Bioresorbable Scaffold Designed for PAD Yields Good Early Results

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At 6 months, a bioresorbable vascular scaffold (BVS) produced substantially increased patency in diseased iliac and superficial femoral arteries (SFAs), with no cases of target lesion revascularization (TLR), scaffold thrombosis, or other adverse outcomes, according to a small study presented January 22, 2014, at the 26th Annual International Symposium on Endovascular Therapy in Miami Beach, FL. Functional status also improved substantially with the novel device.

Researchers led by Johannes Lammer, MD, of the Medical University of Vienna (Vienna, Austria), conducted a first-in-man study of 35 patients with symptomatic disease of the SFA or iliac artery. All patients were treated with the Esprit everolimus-eluting BVS (Abbott Vascular, Santa Clara, CA), which is designed to fully metabolize within 18 months of implantation.

Acute procedural success was complete, with no indications of acute scaffold recoil. At 6-month follow-up including 34 patients, angiographic, hemodynamic, and functional parameters improved substantially (table 1).

Table 1. Angiographic, Hemodynamic, and Functional Measures: Baseline vs 6 Months

 

Baseline

6 Months

In-Segment Diameter Stenosis

80.0%

13.1%

Ankle-Brachial Index

0.75

0.99

Rutherford Class 0 (No Claudication)

0%

67.6%

Rutherford Class 3 (Severe Claudication)

57.1%

0%


There were no instances of any of key study endpoints including death, limb amputation, bypass surgery of the treated limb, scaffold thrombosis, TLR, TVR, or target extremity revascularization.

Importantly, though, the study included only relatively simple lesions. Most were in the SFA (88.6%), and the average target lesion length was 35.5 mm. Total occlusions were present in 22.9% of patients, and occlusion length was 30.6 mm.

Designed for the Periphery

In a telephone interview with TCTMD, Dr. Lammer noted that Esprit represents a totally new design from BVS for the coronary arteries, as peripheral lesions tend to be longer and scaffolds need to be more resistant to external compression.

In spite of the study’s focus on simple lesions, he called the 6-month results promising. “If you use a completely new device, you always are a little skeptical about whether it will really work as it did in animal studies, but the complete success and no problems at 6 months is really better than expected,” Dr. Lammer said.

Aside from the potential long-term advantage of a device that does not remain in the artery, Dr. Lammer said BVS also carry significant acute benefits. Because it is made of polylactide, the device produces no artifact on either MR or CT angiography. “So you can do these examinations nicely, seeing the lumen completely and potential intimal hyperplasia and so on, without the metallic artifacts you have with nitinol stents,” he explained.

Also Effective in Complicated Lesions?

It is too early to tell if BVS will prove superior to traditional DES, Ajay J. Kirtane, MD, SM, of Columbia University Medical Center (New York, NY), told TCTMD in a telephone interview, noting that “in some respects, this is a proof of concept.”

“Depending on the material and construction, these devices tend to be a little less flexible than stents,” Dr. Kirtane observed. “So, especially when exposed to the torsion of the SFA or other less hospitable territories, and especially with longer lesions, you want to make sure that patients will be able to tolerate them and that the devices will hold up.”

Dr. Lammer noted that Abbott is working to make the devices available for the longer lesions commonly seen in the SFA, after which randomized trials are likely to begin.

“Especially in areas where stents might be suboptimal—like the SFA and perhaps behind the knee or across certain joints—there is obvious appeal for these types of devices,” Dr. Kirtane said. “But whether these results can be extrapolated to more complex lesion subsets remains to be seen.”


 


Source:

 

Lammer J. Biodegradable DES to treat iliac and femoral lesions: Are they promising? Results from the ESPRIT trial. Presented at: International Symposium on Endovascular Therapy; January 22, 2014; Miami Beach, FL.


Disclosures:

  • The study was sponsored by Abbott Vascular.
  • Dr. Lammer reports serving on the scientific advisory board of Abbott Vascular.
  • Dr. Kirtane reports participating in studies through his institution, which receives institutional research support from Abbott Vascular, Abiomed, Boston Scientific, Medtronic, and St. Jude Medical.

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