It’s DESTINY: DES Superior to BMS for Below-the-Knee Lesions

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In patients with critical limb ischemia (CLI) and infrapopliteal arterial disease, treatment with drug-eluting stents (DES) results in improved patency and reduced target lesion revascularization compared with bare-metal stents (BMS). Results of the small, randomized DESTINY trial were published online December 15, 2011, ahead of print in the Journal of Vascular Surgery.

For DESTINY (Drug Eluting Stents in the Critically Ischemic Lower Leg), researchers led by Marc Bosiers, MD, of AZ Sint-Blasius (Dendermonde, Belgium), randomized 140 CLI patients with Rutherford category 4 or 5 PAD at 5 European centers to receive a Xience V everolimus-eluting stent (n = 74; Abbott Laboratories, Abbott Park, IL) or a Multi-Link Vision BMS (n = 66; Abbott). A total of 154 target lesions were treated, with lesions in the Xience arm being slightly shorter than those in the Vision arm (15.9 ± 10.2 mm vs. 18.9 ± 10.0 mm; P = 0.07). There were no technical complications or failures.

During the first year postprocedure, 23 deaths and 3 major amputations (1 Xience, 2 Vision) occurred, with 7 patients lost to follow-up. At 12 months, primary patency (the primary endpoint), was significantly improved in the Xience group, as were freedom from TLR and several endpoints on quantitative angiographic analysis (table 1).

Table 1. Twelve-Month Outcomes

The most notable improvement in patency with Xience V stents occurred in 116 proximal lesions (85% vs. 58%; P = 0.0002). While patency was also improved in patients with distal lesions treated with Xience V (87% vs. 43%; P = 0.08), the number of distal lesions was too small (38) to show statistical significance.

Survival at 12 months was similar in the Xience (82%) and Vision (84%) groups (P = 0.96), as was clinical success, defined as improvement in Rutherford class. Sixty percent of the Xience patients were Rutherford class 0 or 1 at 12 months compared with 56% of the Vision patients (P = 0.68).

Restenosis showed a trend favoring Xience, but the difference was not statistically significant (17% vs. 36%; P = 0.12).

“These data suggest that Xience V stenting is a useful therapeutic adjunct in patients with CLI that require prolonged patency following endovascular recanalization,” the authors conclude.

Dr. Bosiers and colleagues point out that DESTINY lacked sufficient power to demonstrate meaningful differences in symptomatic relief or limb salvage. “However, the clinical advantage of avoidance of additional procedures was realized,” they note. “This could be expected to reduce the overall cost of therapy, analogous to similar observations after percutaneous coronary intervention in which DESs that reliably reduce the need for reintervention also reduce cost.”

Beating the Drum

Andrew J. Feiring, MD, of Columbia-St. Mary’s Medical Center (Milwaukee, WI), could not agree more, calling the study results “a big deal.”

In a telephone interview with TCTMD, he noted that the findings “should really stimulate a groundswell for endovascular clinicians who specialize in limb salvage to really beat the drum and get industry to do an FDA study.”

Dr. Feiring noted that DESTINY represents the third small, randomized trial after YUKON and ACHILLES (each performed in Europe) to find positive results with DES compared with either BMS or balloon angioplasty in below-the-knee lesions, in addition to about 14 single-center trials. Nevertheless, while DES has European approval for such use, any stenting—including BMS—remains off-label for treatment of infrapopliteal disease in the United States.

This is especially frustrating, Dr. Feiring observed, in light of the consequences of CLI, which include a 1-year mortality rate of roughly 30%, a 1-year amputation rate of 25%, and a 3-year amputation rate of about 50%. “This is a disease that’s tremendously undertreated,” he said. “There’s a real need for industry to get off its butt and decide to do something.”

Drawing from the Coronary Experience

While expressing confidence that a larger trial would show similar results, Dr. Feiring also noted that the DES experience in the coronary circulation adds extra weight to the growing body of literature supporting DES in the lower extremities.

“The vessels below the tibial plateau or the knee joint are basically coronary vessels in size and shape and mostly histology. They’re 2 to 4 mm, they’re relatively straight, they don’t do a lot of bending, and they’re protected by muscular compartments,” he said. “If you go back to the coronary data, looking at SIRIUS and the early DES trials, it’s the exact same differential between DES and BMS. Looking at DESTINY, this tells you that DES placed in medium size muscular arteries of the same size as coronary arteries have the same effect, with minor differences.”

A Note of Caution

While agreeing that the DESTINY report “is an extremely significant article,” Robert A. Lookstein, MD, of Mount Sinai Medical Center (New York, NY), took a more cautious approach. “What we have right now is an avoidance of TLR, but it is not proven yet that that specifically translates to a direct clinical benefit to the patient,” he said. “So we are going to have to be very cautiously enthusiastic and await the mid- and long-term results before we can overtly recommend this technology.”

Nevertheless, “[Dr. Feiring and I] firmly believe there’s a benefit to the primary patency of the lesion treated, and from my own clinical experience, DES represent the default clinical paradigm in my practice,” Dr. Lookstein said. “I think if we’re going to be a little patient and wait for midterm follow-up, we’re going to see the clinical benefit translate out to 24 and 36 months. It just hasn’t been demonstrated yet in the short term.”

If that occurs, DES would supplant a number of methods and technologies, including balloon angioplasty, atherectomy, and the surgical gold standard, a femoral-tibial bypass using a saphenous vein conduit. “But not everybody with CLI can be offered [surgery] as a therapeutic option due to a lack of an appropriate venous conduit or the significant medical comorbidities that frequently coexist with CLI,” Dr. Lookstein said. “So there’s a growing population of patients that cannot receive an infrapopliteal saphenous vein bypass graft. I think we’re on the verge of a transformation in terms of the endovascular options.”

To Dr. Feiring, the argument for DES in the tibial circulation is as simple as it is perplexing. “[The technology] is readily available, it’s off the shelf, you don’t need a lot of extra training to put it in, it shortens the procedure, it lessens the amount of contrast, and yet you can’t use it in the United States,” he said. “It just doesn’t make any damn sense.”

 

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Source:
Bosiers M, Scheinert D, Peeters P, et al. Randomized comparison of everolimus-eluting versus bare-metal stents in patients with critical limb ischemia and infrapopliteal arterial occlusive disease. J Vasc Surg. 2011;Epub ahead of print.

 

 

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