- Email: [email protected]
The Price Is Right (But Buyer Beware)∗
JACC: CARDIOVASCULAR INTERVENTIONS
VOL. 9, NO. 22, 2016
ª 2016 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION PUBLISHED BY ELSEVIER
ISSN 1936-8798/$36.00 http://dx.doi.org/10.1016/j.jcin.2016.10.001
EDITORIAL COMMENT
The Price Is Right (But Buyer Beware)* Salman A. Arain, MD,a Christopher J. White, MDb
E
ndovascular therapy is the treatment of
drug–excipient complex directly onto the arterial
choice for most patients with symptomatic
surface, after which the drug gradually elutes into the
peripheral arterial disease (PAD) (1). Percuta-
vessel wall. DCB therapy has been shown to reduce
neous transluminal angioplasty (PTA) with adjunc-
rates of restenosis without requiring a permanent
tive stent placement is the most commonly used
metallic implant (provided the vessel is adequately
technique for arterial revascularization in the lower
dilated at the time of angioplasty). Randomized trials
extremities. However, PTA with or without stent
have shown improved outcomes with DCBs compared
placement is associated with high restenosis rates
with PTA with adjunctive stent placement in patients
(2). Attempts to lower the rates of target lesion revas-
with symptomatic femoropopliteal disease (6–9). The
cularization (TLR) by plaque modification (e.g.,
Food and Drug Administration has approved 2 DCBs
atherectomy) have largely been unsuccessful (3).
for clinical use in the United States thus far: IN.PACT
Nevertheless, such techniques continue to be used
Admiral (Medtronic, Santa Rosa, California) and
enthusiastically, which raises concerns about their
Lutonix (Bard, Tempe, Arizona).
cost-effectiveness relative to conventional PTA. Drug-eluting stents (DES) and drug-coated bal-
SEE PAGE 2343
loons (DCB) are relatively recent additions to the
In this issue of JACC: Cardiovascular Interventions,
peripheral interventionalist’s toolbox. Randomized
Salisbury et al. (10) analyzed data from the U.S. cohort
studies have shown lower restenosis rates after
of the pivotal IN.PACT SFA II (IN.PACT Admiral Drug-
paclitaxel-coated nitinol stent placement in femo-
Coated Balloon vs. Standard Balloon Angioplasty for
ropopliteal arteries compared with bare-metal stents
the Treatment of Superficial Femoral Artery (SFA) and
or angioplasty alone (4). The beneficial effect of DES
Proximal Popliteal Artery (PPA)) trial to determine the
on TLR rates in these patients appears to be durable
cost-effectiveness of DCB therapy. In this study, 118
over the long term (5). Despite the availability of the
patients with symptomatic stenoses or occlusions of
Food and Drug Administration–approved Zilver-PTX
the superficial femoral or popliteal arteries were
paclitaxel-eluting
Bloo-
randomized to treatment with the IN.PACT Admiral
mington, Indiana), enthusiasm for its use has been
DCB or conventional PTA. At a mean follow-up of
tempered.
2 years, patients treated with the DCB had lower rates
stent
(Cook
Medical,
DCBs are standard angioplasty balloons coated
of restenosis and needed fewer repeat revasculariza-
with an antiproliferative drug (such as paclitaxel) and
tion procedures (DCB 9.9% vs. PTA 30%; p < 0.001).
an excipient or spacer. Balloon inflation deposits the
Interestingly, all-cause mortality was higher in the DCB-treated group (DCB 8.1% vs. PTA 0.9%; p < 0.001), though the deaths were deemed to be
*Editorials published in JACC: Cardiovascular Interventions reflect the views of the authors and do not necessarily represent the views of JACC:
unrelated to the study device or the procedure. This economic analysis looked at resource utiliza-
Cardiovascular Interventions or the American College of Cardiology.
tion and hospital expense data from the IN.PACT
From the aDepartment of Internal Medicine, Division of Cardiovascular
SFA II trial to determine the costs associated with of
Medicine, University of Texas Health Sciences Center–Houston, Houston,
DCBs versus PTA. The authors found that treatment
Texas; and the bDepartment of Medicine, The Ochsner Clinical School,
with DCB angioplasty during the index procedure was
University of Queensland, New Orleans, Louisiana. Dr. White is on the
more expensive than standard PTA despite its higher
scientific advisory board of Bard; and is a clinical investigator for the Bard Lutonix. Dr. Arain has reported that he has no relationships relevant to
rate of provisional stent implantation. The initial cost
the contents of this paper to disclose.
difference of $1,129/patient, related to the higher
2354
Arain and White
JACC: CARDIOVASCULAR INTERVENTIONS VOL. 9, NO. 22, 2016 NOVEMBER 28, 2016:2353–5
The Cost-Effectiveness of Treatment With Drug-Coated Balloons
price of the DCB, was offset by a reduction in TLR
Despite the success of DCB angioplasty over PTA in
with
the
randomized trials involving patients with de novo
DCB-treated cohort during follow-up. Patients treated
stenoses, relatively short occlusions (<10 cm), and
with standard PTA were more likely to require a sec-
post-PTA and in-stent restenosis within the femo-
ond or third revascularization procedure to maintain
ropopliteal arteries (13), it is not known whether these
limb patency. The cost of treatment with both stra-
devices perform equally well in the real-world setting
tegies was very similar (approximately $11,300) after
where the disease may be more complex.
a
cost
savings
of
$1,212/patient
in
2 years, but patients treated with the DCB enjoyed a
A report of DCBs in 260 symptomatic patients with
better quality of life, making it the more cost-
de novo or restenotic disease who were not enrolled
effective therapy.
in a trial points out the challenges of translating re-
The authors are to be commended for highlighting
sults from randomized DCB trials to unselected pa-
an issue that is often overlooked whenever a new
tients (14). Patients in the real-world registry had
device is introduced to the market, that is, the eco-
lower ankle-brachial indices than those in the
nomic implication of incorporating new technologies
IN.PACT SFA trial, and were more likely to have
into routine clinical practice. This is important
critical limb ischemia and restenosis (post-PTA or in-
because of the high economic burden of symptom-
stent). The DCB-treated lesions were nearly 3 times
atic PAD, the growing enthusiasm for endovascular
longer, and included a greater proportion of chronic
procedures, and the paucity of comparative clinical
total occlusions. The increase in lesion complexity led
effectiveness data for many of the techniques and
to the use of more DCBs per patient and a higher rate
devices in use. However, before we accept the
of provisional stent implantation. Furthermore, many
authors’ conclusions about the cost-effectiveness of
patients were also treated with adjunctive therapies
all DCB therapy, we must consider 2 important as-
such as atherectomy. DCBs were more effective at
pects of DCBs that were not addressed in this study:
lowering the rates of restenosis than standard PTA in
the comparative efficacy of different DCBs, and
these more complex lesions; however, this effect was
the performance of these devices in a real-world
clinically less apparent after 2 years. Given the
population.
modest long-term performance of DCBs in patients
Not all DCBs appear to be equal in their clinical
with complex PAD and the higher cost of these pro-
effects. A meta-analysis of 8 randomized DCB trials in
cedures, it is likely an economic analysis of DCBs in
the United States and Europe showed that there is
the real world would be less favorable (if at all)
significant heterogeneity in the treatment effect
compared with the IN.PACT SFA II trial.
among different DCB types (11). If we only consider
So, what can we confidently say about the cost-
the brands that are available for use in the United
effectiveness of DCBs in the treatment of PAD on
States, the Lutonix DCB had a more modest effect on
the basis of the current report (10) and published
restenosis and clinical outcomes after treatment of
data? In the populations tested, DCBs are superior to
symptomatic femoropopliteal disease compared with
PTA in reducing restenosis and TLR rates in patients
the IN.PACT Admiral balloon. A second meta-analysis
with symptomatic femoropopliteal disease. However,
of 11 randomized studies suggested that this vari-
the magnitude of benefit is not uniform among the
ability could be explained by a dose effect (12). The
different DCBs. The use of the IN.PACT Admiral DCB
IN.PACT DCB delivers a higher dose of paclitaxel
is
(3.5 mg/mm 2) compared with the Lutonix DCB
ropopliteal stenoses and occlusions, though it re-
cost-effective
in
patients
with
focal
femo-
(2 m g/mm 2). The 2 balloons utilize different excipients
mains to be seen whether there is a similar economic
(urea vs. polysorbate and sorbitol), which may also
advantage of using this device in patients with more
affect efficiency of drug delivery. These observations
complex PAD. In the absence of head-to-head com-
imply the absence of a “class effect” among different
parisons of DCBs to each other or other devices such
DCBs. If true, this would suggest that the findings of
as DES, the relative value of a routine DCB strategy in
Salisbury et al. (10) apply to one particular product
the management of symptomatic PAD has yet to
(IN.PACT Admiral) in a specific clinical setting
be defined.
(treatment of de novo femoropopliteal disease). Therefore, the cost-effectiveness of other DCBs will
REPRINT REQUESTS AND CORRESPONDENCE: Dr.
need to be evaluated individually going forward.
Salman A. Arain, Department of Internal Medicine,
A limitation of randomized trials is that the pa-
Division of Cardiovascular Diseases, University of
tients and lesion types included for testing must meet
Texas Health Sciences Center–Houston, 6431 Fannin
narrowly defined criteria that often do not reflect the
1.246, Houston, Texas 77030. E-mail: Salman.A.
variety of pathologies seen in clinical practice.
[email protected].
Arain and White
JACC: CARDIOVASCULAR INTERVENTIONS VOL. 9, NO. 22, 2016 NOVEMBER 28, 2016:2353–5
The Cost-Effectiveness of Treatment With Drug-Coated Balloons
REFERENCES 1. Norgren L, Hiatt WR, Dormandy JA, et al. InterSociety Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg 2007;45 Suppl S:S5–67. 2. Armstrong EJ, Saeed H, Alvandi B, et al. Nitinol self-expanding stents vs. balloon angioplasty for very long femoropopliteal lesions. J Endovasc Ther 2014;21:34–43. 3. Diamantopoulos A, Katsanos K. Atherectomy of the femoropopliteal artery: a systematic review and meta-analysis of randomized controlled trials. J Cardiovasc Surg (Torino) 2014;55:655–65. 4. Dake MD, Ansel GM, Jaff MR, et al. Sustained safety and effectiveness of paclitaxel-eluting stents for femoropopliteal lesions: 2-year followup from the Zilver PTX randomized and single-arm clinical studies. J Am Coll Cardiol 2013;61:2417–27. 5. Dake MD, Ansel GM, Jaff MR, et al. Durable clinical effectiveness with paclitaxel-eluting stents in the femoropopliteal artery: 5-year results of the Zilver PTX randomized trial. Circulation 2016;133: 1472–83; discussion 1483. 6. Cassese S, Byrne RA, Ott I, et al. Paclitaxel-coated versus uncoated balloon angioplasty reduces target lesion revascularization in patients with femoropopliteal arterial disease: a meta-analysis
of randomized trials. Circ Cardiovasc Interv 2012;5: 582–9. 7. Laird JR, Schneider PA, Tepe G, et al. Durability of treatment effect using a drug-coated balloon for femoropopliteal lesions: 24-month results of IN.PACT SFA. J Am Coll Cardiol 2015; 66:2329–38. 8. Scheinert D, Duda S, Zeller T, et al. The LEVANT I (Lutonix paclitaxel-coated balloon for the prevention of femoropopliteal restenosis) trial for femoropopliteal revascularization: first-in-human randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty. J Am Coll Cardiol Intv 2014;7:10–9. 9. Tepe G, Laird J, Schneider P, et al. 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. 10. Salisbury AC, Li H, Vilain KR, et al. Costeffectiveness of endovascular femoropopliteal intervention using drug-coated balloons versus standard percutaneous transluminal angioplasty: results from the IN.PACT SFA II trial. J Am Coll Cardiol Intv 2016;9:2343–52.
11. Giacoppo D, Cassese S, Harada Y, et al. Drugcoated balloon versus plain balloon angioplasty for the treatment of femoropopliteal artery disease: an updated systematic review and metaanalysis of randomized clinical trials. J Am Coll Cardiol Intv 2016;9:1731–42. 12. Katsanos K, Spiliopoulos S, Paraskevopoulos I, Diamantopoulos A, Karnabatidis D. Systematic review and meta-analysis of randomized controlled trials of paclitaxel-coated balloon angioplasty in the femoropopliteal arteries: role of paclitaxel dose and bioavailability. J Endovasc Ther 2016;23:356–70. 13. Krankenberg H, Tubler T, Ingwersen M, et al. Drug-coated balloon versus standard balloon for superficial femoral artery in-stent restenosis: the randomized Femoral Artery In-Stent Restenosis (FAIR) trial. Circulation 2015;132:2230–6. 14. Schmidt A, Piorkowski M, Gorner H, et al. Drug-coated balloons for complex femoropopliteal lesions: 2-year results of a real-world registry. J Am Coll Cardiol Intv 2016;9:715–24.
KEY WORDS cost-effectiveness, drug-coated balloons, percutaneous transluminal balloon angioplasty, peripheral arterial disease
2355
VOL. 9, NO. 22, 2016
ª 2016 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION PUBLISHED BY ELSEVIER
ISSN 1936-8798/$36.00 http://dx.doi.org/10.1016/j.jcin.2016.10.001
EDITORIAL COMMENT
The Price Is Right (But Buyer Beware)* Salman A. Arain, MD,a Christopher J. White, MDb
E
ndovascular therapy is the treatment of
drug–excipient complex directly onto the arterial
choice for most patients with symptomatic
surface, after which the drug gradually elutes into the
peripheral arterial disease (PAD) (1). Percuta-
vessel wall. DCB therapy has been shown to reduce
neous transluminal angioplasty (PTA) with adjunc-
rates of restenosis without requiring a permanent
tive stent placement is the most commonly used
metallic implant (provided the vessel is adequately
technique for arterial revascularization in the lower
dilated at the time of angioplasty). Randomized trials
extremities. However, PTA with or without stent
have shown improved outcomes with DCBs compared
placement is associated with high restenosis rates
with PTA with adjunctive stent placement in patients
(2). Attempts to lower the rates of target lesion revas-
with symptomatic femoropopliteal disease (6–9). The
cularization (TLR) by plaque modification (e.g.,
Food and Drug Administration has approved 2 DCBs
atherectomy) have largely been unsuccessful (3).
for clinical use in the United States thus far: IN.PACT
Nevertheless, such techniques continue to be used
Admiral (Medtronic, Santa Rosa, California) and
enthusiastically, which raises concerns about their
Lutonix (Bard, Tempe, Arizona).
cost-effectiveness relative to conventional PTA. Drug-eluting stents (DES) and drug-coated bal-
SEE PAGE 2343
loons (DCB) are relatively recent additions to the
In this issue of JACC: Cardiovascular Interventions,
peripheral interventionalist’s toolbox. Randomized
Salisbury et al. (10) analyzed data from the U.S. cohort
studies have shown lower restenosis rates after
of the pivotal IN.PACT SFA II (IN.PACT Admiral Drug-
paclitaxel-coated nitinol stent placement in femo-
Coated Balloon vs. Standard Balloon Angioplasty for
ropopliteal arteries compared with bare-metal stents
the Treatment of Superficial Femoral Artery (SFA) and
or angioplasty alone (4). The beneficial effect of DES
Proximal Popliteal Artery (PPA)) trial to determine the
on TLR rates in these patients appears to be durable
cost-effectiveness of DCB therapy. In this study, 118
over the long term (5). Despite the availability of the
patients with symptomatic stenoses or occlusions of
Food and Drug Administration–approved Zilver-PTX
the superficial femoral or popliteal arteries were
paclitaxel-eluting
Bloo-
randomized to treatment with the IN.PACT Admiral
mington, Indiana), enthusiasm for its use has been
DCB or conventional PTA. At a mean follow-up of
tempered.
2 years, patients treated with the DCB had lower rates
stent
(Cook
Medical,
DCBs are standard angioplasty balloons coated
of restenosis and needed fewer repeat revasculariza-
with an antiproliferative drug (such as paclitaxel) and
tion procedures (DCB 9.9% vs. PTA 30%; p < 0.001).
an excipient or spacer. Balloon inflation deposits the
Interestingly, all-cause mortality was higher in the DCB-treated group (DCB 8.1% vs. PTA 0.9%; p < 0.001), though the deaths were deemed to be
*Editorials published in JACC: Cardiovascular Interventions reflect the views of the authors and do not necessarily represent the views of JACC:
unrelated to the study device or the procedure. This economic analysis looked at resource utiliza-
Cardiovascular Interventions or the American College of Cardiology.
tion and hospital expense data from the IN.PACT
From the aDepartment of Internal Medicine, Division of Cardiovascular
SFA II trial to determine the costs associated with of
Medicine, University of Texas Health Sciences Center–Houston, Houston,
DCBs versus PTA. The authors found that treatment
Texas; and the bDepartment of Medicine, The Ochsner Clinical School,
with DCB angioplasty during the index procedure was
University of Queensland, New Orleans, Louisiana. Dr. White is on the
more expensive than standard PTA despite its higher
scientific advisory board of Bard; and is a clinical investigator for the Bard Lutonix. Dr. Arain has reported that he has no relationships relevant to
rate of provisional stent implantation. The initial cost
the contents of this paper to disclose.
difference of $1,129/patient, related to the higher
2354
Arain and White
JACC: CARDIOVASCULAR INTERVENTIONS VOL. 9, NO. 22, 2016 NOVEMBER 28, 2016:2353–5
The Cost-Effectiveness of Treatment With Drug-Coated Balloons
price of the DCB, was offset by a reduction in TLR
Despite the success of DCB angioplasty over PTA in
with
the
randomized trials involving patients with de novo
DCB-treated cohort during follow-up. Patients treated
stenoses, relatively short occlusions (<10 cm), and
with standard PTA were more likely to require a sec-
post-PTA and in-stent restenosis within the femo-
ond or third revascularization procedure to maintain
ropopliteal arteries (13), it is not known whether these
limb patency. The cost of treatment with both stra-
devices perform equally well in the real-world setting
tegies was very similar (approximately $11,300) after
where the disease may be more complex.
a
cost
savings
of
$1,212/patient
in
2 years, but patients treated with the DCB enjoyed a
A report of DCBs in 260 symptomatic patients with
better quality of life, making it the more cost-
de novo or restenotic disease who were not enrolled
effective therapy.
in a trial points out the challenges of translating re-
The authors are to be commended for highlighting
sults from randomized DCB trials to unselected pa-
an issue that is often overlooked whenever a new
tients (14). Patients in the real-world registry had
device is introduced to the market, that is, the eco-
lower ankle-brachial indices than those in the
nomic implication of incorporating new technologies
IN.PACT SFA trial, and were more likely to have
into routine clinical practice. This is important
critical limb ischemia and restenosis (post-PTA or in-
because of the high economic burden of symptom-
stent). The DCB-treated lesions were nearly 3 times
atic PAD, the growing enthusiasm for endovascular
longer, and included a greater proportion of chronic
procedures, and the paucity of comparative clinical
total occlusions. The increase in lesion complexity led
effectiveness data for many of the techniques and
to the use of more DCBs per patient and a higher rate
devices in use. However, before we accept the
of provisional stent implantation. Furthermore, many
authors’ conclusions about the cost-effectiveness of
patients were also treated with adjunctive therapies
all DCB therapy, we must consider 2 important as-
such as atherectomy. DCBs were more effective at
pects of DCBs that were not addressed in this study:
lowering the rates of restenosis than standard PTA in
the comparative efficacy of different DCBs, and
these more complex lesions; however, this effect was
the performance of these devices in a real-world
clinically less apparent after 2 years. Given the
population.
modest long-term performance of DCBs in patients
Not all DCBs appear to be equal in their clinical
with complex PAD and the higher cost of these pro-
effects. A meta-analysis of 8 randomized DCB trials in
cedures, it is likely an economic analysis of DCBs in
the United States and Europe showed that there is
the real world would be less favorable (if at all)
significant heterogeneity in the treatment effect
compared with the IN.PACT SFA II trial.
among different DCB types (11). If we only consider
So, what can we confidently say about the cost-
the brands that are available for use in the United
effectiveness of DCBs in the treatment of PAD on
States, the Lutonix DCB had a more modest effect on
the basis of the current report (10) and published
restenosis and clinical outcomes after treatment of
data? In the populations tested, DCBs are superior to
symptomatic femoropopliteal disease compared with
PTA in reducing restenosis and TLR rates in patients
the IN.PACT Admiral balloon. A second meta-analysis
with symptomatic femoropopliteal disease. However,
of 11 randomized studies suggested that this vari-
the magnitude of benefit is not uniform among the
ability could be explained by a dose effect (12). The
different DCBs. The use of the IN.PACT Admiral DCB
IN.PACT DCB delivers a higher dose of paclitaxel
is
(3.5 mg/mm 2) compared with the Lutonix DCB
ropopliteal stenoses and occlusions, though it re-
cost-effective
in
patients
with
focal
femo-
(2 m g/mm 2). The 2 balloons utilize different excipients
mains to be seen whether there is a similar economic
(urea vs. polysorbate and sorbitol), which may also
advantage of using this device in patients with more
affect efficiency of drug delivery. These observations
complex PAD. In the absence of head-to-head com-
imply the absence of a “class effect” among different
parisons of DCBs to each other or other devices such
DCBs. If true, this would suggest that the findings of
as DES, the relative value of a routine DCB strategy in
Salisbury et al. (10) apply to one particular product
the management of symptomatic PAD has yet to
(IN.PACT Admiral) in a specific clinical setting
be defined.
(treatment of de novo femoropopliteal disease). Therefore, the cost-effectiveness of other DCBs will
REPRINT REQUESTS AND CORRESPONDENCE: Dr.
need to be evaluated individually going forward.
Salman A. Arain, Department of Internal Medicine,
A limitation of randomized trials is that the pa-
Division of Cardiovascular Diseases, University of
tients and lesion types included for testing must meet
Texas Health Sciences Center–Houston, 6431 Fannin
narrowly defined criteria that often do not reflect the
1.246, Houston, Texas 77030. E-mail: Salman.A.
variety of pathologies seen in clinical practice.
[email protected].
Arain and White
JACC: CARDIOVASCULAR INTERVENTIONS VOL. 9, NO. 22, 2016 NOVEMBER 28, 2016:2353–5
The Cost-Effectiveness of Treatment With Drug-Coated Balloons
REFERENCES 1. Norgren L, Hiatt WR, Dormandy JA, et al. InterSociety Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg 2007;45 Suppl S:S5–67. 2. Armstrong EJ, Saeed H, Alvandi B, et al. Nitinol self-expanding stents vs. balloon angioplasty for very long femoropopliteal lesions. J Endovasc Ther 2014;21:34–43. 3. Diamantopoulos A, Katsanos K. Atherectomy of the femoropopliteal artery: a systematic review and meta-analysis of randomized controlled trials. J Cardiovasc Surg (Torino) 2014;55:655–65. 4. Dake MD, Ansel GM, Jaff MR, et al. Sustained safety and effectiveness of paclitaxel-eluting stents for femoropopliteal lesions: 2-year followup from the Zilver PTX randomized and single-arm clinical studies. J Am Coll Cardiol 2013;61:2417–27. 5. Dake MD, Ansel GM, Jaff MR, et al. Durable clinical effectiveness with paclitaxel-eluting stents in the femoropopliteal artery: 5-year results of the Zilver PTX randomized trial. Circulation 2016;133: 1472–83; discussion 1483. 6. Cassese S, Byrne RA, Ott I, et al. Paclitaxel-coated versus uncoated balloon angioplasty reduces target lesion revascularization in patients with femoropopliteal arterial disease: a meta-analysis
of randomized trials. Circ Cardiovasc Interv 2012;5: 582–9. 7. Laird JR, Schneider PA, Tepe G, et al. Durability of treatment effect using a drug-coated balloon for femoropopliteal lesions: 24-month results of IN.PACT SFA. J Am Coll Cardiol 2015; 66:2329–38. 8. Scheinert D, Duda S, Zeller T, et al. The LEVANT I (Lutonix paclitaxel-coated balloon for the prevention of femoropopliteal restenosis) trial for femoropopliteal revascularization: first-in-human randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty. J Am Coll Cardiol Intv 2014;7:10–9. 9. Tepe G, Laird J, Schneider P, et al. 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. 10. Salisbury AC, Li H, Vilain KR, et al. Costeffectiveness of endovascular femoropopliteal intervention using drug-coated balloons versus standard percutaneous transluminal angioplasty: results from the IN.PACT SFA II trial. J Am Coll Cardiol Intv 2016;9:2343–52.
11. Giacoppo D, Cassese S, Harada Y, et al. Drugcoated balloon versus plain balloon angioplasty for the treatment of femoropopliteal artery disease: an updated systematic review and metaanalysis of randomized clinical trials. J Am Coll Cardiol Intv 2016;9:1731–42. 12. Katsanos K, Spiliopoulos S, Paraskevopoulos I, Diamantopoulos A, Karnabatidis D. Systematic review and meta-analysis of randomized controlled trials of paclitaxel-coated balloon angioplasty in the femoropopliteal arteries: role of paclitaxel dose and bioavailability. J Endovasc Ther 2016;23:356–70. 13. Krankenberg H, Tubler T, Ingwersen M, et al. Drug-coated balloon versus standard balloon for superficial femoral artery in-stent restenosis: the randomized Femoral Artery In-Stent Restenosis (FAIR) trial. Circulation 2015;132:2230–6. 14. Schmidt A, Piorkowski M, Gorner H, et al. Drug-coated balloons for complex femoropopliteal lesions: 2-year results of a real-world registry. J Am Coll Cardiol Intv 2016;9:715–24.
KEY WORDS cost-effectiveness, drug-coated balloons, percutaneous transluminal balloon angioplasty, peripheral arterial disease
2355