Atherectomy and Drug-Coated Balloon Angioplasty for the Treatment of Long Infrapopliteal Lesions: A Randomized Controlled Trial.

Circulation. Cardiovascular Interventions
Aljoscha RastanThomas Zeller

Abstract

Prospective, randomized, multicenter trials show no beneficial impact of drug-coated balloon (DCB) therapy alone on the technical and clinical outcomes of infrapopliteal artery lesions in comparison to plain old balloon angioplasty. The aim of this study was to evaluate the performance of directional atherectomy (DA) plus DCB angioplasty versus DCB alone in treatment of long infrapopliteal artery lesions. We conducted a prospective, randomized, 2-center trial comparing the performance of DA+DCB and DCB alone in treatment of 80 patients with de novo infrapopliteal artery lesions. The primary study end point was the 6-month primary patency of the target lesion detected by angiography and duplex ultrasound. Secondary end points included clinically driven target vessel revascularization, amputation rates, and changes in Rutherford-Becker class at 1 year. A core laboratory provides independent analyses for all scheduled and unscheduled duplex ultrasound examinations and angiographies, and a research institute ensured independent data collection. The mean target lesion length was 179.7±98.2 mm. Nine patients (11.3%) died during the follow-up period. At 6 months, primary patency was 49% (n=18) with DA+DCB versus 34% (n=12) with DCB al...Continue Reading

References

Dec 14, 2004·Journal of Vascular and Interventional Radiology : JVIR·Thomas ZellerFranz-Josef Neumann
May 9, 2007·Journal of Endovascular Therapy : an Official Journal of the International Society of Endovascular Specialists·Thomas ZellerAljoscha Rastan
Jun 3, 2010·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Andrej SchmidtDierk Scheinert
Sep 3, 2011·Journal of the American College of Cardiology·Andrej SchmidtDierk Scheinert
Feb 8, 2014·Journal of Endovascular Therapy : an Official Journal of the International Society of Endovascular Specialists·Frederic BaumannNicolas Diehm
Mar 17, 2015·Journal of Endovascular Therapy : an Official Journal of the International Society of Endovascular Specialists·Aljoscha RastanThomas Zeller
Oct 9, 2015·Journal of Endovascular Therapy : an Official Journal of the International Society of Endovascular Specialists·Aljoscha RastanUNKNOWN DEFINITIVE LE Investigators
Feb 23, 2020·JACC. Cardiovascular Interventions·Thomas ZellerUNKNOWN IN.PACT DEEP Trial Investigators

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