“It has really naturally become our default strategy in a high-volume cath lab, in which we also feature a same-day discharge lounge,” he said.
Session moderator and former SCAI president David Cox, MD, Cardiovascular Associates, Brookwood Baptist Hospital, Birmingham, Alabama, said the back-end savings are important because roughly two-thirds of patients treated with the TR Band bleed, which “creates a lot of hoorah.”
“If you can get your patient home an hour or 2 earlier, particularly people who come from further away, that may be the difference between an overnight stay and discharge the next morning and a discharge home,” he said.
Safirstein enthusiastically agreed. “There’s no doubt about it, and you can throw in late cases — a PCI at 5 o’clock that might require a lengthy hemostasis. With StatSeal, it formalizes the whole process and we have less staff and less physicians having to go back and check on the patient, having to do multiple deflations. It really has made life more streamlined for us.”
They typically don’t use the StatSeal patch in patients who have undergone transfemoral procedures, he noted, but it has been used in other situations where bleeding was an issue.
Biolife did not fund the study and had no involvement in the design or conduct of the trial. Seto reports research grants from Philips and Acist and serving as a speaker for Terumo, GE, and Janssen.
Society for Cardiovascular Angiography and Interventions (SCAI) 2021 Scientific Sessions: Abstract FCR-10. Presented April 28, 2021.
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