A self-expanding nitinol stent is associated with high patency and durability in patients with atherosclerotic popliteal artery disease, according to a study published in the January 2013 issue of JACC: Cardiovascular Interventions.

Dierk Scheinert, MD, of Park Hospital Leipzig (Leipzig, Germany), and colleagues retrospectively analyzed data from 101 consecutive patients with severe popliteal artery disease, who received 125 implantations with the Supera stent (IDEV Technologies, Webster, TX) between January 2008 and April 2010.

Patency rates, defined as the absence of binary restenosis without repeat target lesion interventions, were high at 6 and 12 months. Additionally, patients saw increases in ankle-brachial index (ABI) and decreases in Rutherford-Becker class (RBC; table 1).

Table 1. Stent Patency Rates, ABI, and RBC

Ten patients experienced either in-stent occlusion or restenosis. Of these individuals, 7 were recanalized percutaneously, while the remaining patients were conservatively treated.

Procedural success, defined as 30% residual stenosis, occurred in 98% of patients. Radiographs confirmed that none of the 51 patients available at mean follow-up of 15.2 months experienced stent fractures.

Overall, 10 patients died during the study period, and adverse events were limited (table 2).

Table 2. Cumulative Adverse Events

“The question of how liberally these novel stents should be used in the popliteal artery is difficult to answer from this initial dataset and certainly requires a randomized head-to-to-head comparison to other available techniques and treatment strategies,” Dr. Scheinert and colleagues conclude.

Clinical Changes Ahead?

In a telephone interview, Christopher J. White, MD, of the Ochsner Heart and Vascular Institute (New Orleans, LA), told TCTMD that the study has the potential to impact clinical practice. “The first thing to understand is that the popliteal artery is in the joint space behind the knee and is difficult to treat because stents, including those that are drug-eluting, and other devices tend to fracture there,” he said.

Because of the self-expanding design of Supera, it is “very flexible and can’t be crushed. It doesn’t fracture,” Dr. White explained.

A drawback of the Supera stent, however, is that it has a 7-Fr diameter catheter, while interventional cardiologists typically use 5- and 6-Fr catheters, he noted. “It would be better if the catheter were on the smaller side,” Dr. White commented.

In an e-mail communication, a spokesperson for IDEV Technologies pointed out that a 6-Fr version of Supera has been on the market since January 2012.

He lauded the study authors for achieving a low stent failure rate, saying that the data show superiority over balloons, the current standard of treatment in popliteal artery disease.

While the Supera stent might be a good option for popliteal arteries, it needs to be directly compared with drug-coated balloons, Dr. White said. “But until that trial gets done, I don’t know of any better way to treat the popliteal artery than with the new stent,” he added.

Potential for Use in Other Arteries

Referring to their prior research, Dr. Scheinert and colleagues observed that the patency rates demonstrated by Supera in the popliteal artery mirror those already found in the superficial femoral artery (SFA; Scheinert D, et al. J Endovasc Ther. 2011;18:745-752), potentially making it a suitable treatment option for disease in both locations.

While the US Food and Drug Administration approved the polymer-free paclitaxel-eluting Zilver PTX stent (Cook Medical, Bloomington, IN) for SFA disease in November 2012, Dr. White noted that the device has not been tested in the popliteal artery and that he would be concerned it would fracture when placed in there.

Study Details

Study enrollment included a wide variety of obstructions without pre-specified inclusion or exclusion criteria. The mean age of patients was 73.1 years and 52.5% were men. Additionally, mean stent length was 84.4 ± 45.1 mm and mean lesion length was 58.5 ± 34.2 mm.

 

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Source:
Scheinert D, Werner M, Scheinert S, et al. Treatment of complex atherosclerotic popliteal artery disease with a new self-expanding interwoven nitinol stent: 12-month results of the Leipzig SUPERA popliteal artery stent registry. J Am Coll Cardiol Intv. 2013;6:65-71.

 

 

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