Transradial PCI noninferior to transfemoral, results in fewer bleeding events

SAN FRANCISCO — Transradial access before PCI is as effective as transfemoral access in terms of MACCE, according the results of a late-breaking clinical trial presented at the annual TCT Scientific Symposium.

Perspective from Daniel I. Simon, MD

“The benefit [is] shown … in terms of clinical effectiveness at 1 year and the superiority of [the transradial approach] to reduce major bleeding complications at 7 days compared with [the transfemoral approach],” said Shigeru Saito, MD, director, cardiology and catheterization laboratories, and vice director of Shonan Kamakura General Hospital, Kanagawa, Japan.

Saito and colleagues included 2,042 patients in the DRAGON trial, with random assignment in a 2:1 fashion to transradial (n = 1,366) or transfemoral (n = 676) access to PCI. A small portion of patients in the transradial group (n = 154) and in the transfemoral group (n = 149) were assigned to coronary arteriography only.

The primary endpoint was freedom from MACCE at 12 months, according to Saito. The secondary endpoint was lack of major bleeding (Bleeding Academic Research Consortium definition of type 3 or 5) 7 days after PCI.

The overall rate of follow-up at 12 months was 97.6%. The transradial approach was as effective as the transfemoral approach to PCI, according to Saito, and fewer complications from bleeding occurred with the transradial approach.

“In real-world PCI situations, with [an] ad hoc PCI strategy, [the transradial approach] is as effective as [the transfemoral approach] in terms of 12-month MACCE,” Saito said. “The [transradial approach] [reduces] the instance of bleeding complications at 1 week after PCI.” – by Julia Ernst, MS

Reference:

Saito S, et al. Plenary Session VI. Late-Breaking Clinical Trials 1. Presented at: TCT Scientific Symposium; Oct. 11-15, 2015; San Francisco.

Disclosure: Saito reports no relevant financial disclosures.

Perspective

Daniel I. Simon, MD

The US, at last check, was somewhere between 16% and 20% transradial access. It is increasing annually in the US – it’s about 40% to 50% in our institution.

I would say, though, that what’s interesting is there are two sort of diverging paths here. One is that interventions are getting more and more complex. We are doing cases now, such as CTO and multi-vessel disease, that we did not tackle in the past. There are advantages of femoral access in these cases. One of the things that I’d hate to see is our trainees and fellows lose the techniques that you need to so these cases.

Certainly, femoral access will still be required for some procedures and I think there is a question of what’s the appropriate mix, but it certainly seems that you can make a very strong case for radial access in acute coronary syndromes because that’s where I think the data is the most robust.

Daniel I. Simon, MD

Division chief, cardiovascular medicine, UH Case Medical Center

Professor of medicine, Case Western Reserve University School of Medicine

President, Harrington Heart and Vascular Institute, University Hospitals

Disclosures: Simon reports serving on advisory boards for Heartflow and Medtronic.