Long-term outcomes after treatment of diffuse in-stent restenosis with rotational atherectomy followed by beta-radiation therapy with a 188Re-MAG3-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-MAG3-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-MAG3-filled balloon after rotational atherectomy is associated with favorable long-term angiographic and clinical outcomes.     

Results of intracoronary beta-brachytherapy administered by 60 mm transfer device/radiation source train: a subgroup analysis from the RENO registry

To investigate the safety and efficacy of a 60 mm transfer device, delivering 60 mm radiation source train, in the treatment of coronary lesions by b-brachytherapy employing the BetaCath system (Novoste, Norcross, Georgia). METHODS AND RESULTS: As part of the REgistry NOvoste (RENO), the first large-scale registry of intracoronary beta-radiation applied in routine clinical practice, 46 centers registered 1,098 consecutive patients undergoing brachytherapy with the BetaCath system. Of these, 49 patients with 56 lesions were treated with a 60 mm transfer device/radiation source train (TD/RST) in at least 1 vessel, constituting the study population. With 75.4% in-stent restenosis (ISR), 3.6% graft lesions, long lesions (30.9 +/- 14.7 mm) and 19% diabetes, the cohort had a high-risk for recurrence. The in-hospital major adverse cardiac event (MACE) rate was 4.1%. The 6-month follow-up revealed 2.0% death, 4.1% myocardial infarction, 8.2% target vessel revascularization, 12.2% MACE, 82.6% improved angina, 16.7% binary restenosis and 4.1% late thrombosis. The results were comparable to all other patients in the registry treated with standard source lengths of 30 mm and 40 mm, although much longer lesions were treated by the 60 mm device (18.4 +/- 11.3 mm versus 30.9 +/- 14.7 mm; p < 0.0001). In the ISR subgroup (mean lesion length, 32.03 +/- 14.99 mm), the 6-month MACE rate was 12.8%, while the angiographic restenosis rate was 16.0% and the late thrombosis rate was 2.6%. CONCLUSION: Beta-brachytherapy with 60 mm TD/RST was safe, feasible and effective in this broad population of high-risk patients presenting in day-to-day practice. Its efficacy in long-segment ISR, where conventional interventional strategies have poor outcome rates, is particularly noteworthy.     

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-MAG3)-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-MAG3-filled balloon for diffuse ISR has a synergistic effect, in terms of 6-month angiographic restenosis and 1-year cardiac event-free survival.     

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

OBJECTIVES: This study was done to evaluate the feasibility and efficacy of beta-radiation therapy with a rhenium-188-mercaptoacetyltriglycine ((188)Re-MAG(3))-filled balloon after rotational atherectomy for diffuse in-stent restenosis (ISR). BACKGROUND: Rotational 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. METHODS: Fifty 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 (188)Re-MAG(3)-filled balloon catheter. The radiation dose was 15 Gy at a depth of 1.0 mm into the vessel wall. RESULTS: The 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. CONCLUSIONS: Beta-irradiation using a (188)Re-MAG(3)-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.     

Serial intravascular ultrasound analysis after intracoronary beta-radiation in long in-stent restenotic lesions

In-stent restenosis (ISR) represents the major limitation of stent implantation. Treatment, although of relative technical ease, is unsatisfactory due to the high incidence of recurrent restenosis. Long ISR lesions are especially prone to restenosis. Vascular brachytherapy (VBT) has emerged as a powerful adjunct therapeutic modality to treat ISR. However, VBT may be less effective in very long, diffuse ISR lesions. The present study investigated serial changes of the extent and distribution of neointima formation after beta-radiation as assessed by intravascular ultrasound (IVUS). Following interventional procedures of long ISR in 30 patients, a 40 mm or 60 mm non-centered 90Sr/90Y seed train was used for VBT. Serial (post radiation (PR) and follow-up (FU)) quantitative coronary angiography (QCA) measurements of minimal lumen diameter (MLD) and late lumen loss (LLL) and intravascular ultrasound measurements (IVUS) of cross-sectional areas of the lumen (L-CSA), stent (S-CSA) and intimal hyperplasia (IH-CSA) were performed and compared with historic controls. LLL (0.34 +/- 0.27 mm; p = 0.196), mean decrease of L-CSA (-1.0 +/- 0.8 mm2; p = 0.024) and mean increase of IH-CSA (0.5 +/- 1.3 mm2; p = 0.038) in long ISR were comparable with previously reported results of short ISR. In conclusion the average changes of lumen and intimal hyperplasia after beta-radiation of long ISR are similar to those of short ISR.     

Three-year follow-up after intracoronary beta-radiation therapy for in-stent restenosis.

BACKGROUND: Most studies that proved intracoronary radiation therapy (IRT) to be highly effective to reduce recurrent restenosis after treatment of in-stent restenosis (ISR) have looked at time periods up to 12 months. Whether the beneficial effect from radiation is sustained during long-term follow-up remains a concern. This study sought to evaluate the effectiveness of IRT using a beta-emitter during a 3-year follow-up period. METHODS: One hundred twenty-eight consecutive symptomatic patients (mean age, 63 +/- 11 years) with 134 in-stent restenotic lesions were treated for ISR with IRT (noncentred beta-emitter, Novoste; radiation dosis 21.1 +/- 3.1 Gy). Six-month angiographic follow-up was obtained in 104 patients (81%) with 105 lesions (78%). All patients underwent 36-month clinical follow-up. RESULTS: Six-month angiographic restenosis rate was 22% in stent (29% in lesion) with an in-stent late loss of 0.49 +/- 0.62 mm. Target lesion resvascularization (TLR) at 6-month follow-up was performed in 23 cases (18%). MACE (death, myocardial infarction, and target vessel revascularisation) was observed in 24 patients (19%). At 36-month follow-up, TLR increased to 36 cases (28%) and MACE was observed in 47 patients (37%). In a multivariate analysis, minimal lumen diameter before treatment of ISR using IRT was the only predictor of recurrent TLR at 36 months (OR = 0.131; 95% CI, 0.068-0.254; p = 0.002). In a subgroup of patients (N = 15) without restenosis at 6-month angiography but with clinically driven recurrent late angiography (mean, 18 +/- 7 months); in-lesion late loss increased from 0.47 +/- 0.54 mm at 6 months to 1.27 +/- 0.76 mm at repeated angiography (p = 0.005). CONCLUSION: There is a considerable number of delayed recurrent restenosis post IRT for ISR. This is due to ongoing late loss more than 6-month post IRT. The minimal lumen diameter before IRT predicts the need for recurrent TLR at 36 months.     

Comparison of a centered P source wire system with a noncentered Sr/Y brachytherapy system for intracoronary β-radiation following PCI of diffuse in-stent restenosis

BACKGROUND: We investigated the potential impact of differences in effective radiation dose between the centered Guidant 32P source wire system and the noncentered Novoste 90Sr/Y BetaCath system on clinical and angiographic outcomes of intracoronary brachytherapy for the prevention of in-stent restenosis. METHODS: From 10/00 to 05/04, a total of 400 patients underwent percutaneous coronary intervention (PCI) with brachytherapy for diffuse in-stent restenosis at our institution. Following balloon dilatation, patient Group A (n=200) was treated with the centered 32P Galileo source wire system, patient Group B (n=200) was treated with the noncentered 90Sr/Y BetaCath radiation system. In Group A, the prescribed dose of 20 Gy was applied in 1-mm depth of the vessel wall. In Group B, the prescribed dose of 18.4 Gy was applied for visual reference vessel sizes >2.7 and <3.35 mm, 23 Gy for >3.36 and <4.00 mm, and 25.3 Gy for >4.00 mm, each calculated at a distance of 2 mm from the center line of the radiation source. Patients received aspirin and clopidogrel over 12 months. Primary endpoint was target lesion revascularization (TLR) at 6 months. Secondary endpoints were the binary restenosis rate and major adverse cardiac event (MACE) at 30 days and 6 months. RESULTS: At 30 days, one patient of each group underwent PCI at a nontarget lesion (0.5%). At 6 months, MACEs were equally distributed in both groups. Target lesion revascularization at 6 months was 5.9% in Group A and 9.2% in Group B (P=.08). Binary angiographic restenosis rate at 6 months was 5.5% in Group A and 11.2% in Group B (P=.014). CONCLUSION: Intracoronary beta-radiation using the centered 32P source wire system yielded a significant reduction of recurrence rate compared to the noncentered 90S/Y BetaCath system after PCI of diffuse in-stent restenosis. There was a nonsignificant trend toward reduction of TLR among patients treated with the centered 32P source wire system.     

Long-term clinical and angiographic outcome of patients with occlusive in-stent restenosis treated with (32P) beta-brachytherapy.

The objective of this study was to determine the safety and efficacy of (32)P beta-brachytherapy in totally occlusive in-stent restenosis (ISR). Patients with occlusive ISR were generally excluded from the randomized clinical trials on intracoronary brachytherapy (utilizing either gamma- or beta-sources) that have shown reductions in restenosis rate and need for revascularization procedures. We analyzed short- and long-term effects of (32)P beta-brachytherapy (20 Gy) in 27 patients (28 lesions) with occlusive ISR and 84 (99 lesions) patients with nonocclusive high-risk ISR. The primary outcome measure was frequency of in-lesion angiographic binary restenosis at 7 months. Secondary endpoints were rates of major adverse cardiac events (MACE), target vessel revascularization (TVR), clinically driven TVR, and target lesion revascularization (TLR). (32)P beta-brachytherapy was feasible and safe and provided similar postprocedural angiographic results in the two clinically comparable groups. However, the 7-month binary restenosis rate was higher in the occlusive group, as were the MACE and late total occlusion rates. Multivariate logistic analysis of the overall population indicated occlusive pattern to be the only independent predictor of angiographic restenosis. In both groups, recurrent lesions most often showed a focal pattern with significant reduction of length. Although safe and effective in high-risk ISR, (32)P brachytherapy at 20 Gy does not appear to be sufficient to avoid long-term restenosis in patients with occlusive lesions. Further studies should determine the most suitable source and dosage of brachytherapy for patients with occlusive ISR.     

Clinical outcome following combination of cutting balloon angioplasty and coronary beta-radiation for in-stent restenosis: a report from the RENO registry

At present, vascular brachytherapy is the only efficient therapy for in-stent restenosis. Nevertheless, edge restenosis often related to geographical miss has been identified as a major limitation of the technique. The non-slippery cutting balloon has the potential to limit vascular barotraumas, which, together with low-dose irradiation at both ends of the radioactive source, are the prerequisite for geographical miss. This prospective study aimed to examine the efficacy of combining cutting balloon angioplasty and brachytherapy for in-stent restenosis. The Radiation in Europe NOvoste (RENO) registry prospectively tracked all patients who had been treated by coronary beta-radiation with the Beta-Cath System (Novoste Corporation, Brussels, Belgium) but were not included in a randomized radiation trial. A subgroup of patients with in-stent restenosis treated by cutting balloon angioplasty and coronary beta-radiation (group 1, n = 166) was prospectively defined, and clinical outcomes of patients at 6 months were compared with those of patients treated by conventional angioplasty and coronary beta-radiation (group 2, n = 712). At 6-month follow-up, there was a significant difference between groups 1 and 2 in target vessel revascularization (10.2% versus 16.6% respectively; p = 0.04) and in the incidence of major adverse clinical events (MACE) including death, myocardial infarction, and revascularization (10.8% versus 19.2%; p = 0.01). This observation was confirmed by a multivariate analysis indicating a lower risk for MACE at 6 months (odds ratio: 0.49; confidence intervals: 0.27 0.88; p = 0.02). Compared to conventional angioplasty, cutting balloon angioplasty prior to coronary beta-radiation with the Beta-Cath System seems to improve the 6-month clinical outcome in patients with in-stent restenosis.     

Optimizing dosimetry with high-dose intracoronary gamma radiation (21 Gy) for patients with diffuse in-stent restenosis

BACKGROUND: The efficacy of intracoronary gamma radiation (IRT-gamma) in reducing recurrent in-stent restenosis (ISR) is well established using doses of 14-18 Gy. We sought to examine whether an escalation in dose to 21 Gy is safe and confers additional benefit in reducing repeat revascularization and major adverse cardiac events (MACE) in patients with diffuse ISR. METHODS: Forty-seven patients with diffuse ISR (lesion length 20-80 mm) in native coronary arteries (n=25) and saphenous vein grafts (n=22) underwent percutaneous transluminal coronary angioplasty and/or additional stents followed by IRT-gamma using the Checkmate system (Cordis) with a dose of 21 Gy. All patients were discharged with clopidogrel for 12 months and aspirin indefinitely. Six-month angiographic and 12-month clinical outcomes of these patients were compared to 120 patients treated with 18 Gy using the same system. RESULTS: At baseline, patients in the 21-Gy group had more multivessel, vein graft disease and history of prior myocardial infarctions and coronary artery bypass grafts (P<.001). The use of debulking devices and stents was less in this group (P<.001). Procedural and in-hospital complications were similar. Follow-up at 6 months revealed nonsignificant but lower late loss (in-stent, 0.33+/-0.7 mm; in-lesion, 0.41+/-0.6 mm) in the 21-Gy group compared to the 18-Gy group; follow-up at 12 months revealed a trend toward less overall myocardial infarction, although repeat revascularization and MACE rates were similar. CONCLUSIONS: IRT-gamma therapy for diffuse ISR lesions with a 21-Gy dose is clinically safe and feasible with marked reduction in late loss but does not confer additional benefit with regard to repeat revascularization and MACE when compared to a dose of 18 Gy.     

Repeat intracoronary beta-brachytherapy using a rhenium-188-filled balloon catheter for recurrent restenosis in patients who failed intracoronary radiation therapy.

BACKGROUND: Conventional percutaneous coronary intervention (PCI) in restenotic lesions after brachytherapy failure is associated with a high recurrence rate of restenoses and revascularizations. Intracoronary brachytherapy using a liquid rhenium-188-filled balloon in de novo or restenotic lesions safely and effectively reduced restenosis rates. We report clinical and angiographic data regarding the safety and efficacy of rhenium-188 brachytherapy in restenoses after brachytherapy failure. METHODS: Fourteen patients with restenosis after brachytherapy failure received rhenium-188 beta-brachytherapy. Follow-up was performed angiographically after 6 months and clinically after 12 months. Primary clinical endpoint was the incidence of major adverse cardiac events (MACE) defined as any death, myocardial infarction or repeat revascularization in the target vessel within 12 months. Secondary angiographic endpoints were the binary restenosis rate and late loss in the total segment including edge effects at 6 months. RESULTS: The prescribed dose of 22.5 Gy (n=12) or 30 Gy (n=2) was successfully delivered in all patients. In two lesions, a bare-metal stent was implanted. The mean length of the irradiated segment was 40.0+/-15.7 mm. The mean diameter of the irradiation balloon was 2.96+/-0.37 mm. Angiographic follow-up was done in 13 of 14 patients. There was no edge stenosis or coronary aneurysm. Within the total segment, late loss was 0.39+/-0.64 mm and late loss index was 0.18+/-0.40 with a binary restenosis rate of 23%. Twelve months' clinical follow-up was available in all patients, which showed a MACE rate of 7% due to one target lesion revascularization (TLR). CONCLUSIONS: Intracoronary beta-brachytherapy with a liquid rhenium-188-filled balloon in restenoses after intracoronary radiation therapy failure including 12 months combined antiplatelet therapy is safe with respect to vessel thrombosis, late coronary occlusion or aneurysm formation. With limited use of stenting, angiographic and clinical follow-up for repeat brachytherapy were favorable and it is associated with low restenosis and target vessel revascularization rate.     

Use of Taxus polymer-coated paclitaxel-eluting stents for treatment of in-stent restenosis in real world patients: results of clinical and angiographic follow-up at six months in a single-center registry.

OBJECTIVE: To evaluate the safety and efficacy of Taxus paclitaxel-eluting stents in a real world group of unselected patients with coronary in-stent restenosis (ISR) lesions. METHODS: This is a prospective single-center registry of a consecutive series of 94 patients with 104 ISR lesions, without previous brachytherapy, over a period of 1 year. Quantitative coronary angiographic analyses were performed at baseline and at 6-month angiographic follow-up. Clinical follow-up were obtained at 6 months. RESULTS: Pre-intervention mean reference vessel diameter was 2.62 +/- 0.50 mm and mean lesion length was 13.95 +/- 6.78 mm. Baseline ISR patterns were mostly either Type I focal (32.7%) or Type II diffuse intrastent (48.1%). At 6-month angiographic follow-up, the in-stent and in-segment binary restenosis was 3.8% (4/105) and 7.6% (8/105) respectively, and the in-stent and in-segment late loss was 0.30 +/- 0.50 mm and 0.57 +/- 0.54 mm, respectively. Seven of these eight restenosed lesions had a diffuse or proliferative ISR pattern prior to intervention. Lesions that restenosed had longer mean stent length per lesion (37.3 mm vs. 22.5 mm in nonrestenosed group; P = 0.001) and more likely to have had a pattern of total occlusion pre-intervention (25.0% vs. 3.1% in nonrestenosed group; P = 0.046). At 6-month clinical follow-up, the MACE rate was 8.5% and target lesion revascularization rate was 7.4%. There was no death but subacute stent thrombosis occurred in 1 patient (1.1%) at 3 days after intervention. CONCLUSIONS: Paclitaxel-eluting Taxus stent for the treatment of ISR effectively suppresses recurrent neointimal proliferation, and was safe and efficacious at 6-month follow-up.     

Beta-radiation for coronary in-stent restenosis.

To determine the feasibility and safety of an intracoronary beta-radiation device in preventing the recurrence of in-stent restenosis (ISR) after successful angioplasty, we studied 37 patients treated with beta-radiation (30-mm strontium-90 source) after angioplasty. The mean reference diameter was 2.9 +/- 0.5 mm, and 62% of lesions were diffuse, including four total occlusions. Beta-radiation was successfully delivered in 36 of 37 (97%) cases. Over the course of 7.1 +/- 4.5 mo follow-up, there were no myocardial infarctions and three deaths: one from preexisting malignancy, one from progressive cardiac failure, and one from sudden cardiac death. Target vessel revascularization (TVR) was performed in seven of 36 (19%) patients. Thirty patients underwent angiography at 6 mo; three (10%) experienced restenosis (diameter stenosis > 50%) at the target site, four (13%) had edge stenoses, and two (7%) had late (> 1 mo) thrombotic occlusions. Beta-radiation for ISR is associated with encouragingly low rates of target lesion restenosis and TVR. Further improvements are needed to solve the limitations of the edge effect and late occlusion.     

Intracoronary brachytherapy for in-stent restenosis using long sources reduces restenosis

Edge restenosis (candy wrapper effect) and late thrombosis remain a problem in various randomized intracoronary brachytherapy (ICBT) trials for the treatment of in-stent restenosis (ISR). Target vessel revascularization (TVR) due to target lesion revascularization (TLR) and edge restenosis can be decreased with the use of longer ICBT sources and debulking devices and has not been systematically studied. We analyzed 226 patients with ISR (240 vessels of 264 lesions; average lesion length 17.5+/-8.9 mm) who had lesion debulking followed by 90 Strontium (Sr) beta-irradiation using the Novoste Betacath system (30 mm source in 144 vessels and 40 mm source in 96 vessels). Dual antiplatelet therapy was recommended for one year. At follow-up of 12+/-2 months, clinical TVR occurred in 9.7%, with TLR in 7.1% and non-TLR in 2.6% of cases. There was no delayed or late subacute thrombosis. Beta-irradiation using a longer 90Sr source after lesion modification with cutting balloon (CB) and or rotational atherectomy (RA), along with the use of long-term dual antiplatelet therapy is safe and associated with single-digit clinical restenosis.     

Comparison of six-month angiographic and three-year outcomes after sirolimus-eluting stent implantation versus brachytherapy for bare metal in-stent restenosis

To evaluate long-term effectiveness of sirolimus-eluting stent (SES) implantation for diffuse bare metal in-stent restenosis (ISR), we compared 6-month angiographic and long-term (3-year) clinical outcomes of SES implantation and intracoronary brachytherapy (ICBT). SES implantation for diffuse ISR was performed in 120 consecutive patients and their results were compared with those from 240 patients treated with beta-radiation with balloons filled with rhenium-188 and mercaptoacetyltriglycine. The radiation dose was 15 or 18 Gy at a depth of 1.0 mm into the vessel wall. The primary end point was 3-year major adverse cardiac events including myocardial infarction, cardiac death, and target lesion revascularization. The 2 groups were similar in baseline clinical and angiographic characteristics. Lesion lengths were 25.1 +/- 14.2 mm in the SES group and 24.5 +/- 10.4 mm in the ICBT group (p = 0.15). In-stent acute gain was greater in the SES group than in the ICBT group (2.23 +/- 0.62 vs 1.91 +/- 0.54 mm, p <0.001). We obtained 6-month angiographic follow-up in 287 patients (79.7%). In-segment angiographic restenoses were 7.4% (7 of 94) in the SES group and 26.4% (51 of 193) in the ICBT group (p <0.05). Two myocardial infarctions (1 in each group) and 5 deaths (4 in SES group, 1 in ICBT group) occurred during 3-year follow-up. At 3 years, survival rates without target lesion revascularization (94.1 +/- 2.2% vs 84.6 +/- 2.3%, p = 0.011) and major adverse cardiac events (92.5 +/- 2.4% vs 84.2 +/- 2.4%, respectively, p = 0.03) were higher in the SES than in the ICBT group. In conclusion, compared with ICBT, SES implantation for diffuse ISR is more effective in decreasing recurrent restenosis and improving long-term outcomes.     

Combined cutting balloon angioplasty and intracoronary beta radiation for treatment of in-stent restenosis: clinical outcomes and effect of pullback radiation for long lesions.

Intracoronary beta (beta) radiation decreases the incidence of target lesion revascularization after percutaneous intervention (PCI) for in-stent restenosis (ISR). Cutting balloon (CB) angioplasty may also be superior to other percutaneous techniques for the treatment of ISR. We sought to study the outcomes of patients with ISR who underwent both CB angioplasty and intracoronay beta radiation and compare them to patients with ISR who underwent other PCI techniques without concomitant radiation. We also sought to evaluate the safety and efficacy of pullback intracoronary beta radiation for the treatment of long ISR lesions. Between January 2001 and November 2001, 102 patients (mean age = 55 +/- 13 years) with ISR underwent both CB angioplasty and intracoronay beta radiation. beta radiation was delivered using the Beta Cath (Novoste) 30 mm system, and pullback radiation was performed in 41 patients. A comparison group included a total of 393 patients with ISR who underwent other PCI techniques without concomitant intracoronary radiation therapy. Follow-up was obtained in 99 patients (97%) in the CB angioplasty with intracoronary radiation group and 377 patients (96%) in the comparison group. At follow-up, both target vessel revascularization (TVR) and major adverse cardiovascular events (MACE) occurred significantly less in the CB angioplasty with intracoronary radiation group than in the comparison group (7% vs. 18% for TVR, and 14% vs. 24% for MACE; P < 0.05 for both). In the pullback radiation group, TVR was performed in five patients (12%), and MACE occurred in eight patients (20%). A combination of CB angioplasty and intracoronay beta radiation for ISR seems to yield low rates of subsequent target vessel revascularization and adverse cardiac events. In addition, pullback beta radiation using the Beta Cath (Novoste) 30 mm system is safe and can be used to treat long ISR lesions effectively. Further randomized trials are needed to confirm these findings.     

Routine intracoronary beta-irradiation. Acute and one year outcome in patients at high risk for recurrence of stenosis.

AIMS: Intracoronary radiation is a promising therapy potentially reducing restenosis following catheter-based interventions. Currently, only limited data on this treatment are available. The feasibility and outcome in daily routine practice, however, is unknown. METHODS AND RESULTS: In 100 consecutive patients, intracoronary beta-radiation was performed with a (90)Strontium system (Novoste Beta-Cathtrade mark) following angioplasty. Predominantly complex (73% type B2 and C) and long lesions (length 24.3+/-15.3 mm) were included (37% de novo, 19% restenotic and 44% in-stent restenotic lesions). Radiation success was 100%. Mean prescribed dose was 19.8+/-2.5 Gy. A pullback procedure was performed in 19% lesions. Geographic miss occurred in 8% lesions. Periprocedural thrombus formation occurred in four lesions, dissection in nine lesions. During hospital stay, no death, acute myocardial infarction, or repeat revascularization was observed. Major adverse cardiac events occurred predominantly between 6 and 12 months after the index procedure with major adverse cardiac event-free survival of 66% at 12 months (one death, 10 Q-wave myocardial infarctions, 23 target vessel revascularizations; ranked for worst event). CONCLUSION: Routine catheter-based intracoronary beta-radiation therapy after angioplasty is safe and feasible with a high acute procedural success. The clinical 1-year follow-up showed delayed occurrence of major adverse cardiac events between 6 and 12 months after the index procedure.     

Debulking does not benefit patients undergoing intracoronary beta-radiation therapy for in-stent restenosis: insights from the START trial.

Intracoronary brachytherapy has become the current treatment of choice for patients with in-stent restenosis (ISR). The aim of the present study was to determine whether plaque extraction using debulking techniques prior to brachytherapy would improve the outcomes of patients with ISR. Patients enrolled into the START (n = 476) and START-40 (n = 205) trials were divided into four subgroups according to their treatment assignments: debulking-radiation, debulking-placebo, balloon angioplasty (BA) radiation, and BA placebo. Patients were further divided according to their ISR lesion length: all lesions, > 15 mm, and > 19 mm. Restenosis rates were higher in placebo, nonradiated lesions undergoing debulking (52.7%) vs. BA alone (38.5%; P = 0.04). Postprocedural minimal lumen diameter (MLD) was similar among the subgroups. Outcomes were similar between debulking and BA within each therapeutic arm. MLD after debulking radiation was greater in patients with ISR > 15 mm (post-MLD was 1.9 vs. 1.7 mm; P = 0.06) but not in the placebo. Debulking radiation patients had greater MLD at follow-up, but restenosis (23.5% after debulking vs. 32.7% BA alone) and late loss (0.3 mm in both subgroups) were not statistically different. There was a trend toward higher mortality among debulked patients (3.7%) compared to BA alone (0.8%). In patients with ISR > 19 mm, four patients died following debulking radiation as compared to no death after BA (P = 0.05). Our results do not support the strategy of plaque extraction prior to intracoronary beta-radiation for ISR.