Abstract 11993: Three Year Clinical and Imaging Data of the Paclitaxel-Eluting Absorbable Magnesium Scaffold (Dreams) From the Biosolve-I Study

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Michael Haude ◽  
Raimund Erbel ◽  
Paul Erne ◽  
Stefan Verheye ◽  
Paul Vermeersch ◽  
...  
Keyword(s):  
Clinical Performance ◽  
Target Lesion ◽  
Imaging Data ◽  
Absorption Process ◽  
Efficacy Data ◽  
Scaffold Thrombosis ◽  
Ultrasound Signal ◽  
Target Lesion Failure

AIMS: In order to assess the long term safety, clinical performance and the bioabsorption process of the paclitaxel-pluting absorbable magnesium scaffold (DREAMS) 3-year clinical data and multi-modality imaging outcomes are reported. METHODS AND RESULTS: Forty-six subjects were enrolled in the first-in-man BIOSOLVE-I study in two different cohorts with clinical follow-up at 1, 6, 12, 24 and 36 months; angiographic and IVUS follow-up for cohort 1 at 6-month and for cohort 2 at 12-month. A subgroup of patients underwent OCT and vasomotion testing. The primary endpoint is Target Lesion Failure (TLF) at 6-month for cohort 1 and at 12-month for cohort 2. For some patients also 18-month and 24-month imaging data are available.TLF rate at 36-month was 6.8% including 2 TLRs and 1 peri-procedural MI occurring at the 12-month follow-up angiography; no events emerged from 12- to 36-month. No cardiac death or scaffold thrombosis was observed. Vasoconstriction after acetylcholine at 6-month (delta=-10.04%; p=0.0008 versus baseline) followed by vasodilatation after nitroglycerine (delta=8.69%; p<0.0001 versus baseline) demonstrates the uncaging aspect of the absorption process with no further change at the 12-month follow-up. Six-month virtual histology (VH) data showed a significant decrease in the dense calcium by 39.5% (p=0.0015) remaining stable from 6- to 12-month follow-up.This decrease is interpreted as a surrogate assessment for the bioabsorption process of the scaffold material. Echogenicity data using the decrease in intensity of the ultrasound signal to quantify the change in strut structure demonstrate a continuous decrease in % hyperechogenicity over the follow-up period, with the most pronounced changes within the first 6 months (22 to 16% p<0.001). CONCLUSIONS: DREAMS shows excellent safety and efficacy data with no death and no scaffold thrombosis up to 3 years in the BIOSOLVE-I trial. Multi-modality imaging documented the absorption process and the uncaging aspect of this device already at 6 months.

Abstract 11320: Long-Term Stent-Related and Patient-Related Outcomes of Second-Generation Everolimus-Eluting Xience V Stents versus Zotarolimus-Eluting Resolute Stents in Real-World Practice: Three Year Results From the Multicenter Prospective EXCELLENT and RESOLUTE-Korea Registries

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Jonghanne Park ◽  
Joo Myung Lee ◽  
Kyung Woo Park ◽  
Jung-Kyu Han ◽  
Han-Mo Yang ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Stent Thrombosis ◽  
Second Generation ◽  
Target Lesion ◽  
Off Label ◽  
Drug Eluting ◽  
Target Lesion Failure ◽  
Label Indication

Background: Long term outcomes are imperative to confirm safety of drug-eluting stents. There have been two randomized controlled trials comparing everolimus-eluting stents (EES) and Resolute zotarolimus-eluting stents (ZES-R). To date, long-term clinical outcomes of these stents were limited to only one report which has recently reported 4-year comparisons of these stents. Therefore, more evidences are needed regarding long-term clinical outcomes of the second generation stents. This study compared the long-term clinical outcomes of EES with ZES-R in “all-comer” cohorts up to 3-year follow-up. Methods: The EXCELLENT and RESOLUTE-Korea registries prospectively enrolled 3,056 patients treated with EES and 1,998 with ZES-R. Target lesion failure and patient-related composite events were compared in crude and propensity score matched analyses. Results: Of 5054 patients, 3830 patients (75.8%) had off label indication (2217 with EES and 1613 with ZES-R). The stent-related outcome (189 [6.2%] vs. 127 [6.4%], p=0.812) and the patient-related outcome (420 [13.7%] vs. 250 [12.5%], p=0.581) did not differ between EES and ZES-R respectively at 3 year, which was corroborated by similar results from the propensity score-matched cohort (HR 0.92, 95% CI 0.70-1.20, p=0.523 and 0.85, 95% CI 0.70-1.02, p=0.081, for stent and patient related outcomes, respectively). The rate of definite or probable stent thrombosis up to 3 years (22 [0.7%] vs. 10 [0.5%], p=0.370) was also similar. The rate of stent thrombosis was very low and comparable between the two stents (3 [0.1%] vs. 1 [0.1%], p=0.657). In multivariate analysis, chronic renal failure (adjusted HR 3.615, 95% CI 2.440-5.354, p<0.001) and off label indication (adjusted HR 1.782, 95% CI 1.169-2.718, p=0.007) were the strongest predictors of target lesion failure. Conclusion: In this robust real world registry with unrestricted use of EES and ZES-R, both stents showed comparable safety and efficacy at 3-year follow-up. Overall incidences of target lesion failure and definite stent thrombosis, including very late stent thrombosis, were low, even in the patients with off label indications, suggesting excellent long term safety and sustained efficacy of both types of second generation drug-eluting stents.

scholarly journals One-year clinical outcomes of patients implanted with a Resolute Onyx™ zotarolimus-eluting stent

2017 ◽  
Vol 46 (1) ◽  
pp. 457-463 ◽  
Author(s):  
Chor Cheung Tam ◽  
Kelvin Chan ◽  
Simon Lam ◽  
Arthur Yung ◽  
Yui Ming Lam ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Small Vessel Disease ◽  
Clinical Performance ◽  
Cardiovascular Death ◽  
Target Lesion ◽  
World Population ◽  
Vessel Disease ◽  
One Year ◽  
Target Lesion Failure

Objective To evaluate the 1-year clinical outcomes of patients who received the Resolute Onyx™ stent. Methods This was a single-centre, retrospective registry analysis that reviewed the clinical data from all patients who were implanted with a Resolute Onyx™ stent between March 2015 and February 2016. Clinical follow-up was performed at 1 year post-implantation. Results A total of 252 patients received a Resolute Onyx™ stent and two patients were lost to follow-up. The mean age of the cohort was 66.9 years and 113 (45.2%) had diabetes mellitus. Thirty-eight patients (15.2%) had left main disease and 73 (29.2%) had three-vessel disease. A total of 175 patients (70.0%) had small vessel disease (<2.75 mm) and 210 (84.0%) had long lesions (>20 mm). The 1-year target lesion failure was 4.4% (11 of 250), cardiovascular death occurred in eight patients (3.2%), ischaemia-driven target lesion revascularization was undertaken in five patients (2.0%) and stent thrombosis occurred in one patient (0.4%). Conclusion The Resolute Onyx™ stent showed a favourable 1-year clinical performance in a real-world population.

PP095 Assessment Of Magmaris Resorbable Metal Stent In Patients With Angina

2017 ◽  
Vol 33 (S1) ◽  
pp. 116-116
Author(s):  
Luis Maria Sanchez-Gomex ◽  
Juan Pablo Chalco Orrego ◽  
Setefilla Luengo-Matos ◽  
Mar Polo-Desantos
Keyword(s):  
Myocardial Infarction ◽  
Balloon Angioplasty ◽  
Target Lesion ◽  
Cochrane Library ◽  
Target Vessel ◽  
Early Assessment ◽  
Silent Ischaemia ◽  
Scaffold Thrombosis

INTRODUCTION:Ischaemic heart disease is the leading cause of death worldwide. Magmaris™ is a new drug-eluting resorbable stent used for coronary reperfusion during a balloon angioplasty. Magmaris™ is composed of absorbable magnesium scaffold and its surface is coated with bioresorbable poly-L-lactide, which incorporates Sirolimus. Magmaris™ has theoretical advantages as the stent body disappears after vascular constrictive remodeling. It would provide the stability and elasticity of non-resorbable metal stents, but without long-term problems such as endothelial dysfunction, delay in endothelialization, risk of thrombosis and complications due to long-term antiplatelet medication. The objective of this work is to assess efficacy and safety of Magmaris ™ in patients with angina or silent ischaemia.METHODS:Early assessment of Magmaris™ identified through the Early-Awareness and Alert-System, “SINTESIS-new technologies”, of The Instituto De Salud Carlos III (AETS-ISCIII). The searched databases were: MEDLINE (PubMed), EMBASE, WOS, Clinical Trials and Cochrane Library. Clinical studies using Magmaris™ published in any language until December 2016 were reviewed.RESULTS:One prospective, non-randomized, non-controlled, multicenter, clinical trial with two publications was retrieved. The first publication (123 patients) showed mainly imaging outcomes of angiography, intravascular ultrasound and tomography at 6 months of follow up. The second publication (118 patients) with data from 12 months of follow up also reported: Target lesion failure in four patients (3.4 percent; 95 percent Confidence Interval, CI:0.9–8.4); one target-vessel myocardial infarction (0.8 percent; one myocardial infarction (0.8 percent); two clinically driven target lesion revascularisation (1.7 percent) and two clinically driven target-vessel revascularisation (1.7 percent). No definite scaffold thrombosis was observed. No procedural complications were reported. This trial is expected to continue up to 36 months of follow up.CONCLUSIONS:Clinical data show that Magmaris™ seems to be an effective and safe treatment in patients with angina or silent ischaemia undergoing balloon angioplasty. More research specially randomized controlled trials are necessary to confirm these results.

scholarly journals Two-year clinical performance of Absorb BVS compared to Xience EES in ST-segment elevation myocardial infarction: a pooled analysis of AIDA and COMPARE-ABSORB trials

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
L.S.M Kerkmeijer ◽  
G Chao ◽  
R Tijssen ◽  
T Gori ◽  
R.P Kraak ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Target Lesion ◽  
Pooled Analysis ◽  
St Segment Elevation ◽  
Patient Level ◽  
Segment Elevation Myocardial Infarction ◽  
St Segment ◽  
Absorb Bvs ◽  
Target Lesion Failure

Abstract Introduction Bioresorbable vascular scaffolds (BVS) use appears theoretically attractive in patients presenting with ST-segment elevation myocardial infarction (STEMI) as acute lesions are generally composed of soft plaques, in which optimal BVS deployment and expansion is easier to achieve. Furthermore, those patients are generally younger and would benefit longer from the promise of vascular restoration therapy. Purpose In this patient level pooled analysis of two clinical trials, we evaluated the clinical outcomes of Absorb BVS versus Xience everolimus-eluting stent (EES) in STEMI patients at 2-year follow-up. Methods We performed an individual patient-level pooled analysis of the AIDA and COMPARE-ABSORB trials in which 3515 patient were randomly assigned to Absorb BVS (n=1772) or Xience EES (n=1743). Clinical outcomes in STEMI patients were analyzed by randomized treatment assignment cumulative through 2 years. The primary efficacy outcomes measure was target lesion failure (cardiac death, target-vessel myocardial infarction or target lesion revascularization), and the primary safety outcome measure was device thrombosis at 2-year follow-up. Results 350 (19.8%) STEMI patients were allocated to Absorb BVS versus 328 (18.8%) to Xience EES. The mean age of patient presenting with STEMI was 60 years old, 76.0% were males and 15.3% had diabetes mellitus. At 2-years target lesion failure occurred in 8.4% of BVS STEMI patients and 6.2% of EES STEMI patients (p=0.253). The 2-year rates of cardiac death (2.6% vs 1.6%, p=0.332), TV-MI (4.7% vs 2.5%) and TLR (6.8% vs 4.1%) were not significantly different. The 2-year incidence of definite device thrombosis was 4.7% in Absorb BVS versus 1.8% in Xience EES (p=0.045). Conclusion In the present patient-level pooled analysis of the AIDA and COMPARE-Absorb trials, BVS was associated with increased rates of device thrombosis in STEMI patients compared to Xience EES. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Abbott

scholarly journals Long-Term Follow-Up of Denosumab Discontinuers with Multiple Vertebral Fractures in the Real-World: A Case Series

2021 ◽  
Author(s):  
Liana Tripto-Shkolnik ◽  
Yair Liel ◽  
Naama Yekutiel ◽  
Inbal Goldshtein
Keyword(s):  
Real World ◽  
Vertebral Fractures ◽  
Clinical Laboratory ◽  
Case Series ◽  
High Risk Group ◽  
Imaging Data ◽  
Long Term Follow Up ◽  
Multiple Vertebral Fractures

AbstractDenosumab discontinuation is associated with rapid reversal of bone turnover suppression and with a considerable increase in fracture risk, including a risk for multiple vertebral fractures (MVF). Long-term follow-up of patients who sustained MVF after denosumab discontinuation has not been reported. This case-series was aimed to provide a long-term follow-up on the management and outcome of denosumab discontinuers who initially presented with multiple vertebral fractures. Denosumab discontinuers were identified from a computerized database of a large healthcare provider. Baseline and follow-up clinical, laboratory, and imaging data were obtained from the computerized database and electronic medical records. The post-denosumab discontinuers MVF patients consisted of 12 women aged 71±12. Osteoporotic fractures were prevalent before denosumab discontinuation in 6 of the patients. The majority received bisphosphonates before denosumab. MVF occurred 134±76 days after denosumab discontinuation. The patients were followed for a median of 36.5 (IQR 28.2, 42.5) months after MVF. Two patients passed-away. Two patients suffered recurrent vertebral fractures. Following MVF, patients were treated inconsistently with denosumab, teriparatide, oral, and intravenous bisphosphonates, in various sequences. Two patients underwent vertebroplasty/kyphoplasty. This long-term follow-up of real-world patients with MVF following denosumab discontinuation reveals that management is inconsistent, and recurrent fractures are not uncommon. It calls for clear management guidelines for patients with MVF after denosumab discontinuation and for special attention to this high-risk group.

Abstract 12022: Long-Term Clinical Outcomes of Everolimus-Eluting Stents versus Sirolimus-Eluting Stents: Systematic Review and a Meta-Analysis of 14 Randomized Control Trials, Focused on Stent Thrombosis

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
TOSHIAKI TOYOTA ◽  
Hiroki Shiomi ◽  
Takeshi Morimoto ◽  
Takeshi Kimura
Keyword(s):  
Clinical Outcomes ◽  
Stent Thrombosis ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Target Lesion ◽  
Pooled Analysis ◽  
Significant Difference ◽  
Artery Disease

Background: We sought to compare the long-term clinical outcomes between everolimus-eluting stent (EES) and sirolimus-eluting stents (SES) with a meta-analysis method. The long-term clinical outcomes, especially stent thrombosis (ST), after EES versus SES implantation has not been clearly defined among trials directly comparing the 2 types of stents. Methods: We searched PubMed, Cochrane database, and ClinicalTrials.gov. for trials comparing outcomes between EES (Xience V/Promus) and SES (Cypher select/Cypher select plus) in patients with native coronary artery disease using randomized controlled trial (RCT) design. We selected the article reporting the longest follow-up outcomes from each RCT. The outcome measure was all-cause death, myocardial infarction (MI), definite ST, and target-lesion revascularization (TLR). ST was further classified as those occurring early (<=30 days), late (30-365 days), or very late (<365 days). Results: We identified 14 RCT comparing EES and SES including 2 trials reporting the longest follow-up outcomes as a pooled analysis. We analyzed 13,434 randomly assigned patients with the weighted follow-up period of 2.1 years (Follow-up <=1-year: 7 trials, and 3191 patients; >1-year: 7 trials, and 10243 patients). EES as compared to SES was associated with significantly lower risks for overall ST, and early ST (pooled odds ratio (OR) 0.49, 95% confidence interval (CI) 0.30-0.81, P=0.01, and OR 0.42, 95% CI 0.18-0.99, P=0.046, respectively), while there was no significant difference in the risk for late ST and very late ST (OR 0.49, 95% CI 0.17-1.43, P=0.19, and OR 0.66, 95% CI 0.23-1.85, P=0.43, respectively). EES as compared to SES was also associated with significantly lower risks for TLR (OR 0.84, 95% CI 0.71-0.99, P=0.04). There was no significant difference in the risk for all-cause death, and MI between EES and SES. (OR 0.91, 95% CI 0.78-1.07, P=0.11, and OR 0.92, 95% CI 0.75-1.13, P=0.44, respectively). Conclusions: In the current meta-analysis of 14 RCT directly comparing EES with SES, implantation of EES as compared to SES implantation was associated with significantly lower risk for definite ST and TLR.

124Impact of intimal tracking for recanalization of CTO lesions on long-term clinical outcomes

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
S Kano ◽  
K Nasu ◽  
M Habara ◽  
T Shimura ◽  
M Yamamoto ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Cox Regression ◽  
Target Lesion ◽  
Hazard Ratio ◽  
Rank Test ◽  
Total Occlusion ◽  
Significant Difference ◽  
The Impact

Abstract Background For recanalization of coronary chronic total occlusion (CTO) lesions, subintimal guidewire tracking in both antegrade and retrograde approaches are commonly used. Purpose This study aimed to assess the impact of subintimal tracking on long-term clinical outcomes after recanalization of CTO lesions. Methods Between January 2009 and December 2016, 474 CTO lesions (434patients) were successfully recanalized in our center. After guidewire crossing in a CTO lesion, those lesions were divided into intimal tracking group (84.6%, n=401) and subintimal tracking group (15.4%, n=73) according to intravascular ultrasound (IVUS) findings. Long-term clinical outcomes including death, target lesion revascularization (TLR), target vessel revascularization (TVR) were compared between the two groups. In addition, the rate of re-occlusion after successful revascularization was also evaluated. Results The median follow-up period was 4.7 years (interquartile range, 2.8–6.1). There was no significant difference of the rate of cardiac death between the two groups (intimal tracking vs. subintimal tracking: 7.0% vs. 4.1%; hazard ratio, 0.61; 95% confidence interval [CI], 0.19 to 2.00; p=0.41), TLR (14.3% vs. 16.2%; hazard ratio, 1.34; 95% CI, 0.71 to 2.53; p=0.37), and TVR (17.5% vs. 20.3%; hazard ratio, 1.27; 95% CI, 0.72 to 2.23; p=0.42). However, the rate of re-occlusion was significantly higher in the subintimal tracking group than intimal tracking group at 3-years re-occlusion (4.2% vs. 14.5%; log-rank test, p=0.002, Figure). In the multivariate COX regression, subintimal guidewire tracking was an independent predictor of re-occlusion after CTO recanalization (HR: 5.40; 95% CI: 2.11–13.80; p<0.001). Figure 1 Conclusions Subintimal guidewire tracking for recanalization of coronary CTO was associated with significantly higher incidence of target lesion re-occlusion during long-term follow-up period.

Orsiro: ultrathin bioabsorbable polymer sirolimus-eluting stent

2019 ◽  
Vol 15 (4) ◽  
pp. 295-300 ◽  
Author(s):  
Ofer Kobo ◽  
Ariel Roguin
Keyword(s):  
Clinical Performance ◽  
Drug Eluting Stents ◽  
Bioabsorbable Polymer ◽  
Coronary Syndrome ◽  
Long Term Follow Up ◽  
Potential Benefits ◽  
Drug Eluting ◽  
Sirolimus Eluting Stent

Recent stent developments aimed to reduce and eliminate the long-term inflammatory response include thinner struts, modifications to stent design and the development of bioresorbable polymers (BP). We aimed to summarize the main findings and to discuss the established and the potential benefits of the Orsiro BP sirolimus-eluting stents in everyday clinical use. We have reviewed the available evidence on the clinical performance of the Orsiro BP drug-eluting stents. Orsiro BP sirolimus-eluting stents is clinically proven and showed noninferiority against major drug-eluting stents and provides high safety and efficacy profile at long-term follow-up. Furthermore, it may be the preferred treatment option in specific subgroups as acute coronary syndrome, as shown in the BIOFLOW V trial.

scholarly journals Long-term occlusion results with SILK flow diversion in 28 aneurysms: Do recanalizations occur during follow-up?

2015 ◽  
Vol 21 (3) ◽  
pp. 300-310 ◽  
Author(s):  
Anastasios Mpotsaris ◽  
Martin Skalej ◽  
Oliver Beuing ◽  
Bernd Eckert ◽  
Daniel Behme ◽  
...  
Keyword(s):  
Prospective Study ◽  
Intracranial Aneurysms ◽  
Flow Diverter ◽  
Success Rates ◽  
Imaging Data ◽  
Complete Occlusion ◽  
Complex Aneurysms ◽  
Multicenter Prospective Study

Background and purpose The purpose of this article is to report on the long-term success rates of Silk flow-diverter (FD) treatment in a multicenter prospective study for the treatment of complex aneurysms. Methods Between May 2008 and January 2011, all consecutive patients featuring complex intracranial aneurysms eligible for FD treatment with the Silk in three neurovascular centers were included. Clinical and imaging data were assessed during hospitalization and follow-up. Results Five patients were initially asymptomatic, 20 patients showed various neurological symptoms. Twenty-eight FDs were implanted in 25 patients treating 28 aneurysms. The immediate procedure-related morbidity was 8% (two of 25), mortality 0%. One procedure-related death was observed during follow-up (in-stent thrombosis). Compared to the immediate result nearly two of three aneurysms improved during follow-up; all angiographically confirmed inflow changes took place within six months after treatment. Final anatomic outcome in 24 aneurysms of 22 patients comprised 14 (59%) with complete occlusion, seven (29%) with a neck remnant, two (8%) with residual filling <50%, none with residual filling >50% and one (4%) unchanged in comparison to its pretreatment status. Postinterventional recanalizations were seen in three of 13 (23%) aneurysms treated with FD alone; none were observed in 15 aneurysms treated with adjunctive coiling. Conclusion Anatomic presentation and location are key for successful FD treatment. The rate of successful occlusion increases during follow-up. Postinterventional monitoring for at least six months is paramount, as anatomic outcome is not reliably predictable and recanalizations may occur in initially completely occluded aneurysms.

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