Original Title: Sustained Durability of Treatment Effect Using a Drug-Coated Balloon for Femoropopliteal Lesions. 24-Month Results of IN.PACT SFA. Reference: John R. Laird et al. J Am CollCardiol. 2015 [Epub ahead of print].
The IN.PACT SFA studies and follows up patients treated with IN.PACT Admiral DCB (Medtronic®) for superficial femoral artery (SFA) and popliteal artery disease.
Prior 1 year follow up outcomes have shown benefits with significant differences in primary patency and target lesion revascularization, when compared to conventional percutaneous transluminal angioplasty (PTA). The present study reports 2 year outcomes. Its relevance relies on the fact that there is no literature on long-term follow-up data from large-scale randomized studies on DCB in femoropopliteal territory.
The trial enrolled 331 patients with significant symptomatic femoropopliteal lesions (Rutherford 2 to 4, between 70 and 99%), 4 to18 cm long, randomizing 2:1 to treatment with DCB vs. PTA(220 and 111 patients respectively).
The 2 year follow up included primary patency, freedom from clinically driven target lesion revascularization, major adverse events, and quality of life and functional outcomes as assessed by the EuroQOL-5D quality-of-life questionnaire, walking impairment questionnaire, and 6-min walk test.
It is worth to mention all patients enrolled in the DCB group received predilation prior to DCB implantation.
At 2 year follow up, DCB patients showed favorable statistically significant differences in primary patency (78.9% vs. 50.1%; p < 0.001) and clinically driven target lesion revascularization (9.1% vs. 28.3%; p < 0.001) compared to PTA patients.
Overall mortality in the DCB group was8.1%, vs.0.9% in the PTA group(p=0.008). There were no procedure related, or device related deaths, neither were there major amputations in either group through the 2 year follow up. Vessel thrombosis rate was low in both groups(1.5% BLF vs. 3.8% ATP; p=0.243), and there were no cases reported between the first and second years.
Both groups presented similar functional improvement at 2 years, though DCB patients reached this level with 58% fewerreinterventions.
Conclusion
The authors emphasize this trial shows the significant benefit of the IN.PACT Admiral DCB in terms of primary patency and target lesion revascularization, with similar functional status improvement but fewer number of reinterventions.
Editorial Comment
It is worth noticing
FOR:
There was great benefit in all end points and sustained benefit in nearly all subgroups, including diabetics and women. As regards primary patency and clinically driven target lesion revascularization, Kaplan-Meier curves remained parallel between 1 and 2 years, showing the absence of ‘late catch-up’ in the DCB group.
The authors highlight these benefits should not extrapolate to other paclitaxel drug coated balloons, given that these devices differ in drug amount and technical features, among other things.
AGAINST:
Though higher in the DCB group, there was high patient loss rate in both groups.
There were dropouts in both groups: 17 patients in the DCB groupand 6 in the PTA group.
Throughthe 24 months follow up, there were deaths in both groups: 16 in the DCB and 1 in the PTA.
Follow up dropouts: 17 patients in the DCB group and 10 in the PTA.
The higher overall mortality ratein the DCB group has statistical importance and cannot be ignored, even though the authors see deaths as fortuitous (causes of death were reported and were in no case procedure or devicerelated). Regarding the latter, the authors suggest caution and point out the need for evolution long term follow up.
“Bailout stenting” rate in the DCB group was 7.3%.
The paclitaxel coated balloon was compared to PTA with balloon, though the benefit of stents over balloons has been shown. To this date, bare metal stents have not yet been compared head-to-head with nitinol stents or drug eluting stents.
Courtesy of Dr. Santiago F. Coroleu. Interventional Cardiologist
Cardiology Institute of Santiago del Estero (Argentina).