Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment of Femoropopliteal Lesions Five-Year Outcomes From the IN.PACT SFA Randomized Trial

被引：138

作者：

Laird, John A. ^{[1
]}

Schneider, Peter A. ^{[2
]}

Jaff, Michael R. ^{[3
]}

Brodmann, Marianne ^{[4
]}

Zeller, Thomas ^{[5
]}

Metzger, D. Chris ^{[6
]}

Krishnan, Prakash ^{[7
]}

Scheinert, Dierk ^{[8
]}

Micari, Antonio ^{[9
]}

Wang, Hong ^{[10
]}

Masters, Michele ^{[10
]}

Tepe, Gunnar ^{[11
]}

机构：

[1] Adventist Heart & Vasc Inst, St Helena, CA USA

[2] Kaiser Fdn Hosp, Honolulu, HI USA

[3] Harvard Med Sch, Boston, MA 02115 USA

[4] Med Univ, Graz, Austria

[5] Univ Herzzentrum Freiburg Bad Krozingen, Bad Krozingen, Germany

[6] Ballad Hlth Syst CVA Heart & Vasc Inst, Kingsport, TN USA

[7] Mt Sinai Hosp, New York, NY 10029 USA

[8] Univ Hosp Leipzig, Leipzig, Germany

[9] Gavazzeni Hosp Humanitas, Bergamo, Italy

[10] Medtronic Inc, Santa Rosa, CA USA

[11] Ro Med Clin Rosenheim, Rosenheim, Germany

来源：

CIRCULATION-CARDIOVASCULAR INTERVENTIONS | 2019年 / 12卷 / 06期

关键词：

angioplasty; drug-coated balloons; paclitaxel; peripheral artery disease; IN-STENT RESTENOSIS; PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY; PERIPHERAL ARTERY-DISEASE; ELUTING STENTS; NETWORK METAANALYSIS; POPLITEAL ARTERIES; COVERED STENTS; INTERVENTIONS;

D O I：

10.1161/CIRCINTERVENTIONS.118.007702

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

BACKGROUND: While randomized trials have demonstrated the superiority of drug-coated balloon (DCB) angioplasty versus standard percutaneous transluminal angioplasty (PTA) in patients with femoropopliteal peripheral artery disease, the long-term durability of DCB angioplasty remains uncertain. METHODS AND RESULTS: IN.PACT SFA is a prospective, multicenter, randomized single-blinded trial (Randomized Trial of IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty [PTA] Balloon Catheter vs Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery [SFA] and/or Proximal Popliteal Artery [PPA]) that enrolled 331 subjects with symptomatic (Rutherford 2-4) femoropopliteal lesions. Subjects were randomly assigned 2:1 to the IN.PACT Admiral DCB or PTA. Assessments through 5 years included freedom from clinically driven target lesion revascularization, the primary safety end point, and major adverse events. Through 5 years, patients treated with the IN.PACT Admiral DCB demonstrated a sustained treatment effect with superior freedom from clinically driven target lesion revascularization when compared with PTA (Kaplan-Meier estimate of 74.5% versus 65.3%; log-rank P=0.020). The primary safety composite was achieved in 70.7% of subjects in the DCB and 59.6% in the PTA groups (P=0.068). The major adverse event rate was 42.9% for DCB and 48.1% for PTA (P=0.459). There were no device- or procedure-related deaths in either group as adjudicated by an independent and blinded Clinical Events Committee. CONCLUSIONS: The IN.PACT SFA randomized trial demonstrates that the IN.PACT Admiral DCB continues to perform better than PTA through 5 years with higher freedom from clinically driven target lesion revascularization. The sustained safety and effectiveness profile of this DCB supports its use as a preferred treatment choice compared with PTA for femoropopliteal lesions.

引用

页数：10

共 30 条

[1] Two-Year Mortality After Angioplasty of the Femoro-Popliteal Artery with Uncoated Balloons and Paclitaxel-Coated BalloonsA Pooled Analysis of Four Randomized Controlled Multicenter Trials [J].