Five-Year Follow-Up After Sirolimus-Eluting Stent Implantation (original) (raw)
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Long-Term Clinical Outcomes With Sirolimus-Eluting Coronary Stents
Journal of The American College of Cardiology, 2007
This study examined the clinical outcomes at 5 years in RAVEL (A Randomized Comparison of a Sirolimus-Eluting Stent With a Standard Stent for Coronary Revascularization), the first controlled trial of drug-eluting stents.
Two-Year Outcomes After Sirolimus-Eluting Stent Implantation
Journal of the American College of Cardiology, 2006
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).
5Year Clinical Outcomes After Sirolimus-Eluting Stent Implantation
Journal of The American College of Cardiology, 2009
Five-year clinical follow-up has been scheduled per protocol by the 4 Cypher (Cordis/Johnson & Johnson, Warren, New Jersey) sirolimus-eluting stent (SES) versus bare-metal stent (BMS) randomized trials.A delayed arterial healing response after drug-eluting stent implantation has raised concerns about the long-term safety of drug-eluting stents.In a pooled analysis of 4 randomized trials, 1,748 patients were assigned to receive either an SES (n = 878) or BMS (n = 870).At 5 years, there was no significant difference in the rate of death, myocardial infarction (MI), or the composite of death/MI between the 2 groups (15.1% in the SES group vs. 13.6% in the BMS group; p = 0.36). The 5-year incidence of stent thrombosis by the Academic Research Consortium definition did not differ between SES and BMS (definite/probable stent thrombosis, 2.1% vs. 2.0%; p = 0.99). The incidence of very late stent thrombosis was also similar between the SES and BMS groups (1.4% vs. 0.7%; p = 0.22). The annualized rates of definite/probable stent thrombosis after 1 year were 0.4% for SES and 0.2% for BMS. The 5-year incidence of target vessel revascularization was significantly lower in the SES group (15.2% vs. 30.1%; p < 0.0001).In this patient-level pooled analysis, overall use of SES compared with BMS demonstrated persistent superior efficacy at 5 years in terms of a reduction in target vessel revascularization, without an increase in rates of death, MI, or stent thrombosis. (The Initial Double-Blind Drug-Eluting Stent vs Bare-Metal Stent Study, NCT00233805; The Study of the BX Velocity Stent in the Treatment of De Novo Artery Lesions, NCT00381420; Study of Sirolimus-Coated BX VELOCITY Balloon-Expandable Stent in Treatment of de Novo Native Coronary Artery Lesions [SIRIUS], NCT00232765; The Study of the BX VELOCITY Stent In Patients With De Novo Coronary Artery Lesions, NCT00235144)
Circulation, 2004
Background-This study evaluated a large group of patients enrolled in a double-blind randomized trial of the sirolimus-eluting stent to document whether the initial clinical improvement seen in previous smaller series is maintained out to 12 months and to study the potential treatment effect in patient subsets known to be at increased risk of restenosis. Methods and Results-A total of 1058 patients with de novo native coronary stenosis undergoing clinically indicated percutaneous coronary intervention were randomly assigned to sirolimus-eluting stent (533) or control bare stent (525). Procedural success and in-hospital outcomes were excellent and did not differ between the 2 groups. At 9 months, clinical restenosis, defined as target-lesion revascularization, was 4.1% in the sirolimus limb versus 16.6% in the control limb (PϽ0.001). At 12 months, the absolute difference in target-lesion revascularization continued to increase and was 4.9% versus 20% (PϽ0.001). There were no differences in death or myocardial infarction rates. In high-risk patient subsets, defined by vessel size, lesion length, and presence of diabetes mellitus, there was a 70% to 80% reduction in clinical restenosis at 1 year. Conclusions-Placement of the sirolimus-eluting stent results in continued clinical improvement at 1 year after initial implantation, with significant reduction in clinical restenosis as defined by target-lesion revascularization. Between 9 and 12 months, the absolute reduction of clinical restenosis continues to increase. Even in high-risk subsets of patients, there is a 70% to 80% relative reduction in clinical restenosis at 12 months with this drug-eluting stent. (Circulation. 2004;109:634-640.) Key Words: stents Ⅲ sirolimus Ⅲ restenosis Ⅲ coronary disease C ompared with other percutaneous techniques, including balloon angioplasty, the unique attribute of coronary stents has been their consistent ability to reduce restenosis rates by producing consistently large target-lesion lumens. 1-5 Angiographic binary restenosis rates were reported to be Ϸ20% or lower during the early stent era of the mid-1990s. 6-8 However, as stenting has been applied to more challenging coronary lesions, observed restenosis rates have drifted upward to 30% or even higher, largely because of the increasing prevalence of adverse risk factors for restenosis, including the presence of diabetes mellitus, small-vessel disease, and long lesion lengths. 9-11
Journal of the American College of Cardiology, 2008
Our purpose was to evaluate the long-term use of sirolimus-eluting stents (SES) and bare-metal stents (BMS) in patients with complex coronary artery lesions. Background Although the use of SES has proved to be effective in patients with simple coronary artery lesions, there are limited data of the long-term outcome of patients with complex coronary artery lesions. Methods We randomly assigned 322 patients with total coronary occlusions or lesions located in bifurcations, ostial, or angulated segments of the coronary arteries to have SES or BMS implanted. Results At 3 years, major adverse cardiac events had occurred in 20 patients (12%) in the SES group and in 59 patients (38%) in the BMS group (p Ͻ 0.001). Four versus 2 patients suffered a cardiac death (p ϭ NS), and 5 versus 1 died of a noncardiac disease (p ϭ NS) in the SES versus the BMS group. Six patients in the SES group versus 15 patients in the BMS group suffered a myocardial infarction (p Ͻ 0.05) during the 3-year observation period, and target lesion revascularization was performed in 8 patients (4.9%) versus 53 patients (33.8%), respectively (p Ͻ 0.001); of these, 4 in the SES versus 7 in the BMS group were performed between 1 and 3 years after the index treatment (p ϭ NS). According to revised definitions, stent thrombosis occurred in 5 patients (3.1%) in the SES group and in 7 patients (4.4%) in the BMS group (p ϭ NS); very late stent thrombosis was observed in 4 versus 1 patient. Conclusions A continued benefit was observed up to 3 years after implantation of SES in patients with complex coronary artery lesions. The rate of late adverse events was similar in the 2 groups, and stent thromboses occurred rarely after 1 year. (Sirolimus Eluting Stents in Complex Coronary Lesions [SCANDSTENT]; NCT00151658) (
Sirolimus-Eluting Versus Bare-Metal Stents for the Reduction of Coronary Restenosis
Herz Kardiovaskuläre Erkrankungen, 2007
Purpose: The GERSHWIN study (German Stent Health Outcome and Economics Within Normal Practice) was designed to evaluate long-term effects of treatment of coronary artery disease (CAD) with sirolimus-eluting stents (SES), as compared to bare-metal stents (BMS). Patients and Methods: Within a multicenter, prospective intervention study in 35 hospitals throughout Germany, CAD patients with coronary stenosis and elective percutaneous coronary intervention (PCI) indication were treated either with SES or BMS (sequential control design with a case-to-control ratio of 2 : 1). Standardized questionnaires were completed by patients and their physicians at baseline, 3, 6, 12, and 18 months following PCI to document re-PCI for restenosis, myocardial infarction (MI), coronary bypass surgery (CABG), and death. Angiographic PCI documentation was evaluated by an independent expert.
Very long sirolimus-eluting stent implantation for de novo coronary lesions
The American Journal of Cardiology, 2004
Long-length stenting has a poor outcome when bare metal stents are used. The safety and efficacy of the sirolimus-eluting stent (SES) in long lesions has not been evaluated. Therefore, the aim of the present study was to evaluate the clinical and angiographic outcomes of SES implantation over a very long coronary artery segment. Since April 2002, all patients treated percutaneously at our institution received a SES as the device of choice as part of the Rapamycin Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry. During the RESEARCH registry, stents were available in lengths of 8, 18, and 33 mm. The present report includes a predefined study population consisting of patients treated with >36-mm-long stented segments. Patients had a combination of >2 overlapping stents at a minimum length of 41 mm (i.e., one 33-mm SES overlapping an 8-mm SES) to treat native de novo coronary lesions. The incidence of major cardiac adverse events (death, nonfatal myocardial infarction, and target lesion revascularization) was evaluated. The study group comprised 96 consecutive patients (102 lesions). Clinical follow-up was available for all patients at a mean of 320 days (range 265 to 442). In all, 20% of long-stented lesions were chronic total occlusions, and mean stented length per lesion was 61.2 ؎ 21.4 mm (range 41 to 134). Angiographic follow-up at 6 months was obtained in 67 patients (71%). Binary restenosis rate was 11.9% and in-stent late loss was 0.13 ؎ 0.47 mm. At long-term follow-up (mean 320 days), there were 2 deaths (2.1%), and the overall incidence of major cardiac events was 8.3%. Thus, SES implantation appears safe and effective for de novo coronary lesions requiring multiple stent placement over a very long vessel segment. ᮊ2004 by
Circulation, 2012
Background-Several recent randomized trials comparing everolimus-eluting stent (EES) and sirolimus-eluting stent (SES) reported similar outcomes. However, only 1 trial was powered for a clinical end point, and no trial was powered for evaluating target-lesion revascularization. Methods and Results-Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial is a prospective multicenter randomized open-label trial comparing EES with SES in Japan. The trial was powered for evaluating noninferiority of EES relative to SES in terms of target-lesion revascularization. From February and July 2010, 3197 patients were randomly assigned to receive either EES (1597 patients) or SES (1600 patients). At 1 year, the primary efficacy end point of target-lesion revascularization occurred in 65 patients (4.3%) in the EES group and in 76 patients (5.0%) in the SES group, demonstrating noninferiority of EES to SES (P noninferiority Ͻ0.0001, and P superiority ϭ0.34). Cumulative incidence of definite stent thrombosis was low and similar between the 2 groups (0.32% versus 0.38%, Pϭ0.77). An angiographic substudy enrolling 571 patients (EES, 285 patients and SES, 286 patients) demonstrated noninferiority of EES relative to SES regarding the primary angiographic end point of in-segment late loss (0.06Ϯ0.37 mm versus 0.02Ϯ0.46 mm, P noninferiority Ͻ0.0001, and P superiority ϭ0.24) at 278Ϯ63 days after index stent implantation. Conclusions-One-year clinical and angiographic outcome after EES implantation was noninferior to and not different from that after SES implantation in a stable coronary artery disease population with relatively less complex coronary anatomy. One-year clinical outcome after both EES and SES use was excellent with a low rate of target-lesion revascularization and a very low rate of stent thrombosis.
Journal of the American College of Cardiology, 2009
Paclitaxel-Eluting, and Bare-Metal Coronary Stents: Results From the WDHR 2-Year Clinical Outcomes After Implantation of Sirolimus-Eluting, This information is current as of May 15, 2011 http://content.onlinejacc.org/cgi/content/full/53/8/658 located on the World Wide Web at: The online version of this article, along with updated information and services, is by on May 15, 2011 content.onlinejacc.org Downloaded from Objectives This registry study assessed the safety and efficacy of the 2 types of drug-eluting stents (DES), sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES), compared with bare-metal stents (BMS).