In the Journals

IN.PACT Global: DCB safe, effective in femoropopliteal in-stent restenosis

Patients with femoropopliteal in-stent restenosis lesions who were treated with a paclitaxel drug-coated balloon had high primary patency and low rates of clinically driven target lesion revascularization at 12 months, according to published data.

In the multicenter, single-arm, prospective IN.PACT Global study, 131 patients with de novo in-stent restenosis lesions enrolled in the prespecified imaging cohort were treated with the DCB (IN.PACT Admiral, Medtronic). The mean lesion length was 17.17 cm, 34% were total occlusions and 8.3% were severely calcified, the researchers noted.

Results revealed high rates of device success (99.6%), procedural success (99.3%) and clinical success (98.5%). According to Kaplan-Meier estimates, the primary patency in the in-stent restenosis imaging cohort was 88.7% and freedom from clinically driven TLR was 92.9% at 12 months. After 13-month follow-up, however, primary patency was 80.7%.

Additionally, primary patency at 12 months was 89.6% for patients who did not require provisional stenting and 83.3% for those who did. After 13-month follow-up, primary patency was higher in patients who did not require provisional stenting vs. those who did (84.5% vs. 57.7%; P = .0132).

Also at 12 months, the researchers noted improvements in Rutherford category. More than three-quarters of patients (76.7%) were in Rutherford category 0 to 1 at 12 months, whereas 9.2% were Rutherford category 4 to 5 and 90.8% were Rutherford category 2 to 3 at baseline (P < .001).

The primary composite safety outcome, defined as freedom from device- and procedure-related mortality at 30 days and freedom from major target limb amputation and TLR at 12 months after the procedure, was 92.7%, with no acute adverse events or cumulative major adverse events at 30 days. At 12 months, 8.9% of patients experienced major adverse events, including thrombosis at the target lesion, but there were no deaths from any cause and no major target limb amputations.

Although the data are promising, the researchers noted that the IN.PACT Global study in-stent restenosis imaging cohort analysis did not include a control group or active comparator. Therefore, the data do not suggest the DCB is superior to other treatment strategies.

In an accompanying editorial, Khusrow Niazi, MD, from Emory University, and Deepali N. Tukaye, MBBS, PhD, from Jack Stephens Heart Institute in Little Rock, Arkansas, echoed these sentiments.

They noted that the high primary patency rate in this patient population with long complex lesions is “impressive” and demonstrates the feasibility of DCBs in these patients. Nevertheless, without head-to-head comparison with conventional treatment such as percutaneous transluminal angioplasty or other treatment modalities, the findings remain limited. More investigation is also needed in patients with diabetes, they added.

“Long-term follow-up is needed to evaluate rates of continued patency and time to restenosis,” Niazi and Tukaye wrote. – by Melissa Foster

Disclosures: Brodmann reports she has received honoraria from Bard Peripheral Vascular, Biotronik, Medtronic and Spectranetics. Please see the study for all other authors’ relevant financial disclosures. Niazi reports he has received research grant support from Medtronic. Tukaye reports no relevant financial disclosures.

Patients with femoropopliteal in-stent restenosis lesions who were treated with a paclitaxel drug-coated balloon had high primary patency and low rates of clinically driven target lesion revascularization at 12 months, according to published data.

In the multicenter, single-arm, prospective IN.PACT Global study, 131 patients with de novo in-stent restenosis lesions enrolled in the prespecified imaging cohort were treated with the DCB (IN.PACT Admiral, Medtronic). The mean lesion length was 17.17 cm, 34% were total occlusions and 8.3% were severely calcified, the researchers noted.

Results revealed high rates of device success (99.6%), procedural success (99.3%) and clinical success (98.5%). According to Kaplan-Meier estimates, the primary patency in the in-stent restenosis imaging cohort was 88.7% and freedom from clinically driven TLR was 92.9% at 12 months. After 13-month follow-up, however, primary patency was 80.7%.

Additionally, primary patency at 12 months was 89.6% for patients who did not require provisional stenting and 83.3% for those who did. After 13-month follow-up, primary patency was higher in patients who did not require provisional stenting vs. those who did (84.5% vs. 57.7%; P = .0132).

Also at 12 months, the researchers noted improvements in Rutherford category. More than three-quarters of patients (76.7%) were in Rutherford category 0 to 1 at 12 months, whereas 9.2% were Rutherford category 4 to 5 and 90.8% were Rutherford category 2 to 3 at baseline (P < .001).

The primary composite safety outcome, defined as freedom from device- and procedure-related mortality at 30 days and freedom from major target limb amputation and TLR at 12 months after the procedure, was 92.7%, with no acute adverse events or cumulative major adverse events at 30 days. At 12 months, 8.9% of patients experienced major adverse events, including thrombosis at the target lesion, but there were no deaths from any cause and no major target limb amputations.

Although the data are promising, the researchers noted that the IN.PACT Global study in-stent restenosis imaging cohort analysis did not include a control group or active comparator. Therefore, the data do not suggest the DCB is superior to other treatment strategies.

In an accompanying editorial, Khusrow Niazi, MD, from Emory University, and Deepali N. Tukaye, MBBS, PhD, from Jack Stephens Heart Institute in Little Rock, Arkansas, echoed these sentiments.

They noted that the high primary patency rate in this patient population with long complex lesions is “impressive” and demonstrates the feasibility of DCBs in these patients. Nevertheless, without head-to-head comparison with conventional treatment such as percutaneous transluminal angioplasty or other treatment modalities, the findings remain limited. More investigation is also needed in patients with diabetes, they added.

“Long-term follow-up is needed to evaluate rates of continued patency and time to restenosis,” Niazi and Tukaye wrote. – by Melissa Foster

Disclosures: Brodmann reports she has received honoraria from Bard Peripheral Vascular, Biotronik, Medtronic and Spectranetics. Please see the study for all other authors’ relevant financial disclosures. Niazi reports he has received research grant support from Medtronic. Tukaye reports no relevant financial disclosures.