With the new devices (drug-eluting balloons [DEB], drug-eluting stents [DES], and atherotomes) percutaneous treatment is becoming the first line of approach for femoropopliteal disease, especially when dealing with not very long total occlusions.
Randomized studies and registries on the use of drug-coated balloons (DCB) in femoropopliteal disease are currently available, but their evolution beyond 2 or 3 years has not been well analyzed.
This study is a subanalysis of the IN.PACT study that analyzed a subsample of 114 Asian patients (7.42%) of the 1535 patients included.
IN.PACT Study DCBs in Cases of Femoropopliteal Disease
The safety endpoint (SEP) was a composite of freedom from device-related mortality at 30 days and freedom from major amputation and clinically driven target lesion revascularization (TLR) at 60 months.
Mean age was 67 years, 87% of patients were male, 78% had hypertension, 55% had diabetes, 12.3% had insulin-requiring diabetes, 30% were smokers, 19.8% had impaired kidney function, 8.8% required dialysis, 39.5% had infrapatellar disease, and 5.3% had undergone a previous amputation.
Ninety-three percent of patients were in Rutherford functional class 2 or 3; ABI was 0.61.
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Twenty-seven percent of patients experienced in-stent restenosis, 6% suffered from severe calcification, 54% had total occlusions, diameter stenosis was 90% and lesion length was 174 mm.
Sixteen percent of patients required stenting due to residual lesion >50%, flow-compromising dissections, or a gradient >10mmHg, with a provisional stent length of 156.1 mm.
At 60 months, the SEP was 76%, clinically driven TLR freedom was 77.1% (95% confidence interval [CI]: 67.0% to 84.5%), and the occurrence of the first episode of clinically driven TLR was at 155±49 days.
There was no device-related mortality at 30 days.
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The presence of MAE or all-cause mortality at 5 years was 38.1% and 19.9%, respectively. No patient underwent amputation and only one patient had thrombosis.
All patients improved their functional class of claudication. Furthermore, more than half of them did not present claudication and improved their quality of life.
Conclusion
This analysis of an Asian population within the IN.PACT Global Study showed results consistent with previously reported data from the IN.PACT Admiral. These data confirm the durable clinical effectiveness and 5-year safety of DCBs for femoropopliteal atherosclerotic disease in this “real-world” population.
Dr. Carlos Fava.
Member of the Editorial Board o SOLACI.org.
Original Title: Long‐term outcomes after paclitaxel‐coated balloon angioplasty of femoropopliteal arteries in Asian patients of the IN.PACT Global Study.
Reference: Young‐Guk, et al. Catheter Cardiovasc Interv. 2022;100:1273–1283.
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