DCB shows benefit in PAD, CLI studies

A drug-coated balloon was safe and effective at 2 years in patients with peripheral artery disease and at 1 year in patients with critical limb ischemia, according to two presentations at the Leipzig Interventional Course.

Researchers presented 2-year results from the IN.PACT SFA Japan study and 1-year results from a CLI subgroup analysis of the IN.PACT Global study, both of which evaluated the performance of a DCB (IN.PACT Admiral, Medtronic).

DCB in SFA

For the IN.PACT SFA Japan Study, conducted at 11 centers in Japan, researchers randomly assigned 100 patients with de novo or non-stented restenotic lesions in the superficial femoral or proximal popliteal arteries on a 2:1 basis to the DCB or percutaneous transluminal angioplasty, Osamu Iida, MD, from Kansai Rosai Hospital in Amagasaki, Japan, said during a presentation.

The primary effectiveness endpoint was primary patency at 12 months, defined as freedom from clinically driven target lesion revascularization and freedom from restenosis as determined by ultrasound-derived peak systolic velocity ratio 2.4. The primary safety endpoint was freedom from device- and procedure-related death at 30 days and freedom from target limb major amputation and clinically driven target vessel revascularization at 12 months.

The DCB outperformed percutaneous transluminal angioplasty (PTA) in the primary effectiveness endpoint at 12 months, as Cardiology Today’s Intervention previously reported. At 2 years, primary patency was 79.8% in the DCB group vs. 46.9% in the PTA group (log-rank P = .0006), Iida said.

Freedom from clinically driven TLR at 2 years was 90.8% in the DCB group vs. 81.3% in the PTA group (log-rank P = .114), according to the researchers.

Time to first clinically driven TLR was longer in the DCB group (470.2 days vs. 168.2 days; P = .012).

The primary safety outcome did not differ between the groups at 2 years (DCB group, 89.4%; PTA group, 79.3%; P = .207), Iida said.

There were no cases of device- or procedure-related death or major target limb amputations in either group. Adverse events at 2 years occurred in 10.6% of the DCB group and 20.7% of the PTA group (P = .207).

“The results demonstrate a consistent and durable effect of the [IN.PACT Admiral] in a more complex patient demographic than typically seen in other DCB pivotal trials,” Iida said. “The data are consistent with the superior treatment effect seen in the IN.PACT SFA DCB trials.”

DCB in CLI

Researchers analyzed 156 patients (mean age, 72 years; 56% men) with CLI, defined as Rutherford class 4 or 5, from the IN.PACT Global study of real-world use of the DCB to determine whether it was a feasible treatment in this population.

The primary efficacy endpoint was freedom from clinically driven TLR at 12 months. The primary safety endpoint was freedom from device- and procedure-related death at 30 days and freedom from target limb major amputation and clinically driven TVR at 12 months.

The primary efficacy endpoint occurred in 86.6% of those with Rutherford class 4 and 85.5% of those with Rutherford class 5 (log-rank P = .6881), Michel Reijnen, MD, vascular surgeon at Rijnstate Hospital in Arnhem, the Netherlands, said during a presentation.

Freedom from major target limb amputation at 12 months was 99.1% in those with Rutherford class 4 and 97% in those with Rutherford class 5 (log-rank P = .3688), he said.

Clinically driven TLR occurred in 14.1% of patients at 12 months, and time to first clinically driven TLR within 12 months was 97.8 days.

The primary safety endpoint occurred in 83.1% of patients at 12 months. Major adverse events occurred in 22.5% of patients, including 7% who died, 0.6% who experienced device- or procedure-related death at 30 days and 1.4% who experienced major target limb amputation.

Ankle-brachial index and quality-of-life measures improved in most patients during the study, according to the researchers.

“The treatment of CLI in PAD remains a challenge and has led to the need for more clinical evidence around the safety and efficacy of DCB in this population,” Reijnen said in a press release. “The data presented today are very encouraging in that we were able to confirm IN.PACT Admiral’s strong performance in this clinically complex patient subset, as well as improved quality of life.” – by Erik Swain

References:

Iida O, et al.

Reijnen M, et al. Latest results with new technologies for femoropopliteal obstructions: Drug-eluting devices, atherectomy and new implants. Both presented at: Leipzig Interventional Course; Jan. 30-Feb. 2, 2018; Leipzig, Germany.

Disclosure s : The studies were funded by Medtronic. Iida and Reijnen report no relevant financial disclosures.