Top News in Endovascular Therapy: 2018

Sometimes the waning weeks of December unexpectedly produce news that is bigger than anything presented at meetings, read in journals, or bandied about on Twitter earlier in the year. Such was the case in 2018, when a meta-analysis published this month showed higher mortality for paclitaxel-coated balloons and stents in PAD.

The paper has quickly become the topic of the year for the endovascular community.

“This has turned the whole field upside down on its head," Sahil A. Parikh, MD (NewYork-Presbyterian/Columbia University Irving Medical Center, New York, NY), told TCTMD. Similarly, in an email Michael Jaff, DO (Newton-Wellesley Hospital, Newton, MA), said it is “by far and away the biggest” endovascular news of the year.

Led by Konstantinos Katsanos, MD, PhD (Patras University Hospital, Rion, Greece), the meta-analysis of 28 trials set off alarms when it was published December 6, 2018, online ahead of print in the Journal of the American Heart Association. While mortality rates for the drug-coated balloons (DCBs) and stents were similar to those of uncovered balloon angioplasty at 1 year, there was a 68% relative risk increase in all-cause death with paclitaxel-coated devices at 2 years, with a number-needed-to-harm of 29, and a 93% relative risk increase by 5 years, with a number-needed-to-harm of 14.

Within a week of its publication TCTMD reported that two trial groups (BASIL-3 and SWEDEPAD 1 and 2) announced they were halting recruitment efforts so they could review their protocols in light of the findings. Additionally, leaders of the VIVA meeting announced they will convene a special forum in February 2019 to discuss the issue in depth.

“One can speculate what the relationships are, and whether causality has been proven,” Parikh said. “But I have to say that whether or not this causality is linked, this is awfully reminiscent of the DES firestorm of 2006, where DES were impugned as killing people and it changed the field for a decade or more.”

This is awfully reminiscent of the DES firestorm of 2006, where DES were impugned as killing people and it changed the field for a decade or more. Sahil Parkih

In an interview with TCTMD, Christopher J. White, MD (Ochsner Medical Center, New Orleans, LA), agreed, adding that the coming year will likely see a variety of efforts devoted to ongoing assessment of what is now known as the “Katsanos meta-analysis.”

Echoing the sentiments of others, White said the findings will not prevent him from continuing to use DCBs in PAD. “The benefit still far outweighs the potential risk,” he observed, adding that the Zilver PTX paclitaxel-eluting stent (Cook Medical) has produced 5-year data to this point with no suggestion of a mortality signal compared with an uncoated balloon.

In related news, Jaff pointed to IMPERIAL as one of the biggest endovascular trials of the year. The head-to-head study presented at TCT 2018 showed that patency at 1 year was superior with the Eluvia paclitaxel-eluting stent (Boston Scientific) versus Zilver PTX in patients with femoropopliteal disease. Days later, Eluvia was granted US Food and Drug Administration approval on the strength of the IMPERIAL findings.

Medical Therapy for PAD

"There's also a lot to talk about in the area of medical therapy these days, which was not the case 5 ago,” Parikh noted.

He cited the recently expanded indications for rivaroxaban (Xarelto; Bayer/Janssen) , which now include the treatment of patients with stable atherosclerotic vascular disease. The move by the FDA in October made rivaroxaban the first direct oral anticoagulant cleared for use in this patient population and was based in part on data from the COMPASS trial. At VIVA 2018, which was held just a few weeks later, multiple presentations, panel discussions, and audience questions revolved around the rivaroxaban conundrum.

Parikh said more data and experience are needed to help clinicians decide which PAD patients will benefit most from adding rivaroxaban to their therapy regimens. “[I]t's definitely an issue that we're going to need to continue to grapple with,” he added.

He also pointed to new data that emerged this year on PCSK9 antagonists. The ODYSSEY trial showed a mortality benefit of alirocumab that was most pronounced in patients with the highest baseline LDL cholesterol levels despite intensive statin therapy. Many PAD patients fall into that high-risk category and may derive benefit from the drug, Parikh said.

Click here for more from TCTMD’s 2018 Year in Review.