Abstract
Background: Femoropopliteal (FP) artery is one of the most anatomically challenging areas for sustained stent patency. The incidence of FP in-stent restenosis (ISR) is estimated at 50% at 24 months. Prior studies have shown that lesion debulking with laser atherectomy (LA) combined with drug coated balloon (DCB) have superior outcomes compared to LA + balloon angioplasty (BA) ISR, but there have not been studies evaluating 2-year outcomes. Methods: This was a dual-center retrospective cohort study that compared patients with FP-ISR treated with LA + DCB versus LA + BA. Cox regression analysis was used to examine 2-year outcomes of target lesion revascularization (TLR) and the composite outcome of TLR or restenosis. Multivariable analysis was performed for clinical and statistically significant (in the univariate analysis) variables. Results: One hundred and seventeen consecutive patients with Tosaka II (n = 32) and III (n = 85) ISR were analyzed. Sixty-six patients were treated with LA + DCB and 51 with LA + BA. The LA + DCB group had more lesions with moderate to severe calcification (58% vs. 13%; p <.0001). The LA + DCB group was more likely to be treated with the use of embolic protection devices (64% vs. 23%, p <.001) and cutting balloons (61% vs. 6%, p <.001). Bail-out stenting rates were lower in the LA + DCB group (32% vs. 57%, p =.008). LA + DCB was superior (HR: 0.57; 95% CI: 0.34–0.9, p =.027) for the composite outcome of 2-year TLR or restenosis. The 12-month KM estimates for freedom from TLR or restenosis were 66% in the LA + DCB group versus 46% in the LA + BA group. The 24-month KM estimates were 45% in the LA + DCB group versus 24% in the LA + BA group. Conclusions: The combination of DCB + LA was associated with decreased rates of bail-out stenting and improved 2-year TLR or restenosis rates. Randomized clinical trials examining the DCB + LA combination for FP-ISR are needed.
| Original language | English (US) |
|---|---|
| Journal | Catheterization and Cardiovascular Interventions |
| DOIs | |
| State | Accepted/In press - Jan 1 2019 |
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Keywords
- atherectomy
- chronic total occlusions
- drug-coated balloon
- femoropopliteal disease
- in-stent restenosis
- laser
- paclitaxel
- peripheral artery disease
ASJC Scopus subject areas
- Radiology Nuclear Medicine and imaging
- Cardiology and Cardiovascular Medicine
Cite this
Laser atherectomy and drug-coated balloons for the treatment of femoropopliteal in-stent restenosis : 2-Year outcomes. / Kokkinidis, Damianos G.; Behan, Sean; Jawaid, Omar; Hossain, Prio; Giannopoulos, Stefanos; Singh, Gagan D.; Laird, John R.; Valle, Javier A.; Waldo, Stephen W.; Armstrong, Ehrin J.
In: Catheterization and Cardiovascular Interventions, 01.01.2019.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Laser atherectomy and drug-coated balloons for the treatment of femoropopliteal in-stent restenosis
T2 - 2-Year outcomes
AU - Kokkinidis, Damianos G.
AU - Behan, Sean
AU - Jawaid, Omar
AU - Hossain, Prio
AU - Giannopoulos, Stefanos
AU - Singh, Gagan D.
AU - Laird, John R.
AU - Valle, Javier A.
AU - Waldo, Stephen W.
AU - Armstrong, Ehrin J.
PY - 2019/1/1
Y1 - 2019/1/1
N2 - Background: Femoropopliteal (FP) artery is one of the most anatomically challenging areas for sustained stent patency. The incidence of FP in-stent restenosis (ISR) is estimated at 50% at 24 months. Prior studies have shown that lesion debulking with laser atherectomy (LA) combined with drug coated balloon (DCB) have superior outcomes compared to LA + balloon angioplasty (BA) ISR, but there have not been studies evaluating 2-year outcomes. Methods: This was a dual-center retrospective cohort study that compared patients with FP-ISR treated with LA + DCB versus LA + BA. Cox regression analysis was used to examine 2-year outcomes of target lesion revascularization (TLR) and the composite outcome of TLR or restenosis. Multivariable analysis was performed for clinical and statistically significant (in the univariate analysis) variables. Results: One hundred and seventeen consecutive patients with Tosaka II (n = 32) and III (n = 85) ISR were analyzed. Sixty-six patients were treated with LA + DCB and 51 with LA + BA. The LA + DCB group had more lesions with moderate to severe calcification (58% vs. 13%; p <.0001). The LA + DCB group was more likely to be treated with the use of embolic protection devices (64% vs. 23%, p <.001) and cutting balloons (61% vs. 6%, p <.001). Bail-out stenting rates were lower in the LA + DCB group (32% vs. 57%, p =.008). LA + DCB was superior (HR: 0.57; 95% CI: 0.34–0.9, p =.027) for the composite outcome of 2-year TLR or restenosis. The 12-month KM estimates for freedom from TLR or restenosis were 66% in the LA + DCB group versus 46% in the LA + BA group. The 24-month KM estimates were 45% in the LA + DCB group versus 24% in the LA + BA group. Conclusions: The combination of DCB + LA was associated with decreased rates of bail-out stenting and improved 2-year TLR or restenosis rates. Randomized clinical trials examining the DCB + LA combination for FP-ISR are needed.
AB - Background: Femoropopliteal (FP) artery is one of the most anatomically challenging areas for sustained stent patency. The incidence of FP in-stent restenosis (ISR) is estimated at 50% at 24 months. Prior studies have shown that lesion debulking with laser atherectomy (LA) combined with drug coated balloon (DCB) have superior outcomes compared to LA + balloon angioplasty (BA) ISR, but there have not been studies evaluating 2-year outcomes. Methods: This was a dual-center retrospective cohort study that compared patients with FP-ISR treated with LA + DCB versus LA + BA. Cox regression analysis was used to examine 2-year outcomes of target lesion revascularization (TLR) and the composite outcome of TLR or restenosis. Multivariable analysis was performed for clinical and statistically significant (in the univariate analysis) variables. Results: One hundred and seventeen consecutive patients with Tosaka II (n = 32) and III (n = 85) ISR were analyzed. Sixty-six patients were treated with LA + DCB and 51 with LA + BA. The LA + DCB group had more lesions with moderate to severe calcification (58% vs. 13%; p <.0001). The LA + DCB group was more likely to be treated with the use of embolic protection devices (64% vs. 23%, p <.001) and cutting balloons (61% vs. 6%, p <.001). Bail-out stenting rates were lower in the LA + DCB group (32% vs. 57%, p =.008). LA + DCB was superior (HR: 0.57; 95% CI: 0.34–0.9, p =.027) for the composite outcome of 2-year TLR or restenosis. The 12-month KM estimates for freedom from TLR or restenosis were 66% in the LA + DCB group versus 46% in the LA + BA group. The 24-month KM estimates were 45% in the LA + DCB group versus 24% in the LA + BA group. Conclusions: The combination of DCB + LA was associated with decreased rates of bail-out stenting and improved 2-year TLR or restenosis rates. Randomized clinical trials examining the DCB + LA combination for FP-ISR are needed.
KW - atherectomy
KW - chronic total occlusions
KW - drug-coated balloon
KW - femoropopliteal disease
KW - in-stent restenosis
KW - laser
KW - paclitaxel
KW - peripheral artery disease
UR - http://www.scopus.com/inward/record.url?scp=85076540355&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85076540355&partnerID=8YFLogxK
U2 - 10.1002/ccd.28636
DO - 10.1002/ccd.28636
M3 - Article
C2 - 31816169
AN - SCOPUS:85076540355
JO - Catheterization and Cardiovascular Interventions
JF - Catheterization and Cardiovascular Interventions
SN - 1522-1946
ER -