Northwell intracoronary brachytherapy for the treatment of recurrent drug eluting stent in-stent restenosis (NITDI study group).


Journal

Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
ISSN: 1522-726X
Titre abrégé: Catheter Cardiovasc Interv
Pays: United States
ID NLM: 100884139

Informations de publication

Date de publication:
01 01 2021
Historique:
received: 18 11 2019
accepted: 28 12 2019
pubmed: 14 1 2020
medline: 25 9 2021
entrez: 14 1 2020
Statut: ppublish

Résumé

The purpose of this study is to report on safety, short-term and long-term clinical efficacy following intracoronary brachytherapy (ICBT) for restenosis (ISR) in patients with drug eluting stents (DES). ICBT is an effective treatment for ISR of bare metal stents (BMS) but its utilization has waned due to the advent of DES. ISR following DES occurs at a frequency of 8% or greater. A retrospective analysis was performed on patients treated on an institutional review board (IRB) approved protocol using ICBT for DES ISR between January 2011 and October 2016. All patients were followed for 24 months for procedural complications, mortality, clinical ISR/target lesion revascularization (TLR) and stroke. A total of 290 patients were identified with a mean age of 66.6 years. All of them had high rates of typical coronary artery disease risk factors. Our primary outcome, composite of in-hospital mortality, myocardial infarction (MI), safety outcomes and procedural failure was noted in 1(0.3%) patient who had a MI. No other secondary outcome was noted in-hospital. At 1-year follow up, 12.4% patients had ISR, 1.7% patients died, and 1 (0.3%) had ischemic stroke. At 2-year, 14.7% had ISR, and total 6 (2.1%) patients had MI. ICBT demonstrates excellent technical success rates for treatment, safety, and reasonable efficacy over 2-years to be free from recurrent clinical ISR. This study represents the largest ICBT data for DES ISR to date among very complex lesion subsets, however, more prospective data will be needed to determine the optimal patient for treatment.

Sections du résumé

OBJECTIVE
The purpose of this study is to report on safety, short-term and long-term clinical efficacy following intracoronary brachytherapy (ICBT) for restenosis (ISR) in patients with drug eluting stents (DES).
BACKGROUND
ICBT is an effective treatment for ISR of bare metal stents (BMS) but its utilization has waned due to the advent of DES. ISR following DES occurs at a frequency of 8% or greater.
METHOD
A retrospective analysis was performed on patients treated on an institutional review board (IRB) approved protocol using ICBT for DES ISR between January 2011 and October 2016. All patients were followed for 24 months for procedural complications, mortality, clinical ISR/target lesion revascularization (TLR) and stroke.
RESULTS
A total of 290 patients were identified with a mean age of 66.6 years. All of them had high rates of typical coronary artery disease risk factors. Our primary outcome, composite of in-hospital mortality, myocardial infarction (MI), safety outcomes and procedural failure was noted in 1(0.3%) patient who had a MI. No other secondary outcome was noted in-hospital. At 1-year follow up, 12.4% patients had ISR, 1.7% patients died, and 1 (0.3%) had ischemic stroke. At 2-year, 14.7% had ISR, and total 6 (2.1%) patients had MI.
CONCLUSION
ICBT demonstrates excellent technical success rates for treatment, safety, and reasonable efficacy over 2-years to be free from recurrent clinical ISR. This study represents the largest ICBT data for DES ISR to date among very complex lesion subsets, however, more prospective data will be needed to determine the optimal patient for treatment.

Identifiants

pubmed: 31930652
doi: 10.1002/ccd.28708
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

41-46

Commentaires et corrections

Type : CommentIn

Informations de copyright

© 2020 Wiley Periodicals, Inc.

Références

Morice M. Randomized study with the sirolimus-coated Bx velocity balloon-expandable stent in the treatment of patients with de novo native coronary artery lesions: a randomized comparison of a sirolimus eluting stent with standard stent for coronary revascularization. N Engl J Med. 2002;346:1773-1780.
Spaulding C, Daemen J, Boersma E, Cutlip DE, Serruys PW. A pooled analysis of data comparing sirolimus-eluting stents with bare-metal stents. N Engl J Med. 2007;356(10):989-997.
Dangas GD, Claessen BE, Caixeta A, Sanidas EA, Mintz GS, Mehran R. In-stent restenosis in the drug-eluting stent era. J Am Coll Cardiol. 2010;56(23):1897-1907.
Rittger H, Waliszewski M, Brachmann J, et al. Long-term outcomes after treatment with a paclitaxel-coated balloon versus balloon angioplasty: insights from the PEPCAD-DES study (treatment of drug-eluting stent [DES] in-stent restenosis with sequent please paclitaxel-coated percutaneous transluminal coronary angioplasty [PTCA] catheter). J Am Coll Cardiol Intv. 2015;8(13):1695-1700.
Condado JA, Waksman R, Gurdiel O, et al. Long-term angiographic and clinical outcome after percutaneous transluminal coronary angioplasty and intracoronary radiation therapy in humans. Circulation. 1997;96(3):727-732.
Wiedermann JG, Marboe C, Amols H, Schwartz A, Weinberger J. Intracoronary irradiation markedly reduces restenosis after balloon angioplasty in a porcine model. J Am Coll Cardiol. 1994;23(6):1491-1498.
Waksman R, Rodriguez JC, Robinson KA, et al. Effect of intravascular irradiation on cell proliferation, apoptosis, and vascular remodeling after balloon overstretch injury of porcine coronary arteries. Circulation. 1997;96(6):1944-1952.
Leon MB, Teirstein PS, Moses JW, et al. Localized intracoronary gamma-radiation therapy to inhibit the recurrence of restenosis after stenting. N Engl J Med. 2001;344(4):250-256.
Waksman R, White RL, Chan RC, et al. Intracoronary gamma-radiation therapy after angioplasty inhibits recurrence in patients with in-stent restenosis. Circulation. 2000;101(18):2165-2171.
Ellis SG, O'Shaughnessy CD, Martin SL, et al. Two-year clinical outcomes after paclitaxel-eluting stent or brachytherapy treatment for bare metal stent restenosis: the TAXUS V ISR trial. Eur Heart J. 2008;29(13):1625-1634.
Stone GW, Ellis SG, O'Shaughnessy CD, et al. Paclitaxel-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents: the TAXUS V ISR randomized trial. Jama. 2006;295(11):1253-1263.
Holmes DR Jr, Teirstein PS, Satler L, et al. 3-year follow-up of the SISR (Sirolimus-eluting stents versus vascular brachytherapy for in-stent restenosis) trial. JACC Cardiovasc Interv. 2008;1(4):439-448.
Levine GN, Bates ER, Blankenship JC, et al. 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention. A report of the American College of Cardiology Foundation/American Heart Association task force on practice guidelines and the Society for Cardiovascular Angiography and Interventions. J Am Coll Cardiol. 2011;58(24):e44-e122.
Negi SI, Torguson R, Gai J, et al. Intracoronary brachytherapy for recurrent drug-eluting stent failure. JACC Cardiovasc Interv. 2016;9(12):1259-1265.
Mangione FM, Jatene T, Badr Eslam R, et al. Usefulness of intracoronary brachytherapy for patients with resistant drug-eluting stent restenosis. Am J Cardiol. 2017;120(3):369-373.
Ohri N, Sharma S, Kini A, et al. Intracoronary brachytherapy for in-stent restenosis of drug-eluting stents. Adv Radiat Oncol. 2016;1(1):4-9.
Kim S-W, Mintz GS, Escolar E, et al. An intravascular ultrasound analysis of the mechanisms of restenosis comparing drug-eluting stents with brachytherapy. Am J Cardiol. 2006;97(9):1292-1298.
Kuchulakanti P, Torguson R, Canos D, et al. Optimizing dosimetry with high-dose intracoronary gamma radiation (21 Gy) for patients with diffuse in-stent restenosis. Cardiovasc Revasc Med. 2005;6(3):108-112.
Ajani AE, Waksman R, Sharma AK, et al. Three-year follow-up after intracoronary gamma radiation therapy for in-stent restenosis: original WRIST. Cardiovasc Radiat Med. 2001;2(4):200-204.
Limpijankit T, Mehran R, Mintz GS, et al. Long-term follow-up of patients after gamma intracoronary brachytherapy failure (from GAMMA-I, GAMMA-II, and SCRIPPS-III). Am J Cardiol. 2003;92(3):315-318.
Kawamoto H, Ruparelia N, Latib A, et al. Drug-coated balloons versus second-generation drug-eluting stents for the management of recurrent multimetal-layered in-stent restenosis. JACC Cardiovasc Interv. 2015;8(12):1586-1594.

Auteurs

Perwaiz M Meraj (PM)

Department of Cardiology, Northwell Health, Manhasset, New York.

Krunalkumar Patel (K)

Department of Cardiology, Northwell Health, Manhasset, New York.

Amitkumar Patel (A)

Department of Cardiology, Northwell Health, Manhasset, New York.

Rajkumar Doshi (R)

Department of Cardiology, Northwell Health, Manhasset, New York.

Guruprasad Srinivas (G)

Department of Cardiology, Northwell Health, Manhasset, New York.

Rajiv Jauhar (R)

Department of Cardiology, Northwell Health, Manhasset, New York.

Barry Kaplan (B)

Department of Cardiology, Northwell Health, Manhasset, New York.

Ruby Garzon (R)

Department of Cardiology, Northwell Health, Manhasset, New York.

Anurag Sharma (A)

Department of Radiation Medicine, Northwell Health, Manhasset, New York.

Yijian Cao (Y)

Department of Radiation Medicine, Northwell Health, Manhasset, New York.

Ferney Diaz Molina (F)

Department of Radiation Medicine, Northwell Health, Manhasset, New York.

Rajiv Sharma (R)

Department of Radiation Medicine, Northwell Health, Manhasset, New York.

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