In this prospective study, we analyzed the impact of
a DA device before DCB angiography for the vascular
preparation of calcified long-segment femoropopliteal
lesions by comparing two groups of patients treated
with a DCB with or without DA. Our analysis
showed that vascular preparation with DA before
DCB enhanced the primary patency and lowered
the rates of both perioperative flow-limiting and
nonflow-limiting dissections and the necessity of the
bail-out stent according to the DCB method alone.
The lesion length and calcification burden are
some of the prime factors affecting the success and
durability of the endovascular treatment. Increased
length of the diseased segment and severe calcification
are associated with unsatisfactory outcomes.[5] The
current European Society of Cardiology guideline
recommends the endovascular strategy first for
femoropopliteal lesions ≤25 cm (Class 1C) with primary
stenting (Class IIa) and DCBs (Class IIb). Surgical
revascularization with an autologous saphenous vein
graft is still the best treatment in lesions >25 cm
(Class IB). However, endovascular treatment may also
be considered in this group, whether the patient is
unfit or at high risk for surgery (Class IIb). Therefore,
the endovascular methods have become a preferred
‘first’ approach in parallel to increasing experience
due to short hospital stays and early recovery in long femoropopliteal lesions. The calcification burden has
proven its impact on both procedural success and
midterm restenosis occurrence. Fanelli et al.[3] reported
that both increased cross-sectional calcification burden
in CTA and longitudinal calcification burden in
digital subtraction angiography are associated with a
progressive decrease in clinical success. Additionally,
in their study, a cross-sectional calcification burden
was found to be a more powerful indicator of poor
outcomes than a longitudinal calcification burden.
Similarly, the previous studies have demonstrated
that severe calcification burden is an independent
factor of restenosis following DCB, and this increases
bail-out stent implantation.[6-8] The severity of
the calcification burden causes an increase in the
probability of perioperative flow-limiting dissection
and bail-out stenting.[5] Severe calcification may also
cause an inadequate opening of stents. There are
various devices decreasing the calcification burden or
changing calcification distribution, such as cutting
and scoring balloons and atherectomy devices that
increase patency.[9-13]
Drug-coated balloons decrease restenosis risk
with the antiproliferative properties of the drugs
on their surfaces. Previous studies have revealed
the superiority of DCBs over standard balloon
angioplasty in femoropopliteal lesions.[14-21] However,
the antiproliferative effects of DCBs depend on the
embedding and up-take of drug particles into the
media layer of the arteries with the aid of the balloon
inflation pressure.[18] At this point, the advanced
calcification burden forms a barrier between the drug
and the media layer. Some studies in the literature have reported promising results with DA followed by
DCB angioplasty in severely calcified lesions.[10,22]
Lesion length is another important determinant
of procedural success and patency. In the majority
of previous studies, atherectomy was used for lesions
<100 mm. The mean lesion length was 74±53 mm in
the DEFINITIVE-LE study and patients with lesions
>100 mm were only 28% of the study population.[23]
Similarly, the DEFINITIVE-AR study compared
DCB alone with DA+DCB in patients with a lesion
length between 70-150 mm.[24] In the present study,
lesion length was >150 mm for all patients.
In this study, the primary endpoint was defined
as <30% of restenosis in target lesion assessed with
duplex USG and CTA at the 12-month follow-up.
The rate of restenosis at 12 months after the procedure
was lesser in patients treated with atherectomy for
vascular preparation. Similar studies show similar
primary patency rates.[10] Clinical assessment with ABI
and physical examination showed improved results
in comparison with the preprocedural condition in
the radiologic evaluation at the 12-month followup.
A higher increase of ABI was observed in the
DA+DCB group than in the DCB group, consistent
with radiologic evaluation.
The nonflow-limiting dissections were usually
underestimated in previous studies. However, the
effect of nonflow-limiting dissection on restenosis
rates is still not well known. We separately evaluated
the nonflow-limiting dissections for both groups, and
we think that they may affect the mid-term patency.
As with similar previous studies, the flow-limiting
dissections (types C to F) needing intervention were
more common in the DCB group (13.3% vs. 4.3%),
and the relative risk reduction was 67.6%. Bail-out
stenting was required in 10% of the DCB group
compared to the 8.6% of the DA+DCB group. The
bailout stenting rate in the DA+DCB patients was
reported as 3.2% in the DEFINITIVE-LE study.
In our study, the stenting rate was notably higher
in comparison with previous studies. We consider
that our study population was composed of patients
with longer lesions and a more severe calcification
burden. Therefore, we had to use more stents, unlike
similar studies. Although bail-out stenting incidence
was lower in the DA+DCB group, we found 2.1%
perforation, 2.1% pseudoaneurysm formation, and
2.1% arteriovenous fistula, which did not occur in the
DCB group. The distal arterial embolization was more common in the DCB group (6.6% vs. 2.1%). We used
an antiembolic filter in 86.9% of the DA+DCB group.
Therefore, this insignificant difference is secondary to
the antiembolic filter use.
The major or minor amputation of the extremity
and the healing of the ischemic wound rates did not
differ between the members of the groups, although the
outcomes of the DA group appear more encouraging
depending on the target lesion revascularization and
primary patency at the 12-month follow-up. Further
studies with more patients are required to evaluate
amputation and mortality rates.
In conclusion, vascular preparation with the DA
prior to DCB in patients with long-segment and
severely-calcific lesions may provide better patency,
decrease flow-limiting and nonflow-limiting
dissections, and lower the need for bail-out stents.
Ethics Committee Approval: The study protocol was
approved by the Prof. Dr. Cemil Taşçıoğlu City Hospital
Ethics Committee (Date/no: 14.05.2019/1297). The study
was conducted in accordance with the principles of the
Declaration of Helsinki.
Patient Consent for Publication: A written informed
consent was obtained from each patient.
Data Sharing Statement: The data that support the
findings of this study are available from the corresponding
author upon reasonable request.
Author Contributions: Idea/concept, data collection
and/or processing: S.K.; Design, analysis and/or interpretation,
literature review, writing the article, references and fundings::
S.K., H.G.; Control/supervision, critical review: H.G.
Conflict of Interest: The authors declared no conflicts
of interest with respect to the authorship and/or publication
of this article.
Funding: The authors received no financial support for
the research and/or authorship of this article.