WASHINGTON, DC — A large study testing two different vascular-closure devices suggests that they are as good as manual compression for reducing vascular-site complications among patients undergoing transfemoral diagnostic angiography.
Dr Stefanie Schüpke (Deutsches Herzzentrum, Munich, Germany), who led the ISAR-CLOSURE randomized trial, presented the data at a late-breaking session here at TCT 2014 . The results, according to Schüpke, provide a "sound rationale for the use of vascular-closure devices over manual compression in everyday routine [practice]."
Despite the positive results, experts aren't sure what impact the findings will have in the clinic. Dr Zoltan Turi (Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ), who was not affiliated with the study, said that one unfortunate aspect is that it was conducted in patients undergoing diagnostic procedures. "Where we really need this information is in interventions," said Turi.
Also, because the ISAR-CLOSURE investigators studied two vascular-closure devices—FemoSeal (St Jude Medical) and ExoSeal (Cordis)—the differences when compared against manual compression will be masked. ExoSeal is used infrequently in the US, and FemoSeal is available only in Europe.
Turi said that he primarily performs his procedures via the radial artery but noted that interventionalists have developed much better access techniques, including using fluoroscopy or ultrasound to guide the puncture. That said, he believes the closure devices have a role in interventional procedures, such as carotid artery stenting.
"There is nothing worse than doing a complex carotid, to answer with an anecdote," said Turi. "You have a 7F sheath if you're doing it from the femoral artery, as most of us do, at four o'clock in the afternoon, but still have someone pressing on that groin four, five, or six hours later. I use closure devices pretty routinely for interventional cases but relatively uncommonly in diagnostic cases because most of those cases are radial."
In diagnostic procedures, in which a 5F sheath would be used, Turi said he can't justify the extra cost or risks of a closure device. "It has to be a 6F or larger," he said.
The ISAR-CLOSURE study
In ISAR-CLOSURE, 1509 patients who underwent diagnostic coronary angiography received the FemoSeal device, 1506 received the ExoSeal device, and 1509 were treated with manual compression. Regarding the primary end point—a composite of vascular-access–site complications that included hematoma >5 cm, arteriovenous fistula, pseudoaneurysms, access-site bleeding, ipsilateral leg ischemia, need for surgical/interventional treatment, or local infection—there was no difference among those who received a vascular-closure device and those compressed manually (6.9% in the combined closure-device arm vs 7.9% in the manual-compression arm; p<0.001 for noninferiority).
Time to hemostasis was significantly faster in the vascular-closure–device arm, although there was an increased need for repeat manual compression. Between the two vascular-closure devices, there was no significant difference in the primary efficacy end point. The ExoSeal required more time to achieve hemostasis and was more likely to fail compared with the FemoSeal, however.
Dr Jeffrey Popma (Beth Israel Deaconess Medical Center, Boston, MA), who also performs procedures via the radial artery, noted that the rates of vascular-access–site complications might appear high, but the investigators were looking for those events in the trial. Dr Alexandre Abizaid (Instituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil), who performs 70% of his procedures via the radial artery, said that in academic practice he has lots of fellows to compress the femoral artery when needed. In private practice, vascular-closure devices are more likely to be used.
"What this study is missing is a cost-effectiveness analysis," said Abizaid. "Manual compression is still very efficacious and cheap."
Speaking with the media, Schüpke said the ISAR-CLOSURE trial sets the scene for future trials testing closure devices in interventional procedures. However, she noted that PCI patients require different antithrombotic agents, which could make it hard to determine the relative contribution of the vascular-closure devices to the reduction in vascular bleeding complications.
Schüpke and Turi reported no disclosures. Abizaid reported grant and research support from Biotronik and REVA and consulting fees/honoraria from Abbott Vascular, Medtronic, and Boston Scientific. Popma reported grant and research support from Abbott Vascular, Boston Scientific, Cook Medical, eV3, and Medtronic, and consulting fees/honoraria from Abbott Vascular, eV3, and Boston Scientific.
Heartwire from Medscape © 2014
Cite this: Vascular-Closure Devices as Good as Hands-on After Diagnostic Coronary Angiography - Medscape - Sep 13, 2014.