Laser atherectomy and drug-coated balloons for the treatment of femoropopliteal in-stent restenosis: 2-Year outcomes

Damianos G. Kokkinidis, Sean Behan, Omar Jawaid, Prio Hossain, Stefanos Giannopoulos, Gagan D. Singh, John R. Laird, Javier A. Valle, Stephen W. Waldo, Ehrin J. Armstrong

Research output: Contribution to journalArticle

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 languageEnglish (US)
JournalCatheterization and Cardiovascular Interventions
DOIs
StateAccepted/In press - Jan 1 2019

Fingerprint

Atherectomy
Stents
Lasers
Laser-Assisted Balloon Angioplasty
Pharmaceutical Preparations
Therapeutics
Embolic Protection Devices

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 journalArticle

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. / Laser atherectomy and drug-coated balloons for the treatment of femoropopliteal in-stent restenosis : 2-Year outcomes. In: Catheterization and Cardiovascular Interventions. 2019.
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title = "Laser atherectomy and drug-coated balloons for the treatment of femoropopliteal in-stent restenosis: 2-Year outcomes",
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.",
keywords = "atherectomy, chronic total occlusions, drug-coated balloon, femoropopliteal disease, in-stent restenosis, laser, paclitaxel, peripheral artery disease",
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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

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DO - 10.1002/ccd.28636

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SN - 1522-1946

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