Treatment Of Diffuse In-stent Restenosis Research Articles

Six-Year Clinical Follow-up After Treatment of Diffuse In-Stent Restenosis With Cutting Balloon Angioplasty Followed by Intracoronary Brachytherapy With Liquid Rhenium-188-Filled Balloon via Transradial Approach

Long-term follow-up studies revealed a significant decline in the benefits of intracoronary radiation for in-stent restenosis. A total of 25 study and 25 contemporaneous control patients with diffuse in-stent restenosis who underwent cutting balloon angioplasty (CBA) transradially, followed by subsequent intracoronary irradiation with a liquid β-emitter Rhenium-188 (¹⁸⁸Re)-filled balloon were enrolled in the study. The mean clinical follow-up durations were 64.9 ± 13.0 and 66.3 ± 13.8 months for the irradiated and control patients, respectively. Six-month angiographic restenosis was observed in 16% (4 of 25) of the patients in the irradiated group and 48% (12 of 25) of the patients in the control groups (P = 0.03). The 6-month major adverse cardiac events (MACE) rate was 12% and 44%, respectively (P = 0.025). The 3-year follow-up angiography was performed in 16 of 21 (76%) irradiated patients and in 4 of 13 (31%) control patients who had no significant restenosis at the 6-month angiographic follow-up. Restenosis occurred in 1 of 16 (7%) irradiated patients and 2 of 4 (50%) control patients. Late target lesion revascularization was performed in 1 irradiated and 2 control patients. The MACE rate within 6 years was significantly reduced in the irradiated group (20% vs. 56%, P = 0.019). Brachytherapy using ¹⁸⁸Re-filled balloon following CBA for diffuse in-stent restenotic native coronary arteries is effective in reducing target lesion restenosis and improving long-term outcomes.

Short- and long-term outcomes after treatment of diffuse in-stent restenosis with cutting balloon angioplasty followed by intracoronary β-irradiation with liquid rhenium-188-filled balloon via transradial approach

A one-step radiolabeling procedure of highly magnetic particles with the therapeutic β-emitter rhenium-188 (188Re) has been developed. Magnetic targeted carriers (MTCs) are composites of metallic iron and activated carbon that can be labeled in the presence of the reducing agent SnCl2. As MTCs are effectively targeted to solid tumors, the 188Re-MTC complex has the potential to deliver therapeutically relevant doses of radiation to tumors while minimizing radiation exposure to surrounding tissues or organs.

Comparison between drug-eluting stents and beta-radiation for the treatment of diffuse in-stent restenosis: Clinical and angiographic outcomes

Initial reports on drug-eluting stents (DES) for the treatment for in-stent restenosis (ISR) show very good outcomes. Nevertheless, few data are available on direct comparison with intracoronary brachytherapy (IBT). The aim of this study was to compare brachytherapy and DES in treatment of diffuse ISR. One hundred forty-one consecutive patients with diffuse ISR were treated with IBT (68 patients; beta (90Sr/90Y) emitters) or with DES (73 patients; 32 with sirolimus-eluting and 41 with paclitaxel-eluting stents). Angiographic and clinical follow-up was scheduled within 9 months. The first 74 lesions were treated with IBT (group 1) and the latter 74 with DES (group 2). The two groups were well matched for clinical/angiographic characteristics. At follow-up, restenosis rates were 37.8% (28/74) in IBT group and 14.9% (11/74) in DES group (P = .0028). A diffuse pattern of recurrence was more frequent after IBT (20/74 vs 6/74, P = .005). A worse outcome after IBT was associated with the "edge effect," accounting for most failures. Recurrence within the original restenotic stent was similar in both groups (12.9% vs 14.9% in groups 1 and 2 respectively, P = .8). Drug-eluting stents are more effective than IBT with beta-irradiation in reducing recurrence rates after treatment of diffuse ISR. In case of failure, the pattern of restenosis is more benign after treatment with DES.

Randomized comparison between intracoronary β-radiation brachytherapy and implantation of paclitaxel-eluting stents for the treatment of diffuse in-stent restenosis

Background and purpose Intracoronary brachytherapy was the primary therapeutic option for the treatment of in-stent restenosis (ISR) during the last years. Especially for the treatment of diffuse ISR (lesions >10 mm), β-source brachytherapy was significantly superior to singular balloon angioplasty. Despite lacking clinical database, the implantation of drug eluting stents recently became a common procedure for the treatment of ISR. This randomized trial aimed to compare the efficacy of β-brachytherapy with β-radioisotopes 90Sr/ 90Y and paclitaxel-eluting stent implantation for the treatment of diffuse ISR. Material and methods Thirty-seven patients with diffuse ISR were randomly assigned to β-brachytherapy after balloon angioplasty (Beta-Cath™ in 17 patients) or paclitaxel-eluting stent implantation (Taxus-Express2™ in 20 patients). Six-month clinical follow-up was obtained for all patients, while angiographic follow-up was available for 30 patients. Results Binary ISR (restenosis >50%) within target segment was observed in three patients treated with Beta-Cath™, of which one needed target segment revascularisation for recurrent ISR, whereas no significant restenosis occurred in the patients treated with Taxus-Express2™ ( P = 0.037). No further major adverse cardiac (target segment revascularisation, myocardial infarction, death) was found in either group ( P = NS). Stent implantation was the more time-saving (31 ± 11 min versus 60 ± 23 min, P < 0.001) procedure. Conclusions Although this trial revealed a significant reduction of binary restenosis in the Taxus-Express2™ arm, we found no difference in clinical outcome after implantation of paclitaxel-eluting stents for the treatment of diffuse ISR when compared to β-brachytherapy.

Comparison of angiographic and clinical outcomes between rotational atherectomy and cutting balloon angioplasty followed by radiation therapy with a rhenium 188–mercaptoacetyltriglycine–filled balloon in the treatment of diffuse in-stent restenosis

Rotational atherectomy (RA) and cutting balloon angioplasty (CBA) have been shown to effectively dilate in-stent restenosis (ISR). It is not known, however, which of these technique, when followed by beta-radiation, is more effective. Therefore, we performed a prospective randomized study comparing RA and CBA before beta-radiation therapy for diffuse ISR. Patients with diffuse ISR were randomly assigned to receive RA (group 1, n = 58) or CBA (group 2, n = 55) before beta-radiation therapy with a rhenium 188-mercaptoacetyltriglycine-filled balloon, with the radiation dose being 18 Gy at a depth of 1.0 mm into the vessel wall. The primary end point was angiographic restenosis at 6 months, and the secondary end point was major adverse cardiac events (myocardial infarction, death, target lesion revascularization) at 9 months. The 2 groups were similar in baseline characteristics. Mean lesion length was 21.0 +/- 11.2 mm in group 1 and 20.8 +/- 10.2 mm in group 2 (P = .77). Radiation was delivered successfully to all patients. We obtained 6-month angiographic follow-up in 90 patients (80%). The rates of angiographic restenosis were 14.9% (7 of 47) in group 1 and 14.0% (6 of 43) in group 2 (P = .89). No patient experienced myocardial infarction or death during the 9-month follow-up period. Rates of target lesion revascularization or major adverse cardiac events were 3.4% in group 1 and 3.6% in group 2 (P = .94) during the 9-month follow-up. Either RA or CBA, followed by beta-radiation using a rhenium 188-mercaptoacetyltriglycine-filled balloon, is equally safe and effective for diffuse ISR in 6-month angiographic and 9-month clinical outcomes.

Comparison of angiographic and clinical outcomes between rotational atherectomy versus balloon angioplasty followed by radiation therapy with a rhenium-188-mercaptoacetyltriglycine-filled balloon in the treatment of diffuse in-stent restenosis

Background The purpose of this study was to compare the efficacy of rotational atherectomy (RA) with simple balloon angioplasty, prior to beta-radiation therapy with a rhenium-188-mercaptoacetyltriglycine ( 188Re-MAG 3)-filled balloon for diffuse in-stent restenosis (ISR). Methods After completing 50 cases with RA prior to beta-radiation (Group I), we performed optimal balloon angioplasty followed by beta-radiation in the next 53 consecutive patients (Group II) for the treatment of diffuse ISR. The radiation dose was 15 Gy at a depth of 1.0 mm into the vessel wall. Results The baseline clinical and angiographic characteristics were similar between the two groups. The mean length of the lesion was 25.6±12.7 mm in Group I and 22.9±8.6 mm in Group II ( p=0.26). Radiation was successfully delivered to all patients, with a mean irradiation time of 179±55 s. The 6-month angiographic restenosis rate was 10% (5/50) in Group I versus 33% (17/51) in Group II ( p=0.007). No adverse event including myocardial infarction, death, or stent thrombosis occurred during the 1-year follow-up period. The risk of a target lesion revascularization or a major adverse cardiac event was significantly lower in Group I than in Group II (two patients in Group I vs. nine patients in Group II; OR, 0.20; 95% CI, 0.04–0.96; p=0.04). Conclusion Concomitant treatment with rotational atherectomy and beta-irradiation using a 188Re-MAG 3-filled balloon for diffuse ISR has a synergistic effect, in terms of 6-month angiographic restenosis and 1-year cardiac event-free survival.

Long-term outcomes after treatment of diffuse in-stent restenosis with rotational atherectomy followed by beta-radiation therapy with a 188Re-MAG 3-filled balloon

Background: Intracoronary radiation therapy for in-stent restenosis has been demonstrated to reduce restenosis and major adverse cardiac events. However, long-term angiographic and clinical outcomes after beta radiation therapy have not been sufficiently evaluated. Methods: We evaluated the long-term angiographic and clinical outcomes of 50 consecutive patients who had received beta-radiation therapy with a 188Re-MAG 3-filled balloon after rotational atherectomy for diffuse in-stent restenosis (lesion length>10 mm) in native coronary arteries. The radiation dose was 15 Gy at a depth of 1.0 mm into the vessel wall. Results: The mean lesion length was 25.6±12.7 mm. Radiation was delivered successfully to all patients without any procedural or in-hospital complications. At the 6-month angiogram, the restenosis rates was 10% (5/50). There were no major adverse cardiac events (MACE), such as death, myocardial infarction, and target lesion revascularization (TLR) by 6-month follow-up. Long-term clinical follow-up data were obtained in all patients during 30.1±4.5 months. No myocardial infarction and one noncardiac death occurred during follow-up. Two-year follow-up angiogram was performed in 26 (58%) of 45 patients who showed a patent radiation segment at the 6-month angiogram. Significant narrowing of diameter stenosis of more than 50% occurred in 6 (23%) of 26 patients between 6 and 24 months after beta-radiation. Late TLR was performed in 6 patients. The rate of 30-month death-free survival and MACE-free survival were 98.0±2.0% and 86.9±5.0%. Conclusion: Beta-radiation using a 188Re-MAG 3-filled balloon after rotational atherectomy is associated with favorable long-term angiographic and clinical outcomes.

880-2 Randomized comparison of rotational atherectomy and cutting balloon angioplasty followed by radiation therapy with a 188Re-MAG3-filled balloon in the treatment of diffuse in-stent restenosis

880-2 Randomized comparison of rotational atherectomy and cutting balloon angioplasty followed by radiation therapy with a 188Re-MAG3-filled balloon in the treatment of diffuse in-stent restenosis

Long-Term Outcomes after Treatment of Diffuse In-Stent Restenosis with Rotational Atherectomy Followed by Beta-Radiation Therapy with a 188Re-MAG3-Filled Balloon

Long-Term Outcomes after Treatment of Diffuse In-Stent Restenosis with Rotational Atherectomy Followed by Beta-Radiation Therapy with a 188Re-MAG3-Filled Balloon

Cutting balloon angioplasty versus rotational atherectomy for treatment of diffuse in-stent restenosis: Multicenter registry in Japan

Cutting balloon angioplasty versus rotational atherectomy for treatment of diffuse in-stent restenosis: Multicenter registry in Japan

804 Long-term efficacy of intracoronary beta-radiation for treatment of diffuse in-stent restenosis: evidence for late restenosis

804 Long-term efficacy of intracoronary beta-radiation for treatment of diffuse in-stent restenosis: evidence for late restenosis

Treatment of Diffuse In-Stent Restenosis Combined with Cutting Balloon Angioplasty and Intracoronary Holmium Brachytherapy

Treatment of Diffuse In-Stent Restenosis Combined with Cutting Balloon Angioplasty and Intracoronary Holmium Brachytherapy

A prospective single-center registry for the use of intracoronary gamma radiation in patients with diffuse in-stent restenosis.

Based on single-center prospective registry data, the study evaluates short- and long-term results of intracoronary gamma radiation in patients with diffuse in-stent restenosis in the reality of routine clinical practice. Percutaneous coronary intervention and subsequent catheter-based irradiation with iridium-192 was performed in 84 vessels (81 patients) with diffuse in-stent restenosis. Repeat coronary angiography was performed in 35 patients with clinical restenosis. With a mean follow-up of 12.0 +/- 0.5 months, major adverse cardiac events were observed in 29 (34.5%) patients, including 2 cases of cardiac death, 3 myocardial infarctions, 21 target lesion revascularizations, and 4 target vessel revascularizations. Five of six patients with total occlusion of the target vessel at baseline developed target lesion restenosis. Late total occlusion of the target vessel was observed in four patients. The 1-year event-free survival rate was 69.8%. Total occlusion of the target vessel at baseline was the single independent predictor of cardiac events at 1-year follow-up (P < 0.001). In patients with a target lesion in the left anterior descending artery, predictors of cardiac events also included female sex (P = 0.014), current smoking (P = 0.014), stenting during brachytherapy session (P = 0.02), and smaller reference vessel diameter at baseline (P = 0.01). The results of our registry are similar to those of randomized trials. As applied in routine clinical practice, intracoronary gamma radiation is a feasible, safe, and effective tool in the treatment of diffuse in-stent restenosis. Late events in the entire group were predicted by total occlusion at baseline.

Early lumen loss after treatment of diffuse in-stent restenosis: after one-hour study using intracoronary ultrasound

Early lumen loss after treatment of diffuse in-stent restenosis: after one-hour study using intracoronary ultrasound

Treatment of diffuse in-stent restenosis with rotational atherectomy followed by radiation therapy with a rhenium-188-mercaptoacetyltriglycine-filled balloon

Treatment of diffuse in-stent restenosis with rotational atherectomy followed by radiation therapy with a rhenium-188-mercaptoacetyltriglycine-filled balloon

Quantitative angiographic methods for appropriate end-point analysis, edge-effect evaluation, and prediction of recurrent restenosis after coronary brachytherapy with gamma irradiation

ObjectivesThe study was done to investigate the relationship between clinical restenosis and the relative angiographic location of the recurrent restenotic lesion, after treatment of in-stent restenosis with vascular brachytherapy in the Washington Radiation for In-Stent Restenosis Trial (WRIST). BackgroundIntracoronary radiation therapy reduces recurrence of in-stent restenosis. We investigated the above objective in patients enrolled in WRIST. MethodsThe WRIST study randomized 130 patients to double-blinded therapy with gamma irradiation (iridium-192 [192Ir]) versus placebo after interventional treatment of diffuse in-stent restenosis. After the intervention and at follow-up, three vessel segments were individually analyzed with quantitative coronary angiography: 1) the “stent,” 2) the “radiation ribbon,” and 3) the “ribbon+margin” segment (including 5 mm on either end of the injured or radiation-ribbon segment). Receiver operator curves (ROC) were used to assess the value of the follow-up percent diameter stenosis (DS) for each of the three analyzed segments in predicting target vessel revascularization (TVR). Results192Ir reduced recurrent restenosis (23.7% vs. 60.7%, p < 0.001) and the length of recurrent restenosis (8.99 ± 4.34 mm vs. 17.54 ± 10.48 mm, p < 0.001) at follow-up compared to placebo. Isolated stent edge (3.4%) and ribbon edge (1.7%) restenoses were infrequent in both groups. The best angiographic surrogate of TVR was the 50% follow-up DS obtained from the ribbon+margin analysis (ROC area 0.806). ConclusionsIn WRIST, not only was 192Ir therapy effective in reducing restenosis, but it also reduced the lesion length of treatment failures by 50%, and it was not associated with edge proliferation. The restenosis rate obtained from the vessel segment inclusiveof the dose fall-off zones was the best correlate of TVR and should become a standard analysis site in all vascular brachytherapy trials.

Treatment of diffuse in-stent restenosis with rotational atherectomy followed by radiation therapy with a rhenium-188–mercaptoacetyltriglycine-filled balloon

OBJECTIVESThis study was done to evaluate the feasibility and efficacy of beta-radiation therapy with a rhenium-188–mercaptoacetyltriglycine (188Re-MAG3)-filled balloon after rotational atherectomy for diffuse in-stent restenosis (ISR).BACKGROUNDRotational atherectomy has been shown to be safe and efficient for the treatment of ISR, but the recurrence rate is still high. Intracoronary beta-irradiation after rotational atherectomy may be a reasonable approach to prevent recurrent ISR.METHODSFifty consecutive patients with diffuse ISR (length >10 mm) in native coronary arteries underwent rotational atherectomy and adjunctive balloon angioplasty, followed by beta-irradiation using a 188Re-MAG3–filled balloon catheter. The radiation dose was 15 Gy at a depth of 1.0 mm into the vessel wall.RESULTSThe mean lengths of the lesion and irradiated segment were 25.6 ± 12.7 mm and 37.6 ± 11.2 mm, respectively. Radiation was delivered successfully to all patients, with a mean irradiation time of 201.8 ± 61.7 s. No adverse event, including myocardial infarction, death or stent thrombosis, occurred during the follow-up period (mean 10.3 ± 3.7 months), and nontarget vessel revascularization was needed in one patient. The six-month binary angiographic restenosis rate was 10.4%, and the loss index was 0.17 ± 0.31.CONCLUSIONSBeta-irradiation using a 188Re-MAG3–filled balloon after rotational atherectomy is safe and feasible in patients with diffuse ISR, and it may improve their clinical and angiographic outcomes. Further prospective, randomized trials are warranted to evaluate the synergistic effect of debulking and irradiation in patients with diffuse ISR.

Three-year follow-up after rotational atherectomy for the treatment of diffuse in-stent restenosis: predictors of major adverse cardiac events.

Restenosis remains the major limitation of coronary stent implantation, especially in diffuse forms of in-stent restenosis. In this study, rotablation (RA) with adjunct angioplasty of in-stent restenosis was performed in 84 patients. Clinical follow-up and control angiography were obtained 6-month postprocedure. The rate of recurrent restenosis after rotablation for in-stent restenosis at 6-month angiographic follow-up was 45%, resulting in a rate of major adverse cardiac events of 35%. At 3-year follow-up, the cumulative event-free survival rate was 57% for the entire population. The only predictor of MACE at 3-year clinical follow-up by multivariate logistic regression analysis was in-stent lesion length. RA for the treatment of diffuse in-stent restenosis is thereby characterized by high procedural success rates and recurrent angiographic restenosis in 45% of patients with diffuse lesions. Major adverse cardiac events occur most likely within the first 6 months postprocedure. Three years after rotablation of in-stent restenosis, 43% of patients had experienced at least one major adverse cardiac event. Cathet Cardiovasc Intervent 2001;53:334-340.

Treatment of diffuse in-stent restenosis with rotational atherectomy followed by radiation therapy with a 188Re$z.sbnd;MAG3-filled balloon (R4 trial): QCA analysis Seong-Wook Park, Myeong-Ki Hong, Dae-Hyuk Moon, Seung-Jun Oh, Sung-Tae Cho, Cheol Whan Lee, Jae-Joong Kim, Seung-Jung Park. Asan Medical Center, Seoul, South Korea

Treatment of diffuse in-stent restenosis with rotational atherectomy followed by radiation therapy with a 188Re$z.sbnd;MAG3-filled balloon (R4 trial): QCA analysis Seong-Wook Park, Myeong-Ki Hong, Dae-Hyuk Moon, Seung-Jun Oh, Sung-Tae Cho, Cheol Whan Lee, Jae-Joong Kim, Seung-Jung Park. Asan Medical Center, Seoul, South Korea

The impact of cutting balloon angioplasty for the treatment of diffuse in-stent restenosis. Comparison with conventional balloon angioplasty Raisuke Iijima, Masato Nakamura, Yoko Kitagawa, Rintaro Nakajima, Takashi Yoshitama, Takuro Takagi, Hitoshi Anzai, Tarou Tunoda, Tetsu Yamaguchi. Third Department of Internal Medicine Toho University School of Medicine, Tokyo, Japan

The impact of cutting balloon angioplasty for the treatment of diffuse in-stent restenosis. Comparison with conventional balloon angioplasty Raisuke Iijima, Masato Nakamura, Yoko Kitagawa, Rintaro Nakajima, Takashi Yoshitama, Takuro Takagi, Hitoshi Anzai, Tarou Tunoda, Tetsu Yamaguchi. Third Department of Internal Medicine Toho University School of Medicine, Tokyo, Japan