Drug-Coated Balloon Versus Standard Percutaneous Transluminal Angioplasty for the Treatment of Superficial Femoral and/or Popliteal Peripheral Artery Disease - IN.PACT SFA
The goal of the IN.PACT SFA trial was to evaluate treatment with a drug-coated balloon versus percutaneous transluminal angioplasty (PTA) among patients with intermittent claudication or ischemic rest pain due to superficial femoral and popliteal artery disease.
Contribution to the Literature: This study on superficial femoral disease shows that drug-coated balloons were associated with a high frequency of primary vessel patency.
Patients with intermittent claudication or ischemic rest pain due to superficial femoral and popliteal artery disease were randomized to a paclitaxel-coated balloon (n = 220) versus standard PTA (n = 111).
The IN.PACT SFA I trial was conducted in Europe and subjects were randomized once the lesion was crossed. The IN.PACT SFA II trial was conducted in the United States and subjects were randomized after the lesion was crossed and pre-dilated with an undersized balloon. Both trials were combined into the IN.PACT SFA trial.
In both treatment groups, provisional stenting was allowed for a residual stenosis (≥50%) or a flow-limiting dissection (with ≥10 mm Hg pressure gradient).
- Moderate to severe intermittent claudication or ischemic rest pain (Rutherford 2-4)
- Stenosis 70-99% with lesion lengths between 4 and 18 cm, or occlusion ≤10 cm involving the superficial femoral and popliteal arteries
- Total number of enrollees: 331
- Duration of follow-up: 12 months
- Mean patient age: 68 years
- Percentage female: 35%
- Percentage with diabetes: 41%
- Percentage with hypertension: 91%
- Percentage current smokers: 39%
- Percentage with a total occlusion: 26%
Mean lesion length was 8.9 cm in the drug-coated balloon group versus 8.8 cm in the PTA group (p = 0.82). Provisional stenting was performed in 7.3% of the drug-coated balloon group versus 12.6% of the PTA group (p = 0.11).
The primary efficacy outcome, primary patency, occurred in 82.2% of the drug-coated balloon group versus 52.4% of the PTA group (p < 0.001).
At 2 years, primary patency occurred in 78.9% of the drug-coated balloon group versus 50.1% of the PTA group (p < 0.001).
- Clinically driven target lesion revascularization: 2.4% vs. 20.6% (p < 0.001), respectively
- Vessel thrombosis: 1.4% vs. 3.7% (p = 0.10), respectively
- No device or procedure-related deaths and no major amputations in either group
At 2 years, clinically driven target lesion revascularization occurred in 9.1% of the drug-coated balloon group vs. 28.3% of the PTA group (p < 0.001).
Among patients with intermittent claudication or ischemic rest pain due to superficial femoral and popliteal artery disease, the use of a drug-coated balloon improved primary vessel patency compared with standard PTA. This was due to a very low rate of clinically driven revascularization in the drug-coated balloon group.
Two-year outcomes demonstrate a durable and superior treatment effect of the drug-coated balloon versus PTA with significantly higher primary patency, lower clinically driven target lesion revascularization, and similar functional status improvement with fewer repeat interventions.
It is unknown how the drug-coated balloon approach would have compared against routine bare-metal stent or drug-eluting stent implantation.
Laird JR, Schneider PA, Tepe G, et al. Sustained Durability of Treatment Effect Using a Drug-Coated Balloon for Femoropopliteal Lesions: 24-Month Results of IN.PACT SFA. J Am Coll Cardiol 2015;Oct 14:[Epub ahead of print].
Presented by Dr. John R. Laird Jr. at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2015), San Francisco, CA, October 14, 2015.
Tepe G, Laird J, Schneider P, et al., on behalf of the IN.PACT SFA Trial Investigators. Drug-Coated Balloon Versus Standard Percutaneous Transluminal Angioplasty for the Treatment of Superficial Femoral and Popliteal Peripheral Artery Disease: 12-Month Results From the IN.PACT SFA Randomized Trial. Circulation 2015;131:495-502.
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