The effect of intracoronary radiation for the treatment of recurrent in-stent restenosis in patients with chronic renal failure

OBJECTIVES: This study was designed to analyze the in-hospital and six-month clinical and angiographic outcomes of patients with chronic renal failure (CRF) treated with intracoronary radiation for the prevention of recurrence of in-stent restenosis. BACKGROUND: Patients with CRF are at a higher risk than the general population for accelerated atherosclerotic cardiovascular disease and for restenosis after percutaneous coronary intervention. Previous studies have shown the effectiveness of both beta and gamma radiation in preventing recurrent restenosis in patients with in-stent restenosis. METHODS: We studied the in-hospital and six-month clinical and angiographic outcomes of 118 patients with CRF and 481 consecutive patients without CRF who were treated with intracoronary radiation for the prevention of recurrence of in-stent restenosis in native coronaries and saphenous vein grafts. RESULTS: Patients with CRF were usually older, women, hypertensive and diabetic, with multivessel disease and with reduced left ventricular function. In-hospital outcome for patients with CRF was marred by a higher incidence of death, non-Q-wave myocardial infarction and major vascular and bleeding complications. At six-month follow-up, the mortality rate was higher in patients with CRF, 7.6% compared with 1.9% in non-CRF patients (p = 0.003). Restenosis, target lesion revascularization (TLR) and target vessel revascularization (TVR) rates were similar in the two groups. In patients with CRF, radiation therapy compared to placebo reduced restenosis (53.8% vs. 22.6%, p = 0.04), TLR (71.4% vs. 15.3%, p < 0.0001) and TVR (78.6% vs. 23.7%, p = 0.0002). CONCLUSIONS: Intracoronary radiation for the prevention of recurrence of in-stent restenosis achieved similar rates of restenosis and revascularization procedures in patients with and without CRF. Despite this benefit, patients with renal dysfunction continued to have significantly higher in-hospital and six-month adverse outcomes.     

Intracoronary radiotherapy with a 188Rhenium liquid-filled angioplasty balloon system in in-stent restenosis: a single-center, prospective, randomized, placebo-controlled, double-blind evaluation

BACKGROUND: In cases of in-stent restenosis, intracoronary radiotherapy with beta-emitters and gamma-emitters has been shown to reduce the risk of repeat restenosis. The present randomised, placebo-controlled study addresses the question of whether intracoronary radiotherapy applied by the easy-to-handle Rhenium liquid-filled angioplasty balloon system is also able to reduce the angiographic re-restenosis rate in stents. METHODS AND RESULTS: At our center, from May 2000 to December 2003, 165 patients (mean age 64+/-10, median 65 years; 127 men, 38 women) with symptomatic in-stent restenosis underwent either intracoronary brachytherapy or sham procedure. Index clinical and angiographic parameters were largely comparable in both groups. Radiation therapy was performed with a standard percutaneous transluminal coronary angioplasty (PTCA) balloon catheter inflated with liquid Rhenium in the redilated in-stent restenosis for 240-890, mean 384+/-125 s with low pressure (3 atm) in order to reach 30 Gy at 0.5 mm depth of the vessel wall. In 82 patients, intracoronary radiotherapy was carried out without complications, but one of the 83 patients who underwent sham procedure suffered small myocardial infarction. During follow-up, stent thrombosis with subsequent non-Q-wave myocardial infarction occurred in one patient in each group (6 days and 8 months after the procedure, respectively). At 6 months after the index procedure, repeat angiography was performed in 156 of the 164 patients with successful procedure (rate 95%): restenosis (stenosis >50% in diameter) or reocclusion was observed in only 19 of 78 (=24%) patients of the radiation but in 31 of 78 (=40%) patients of the sham procedure group (P=0.04). Event-free survival (free of death, myocardial infarction, target vessel revascularization) at 1 year was 87% for patients being radiated and 74% for patients having undergone sham procedure (P=0.05). CONCLUSIONS: Intracoronary radiation therapy with the liquid-filled beta-emitting Rhenium balloon is not only easy to perform, safe, and comparably inexpensive but also an effective option to prevent repeat restenosis and the need for target vessel revascularization in cases of in-stent restenosis.     

Coronary Stenting with the Sirolimus-Eluting Stent in Clinical Practice: Final Results from the Prospective Multicenter German Cypher Stent Registry

Aims: Drug-eluting coronary stents (DES) have gained widespread use for the treatment of coronary artery disease. However, because of safety concerns and frequent "off-label" use data from "real life," registries are necessary to monitor indications and outcome of DES in daily clinical practice.
Methods and Results: We evaluated data from the German Cypher Stent Registry. A total of 10,894 patients treated with at least one sirolimus-eluting stent (SES) at 152 hospitals were included. Follow-up at a median of 6.4 months was available in 10,006 patients (92%). Median age was 64.8 years and 75.5% were male. Per lesion a mean of 1.09 ± 0.41 SES were implanted with a mean length of 21.1 ± 11.5mm. During follow-up, death rate was 1.8% and the rates of myocardial infarction or stroke were 2.1% and 0.5%. Any target vessel revascularization (TVR) was performed in 8.0% of patients. Independent predictors for death, myocardial infarction, or stroke were: cardiogenic shock, acute coronary syndromes, reduced left ventricular function, renal insufficiency, diabetes mellitus, advanced age, three-vessel disease, degree of stenosis, and prior myocardial infarction. Predictors for a TVR were: two- or three-vessel disease, target vessel = coronary bypass, advanced age, stent diameter, ostial lesions, indication in-stent restenosis, renal failure, and target vessel = left anterior descended artery.
Conclusions: These results demonstrate that SES use in clinical practice is safe and effective. The main predictors of clinical events during follow-up are clinical parameters whereas as predictors of TVR mainly are angiographic parameters. (J Interven Cardiol 2010;23:18–25)     

Long-Term Clinical Follow-up after Sirolimus-Eluting Stent versus Bare Metal Stent Implantation in Patients with Acute Coronary Syndrome

Background and Objective: Drug-eluting stents have been shown to reduce the incidence of restenosis and target vessel revascularization (TVR) compared with bare metal stents (BMSs); however, the long-term efficacy of sirolimus-eluting stent (SES) implantation in patients with acute coronary syndrome (ACS) has not been well established. We have investigated the long-term clinical outcome of SES in patients with ACS.
Methods: Consecutive 245 patients with ACS treated by primary stenting within 24 hours after onset were enrolled. There were 128 patients treated with SES and 117 patients were treated with BMS. We evaluated the incidence of major cardiac events (MACE; total death, nonfatal myocardial infarction, TVR) at 3 years, comparing with 8-month clinical outcome.
Results: Eight-month clinical follow-up shows a significantly lower incidence of TVR in the SES group, 3.1% in the SES group versus 9.4% in the BMS group (P = 0.04). At 3-year clinical follow-up, there was no significant difference in the rate of TVR between the two groups, 8.4% versus 12.4% (P = 0.37). Cumulative incidence of total MACE was 9.2% in the SES group compared with 15.9% in the BMS group (P = 0.18). Only one case of stent thrombosis was observed in the SES (late thrombosis), while two cases of stent thrombosis occurred in the BMS group (late and very late thrombosis; P = 0.55).
Conclusion: SES implantation in patients with ACS is associated with favorable long-term clinical outcome with no excess of late stent thrombosis. Further long-term clinical follow-up will be warranted to confirm the safety and efficacy of SES.     

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.     

药物洗脱支架在冠心病介入治疗中的有效性与安全性研究

目的评价药物洗脱支架在冠心病介入治疗中的有效性和安全性。方法回顾性分析复旦大学附属华山医院心内科2003年11月～2006年12月应用药物洗脱支架的346例冠心病患者,收集15～52个月的临床资料,评价经皮冠脉介入治疗（PCI）术后临床症状的改善情况;主要心脏不良事件（MACE）。MACE包括心源性死亡、非致命性心肌梗死和靶血管重建（TVR）;其中72例复查冠脉造影,对其支架内再狭窄、支架内血栓形成、靶血管动脉瘤的发生率进行统计分析。结果346例冠心病患者共成功植入药物洗脱支架674枚,PCI术后207例患者临床症状完全缓解,109例患者的临床症状明显改善,临床症状缓解率达91．3％。DES植入术后住院期间MACE发生率为0．9％（3／346）,院外随访期间MACE发生率为3．7％（11／346）。冠状动脉造影复查发现晚期支架内血栓形成发生率为0．8％（1／132）;靶血管动脉瘤形成0．8％（1／132）;支架内再狭窄发生率为4．5％（6／132）,其中4例再次于靶病变处植入DES。PCI术后应用双联抗血小板药物过程中的出血并发症37例,白细胞减少2例。结论药物洗脱支架在冠心病介入治疗中应用是安全、有效的,MACE、支架内再狭窄和支架内血栓形成的发生率很低。     

Intracoronary radiotherapy with a (188)rhenium liquid-filled PTCA balloon system in in-stent restenosis: acute and long-term angiographic results, as well as 1-year clinical follow-up

BACKGROUND: Intracoronary radiotherapy with beta- and gamma-emitters has been shown to reduce the risk of restenosis after balloon angioplasty and after coronary stenting. The present study addresses the question whether intracoronary radiotherapy using the (188)rhenium liquid-filled PTCA balloon system is feasible, safe and effective in cases of in-stent restenosis. Acute and long-term angiographic results as well as clinical events within 1 year after the procedure were evaluated. METHODS AND RESULTS: From September 1999 to April 2000, 41 patients (mean age 60+/-10 years, 33 male, 8 female) with symptomatic in-stent restenosis underwent repeat PTCA and immediate intracoronary brachytherapy. After successful repeat PTCA (residual stenosis less than 30% in diameter), a second standard PTCA catheter was inflated with liquid (188)rhenium in the redilated in-stent restenosis for 315-880, mean 540+/-155 s with low pressure (3 atm) in order to reach 30 Gy at 0.5 mm depth of the vessel wall. In all patients with successful reintervention, intracoronary radiotherapy was unproblematically performed; in 16 patients, 21 new stents were implanted during the procedure-either immediately before or after radiation therapy. During follow-up, four episodes of stent thrombosis with subsequent myocardial infarction occurred in three patients (8 days, 37 days, 5 months and 6 months after the procedure, respectively). This complication was seen exclusively in patients with newly implanted stents. One patient of the stent group died suddenly 46 days after the procedure. All 40 surviving patients underwent repeat angiography in cases of repeat angina or routinely 6 months after brachytherapy, respectively. In the redilated target vessels without new stenting, restenosis (stenosis >50% in diameter) or reocclusion was observed in only 5 of 25 (=20%) cases, but in the restented target lesions, in 10 of 15 (=67%). Event-free survival (death, myocardial infarction, TVR) at 1 year after repeat dilatation and subsequent brachytherapy was 80% for patients not newly stented, but only 44% for patients with new stents. CONCLUSIONS: Intracoronary radiation therapy with the liquid-filled beta-emitting (188)rhenium balloon is a safe and effective therapy in cases of in-stent restenosis. The positive effect of irradiation, however, is abolished if a new stent is needed. In the not newly stented patients, 1-year follow-up is encouraging.     

Sirolimus-versus paclitaxel-eluting stents: a comparison of two consecutive series in routine clinical practice

BACKGROUND: We compared two consecutive series of patients treated with sirolimus-eluting stents (SES) or paclitaxel-eluting stents (PES). METHODS: Two hundred and ninety-five patients with 590 coronary lesions were treated with 274 SES and 379 PES. Patients with symptoms or positive dobutamine stress echocardiography were subjected to repeat coronary angiography. RESULTS: During a follow-up of 13.3 +/- 5.7 months, the incidence rate of major adverse cardiac events (MACE) was 4.1%, including, 1 death, 4 Q-wave myocardial infarctions, 2 late angiographic stent thromboses, 3 subacute stent thromboses, and 11 target vessel revascularizations (TVR), and was not significantly different between SES (n = 5) and PES (n = 7).Stent overlapping was found to be an independent predictor of both MACE (odds ratio = 0.078, P = 0.02) and TVR (odds ratio = 0.077, P = 0.02). Follow-up symptoms- or ischemia-driven angiography was performed in 45 patients. Only vessel size was a predictor of stent restenosis (P = 0.02), independent of stent type. Late loss was independently predicted by postdilatation of stent (beta =-0.24, P = 0.03), but not by type of stent (P = 0.14) or other parameters. Edge restenosis was seen in 8 patients subjected to lesion predilatation. The restenosis pattern after SES implantation was focal, but diffuse (n = 1) or proliferative (n = 1) restenosis, and in-stent aneurysm formation (n = 1) was also seen with PES. CONCLUSIONS: Despite a trend for a higher incidence of MACE with PES, no significant differences between the two stent types were detected. Diffuse restenosis was seen only with PES, and edge restenosis only in lesions with balloon predilatation before stent implantation. Stent overlapping was an independent predictor of both TVR and MACE.     

国产西罗莫司洗脱支架与裸支架治疗急性心肌梗死临床疗效的比较

目的探讨国产西罗莫司洗脱支架与裸支架治疗急性心肌梗死（AMI）临床疗效的差异。方法173例连续行直接PCI的AMI患者随机分为西罗莫司洗脱支架组（87例）和裸支架组（86例）,分析住院期间和支架置入后6个月的支架内血栓、主要心血管事件（包括再次心肌梗死、缺血性靶血管重建和死亡）发生率及6个月再狭窄率。结果两组患者在术后血管通畅、肌酸激酶峰值、心功能和住院期间心脏事件方面差异均无统计学意义（P〉0．05）。两组各有2例支架内血栓（2．4％比2．3％,P〉0．05）。6个月时,国产西罗莫司洗脱支架组的支架内再狭窄率（4．5％比40．0％,P〈0．01）、节段内再狭窄率（6．8％比44．9％,P〈0．01）和主要不良心脏事件发生率（8．0％比24．4％,P〈0．01）显著低于裸支架组。国产西罗莫司洗脱支架组主要心脏事件的减少主要是因为缺血性靶血管重建减少所致（3．4％比11．6％,P〈0．05）。结论与裸支架相比,国产西罗莫司洗脱支架治疗AMI患者并未增加6个月内支架内血栓的发生,而显著降低6个月的再狭窄率和主要心脏事件发生率。     

Clinical follow-up of paclitaxel-eluting (TAXUS) stents for the treatment of saphenous vein graft disease

BACKGROUND: Randomized trials in selected patient populations have demonstrated dramatic reductions in the incidence of in-stent restenosis (ISR) following implantation of paclitaxel-eluting (PE) coronary stents compared with bare metal stents in native coronary disease. The clinical outcome following implantation of PE stents for saphenous vein graft (SVG) stenosis is largely unknown. AIM: To assess the safety and efficacy of PE coronary stents for the treatment of SVG stenosis in an unselected population. METHODS: All patients who received PE stents for the treatment of SVG disease from May 1, 2003, to May 1, 2005, were entered into a prospectively collected database. Fifty-five patients were identified with 69 lesions. In-hospital and late major adverse cardiac events (MACE) including death, myocardial infarction (MI), and target lesion revascularization (TLR) were recorded as well as the rate of target vessel revascularization (TVR). RESULTS: Mean follow-up was 13 months with 54 of the 55 patients contacted. The number of stents implanted was 1.12 +/- 0.37 per lesion and 1.38 +/- 0.59 per patient. Clinically significant procedural MACE was 0%. The late MACE rate was 9% with a 2% clinically driven TLR, a 4% coronary artery bypass graft (CABG), and a 4% TVR rate. There were four deaths, two cardiac and two noncardiac. CONCLUSION: PE stents appear safe and effective in the treatment of SVG disease at a mean follow-up time of 13 months. Randomized studies are needed to further delineate the optimal management of this high-risk group.     

Intracoronary brachytherapy for treatment of in-stent restenosis

Randomized, double-blind, placebo-controlled trials have demonstrated that intracoronary brachytherapy is more efficacious than placebo in reducing death, myocardial infarction, and target vessel revascularization at long-term follow up of patients with in-stent restenosis. Intracoronary brachytherapy is efficacious in treating totally occluded in-stent restenotic lesions, in treating de novo and in-stent restenotic lesions in saphenous vein grafts, in treating diffuse in-stent restenosis, in treating native coronary ostial in-stent restenotic lesions, in treating patients with diabetes with in-stent restenosis, in treating patients at high-risk for recurrence of restenosis, in treating elderly patients, and in treating patients who failed intracoronary radiation. Beta and gamma intracoronary brachytherapy are equally effective in treating in-stent restenosis. Long-term aspirin and clopidogrel should be administered for at least 1 year to reduce late vessel thrombosis. Inadequate radiation may cause edge stenosis.     

国产可降解涂层雷帕霉素洗脱支架的中期有效性和安全性

目的:评估第二代国产生物可降解涂层雷帕霉素洗脱支架(EXCELTM,JWMS,China)的中期有效性和安全性。方法:连续观察71例住院的冠心病患者,常规冠状动脉造影及支架植入。主要观察术后平均18个月的无主要不良心脏事件(MACE,包括心源性死亡、心肌梗死、靶血管再次介入治疗)生存率、术后急性、亚急性及晚发血栓的发生率。结果:71例患者90支血管的104处病变共植入了113枚支架。1例患者手术后3d死亡,70例患者完成了随访。随访期间未发生支架内再狭窄。术后18个月无MACE生存率为98.6%,术后亚急性血栓发生率1.4%。结论:国产第二代生物可降解涂层雷帕霉素洗脱支架有良好的中期效果和安全性。     

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.     

Intrakoronare Strahlentherapie in kontrollierten und offenen Studien mit Afterloading-Systemen und “heißen” Ballonkathetern Eine Analyse von 6 692 Patienten

The prevention and treatment of a restenosis, which occurs in ca. 30% of the cases following balloon dilatation of coronary stenoses, using intravascular radiation relies on the inhibition of proliferation that is inherent in every radiation therapy. The analysis is based on 6,692 patients assigned to either a control group (1,717 patients) or to radiation therapy (4,975 patients) in 41 studies. A total of 14 placebo-controlled, randomized and 27 open trials have been completed: 22 regarding in-stent restenosis, ten regarding de-novo stenosis (or restenosis without a stent) as strict inclusion criteria, and nine with all types of stenoses. For in-stent restenoses, vessel size as defined for inclusion was between 2.0 mm and 5.5 mm, stenosis length between 10 mm and 80 mm. In all trials with in-stent restenosis, the primary endpoints were reached; the restenosis rate in the longest coronary segment analyzed was between 45% and 100% in the control groups and between 7.7% and 53.5% in the brachytherapy groups. The respective values for the TVR were between 24.1% and 80% in the control groups and between 2.0% and 41.7% in the brachytherapy groups. In the control groups, MACE was between 25.9% and 80%; it was between 2.0% and 41.7% in the brachytherapy groups. Attaining results for de-novo stenoses was problematic due to "geographic miss" apparently playing a larger role in these cases; but when taking this into consideration, good results were also attained. The known limitations due to late stent thromboses (4-15% in older trials) were to the most part eliminated by administration of clopidogrel for 1 year and the limitations due to the "edge effect" by the application of longer radiation sources. With antiproliferative coated stents as treatment for de-novo stenoses, we can count on intracoronary brachytherapy losing significance in this area. But for in-stent restenoses, intracoronary brachytherapy is the only evidence-based interventional form of therapy.     

Angiographic and clinical outcomes of late total occlusion versus treatment failure without late total occlusion in patients after intracoronary radiation therapy for in-stent restenosis

This study aimed to compare the outcomes of patients with late total occlusion (LTO) versus patients with recurrence in the absence of LTO after intracoronary radiation therapy for in-stent restenosis. LTO, especially in the context of acute myocardial infarction, after intracoronary radiation therapy for in-stent restenosis, is associated with negative clinical outcomes after 6 and 12 months compared with in-stent restenosis without LTO.     

Percutaneous and surgical interventions for in-stent restenosis: long-term outcomes and effect of diabetes mellitus

OBJECTIVE: We examined long-term outcomes of patients with in-stent restenosis (ISR) who underwent different percutaneous interventions at the discretion of individual operators: balloon angioplasty (BA), repeat stent or rotational atherectomy (RA). We also examined long-term outcomes of patients with ISR who underwent coronary artery bypass surgery (CABG). BACKGROUND: In-stent restenosis remains a challenging problem, and its optimal management is still unknown. METHODS: Symptomatic patients (n = 510) with ISR were identified using cardiac catheterization laboratory data. Management for ISR included BA (169 patients), repeat stenting (117 patients), RA (107 patients) or CABG (117 patients). Clinical outcome events of interest included death, myocardial infarction, target vessel revascularization (TVR) and a combined end point of these major adverse cardiovascular events (MACE). Mean follow-up was 19+/-12 months (range = 6 to 61 months). RESULTS: Patients with ISR treated with repeat stent had significantly larger average post-procedure minimal lumen diameter compared with BA or RA (3.3+/-0.4 mm vs. 3.0+/-0.4 vs. 2.9+/-0.5, respectively, p < 0.05). Incidence of TVR and MACE were similar in the BA, stent and RA groups (39%, 40%, 33% for TVR and 43%, 40%, 33% for MACE, p = NS). Patients with diabetes who underwent RA had similar outcomes as patients without diabetes, while patients with diabetes who underwent BA or stent had worse outcomes than patients without diabetes. Patients who underwent CABG for ISR, mainly because of the presence of multivessel disease, had significantly better outcomes than any percutaneous treatment (8% for TVR and 23% for MACE). CONCLUSIONS: In this large cohort of patients with ISR and in the subset of patients without diabetes, long-term outcomes were similar in the BA, repeat stent and RA groups. Tissue debulking with RA yielded better results only in diabetic patients. Bypass surgery for patients with multivessel disease and ISR provided the best outcomes.     

Drug-Eluting Versus Bare Metal Stents in Saphenous Vein Graft Intervention: An Updated Comprehensive Meta-Analysis of Randomized Trials

BackgroundDrug eluting stents (DES) are preferred over bare metal stents (BMS) for native coronary artery revascularization unless contraindicated. However, the preferred stent choice for saphenous venous graft (SVG) percutaneous coronary interventions (PCI) is unclear due to conflicting results.MethodsPubMed, Clinical trials registry and the Cochrane Center Register of Controlled Trials were searched through June 2018. Seven studies (n = 1639) comparing DES versus BMS in SVG-PCI were included. Endpoints were major adverse cardiac events (MACE), cardiovascular mortality, all-cause mortality, myocardial infarction (MI), target vessel revascularization (TVR), target lesion revascularization (TLR), in-stent thrombosis, binary in-stent restenosis, and late lumen loss (LLL).ResultsOverall, during a mean follow up of 32.1 months, there was no significant difference in the risk of MACE, cardiovascular mortality, all-cause mortality, MI, stent thrombosis, TVR and TLR between DES and BMS. However, short-term follow up (mean 11 months) showed lower rate of MACE (OR 0.66 [0.51, 0.85]; p = 0.002), TVR (OR 0.47 [0.23, 0.97]; p = 0.04) and binary in-stent restenosis (OR 0.14 [0.06, 0.37]; p < 0.0001) in DES as compared with BMS. This benefit was lost on long-term follow up with a mean follow up 35.5 months.ConclusionIn this meta-analysis of SVG-PCI, DES use was associated with similar MACE, cardiovascular mortality, all-cause mortality, MI, in-stent thrombosis, TVR and TLR compared with BMS during long-term follow up. There was high incidence of MACE noted in both DES and BMS suggesting a need for exploring novel strategies to treat SVG disease to improve clinical outcomes.     

Comparison of drug-eluting stents with bare metal stents in unselected patients with acute myocardial infarction.

OBJECTIVES: The aim of this study was to compare the procedural characteristics and outcomes of patients with acute myocardial infarction treated with drug-eluting stents (DES) vs. bare metal stents (BMS). BACKGROUND: DES have been shown to reduce the incidence of restenosis and target vessel revascularization (TVR) in clinical randomized studies when compared with BMS in patients undergoing elective percutaneous intervention. Limited data are available with the use of DES in patients with acute ST-segment elevation myocardial infarction. METHODS: Two hundred and sixty-one consecutive patients who presented with myocardial infarction between 7/2001 and 8/2005 were studied. The procedural characteristics, 30-day and 12-month outcomes of 131 patients treated with DES were compared with 130 patients treated with BMS. RESULTS: At 12-months follow-up DES therapy was associated with a substantial decrease in major adverse cardiovascular events (MACE) (HR 0.33; P =0.002), TVR (HR 0.19; P =0.002), and recurrent myocardial infarction (HR 0.23; P =0.051) vs. BMS therapy. Coronary interventions utilizing DES were characterized by a marked increase in the number of stent per target vessel (DES: 1.9 +/- 0.9 vs. BMS: 1.38 +/- 0.6, P < 0.0001), treatment of bifurcation (DES: 21% vs. BMS: 5%, P =0.0004), and multivessel intervention (DES: 22% vs. BMS: 8%, P =0.003). CONCLUSION: The routine use of DES in acute myocardial infarction is associated with reduced rates of MACE at 12 months vs BMS, despite a higher rate of complex procedures in the DES treated patients. In addition to its anti-restenosis effect, the improved outcome of patients treated with DES may be linked to a more complete revascularization in association with prolonged clopidogrel therapy.     

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.