Abstract 2150: A European and Canadian Multicenter Randomized, Double-Blind Trial of the Sirolimus-Eluting Stent (SES) in Patients with De Novo Native Coronary Artery Lesions (NEW-SIRIUS): 5-Year Clinical Outcomes

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Eric Schampaert ◽  
Joachim Schofer ◽  
Guenther Breithardt ◽  
Eric A. Cohen ◽  
Michael Schlüter ◽  
...  

Background : NEW-SIRIUS is the pooled analysis of the E-SIRIUS (n=352) and C-SIRIUS (n=100) studies, respectively, performed in Europe and Canada. Identical in design, these are multicenter randomized, double-blind trials examining the safety and efficacy of the sirolimus-eluting stent (SES) vs. an identical bare-metal stent (BMS) in 452 patients to treat de novo native long lesions in small coronary arteries, with adjunctive clopidogrel for only 2 months. Methods : The primary endpoint was in-stent minimum lumen diameter (MLD) at 8-month follow-up. Among the secondary endpoints were major adverse cardiac events(MACE) at 1, 6, 9 and 12 months, and annually up to 5 years post-procedure, as well as target lesion revascularization (TLR), target vessel revascularization (TVR) and protocol-defined stent thrombosis. Results : At 8 months, the MLD was 2.27±0.47mm in the SES vs. 1.36±0.66 mm in the BMS (p < 0.001). The binary in-lesion restenosis rate was 5.1% in the SES vs. 44.2% in the BMS (p < 0.001). At 4 years, there was a significantly lower incidence of MACE (SES: 15.1% vs BMS: 33.9%, p < 0.001), primarily driven by a significant difference in clinically-driven TLR rates (SES: 7.1% vs. BMS: 26.0%, p < 0.001). A subgroup analysis in diabetic patients (45 SES, 60 BMS) demonstrated that the in-stent MLD was larger in SES than in BMS (2.20±0.47 vs 1.14±0.64 mm, p < 0.001) and the binary in-lesion restenosis rate was reduced from 56.1% (BMS) to 10.0% (RRR: 82.2%, p < 0.001) at 8 months. At 4 years, the freedom from MACE in diabetic patients was 80.0% in the SES vs. 61.7% in the BMS (p = 0.031), again mainly driven by an improved freedom from clinically driven-TLR (SES: 90.8% vs. BMS: 66.9%, p=0.005), with no evidence of a late catch-up effect. Conclusion : Up to 4 years, SES were superior to BMS in the total cohort as well as in the diabetic subgroup without evidence of a late catch-up. Five-year follow-up data, including antiplatelet therapies utilization and a diabetic subgroup analyses will be available by July 2007 and presented.

Angiology ◽  
2018 ◽  
Vol 70 (5) ◽  
pp. 414-422
Author(s):  
Dai Zhang ◽  
Yan Sun ◽  
Xiaoli Liu ◽  
Fang Liu ◽  
Yujing Cheng ◽  
...  

Managing patients with in-stent restenosis (ISR) remains an important clinical challenge. In particular, large, randomized trials assessing the effect of drug-eluting balloons (DEB) in patients with de novo lesions are warranted. We investigated the effect of DEB on procedural complications, target lesion revascularization (TLR), and major adverse cardiac and cerebrovascular events in patients with drug-eluting stent ISR and de novo lesions. The clinical profiles of 238 consecutive patients treated for coronary ISR (n = 174) and de novo lesions (n = 64) using SeQuent Please paclitaxel-coated balloon were analyzed. Study end points were major adverse cardiac events (MACEs). At 1-year follow-up, TLR and MACEs occurred with acceptably low rates (5.0% and 6.3%, respectively). At 2.00 (0.74) years of follow-up, there was a significant difference in the rates of TLR between the ISR and the de novo lesions groups (14.4% [ISR] vs 3.1% [de novo], P = .028), and the occurrence of MACEs distinctly increased in the ISR group compared to the de novo lesions group (21.8% vs 6.2%, P = .009). The long-term outcomes of the ISR group were inferior to those of the de novo group (TLR, log-rank P = .019; MACEs, log-rank P = .010). Drug-eluting balloon for ISR and de novo lesions of small coronary vessels is effective and safe.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K.M.Z Mohd Saad Jalaluddin

Abstract Background Drug-coated balloon has been widely used to treat In-Stent Restenosis as recommended by ESC/EACT coronary intervention guideline. However, trials of effectiveness of DCB in treating de novo lesions in diabetic patients are limited. This study will highlight the impact of DCB in diabetic patients with only de novo lesions against non-diabetic patients. Aim To compare the outcomes of Paclitaxel Drug Coated Balloon (DCB) in Diabetic and non-diabetic patients with only de novo coronary artery disease. Methods A retrospective, single center study was conducted from January 2016 till December 2018. All diabetic and non-diabetic patients underwent angioplasty to only de novo coronary artery lesions were included in the study. Patients' baseline characteristic, angiographic data, post procedural and 12 months follow-up outcomes including major adverse coronary artery event (MACE), target lesion revascularization (TLR) and myocardial infarction (MI) are compared. Results A total of 1257 patients (726 diabetic and 531 non-diabetic patients) with total 1385 de novo coronary artery lesions (791 lesions in diabetic group and 594 lesions in non-diabetic group) were included in this study. Mean age for non-diabetic group was 57.6±10.6 years and diabetic group was 59.6±9.6 years with male predominance (91.1% in non-diabetic group, n=484 and 79.2% in diabetic group, n=575). Majority of diabetic group has hypertension (83.7%, n=608 vs 58.6%, n+311), chronic renal failure (10.3%, n=75 vs 1.9%, n=10), documented coronary artery disease (55.6%, n=404 vs 47.5%, n=252) and previous coronary angioplasty 39.5%, n=287 vs 28.8%, n=153). Adequate pre-dilatation was done in both groups (98.5%, n=585 in non-diabetic group and 99.4%, n=786 in diabetic group; p=0.000). Mean DCB diameter and length were almost similar in both groups. Mean residual stenosis after DCB was 11.15±16.9% in non-diabetic group and 13.13±13.4% in the diabetic group (p=0.008). 74.6% of non-diabetic group (n=396) and 77.1% of diabetic group (n=560) were on double antiplatelet therapy for 12 months. 86.8% (n=461) of non-diabetic and 88.4% (n=642) of diabetic patients were available for follow up. MACE events were significantly higher (p=0.000) in diabetic group (4.3%, n=31) as compare to non-diabetic group (0.6%, n=3). Target lesion revascularization (TLR) and myocardial infarction (MI) was also significantly higher in diabetic group (TLR 1.4%, N=10 vs 0.6%, n=3, p=0.049; MI 2.6%, n=19 vs 0.4%, n=2, p=0.002). Conclusion Treating de novo coronary lesions in diabetic patients with DCB associated with significantly higher MACE events, target lesion revascularization and myocardial infarction. Diabetic patients appear to have a greater volume of atherosclerotic plaque and increased propensity for atherosclerotic plaque rupture. Funding Acknowledgement Type of funding source: None


Scientifica ◽  
2016 ◽  
Vol 2016 ◽  
pp. 1-8 ◽  
Author(s):  
Ranjan Shetty ◽  
Jayesh Prajapati ◽  
Umesh Pai ◽  
Kiran Shetty

Objective. The objective of the MANIPAL-FLEX study was to evaluate the feasibility, preliminary safety, and efficacy of the Supraflex sirolimus-eluting stent (SES) implantation, inde novocoronary artery disease, using clinical and quantitative coronary angiography (QCA) follow-ups.Methods. This was a prospective, nonrandomized, multicenter, single-arm study that enrolled 189 patients withde novocoronary artery disease who were treated with the Supraflex SES. Of 189 patients enrolled, the first 61 consecutive patients who consented to a 9-month follow-up evaluation by QCA, irrespective of presence of symptoms, were to be followed up with angiography at 9 months. The primary endpoint of the study was target lesion failure (TLF), including cardiac death, myocardial infarction, and target lesion revascularization during 12-month follow-up after the index procedure.Results. The mean age of the study population was58±11years, with 51.3% (97/189) of hypertensive patients. Total of 66 lesions, analyzed by offline QCA, showed good scaffolding of the target vessel with in-stent late lumen loss at 9 months of0.18±0.23 mm. The observed TLF at 30-day, 6-month, and 12-month follow-up were 2 (1.1%), 6 (3.2%), and 10 (5.3%), respectively.Conclusion. This study provides preliminary evidence for the feasibility, safety, and efficacy of the Supraflex sirolimus-eluting stent.


Scientifica ◽  
2015 ◽  
Vol 2015 ◽  
pp. 1-6 ◽  
Author(s):  
Anurag Polavarapu ◽  
Raghava Sarma Polavarapu ◽  
Jayesh Prajapati ◽  
Kamlesh Thakkar ◽  
Asif Raheem ◽  
...  

Background. Long lesions being implanted with drug-eluting stents (DES) are associated with relatively high restenosis rates and higher incidences of adverse events.Objectives. We aimed to examine the safety and efficacy of the long (40 mm) biodegradable polymer coated Indolimus sirolimus-eluting stent (SES) in real-world patients with long coronary lesions.Methods. This study was observational, nonrandomized, retrospective, and carried out in real-world patients. A total of 258 patients were enrolled for the treatment of long coronary lesions, with 40 mm Indolimus. The primary endpoints in the study were incidence of major adverse cardiac events (MACE), a miscellany of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR) or target vessel revascularization (TVR), and stent thrombosis (ST) up to 6-month follow-up.Results. The study population included higher proportion of males (74.4%) and average age was 53.2 ± 11.0 years. A total of 278 lesions were intervened successfully with 280 stents. The observed MACE at 6-month follow-up was 2.0%, which included 0.8% cardiac death and 1.2% MI. There were no TLR or TVR and ST observed during 6-month follow-up.Conclusions. The long (40 mm) Indolimus stent demonstrated low MACE rate and was proven to be safe and effective treatment for long lesions in “real-world” patients.


2021 ◽  
Vol 8 ◽  
Author(s):  
Yawei Zheng ◽  
Jie Li ◽  
Lingzhun Wang ◽  
Peng Yu ◽  
Haibo Shi ◽  
...  

Background: At present, there are a variety of treatment strategies for percutaneous coronary intervention. The role of drug-coated balloon (DCB) in the treatment of side branch for de novo coronary bifurcated lesions (CBL) is unclear.Objective: To examine the effect of DCB in side branch protection for de novo CBL.Methods: Electronic databases, including Pubmed, Embase, the Web of science, Cochrance library, CNKI, CBM, WanFang Data and VIP were searched for studies that compared DCB with non-drug-coated balloon (NDCB) in side branch protection for de novo CBL from inception through July 7th, 2021. The primary outcome was target lesion revascularization (TLR). Secondary clinical outcomes included myocardial infarction (MI), cardiac death (CD). The angiographic outcomes included side branch late lumen loss (LLL), minimum lumen diameter (MLD), diameter stenosis (DS) and binary restenosis (BR). The target lesion failure (TLF) was also analyzed.Results: A total of 10 studies, including 5 randomized controlled trials and 5 non-randomized observational studies, with 934 patients were included. Meta-analysis results of angiographic outcomes suggested that DCB group had the less LLL, DS and BR and the higher MLD compared with NDCB group at follow-up (P &lt; 0.05). Meta-analysis results of clinical outcomes suggested that the significant difference in the TLR, MI and CD between DCB group and NDCB group has not been found yet (P &gt; 0.05). However, the MACE of DCB group was significantly less than that of NDCB group at 9-month follow-up [OR = 0.21, 95%CI (0.05, 0.84), P = 0.03] and 12-month follow-up [OR = 0.45, 95%CI (0.22, 0.90), P = 0.02]. In addition, there was no significant difference in TLF between DCB group and NDCB group (P &gt; 0.05).Conclusions: DCB had great effect in side branch protection for de novo CBL at short and medium-term follow-up with no reduction in the procedural success rate.Systematic Review Registration:https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=267426, PROSPERO [Identifier: CRD42021267426].


Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Jung-Sun Kim ◽  
Byung Ho Lee ◽  
Jae-Deok Kim ◽  
Hyun-Soo Kim ◽  
Sungha Park ◽  
...  

Background : The aim of this study is to identify the association of hsCRP with neointimal plaque volume at 9 month follow-up IVUS after implantation of Sirolimus eluting stent (SES) and Paclitaxel-eluting stent (PES). Methods: A total of 127 patients (M:F = 78:49, age 62 ± 8 years), who underwent the elective coronary stenting for a de-novo lesion were prospectively enrolled and randomized according to type of stents (64 SES, 63PES). Infarct-related lesions within 7 days were excluded. Among them, hsCRP was serially measured in 104 patients (50 SES and 54 PES) at baseline, 48 hr after and 9 month follow-up after coronary stenting. IVUS was simultaneously performed at initial, after coronary stenting and 9 month follow-up. Neointimal volume index (neotintimal volume/stent length) at 9 month follow-up was obtained using INDEC system. Result : Baseline clinical, angiographic and IVUS parameters after stenting of both groups showed no significant differences. hsCRP was significantly increased at 48 hrs after coronary stenting but there was no significant difference between two groups (baseline: 2.9 ± 8.7 vs. 3.6 ± 7.6 mg/L, 48 hr: 10.7 ± 21.3 vs. 13.0 ± 15.3 mg/L, 9 month: 1.0 ± 1.6 vs. 1.2 ± 1.8 mg/L). At 9 month follow-up, SES showed a significantly lower neointimal volume index (0.22 ± 0.41 vs. 1.0 ± 0.9 mm 2 , p < 0.001) and lower tendency of in-stent restenosis [1 (2.2 %) vs. 6 (12.5 %), p = 0.111] than PES. Neointimal plaque volume at 9 month was significantly correlated with hsCRP at 48 hr (r= 0.426, p = 0.004) and increase of hsCRP between baseline and 48 hr (r = 0.512, p < 0.001). Also, higher increase of hsCRP between baseline and 48 hr (β = 0.469, p = 0.006) and PES (β = - 0.345, p = 0.024) were independently associated with increased neointimal volume index at 9 month follow-up after adjusting the clinical and angiographic parameters. Conclcusion: Increase of hsCRP at 48 hr after coronary stenting was significantly associated with neointimal volume in drug eluting stent (DES) era. Thus, control of acute inflammation after implantation of DES, especially PES might be beneficial for reducing neointimal plaque volume.


2015 ◽  
Vol 2015 ◽  
pp. 1-5 ◽  
Author(s):  
Anurag Polavarapu ◽  
Raghava Sarma Polavarapu ◽  
Jayesh Prajapati ◽  
Asif Raheem ◽  
Kamlesh Thakkar ◽  
...  

Objective. The main aim is to evaluate safety, efficacy, and clinical performance of the Indolimus (Sahajanand Medical Technologies Pvt. Ltd., Surat, India) sirolimus-eluting stent in high-risk diabetic population with complex lesions.Methods. It was a multicentre, retrospective, non-randomized, single-arm study, which enrolled 372 diabetic patients treated with Indolimus. The primary endpoint of the study was major adverse cardiac events (MACE), which is a composite of cardiac death, target lesion revascularization (TLR), target vessel revascularization (TVR), myocardial infarction (MI), and stent thrombosis (ST). The clinical follow-ups were scheduled at 30 days, 6 months, and 9 months.Results. The mean age of the enrolled patients was 53.4 ± 10.2 years. A total of 437 lesions were intervened successfully with 483 stents (1.1 ± 0.3 per lesion). There were 256 (68.8%) male patients. Hypertension and totally occluded lesions were found in 202 (54.3%) and 45 (10.3%) patients, respectively. The incidence of MACE at 30 days, 6 months and 9 months was 0 (0%), 6 (1.6%), and 8 (2.2%), respectively. The event-free survival at 9-month follow-up by Kaplan Meier method was found to be 97.8%.Conclusion. The use of biodegradable polymer coated sirolimus-eluting stent is associated with favorable outcomes. The results demonstrated in our study depict its safety and efficacy in diabetic population.


2011 ◽  
Vol 6 (1) ◽  
pp. 39
Author(s):  

Background:Since the first reported use of percutaneous transluminal coronary angioplasty, advances in the interventional cardiology arena have been fast paced. Developers and clinicians are adapting from the learning curve awarded by the time-course of drug-eluting stent (DES) evolution. BioMime™ sirolimus-eluting stent (SES) is a step towards biomimicry. The stent is built on a strut of ultra-low thickness (65μm), a cobalt–chromium platform using an intelligent hybrid of closed and open cells allowing for morphology-mediated expansion. It employs a well-known antiproliferative – sirolimus – that elutes from a known biodegradable copolymer formulation within 30 days. The resultant stent demonstrates almost 100% endothelialisation at 30 days in preclinical models.Methods:The meriT-1 was a prospective, single-arm, single-centre trial to evaluate the safety and efficacy of BioMime SES in 30 patients with a single de novo lesion in native coronary arteries. The primary safety and efficacy end-points were major adverse cardiac events (MACE) at 30 days and in-stent late lumen loss at eight months, as measured using quantitative coronary angiographic (QCA) method. Secondary safety and efficacy end-points included MACE at one and two years and angiographic binary restenosis at eight-month angiographic follow-up. Other end-points included the occurrence of stent thrombosis at acute, subacute, late and very late periods and the percentage of diameter stenosis by QCA.Results:No MACE were observed and the median in-stent late luminal loss in 20 (67%) subjects studied by QCA was 0.15mm, with 0% binary restenosis at eight-month follow-up. No stent thrombosis was observed up to one-year follow-up.Conclusions:In comparison to currently available DES, BioMime SES appears to have a considerable scientific basis for prevention of neointimal proliferation, restenosis and associated clinical events.


Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Sunao Nakamura ◽  
Hisao Ogawa ◽  
Jang-Ho Bae ◽  
Yeo Hans Cahyadi ◽  
Wasan Udayachalerm ◽  
...  

Aim : The aim of this study is to compare the 4 years safety and durability of Sirolimus-eluting stent (SES) and Paclitaxel-eluting stent (PES) deployment on the outcome of patients with very long coronary lesions (VLL). Methods : A prospective analysis of 656 patients 730 lesions (male 70.4%, mean age 66.9 yrs) with very long coronary lesion (≥40mm) (368 SES and 288 PES) in five high volume Asian centers after successful stenting in VLL was performed. Lesion locations of VLL were LAD 48.2% (SES 50.2%, PES 45.7%), LCX 18.5%, RCA 33.3%. Complete clinical follow-up to 4 years is being analyzed for all patients. Results : The baseline clinical characteristics between 2 groups were similar. At 4 years overall cardiac events of SES (16.3%) were lower than PES (24.0%) (p=0.03). See table for clinical results. Conclusion : The use of SES and PES in patients with very long coronary lesion was safe and feasible with low acute complication and low incidence of restenosis. SES showed lesser incidence of cardiac events (death, myocardial infarction, CABG and PCI) at 4 years clinical follow-up. SAT (sub acute stent thrombosis), LAST (late stent thrombosis: ~1year), VLAST (very late stent thrombosis: 1year~ 4years) MACE (death, myocardial infarction, CABG and PCI).


2016 ◽  
Vol 9 (1) ◽  
pp. 49-54
Author(s):  
Afzalur Rahman ◽  
Farhana Ahmed ◽  
Mohammad Arifur Rahman ◽  
Syed Nasir Uddin ◽  
Md Zillur Rahman ◽  
...  

Background: The ostial left anterior descending coronary artery (LAD) lesion is an important target for coronary revascularization because its location subtends a large territory of myocardium. Ostial lesions have a reputation of being fibrotic, calcified, and relatively rigid. Greater degraees of rigidity and recoil resulted in lower acute gain and higher rates of target lesion revascularization (TLR) following percutaneous coronary intervention (PCI). In addition, procedural complications such as dissections, vessel closure and myocardial infarction were more frequent. Aim of the study was to evaluate a simple but innovative technique to deal with significant LAD ostial lesion.Methods: This prospective study was conducted between January 2010 and February 2013. Patients with significant angiographic de novo ostial LAD artery stenoses were identified and screened for study eligibility. An ostial stenosis was defined as an angiographic narrowing of e” 70% located within 3 mm of the vessel origin. Study included all consecutive patients with ostial lesions who underwent elective PCI and stent deployment. The study population consisted of 36 patients.Results: Among 36 patients 27 (75%) were male. mean age was 55.75 ± 8.07 years. 21 (58.3%) had diabetes, 15 (41.7%) hypertension, 21 (58.3%) hypercholesterolemia, 24 (66.66%) were smoker and 18 (50%) had F/H of CAD. Among them 6 (16.7%) had STEMI, 9 (25%) had NSTEMI, 12 (33.3%) had UA and 9 (25%) CSA. CAG showed 15 (41.7%) SVD, 15 (41.7%) DVD and 6 (16.7%) were TVD. LAD ostial stenosis were 83.16 ± 10.14%. Considering procedural characteristics, DES were 33 (91.7%) and BMS were 3 (8.3%). DES polymers were Evarolimus 15 (41.7%), Zotarolimus 12 (33.3%) and Biolimus 6 (16.7%). Mean stent length were 21.75 ± 8.07 mm. Mean stent diameter were 2.83 ± 0.28 mm. Minimum follow up time was 9 months and maximum follow up time was 44 months. There were no MACE but Angina (CCS II) were 2 (5.55%) and LVF (NYHA II) were 1(2.77%).Conclusion: Precise placement of LAD ostial stent is always challenging. Several technique applied but results not always satisfactory. Our strategies were precise location of stent implantation at ostium by adopting special technique of simultaneous balloon placement from distal LM to proximal LCX preventing unwanted stent movement during its placement and also properly guiding us for precise stent placement at the ostium. Parked balloon from distal LM to LCX will also be helpful for quick measure for any plaque shifting into LCX.Cardiovasc. j. 2016; 9(1): 49-54


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