Coronary artery radiation therapy for the prevention of restenosis after percutaneous coronary angioplasty, II: Outcomes of clinical trials

doi:10.1053/srao.2002.28659

Seminars in Radiation Oncology

Volume 12, Issue 1, January 2002, Pages 17-30

https://doi.org/10.1053/srao.2002.28659 Get rights and content

Coronary artery radiation therapy (CART) has become the standard of care for the treatment of coronary instent restenosis after repeat angioplasty. More than 5,000 patients have been enrolled into various clinical trials using 3 major systems. Based on the results of GAMMA I and START trials, both the Checkmate system using ¹⁹²Ir and the Betacath system using ⁹⁰Sr/Y have been approved for routine clinical use in the treatment of in-stent restenosis. The Galileo system using ³²P with data from INHIBIT trial is pending premarketing approval. With a better understanding and application of radiation oncology concepts to vascular brachytherapy, problems such as geographic miss and/or edge failure should be overcome. The complication of late thrombosis should also become less notable by eliminating restenting at the brachytherapy procedure and the prolonged use of antiplatelet therapy. Although there are other competing modalities in the very early phases of clinical trials, the future of CART appears bright. The durability of results, lack of any important complications, and confirmation of the efficacy in other sites will further consolidate the role of CART in preventing vascular restenosis.

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Cited by (11)

Endobronchial brachytherapy provides excellent long-term control of recurrent granulation tissue after tracheal stenosis
2012, Brachytherapy
Citation Excerpt :
For this reason, radiation therapy has been used in benign diseases such as heterotopic ossification (8) and keloids (9). In a similar vein, brachytherapy has been used in the setting of vascular stents when recurrent scar tissue occurs to prevent in-stent restenosis (9–13). This technique has been shown to be highly successful in the setting of vascular stenosis both in cardiac and peripheral vessels.
To review the experience of using endobronchial brachytherapy (EBB) as a treatment for recurrent tracheal granulation tissue.
Patients referred for EBB at the Rabin Medical Center for benign stenosis were reviewed with institutional review board approval. Patients underwent bronchoscopic resection of granulation tissue followed by insertion of self-expanding metallic stents. After stenting, repeat laser resection was done at least 1 week before brachytherapy. After CT simulation, patients had three-dimensional brachytherapy treatment planning. A single 10-Gy dose was prescribed to 1.0 cm from the source and treatment was delivered using high-dose-rate afterloader with ¹⁹²Ir source. Patients were followedup with bronchoscopy every 3 months after the completion of therapy.
From November 2001 to January 2009, 29 patients were treated with EBB to prevent granulation tissue reformation. Median age was 70 years and 55% of patients were male. Ninety percent of patients were treated to the trachea and the remaining patients had stenoses in the main stem bronchi. The primary cause of stenosis was prolonged mechanical ventilation (76%). The median time from stent placement to brachytherapy was 69 days. Median active length of treatment was 7 cm. With a median followup of 36 months, 66% (19 of 29) of patients remained free of granulation tissue. Forty-eight percent of patients have died, with all except 1 patient dying of their underlying condition. A single patient experienced death from tracheoesophageal fistula.
EBB is an effective and safe treatment to prevent recurrent granulation tissue formation after endobronchial resection and should be considered in patients who are unable to undergo surgical resection.
High-dose-rate brachytherapy of recurrent rectal adenocarcinoma presenting as a solitary intravascular metastasis of the iliac vein: A case report
2003, Brachytherapy
To describe a novel use of high-dose-rate intravascular brachytherapy in the first reported case of macroscopic metastatic rectal adenocarcinoma within a peripheral vein.
Following thrombolytic therapy to ablate an overlying venous thrombosis, a vascular stent was deployed across the entire length of the tumor. Using the stent as a target, 4300 cGy was delivered to the tumor via megavoltage external beam radiation. This was followed by two weekly intravascular high-dose-rate ¹⁹²Ir brachytherapy applications of 400 cGy each.
There is no evidence of recurrence in the treated vein at 43 months of follow-up.
In this unique case, a combination of external beam radiation therapy and intravascular brachytherapy provided effective control of a solitary intravascular metastasis from rectal carcinoma.
Brachytherapy for in-stent restenosis in general interventional practice: A single institution's experience using four radiation devices
2003, Cardiovascular Radiation Medicine
The effectiveness of brachytherapy for the treatment of in-stent restenosis (ISR) has been established in a number of large randomized controlled trials. Efficacy of this therapy in general population is less well established.
We report our experience of 207 patients, 236 coronary lesions, treated with brachytherapy between November 2000 and November 2002. All commercially available brachytherapy devices, as well as one investigational device, were utilized. This cohort was followed over 9 months and clinical outcomes were obtained with subsequent analysis of patient and lesion-specific characteristics.
Average treatment age was 62.5 years; 73% were male and the most frequent presentation was unstable angina (74%). All patients had successful delivery of radiation, with no in-hospital deaths. Novoste BetaCath device was used for 163 (65%) lesions, Cordis Checkmate for 56 (24%) lesions, Interventional Therapies device in 13 (8%) lesions, and Guidant Galileo in 4 lesions (3%). At a mean follow-up of 9.1 months, 78.7% were free of major adverse cardiac event (MACE). Twenty-one patients required repeat PTCA (10.1%), 19 had CABG (9.2%), 3 had MI (1.4%), and there was 1 death (0.5%). Unadjusted MACE rates for each device were 21% for Novoste, 28% for Checkmate, 8% for Interventional Therapies, and 50% for Galileo. Lesion length, minimal lumen diameter, renal failure, diabetes, and smoking did not predict treatment failure; only age was inversely correlated with MACE (P=.002).
When applied across a spectrum of patients, lesions, and devices, brachytherapy retains its effectiveness with outcomes similar to those reported in randomized clinical trials.
Drug-eluting stents: Potential applications for peripheral arterial occlusive disease
2003, Journal of Vascular and Interventional Radiology
Many different approaches have been evaluated to prevent restenosis in stents after vascular implantation. Currently, drug-eluting stents are extremely promising in suppressing neointimal hyperplasia. Various animal studies and randomized trials in humans have shown excellent results in terms of safety and efficacy during intermediate-term follow-up. This article will give an overview of experimental and clinical data of the different agents in published and ongoing trials.
Brachytherapy for coronary restenosis: State of art in 2003
2003, Cancer/Radiotherapie
Sur la base des traitements radioactifs utilisés pour certaines maladies bénignes, la curiethérapie endocoronaire agit par action antiproliférative sur les cellules myofibroblastiques responsables de la néoformation intimale post-angioplastie. L'effet bénéfique des radiations ionisantes s'exerce également en diminuant le remodelage vasculaire consécutif à l'agression due à dilatation. Les essais randomisés ont démontré un bénéfice angiographique au-delà de 6 mois de suivi, avec une diminution du taux de resténose de 50 % sur le segment du stent et sur le segment analysé. La curiethérapie diminue significativement le taux des évènements cardiaques et le taux de revascularisation de la lésion. Ces résultats sont indépendants de l'émetteur utilisé et le choix thérapeutique en France s'est porté sur les sources radioactives avec des émetteurs bêta. L'indication de traitement est la resténose diffuse intrastent. Il n'existe pas d'essai concluant pour le traitement des lésions de novo actuellement. Le défaut de couverture du volume–cible, la qualité du centrage des sources, la thrombose tardive et la procédure pullback sont des facteurs limitant l'efficacité de cette technique. L'apport de l'échographie endocoronaire doit permettre une meilleure définition des volumes cibles pour un niveau plus précis de la qualité de l'application. Uniformiser les pratiques grâce à des règles de prescription internationales comme les recommandations Eva-Gec-Estro est nécessaire pour améliorer la qualité et la comparaison des traitements.
Based on therapeutic approach for benign diseases, vascular brachytherapy decreases smooth vascular muscle cells proliferation and multiplication which lead to the formation of the neo-intima. The radioactive positive action affects arterial recoil due to post angioplasty vessel injury. Randomised studies has shown good angiographic results up to 6 months of follow-up, with 50% in-stent restenosis rate decrease and on the analysed segment as well. Decrease on Mace and TLR show statistically significance. Results don't correlate with emitter and bêta emitters had been introduced in France recently. Vascular brachytherapy is actually indicated for in-stent restenosis, there is no evidence to perform this treatment for de novo lesion. Geographic miss, source centering, late thrombosis and pullback procedure may interfere with treatment quality. IVUS allows best target volume determination to a higher quality level. Internationals guidelines such as Eva-Gec-Estro recommendations could increase treatment safety and enable development of an optimal technique.
External beam radiotherapy in the treatment of extensive vascular malformation of the lower extremity refractory to surgery and interventional embolisation therapy
2009, Journal of Radiotherapy in Practice

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Coronary artery radiation therapy for the prevention of restenosis after percutaneous coronary angioplasty, II: Outcomes of clinical trials

Cardiovasc Radiat Med

Int J Rad Oncol Biol Phys

Cardiovasc Radiat Med

Int J Radiat Oncol Biol Phys

Restenosis: The scope of the problem

Long-term angiographic and clinical outcome after percutaneous transluminal coronary angioplasty and intracoronary radiation therapy in humans

Circulation

Basis of endovascular radiation therapy in human coronary arteries

Semin Interv Cardiol

Feasibility of intracoronary b-irradiation to reduce restenosis after balloon angioplasty

Circulation

Intraarterial beta irradiation to reduce restenosis after PTCA. Experimental and clinical experience

Herz

Catheter-based radiotherapy to inhibit restenosis after coronary stenting

N Engl J Med

Two-year follow-up after catheter based radiotherapy to inhibit coronary restenosis

Circulation

Three-year clinical and angiographic follow-up after coronary radiation: Results of a randomized clinical trial

Circulation

Radiation therapy to inhibit restenosis: Early clinical results

Mt Sinai J Med

Localized intracoronary gamma-radiation therapy to inhibit the recurrence of restenosis after stenting

N Engl J Med

Gamma-I Results Update

Results of Betacath Trial

Peripheral Trials

Results of START Trial

START Trial: START Subanalyses, START 40 Interim

Update of START Results

Update of INHIBIT Trial