scholarly journals Biodegradable Polymer DES (Ultimaster) vs. Magnesium Bioresorbable Scaffold (BRS Magmaris) in Diabetic Population with NSTE-ACS: A One-Year Clinical Outcome of Two Sirolimus-Eluting Stents

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Piotr Rola ◽  
Adrian Włodarczak ◽  
Mateusz Barycki ◽  
Marek Szudrowicz ◽  
Magdalena Łanocha ◽  
...  
Keyword(s):  
Stent Thrombosis ◽  
Biodegradable Polymer ◽  
Randomized Clinical Trials ◽  
Rapid Progression ◽  
Clinical Prognosis ◽  
Bioresorbable Scaffold ◽  
Relative Safety ◽  
Diabetic Population ◽  
One Year

Background. Cardiovascular disease (CVD) with significant involvement of coronary artery disease (CAD) remains a major cause of death and disability among the diabetic population. Although percutaneous coronary intervention (PCI) continues to evolve, type 2 diabetes mellitus (T2DM) is a well-established marker of poor clinical prognosis after PCI, which is mainly attributed to the rapid progression of atherosclerosis requiring recurrent revascularizations. Hence, the use of bioresorbable materials could provide some solution to this problem. Material and Methods. The study was divided into two arms. For the first one, we qualified 169 patients with NSTE-ACS treated with PCI who received the drug-eluting stent (DES) coated with a biodegradable polymer Ultimaster (Terumo, Tokyo, Japan). The second arm was composed of 193 patients with ACS who underwent PCI with a magnesium bioresorbable scaffold Magmaris (Biotronik, Berlin, Germany). Both arms were divided into two subsequent groups: the T2DM (59 and 72) and the non-DM (110 and 121, respectively). The primary outcomes were cardiovascular death, myocardial infarction, and in-stent thrombosis. The main secondary outcomes included target lesion failure (TLF) and were recorded at a 1-year-follow-up. Results. There were no significant differences between the diabetic and nondiabetic populations in primary endpoints or main secondary endpoints (TLF, scaffold restenosis, death from any reason, and other cardiovascular events) either in the Ultimaster or Magmaris group. At a 1-year-follow-up, the primary endpoint in the DM t.2 population was recorded in 2.7% Ultimaster vs. 5.1% Magmaris, respectively. At the same time, the TLF occurred in the diabetic group in 4.1% Magmaris and 3.3% in the Ultimaster arm, respectively. Conclusion. Both, Ultimaster and Magmaris revealed relative safety and efficiency at a one-year follow-up in the diabetic population in ACS settings. The observed rates of TLF were low, which combined with a lack of in-stent thrombosis suggests that both investigated devices might be an interesting therapeutic option for diabetics with ACS. Nevertheless, further large randomized clinical trials are needed to confirm fully our results.

scholarly journals Myocardial Injury as a Prognostic Factor in Mid- and Long-Term Follow-Up of COVID-19 Survivors

2021 ◽  
Vol 10 (24) ◽  
pp. 5900
Author(s):  
Andrea Izquierdo ◽  
Diana Mojón ◽  
Alfredo Bardají ◽  
Anna Carrasquer ◽  
Alicia Calvo-Fernández ◽  
...  
Keyword(s):  
Myocardial Injury ◽  
Hospital Readmissions ◽  
Clinical Prognosis ◽  
Short Term Mortality ◽  
Long Term Follow Up ◽  
One Year ◽  
Poor Clinical Prognosis ◽  
Age And Sex

Myocardial injury, which is present in >20% of patients hospitalized for COVID-19, is associated with increased short-term mortality, but little is known about its mid- and long-term consequences. We evaluated the association between myocardial injury with one-year mortality and readmission in 172 COVID-19 patients discharged alive. Patients were grouped according to the presence or absence of myocardial injury (defined by hs-cTn levels) on admission and matched by age and sex. We report mortality and hospital readmission at one year after admission in all patients and echocardiographic, laboratory and clinical data at six months in a subset of 86 patients. Patients with myocardial injury had a higher prevalence of hypertension (73.3% vs. 50.0%, p = 0.003), chronic kidney disease (10.5% vs. 2.35%, p = 0.06) and chronic heart failure (9.3% vs. 1.16%, p = 0.03) on admission. They also had higher mortality or hospital readmissions at one year (11.6% vs. 1.16%, p = 0.01). Additionally, echocardiograms showed thicker walls in these patients (10 mm vs. 8 mm, p = 0.002) but without functional disorder. Myocardial injury in COVID-19 survivors is associated with poor clinical prognosis at one year, independent of age and sex, but not with echocardiographic functional abnormalities at six months.

Abstract 3343: Incidence and Predictor of Late Stent Thrombosis After Implantation of Sirolimus-eluting Stent: From Two-year Clinical Follow-up of The j-Cypher Registry

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Yoshihisa Nakagawa ◽  
Kazuaki Mitsudo ◽  
Takeshi Kimura ◽  
Takeshi Morimoto ◽  
Toshiya Muramatsu ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
Stent Thrombosis ◽  
Independent Predictor ◽  
Clinical Event ◽  
Emergency Procedure ◽  
Late Stent Thrombosis ◽  
Stent Restenosis ◽  
Sirolimus Eluting Stent ◽  
One Year

Background: Unsolved issue about Sirolimus-eluting stent is thrombosis, especially, the potential for late stent thrombosis (ST). Methods: To clarify the incidence and predictors of ST, two-year data of the j-Cypher Registry were examined using ARC definition. Design of this registry was multi-center prospective enrollment of 15,216 consecutive patients (pts) with anti-platelet regimen of aspirin and ticlopidine in Japan. Results: Pts’ characteristics of this cohort were as follows, age 68+/−10 years, male in 75%, diabetes in 42%, emergency procedure in 6.6%, hemodialysis in 5%, CKD ( CCr<60, non-Hemodialysis ) in 51% and off-label use in 77%. Bifurcation lesion was observed in 19%. The other characteristics of lesions were as follows, in-stent restenosis in 12%, CTO in 9%, STEMI culprit in 6.3%. Cumulative ST (ARC definite/probable) rates within two-year were 0.62% at six-month, 0.71% at one-year and 0.93% at two-year as shown in the table . Annual increase slope of late ST (ARC definite) was 0.25% per year. During follow-up, 439 Surgical operations excluding endovascular and CABG were needed. Within 30 days of operation, clinical event rates were death in 2.2%, MI in 0.65% and ST in 0.44%. Multivariate analysis identified 3 independent predictors of early ST (within three-month); Hemodialysis: Odds Ratio (OR) = 1.75 (95%CI 1.02–2.69) p=0.042, Male gender: OR = 2.00 (1.20–4.08) p=0.0051, and Emergency procedure: OR = 2.15 (1.36–3.22) p= 0.0017. Also, multivariate analysis identified one independent predictor of late ST (beyond three-month); Hemodialysis: OR = 2.44 (1.29–4.14) p=0.042. Conclusions : Stent thrombosis rate up to two years under Ticlopidine anti-platelet regimen in Japan seemed to be lower as compared with those reported from other registries in the real world, despite the fact that high risk pts were more prevalent in the j-Cypher registry. Hemodialysis was identified to be independent predictor of early and late stent thrombosis through two years. Cumulative stent thrombosis rates in j-Cypher registry

scholarly journals TP5.2.9 Mortality following major lower extremity amputation in people with and without diabetes in Scotland 2004-2013

2021 ◽  
Vol 108 (Supplement_7) ◽  
Author(s):  
Ellen Murgitroyd ◽  
Xuehan Yao ◽  
Jan Kerssens ◽  
Jeremy Walker ◽  
Sarah Wild
Keyword(s):  
Lower Extremity ◽  
Economic Status ◽  
Population Based ◽  
Lower Extremity Amputation ◽  
Logistic Regression Models ◽  
Diabetes Status ◽  
Diabetic Population ◽  
One Year ◽  
Extremity Amputation

Abstract Aim To describe short and longer-term mortality following major lower extremity amputation (LEA) by diabetes status over two time periods. Methods A retrospective cohort study of patients who underwent major LEA between 2004 and 2013 was conducted based on linkage of national population-based hospital records and a register of people with diagnosed diabetes. Post-operative mortality was estimated at 30 days, one year and where available, five years. Using logistic regression models, we estimated the odds of death associated with diabetes adjusted for age, sex and socio-economic status within these time points compared to the non-diabetic population stratified by type of diabetes and five-year calendar periods. Results There were a total of 5436 people who received an amputation during the study period of whom approximately 40% had diabetes. Overall mortality for the 2004-8 and 2009-13 cohorts respectively was not significantly different at 7.9% and 7.3% at 30 days and 31% and 27% at one year. Almost 64% of the 2004-8 cohort were dead within five years. The only statistically significantly associations between diabetes and mortality were observed within five year follow-up of the 2004-8 cohort with odds ratios (95% CI) compared to the non-diabetic population of 1.62 (1.17, 2.26) for type 1 diabetes and 1.38 (1.14, 1.66) for type 2 diabetes. Conclusions An adverse association between diabetes and mortality after LEA only became apparent in longer term follow-up.

scholarly journals Better treatment option in chronic superficial femoral artery occlusive disease: comparison of methods (meta-analysis)

2019 ◽  
Vol 11 (3) ◽  
pp. 224-229
Author(s):  
Vladimir Starodubtsev ◽  
Andrey Karpenko ◽  
Evgeniy Lenko ◽  
Pavel Ignatenko
Keyword(s):  
Treatment Option ◽  
Femoral Artery ◽  
Superficial Femoral Artery ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Occlusive Disease ◽  
Qualitative Synthesis ◽  
Effective Treatment Option ◽  
One Year

Introduction: The objective is to evaluate the frequency of primary obstruction events (PrO) during one-year follow-up after performing excisional atherectomy with the SilverHawk/TurboHawk atherectomy device (S/TH) or remote superficial femoral artery endarterectomy (RSFAE) in patients with the chronic superficial femoral artery occlusive disease (СSFAOD). Methods: We included all randomized clinical trials (RCTs) and not-RCTs concerning the treatment of patients with СSFAOD after S/TH and RSFAE without duration. Results: Twenty-nine items (1990-2017) were discovered; 27 articles on the levels of evidence were included in qualitative synthesis; 9 studies (meta-analysis) were included in quantitative synthesis. The results of 2762 patients’ treatment were summed up in our analysis (1422 patients S/TH; 1340 patients RSFAE). All included reports were at low risk of bias. According to the criterion "frequency of PrO" during one-year follow-up, the pooled Hazard Ratios indicate significant favours of S/TH if compared it with RSFAE (HR= 0.66 (0.57 to 0.76, P < 0.00001), I2 = 9%). Conclusion: Our study showed that S/TH with the SpiderFX device (distal embolic protection) are safe and effective treatment option for short lesion (<15 cm) in patients with СSFAOD. The usage of S/TH methods significantly reduced number of PrO if compared it with RSFAE. In long-segment lesion (>15 cm) in patients with СSFAOD, RSFAE may be considered better than an endovascular procedure. But still it is necessary to conduct well-planned randomized studies to determine effectiveness and safety of the compared methods (S/TH and RSFAE) in patients with long-segment lesion (>15 cm).

Frequency, Etiology, Treatment, and Outcomes of Drug-Eluting Stent Thrombosis During One Year of Follow-Up

2007 ◽  
Vol 99 (4) ◽  
pp. 465-469 ◽  
Author(s):  
Gurpreet Sandhu ◽  
Brendan Doyle ◽  
Ripudamanjit Singh ◽  
Malcolm Bell ◽  
John Bresnahan ◽  
...  
Keyword(s):  
Stent Thrombosis ◽  
Drug Eluting Stent ◽  
Drug Eluting ◽  
One Year

scholarly journals Real World Experience of a Biodegradable Polymer Sirolimus-Eluting Stent (Yukon Choice PC Elite) in Patients with Acute ST-Segment Elevation Myocardial Infarction Undergoing Primary Angioplasty: A Multicentric Observational Study (The Elite India Study)

2019 ◽  
Vol 7 (7) ◽  
pp. 1103-1109
Author(s):  
Bhupendra Verma ◽  
Akhilesh Patel ◽  
Deepak Katyal ◽  
Vivek Raj Singh ◽  
Avinash Kumar Singh ◽  
...  
Keyword(s):  
Observational Study ◽  
Biodegradable Polymer ◽  
Composite Endpoint ◽  
Primary Angioplasty ◽  
Drug Eluting Stents ◽  
Safety And Efficacy ◽  
Drug Eluting ◽  
Sirolimus Eluting Stent ◽  
One Year

BACKGROUND: The durable polymer drug-eluting stents (DPDES) reduce the risk of repeated target vessel revascularisation (TLR) compared with BMS, but are associated with increased risk of late adverse events. In broadly inclusive populations, the biodegradable-polymer drug-eluting stents (BPDES) have favourable results compared with DPDES in the long term. However, its use in primary angioplasty has not been adequately studied, and data of real-world clinical experience is lacking. AIM: Aim of this study was to assess the safety and efficacy of Yukon Choice PC Elite sirolimus-eluting stent (a novel BPDES) in STEMI patients undergoing primary angioplasty. METHODS: We have presented here one-year clinical follow-up data of the Yukon Choice PC Elite sirolimus-eluting stent in patients undergoing primary angioplasty. A total of 636 patients were enrolled in this single arm, prospective observational study from five centres. RESULTS: This multicentric observational study showed excellent safety and efficacy profile of the novel device at one year follow up. The device-oriented composite endpoint (DOCE) of cardiac death, target-vessel reinfarction, and target-lesion revascularisation (TLR) was 2.7%, and the patient-oriented composite endpoint (POCE) of all-cause death, any myocardial infarction, and any revascularisation was 4.2% at one year. Definite or probable stent thrombosis rate was 0.6%, and no events were recorded beyond 6 months of follow up. CONCLUSIONS: In patients with STEMI undergoing primary angioplasty, the use of Yukon Choice PC Elite (biodegradable polymer sirolimus-eluting stent) has excellent results at one year. It, therefore, represents an attractive alternative to second generation DES in this high-risk population.

P2797Clinical outcomes of an ultra-thin strut sirolimus-eluting stent with biodegradable polymer in all-comers patients undergoing coronary intervention

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
I B A Menown ◽  
R De Silva ◽  
R Mitra ◽  
K Balachandran ◽  
R More ◽  
...  
Keyword(s):  
Stent Thrombosis ◽  
Primary Endpoint ◽  
Biodegradable Polymer ◽  
Cardiac Death ◽  
Bypass Graft ◽  
Coronary Intervention ◽  
Efficacy And Safety ◽  
Complex Anatomy ◽  
Sirolimus Eluting Stent

Abstract Background Thin stent struts may be associated with reduced vessel injury and use of biodegradable polymers may further improve long term outcomes. However, data with earlier stents has been inconsistent; thus further studies with newer devices are needed. Purpose To evaluate the efficacy and safety of a new ultra-thin (65um) strut cobalt chromium sirolimus-eluting stent with a hybrid design (closed cell at ends and open cells in middle to reduce edge injury and optimise conformability) in all-comers patients undergoing percutaneous coronary intervention (PCI). Methods We enrolled 752 patients from 14 sites undergoing PCI into a prospective, non-randomised, multi-centre, open-label, observational registry. Inclusion of patients with complex anatomy (long stent lengths, bifurcations and chronic total occlusions) was encouraged. Clinical follow-up was scheduled at 1, 9, 12 and 24 months. The primary endpoint was incidence of major adverse cardiac events (MACE) - cardiac death, non-fatal myocardial infarction (MI), or target vessel revascularization (TVR) - at 9 months. Results Mean patient age was 64.7±12.2 years, 20.7% had diabetes, 58.8% had dyslipidaemia, 40.4% had multi-vessel disease, 22% had previous PCI, 4.7% had previous coronary-artery bypass graft, and 19.6% had a clinical history of previous MI. Mean lesion length was 25.7±17.3 mm. The primary endpoint of cumulative MACE up to 9 months (from 624 patients reaching 9 months follow-up) occurred in 12 patients (1.92%), including 6 (0.96%) cardiac death, 5 (0.80%) MI and 6 (0.96%) clinically indicated TVR. Definite stent thrombosis was reported in 3 patients (0.48%) and probable stent thrombosis in 2 patients (0.32%). Conclusions Use of an ultra-thin strut biodegradable polymer sirolimus-eluting stent in all-comers patients undergoing PCI was associated with good clinical efficacy and safety. Acknowledgement/Funding Meril Life

Abstract 2140: Differential Efficacy and Safety of Drug-Eluting Stents With Short Versus Long Term Follow-up: A Meta-Analysis of Randomized Clinical Trials

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Henri Roukoz ◽  
Anthony A Bavry ◽  
Michael L Sarkees ◽  
Dharam J Kumbhani ◽  
Mark G Rabbat ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Stent Thrombosis ◽  
Randomized Clinical Trials ◽  
Drug Eluting Stents ◽  
All Cause Mortality ◽  
Long Term Follow Up ◽  
Drug Eluting ◽  
Q Wave

Introduction: Drug eluting stents (DES) significantly reduce target lesion revascularization (TLR) compared to bare metal stents (BMS) within 1 year of follow-up, however they increase late stent thrombosis. The effect of DES on the need for late revascularization is unclear. Hypothesis: We sought to evaluate the safety and efficacy of DES compared to BMS early after intervention (< 1 year) and late (> 1 year) among both stable patients and acute coronary syndromes. Methods: We searched the Medline database for randomized clinical trials with long-term follow-up, from 2000 to 2007. We also searched relevant journal supplements for abstracts and obtained trial presentations from cardiology meetings. Results: We identified 24 trials (17% acute coronary syndrome patients) with a total of 10,278 patients. The weighted mean duration of follow-up was 28 months. For early outcomes (< 1 year); the incidence of all-cause mortality for DES vs. BMS was 2% vs. 2.1%, RR=0.95, 95%CI (0.70–1.27), p=0.7, cardiovascular mortality was 1.4% vs. 1.5%, RR=0.95 (0.73–1.24), p=0.72, Q-wave myocardial infarction (MI) was 0.8% vs. 0.6%, RR= 1.24 (0.7–2.2), p=0.45, non-Q-wave MI was 3% vs. 4%, RR=0.73 (0.55–0.96), p=0.024, TLR was 5.9% vs. 17.8%, RR=0.29 (0.24–0.34), p<0.001, and stent thrombosis was 0.94% vs. 1.1%, RR=0.83 (0.55–1.27), p=0.4. For late outcomes (>1 year); the incidence of all-cause mortality for DES vs. BMS was 3.9% vs. 3.8%, RR=1.04 (0.79–1.38), p=0.7, cardiovascular mortality 1.4% vs. 1.5%, RR=0.95 (0.73–1.24), p=0.72, Q-wave MI was 0.7% vs.0.6%, RR=1.05 (0.54–2.05), p=0.87, non-Q-wave MI was 1.6% vs. 1.2%, RR=1.39 (0.87–2.21), p=0.16, TLR was 2.6% vs. 3.2%, RR=0.82 (0.59–1.13), p=0.23, and stent thrombosis was 0.59% vs. 0.15%, RR=3.2 (1.22–8.36), p=0.018. Conclusions: Within 1 year of follow-up, DES appears to be safe and efficacious with similar mortality, similar stent thrombosis, decreased TLR, and decreased non-Q-wave MI compared to BMS. After 1 year, DES still has similar mortality compared to BMS, however TLR, while low, is no longer reduced, stent thrombosis is increased, and there is a numerical excess of non-Q-wave MI.

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