DCB successfully treats long lesions in two cohorts of patients with PAD

Results of two studies presented at EuroPCR showed that a drug-coated balloon successfully treated long lesions in the superficial femoral and popliteal arteries of patients with peripheral artery disease.

One presentation covered 12-month results for the long-lesion cohort of the IN.PACT Global study and the other covered 12-month results of the DEB SFA-LONG study. Both assessed the drug-coated balloon (DCB; IN.PACT Admiral, Medtronic) in patients with lesions longer than those studied in randomized controlled trials of the device.

“Currently, IN.PACT Admiral is the only [DCB] with outcomes reported for long lesions,” Dierk Scheinert, MD, chairman of the division for interventional angiology at University Hospital Leipzig, Germany, told Cardiology Today.

IN.PACT Global

Scheinert and colleagues assessed the performance of the DCB in 157 patients (mean age, 69 years; 66% men) with 164 lesions from the long-lesion imaging cohort of the IN.PACT Global real-world prospective study. The mean lesion length was 26.4 cm, nearly three times longer than the mean length of 8.9 cm studied in the IN.PACT SFA randomized controlled trial.

The primary efficacy endpoint was 12-month primary patency, defined as freedom from clinically driven target lesion revascularization and restenosis. The primary safety endpoints were freedom from device-and procedure-related mortality at 30 days and freedom from major target limb amputation and clinically driven target vessel revascularization at 12 months.

The rate of device success was 99.5%, the rate of procedure success was 99.4% and the rate of clinical success was 99.4%, Scheinert said during a presentation.

The primary patency rate at 12 months was 91.1%. For those who did not require provisional stenting, it was 92.5%. The rate was 97.7% for lesions between 15 cm and 25 cm, and 79.2% for lesions > 25 cm, he said. “Longer lesion length appears to be a contributor to lower long-term primary patency,” he said, noting, however, that 79.2% is a good result for very long lesions.

The rate of clinically driven TLR was 6%. “With such a low rate reported, it will likely be difficult to determine which characteristics, if any, may have been associated with that,” Scheinert said in an interview.

There were no major target limb amputations and the rate of freedom from major adverse safety events was 94%. The rate of all-cause mortality was 4.5%.

“I believe that particularly for long lesions this DCB holds a lot of promise because other technologies including stent have obvious limitations (stent fractures, etc),” Scheinert told Cardiology Today.

The DCB has demonstrated consistent rates of clinically driven TLR across studies and complex lesions, Scheinert said. He noted that the rate was 6% in this cohort, 2.4% in the DCB arm of IN.PACT SFA and 8.7% in the overall IN.PACT Global cohort analyzed so far.

“It is my impression that DCB really takes the treatment options to the next level,” Scheinert said. “With reported patency rates of 80%+ at 1 year, endovascular therapy becomes a very reasonable option for many patients with such long segment disease.”

DEB SFA-LONG

The DEB SFA-LONG study analyzed 105 patients with lesions > 15 cm (mean age, 68.03 years; 82% men; mean lesion length, 25.2 cm) who received the DCB at six centers in Italy.

The primary endpoint was rate of primary patency, defined as freedom from clinically driven TLR and > 50% restenosis in the treated lesion, at 12 months.

The primary patency rate at 12 months was 89.3%, and the rate of clinically driven TLR at 12 months was 4%, Antonio Micari, MD, from Maria Cecilia Hospital, Cotignola, Italy, said during a presentation.

“I am particularly impressed to see the high consistency of the data [between the two studies],” Scheinert said. “The consistency is reassuring of the treatment effect, [and reconfirms] the validity of our scientific work.” – by Erik Swain

References:

Micari A, et al.

Scheinert D, et al. Hot Line: Peripheral Interventions. Both presented at: EuroPCR; May 19-22, 2015; Paris.

Disclosures: The IN.PACT Global study was funded by Medtronic. The DEB SFA-LONG study was funded by ES Health Science Foundation. Micari reports consulting for Endocross, Medtronic and Spectranetics, speaking for AstraZeneca, Boston Scientific, C.R. Bard, Spectranetics and Terumo, and receiving institutional grant/research support from Medtronic. Scheinert reports consulting for Abbott, Angioslide, Biotronik, Boston Scientific, Cook Medical, Cordis, C.R. Bard, Gardia Medical, Hemoteq, Intact Vascular, Medtronic/Covidien, Ostial, TriReme Medical, TriVascular and Upstream Peripheral Technologies and holding equity in iDEV Technologies.