FDA Approves Newest Generation of XIENCE Stent for Blockage in CAD

The US Food and Drug Administration has approved the use of Abbott’s newest generation of the XIENCE everolimus-eluting coronary stent system—the XIENCE Sierra—for the treatment of complex blockages in coronary artery disease (CAD).

The new stent’s design and technology now allow for its use in up to 70% of blockage cases, according to Abbott. The new designs for the device include a thinner profile, increased flexibility, increased lengths, and smaller diameters, specifically designed for use in complex cases with multiple or completely obstructed vessels.

"We developed XIENCE Sierra so that physicians can more easily deliver the stent even in challenging cases," Chuck Brynelsen, MBA, the senior vice president of Abbott's vascular business, said in a statement. "The updated design and improved deliverability mean doctors can access and unblock difficult-to-treat lesions with more flexibility and precision than other stents."

Since its original approval in 2008 (and 2006 in Europe), more than 8 million patients worldwide have received a XIENCE stent, according to Abbott.

As of the approval, more than 100 clinical trials have studied the XIENCE stent system, including a decade of use in real-world scenarios. The device boasts one of the lowest rates of stent thrombosis coupled with a consistent safety profile.

CAD is a leading cause of death among both men and women in the United States, with heart disease alone accounting for more than 600,000 deaths annually.

Additionally, Abbott recently announced results from the 5-year FAME 2 study, an evaluation of the company’s fractional flow reserve (FFR) diagnostic tool in conjunction with medical therapy in patients who received a heart stent.

The findings, presented at the 2018 EuroPCR Annual Meeting in Paris, France, showed a reduction in major adverse cardiac events (MACE) when the PressureWire FFR tool was used. The findings included data from 733 patients with stable CAD and significant blockages or narrowing of the arteries.

Ultimately, 13.9% of those receiving FFR-guided percutaneous coronary intervention (PCI; n = 62) experienced MACE compared to 27% (n = 119) in the medical therapy only group (P <.001). This lower rate was driven mostly by the reduced need for urgent revascularization, a component of the primary endpoint of MACE, which occurred in 6.3% of the FFR group as opposed to 21.1% of the medical therapy only group (P <.001).

Additionally, those in the FFR group experienced 3.9% fewer heart attacks (36 cases compared to 53 cases; P = .049). All-cause death was similar between the 2 groups, with the FRR group reporting it in 5.1% (n = 23) of patients, and the medical therapy only group reporting death in 5.2% (n = 23) of patients.

"For the first time, a study has shown that patients with stable coronary artery disease who received a stent guided by an FFR diagnostic had a benefit over medical therapy alone, including fewer heart attacks and needs for urgent revascularization," principal investigator Bernard De Bruyne, MD, PhD, of the Cardiovascular Center Aalst at the Onze Lieve Vrouw Ziekenhuis, in Aalst, Belgium, said in a statement. "Data from this study confirm the importance of FFR-guided stenting decisions combined with medical therapy over medical therapy alone."