Biodegradable Polymer-coated Sirolimus-eluting Stent Research Articles

Evaluation of Ultrathin Strut Biodegradable Polymer-Coated Sirolimus-Eluting Stents in an All-Comers Patient Population: 1-Year Results of the S-FLEX Slovakia Registry.

Supraflex (Sahajanand Medical Technologies Limited, Surat, India) is a new-generation, biodegradable polymer-coated sirolimus-eluting stent (SES) designed on an ultrathin (60 µm) cobalt-chromium platform with a flexible 'S-link.' The S-FLEX Slovakia registry aimed to assess the safety and effectiveness of Supraflex SES in an all-comers population, with a subgroup of diabetic patients. This was a prospective, observational, multi-center, post-market registry conducted between February 2018 and May 2019. All consecutive patients with symptomatic coronary artery disease scheduled for percutaneous coronary intervention with Supraflex SES were enrolled. The primary endpoint was target lesion failure (TLF), defined as a composite of cardiac death, target vessel myocardial infarction (TV-MI), or clinically indicated target lesion revascularization (CI-TLR) by percutaneous or surgical methods at 1-year follow-up. Stent thrombosis was a safety endpoint. A total of 413 patients was assessed (145 diabetics and 268 nondiabetics). At 1-year follow-up, the primary endpoint of TLF occurred in 5.1% patients, comprised of 3.9% cardiac deaths, 0.5% TV-MI, and 0.7% CI-TLR. Overall stent thrombosis occurred in 0.5% patients at 1-year follow-up. In the subgroup analysis, TLF occurred in 6.2% diabetics and 4.5% nondiabetics (P =.433) and comprised 4.8% and 3.4% cardiac deaths (P =.447), 0.7% and 0.4% TV-MI (P =.653), and 0.7%, and 0.7% CI-TLR (P =.952) in diabetics and non-diabetics, respectively. Overall stent thrombosis occurred in 0.7% diabetic and 0.4% non-diabetic patient (P =.659). This registry demonstrates favourable clinical outcomes after the implantation of the ultrathin biodegradable polymer coated Supraflex SES in an all-comers population, with event rates that were similar in diabetic and nondiabetic patients.

A novel biodegradable polymer-coated sirolimus-eluting stent: the 1-year results of the HELIOS registry.

The HELIOS stent is a sirolimus-eluting stent with a biodegradable polymer and titanium oxide film as the tie-layer. The study aimed to evaluate the safety and efficacy of HELIOS stent in a real-world setting. The HELIOS registry is a prospective, multicenter, cohort study conducted at 38 centers across China between November 2018 and December 2019. A total of 3060 consecutive patients were enrolled after application of minimal inclusion and exclusion criteria. The primary endpoint was target lesion failure (TLF), defined as a composite of cardiac death, non-fatal target vessel myocardial infarction (MI), and clinically indicated target lesion revascularization (TLR) at 1-year follow-up. Kaplan-Meier methods were used to estimate the cumulative incidence of clinical events and construct survival curves. A total of 2998 (98.0%) patients completed the 1-year follow-up. The 1-year incidence of TLF was 3.10% (94/2998, 95% closed interval: 2.54%-3.78%). The rates of cardiac death, non-fatal target vessel MI and clinically indicated TLR were 2.33% (70/2998), 0.20% (6/2998), and 0.70% (21/2998), respectively. The rate of stent thrombosis was 0.33% (10/2998). Age ≥60 years, diabetes mellitus, family history of coronary artery disease, acute myocardial infarction at admission, and device success were independent predictors of TLF at 1 year. The 1-year incidence rates of TLF and stent thrombosis were 3.10% and 0.33%, respectively, in patients treated with HELIOS stents. Our results provide clinical evidence of the HELIOS stent for the evaluation of Interventional Cardiologists and Policymakers. ClinicalTrials.gov, NCT03916432.

The Outcome of Ultrathin-Strut Biodegradable Polymer-Coated Sirolimus-Eluting Stents in Coronary Artery Disease Patients - A Feasibility Study.

Drug-eluting coronary stents with ultrathin struts and biodegradable polymers have been shown to reduce inflammation, neointimal proliferation, and thrombus formation, leading to less early and late complications in patients with coronary artery disease as compared to thinner strut and durable polymer second-generation stents. In Oman, currently, second-generation stents are used for all patients. The purpose of this feasibility study was to evaluate the clinical safety and performance of ultrathin-strut (60 μm) biodegradable polymer-coated sirolimus-eluting stents in an all-comers patient population. This was a prospective, observational, single-center, and single-arm investigator-initiated study from August 2018 to August 2019. Inclusion criteria: 18 years of age, patients with symptomatic coronary artery disease indicated for percutaneous coronary intervention, and stenting of at least one coronary lesion. All patients were followed clinically or telephonically at 12 months after the index procedure. A total of 88 patients were recruited in the study, but 10 patients were lost to follow-up and hence excluded from the analysis. The overall mean age was 63 ± 13 years and 78% were males. The main comorbid conditions were hypertension (58%), diabetes mellitus (49%), and hyperlipidemia (26%). Fifty-three percent presented with unstable angina or non-ST elevation myocardial infarction (MI), 10% with ST elevation MI, recent MI 16%, 18% with stable angina, and 1.3% in cardiogenic shock. The mean left ventricular ejection fraction of the cohort was 46 ± 14%. Angiographically, Type A lesions were seen in 25%, Type B in 32%, and Type C in 42%. Left anterior descending stenting was done in 44%, right coronary artery in 32%, left circumflex artery in 14%, left main in 5%, and graft stenting in 4%. Device success was 96%. Procedural success was seen in 97% of patients. At 1-year follow-up, 93% were asymptomatic; overall device-oriented clinical events were 6.8% including cardiac death in 2.7%, target-vessel MI in 2.7%, and target-lesion revascularization in 1.3% which all occurred in uncontrolled diabetic patients. At index admission and 1 year, ultrathin-strut biodegradable polymer-coated sirolimus-eluting stent study showed low device-related adverse clinical events which are comparable to published data for the second-generation stents. This feasibility study shows that these stents can be used in all types of stent-indicated patients with added advantages of biodegradable polymer and ultrathin struts. In addition, measures to prevent, diagnose, and control diabetes need to be taken in Oman as this cohort of patients develop ST after stenting.

3-Year Clinical Outcomes of Ultrathin Biodegradable Polymer-Coated Sirolimus-Eluting Stents: T-Flex Registry With High-Risk Subgroups.

3-Year Clinical Outcomes of Ultrathin Biodegradable Polymer-Coated Sirolimus-Eluting Stents: T-Flex Registry With High-Risk Subgroups.

E-24 | Clinical Outcomes of Biodegradable Polymer-coated Ultrathin Strut Sirolimus-eluting Stents in a Real-world Patient Population with High-risk Subgroups: Three-year Results

New-generation drug-eluting stents (DES) are superior to earlier-generation DES in terms of efficacy and safety — this may be attributable to the ultrathin metallic backbone. T-Flex registry sought to assess clinical outcomes of ultrathin (60 μm) biodegradable polymer-coated sirolimus-eluting stents (SES) designed with a unique long dual Z (LDZ) link on a cobalt-chromium platform (Sahajanand Medical Technologies Ltd., Surat, India) in a real-world population with high-risk subgroups at 3-year follow-up.

E-9 | Prospective Evaluation of Ultrathin-strut Biodegradable Polymer-coated Sirolimus-eluting Stents in an All-comers Patient Population: Slovakia Registry with a Subgroup Analysis

Thicker struts affording a smaller minimum in-stent diameter are known predictors of restenosis in coronary stents. The Slovakia Registry aimed to assess safety and efficacy of the ultrathin (60 μm) biodegradable polymer-coated Supraflex sirolimus-eluting stents (SES) (Sahajanand Medical Technologies Ltd., Surat, India), in an all-comers population with a subgroup of diabetic patients.

Clinical outcomes of ultrathin biodegradable polymer-coated sirolimus-eluting stents in an all-comer population: One-year results from the T-FLEX registry including high-risk subgroups.

T-Flex registry was designed to investigate the safety and clinical performance of the ultrathin (60 µm) strut biodegradable polymer-coated sirolimus-eluting stent (SES) with a unique long dual Z (LDZ) link design on a cobalt-chromium stent platform (Sahajanand Medical Technologies Pvt. Ltd., Surat, India) in a real-world all-comer population including high-risk subgroups. This was an observational, multicenter, single-arm, and investigator-initiated retrospective registry. A total of 1,203 patients treated with an ultrathin biodegradable polymer-coated SES, irrespective of lesion complexity, comorbidities, and acute presentation were analyzed from May 2016 to January 2017. The primary endpoint was the one-year incidence of target lesion failure (TLF), a composite of cardiac death, target-vessel myocardial infarction (TV-MI), and clinically-indicated target lesion revascularization (CI-TLR). Stent thrombosis was assessed as an additional safety endpoint. At the one-year follow-up, TLF was observed in 3.8% [95% confidence interval (CI) 2.9-5.1] patients, composed of 0.6% (95% CI: 0.3-1.3) cardiac death, 1.3% (95% CI: 0.8-2.2) TV-MI, and 1.9% (95% CI: 1.3-2.9) CI-TLR. In the high-risk subgroups, TLF at one-year was 6.8% (95% CI: 4.6-9.8) in patients with diabetes, 5.2% (95% CI: 3.4-8) in patients with small-vessel disease, 6.1% (95% CI: 3.9-9.6) in patients with ST-elevation myocardial infarction, and 4.5% (95% CI: 2.4-8.3) in patients with total occlusion. During follow-up, stent thrombosis was reported in 0.8% (95% CI: 0.4-1.5) patients in the overall population. Low event rates of TLF and stent thrombosis at one-year follow-up indicate that this ultrathin biodegradable polymer-coated SES has encouraging safety and clinical performance in real-world all-comer populations as well as in high-risk subgroups.

Biodegradable polymer-coated thin strut sirolimus- -eluting stent versus durable polymer-coated everolimus-eluting stent in the diabetic population.

The number of patients with diabetes mellitus (DM) presenting with coronary artery disease is increasing and accounts for more than 30% of patients undergoing percutaneous coronary interventions (PCI). The biodegradable polymer drug-eluting stents were developed to improve vascular healing. It was sought herein, to determine 1-year clinical follow-up in patients with DM treated with the thin strut biodegradable polymer-coated sirolimus-eluting stent (BP-SES) versus durable coating everolimus-eluting stent (DP-EES). Patients were retrospectively analyzed with DM were treated with either a BP-SES (ALEX™, Balton, Poland, n = 670) or a DP-EES (XIENCE™, Abbott, USA, n = 884) with available 1 year clinical follow-up using propensity score matching. Outcomes included target vessel revascularization (TVR) as efficacy outcome and all-cause death, myocardial infarction, and definite/probable stent thrombosis as safety outcomes. After propensity score matching 527 patients treated with BP-SES and 527 patients treated with DP-EES were selected. Procedural and clinical characteristics were similar between both groups. In-hospital mortality was 3.23% in BP-SES vs. 2.09% in DP-EES group (p = 0.25). One-year followup demonstrated comparable efficacy outcome TVR (BP-SES 6.64% vs. DP-EES 5.88%; p = 0.611), as well as similar safety outcomes of all-cause death (BP-SES 10.06% vs. DP-EES 7.59%; p = 0.158), myocardial infarction (BP-SES 7.959% vs. DP-EES 6.83%; p = 0.813), and definite/probable stent thrombosis (BP-SES 1.14% vs. DP-EES 0.76%; p = 0.525). The thin-strut biodegradable polymer coated, sirolimus-eluting stent demonstrated comparable clinical outcomes at 1-year after implantation to DP-EES. These data support the relative safety and efficacy of BP-SES in diabetic patients undergoing PCI.

Twelve-months clinical outcomes of biodegradable polymer-coated sirolimus-eluting coronary stent in real-world patients: A single-center experience.

This study was designed to evaluate the safety and performance of Metafor™ SES in real-world patients with coronary artery disease. This was retrospective, single-centre, post-marketing, observational study. The primary endpoint was the occurrence of major adverse cardiac event (MACE). A total of 141 patients (187 lesions) were treated with the study device. The average stent length and diameter was 24.75 ± 9.50 mm and 2.93 ± 0.38 mm, respectively. The cumulative incidence of MACE was 1.42%. No incidence of stent thrombosis was observed at 12-months follow-up. This retrospective study demonstrated favourable safety and performance of Metafor™ SES.

Thin, very thin, or ultrathin-strut biodegradable or durable polymer-coated drug-eluting stents.

The current article will review recently published clinical studies that evaluate very thin or ultrathin-strut drug-eluting stents (DES), focusing on major randomized clinical trials in broad patient populations. Multiple randomized trials recently assessed the clinical performance of novel very thin to ultrathin-strut DES. Most randomized trials established noninferiority of the novel device. To date, only one major randomized clinical trial (i.e., BIOFLOW V) showed superiority of an ultrathin-strut biodegradable polymer-coated sirolimus-eluting stent over a very thin-strut durable polymer-coated everolimus-eluting stent in a relatively broad patient population. There are signals that the same ultrathin-strut biodegradable polymer-coated sirolimus-eluting stent may improve clinical outcome in specific patient populations. For example, in the randomized BIOSTEMI trial, 1-year superiority of the ultrathin-strut DES was found in patients presenting with an acute ST-segment elevation myocardial infarction. Yet, substudies of large randomized trials that assessed patients with small-vessel treatment showed equivocal results. Although two randomized trials showed advantages for ultrathin-strut DES, other clinical trials provided no significant evidence that ultrathin-strut DES improve clinical outcome. The question whether ultrathin-strut DES may reduce the repeat revascularization risk following implantation in small vessels is a matter of further debate and future research.

Comparison of neointimal coverage between ultrathin biodegradable polymer-coated sirolimus-eluting stents and durable polymer-coated everolimus-eluting stents: 6 months optical coherence tomography follow-up from the TAXCO study.

AimThe TAXCO study was designed to compare the degree of neointimal coverage and the prevalence of malapposition at 6 months subsequent to implantation of ultrathin biodegradable polymer‐coated sirolimus‐eluting stents (SES) and durable polymer‐coated everolimus‐eluting stents (EES) of thin strut thickness using optical coherence tomography (OCT).MethodsThe TAXCO study included a total of 42 patients who gave consent and underwent OCT examination between August 2017 and September 2017. Of 42, five patients' OCT examinations were of insufficient quality for quantitative analysis. Thus, the OCT analysis group consisted of 37 patients. Among them, 16 patients were treated with Xience (Abbott Vascular) and 21 with Tetriflex (Sahajanand Medical Technologies Pvt. Ltd., Surat, India), 6 (±1) months earlier at our institution. The OCT was performed using a C7 Dragonfly™ imaging catheter (St. Jude Medical Inc.). All OCT images were analyzed at an independent core laboratory (Cardiovascular Research Center, São Paulo, Brazil) by analysts who were blinded to patient and procedural information.ResultsA total of 763 crosssections (6,882 struts) were analyzed in Xience group, and 1,127 crosssections (9,968 struts) in Tetriflex group. At 6 months, on per‐lesion basis, no significant differences were observed between Xience group and Tetriflex group in mean percentage of uncovered struts (1.87 ± 3.86 vs. 2.42 ± 3.46, p = .137) and malapposed struts (0.05 ± 0.2 vs. 0.21 ± 0.69, p = .302). Strut‐level neointimal thickness also did not differ between Xience group and Tetriflex group (0.18 ± 0.12 vs. 0.14 ± 0.08 mm, p = .286).ConclusionThis OCT study found no significant difference in strut coverage and neointimal thickness at 6 months after implantation of biodegradable polymer‐coated Tetriflex, when compared with durable polymer‐coated Xience.

Ultrathin (60 μm), ultralong (≥40 mm) sirolimus-eluting stent: study of clinical and safety profiles among real-world patients.

Although thin-strut drug-eluting stents (DES) with a more flexible design are easily obtainable, data regarding using ultralong DES (≥40 mm) for long coronary lesions are limited in the literature. Therefore, the current study assessed the safety and efficacy of an ultralong (≥40 mm) and ultrathin (60 μm) biodegradable polymer-coated sirolimus-eluting stent (SES), Supralimus Grace, with a unique Long Dual Z-link (LDZ-link) design (Sahajanand Medical Technologies Pvt. Ltd., Surat, India) in real-world patients with long coronary lesions. The assigned stents were implanted in 684 patients. The primary endpoint was target lesion failure (TLF), which is a composite of cardiovascular death, target vessel myocardial infarction (MI), and target lesion revascularization (TLR), whereas periprocedural secondary endpoints included device failure (failure of stent delivery, change of stent, and stent fracture) and patient-oriented composite endpoint (POCE), which is a composite of all deaths, any MI, and any revascularization, and stent thrombosis (ST). These outcomes were analyzed at one-year follow-up and during the procedure. The patients' mean age was 52.7±15.9 years; 537 (78.5%) were males. 626 (91.5%) patients suffered from acute coronary syndrome and 58 (8.5%) patients from chronic coronary syndrome (CSS). 989 lesions were removed. The mean numbers of lesions and stents implanted per patient were 1.3±0.2 mm and 1.4±0.3 mm, respectively. TLF occurred in 42 (6.1%) as a result of cardiac death, target vessel MI, and TLR in 9 (1.3%), 20 (2.9%), and 13 (1.9%) patients, respectively. POCE was observed in 131 patients (19.1%) at one-year follow-up, mainly in 63 (9.2%) patients because of any revascularization. Stent failure was seen in 21 patients (3.1%) as a result of delivery failure (2.2%), edge dissection (0.8%), and fracture (0.1%). Definite and probable ST were observed in 8 (1.1%) and 9 (1.3%) patients, respectively. Ultralong (≥40 mm), ultrathin (60 μm) Supralimus Grace stent can be safely implanted in vessels having long and multiple lesions.

Twelve-month clinical outcomes of sirolimus-eluting stent in coronary artery disease: An experience in real-world Indian patients.

Objective:Supraflex (Sahajanand Medical Technologies Pvt. Ltd, Surat, India) is the latest generation of biodegradable polymer-coated sirolimus-eluting coronary stent designed on ultra-thin (60 µm) cobalt–chromium platform with flexible “S-link.” The present study was designed to establish the safety and clinical performance of Supraflex in real-world Indian patients with coronary artery disease.Methods:The study included 839 consecutive patients with coronary artery disease who were implanted with Supraflex from January 2014 to August 2017 at six different tertiary care centers in India. Follow-up was performed at 30 days, 6 months, and 12 months after the index procedure. The primary end-point of the study was the incidence of major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR) at the 12-month follow-up. The occurrence of stent thrombosis was analyzed as safety end-point.Results:A total of 1025 lesions were treated by implantation of 1098 Supraflex stents. At the 12-month follow-up, MACE was 4.92%, including 7 (0.86%) cardiac deaths, 16 (1.97%) MI, and 17 (2.09%) TLR. Only three incidences of stent thrombosis were found at the 12-month follow-up.Conclusion:The study results showed excellent safety and clinical effectiveness of Supraflex in a high proportion of high-risk real-world Indian patients with coronary artery disease. (Anatol J Cardiol 2020; 24: 364-9)

Prospective evaluation of an ultrathin strut biodegradable polymer-coated sirolimus-eluting stent: 12 months’ results from the S-FLEX UK registry

ObjectiveTo prospectively evaluate safety and efficacy of the ultrathin strut biodegradable polymer-coated Supraflex sirolimus-eluting stent (S-SES) in ‘real world’ patient population requiring percutaneous coronary intervention (PCI).MethodsNational, prospective, multicentre, single-arm, all-comers,...

Comparison of neointimal coverage between ultrathin biodegradable polymer-coated sirolimus-eluting stents and durable polymer-coated everolimus-eluting stents: 6 months optical coherence tomography follow-up from the TAXCO study

Comparison of neointimal coverage between ultrathin biodegradable polymer-coated sirolimus-eluting stents and durable polymer-coated everolimus-eluting stents: 6 months optical coherence tomography follow-up from the TAXCO study

Safety and efficacy of biodegradable polymer-coated thin strut sirolimus-eluting stent vs. durable polymer-coated everolimus-eluting stent in patients with acute myocardial infarction.

IntroductionThe biodegradable polymer drug-eluting stents were developed to improve vascular healing. However, further data are needed to confirm the safety and efficacy of these stents in patients with acute myocardial infarction (AMI).AimWe sought to determine the 1-year clinical follow-up in patients with AMI treated with a thin strut biodegradable polymer-coated sirolimus-eluting stent (BP-SES) versus a durable coating everolimus-eluting stent (DP-EES).Material and methodsWe analyzed patients with AMI (STEMI and NSTEMI) treated with either a BP-SES (ALEX, Balton, Poland, n = 886) or DP-EES (XIENCE, Abbott, USA, n = 1054) with available 1-year clinical follow-up using propensity score matching. Outcomes included target vessel revascularization (TVR) as the efficacy outcome and all-cause death, myocardial infarction, and definite/probable stent thrombosis as safety outcomes.ResultsAfter propensity score matching 672 patients treated with BP-SES and 672 patients treated with DP-EES were selected. Procedural and clinical characteristics were similar between the groups. In-hospital mortality was similar in both tested groups. One-year follow-up demonstrated comparable efficacy outcome TVR (BP-SES 7.1% vs. DP-EES 5.2%, p = 0.14), as well as similar safety outcomes of all-cause death, myocardial infarction, and definite/probable stent thrombosis.ConclusionsThe thin-strut biodegradable polymer coated sirolimus-eluting stent demonstrated comparable clinical outcomes at 1 year after implantation to the DP-EES. These data support the relative safety and efficacy of BP-SES in AMI patients undergoing percutaneous coronary intervention.

One-Year Clinical Outcomes of Biodegradable Polymer-Coated Sirolimus-Eluting Coronary Stent System in Patients with Coronary Artery Disease

Background: The biodegradable polymer-coated sirolimus-eluting coro-nary stent (SES) system for the treatment of coronary artery disease (CAD) has been implanted in a real-world patient population. Aim: The present study was designed to evaluate the safety and performance of MetaforTM sirolimus- eluting coronary stent (SES) system in consecutive patients with CAD in a real-world patient population. Methods: All the consecutive 251 patients who underwent percutaneous coronary interventions with the use of Metafor sirolimus-eluting stents were included in this study. Patients were clinically/tele- phonically followed-up at one-year from August 2015 to August 2016. We observed and analyzed major adverse cardiac event (MACE) defined as the aggregate of cardiac death, myocardial infarction (MI), and any target lesion revascularization (TLR) at one-year. Also, stent thrombosis (ST) was observed at one-year patients follow-up. Results: We collected and analyzed the data for 251 patients. Out of 251 participants, 191 (76.1%) were males, 95 (37.8%) patients had diabetes, 117 (46.6%) had ST-segment-elevation myocardial infarction (STEMI), and 134 (53.4%) had hypertension. Mean patient age was 56.35 ± 11.23 years. A total of 295 lesions were treated, out of which 13.6% of the lesions were the long lesion of ≥40 mm. At one-year, MACE occurred in 4 (1.6%) of 251 patients, consisting of 2 (0.8%) cardiac deaths, 2 (0.8%) MI, and 0 (0%) TLR. Stent thrombosis was reported in one patient (0.4%). Conclusions: This retrospective data demonstrated excellent safety and performance of Metafor SES in a “real-world” consecutive CAD patient, indicating low rates of MACE and ST at one-year follow-up.

Five-year outcomes of ST-elevation myocardial infarction versus non-ST-elevation acute coronary syndrome treated with biodegradable polymer-coated sirolimus-eluting stents: Insights from the CREATE trial

BackgroundLong-term outcome of drug-eluting stents (DES) for ST-elevation myocardial infarction (STEMI) versus non-ST-elevation acute coronary syndrome (NSTE-ACS) remains unclear. This study sought to compare the long-term outcomes of biodegradable polymer-coated DES in patients with STEMI versus NSTE-ACS. MethodsWe explored a post hoc analysis of the 5-year outcome of the CREATE trial in the subgroup of patients with STEMI (n=318) versus NSTE-ACS (n=1223) who were implanted with biodegradable polymer-coated DES. The primary outcome was the rate of major adverse cardiac events (MACE) at 5 years. Clopidogrel and aspirin for 6 months followed by chronic aspirin therapy were recommended. ResultsSTEMI patients showed a trend of increase in MACE (8.7% vs. 6.8%, log rank p=0.289) compared to NSTE-ACS patients at 5 years, and a greater risk of cardiac death (5.4% vs. 2.1%, log rank p=0.003), mainly driven by the higher cardiac death rate within the first month after stent placement (log rank p=0.003) and the last year of follow-up (log rank p=0.001). No significant difference in stent thrombosis was found between them (3.1% vs. 2.5%, log rank p=0.653). Prolonged clopidogrel therapy (>6 months) showed no effect on risk of MACE or stent thrombosis between the two groups (both p for interaction >0.1). ConclusionsSTEMI patients have a higher risk of cardiac mortality compared with NSTE-ACS patients after biodegradable polymer-coated DES placement, primarily attribute to more cardiac deaths that happened within the first month after the event and the last year of follow-up.

Clinical outcomes in 995 unselected real-world patients treated with an ultrathin biodegradable polymer-coated sirolimus-eluting stent: 12-month results from the FLEX Registry

ObjectivesTo evaluate, in the FLEX Registry, clinical outcomes of an ultrathin (60 µm) biodegradable polymer-coated Supraflex sirolimus-eluting stent (SES) for the treatment of coronary artery disease. Additionally, to determine the...

Clinical performance of biodegradable polymer coated Sirolimus-eluting stent in multivessel disease: Results from MULTIDES study

Context: The role of percutaneous coronary intervention in the treatment of multivessel coronary artery disease (CAD) is still controversial and widely discussed. Aim: The aim of this study was to examine the incidence of clinical outcomes after utilization of Indolimus, biodegradable polymer coated sirolimus-eluting stent (SES), in multivessel coronary stenting in an unselected patient population. Settings and Design: From April-2012 to June-2014, patients with multivessel (≥2 vessels) disease were examined in the retrospective, nonrandomized, observational, multicenter MULTIDES study. Materials and Methods: A total of 151 patients, exclusively treated with Indolimus SES in multivessel, were included in the study. The study was conducted in accordance with the Declaration of Helsinki and country-specific regulatory requirements. All patients signed informed consent form. Statistical Analysis Used: Continuous variables are presented as mean ± standard deviation and categorical variables as counts and percentages. All data were analyzed using Statistical Package for Social Sciences program. Results: The mean age was 53.7 ± 10.7 years; male gender represented 108 (71.5%) patients. A total of 314 Indolimus stents were implanted. Clinical follow-up was performed at 30-day, at 6-month, and at 9-month. The primary endpoint, major adverse cardiac events (MACEs) at 9-month follow-up, occurred in 5 (3.3%) patients, consisting of 1 (0.7%) cardiac death, 2 (1.3%) myocardial infarction, 2 (1.3%) target lesion revascularization, 0 (0%) target vessel revascularization, and 0 (0%) stent thrombosis. Conclusion: The present study describes that Indolimus implantation is safe and effective treatment in multivessel CAD, showing low rates of MACEs during 9-month follow-up.