Paclitaxel Stents Research Articles

Overview of the 2007 Food and Drug Administration Circulatory System Devices Panel Meeting on the Endeavor Zotarolimus-Eluting Coronary Stent

Initial trials comparing stenting with balloon angioplasty demonstrated improved angiographic and clinical outcomes with the former.1–3 The main clinical problem with bare metal stents (BMS) became the development of in-stent restenosis.4–6 Early data suggested that drug-eluting stents (DES) could mitigate, if not abolish, this problem.7–9 Since the approval of DES, these devices have become the predominant stents used in percutaneous coronary interventions, regardless of indication. As of September 2007, the Cypher sirolimus-eluting stent (SES) (Cordis Johnson & Johnson, Miami Lakes, Fla) had been deployed in >3 million patients worldwide,10 and the millionth Taxus paclitaxel-eluting stent (PES) (Boston Scientific, Natick, Mass) was implanted as of January 2005.11 Over the past 2 years, numerous reports of very late stent thrombosis (ST) with first-generation DES have surfaced. This highly morbid complication and data suggesting that death and myocardial infarction (MI) may be more common with DES12,13 have altered the focus of trials and registries working to determine optimal DES use. There is a hope that second-generation DES will be less prone to ST as a result of differences in drug, stent design, and polymer. Medtronic, Inc (Minneapolis, Minn) presented safety and efficacy data to a public meeting of the US Food and Drug Administration (FDA) Circulatory System Devices Panel (CSDP) in October 2007 on its Endeavor zotarolimus-eluting stent (ZES), seeking approval for the indication of treating de novo native coronary lesions ≤27 mm with reference vessel diameters of 2.5 to 3.5 mm. The FDA asked the CSDP to determine whether the data presented demonstrated a reasonable level of safety and effectiveness, with clinical benefits clearly outweighing short- and long-term risks of ZES use. Important efficacy end points included ischemia-driven target lesion revascularization (TLR) or target vessel revascularization (TVR); safety end points included death, MI, and ST. The …

Safety and efficacy of overlapping sirolimus-eluting versus paclitaxel-eluting stents

The short-term and long-term safety and efficacy of paclitaxel versus sirolimus-overlapping drug-eluting stents (DES) is unknown. We sought to examine the clinical consequences of overlapping sirolimus versus paclitaxel DES. We reviewed catheterization reports from April 2003 to May 2005 for all patients who underwent percutaneous coronary revascularization with DES. All patients were followed-up for at least 1 year. Patients were included if they received only 2 single-type overlapping stent (eg, sirolimus-sirolimus) during the index procedure. The end points included early (inhospital and 30-day) and late composite of all-cause mortality, stent thrombosis, myocardial infarction, and target lesion revascularization. A total of 282 individuals met our study criteria. Of these, 188 had sirolimus and 94 had paclitaxel-overlapping DES. There were 78 events for a median follow-up of 24 months for the composite end point. No statistically significant differences between overlapping sirolimus and paclitaxel DES were seen for inhospital, 30-day (16% vs 23%, respectively; P = .13), and long-term (25% vs 33%, respectively; P = .16) composite end points. In addition, in Kaplan-Meier and Cox proportional hazard analysis, no significant differences for the composite end point were noted. In this analysis, there were no significant differences in safety or efficacy between the 2 types of overlapping DES. Trends toward more events with overlapping paclitaxel stents should be evaluated in an adequately powered randomized controlled trial.

Application of Paclitaxel-Eluting Metal Stents in Renal Artery of Pig Model

Recent reports concerning coronary, carotid, and femoral vasculature have proposed the use of drug-eluting metal stents (MS) to improve clinical and angiographic outcomes. Based on these reports, we used paclitaxel-eluting MS within an animal renal artery lumen and compared the results with those using a bare-metal stent. The experimental model in this study was the female pig renal artery. Ten pigs with weights ranging from 25 to 30 kg were used. Twenty stents were placed, two in each animal. The MS placement was randomly performed in either the right or left renal artery of each animal. In 10 arteries, a 3.5 x 18 mm R-stent (group A) was placed; in the remaining 10 arteries, a 3 x 32 mm paclitaxel-eluting coronary stent (T-stent, group B) was inserted. Patency was estimated with the use of digital subtraction angiography, CT angiography, and virtual endoscopy at 24 hours and 1 month poststent placement. The positioning of the MS was successful in all cases. The initial angiographic result was maintained 24 hours after the intervention. No stent migration was seen, except for one paclitaxel stent that was acutely occluded. The one-month patency rate, as demonstrated by angiography, CT angiography, and virtual endoscopy, was 70% (8 arteries) in group A and 90% (9 arteries) in group B. The thickness of the endothelium and of the muscular coat was statistically significantly less in group B compared with group A (P = 0.0352 and P = 0.0046, respectively). These preliminary experimental study results suggest that the paclitaxel-eluting MS is more efficient than the bare-metal stent when used within the pig renal artery. Further experimental and clinical studies are necessary to validate our preliminary encouraging results.

Pimecrolimus and dual pimecrolimus‐paclitaxel eluting stents decrease neointimal proliferation in a porcine model

The purpose of this study was to determine the effectiveness and vascular response of a pimecrolimus drug eluting stent and a combination (pimecrolimus + paclitaxel) stent as compared with bare metal controls in the porcine coronary model. In the first phase of the study, cobalt chromium stents were loaded with an erodible polymer and either a slow release or a fast release formulation of pimecrolimus. Thirty stents (metal, n = 10; pimecrolimus slow, n = 10; pimecrolimus fast, n = 10) were implanted in the coronary arteries of 10 pigs. At 30 days, neointimal proliferation and inflammation were both significantly less in the pimecrolimus fast release group as compared with the bare metal controls. Endothelialization was complete and equal in all three groups of stents. In the second phase of the study, stents were loaded with an erodible polymer with alternating reservoirs of paclitaxel and pimecrolimus. Twenty stents (8 control stents and 12 dual stents) were implanted in the coronary arteries of seven pigs. At 30 days, neointimal proliferation was significantly less in the dual drug group as compared with the bare metal controls. Endothelialization was complete in both groups of stents, suggesting complete healing of the arteries. In a 30-day porcine stent model, pimecrolimus inhibits neointimal proliferation as compared with bare metal stents. Also, the proof of concept of a dual drug eluting stent was established showing both safety and efficacy.

Multiple stent strut fracture-induced restenosis in a diffuse long lesion treated with overlapping heterogeneous drug-eluting stent

Coronary stent fracture can be a potentially serious complication to stenting leading to various complications, such as restenosis, and even occlusion. We reported multiple stent fracture of overlapping paclitaxel and sirolimus-eluting stent. Although an overwhelming majority of stent fracture was reported from sirolimus-eluting stent, our case showed that fracture of paclitaxel-eluting stent could occur by similar mechanisms as in sirolimus-eluting stent. So angiographic follow-up with intravascular ultrasound should be performed to elucidate the clinical significance of stent fracture of DES regardless of DES type.

PASSION shows no pros or cons with paclitaxel vs bare metal stents

PASSION shows no pros or cons with paclitaxel vs bare metal stents

Three‐year follow‐up of the first prospective randomized comparison between paclitaxel and sirolimus stents: The TAXi‐LATE trial

Analysis of the 3-year outcome of the original population of the TAXi trial which compared the efficacy of the paclitaxel (PES) and the sirolimus (SES) stents in a randomized "real world" investigation. The widespread use of drug-eluting stents strongly modified the world of interventional cardiology. The TAXi trial was a randomized comparison between PES and SES and showed similar efficacy between the two prostheses. Recently, emerging discussions raised questions about potential long-term risk with the use of DES. The present work attempts to describe the long-term outcome of the patients compared during the TAXi trial. During April 2003 and January 2004, 202 patients were prospectively randomly assigned to the PES group (102 patients) and to the SES group (100 patients). The primary aim of the present investigation was the comparison of combined incidence of cardiac death, myocardial infarction, and target lesion revascularization within 36-months. No difference in mortality of all causes was noted in the PES and the SES groups (3% vs. 7%, P=0.98) or in major adverse cardiac event free survival (89% vs. 83%, P=0.28). Four stent thromboses were observed, two in the PES group (205 and 788 days) and two in the SES group (210 and 772 days). The long-term outcome analysis of the TAXi trial confirms available published data showing the equivalence of PES and SES on clinical basis.

A look at drug eluting stents with optical coherence tomography

In the last year, following several publications in peer reviewed journals and presentations during the 2006 European Society of Cardiology congress,1 concerns have been raised about a possible increase in the incidence of death and myocardial infarction in patients treated with drug eluting stents (DESs) due to the occurrence of stent thrombosis. The incidence of stent thrombosis in the bare metal stent (BMS) era has become low after the introduction of dual antiplatelet therapy.2 Stent thrombosis in this setting is associated with persistent dissection, stent length, and final diameter.3 With paclitaxel and sirolimus-eluting stents, premature discontinuation of thienopyridine therapy has become the most important risk factor for stent thrombosis.4 In event-free patients 6 months after stent implantation, there was still an increase in death and/or myocardial infarction at 24 months follow-up in patients treated with DES without long-term thienopyridine therapy compared with DES with thienopyridine therapy.5 This impact on outcome of clopidogrel was not … *Corresponding author. Tel: +31 50 3611347; fax: +31 50 3611347. E-mail address : b.j.g.l.de.smet{at}thorax.umcg.nl

Drug eluting stents may not be the answer for myocardial bridges

Although medical treatment is the first-line therapy for myocardial bridges, in some cases revascularization may be required. Percutaneous intervention with bare metal stents is associated with a high restenosis rate. It has been speculated that drug eluting stents might be useful in this setting, although data are limited. We present a patient who suffered multifocal in-stent restenosis after a paclitaxel stent in a myocardial bridge.

Drug-eluting stents for the treatment of bifurcation lesions: A randomized comparison between paclitaxel and sirolimus stents

Drug-eluting stents have been shown to reduce restenosis in many types of lesions. The purpose of this article is to assess the efficacy of sirolimus- and paclitaxel-eluting stents in patients with bifurcation lesions. Between June 2003 and October 2004, 205 patients were enrolled in a prospective randomized trial; 103 patients were assigned to sirolimus stents and 102 patients to paclitaxel stents. All patients were treated by provisional T-stenting. There were no differences between groups in terms of age, risk factors, clinical condition, location of the bifurcation lesion, or other technical factors. Angiographic data and immediate results were also similar in both groups. Three patients developed inhospital non-Q-wave acute myocardial infarction (2 from the sirolimus group and 1 from the paclitaxel group). Follow-up angiography was obtained in 109 patients (53%). In the sirolimus group, 5 patients developed restenosis (9%): 1 at the main vessel, 2 at the side branch, and 2 in both branches. In contrast, 16 patients from the paclitaxel group had restenosis (29%): 6 at the main vessel, 5 at the side branch, and 5 in both branches. Target lesion revascularization at 24 +/- 5 months post stenting occurred in 4 patients from the sirolimus group (4%) and in 13 from the paclitaxel group (13%) (P < .05). Late loss at the main vessel in the sirolimus group patients was 0.31 +/- 0.59 versus 0.60 +/- 0.77 mm in patients from the paclitaxel group (P < .05). Patients with bifurcation lesions treated by sirolimus showed significantly lower rates of late loss, restenosis and target lesion revascularization than patients treated with paclitaxel-eluting stents.

Late Thrombosis of Drug-Eluting Stents: A Meta-Analysis of Randomized Clinical Trials

Purpose Drug-eluting stents are commonly used for percutaneous coronary intervention. Despite excellent clinical efficacy, the association between drug-eluting stents and the risk for late thrombosis remains imprecisely defined. Methods We performed a meta-analysis on 14 contemporary clinical trials that randomized 6675 patients to drug-eluting stents (paclitaxel or sirolimus) compared with bare metal stents. Eight of these trials have reported more than a year of clinical follow-up. Results The incidence of very late thrombosis (>1 year after the index procedure) was 5.0 events per 1000 drug-eluting stent patients, with no events in bare metal stent patients (risk ratio [RR] = 5.02, 95% confidence interval [CI], 1.29 to 19.52, P = .02). Among sirolimus trials, the incidence of very late thrombosis was 3.6 events per 1000 sirolimus stent patients, with no events in bare metal stent patients (RR = 3.99, 95% CI, .45 to 35.62, P = .22). The median time of late sirolimus stent thrombosis was 15.5 months, whereas with bare metal stents it was 4 months. Among paclitaxel trials, the incidence of very late thrombosis was 5.9 events per 1000 paclitaxel stent patients, with no events in bare metal stent patients (RR = 5.72, 95% CI, 1.08 to 32.45, P = .049). The median time of late paclitaxel stent thrombosis was 18 months, whereas it was 3.5 months in bare metal stent patients. Conclusions Although the incidence of very late stent thrombosis more than 1 year after coronary revascularization is low, drug-eluting stents appear to increase the risk for late thrombosis. Although more of this risk was seen with paclitaxel stents, it remains possible that sirolimus stents similarly increase the risk for late thrombosis compared with bare metal stents.

Integrated analysis of medically treated diabetic patients in the TAXUS(R) program: benefits across stent platforms, paclitaxel release formulations, and diabetic treatments.

The TAXUS(R) database was used to perform an integrated analysis across several large phase II and III trials to assess outcomes of polymer-based paclitaxel-eluting TAXUS stents in diabetic patients. While drug-eluting stents have reduced the risk for restenosis, diabetic patients remain at higher risk. This post hoc analysis of clinical and angiographic outcomes combined individual patient data from four randomized, multicentre, controlled clinical trials (TAXUS II, IV, V, and VI) representing outcomes across two paclitaxel release formulations and stent platforms. Breslow-Day analysis indicated homogeneous odds ratios across dose formulations and stent platforms, thus clinical data (9 months) were pooled from 3445 patients, including 814 diabetic patients. The randomized quantitative coronary angiography subset (n=2863) included 469 diabetic patients requiring oral medications only and 216 insulin-treated. Among patients receiving bare metal stents (BMS), those with diabetes had worse clinical and angiographic outcomes than non-diabetic patients. Target lesion revascularization rates were decreased in TAXUS patients relative to BMS controls by 59% (p=0.0001) among diabetic patients requiring oral medications, by 66% (p=0.006) among insulin-treated. Insulin-treated patients showed a significant TAXUS benefit for in-stent and in-segment percent diameter stenosis (p=0.0001, p=0.001, respectively) and late loss (p=0.001); a similar TAXUS benefit was seen in diabetic patients treated with oral medications (p<0.0001). Binary restenosis in-segment was significantly decreased 65% in both diabetic subsets (p=0.0001). This post hoc analysis of data from four combined randomized TAXUS trials suggests the TAXUS benefit observed in non-diabetic patients is carried over into the high-risk diabetic population.

Sirolimus- or paclitaxel-eluting stents for coronary artery revascularisation

In coronary artery disease treatment, the rate of restenosis has been reduced by the introduction of sirolimus- and paclitaxel-eluting stents. Recently, two clinical trials have directly compared these stents. The first study enrolled 1012 patients with either stable angina, or an acute coronary syndrome with a stenotic lesion of ≥ 50% in a vessel. The primary end point was the composite of major adverse events by 9 months, and occurred in fewer patients with sirolimus than paclitaxel stents (6.2 and 10.8%, respectively), due to a lower rate of target-lesion revascularisation with sirolimus- than paclitaxel-eluting stents (4.8 and 8.3%, respectively). The second study enrolled 250 patients with diabetes, angina pectoris and/or a positive stress test, and clinically significant angiographic stenosis in a native coronary artery. The primary end point was in-segmental luminal loss on follow-up angiography, and showed a late luminal in-stent loss of 0.46 and 0.19 mm in the paclitaxel and sirolimus groups, representing 24 and 17% stenosis, and 14 and 5% restenosis, respectively. Therefore, evidence from recent clinical trials favours sirolimus- over paclitaxel-eluting stents.

Randomized Trial of a Nonpolymer-Based Rapamycin-Eluting Stent Versus a Polymer-Based Paclitaxel-Eluting Stent for the Reduction of Late Lumen Loss

Although drug-eluting stents (DESs) constitute a major achievement in preventing restenosis, concerns remain regarding the increased inflammatory and thrombogenic responses associated with the polymers used. Recently, we showed that a nonpolymer on-site coating with rapamycin not only is feasible and safe but also leads to a dose-dependent reduction in restenosis. To assess whether polymer-free stents coated on-site with 2% rapamycin solution are inferior to polymer-based paclitaxel-eluting stents for the prevention of restenosis, we randomly assigned a total of 450 patients with de novo lesions in native coronary vessels, excluding the left main trunk, to either the polymer-free, rapamycin-coated Yukon DES (rapamycin stent) or the polymer-based, paclitaxel-eluting Taxus stent (paclitaxel stent). The primary end point was in-stent late lumen loss. Secondary end points were angiographic restenosis and target lesion revascularization. The study was designed to test the noninferiority of the rapamycin stent compared with the paclitaxel stent with respect to late lumen loss according to a noninferiority margin of 0.13 mm. Follow-up angiography was completed in 81% of the patients. The mean difference in in-stent late lumen loss between the rapamycin-stent group and the paclitaxel-stent group was 0.002 mm, and the upper limit of the 1-sided 95% confidence interval was 0.10 mm (P=0.02 from test for noninferiority). No significant differences were observed regarding angiographic restenosis rates (14.2% with the rapamycin stent and 15.5% with the paclitaxel stent) and target lesion revascularization rates due to restenosis (9.3% in both groups). The polymer-free, rapamycin-coated stent has an antirestenotic effect that is not inferior to that observed with the polymer-based paclitaxel-eluting stent.

Prolongation of patency of airway bypass stents with use of drug-eluting stents

Airway bypass by transbronchial fenestration has been shown to improve forced expiratory volume and flow in explanted emphysematous human lungs. We previously demonstrated the feasibility and safety of airway bypass stent placement in a canine model, but we found that most stents occluded within 1 week. The aim of this study was to evaluate the influence of controlled-release paclitaxel-eluting stents on prolongation of patency. With the subject dogs under general anesthesia, suitable segmental and subsegmental bronchial wall sites were selected by direct visualization with a flexible bronchoscope. A Doppler probe was used to detect and avoid sites with adjacent blood vessels. Transbronchial passages were formed with a 25-gauge transbronchial needle-tipped catheter and dilated with a 2.5-mm balloon integrated into the needle catheter. A specifically designed expandable stainless steel stent (3 mm long x 3 mm wide) embedded in a sleeve of silicone rubber was placed within the passage and expanded until secured about the bronchial wall. Fifty control stents (no paclitaxel impregnation) and 107 paclitaxel-eluting stents were placed in 25 dogs. Animals underwent bronchoscopy at intervals to assess stent patency. Eight instances of minor and brief bleeding occurred during stent placement; all resolved without incident. There were no pneumothoraces or deaths associated with stent placement. No delayed complications occurred. No identifiable paclitaxel-related toxicity was observed. At 1, 4, 8, and 12 weeks, the patency rates were 10%, 0%, 0%, and 0% for control stents and 100%, 96%, 76%, and 65% for paclitaxel stents. In an animal model, the use of specifically designed paclitaxel-eluting airway bypass stents was both feasible and safe. These stents resulted in a significant prolongation of patency.

Pharmacists’ role in preventing stent thrombosis

In this issue, Nawarskas and Osborn[1][1] review the paclitaxel drug-eluting stent (DES). The sirolimus and paclitaxel stents have virtually eliminated in-stent restenosis—a common problem with bare-metal stents (BMSs). The average use of DESs during summer 2004 reached approximately 80%.[2][2]

Comparative study of tacrolimus and paclitaxel stent coating in the porcine coronary model

Tacrolimus is a potent antiproliferative and immunosuppressive agent allowing for improved endothelial regeneration. The aim of our study was the preclinical evaluation of tacrolimus in a drug eluting nonerodable polymer stent system and its comparison with paclitaxel. A total of 40 domestic pigs and 10 mini-pigs underwent coronary stenting with a follow-up time between 6 hours and 3 months. Stents were implanted in coronary arteries with an overstretch ratio of 1.2. After 3 days, a 1.73 microg/mm(2) coating produced tacrolimus tissue levels of 20 mumol/l in the coronary artery wall. Effective tissue concentrations were sustained for 28 days. Based on histomorphometric analysis, tacrolimus stent treated vessels had a reduced extent of neointima formation compared with controls at 28 days (-51% compared to control) but not at 3 months. High dose paclitaxel stent coating (1.44 microg/mm(2)) was complicated by unexpected deaths of pigs and thrombotic stent occlusion at control angiography. Long-term porcine data showed no persistent inhibition of neointimal growth by paclitaxel and tacrolimus stent coating. Similar to paclitaxel, tacrolimus stent coating reduces neointimal proliferation in the porcine coronary model. However, dosing and long-term efficacy remains a critical issue in stent-based local drug delivery.

Thirty-day incidence and six-month clinical outcome of thrombotic stent occlusion after bare-metal, sirolimus, or paclitaxel stent implantation

We sought to determine the real-world incidence of angiographically confirmed and possible stent thrombosis (ST) in an unrestricted population during the first 30 days after bare-metal stent (BMS), sirolimus-eluting stent (SES), and paclitaxel-eluting stent (PES) implantation. Current data on ST in drug-eluting stents (DES) have come from randomized trials with strict entry criteria, which limits their generalizability to daily practice. The study population comprised three sequential cohorts of 506 consecutive patients with BMS, 1,017 consecutive patients with SES, and 989 consecutive patients treated with PES. In the first 30 days after stent implantation, 6 BMS (1.2%, 95% confidence interval [CI] 0.5% to 2.6%; p = 0.9), 10 SES (1.0%, 95% CI 0.5% to 1.8%), and 10 PES (1.0%, 95% CI 0.6% to 1.9%) patients developed angiographically proven ST. Multiple potential risk factors were identified in most patients with ST. Bifurcation stenting in the setting of acute myocardial infarction was an independent risk factor for angiographic ST in the entire population (odds ratio [OR] 12.9, 95% CI 4.7 to 35.8, p < 0.001). In patients with DES who had angiographic ST, 30-day mortality was 15%, whereas another 60% suffered a nonfatal myocardial infarction; no further deaths occurred during six months of follow-up. Including possible cases, 7 BMS (1.4%, 95% CI 0.7% to 2.8%), 15 SES (1.5%, 95% CI 0.9% to 2.4%), and 16 PES (1.6%, 95% CI 1.0% to 2.6%) patients had ST. The unrestricted use of SES or PES is associated with ST rates in the range expected for BMS. Stent thrombosis was associated with a high morbidity and mortality. Bifurcation stenting, when performed in patients with acute myocardial infarction, was associated with an increased risk of ST.

Meta-analysis comparing drug-eluting stents with bare metal stents

We performed a meta-analysis of 10 randomized trials of 5,066 patients with 6 to 12 months of follow-up. The summary risk differences excluded any major differences between the 2 types of stents for death (0.12%, 95% confidence interval [CI] -0.34% to 0.58%, p = 0.60) and overall myocardial infarction (0.04%, 95% CI -0.72% to 0.81%, p = 0.91). There was a modest increase in the risk of Q-wave myocardial infarction with drug-eluting stents (0.36%, 95% CI -0.04% to 0.77%, p = 0.080) but no difference in non-Q-wave myocardial infarction (-0.26%, 95% CI -0.95% to 0.43%, p = 0.47). The trend for increased risk of Q-wave myocardial infarction was seen for paclitaxel and sirolimus stents (risk differences 0.28% and 0.58%, respectively). Drug-eluting stents also had a nonsignificant trend for higher risk of thrombosis (0.29%, 95% CI -0.08% to 0.66%, p = 0.13). We conclude that sirolimus- and paclitaxel-eluting stents are equivalent to bare-metal stents in terms of mortality and overall myocardial infarction risk for the first year of follow-up; the meta-analysis excludes with considerable confidence the presence of large, clinically relevant differences for these outcomes.

Sirolimus-Eluting Stent or Paclitaxel-Eluting Stent vs Balloon Angioplasty for Prevention of Recurrences in Patients With Coronary In-Stent Restenosis

In patients with de novo coronary lesions, drug-eluting stents have drastically reduced restenosis risk compared with bare metal stents and conventional balloon angioplasty. It is less clear whether drug-eluting stents are superior to conventional balloon angioplasty for the treatment of patients with in-stent restenosis. To assess if drug-eluting stents are a more effective treatment of in-stent restenosis than conventional balloon angioplasty, and to assess the relative merits of 2 drug-eluting stents, a sirolimus-eluting stent and a paclitaxel-eluting stent. Randomized, open-label, active-controlled trial conducted among 300 patients with angiographically significant in-stent restenosis in 2 tertiary German centers from June 1, 2003, to October 20, 2003. After pretreatment with 600 mg of clopidogrel for at least 2 hours before intervention, all patients were randomly assigned to 1 of 3 treatment groups: sirolimus stent, paclitaxel stent, or balloon angioplasty (100 patients in each group). Primary end point: angiographic restenosis (diameter stenosis > or =50%) at 6-month follow-up angiography based on "in-segment" analysis. Primary analysis was comparison between stent groups and balloon angioplasty groups; a secondary analysis compared sirolimus and paclitaxel stents. Follow-up angiography was performed in 275 (92%) of 300 patients. The incidence of angiographic restenosis was 44.6% (41/92) in the balloon angioplasty group, 14.3% (13/91) in the sirolimus stent group (P<.001 vs balloon angioplasty), and 21.7% (20/92) in the paclitaxel stent group (P = .001 vs balloon angioplasty). When compared with balloon angioplasty, receiving a sirolimus stent had a relative risk (RR) of angiographic restenosis of 0.32 (95% confidence interval [CI], 0.18-0.56); a paclitaxel stent had an RR of 0.49 (95% CI, 0.31-0.76). The incidence of target vessel revascularization was 33.0% (33/100) in the balloon angioplasty group, 8.0% (8/100) in the sirolimus stent group (P<.001 vs balloon angioplasty), and 19.0% (19/100) in the paclitaxel stent group (P = .02 vs balloon angioplasty). The secondary analysis showed a trend toward a lower rate of angiographic restenosis (P = .19) and a significantly lower rate of target vessel revascularization (P = .02) among sirolimus stent patients compared with paclitaxel stent patients. In patients with in-stent restenosis, a strategy based on sirolimus- or paclitaxel-eluting stents is superior to conventional balloon angioplasty for the prevention of recurrent restenosis. Sirolimus-eluting stents may be superior to paclitaxel-eluting stents for treatment of this disorder.