[Sirolimus-eluting stent for in-stent restenosis treatment: single center results in an unselected study population] (original) (raw)
Related papers
Sirolimus-Eluting Stent for the Treatment of In-Stent Restenosis
Circulation, 2002
Background— We have previously reported the safety and effectiveness of sirolimus-eluting stents for the treatment of de novo coronary lesions. The present investigation explored the potential of this technology to treat in-stent restenosis. Methods and Results— Twenty-five patients with in-stent restenosis were successfully treated with the implantation of 1 or 2 sirolimus-eluting Bx VELOCITY stents in São Paulo, Brazil. Nine patients received 2 stents (1.4 stents per lesion). Angiographic and volumetric intravascular ultrasound (IVUS) images were obtained after the procedure and at 4 and 12 months. All vessels were patent at the time of 12-month angiography. Angiographic late loss averaged 0.07±0.2 mm in-stent and −0.05±0.3 mm in-lesion at 4 months, and 0.36±0.46 mm in-stent and 0.16±0.42 mm in-lesion after 12 months. No patient had in-stent or stent margin restenosis at 4 months, and only one patient developed in-stent restenosis at 1-year follow-up. Intimal hyperplasia by 3-dim...
Circulation, 2005
Background-In-stent restenosis is notoriously difficult to treat by repeat catheter intervention because of its propensity for aggressive recurrent neointimal formation. This study sought to assess the effectiveness and safety of the sirolimus-eluting stent in the treatment of in-stent restenosis. Methods and Results-The study was designed as a prospective multicenter registry. We included 162 patients with in-stent restenosis of a native coronary artery who had a clinical indication for repeat intervention. Patients were scheduled for follow-up angiography at 6 months. The primary end point was in-lesion late loss. Follow-up angiography was performed in 155 patients. We obtained an in-lesion late loss of 0.08Ϯ0.49 mm and a binary restenosis rate of 9.7% (15/155), which prompted reintervention in 7.4% (12/162) at 9 months. The 9-month rate of death was 1.2% (2/162) and that of nonfatal myocardial infarction was 1.2% (2/162). Conclusions-Sirolimus-eluting stents were highly efficacious and safe in the treatment of in-stent restenosis. Our study provides rationale for the use of sirolimus-eluting stents in the treatment of in-stent restenosis.
Sirolimus-Eluting Stents for Treatment of In-Stent Restenosis: Immediate and Late Results
Texas Heart Institute Journal from the Texas Heart Institute of St Luke S Episcopal Hospital Texas Children S Hospital, 2005
We analyzed the clinical, angiographic, and late intravascular ultrasonographic findings from 140 patients whose in-stent restenosis was treated with sirolimus-eluting stents. In-stent restenosis remains the main limitation to percutaneous coronary revascularization and has a high recurrence rate after bare stent implantation.From May 2002 through July 2003, we studied 140 patients with clinical restenosis after bare-stent treatment. In 107 patients, in-stent restenosis occurred de novo; in 28 patients, this was the 2nd restenosis; and in another 5, it was the 3rd occurrence. A sirolimus-eluting stent was implanted directly after angiographic evaluation of the in-stent restenosis in 79 patients and after pre-dilation in 61 patients. All patients were given the following antithrombotic regimen: low-molecular-weight heparin, ticlopidine, and aspirin for 1 month, followed by clopidogrel and aspirin for 1 year.Primary success was achieved in 137 patients. Three patients had a non-Q wave myocardial infarction. At the 1-month evaluation, 2 patients had died: 1 due to subacute stent thrombosis and another due to acute mesenteric ischemia. After a mean follow-up of 16 ± 4 months, the major adverse cardiac events were acute myocardial infarction due to late stent thrombosis in 2 patients and the need for target lesion revascularization in 15 patients. Late angiographic evaluation was performed in 97 patients (69%), 16 of whom had new restenosis: 14 of the restenoses were intrastent, and 2 were at the edges of the stent.Our results suggest that sirolimus-eluting stents are effective in the prevention of in-stent restenosis and, therefore, may become the leading treatment alternative for patients with in-stent restenosis.
Sirolimus-eluting stent for treatment of complex in-stent restenosis
Journal of the American College of Cardiology, 2003
clinical experience Sirolimus-eluting stent for treatment of complex in-stent restenosis: The first This information is current as of July 16, 2011 http://content.onlinejacc.org/cgi/content/full/41/2/184 located on the World Wide Web at: The online version of this article, along with updated information and services, is by on July 16, 2011 content.onlinejacc.org Downloaded from CLINICAL STUDIES Interventional Cardiology OBJECTIVES
Circulation, 2003
Background-We have previously reported the safety and effectiveness of sirolimus-eluting stents for the treatment of de novo coronary lesions. The present investigation explored the potential of this technology to treat in-stent restenosis. Methods and Results-Twenty-five patients with in-stent restenosis were successfully treated with the implantation of 1 or 2 sirolimus-eluting Bx VELOCITY stents in São Paulo, Brazil. Nine patients received 2 stents (1.4 stents per lesion). Angiographic and volumetric intravascular ultrasound (IVUS) images were obtained after the procedure and at 4 and 12 months. All vessels were patent at the time of 12-month angiography. Angiographic late loss averaged 0.07Ϯ0.2 mm in-stent and Ϫ0.05Ϯ0.3 mm in-lesion at 4 months, and 0.36Ϯ0.46 mm in-stent and 0.16Ϯ0.42 mm in-lesion after 12 months. No patient had in-stent or stent margin restenosis at 4 months, and only one patient developed in-stent restenosis at 1-year follow-up. Intimal hyperplasia by 3-dimensional IVUS was 0.92Ϯ1.9 mm 3 at 4 months and 2.55Ϯ4.9 mm 3 after 1 year. Percent volume obstruction was 0.81Ϯ1.7% and 1.76Ϯ3.4% at the 4-and 12-month follow-up, respectively. There was no evidence of stent malapposition either acutely or in the follow-up IVUS images, and there were no deaths, stent thromboses, or repeat revascularizations.
Heart, 2004
To assess the effectiveness of routine sirolimus eluting stent (SES) implantation for unselected patients with in-stent restenosis and to provide preliminary information about the angiographic outcome for lesion subgroups and for different in-stent restenosis patterns. Design: Prospective, single centre registry. Setting: Tertiary referral centre. Patients: 44 consecutive patients (53 lesions) without previous brachytherapy who were treated with SES for in-stent restenosis were evaluated. Routine angiographic follow up was obtained at six months and the incidence of major adverse cardiovascular events was evaluated. Results: At baseline, 42% of the lesions were focal, 21% diffuse, 26% proliferative, and 11% total occlusions. Small vessel size (reference diameter (2.5 mm) was present in 49%, long lesions (. 20 mm) in 30%, treatment of bypass grafts in 13%, and bifurcation stenting in 18%. At follow up, post-SES restenosis was observed in 14.6%. No restenosis was observed in focal lesions. For more complex lesions, restenosis rates ranged from 20-25%. At the one year follow up, the incidence of death was 0, myocardial infarction 4.7% (n = 2), and target lesion revascularisation 16.3% (n = 7). The target lesion was revascularised because of restenosis in 11.6% (n = 5). Conclusions: Routine SES implantation is highly effective for focal in-stent restenosis and appears to be a promising strategy for more complex patterns of restenosis.
Catheterization and Cardiovascular Interventions, 2004
The purpose of this study was to compare the mid-term clinical outcome of sirolimuseluting stent (SES) implantation and vascular brachytherapy (VBT) for in-stent restenosis (ISR). We assessed the 9-month occurrence of major adverse cardiac events (MACE) in 44 consecutive patients with ISR treated with SES implantation and 43 consecutive patients treated with VBT in the period immediately prior. Baseline clinical and angiographic characteristics of the two groups were similar. During follow-up, three patients (7%) died in the VBT group and none in the SES group. The incidence of myocardial infarction was 2.3% in both groups. Target lesion revascularization was performed in 11.6% of the VBT patients and 16.3% of the SES patients (P ؍ NS). The 9-month MACE-free survival was similar in both groups (79.1% VBT vs. 81.5% SES; P ؍ 0.8 by log rank). The result of this nonrandomized study suggests that sirolimus-eluting stent implantation is at least as effective as vascular brachytherapy in the treatment of in-stent restenosis.
Clinical Research in Cardiology, 2008
j Abstract Aims Drug-eluting stents have been reported to effectively reduce in-stent restenosis (ISR). However, the effectiveness and safety have yet been investigated only in small trials or case series. The aim of this prospective large scale registry was to show that treatment of ISR with sirolimus eluting stents (SES) is safe, effective and feasible in daily routine. Methods and results The German Cypher registry prospectively enrolled 6,555 patients undergoing implantation with SES for various indications, including 1,533 patients treated for ISR. Follow-up data (median 6.6 months) of this cohort was available for 1,531 patients (99.8%). Of these patients 75.8% were male. Of these patients 36.5% (n = 552) presented with acute coronary syndromes. In total, 1,932 SES were used with successful implantation in 98.9%. MI during hospitalization was observed in 0.7% (n = 11) while in-hospital mortality was only 0.1% (n = 2). MACE-rate at follow-up was 13.8% (n = 211) including a mortality of 1.3% (n = 20) and MI in 1.9% (n = 29). Total revascularization procedures including CABG (1.7%) were necessary in 12.3% (n = 186). Target vessel revascularization (TVR) rate was 9.3% (n = 139) and thus similar to patients with de novo lesions (8.1%, P = 0.69). Ten patients (0.65%) suffered from subacute stent thrombosis Vs. 0.24% observed in patients with de novo lesions (P = 0.03). Conclusion This large registry confirms that treatment of ISR with sirolimus-eluting-stents is effective and save with good clinical results at index procedure and follow-up. TVR was not different from de novo lesions.
Post–Sirolimus-Eluting Stent Restenosis Treated With Repeat Percutaneous Intervention
Circulation, 2004
Background— We evaluated the clinical and angiographic outcomes of patients presenting with restenosis after sirolimus-eluting stent (SES) implantation treated with repeated percutaneous intervention. Methods and Results— A total of 24 consecutive patients have undergone repeated percutaneous intervention to treat post-SES restenosis (27 lesions). The restenosis was located within the stent in 93% of lesions. From the 27 lesions, 1 (4%) was re-treated with a bare stent, 3 (11%) were treated with balloon dilatation, and the remaining 23 lesions (85%) were treated with repeated drug-eluting stent implantation (SES in 12 lesions [44%], paclitaxel-eluting stents in 11 lesions [41%]). The event-free survival rate was 70.8% after a median follow-up of 279 days from the post-SES treatment. The overall recurrent restenosis rate was 42.9%. The risk of recurrent restenosis was increased for patients with hypercholesterolemia, previous angioplasty, failed brachytherapy, post-SES restenosis nee...