Drug-Coated Balloon Versus Standard Percutaneous Transluminal Angioplasty for the Treatment of Superficial Femoral and Popliteal Peripheral Artery Disease

Tepe, Gunnar; Laird, John R.; Schneider, Peter A.; Brodmann, Marianne; Ramanathan, Krishnan; Micari, Antonio; Metzger, Christopher; Scheinert, Dierk; Zeller, Thomas; Cohen, David J.; Snead, D.; Alexander, Beaux; Landini, Mario; Jaff, Michael R.

doi:10.1161/circulationaha.114.011004

Cited by 550 publications

(201 citation statements)

References 31 publications

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“…The In.PACT data had a lesion length of 10 cm and compared DCB with PTA alone. 13 The stenting rate in this trial was only 6%, suggesting that this is a DCB trial alone in the SFA for the lesion length tested. The primary patency at a PSVr of 2.0 was 89% at 12 months.…”

Section: Leaving Nothing Behindmentioning

confidence: 75%

“…However there remains no impediment to retherapy and no limit to the options for retherapy, because there is an absence of an endoprosthesis. [10][11][12][13][14][15][16][17] The recent data from DEFInITIVE Ar 12 suggest that a combined therapy of atherectomy with drug-coated balloons (DCBs) may provide a signal that allows similar 1-year outcomes to the most robust randomized trial using DES. In addition, 24-month outcome data will evaluate whether there is late catch-up or failure.…”

Section: Why Consider Leaving Nothing Behindmentioning

confidence: 99%

“…Let's start with the Drug Coated Balloon Versus Standard Angioplasty for the Treatment of Superficial Femoral and/ or Popliteal Peripheral Artery Disease (In.PACT) and LUTOnIX data sets. 13,14 These DCB trials produced some of the most anticipated data in recent memory. The In.PACT data had a lesion length of 10 cm and compared DCB with PTA alone.…”

Section: Leaving Nothing Behindmentioning

confidence: 99%

“…To date, there remains no clear-cut de facto gold therapy for endovascular applications in the lower limb with the best outcomes that we can apply to most if not all our patients who present with symptomatic lower limb disease (Table). Current data from numerous trials at various lengths of outcome duration (ranging from 12 to 60 months) [2][3][4][5][6][7][8][9][10][11][12][13] have shown that there remains a consistent but steady decline in primary patency with all devices over time. There has been a robust interest in what should be the default therapy for lower extremity disease.…”

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confidence: 99%

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Endovascular Therapy for Femoropopliteal Disease: Drug-Eluting Stents Are Not the Default Therapy

Garcia

2016

Circulation

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Section: Leaving Nothing Behindmentioning

confidence: 75%

Section: Why Consider Leaving Nothing Behindmentioning

confidence: 99%

Section: Leaving Nothing Behindmentioning

confidence: 99%

mentioning

confidence: 99%

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Endovascular Therapy for Femoropopliteal Disease: Drug-Eluting Stents Are Not the Default Therapy

Garcia

2016

Circulation

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“…21 Remarkably, after >40 years, PTA remains the standard of reference for all percutaneous technologies. [22][23][24][25][26][27][28][29][30][31] The appeal of endovascular therapy was obvious. Conscious sedation and local anesthesia completely sidestepped the complexity, risk, and expense of general anesthesia.…”

Section: The Sweet Spot: Endovascular Therapymentioning

confidence: 99%

Drug-Eluting Stents Are the Default Strategy for Superficial Femoral Artery Intervention Now

Burket

2016

Circulation

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Association of Survival With Femoropopliteal Artery Revascularization With Drug-Coated Devices

et al. 2019

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IMPORTANCE In a recent meta-analysis of randomized clinical trials, femoropopliteal artery revascularization with paclitaxel drug-coated devices was associated with increased long-term all-cause mortality compared with non-drug-coated devices. However, to our knowledge, these findings have not been replicated in other data sources and may be subject to confounding from missing data associated with patient withdrawal and loss to follow-up. OBJECTIVE To evaluate differences in all-cause mortality between patients who were treated with drug-coated devices vs non-drug-coated devices for femoropopliteal artery revascularization. DESIGN, SETTING, AND PARTICIPANTS This nationwide, multicenter retrospective cohort study included 16 560 Centers for Medicare and Medicaid Services beneficiaries who were admitted for femoropopliteal artery revascularization from January 1, 2016, to December 31, 2016. All-cause mortality was analyzed through September 30, 2017.EXPOSURES Drug-coated devices (drug-eluting stent [DES] or drug-coated balloon [DCB]) compared with non-drug-coated devices (bare metal stent or uncoated percutaneous transluminal angioplasty balloon). MAIN OUTCOMES AND MEASURESThe primary outcome was all-cause mortality analyzed through the end of follow-up. RESULTSAmong 16 560 patients treated at 1883 hospitals, the mean (SD) age was 72.9 (11) years, 7734 (46.7%) were men, 12 232 (73.9%) were white, 8222 (49.7%) currently or had previously used tobacco, 9817 (59.3%) had diabetes, and 8450 (51.0%) had critical limb ischemia (CLI). Drug-coated devices were used in 5989 participants (36.2%). The median follow-up was 389 days (interquartile range, 277-508 days). Among all patients, treatment with drug-coated devices was associated with a lower cumulative incidence of all-cause mortality compared with treatment with non-drug-coated devices through 600 days postprocedure (32.5% vs 34.3%, respectively; log-rank P = .007). Similar survival trends were observed when treatment was stratified by using a DCB alone or DES with or without DCB. After multivariable adjustment, drug-coated devices were not associated with a difference in all-cause mortality compared with non-drug-coated devices (hazard ratio [HR], 0.97; 95% CI, 0.91-1.04; P = .43). These findings were consistent among those with CLI (HR, 0.93; 95% CI, 0.85-1.01; P = .09) or without CLI (HR, 0.94; 95% CI, 0.85-1.03; P = .20), and for those treated with DCB alone (HR, 0.94; 95% CI, 0.86-1.03; P = .17) or DES with or without DCB (HR, 0.97; 95% CI, 0.89-1.06; P = .48). CONCLUSIONS AND RELEVANCEIn this large nationwide analysis of Centers for Medicare and Medicaid Services beneficiaries, there was no evidence of increased all-cause mortality following femoropopliteal artery revascularization with drug-coated devices compared with non-drug-coated devices.

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Drug-Coated Balloon Versus Standard Percutaneous Transluminal Angioplasty for the Treatment of Superficial Femoral and Popliteal Peripheral Artery Disease

Abstract: Supplemental Digital Content is available in the text.

Cited by 550 publications

References 31 publications

Endovascular Therapy for Femoropopliteal Disease: Drug-Eluting Stents Are Not the Default Therapy

Endovascular Therapy for Femoropopliteal Disease: Drug-Eluting Stents Are Not the Default Therapy

Drug-Eluting Stents Are the Default Strategy for Superficial Femoral Artery Intervention Now

Association of Survival With Femoropopliteal Artery Revascularization With Drug-Coated Devices

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