TCT: EES Holds Top Spot for Stenting Within a Stent

WASHINGTON -- The everolimus-eluting Xience stent was the solid winner for percutaneous coronary intervention for in-stent restenosis, beating a bioresorbable vascular scaffold (BVS) and a drug-eluting balloon (DEB) for the top spot, a researcher said here.

On quantitative coronary angiography at 1-year follow-up, in-segment minimal luminal diameters were similar for the Absorb bioresorbable vascular scaffold and SeQuent Please DEB (1.87 mm and 1.88 mm, respectively), according to the presentation at the annual Transcatheter Cardiovascular Therapeutics (TCT) meeting.

Everolimus-eluting stent (EES) recipients, however, had in-segment luminal diameters of 2.16 mm (P<0.001), said Fernando Alfonso, MD, PhD, of Hospital Universitario La Princesa in Madrid, Spain, reporting data from three RIBS studies which individually examined outcomes with EES, DEB and BVS devices.

In-lesion minimal luminal diameters also favored the EES group (2.30 mm versus 1.94 mm with each of the other two devices, P<0.001). But Alfonso noted that this was not a parallel-group trial; rather, it was a comparison of DEB data from RIBS IV, EES outcomes from RIBS V, and Absorb's performance in RIBS VI.

"The acute and late angiographic findings of bioresorbable vascular scaffolds appear to be similar to those obtained with DEB ('leave nothing behind strategy') but poorer than those seen after EES implantation," Alfonso said during a TCT press conference.

He also noted that the EES group had the most substantial in-segment acute gain (1.47 mm versus 1.16 mm and 1.24 mm, P<0.001) and the lowest late loss (0.12, versus 0.23 mm and 0.24 mm, P<0.05).

As well, Xience appeared superior in terms of freedom from target lesion revascularization (89% each for BVS and DEB versus 97% for EES, log-rank P=0.002).

"It's important to think carefully about where bioresorbable vascular scaffolds would fit," commented William A. Gray, MD, of Main Line Health in Wynnewood, Pa., noting that these products may have late-term issues, and EES is known to work well.

"The only way bioresorbable vascular scaffolds are going to win this is with long-term follow-up when it goes away and there's no stent. By 1 year you're not going to see anything. If you're going to use it you almost have to mandate adjunctive imaging," said D. Christopher Metzger, MD, of Wellmont CVA Heart Institute in Kingsport, Tenn.

Alfonso's present analysis included patients in the RIBS VI registry who had in-stent restenosis of bare-metal stents and drug-eluting stents (DES) who subsequently received Absorb bioresorbable vascular scaffolds from 2014 to 2015 with angiographic follow-up (n=134) as well as patients from the randomized RIBS IV and V studies who got SeQuent Please DEB (n=223) or Xience Prime EES (n=219), respectively.

Procedures were performed at 19 Spanish hospitals with 100% success in all treatment groups.

At 1 year, adverse events were observed in BVS recipients:

• Stent thrombosis in 0.7%
• Acute MI in 2.8%
• Target lesion revascularization in 11.3%
• Target vessel revascularization in 13.5%

"BVS are safe and effective in the treatment of selected patients with in-stent restenosis," Alfonso said. But "when should I use bioresorbable vascular scaffolds? I don't know which subset of patients."

"The study reinforces the high performance of EES," said Jonathan A. Hill, MD, PhD, of University of Texas Southwestern Medical Center in Dallas.

"There's an intuitive appeal of bioresorbable vascular scaffolds in this population," he added, but said the "practicalities of BVS implantation and sizing based on QCA [quantitative coronary angiography]" complicate the picture.

"Perhaps QCA is not the way to select patients for treatment irrespective of whether there's a stent already there," said Hill.

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