Studies Provide Encouraging Results for DCB in Long SFA Lesions

PARIS, France—Observational data presented in a Hotline Session at EuroPCR on May 20, 2015, show positive 1-year results for a drug-coated balloon (DCB) in patients with long peripheral artery lesions.

Both the DEB SFA-LONG Study and the IN-PACT Global Study employed the IN.PACT Admiral balloon (Medtronic), which is coated with paclitaxel.

Dedicated Study on Long Lesions

For DEB SFA-LONG, researchers led by Antonio Micari, MD, of Maria Cecilia Hospital (Cotignola, Italy), enrolled 105 symptomatic patients with SFA lesions greater than 15 cm being treated at their center. Reference vessel diameter ranged from 4 to 7 mm, and all were considered to be Rutherford class 2, 3, or 4. All had at least 1 patent crural vessel, either preexisting or successfully established, as well as adequate inflow. Follow-up data were available for 99 patients at 12 months, and outcomes were independently adjudicated.

Angioplasty success was 84.8%. Provisional stenting was required in 10.5% of cases. The mean total lesion length was 252 mm, and the mean total treated length was 263 mm.

Primary patency at 12 months (primary endpoint; freedom from clinically driven TLR and from > 50% restenosis in the treated lesion) was seen in 83.2% of the per-protocol population, with 96% free of TLR and 84.2% free of restenosis. Secondary endpoints included 4 deaths, 1 case of thrombosis, and 1 revascularization in a nontarget lesion.

On Kaplan-Meier analysis, the rate of primary patency was 89.3% at 360 days.

Changes in Rutherford class also occurred. For example, at baseline 62% of patients were class 3 and 28% class 2. But by 12 months, 58% were class 0 and 18% class 1.

“To our knowledge, this is the first study focused on the use of DEB in very long SFA lesions,” Dr. Micari concluded. “Preliminary 1-year results support the usefulness of [DEB] in limiting the need for clinically-driven revascularizations. Instrumental results are corroborated by good maintenance of clinical benefit.”

Session chair Elazer Edelman, MD, of Brigham and Women’s Hospital (Boston, MA), said that mechanism as well as clinical outcomes must be considered. In the artery, he asked, what is going on “from a biological point of view?”

Paclitaxel must be an important ingredient, based on how much better these results are than what has been seen for plain balloons, Dr. Micari noted.

Discussion continued over whether results could be further improved by use of atherectomy or implantation of DES. The core treatment should be a DCB, all agreed, but the benefit of the other therapies was less certain. “Maybe stenting,” said Dr. Micari. “But I would not stent myself 30 centimeters [in my leg].”

Global Registry Findings

Also presented in the same session were data on long lesions from the observational IN.PACT Global Study.

“Complex lesion types, including long lesions, chronic total occlusions, and in-stent restenosis remain unmet clinical needs, with no current treatment standard identified,” said researcher Dierk Scheinert, MD, of University Hospital (Leipzig, Germany). Although high patency and low TLR rates at 12 months were reported by the IN.PACT SFA trial, he said, these results have not yet been confirmed in long lesions.

Of the 1,538 patients from more than 25 countries prospectively enrolled in IN.PACT Global Study, 157 had lesion lengths of at least 15 cm. Mean lesion length in this group was 26.4 cm. Most (61.5%) were Rutherford class 3.

Primary patency at 360 days (defined as freedom from clinically driven TLR and from restenosis as determined by Doppler ultrasound peak systolic velocity ratio ≤ 2.4) in the long-lesion cohort was 91.1%, according to Kaplan-Meier analysis. Freedom from adverse safety events (including 30-day freedom from device- and procedure-related mortality as well as 12-month freedom from target limb amputation and clinically driven TLR) was 94%. There were no major target limb amputations. Rates of all-cause death and any TLR were 4.5% and 6.0%, respectively.

Provisional stenting was more common in patients with lesion lengths greater than 25 cm. In those who did not require provisional stenting, the primary patency rate at 360 days was 92.5%. This “confirms the effectiveness of the IN.PACT Admiral DCB as a standalone device in long, complex SFA lesions,” Dr. Sheinert concluded.

Sources:

1. Micari A. The Drug-eluting Balloon Superficial Femoral Artery-Long Study: the DEB SFA-LONG study. Presented at: EuroPCR; May 19, 2015; Paris, France.
2. Scheinert D. Drug-coated balloon treatment for patients with intermittent claudication: new insights from the IN.PACT Global Study long lesion (≥ 15 cm) imaging cohort. Presented at: EuroPCR; May 19, 2015; Paris, France.

Disclosures:

• Dr. Micari reports serving as a consultant to Endocross, Medtronic, and Spectranetics; serving on the speakers’ bureaus of AstraZeneca, Bard, Boston Scientific, Spectranetics, and Terumo; and receiving institutional grant/research support from Medtronic.
• Dr. Scheinert reports consulting for multiple drug and device companies and being a stockholder of iDEV Technologies.

Related Stories:

• Drug-Eluting Balloon Provides Strong Primary Patency in SFA at 1 Year
• Drug-Eluting Balloon Continues Strong Showing in SFA Lesions
• Drug-Eluting Balloon Continues to Show Positive Results in SFA, Popliteal Disease