Ultrathin Strut Research Articles

Early vascular responses to ultrathin biodegradable polymer sirolimus-eluting stent for the treatment of st-elevation myocardial infarction

Abstract Background Recent clinical study suggests newer-generation drug-eluting stents (DES) that combine ultrathin strut and nano-coating with biodegradable polymers sirolimus-eluting stent (BP-SES) could improve long-term clinical outcomes in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) over current generation DES. However, safety profiles in very early phase have not been systematically addressed. Objective and method We exploratory investigate early vascular response following BP-SES implantation in patients with STEMI to reveal mechanism of the favorable clinical outcomes in recent studies using frequency domain-optical coherence tomography (FD-OCT). Consecutive twenty patients with STEMI who underwent FD-OCT immediately after primary PCI and were eligible for follow-up FD-OCT at 2 weeks after implantation were enrolled between June 2018 and November 2019. Results Twenty patients (age 62.7±11.3 years, male 85.0%) were enrolled with frequencies of hypertension (45.0%), diabetes mellitus (35.0%), dyslipidemia (55.0%) and smoking (80.0%). Aspiration catheter were used in all patients, and 1.13±0.34 stents were used. Only one patient (5.0%) received chronic antiplatelet therapy with aspirin prior to the onset of STEMI. All patients started to receive prasugrel as thienopyridine from this event and continued dual antiplatelet therapy for 2 weeks. The percentage of uncovered struts significantly decreased from post-procedure to 2W follow-up (69±18% post-procedure versus 30±11% at 2W follow up, p<0.0001). Malapposed struts also decreased (5.6±5.7% post-procedure versus0.9±1.2% at 2W follow up, p<0.0001).The average protrusion area of athero-thrombotic burden numerically decreased (0.37±0.19 at post-procedure versus 0.34±0.14 mm2 at 2W follow up, p=0.19) and its volume showed similar tendency (10.60±6.40 at post-procedure versus 9.36±5.14 mm3 at 2W follow up, p=0.19). Conclusion(s) This study firstly elucidated very early vascular responses following ultrathin strut BP-SES implantation in STEMI patients, showing early progression of strut coverage and resolution of athero-thrombotic materials. This technology may have a potential to overcome the current generation DESs in this clinical setting. Thrombus, uncovered and malapposed struts Funding Acknowledgement Type of funding source: None

Biodegradable-polymer versus durable-polymer drug eluting stents for coronary artery disease: systematic review and a meta-analysis

Abstract Background Biodegradable polymer drug-eluting stents (BP-DES) has been developed to overcome the potential drawbacks of the first-generation durable polymer drug-eluting stents (DP-DES). However, it is still under debate whether BP-DES is associated with superior efficacy and safety over DP-DES. Purpose We sought to compare the effects of BP-DES and DP-DES in patients with coronary artery disease. Methods We performed systematic review and a meta-analysis of randomized controlled trials comparing BP-DES and DP-DES on clinical outcomes in patients with coronary artery disease using CE-mark approved drug-eluting stents (DES) with at least 1-year follow-up. We included 32 studies involving 39,686 patients (BP-DES: 21,439 patients, and DP-DES: 18,247 patients). Primary outcome measure was target vessel failure (TVF; equivalent to the composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target vessel revascularization). We performed subgroup analysis according to the DP-DES generations (newer-generation DP-DES: 15,179patients, and first-generation DP-DES: 3,068 patients), and the effects of newer-generation DP-DES was compared with the BP-DES according to the BP-DES strut thickness (Ultra-thin strut [<80μm]: 7,572 patients, Thin-strut [80–100μm]: 5,465 patients, and Thick-strut [≥80μm]: 5,876 patients). Results The odds for TVF was not significantly different between the BP-DES group and the DP-DES group in the entire study population (odds ratio [OR] 0.96, 95% confidence interval [CI] [0.90–1.02], P=0.20). The odds for TVF was significantly low in the BP-DES group relative to the first-generation DP-DES group, however the odds were comparable between the BP-DES group and the newer-generation DP-DES group (BP-DES versus first-generation DP-DES: OR 0.82, 95% CI [0.73–0.92], P<0.001, and BP-DES versus newer-generation DP-DES: OR 1.00, 95% CI [0.93–1.08], P=0.99). We also found no significant differences between the BP-DES and newer-generation DP-DES, in all subgroups stratified by the BP-DES strut thickness (Ultra-thin strut BP-DES versus newer-generation DP-DES: OR 0.88, 95% CI [0.76–1.02], P=0.10, Thin-strut BP-DES versus newer-generation DP-DES: OR 1.01, 95% CI [0.90–1.13], P=0.89, and Thick strut BP-DES versus newer-generation DP-DES: OR 1.11, 95% CI [0.99–1.25], P=0.08). Conclusions In this meta-analysis of randomized controlled trials evaluating clinical outcomes, there was no significant differences between BP-DES and DP-DES. We found beneficial effects of BP-DES relative to the first-generation DP-DES, however, there was no statistical differences between BP-DES and newer-generation DP-DES, irrespective of the BP-DES strut thickness. Pooled odds ratios for clinical outcomes Funding Acknowledgement Type of funding source: None

Safety and performance of everolimus-eluting stents comprising of biodegradable polymers with ultrathin stent platforms.

The registry investigated clinical outcomes after 12 months of implantation of ultra-thin strut (60 µm) biodegradable polymer-coated Tetrilimus everolimus-eluting stents (EES; Sahajanand Medical Technologies Pvt. Ltd., Surat, India) in patients with atherosclerotic coronary lesions. Additionally, sub-group analysis was performed to evaluate outcomes of ultra-long (44/48 mm) Tetrilimus EES in patients with long lesions. This was an observational, single-center, single-arm and investigator-initiated retrospective registry. In this all-comers registry, patients who underwent implantation of Tetrilimus EES for treatment of coronary artery disease during routine clinical practice between February-2016 and August-2016 at tertiary care center of India were included. Primary endpoint was occurrence of any major adverse cardiac event (MACE) up to 12 months' follow-up. MACE was a composite of cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR). Similar endpoints were observed in sub-group patients. Total 766 stents were implanted to treat 695 lesions in 558 patients. Of treated lesions, 11.4% lesions were type B2 and 78.3% were type C lesions. In sub-group analysis of 143 patients, a total of 155 long coronary lesions were intervened successfully with only one stent been implanted per lesion. At 12 months' follow-up, four (0.7%) cases of cardiac death, eight (1.4%) of MI, and two (0.4%) of TLR were reported, resulting in a 2.5% rate of MACE. The MACE rate was 2.8% in sub-group patients. Twelve months' clinical data demonstrated favorable safety and excellent performance of Tetrilimus EES in high-risk patients and complex coronary lesions in routine clinical practice and also in patients with ultra-long lesions.

Ultrathin Biodegradable-Polymer Orsiro Drug-Eluting Stent Performance in Real Practice Challenging Settings

BackgroundThe Orsiro cobalt-chromium stent platform (Biotronik, Bülach, Switzerland) is one of the first devices in the era of ultrathin struts. However, data regarding the efficacy of Orsiro stent in patients with challenging anatomical conditions obtained from daily clinical practice are scant. MethodsWe retrospectively reviewed the long-term outcomes, defined as target lesion revascularization (TLR), target vessel revascularization (TVR), stent thrombosis (ST) and cardiovascular (CV) mortality over a six years period, in 1161 consecutive patients (mean age 64.3 ± 11.2 years old, 681 males) treated with 2327 Orsiro stents in our institution who presented with challenging anatomic/angiographic features. ResultsThe mean number of implanted stents was 1.7 ± 2.1 whereas the mean stent diameter and length were 3.6 ± 1.1 and 32.7 ± 15.6 mm, respectively. Mean follow-up duration was 35.6 ± 17 months (range 1–77 months); 923 patients (79.5%) reached the 3-year follow-up. The global rates of TLR, TVR, ST and CV mortality were 0.1%, 1.37%, 0.002%, and 1.9%, respectively with scarce statistically significant differences in multivessel disease, severe calcification, and lesion length > 41 mm. Multivariate regression analysis revealed that age, stent dislodgement, early stent thrombosis (p = 0.001) and lesion length ≥ 41 mm (p = 0.001) were independent predictors of TVR. Similarly, the occurrence of TLR was independently predicted by age, severe calcification, use of IVUS and Rotablator (p = 0.002), early stent thrombosis, LM bifurcation and length ≥ 41 mm (p = 0.001). ConclusionsThe Orsiro stent confirmed a very high efficacy profile in all anatomical scenarios with very low rates of clinically driven TLR and TVR, CV mortality and ST at 3-years.

The ultra-thin strut sirolimus-eluting coronary stent: SUPRAFLEX.

Percutaneous coronary interventions with drug-eluting stents is currently the preferred revascularization treatment strategy for coronary artery disease. Following the first generation, the second-generation drug-eluting stents was designed with athinner strut, better biocompatible polymer with/without bioresorbable coating or even polymer-free struts. The SUPRAFLEX stent system has ultra-thin struts (60μm) across all stent diameters and a biodegradable polymer coating, enabling 70% of the sirolimus elution within 7 days. SUPRAFLEX has been assessed in large scale randomized controlled trials. This review summarizes the design of the SUPRAFLEX stent, the results of the pivotal clinical trials and outlines the ongoing research programs.

Individual patient data analysis of the BIOFLOW study program comparing safety and efficacy of a bioresorbable polymer sirolimus eluting stent to a durable polymer everolimus eluting stent.

ObjectivesThis analysis of pooled individual patient data (IPD) aimed to evaluate the safety and efficacy of a bioresorbable polymer sirolimus eluting stent system (BP‐SES; Orsiro) compared to a durable polymer everolimus eluting stent system (DP‐EES; Xience) in the pooled population as well as in subgroups.MethodsIPD with up to 12 months follow‐up of the randomized controlled trials BIOFLOW‐II (NCT01356888), ‐IV (NCT01939249), and ‐V (NCT02389946) as well as the all comers registry BIOFLOW‐III (NCT01553526) were pooled. A total of 3,717 subjects (2,923 in BP‐SES and 794 in DP‐EES) with 5,328 lesions (4,225 lesions in BP‐SES and 1,103 in DP‐EES) were included in the IPD. The primary endpoint was target lesion failure (TLF) at 12 months follow‐up. Subgroups analyzed included diabetes, age (≥65 years), gender, complex lesions (B2/C), small vessels (reference vessel diameter ≤2.75 mm), multivessel treatment, renal disease, and patients with acute coronary syndrome.ResultsOverall, TLF at 12 months was significantly lower with 5.2%in the BP‐SES group versus 7.6% in the DP‐EES group (p = .0098). Similarly, target vessel myocardial infarction (TV‐MI) was 3.1 versus 5.7% (p = .0005). The rate of stent thrombosis was similar in both groups (0.004%). By regression analysis, an independent stent effect in favor of BP‐SES was observed for TLF (p = .0043) and TV‐MI (p = .0364) in small vessels.ConclusionResults of this IPD analysis suggest that the BP‐SES with ultrathin struts is as safe as and more efficacious than DP‐EES in the overall cohort and especially in small vessels.

Ultrathin biodegradable polymer sirolimus-eluting stent versus contemporary durable polymer everolimus-eluting stent for percutaneous coronary intervention: a meta-analysis of randomized trials.

Improvements in coronary drug-eluting stent technology has focused on reducing the long-term complications associated with the effects of the residual footprint on the vessel wall. Although many of the newer stents have exhibited noninferiority to the durable polymer everolimus-eluting stent (DP-EES), they have yet to exhibit clear superiority. We compared the performance of the latest ultrathin strut biodegradable polymer sirolimus-eluting stents (BP-SES) to DP-EES. We searched the electronic databases for randomized controlled trials comparing BP-SES to DP-EES. A random effect meta-analysis was performed using the Poisson regression model. The primary end point was target lesion failure (TLF), a composite of target vessel myocardial infarction (TVMI), cardiac death and target lesion revascularization (TLR). There was no difference between the stents in stent thrombosis [incidence rate ratio (IRR) = 0.79, 95% confidence interval (CI) 0.58-1.06), TLR (IRR = 0.88, 95% CI 0.57-1.38), TVMI (IRR = 0.79, 95% CI 0.61-1.01), cardiac death (IRR = 0.99, 95% CI 0.76-1.29) and target vessel failure (IRR = 0.82, 95% CI 0.64-1.06). In addition, there was no difference in TLF (IRR = 0.82, 95% CI 0.64-1.06). There was evidence of reduced TLF in small vessels with BP-SES based on definition used (defined as ≤2.75 mm; IRR 0.64, 95% CI 0.46-0.91 versus ≤3 mm; IRR 1.11, 95% CI 0.90-1.36). In our study, the performance of the latest generation BP-SES was comparable to DP-EES but failed to show superiority. The possible benefit in patients with small vessels should be explored future trials.

Clinical outcomes following polymer-free sirolimus-eluting stent implantations in unselected patients: A descriptive subgroup analysis in patients with renal impairment.

Patients with chronic kidney disease (CKD are frequently excluded from coronary artery disease trials. The aim of this assessment was to study the clinical outcomes of polymer-free sirolimus-eluting stent implantations in patients with impaired renal function.Large-scale, international, single-armed, multicenter, ‘all comers’ observational studies (ClinicalTrials.gov Identifier: NCT02629575 and NCT02905214) were used for this post-hoc subgroup analysis to compare the clinical outcomes in patients with normal renal function (NRF) to those with renal insufficiency (CKD, dialysis dependence). The accumulated target lesion revascularization rate was the primary endpoint at 9 to 12 months whereas the accumulated major adverse cardiac event, stent thrombosis (ST) and procedural success rates were part of the secondary endpoints.There were 6791 patients with NRF, whereas 369 patients had CKD and 83 patients were dialysis dependent. The target lesion revascularization rate at 9 to 12 months was significantly higher in dialysis patients (2.1% vs 3.3% vs 6.7%, P = .011). The accumulated major adverse cardiac events rates in the dialysis and in the CKD group were significantly higher as compared to patients with NRF (13.3% vs 4.0%, P < .001; 6.5% vs 4.0%, P = .024). Finally, ST rates (NRF: 0.7%, CKD: 0.6%, dialysis: 1.3%) were not statistically different between subgroups (P = .768). All-cause cumulative mortality rates were 3.3% (CKD) and 4.0% (dialysis) respectively.Percutaneous coronary interventions with polymer-free, ultra-thin strut sirolimus-eluting stents have comparable revascularization rates in CKD and dialysis dependent patients as compared to percutaneous coronary interventions with other 2nd generation drug-eluting stents. ST and all-cause mortality rates were low as compared to available literature references.

Early vascular response of ultra-thin bioresorbable polymer sirolimus-eluting stents assessed by optical frequency domain imaging: the EVALUATION study.

This study aimed to evaluate the early vascular response of ultra-thin strut bioresorbable polymer sirolimus-eluting stents (BP SES) using optical frequency domain imaging (OFDI). Ultra-thin strut BP SES have superior outcomes in terms of efficacy and safety endpoints when compared to other thin strut new-generation stents. However, the factors contributing to the superiority of BP SES over other thin strut new-generation stents are unclear. A total of 32 patients with multivessel disease requiring staged procedures at 1month were enrolled from 3 cardiovascular institutions; of these, 31 were immediately assessed by OFDI (n = 31). All patients were assessed at 1month after ultra-thin strut BP SES implantation. The primary endpoint was % of uncovered struts. A total of 1723 cross sections(17,014 struts) were analyzed at baseline and 1month after percutaneous coronary intervention. The % uncovered struts at 1-month follow-up was 7.7% (4.0, 13.8). Furthermore, the covered strut % (88.4% and 80.4%, P = 0.013) and malapposition rate (2.7% and 4.3%, P = 0.012) were significantly different between the 60-μm and 80-μm stents. Ultra-thin strut BP SES implantation may feasibly achieve early vascular responses due to the ultra-thin struts. This may ultimately lead to lower stent thrombosis and target lesion failure rates.Clinical trial registration University Hospital Medical Information Network Clinical Trials Registry (No. UMIN000033406).

Bioresorbable zinc stent with ultra-thin center struts attenuates stent jail in porcine femoral artery bifurcations

Introduction An ultra-thin, fracture-resistant and bioresorbable stent may be advantageous for provisional stenting in vessel bifurcations, if catheter passage and side-branch post-dilatation is facilitated to prevent a ‘stent jail’ by struts obstructing the orifice of a major side branch. Material and methods We studied a highly radiopaque, slowly bioresorbable zinc alloy stent characterized by a novel design of a radiopaque-marked region of ultra-thin struts in the center of the stent. The stent is characterized by an extended range flexibility and high fracture resistance. Zn-stents and Zn-drug eluting stents (DES) were implanted opposite to rigid Nitinol stents into both femoral artery bifurcations of 21 juvenile pigs, followed for one and three months and studied by angiography and histomorphometry. Results and conclusion: Bare Zn-stents with thinner stent struts showed less neointimal hyperplasia compared to Zn-stents with thicker struts. Neointimal formation was further reduced by 12% in Zn-alloy DES. Both, bare Zn-stents and Zn-DES, can be precisely positioned into the femoral artery bifurcation, allowing easy balloon catheter passage through the very thin strut mesh. Side branch orifices remained open after Zn-stent deployment without stent jailing. No stent fractures or particles emboli occurred after the deployment. A Zn-stent with ultra-thin center struts may be useful for provisional stenting in vessel bifurcations.

Coronary artery double stenting techniques and their results in complex left main bifurcation disease.

Aim: Complex left main (LM) bifurcation disease seems to be better approached by a planned double stent technique. Materials & methods: Medline search for articles including randomized trials, prospective series, large registries and retrospective studies >50 patients has been performed. Results: Double kissing crush demonstrated its superiority over culotte stenting and cross over, while other techniques such as the T-stenting and T-stent and Protrusion have not been extensively reported in LM setting. The nano inverted-T-stenting has provided evidences that the use of ultrathin strut stents and very minimal crush is beneficial for both the physiological and rheological properties. Conclusion: The double stenting techniques used in LM should be evaluated in terms of procedural differences and technical simplicity.

Randomized Comparison of the Polymer-Free Biolimus-Coated BioFreedom Stent With the Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Orsiro Stent in an All-Comers Population Treated With Percutaneous Coronary Intervention: The SORT OUT IX Trial.

In patients with increased bleeding risk, the biolimus A9-coated BioFreedom stent, a stainless steel drug-coated stent free from polymer, has shown superiority compared with a bare-metal stent. The aim of this study was to investigate whether the BioFreedom stent is noninferior to a modern ultrathin strut biodegradable polymer cobalt-chromium sirolimus-eluting Orsiro stent in an all-comers patient population treated with percutaneous coronary intervention. The SORT OUT IX trial (Scandinavian Organization for Randomized Trials With Clinical Outcome IX), was a large-scale, registry-based, randomized, multicenter, single-blind, 2-arm, noninferiority trial. The primary end point, major adverse cardiovascular events, was defined as the composite of cardiac death, myocardial infarction not related to any segment other than the target lesion, or target lesion revascularization within 1 year, analyzed by intention-to-treat. The trial was powered to assess noninferiority for major adverse cardiovascular events of the BioFreedom stent compared with the Orsiro stent with a predetermined noninferiority margin of 0.021. Between December 14, 2015 and April 21, 2017, 3151 patients were assigned to treatment with the BioFreedom stent (1572 patients, 1966 lesions) or to the Orsiro stent (1579 patients, 1985 lesions). Five patients were lost to follow-up because of emigration (99.9% follow-up rate). Mean age was 66.3±10.9, diabetes mellitus was seen in 19.3% of patients, and 53% of the patients had acute coronary syndromes. At 1 year, intention-to-treat analysis showed that 79 (5.0%) patients, who were assigned the BioFreedom stent, and 59 (3.7%), who were assigned the Orsiro stent, met the primary end point (absolute risk difference 1.29% [upper limit of one-sided 95% CI 2.50%]; Pnoninferiority=0.14). Significantly more patients in the BioFreedom stent group had target lesion revascularization than those in the Orsiro stent group (55 [3.5%] vs 20 [1.3%], rate ratio 2.77 [95% CI, 1.66-4.62]; P<0.0001). The biolimus A9-coated BioFreedom polymer-free stent did not meet criteria for noninferiority for major adverse cardiovascular events at 12 months when compared with the ultrathin strut biodegradable polymer sirolimus-eluting Orsiro stent in an all-comers population Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02623140.

PK Papyrus coronary stent system: the ultrathin struts polyurethane-covered stent.

In the emergency setting of a coronary vessel perforation, the knowledge of materials needed to fix it and the intrinsic quality of the device used is mandatory for the interventional cardiologist. The PK Papyrus covered stent (Biotronik AG) is an ultrathin strut (60μm) balloon-expandable stent covered on the abluminal surface with an electrospun polyurethane matrix. It is intended to facilitate device delivery and effectively treat coronary artery perforations.In published studies, rates of successful device delivery and perforation sealing were above 90%, respectively, and most events were usually resolved with a single stent. In this review we focused on the main technical characteristics as well on the published evidence that compare its performance with other coronary covered stent.

Clinical outcomes of ultrathin strut biodegradable polymer-coated everolimus-eluting stent in patients with coronary artery disease.

BACKGROUNDEvermine 50™ (Meril Life Sciences Pvt. Ltd., India) everolimus-eluting stent system (EES) is a novel ultrathin strut (50 µm) cobalt-chromium coronary drug-eluting stent (DES) platform with biodegradable polymer coating. The Evermine 50 EES-KLES study aimed to evaluate the Evermine 50 EES in terms of 24-month clinical safety and performance in patients with coronary artery disease (CAD).METHODSThis retrospective study consisted of 171 patients (258 lesions) implanted with Evermine 50 EES for managing CAD. We analyzed the major adverse cardiac events (MACE) incidence, defined as a composite of cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization (ID-TLR) at 6-, 12-, and 24-month follow-up.RESULTSA total of 171 patients were included with a mean age of 57.85 ± 10.05 years, of which, 139 (81.29%) were men, 69 (40.35%) were hypertensive, and 70 (40.94%) were diabetic. The incidence of MACE was 1 (0.58%), 3 (1.81%), and 4 (2.42%) at 6-, 12-, and 24-month follow-up, respectively. There were three cases (1.82%) of cardiac death and one case (0.61%) of ID-TLR up to 24 months. None of the patients was presented with definite or probable stent thrombosis (ST).CONCLUSIONThis study demonstrated that implantation of ultrathin strut Evermine 50 EES resulted in a low rate of incidence of MACE, indicating a favourable clinical safety and performance profile of Evermine 50 EES in patients with CAD [Clinical Trials Registry-India (CTRI) Number: CTRI/2017/09/009939)].

Comparison of the Ultrathin Strut, Biodegradable Polymer Sirolimus-eluting Stent With a Durable Polymer Everolimus-eluting Stent in a Chinese Population: The Randomized BIOFLOW VI Trial

PurposeThe BIOFLOW-VI (Biotronik–Safety and Clinical Performance of the Drug Eluting Orsiro Stent in the Treatment of Subjects With De Novo Coronary Artery Lesions–VI) study evaluates the angiographic efficacy, clinical safety, and effectiveness of the ultrathin strut, biodegradable polymer sirolimus-eluting stent (BP-SES) compared with a durable polymer everolimus-eluting stent (DP-EES). This randomized controlled clinical trial was designed to enable approval of new drug-eluting stents in China. MethodsA total of 440 eligible patients from 11 sites with up to 2 de novo native coronary artery lesions were randomly assigned to receive either BP-SES (n = 220) or DP-EES (n = 220) from July 2014 to September 2016 in this prospective, multicenter, noninferiority trial. FindingsThe primary end point of 9-month in-stent late lumen loss (LLL) was 0.05 (0.02) mm in the BP-SES group versus 0.07 (0.02) mm in the DP-EES group, with a mean difference of −0.02 mm (95% CI, −0.06 to 0.03; P = 0.44; Pnoninferiority < 0.0001). At 1 year, the target lesion failure rate (cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization) was similar between the 2 groups (BP-SES 2.3% vs DP-EES 1.4%; P = 0.50). No definite or probable stent thrombosis had occurred in any of the 2 treatment arms. ImplicationsThe randomized BIOFLOW-VI trial showed that BP-SES was noninferior to DP-EES with regard to the primary end point of 9-month in-stent LLL in a Chinese population. ClinicalTrials.gov Identifier: NCT02870985

Risk of Dislodgement of Ultrathin Drug Eluting Stents Versus Thick Drug Eluting Stents

Modern ultrathin struts drug eluting stents (DES), due to their constructive characteristics, might be more prone to stent dislodgment than the old thick DES. Our study is aimed to retrospectively analyze and compare the incidence and outcomes of stents dislodgment in thick (TSS) and ultrathin strut stents (USS).We retrospectively analyzed the procedural and medical data of 8,564 consecutive patients (mean age 64.3 ± 11.2 years old, 4442 males) who underwent percutaneous coronary intervention with DES implantation in our Institution between 1st January 2005 to 1st January 2020. Overall, 25,692 (mean of 3.2 stent for patients) have been implanted over the study period (10648 TSS and 15044 and USS, respectively). Stent dislodgment globally occurred in 0.56% of the implanted stents (0.28% vs 0.78%, p <0.001 for TTS and USS, respectively). Coronary artery calcifications, ostial lesion, coronary artery tortuosity, and a lesion length >25 mm were independent predictors of type I and II USS dislodgments. At 12 months follow up, the rate of target lesion failure was higher in the TTS group (30.7 vs 12.7 %, p <0.001). Stent dislodgement is unusual in the modern era but is more frequent using USS than TTS DES.

BIODEGRADABLE POLYMER SIROLIMUS ELUTING STENT (ORSIRO) VERSUS SECOND GENERATION DURABLE POLYMER DRUG ELUTING STENTS: A META-ANALYSIS OF RANDOMISED TRIALS

Emerging clinical trial data in STEMI patients support using an ultra-thin strut biodegradable polymer sirolimus eluting stent (BP-SES), ‘Orsiro’, over contemporary second-generation durable polymer drug eluting stents (DP-DES) however the net clinical outcomes in all-comers is unknown. We

878 Safety and Efficacy of the Ultrathin Orsio Sirolimus-Eluting Stent use in ST-Elevation Myocardial Infarct. An Analysis From a Large Australian Regional Centre

We aim to review the real-world safety and efficacy of the Orsiro stent in STEMI population in Wollongong Hospital. We are a large tertiary centre with an extensive catchment area attending 75 STEMI per year on average. The Orsiro sirolimus-eluting stent is designed with ultrathin struts and biodegradable polymer, conferring potential favourable clinical outcomes. Recent meta-analysis comparing Orsiro stent against contemporary DES showed similar outcomes with trend toward lesser target lesion failure (TLF) and MI. We analysed 75 STEMI patients receiving 117 Orsiro stents in total from April 2019 to January 2020. Our analysis group entailed 20 female (25.6%) and 56 male (74.4%) patients, 65 primary PCI (83.3%) and 13 rescue PCI (16.7%). Target lesions encompassed 61 RCA (52.1%), 32 LAD (27.4%), 20 LCx (17.1%) and 4 LMCA (3.4%). Mean stent diameter was 3.04mm and mean stent length was 21.8mm. The primary endpoint was TLF, target lesion revascularization (TLR) and definite stent thrombosis at 3 months. Secondary endpoints were death of all cause, stroke, and major bleeding at 3 months. At 3 months, there was 1 of 78 (1.3%) definite stent thrombosis, 1 major bleeding and 1 stroke. There were 5 all-cause deaths from 7 out-of-hospital cardiac arrests. The primary finding showed Orsiro stent has low rate of MACE with low rate of TLF, TLR and definite stent thrombosis. Further analysis of long-term outcomes from Osiro stent in this high-risk group would be highly informative, and we will continue analysing data in this subgroup population.

A critical analysis of the noninferiority design of the TALENT trial

In recent years, regulatory approval of stents has been based on studies that have a noninferiority design, which has its own inherent complexities. We critically appraise in this article, the TALENT trial that established the noninferiority of the Indian-manufactured Supraflex stent (a third-generation, sirolimus-eluting stent with an ultrathin strut thickness) compared with the Xience stent (an internationally available, everolimus-eluting stent with a thicker strut) for a device-oriented composite end point at the end of 12 months. Our analysis shows that if the risk ratio rather than absolute risk difference was used to calculate the noninferiority margin, we would obtain a value of 1.48 for the risk ratio. Supraflex would then be noninferior to Xience by 0.92 [95% confidence interval (CI) = 0.59 to 1.47]. The upper bound of the 95% CI of 1.47 is dangerously close to 1.48, indicating that the TALENT trial would just about manage to prove noninferiority.

Safety and Efficacy of a New Ultrathin Sirolimus-Eluting Stent with Abluminal Biodegradable Polymer in Real-World Practice.

Background and ObjectivesRecently, Genoss drug-eluting stent (DES)™ stent comprising cobalt-chromium platform with an ultrathin strut thickness, sirolimus, and an abluminal biodegradable polymer was developed. Owing to the lack of substantial evidence for the safety and efficacy of this stent, we report 12-month results of the Genoss DES™ stent.MethodsWe analyzed subjects who were eligible for a 12-month follow-up from the ongoing Genoss DES™ registry, which is a prospective, single-arm, observational, multicenter trial to investigate the clinical outcomes after the successful Genoss DES™ stent implantation among all-comers. The primary endpoint was a device-oriented composite outcome, defined as cardiac death, target vessel-related myocardial infarction, and target lesion revascularization at 12-month follow-up.ResultsAmong 622 subjects, the mean age of subjects was 66.5±10.4 years, 70.6% were males, 67.5% had hypertension, and 38.3% had diabetes. The implanted stent number, diameter, and length per patient were 1.5±0.8, 3.1±0.4 mm, and 36.0±23.3 mm, respectively. At 12-month clinical follow-up, the primary endpoint occurred only in 4 (0.6%) subjects.ConclusionsThe novel Genoss DES™ stent exhibited excellent safety and efficacy in real-world practice.