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We assessed the effectiveness of intracoronary brachytherapy and compared treatment effects for the two radiation sources as well as the performance of the procedure in saphenous vein grafts (SVG) and native coronary arteries. Five randomized controlled trials comparing intracoronary brachytherapy with placebo involving a total of 1310 patients were reviewed for a meta-analysis. Risk differences (RD) for major adverse cardiac events (MACE), target vessel revascularization, target lesion revascularization, and angiographic binary restenosis at 6–12 months were computed, and a meta-regression analysis of MACE was performed. For MACE, the RD was 0.19 (95% confidence interval [CI], 0.09%–0.29%; P value, 0.00); there was significant between-study variance of 0.2395. In univariate meta-regression analyses, diabetes was a significant factor for the between-study variance ( P value, 0.000). In multivariate meta-regression analyses adjusted for diabetes and lesion length, neither gamma-radiation source nor SVG was a significant factor for the between-study variance ( P value, 0.675 and 0.433, respectively); the adjusted between-study variance was 0.000. Intra-coronary brachytherapy is effective compared with placebo at mid-term follow up. Neither procedure in SVG (gamma radiation) nor difference in radiation source (beta or gamma) in native coronary arteries was a significant factor in brachytherapy effectiveness compared to placebo. [ABSTRACT FROM AUTHOR]

Abstract: Drug-eluting stents have revolutionized the field of interventional cardiology and have provided a significant innovation for preventing coronary artery restenosis. Polymer coatings that deliver anti-proliferative drugs to the vessel wall are key components of these revolutionary medical devices. This article focuses on the development of stents which elute the potent anti-proliferative agent, zotarolimus, from a synthetic phosphorylcholine-based polymer known for its biocompatible profile. Zotarolimus is the first drug developed specifically for local delivery from stents for the prevention of restenosis and has been tested extensively to support this indication. Clinical experience with the PC polymer is also extensive, since more than 120,000 patients have been implanted to date with stents containing this non-thrombogenic coating. This review provides background on pre-clinical studies with zotarolimus, on the development of the biocompatible PC polymer and on the clinical trials conducted using two stent platforms which deliver this drug to patients with coronary artery disease. [Copyright &y& Elsevier]

Context Although vascular brachytherapy is the only approved therapy for restenosis following bare-metal stent implantation, drug-eluting stents are now being used. Data on the relative merits of each are limited. Objective To determine the safety and efficacy of the sirolimus-eluting stent compared with vascular brachytherapy for the treatment of patients with restenosis within a bare-metal stent. Design, Setting, and Patients Prospective, multicenter, randomized trial of 384 patients with in-stent restenosis who were enrolled between February 2003 and July 2004 at 26 academic and community medical centers. Data presented represent all follow-up as of June 30, 2005. Interventions Vascular brachytherapy (n = 125) or the sirolimus-eluting stent (n = 259). Main Outcome Measure Target vessel failure (cardiac death, myocardial infarction, or target vessel revascularization) at 9 months postprocedure. Results Baseline patient characteristics were well matched. Lesion length was similar between vascular brachytherapy and sirolimus-eluting stent patients (mean [SD], 16.76 [8.55] mm vs 17.22 [7.97] mm, respectively; P = .61). Procedural success was 99.2% (124/125) in the vascular brachytherapy group and 97.3% (250/257) in the sirolimus-eluting stent group (P = .28). The rate of target vessel failure was 21.6% (27/125) with vascular brachytherapy and 12.4% (32/259) with the sirolimus-eluting stent (relative risk [RR], 1.7; 95% confidence interval [CI], 1.1-2.8; P = .02). Target lesion revascularization was required in 19.2% (24/125) of the vascular brachytherapy group and 8.5% (22/259) of the sirolimus-eluting stent group (RR, 2.3 [95% CI, 1.3-3.9]; P = .004). At follow-up angiography, the rate of binary angiographic restenosis for the analysis segment was 29.5% (31/105) for the vascular brachytherapy group and 19.8% (45/227) for the sirolimus-eluting stent group (RR, 1.5 [95% CI, 1.0-2.2]; P = .07). Compared with the vascular brachytherapy group, minimal lumen diameter was larger in the sirolimus-eluting stent group at 6-month follow-up (mean [SD], 1.52 [0.63] mm vs 1.80 [0.63] mm; P<.001), reflecting greater net lumen gain in the analysis segment (0.68 [0.60] vs 1.0 [0.61] mm; P<.001) due to stenting and no edge restenosis. Conclusion Sirolimus-eluting stents result in superior clinical and angiographic outcomes compared with vascular brachytherapy for the treatment of restenosis within a bare-metal stent. [ABSTRACT FROM AUTHOR]

Background: It is an ongoing concern that intracoronary brachytherapy may possibly just delay the problem of in-stent restenosis ("late catch up"). For gamma-radiation, 3 placebo-controlled studies have shown the maintenance of the initially positive effect after 2 years, but similar data do not exist for beta-radiation. STents And Restenosis Trial (START) was the first placebo-controlled randomized trial for in-stent restenosis with beta-radiation; herein, we report the 2-year clinical follow-up. Methods and Results: Two hundred and forty-four patients were randomized to active treatment, 232 patients to placebo (nonactive source train) treatment. The primary end point of efficacy was target vessel revascularization (TVR); primary safety end point was any major adverse cardiac event (MACE) at 8 months and 2 years. Two-year clinical outcome in patients receiving brachytherapy was based on 195 of 244 original patients (79.9%) and in the placebo arm on 183 of 232 original patients (78.9%). TVR was significantly reduced by 25%; from 36.6% (placebo) to 27.5% (brachytherapy) remained significant after 2 years (RR .7 [.57-.98], 95% CI -9.2 [-17.5-0.8]). The Kaplan-Meier analysis for TVR and MACE showed improvement beginning approximately 90 days after radiation and remained almost constant for the 2 following years. Freedom from TVR was significantly increased from 62.4% +/- 3.8% to 71.6% +/- 3.3% (P = .027) and freedom from MACE from 58.9% +/- 3.7% to 68.0% +/- 3.4% (P = .035). Conclusions: The START trial shows for the first time that the initial beneficial effects of intracoronary brachytherapy with beta-radiation using 90 Sr/ 90 Y are maintained at 2-year clinical follow-up period. [ABSTRACT FROM AUTHOR]

The advent of intravascular stenting dramatically reduced the incidence of restenosis among patients undergoing percutaneous transluminal coronary angioplasty. However, a substantial percentage of patients, particularly those with risk factors such as diabetes mellitus or complicated lesions, remain at risk for restenosis. Drug-eluting stents overcome this problem by releasing bioactive agents from a polymeric coating directly into the vessel wall, inhibiting the cellular mechanisms of restenosis while avoiding systemic toxicity. Recent data indicate that local targeting of the proliferative process with drug-eluting stents dramatically reduces the risk for restenosis, even among high-risk patients. A range of bioactive coatings are currently available or in late clinical trials. Both sirolimus- and paclitaxel-eluting stents have demonstrated efficacy in a broad range of patient types; early data from clinical trials of second-generation stent coatings, such as everolimus and ABT-578 (zotarolimus), suggest that these agents are also effective in preventing restenosis. This article reviews the pathophysiology of in-stent restenosis and surveys recent key clinical trials of drug-eluting stents. [Copyright &y& Elsevier]

Although clinical outcomes after sirolimus-eluting stents (SESs) have been previously described (“primary” success rates), the fate of patients whose SES implantation fail and who require ischemia-driven target lesion revascularization is poorly understood. The SIRIUS trial is a prospective, randomized, clinical trial that includes 533 evaluable patients with SESs. Twenty-two of these patients had adjudicated ischemia-driven target lesion revascularization (4.1%) within the first year of follow-up and comprised the study population of this analysis. Of these patients, 11 (50%) had diabetes, and restenotic lesions were focal and located at the proximal stent edge in 91% and 73% of patients, respectively. Restenosis was treated with bare metal stent implantation, balloon dilatation, or intravascular brachytherapy in 82%, 13.5%, and 4.5% of patients, respectively. At 1-year follow-up after the first recurrence (2-year follow-up after the index procedure), only 5 of these patients (23%) required a second repeat revascularization procedure. Risk factors for a second recurrence after treatment of SES restenosis were female gender, long lesions that required long stents at the index procedure, and an early first recurrence. In conclusion, SES failure treated with traditional percutaneous coronary intervention yielded good outcome at 1-year follow-up (secondary failure rate only 23%), perhaps due to the focal nature of the SES restenotic lesion. Future studies should evaluate other methods, including drug-eluting stents, to further optimize the outcome of treatment of SES failures. [Copyright &y& Elsevier]

Background: Carotid endarterectomy is more effective than medical management in the prevention of stroke in patients with severe symptomatic or asymptomatic atherosclerotic carotid-artery stenosis. Stenting with the use of an emboli-protection device is a less invasive revascularization strategy than endarterectomy in carotid-artery disease. Methods: We conducted a randomized trial comparing carotid-artery stenting with the use of an emboli-protection device to endarterectomy in 334 patients with coexisting conditions that potentially increased the risk posed by endarterectomy and who had either a symptomatic carotid-artery stenosis of at least 50 percent of the luminal diameter or an asymptomatic stenosis of at least 80 percent. The primary end point of the study was the cumulative incidence of a major cardiovascular event at 1 year — a composite of death, stroke, or myocardial infarction within 30 days after the intervention or death or ipsilateral stroke between 31 days and 1 year. The study was designed to test the hypothesis that the less invasive strategy, stenting, was not inferior to endarterectomy. Results: The primary end point occurred in 20 patients randomly assigned to undergo carotid-artery stenting with an emboli-protection device (cumulative incidence, 12.2 percent) and in 32 patients randomly assigned to undergo endarterectomy (cumulative incidence, 20.1 percent; absolute difference, –7.9 percentage points; 95 percent confidence interval, –16.4 to 0.7 percentage points; P=0.004 for noninferiority, and P=0.053 for superiority). At one year, carotid revascularization was repeated in fewer patients who had received stents than in those who had undergone endarterectomy (cumulative incidence, 0.6 percent vs. 4.3 percent; P=0.04). Conclusions: Among patients with severe carotid-artery stenosis and coexisting conditions, carotid stenting with the use of an emboli-protection device is not inferior to carotid endarterectomy. N Engl J Med 2004;351:1493-501. [ABSTRACT FROM AUTHOR]

Zotarolimus-eluting phosphorylcholine-coated cobalt-chromium alloy Driver stents (ZES) demonstrated significant reductions in target lesion revascularization rate with few apparent adverse events compared with bare metal stents (BMS; uncoated Driver stents) in a prospective, multicenter, double-blind, randomized controlled trial in de novo coronary lesions. The aim of this study was to examine detailed vascular responses to ZES compared with BMS using serial intravascular ultrasound analysis. A total of 343 patients (ZES n = 178, BMS n = 165) were enrolled in this formal, prespecified intravascular ultrasound substudy of the Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Medtronic AVE Zotarolimus-Eluting Driver Coronary Stent in de Novo Native Coronary Artery Lesions (ENDEAVOR II), a prospective, multicenter, double-blind, randomized controlled trial to compare ZES and BMS in de novo native coronary artery lesions. Quantitative and qualitative intravascular ultrasound analyses were performed postprocedurally and at 8-month follow-up in stented and reference segments. ZES showed significantly less neointima, with a larger lumen than BMS at 8 months (percentage neointimal volume 17.6 ± 10.1% vs 29.4 ± 17.2%, p <0.0001; maximum percentage neointimal area 32.9 ± 13.0% vs 47.6 ± 18.6%, p <0.0001; minimum luminal area 4.9 ± 1.6 vs 4.0 ± 1.7 mm2, p <0.0001) and no unfavorable edge effect. In the 18-mm single stents, ZES showed evenly inhibited neointima compared with BMS. Neither persistent stent-edge dissection nor late-acquired incomplete stent apposition was observed in either group. In conclusion, ZES showed evenly inhibited neointima with no apparent adverse vascular response in stented and reference segments at 8 months compared with BMS. [Copyright &y& Elsevier]

Smaller reference vessel diameter is a recognized determinant of in-stent restenosis. The SIRIUS 2.25 trial was a prospective, nonrandomized study including 100 patients (mean age 63.4 years; 64% men, 40% with diabetes mellitus) assessing the safety and efficacy of the 2.25-mm sirolimus-eluting Bx Velocity stent in patients with de novo native coronary lesions. Using propensity score matching for gender, diabetes mellitus, left anterior descending artery target vessel, lesion length, and reference vessel diameter, the outcomes were compared with historical control groups (angioplasty and Palmaz-Schatz stent arms from the STRESS/BENESTENT I/II trials and the Bx Velocity bare metal stent arm from the RAVEL and SIRIUS trials having a reference vessel diameter <3 mm). Use of the 2.25-mm sirolimus-eluting Bx Velocity stent was associated with a high rate of procedural success (97%) and a low rate of in-hospital major adverse cardiac events (2%). The primary end point, 6-month in-lesion binary angiographic restenosis, occurred less frequently in patients treated with the 2.25-mm sirolimus-eluting Bx Velocity stent than in each of 3 historical controls (16.9% vs 30.6%, p = 0.12; 36.5%, p <0.001; 45.9%, p <0.001, respectively). This translated into lower rates of 6-month target lesion revascularization in the 2.25-mm sirolimus-eluting Bx Velocity stent group (4.0% vs 15.0% in each of 3 control groups, p = 0.01 to <0.001). By multivariate analysis, in-lesion binary restenosis was predicted by multiple implanted stents (odds ratio 10.4, p = 0.002). Four of 13 patients who developed restenosis (30.8%) had a diffuse pattern of restenosis. In the long lesion tertile (mean lesion length 19.5 mm), the in-lesion binary restenosis rate was 27.6%. In conclusion, use of the 2.25-mm sirolimus-eluting Bx Velocity stent was safe and provided favorable 6-month clinical outcomes. Use of multiple stents (in longer lesions) was an independent predictor of in-lesion restenosis. [Copyright &y& Elsevier]

Prospective follow-up at 2 years was obtained for 98.7% of the pooled 1,510 patients enrolled in SIRIUS, E-SIRIUS and C-SIRIUS, 3 randomized controlled trials that compared sirolimus-eluting stents (SESs) with bare metal stents (BMSs) to treat long stenoses in small coronary arteries. By 720 days, clinically driven target lesion revascularizations were performed in 5.7% of patients with SESs versus 22.6% of patients with BMSs (risk ratio 0.25, 95% confidence interval 0.18 to 0.35, p <0.001). Of these, late target lesion revascularization (from 271 to 720 days) was performed in 12 patients who received SESs (1.6%) compared with 37 patients with BMSs (4.9%) (risk ratio 0.32, 0.17 to 0.61, p <0.001). Stent thromboses occurred in 7 of 758 patients with SESs (0.9%, 4 subacute, 3 late) and 5 of 752 patients with BMSs (0.7%, 1 subacute, 4 late) (risk ratio 1.39, 95% confidence interval 0.44 to 4.36, p = 0.774). The Kaplan-Meier estimate of freedom from major cardiac adverse events was 89.3% for patients with SESs versus 73.4% for patients with BMSs (p <0.001). This analysis demonstrates the sustained efficacy and safety of sirolimus-eluting stents at 2 years, characterized by a persistent significant benefit in freedom from repeat revascularization compared with BMSs and a low risk of late stent thrombosis, not different from BMSs. [Copyright &y& Elsevier]

Objectives: The purpose of this study was to examine the two-year clinical outcomes in patients enrolled in the Sirolimus-Eluting Stent in De Novo Native Coronary Lesions (SIRIUS) study. Background: The SIRIUS study was a double-blinded randomized study which demonstrated that sirolimus-eluting stents (SES) significantly improved angiographic results (at 8 months) and clinical outcomes (at 9 and 12 months) compared with bare-metal stents (BMS). Methods: Patients with de novo native coronary artery lesions randomized to either SES (533 patients) or control BMS (525 patients) were followed for two years. Results: Between one and two years, there were infrequent additional clinical events that were equally distributed between the sirolimus and control groups. After two years, target lesion revascularization was 5.8% and 21.3% in SES and control patients, respectively (p < 0.001), and major adverse cardiovascular events and target vessel failure rates were 10.1% versus 24.4% and 12.0% versus 26.7%, respectively (p < 0.0001 for both). There were no differences in death, myocardial infarction, and stent thrombosis between the two groups. Conclusions: Clinical outcomes two years after implantation of SES continue to demonstrate significant reduction in the need for repeat target lesion (and vessel) revascularization compared with BMS without evidence for either disproportionate late restenosis or late stent thrombosis. [Copyright &y& Elsevier]

Selection of coronary stent length varies from covering only the zone of maximum obstruction to stenting from normal- to normal-appearing vessels. With bare metal stenting, for any given lesion there is a high restenotic risk associated with longer stent length. With drug-eluting stents, the relation between stent length and restenosis has not been evaluated. In the angiographic follow-up cohort of the SIRIUS trial that compared the sirolimus-eluting Bx Velocity stent with the standard Bx Velocity stent (n = 699), we constructed a multiple regression model to predict 8-month percent diameter stenosis using the main effects of lesion length and excess stent length beyond the lesion length and adjusting for known predictors of restenosis. Stent length exceeded lesion length in 94% of lesions overall. Mean difference in length was 8.3 ± 8.3 mm (mean lesion length 14.6 ± 5.9 mm, mean stent length 22.9 ± 9.6 mm). Stented lesion length and excess stent length were associated with absolute increases in percent diameter stenosis per 10 mm of 9.1% (p &#60;0.0001) and 3.6% (p = 0.053) in the bare metal arm and 3.5% (p = 0.047) and 2.1% (p = 0.040) in the sirolimus-eluting stent arm. Although the effects of lesion length and excess stent length on restenosis were markedly decreased with sirolimus-eluting stents (vs bare metal stents), a small restenotic penalty is still paid for excessive stent length. Longer stent-to-lesion length strategies should be used only when a shorter stent is likely to result in incomplete lesion coverage and edge dissection, a strong determinant of stent thrombosis. [Copyright &y& Elsevier]

The choice of drug-eluting versus bare metal stents is based on costs and expectations of restenosis and thrombosis risk. Approaches to stent placement vary from covering just the zone of maximal obstruction to stenting well beyond the lesion boundaries (normal-to-normal vessel). The independent effects of stented lesion length, nonstented lesion length, and excess stent length, on coronary restenosis have not been evaluated for bare metal or drug-eluting stents. We analyzed the angiographic follow-up cohort (1,181 patients) from 6 recent bare metal stent trials of de novo lesions in native coronary arteries. Stent length exceeded lesion length in 87% of lesions (mean lesion length 12.4 ± 6.3 mm, mean stent length 20.0 ± 7.9 mm, mean difference 7.6 ± 7.9 mm). At 6- to 9-month follow-up, the mean percent diameter stenosis was 39.1 ± 20.1%. In an adjusted multivariable model of percent diameter stenosis, each 10 mm of stented lesion length was associated with an absolute increase in percent diameter stenosis of 7.7% (p <0.0001), whereas each 10 mm of excess stent length independently increased percent diameter stenosis by 4.0% (p <0.0001) and increased target lesion revascularization at 9 months (odds ratio 1.12, 95% confidence interval 1.02 to 1.24). Significant nonstented lesion length was uncommon (12.5% of cases). In summary, stent length exceeded lesion length in most stented lesions, and the amount of excess stent length increased the risk of restenosis independent of the stented lesion length. This analysis supports a conservative approach of matching stent length to lesion length to reduce the risk of restenosis with bare metal stents. [Copyright &y& Elsevier]

Objectives: We assessed the predictive value of minimum stent area (MSA) for long-term patency of sirolimus-eluting stents (SES) implantation compared to bare metal stents (BMS). Background: Although MSA is a consistent predictor of in-stent restenosis, its predictive value in BMS is still limited because of biologic variability in the restenosis process. Methods: From the SIRolImUS (SIRIUS) trial, 122 cases (SES: 72; BMS: 50) with complete serial intravascular ultrasound (IVUS) (baseline and 8-month follow-up) were analyzed. Postprocedure MSA and follow-up minimum lumen area (MLA) were obtained. Based on previous physiologic studies, adequate stent patency at follow-up was defined as MLA >4 mm(2). Results: In both groups, a significant positive correlation was observed between baseline MSA and follow-up MLA (SES: p < 0.0001, BMS: p < 0.0001). However, SES showed higher correlation than BMS (0.8 vs. 0.65) with a higher regression coefficient (0.92 vs. 0.59). The sensitivity and specificity curves identified different optimal thresholds of MSA to predict adequate follow-up MLA: 5 mm(2) for SES and 6.5 mm(2) for BMS. The positive predictive values with these cutoff points were 90% and 56%, respectively. Conclusions: In this SIRIUS IVUS substudy, SES reduced both biologic variability and restenosis, resulting in increased predictability of long-term stent patency with postprocedure MSA. In addition, SES had a considerably lower optimal MSA threshold compared to BMS. [ABSTRACT FROM AUTHOR]

: ObjectivesWe sought to evaluate clinical restenosis in a large population of patients who had undergone coronary stent placement.: BackgroundOne-year success after coronary stenting is limited mainly by restenosis of and requirement for repeat revascularization of the treated lesion.: MethodsWe studied 6,186 patients (6,219 lesions) pooled from several recently completed coronary stent trials. Clinical restenosis was defined using three different definitions: target lesion revascularization (TLR) beyond 30 days, target vessel revascularization (TVR) beyond 30 days, and target vessel failure (TVF), defined as TVR, any death, or myocardial infarction (MI) of the target vessel territory after hospital discharge.: ResultsBy one year, 638 (12.2%) patients had TLR, 748 (14.3%) had TVR, and 848 (16.0%) had TVF, more than two-thirds higher than the rate of these end points at six months. The severity of angiographic restenosis (≥50% follow-up diameter stenosis [DS]) in 419 of 1,437 (29%) patients undergoing routine angiographic follow-up correlated directly with the likelihood of TLR (73% vs. 26% for >70% DS compared with <60% DS). Smaller pretreatment minimum lumen diameter (MLD), smaller final MLD, longer stent length, diabetes mellitus, unstable angina, and hypertension were independent predictors of TLR. Prior MI and current smoking were negative predictors.: ConclusionsAt one year after stenting, most clinical restenosis reflected TLR, which was predicted by the same variables previously associated with an increased risk of angiographic restenosis. The lower absolute rate of clinical restenosis relative to angiographic restenosis was due to infrequent TLR in lesions with less severe (<60% DS) angiographic renarrowing. [Copyright &y& Elsevier]

The MULTI-LINK (ML) stent is a novel second generation coronary stent. The ACS MultiLink Stent Clinical Equivalence in De Novo Lesions Trial (ASCENT) randomized 1,040 patients with single, de novo native vessel lesions to treatment with the ML stent or the benchmark Palmaz-Schatz (PS) stent, to demonstrate that the ML stent was not inferior to (i.e., equivalent or better than) the PS stent in terms of target vessel failure by 9 months. Successful stent delivery was achieved in 98.8% versus 96.9% of patients, with a slightly lower postprocedural diameter stenosis (8% vs 10%, p = 0.04), and no difference in 30-day major adverse cardiac events (5.0% vs 6.5%) for the ML stent versus the PS stent. The primary end point of target vessel failure at 9 months was seen in 15.1% of ML-treated patients versus 16.7% of PS-treated patients, with the ML proving to be equal or superior to the PS stent (p <0.001 by test for equivalency). In a prespecified subset, angiographic restudy showed a nonsignificant trend for reduced ML restenosis (16.0% vs 22.1%). Thus, the ML stent showed excellent deliverability and acute results, with 9-month clinical and 6-month angiographic outcomes that were equivalent or better than the PS stent. [ABSTRACT FROM AUTHOR]

The NIR stent is a novel second generation tubular stent that was designed to overcome some of the limitations of the earlier Palmaz-Schatz (PS) stent design. The NIR Vascular Advanced North American (NIRVANA) trial randomized 849 patients with single coronary lesions to treatment with the NIR stent or the PS stent. The study was an "equivalency" trial, designed to demonstrate that the NIR stent was not inferior to (i.e., equivalent or better than) the PS stent, for the primary end point of target vessel failure (defined as death, myocardial infarction, or target vessel revascularization) by 9 months. Successful stent delivery was achieved in 100% versus 98.8%, respectively, with a slightly lower postprocedural diameter stenosis (7% vs. 9%, p = 0.04) after NIR and PS stent placement, respectively. Major adverse cardiac events (death, myocardial infarction, repeat target lesion revascularization) were not different at 30 days (4.3% vs. 4.4%). The primary end point of target vessel failure at 9 months was seen in 16.0% of NIR versus 17.2% of PS patients, with the NIR proving to be equal or superior to the PS stent (p <0.001 by test for equivalency). Angiographic restudy in 71% of a prespecified cohort showed no significant difference in restenosis (19.3% vs 22.4%). Thus, the NIR stent showed excellent deliverability with slightly better acute angiographic results and equivalent or better 9-month target vessel failure rate when compared with the PS stent. [ABSTRACT FROM AUTHOR]

Previous studies have shown a high rate of repeat intervention after treating diffuse in-stent restenosis with percutaneous transluminal coronary angioplasty (PTCA) alone. It is not clear whether debulking with atherectomy is more effective in this condition. Between January 1994 and February 1997, we treated 60 consecutive patients with diffuse in-stent restenosis of a native coronary artery using conventional PTCA (n=30) or debulking (with rotational or directional atherectomy) plus adjunctive PTCA (n=30). Paired angiograms were analyzed by quantitative angiography, and clinical follow-up was obtained in all patients at 1 month, 6 months, and 1 year after revascularization. The mean lesion lengths were 13.5+/-8.3 and 18.4+/-13.2 mm in the debulking and PTCA groups, respectively (p=0.09). Acute procedural success was 100% in both cohorts, with no major complications in either group. Treatment with atherectomy plus adjunctive PTCA resulted in lower postprocedure stenoses (18+/-10 vs 26+/-13%, p=0.01) than treatment with balloon angioplasty alone. At 1-year follow-up, repeat target vessel revascularization was required in 28% of patients in the debulking group compared with 46% in the PTCA group (p=0.18). Independent predictors of the need for repeat target vessel revascularization were longer lesion lengths, diabetes mellitus, and smaller postprocedure lumen diameter. Thus, the strategy of atherectomy and adjunctive PTCA for diffuse in-stent restenosis is safe, improves acute angiographic results compared with PTCA alone, and may decrease the need for target vessel revascularization. [ABSTRACT FROM AUTHOR]

Early studies of a cobalt-based alloy stent coated with the novel antiproliferative agent zotarolimus and a phosphorylcholine polymer have demonstrated significant reductions in angiographic restenosis and target vessel revascularization compared with bare metal stents. However, the generalizability of the angiographic outcomes and clinical benefit of zotarolimus-eluting stents (ZESs) to a more real-world patient population is undetermined. Clinical and angiographic outcomes in 1,317 patients treated with the ZES in the first 4 trials of the Endeavor ZES (Medtronic Vascular, Santa Rosa, CA) clinical trials program were pooled for systematic analysis. Protocol-specified follow-up angiography was performed at 8 or 12 months for a subset of 750 of these patients, and clinical follow-up was performed at 9 months after the index procedures in all patients. Diabetes mellitus was present in 22.5% of patients, the mean reference vessel diameter was 2.73 mm, and the mean lesion length was 14.59 mm. At 8 months (12 months for ENDEAVOR I), mean ± SD in-stent late luminal loss was 0.61 ± 0.49 mm. In-stent late luminal loss was greatest in larger caliber (>2.9 mm) vessels (0.65 ± 0.49 mm) and longer (>16.3 mm) lesions (0.70 ± 0.52 mm) but did not statistically vary according to diabetic status. At 9 months, overall rates of target lesion revascularization (TLR) and major adverse cardiac events (MACE) were 4.9% and 7.7%, respectively. The rate of TLR at 12 months was not significantly different relative to diabetes and lesion length >16.3 mm (7.2% and 7.7%, respectively), although TLR was significantly more common when reference vessel diameter was <2.5 mm (8.5%; p = 0.013). At 24 months, overall rates of TLR and MACE were 6.5% and 9.9%, respectively. The overall 24-month rate of stent thrombosis was 0.3%, with no events occurring >14 days after the procedure. Despite varied clinical and angiographic characteristics, treatment with the ZES is associated with consistently low rates of TLR and overall major adverse events, including stent thrombosis. Although these findings indicate the efficacy and safety of the ZES over the time course of the first 4 ENDEAVOR clinical trials, additional ongoing study with more open patient inclusion criteria (including long lesions, small vessels, bifurcations, etc) will be important for discerning whether comparable clinical outcomes can be extended to lesion subsets of higher complexity. [Copyright &y& Elsevier]

Background: Although the frequency of restenosis after coronary angioplasty is reduced by stenting, when restenosis develops within a stent, the risk of subsequent restenosis is greater than 50 percent. We report on a multicenter, double-blind, randomized trial of intracoronary radiation therapy for the treatment of in-stent restenosis. Methods: Of 252 eligible patients in whom in-stent restenosis had developed, 131 were randomly assigned to receive an indwelling intracoronary ribbon containing a sealed source of iridium-192, and 121 were assigned to receive a similar-appearing nonradioactive ribbon (placebo). Results: The primary end point, a composite of death, myocardial infarction, and the need for repeated revascularization of the target lesion during nine months of follow-up, occurred in 53 patients assigned to placebo (43.8 percent) and 37 patients assigned to iridium-192 (28.2 percent, P=0.02). However, the reduction in the incidence of major adverse cardiac events was determined solely by a diminished need for revascularization of the target lesion, not by reductions in the incidence of death or myocardial infarction. Late thrombosis occurred in 5.3 percent of the iridium-192 group, as compared with 0.8 percent of the placebo group (P=0.07), resulting in more late myocardial infarctions in the iridium-192 group (9.9 percent vs. 4.1 percent, P=0.09). Late thrombosis occurred in irradiated patients only after the discontinuation of oral antiplatelet therapy (with ticlopidine or clopidogrel) and only in patients who had received new stents at the time of radiation treatment. Conclusions: Intracoronary irradiation with iridium-192 resulted in lower rates of clinical and angiographic restenosis, although it was also associated with a higher rate of late thrombosis, resulting in an increased risk of myocardial infarction. If the problem of late thrombosis within the stent can be overcome, intracoronary irradiation with iridium-192 may become a useful approach to the treatment of in-stent restenosis. (N Engl J Med 2001;344:250-6.) [ABSTRACT FROM AUTHOR]

Background: Antithrombotic drugs are used after coronary-artery stenting to prevent stent thrombosis. We compared the efficacy and safety of three antithrombotic-drug regimens — aspirin alone, aspirin and warfarin, and aspirin and ticlopidine — after coronary stenting. Methods: Of 1965 patients who underwent coronary stenting at 50 centers, 1653 (84.1 percent) met angiographic criteria for successful placement of the stent and were randomly assigned to one of three regimens: aspirin alone (557 patients), aspirin and warfarin (550 patients), or aspirin and ticlopidine (546 patients). All clinical events reflecting stent thrombosis were included in the prespecified primary end point: death, revascularization of the target lesion, angiographically evident thrombosis, or myocardial infarction within 30 days. Results: The primary end point was observed in 38 patients: 20 (3.6 percent) assigned to receive aspirin alone, 15 (2.7 percent) assigned to receive aspirin and warfarin, and 3 (0.5 percent) assigned to receive aspirin and ticlopidine (P=0.001 for the comparison of all three groups). Hemorrhagic complications occurred in 10 patients (1.8 percent) who received aspirin alone, 34 (6.2 percent) who received aspirin and warfarin, and 30 (5.5 percent) who received aspirin and ticlopidine (P<0.001 for the comparison of all three groups); the incidence of vascular surgical complications was 0.4 percent (2 patients), 2.0 percent (11 patients), and 2.0 percent (11 patients), respectively (P=0.02). There were no significant differences in the incidence of neutropenia or thrombocytopenia (overall incidence, 0.3 percent) among the three treatment groups. Conclusions: As compared with aspirin alone and a combination of aspirin and warfarin, treatment with aspirin and ticlopidine resulted in a lower rate of stent thrombosis, although there were more hemorrhagic complications than with aspirin alone. After coronary stenting, aspirin and ticlopidine should be considered for the prevention of the serious complication of stent thrombosis. (N Engl J Med 1998;339:1665-71.) [ABSTRACT FROM AUTHOR]