Biodegradable Polymer Sirolimus-eluting Stent Research Articles

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

Clinical rationale and experimental feasibility of the first national drug-eluting stent platform

Background.The availability of drug-eluting stents with evidence-based clinical safety and efficacy produced in the Russian Federation is one of the relevant goals for successful treating of patients with coronary artery disease, including acute coronary syndrome. Aim To confirm clinical rationale and experimental feasibility of the first Russian drugeluting stent, Calypso (Angioline, LLC, Russian Federation), for the clinical practice.Methods.The study included four phases. The first phase was aimed at selecting the optimal stent platform with superior healing properties. Then, the selected Russian coronary stents based on the optimal platforms underwent preclinical studies. The third phase included the clinical assessment using optical coherence tomography (OCT) in order to confirm the preclinical results. The last phase was focused on assessing clinical safety and efficacy of the Russian coronary stent based on the comparative analysis of angiographic findings within the 12-months follow-up.Results.At the first phase, biodegradable polymer sirolimus-eluting stent showed superior healing properties in comparison with the healing score of 18±14.97 for Orsiro stents (Biotronik, Germany) versus 25.6±1.0 for Xience stents (Abbott Vascular, USA) versus 32.5±20.3 for Synergy (Boston Scientific, USA), p&lt;0.001. The Russian stent consistently demonstrated a high healing profile in preclinical and OCT clinical studies. The results of the comparative clinical study proved the clinical safety and efficacy of the Russian stent that was similar to the best foreign stents. None of the differences in the incidence of binary restenosis were found between the groups (p&lt;0.05).Conclusion.The biodegradable polymer sirolimus-eluting stent Calypso manufactured in the Russian Federation demonstrated superior neointimal healing pattern with no signs of chronic inflammation in the experiment. This stent reported high neointimal healing properties according to the clinical OCT study. According to the angiographic findings, the incidence of binary restenosis between the Russian biodegradable polymer sirolimus-eluting stent and durable polymer everolimuseluting stents was similar at the 12-months follow-up (p&gt;0.05).

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

One‐year clinical outcome of biodegradable polymer sirolimus‐eluting stent in diabetic patients: Insight from the ULISSE registry (ULtimaster Italian multicenter all comerS Stent rEgistry)

The ULISSE registry evaluated the real-world performance of the Ultimaster® biodegradable polymer sirolimus-eluting stent (BP-SES) in a multicenter-independent cohort of patients undergoing percutaneous coronary intervention, including a large proportion of diabetes mellitus (DM) patients. In this subgroup analysis, 1,660 consecutive patients, 2,422 lesions, treated with BP-SES enrolled in the ULISSE registry were divided in two groups: DM (485 patients, 728 lesions) and non-DM (1,175 patients, 1,694 lesions). Primary endpoint was target lesion failure (TLF), a composite endpoint of cardiac-death, target-vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization (TLR) at 1-year. Secondary endpoint was TLR at 1-year. At 1-year follow-up TLF occurred in 5% overall patients and was significantly higher in DM patients (8 vs. 3.7%; p = .001), due to more cardiac deaths (3.4 vs. 1.1%; p = .002). TLR occurred in 3.2% overall patients, and it was not significantly higher in DM compared to non-DM patients (4.4 vs. 2.8%; p = .114). The incidence of stent thrombosis was low and similar between groups (0.4 vs. 0.9%; p = .526). Insulin-treated DM (ITDM) patients showed higher rate of TLF as compared to non-ITDM patients (13 vs. 6.5%; p = .041), but similar rate of TLR (6 vs. 4%; p = .405). After adjustment for relevant comorbidities, DM was not significantly associated with TLF or cardiac death in patients undergoing BP-SES implantation. This study is the first all-comers evaluation of BP-SES in DM patients. Our findings show that DM patients, mostly those with ITDM, still represent a vulnerable population and experience significantly higher rate of TLF. Overall BP-SES efficacy is considerable, although not statistically significant higher rate of TLR is still present in DM compared to non-DM patients.

An abluminal biodegradable polymer sirolimus-eluting stent versus a durable polymer everolimus-eluting stent in patients undergoing coronary revascularization: 3-year clinical outcomes of a randomized non-inferiority trial

The Cordimax stent has proved non-inferior to the Cypher Select durable polymer sirolimus-eluting stent for the primary endpoint of angiographic in-stent late luminal loss and in-stent mean diameter stenosis at 9 months. The trial was designed to compare the efficacy and safety of the Cordimax stent with the Xience V stent in patients undergoing coronary revascularization. This randomized, multicenter trial enrolled 3697 patients treated with Cordimax stent (2460 patients) and Xience V stent (1237 patients). The primary efficacy endpoint was a target-lesion failure (TLF) at 1 year and the primary safety endpoint was a composite of death or myocardial infarction (MI) at 3 years. 3399 patients (91.9%) completed 3-year follow-up. At 1 year, the primary efficacy endpoint occurred in 86 (3.5%) patients in the Cordimax group versus 40 (3.2%) patients in the Xience V group (0.3% absolute risk difference, 95% CI −1.0–1.5%, Pnon-inferiority < 0.0001). At 3 years, the primary safety endpoint occurred in 39 (1.6%) patients in the Cordimax group versus 19 (1.5%) patients in the Xience V group (0.05% absolute risk difference, 95% CI −0.8–0.9%, Pnon-inferiority < 0.0001). The incidence of target lesion revascularization was low in Cordimax group compared with Xience V group (3.6% versus 5.1%, P = 0.03). There were no differences between Cordimax and Xience V in terms of Cardiac death (0.3% versus 0.4%, P = 0.70), myocardial infarction (1.2% versus 0.9%, P = 0.37), and the stent thrombosis (0.4% versus 0.6%, P = 0.61). In conclusion, safety and efficacy outcomes of Cordimax stent were non-inferior to the Xience V stent 3 years after stent implantation.

Comparison of clinical outcomes between Magmaris and Orsiro drug eluting stent at 12 months: Pooled patient level analysis from BIOSOLVE II–III and BIOFLOW II trials

BackgroundThe aim of this study was to compare the 12-month clinical outcomes of patients treated with Magmaris or Orsiro. Second generation drug-eluting absorbable metal scaffold Magmaris (Dreams 2G) has proved to be safe and effective in the BIOSOLVE-II study. Similarly, biodegradable polymer sirolimus-eluting stent, Orsiro has shown notable clinical results even in all-comer populations. MethodsMagmaris group patients were taken from the BIOSOLVE-II and BIOSOLVE-III trials, while the patients from Orsiro group were enrolled in BIOFLOW-II trial. The primary outcome was explored using a time-to-event assessment of the unadjusted clinical outcomes for target lesion failure (TLF) at 12 months, followed by a multivariate analysis adjusting for all the significantly different covariates between the groups. ResultsThe study population consisted of 482 patients (521 lesions), 184 patients (189 lesions) in Magmaris group and 298 patients (332 lesions) in Orsiro group. The mean age was 65.5 ± 10.8 and 62.7 ± 10.4 years in Magmaris and Orsiro groups, respectively (p = 0.005). Magmaris and Orsiro unadjusted TLF rates were 6.0 and 6.4% with no significant difference between the groups (p = 0.869). In the multivariate analysis, there were no meaningful differences between Magmaris and Orsiro groups. Finally, none of the groups presented device thrombosis cases at 12 months. ConclusionAt 12 months there were no significant differences between Magmaris and Orsiro groups neither in the unadjusted assessment nor in the multivariate analysis for target lesion failure. These results should be taken as hypothesis generating and may warrant a head to head comparison on a randomized fashion.

Long-term efficacy of a second generation biodegradable polymer sirolimus-eluting stent (EXCEL2) in treating patients with de novo coronary artery diseases

Objective: To evaluate the long-term efficacy of a second generation biodegradable polymer sirolimus-eluting stent (EXCEL2) in treating patients with de novo coronary artery diseases. Methods: CREDIT Ⅱ trial was a prospective, multicenter, randomized, controlled study, conducted at 15 Chinese cardiac centres from November 2013 to December 2014. In this analysis, eligible patients for coronary stenting (n=419) were randomized to receive either the EXCEL2 stent (n=208) or the EXCEL stent (n=211). The primary endpoint was target lesion failure (TLF) at 3 years after PCI defined as a composite endpoints of cardiac death, target vessel myocardial infarction (TVMI), or clinically indicated target lesion revascularization (CI-TLR). Secondary endpoints included patient-oriented composite endpoint (PoCE) including all-cause death, all MI, or any revascularization at 3 years and independent components, and stent thrombosis according to Academic Research Consortium's (ARC) definition. Results: Among 419 enrolled patients, 413 (98.6%) patients completed 3-year clinical follow-up. Compared with the EXCEL group, 3-year TLF (5.4%(11/204) vs. 11.5% (24/209), P=0.025) and PoCE (9.8% (20/204) vs. 20.1% (42/209), P=0.003) were significantly lower in the EXCEL2 group. The cumulative event rate of CI-TLR (2.0% (4/204) vs. 5.7% (12/209), P=0.042) and any revascularization (4.9% (10/204) vs. 14.4% (30/209), P=0.001) were statistically lower in the EXCEL2 group than in the EXCEL group. There were no significant difference between two groups in terms of all-cause death and all MI. Rates of stent thrombosis were low without significant difference between the two groups (EXCEL2 vs. EXCEL, 1.0% (2/204) vs. 2.9% (6/209), P=0.285). Conclusion: 3-year clinical follow-up results demonstrate that EXCEL2 stents are effective and safe in treating CAD patients with de novo coronary lesions.

P1968Five-year outcomes in patients with diabetes mellitus treated with biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents

Abstract Background Patients with diabetes mellitus (DM) remain at higher risk for adverse events after percutaneous coronary intervention (PCI) compared with non-diabetic individuals. Among available drug-eluting stents (DES), thin-strut durable polymer everolimus-eluting stents (DP-EES) were shown to provide the best safety and efficacy profile in diabetics. Whether biodegradable polymer DES provide additional long-term clinical benefit compared with DP-EES among diabetic patients remains uncertain. Purpose To compare the long-term performance of ultrathin-strut biodegradable polymer sirolimus-eluting stents (BP-SES) versus DP-EES for PCI in patients with insulin-requiring and non-insulin-requiring DM. Methods We performed a prespecified subgroup analysis of the randomized, multicenter, non-inferiority BIOSCIENCE trial (NCT01443104). Patients with stable coronary artery disease or acute coronary syndrome were randomly assigned to treatment with ultrathin-strut BP-SES or thin-strut DP-EES. Patients were further divided according to diabetic status. The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target-vessel myocardial infarction (MI) and clinically-indicated target lesion revascularization (TLR), within 12 months. Results Among 2'119 patients enrolled between March 2012 and May 2013, 486 (22.9%) presented with DM (insulin-requiring, 33.1%). Compared with non-diabetics, patients with DM were older and had a greater baseline cardiac risk profile, including higher prevalence of hypertension, hypercholesterolaemia, peripheral artery disease, chronic renal failure and prior PCI, coronary artery bypass graft surgery, or stroke. At 5 years, TLF occurred similarly in 74 patients (cumulative incidence, 31.0%) treated with BP-SES and 57 patients (25.8%) treated with DP-EES (RR 1.23; 95% CI 0.87–1.73; p=0.24) in diabetics, and in 124 patients (16.8%) treated with BP-SES and 132 patients (16.8%) treated with DP-EES (RR 0.98; 95% CI 0.77–1.26; p=0.90) in non-diabetics (p for interaction=0.31). Cumulative incidences of cardiac death (14.9% vs. 9.5%; p=0.10), target-vessel MI (11.4% vs. 11.0%; p=0.81), clinically-indicated TLR (16.9% vs. 15.8%; p=0.68), and definite thrombosis (3.0% vs. 2.5%; p=0.63) at 5 years were similar among diabetic patients treated with ultrathin-strut BP-SES or thin-strut DP-EES. Overall, there was no interaction between diabetic status and treatment effect of BP-SES versus DP-EES. Conclusion In a prespecified subgroup analysis of the BIOSCIENCE trial, we found no difference in clinical outcomes throughout five years between diabetic patients treated with ultrathin-strut BP-SES or thin-strut DP-EES. Acknowledgement/Funding BIOSCIENCE was an investigator-initiated trial supported by a dedicated research grant from Biotronik, Bülach, Switzerland

P3385Difference of vascular healing after percutaneous coronary intervention between 4 kinds of new generation drug-eluting stents: an optical coherence tomography analysis

Abstract Background New generation drug eluting stents (DES) have improved target vessel failure as compared with early generation DES and bare metal stent. Contemporary several new generation DES are different each other regarding strut thickness and drug and polymer type. A little is known about which stent induces a more favorable vascular healing at follow up. Purpose In this study, we compared the vascular healing at 8-month follow up by optical coherence tomography (OCT) between 4 different kinds of new generation DES. Methods We enrolled 112 consecutive patients (121 lesions) who underwent PCI using 4 kinds of new generation DES including biodegradable-polymer everolimus-eluting stents (BP-EES), biodegradable-polymer sirolimus-eluting stents (BP-SES), durable-polymer everolimus-eluting stents (DP-EES) and durable-polymer zotarolimus-eluting stents (DP-ZES) and who underwent 8-month follow up angiogram and OCT between July 2016 and April 2018. We compared the OCT parameters including percentage of covered struts, uncovered struts, well-apposed and uncovered struts, malapposed strut and mean neointimal hyperplasia (NIH) thickness between them. Results BP-EES consisted of 29 lesions, BP-SES consisted of 25 lesions, DP-EES consisted of 38 lesions and DP-ZES consisted of 29 lesions. A total of 734 frames with 5163 struts in BP-EES, 481 frames with 4214 struts in BP-SES, 783 frames with 6119 struts in DP-EES and 583 frames with 4708 struts in DP-ZES were analyzed. As shown in a table, mean NIH thickness was significantly higher in BP-EES and BP-SES. Thus, we compared the OCT parameters between durable-polymer (DP) group including DP-ZES and DP-EES and biodegradable-polymer (BP) group including BP-EES and BP-SES. The percentage of uncovered struts was significantly lower and mean NIH thickness was significantly higher in BP group than DP group. Results of OCT parameters BP-EES (n=29) BP-SES (n=25) DP-EES (n=38) DP-ZES (n=29) P value BP group (n=54) DP group (n=67) P value Covered struts (%) 89.5±13.6 92.4±8.6 85.5±17.5 85.0±17.7 0.29 90.9±11.6 85.3±17.4 0.08 Uncovered struts (%) 8.8±10.8 7.1±8.7 14.5±17.5 15.0±17.7 0.14 8.0±9.9 14.7±17.4 0.03 Well-apposed and uncovered struts (%) 7.9±9.9 5.9±7.7 11.7±13.1 12.3±14.0 0.15 7.0±8.9 11.9±13.4 0.04 Malapposed struts (%) 0.8±1.6 1.3±2.2 2.7±5.8 2.7±4.7 0.33 1.0±1.9 2.7±5.3 0.07 Mean NIH thickness (μm) 102±57 121±48 78±28 88±33 &lt;0.01 111±53 82±31 &lt;0.01 Conclusion The present OCT study demonstrated that delayed neointimal healing characterized by the presence of uncovered struts and lower mean NIH thickness was less common in BP group than DP gruop. Biodegradable-polymer may be more favorable than durable-polymer from the point of view of vascular healing.

P2800Impact of plaque vulnerability on vascular response after implantation of two types of biodegradable-polymer drug-eluting stent: coronary angioscopic study

Abstract Background Vascular response after drug-eluting stent (DES) implantation depends not only on stent design but also on vulnerability of target coronary lesions. In this study, non-obstructive coronary angioscopy (CAS) revealed vascular response after two types of biodegradable polymer (BP) DES implantation into patients with acute coronary syndrome (ACS) or stable angina pectoris (SAP). Methods Eighteen Nobori BP biolimus-eluting stents (BP-BES) were successfully implanted into 15 patients (9 ACS and 9 SAP lesions). Twenty-three Ultimaster BP sirolimus-eluting stents (BP-SES) were implanted into 16 patients (6 ACS and 17 SAP lesions). At one year after stenting, CAS semi-quantified degree of neointimal stent coverage (NSC) into 4 grades (0, no coverage; 1, thin coverage; 2, thick coverage; 3, embedded in thick neointima and invisible). When NSC through a stent was composed of plural grades, CAS determined dominant, maximum and minimum NSC grades. Heterogeneity index was defined as subtraction of minimum from maximum grade. CAS also semi-quantified degree of yellow plaques (YP) into 3 grades (0, light; 1, dense; 2, glittering yellow). CAS detected presence of in-stent mural thrombi (ISMT). Results At one year after BP-BES implantation: 1) There was no significant difference with regards to dominant NSC between ACS and SAP lesions (1.00±0.50 vs. 0.89±0.60); 2) Heterogeneity index was greater in ACS than in SAP (1.22±0.44 vs. 0.67±0.50, P=0.02); 3) YP grade was greater in ACS than in SAP (1.89±0.33 vs. 1.00±1.00, P=0.02); and 4) We found one ISMT in ACS lesions and two ISMT in SAP lesions. At one year after BP-SES implantation: 1) There was neither significant difference between ACS and SAP lesions with regards to dominant NSC (1.67±1.21 vs. 1.53±1.01), with regards to heterogeneity index (0.50±0.55 vs. 0.35±0.49), nor with regards to YP grade (1.33±1.51 vs. 0.88±0.99); and 2) We found ISMT neither in ACS nor in SAP lesions. Conclusions For BP-SES implantation, vascular response at ACS lesions was similar to SAP lesions. Even one year after BP-BES implantation, however, plaque vulnerability appeared to remain in ACS lesions.

P5624Late acquired tissue protrusion after drug-eluting stent implantation: a serial follow-up of 1-month optical coherence tomography imaging

Abstract Background Tissue protrusion (TP) between the stent struts after stent implantation has been implicated as a potential factor in the subsequent development of stent thrombosis. However, the incidence, natural history, and predictive factor of TP after stent implantation remains unclear. Purpose To elucidate the fate of TP, we undertook the study assessing TP using short term serial optical coherence tomography (OCT), immediately after deployment of stents and at 1-month follow-up. Methods This was a prospective, single-center study evaluating vascular healing responses with OCT both immediately after and at 1-month after biodegradable-polymer sirolimus-eluting stent (SES) implantation. A total of 18 stable angina patients having OCT-guided PCI with SESs underwent assessment of TP with OCT pre-procedure, post-procedure, and at 1-month follow-up. TP was defined as a tissue prolapse for more than 200 μm between stent struts that directly correlates with the underlying plaque, without abrupt transition and different optical properties. TP was classified into the following 3 groups on the basis of serial assessment: (1) healed, TP present after the procedure but covered by tissue with smooth surface at 1-month follow-up; (2) persistent, TP present both after the procedure and 1-month follow-up; and (3) late-acquired, TP not present at baseline but present at 1-month follow-up. Results Immediately after the procedure, 29 TPs in 13 patients (72%) were identified. Of those, 16 (55%) were healed and 13 (45%) were persistent at 1-month follow-up. Although the size of TP on post-procedural OCT was similar, neointimal area in lesions with healed TP was significantly larger than in lesions with persistent TP due to neointimal proliferation at 1-month follow-up. A synchronous comparison between the post-procedural OCT and the follow-up OCT image showed that 5 TPs were observed only at 1-month follow-up (late-acquired). In lesions with late-acquired TP, calcified nodule or thin-cap fibroatheroma was identified as an underlying plaque morphology on pre-procedural OCT. A representative example is presented in Figure. Incidence of TP and representative case Conclusion Short term serial OCT analysis found that TP can occur not only immediately after SES implantation, but also 1 month after SES implantation. This new concept may provide a new insight into the mechanism of in-stent restenosis and stent thrombosis development after stent implantation. Acknowledgement/Funding None

P3393Comparison of intermediate-term vascular response to new-generation biodegradable polymer and durable polymer-based drug-eluting stents: optical coherence tomographic study

Abstract Background Over the last decade, drug-eluting stents (DES) have undergone substantial modifications with thinner struts and more biocompatible durable polymer (DP) or biodegradable polymer (BP). In DP-based DES, after drug elusion has been completed, DP remnants may trigger of local inflammatory vascular reactions and promote delayed healing, leading to accelerated neoatherosclerosis (NA). Thus, BPs have been developed to reduce the above-mentioned risks. Recently, poor strut coverage and in-stent NA are increasingly recognized the cause of late stent failure, but it is unclear whether BPs can reduce the incidence of NA and the poor stent coverage as compared to DPs. Objectives The purpose of this study was to compare the incidence of NA and the stent coverage using optical coherence tomography (OCT) between the DPs and the BPs. Methods Between July 2016 and April 2018, 127 consecutive patients with new-generation DES who underwent 8-month follow up OCT imaging were enrolled. Patients were divided into the two groups: DP group who had the new-generation durable polymer everolimus-eluting and zotarolimus-eluting stents and BP group who had the new-generation biodegradable polymer sirolimus-eluting and everolimus-eluting stents. We compared patient characteristics including hypertension, dyslipidemia and diabetes mellitus and 8-month follow up OCT findings including NA, uncovered struts and malapposed struts between the two groups. Results The DP group comprised 64 patients (50.4%. The incidence of NA, uncovered struts and malapposed struts were similar between the two groups (DPs vs BPs, 1.56% vs 7.94%, P=0.11; 7.80% vs 5.88%, P=0.16 and 2.76% vs 2.01%, P=0.43, respectively) (table). The other parameters were also similar between the two groups. Table 1 DP group (n=64) BP group (n=63) P value Hypertension 44 (68.8%) 50 (79.4%) 0.2251 Dyslipidemia 39 (60.9%) 37 (58.7%) 0.8573 Diabetes mellitus 25 (39.1%) 30 (47.6%) 0.3731 8 month OCT follow up findings Neoatherosclerosis 1 (1.6%) 5 (7.9%) 0.1147 Uncovered struts 7.8% (2.8–20.4) 5.9% (0.7–16.7) 0.1616 Malapposed struts 0.2% (0–2.8) 0% (0–2.8) 0.4392 Conclusions The new-generation DP based-DES may have similar effects on vascular response compared to the new-generation BP-based DES during 8-month follow-up period.

3334Updated meta-analysis of biodegradable polymer drug-eluting stent versus second-generation durable polymer drug-eluting stent implantations

Abstract Background Data regarding clinical outcomes of biodegradable polymer drug-eluting stent (BP-DES) versus second-generation durable polymer drug-eluting stent (DP-DES) in patients undergoing percutaneous coronary intervention (PCI) are inconclusive. Purpose We aimed to perform a meta-analysis to investigate the clinical outcomes of BP-DES compared with second-generation DP-DES in patients who have undergone PCI. Methods We searched PubMed, MEDLINE, EMBASE, and Cochrane databases through January 2019 for randomized controlled trials comparing BP-DES with second-generation DP-DES in patients treated with PCI. All-cause death, cardiac death, myocardial infarction (MI), target vessel revascularization (TVR), target lesion revascularization (TLR), definite/probable stent thrombosis (ST) were compared between the groups. Additionally, a landmark analysis with the landmark set at 1 year and a subgroup analysis according to stent characteristics were performed. Results Data from 23 trials including 28802 randomized patients were analyzed. At a median follow up of 3.1 years, no significant differences were found in terms of all-cause death (odds ratio [OR] 1.05, 95% confidence interval [CI] 0.95–1.16), cardiac death (OR 1.01, 95% CI 0.87–1.17), MI (OR 0.92, 95% CI 0.82–1.03), TVR (OR 0.97, 95% CI 0.86–1.11), TLR (OR 0.97, 95% CI 0.85–1.11), and definite/probable ST (OR 0.86, 95% CI 0.70–1.07) between the groups. Landmark analysis showed that there were similar risks in all-cause death (OR 1.04, 95% CI 0.93–1.17), cardiac death (OR 1.11, 95% CI 0.92–1.36), MI (OR 0.94, 95% CI 0.79–1.13), TVR (OR 0.95, 95% CI 0.73–1.23), TLR (OR 1.00, 95% CI 0.80–1.24), and definite/probable ST (OR 0.92, 95% CI 0.67–1.28) between the groups. The similar tendency of any study endpoints between the groups was consistent in the subgroup, including stent platform (stainless steel vs. alloy), the drug coating distribution (abluminal vs. circumferential), the polymer degradation period (&lt;6 months vs. &gt;6 months), or the drug release duration (&lt;6 months vs. &gt;6 months) of BP-DES, or the DAPT duration (≥6 months vs. ≥12 months). However, the uses of BP-DES with sirolimus-eluting (OR 0.84, 95% CI 0.72–0.98) or ultrathin strut (defined as &lt;70μm; OR 0.81, 95% CI 0.68–0.97) were predictive for lower risk of MI. Clinical outcomes Conclusions In our updated meta-analysis, BP-DES implantation was associated with comparable clinical outcomes compared with second-generation DP-DES implantation. However, PCI with ultrathin biodegradable polymer sirolimus-eluting stent could reduce the risk of MI.

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

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

TCT-303 Efficacy and Safety of the Biodegradable Polymer Sirolimus-Eluting Stents in Routine Clinical Practice: Data From the IRIS-DES Registry

TCT-303 Efficacy and Safety of the Biodegradable Polymer Sirolimus-Eluting Stents in Routine Clinical Practice: Data From the IRIS-DES Registry

Biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with ST-segment elevation myocardial infarction (BIOSTEMI): a single-blind, prospective, randomised superiority trial

Newer-generation drug-eluting stents that combine ultrathin strut metallic platforms with biodegradable polymers might facilitate vascular healing and improve clinical outcomes in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention (PCI) compared with contemporary thin strut second-generation drug-eluting stents. We did a randomised clinical trial to investigate the safety and efficacy of ultrathin strut biodegradable polymer sirolimus-eluting stents versus thin strut durable polymer everolimus-eluting stents in patients with acute ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI. The BIOSTEMI trial was an investigator-initiated, multicentre, prospective, single-blind, randomised superiority trial at ten hospitals in Switzerland. Patients aged 18 years or older with acute STEMI who were referred for primary PCI were eligible to participate. Patients were randomly allocated (1:1) to either biodegradable polymer sirolimus-eluting stents or durable polymer everolimus-eluting stents. Central randomisation was done based on a computer-generated allocation sequence with variable block sizes of 2, 4, and 6, which was stratified by centre, diabetes status, and presence or absence of multivessel coronary artery disease, and concealed using a secure web-based system. Patients and treating physicians were aware of group allocations, whereas outcome assessors were masked to the allocated stent. The experimental stent (Orsiro; Biotronik; Bülach, Switzerland) consisted of an ultrathin strut cobalt-chromium metallic stent platform releasing sirolimus from a biodegradable polymer. The control stent (Xience Xpedition/Alpine; Abbott Vascular, Abbott Park, IL, USA) consisted of a thin strut cobalt-chromium stent platform that releases everolimus from a durable polymer. The primary endpoint was target lesion failure, a composite of cardiac death, target vessel myocardial reinfarction (Q-wave and non-Q-wave), and clinically-indicated target lesion revascularisation, within 12 months of the index procedure. All analyses were done with the individual participant as the unit of analysis and according to the intention-to-treat principle. The trial was registered with ClinicalTrials.gov, number NCT02579031. Between April 26, 2016, and March 9, 2018, we randomly assigned 1300 patients (1623 lesions) with acute myocardial infarction to treatment with biodegradable polymer sirolimus-eluting stents (649 patients and 816 lesions) or durable polymer everolimus-eluting stents (651 patients and 806 lesions). At 12 months, follow-up data were available for 614 (95%) patients treated with biodegradable polymer sirolimus-eluting stents and 626 (96%) patients treated with durable polymer everolimus-eluting stents. The primary composite endpoint of target lesion failure occurred in 25 (4%) of 649 patients treated with biodegradable polymer sirolimus-eluting stents and 36 (6%) of 651 patients treated with durable polymer everolimus-eluting stents (difference -1·6 percentage points; rate ratio 0·59, 95% Bayesian credibility interval 0·37-0·94; posterior probability of superiority 0·986). Cardiac death, target vessel myocardial reinfarction, clinically-indicated target lesion revascularisation, and definite stent thrombosis were similar between the two treatment groups in the 12 months of follow-up. In patients with acute STEMI undergoing primary PCI, biodegradable polymer sirolimus-eluting stents were superior to durable polymer everolimus-eluting stents with respect to target lesion failure at 1 year. This difference was driven by reduced ischaemia-driven target lesion revascularisation in patients treated with biodegradable polymer sirolimus-eluting stents compared with durable polymer everolimus-eluting stents. Biotronik.

One‐year clinical outcome of biodegradable polymer sirolimus‐eluting stent in patients presenting with acute myocardial infarction: Insight from the ULISSE registry

The ULISSE registry has demonstrated the real-world performance of the Ultimaster biodegradable polymer sirolimus-eluting stent (BP-SES) in a large cohort of patients undergoing percutaneous coronary intervention, including a large proportion of patients presenting with acute myocardial infarction (AMI). We performed a subgroup analysis of the ULISSE registry in AMI patients and compared the outcomes of this vulnerable cohort with that of patients presenting without AMI (non-AMI). The primary end point was the incidence of 1-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI), and clinically indicated target lesion revascularization (TLR). Of 1,660 patients included in the ULISSE registry, 381(23%) presented with AMI, 207(54.3%) non-ST elevation myocardial infarction, and 174(45.7%) ST-elevation myocardial infarction. Compared with non-AMI patients, those with AMI were more frequently female and smokers, with lower left ventricular ejection fraction (LVEF) and chronic kidney disease requiring dialysis. At 1 year, TLF rate was significantly higher in AMI than non-AMI patients (7.9 vs. 4.1%; HR 1.98, CI 95% 1.22-3.23; p = .005) driven by higher rate of cardiac death (4.0 vs. 1.1%; HR 3.59, CI 95% 1.64-7.88; p = .01) and TV-MI (2.8 vs 0.9%; HR 2.99,CI 95% 1.22-7.37; p = .01), without differences in TLR rate (4.3 vs. 2.9%,HR 0.66, CI95% 0.35-1.25; p = .2). At multivariate Cox regression analysis, eGFR <40 mL/min (HR: 2.868) and LVEF <40% (HR: 2.394) were the only independent predictors of TLF. In AMI patients, Ultimaster BP-SES implantation was associated with higher rate of TLF and definite stent thrombosis compared with non-AMI patients. The high incidence of adverse events was mainly driven by the unfavorable baseline risk profile.

Two‐year safety evaluation of a biodegradable polymer sirolimus‐eluting stent with increased drug elution and polymer absorption kinetics in complex patient and lesion cohort

The aim of the present report was to compare 2-year safety outcomes of two biodegradable polymer (BP) sirolimus-eluting stents (SESs) with different drug eluting and polymer absorption kinetics in a subgroup of complex patients and lesions. The previously published PANDA III study showed the BuMA BP SES, with faster drug elution and polymer absorption, was non-inferior to the Excel SES in target lesion failure (TLF). In PANDA III trial, patients who fulfilled one or more of the following criteria were included: Small vessel disease (reference vessel diameter ≤ 2.5 mm); long lesion (lesion length ≥ 20 mm); chronic total occlusion lesion; and diabetic patients. Among 2,348 patients randomly assigned to treatment with BuMA (n = 1,174) or Excel SES (n = 1,174) in the PANDA III study, 858 in the BuMA group and 855 in the Excel group satisfied the inclusion criteria. At 2-year follow-up, the incidence of definite/probable stent thrombosis (ST) was significantly lower with BuMA SES as compared with Excel SES (0.7% vs. 1.9%, p = 0.03). This difference was mainly caused by decreased subacute stent thrombosis rate (0% vs. 0.6%, p = 0.03). In patients who did not fulfill the complex patient and lesion criteria, there were no between-group difference in ST (0.7% vs. 0%, p = 0.50). Myocardial infarction and TLF rates were similar (5.7% vs. 6.0%, p = 0.79 and 8.8% vs. 7.5%, p = 0.34, respectively), whereas patient-oriented composite endpoint was higher with BuMA SES mainly due to high risk of revascularization (15.6% vs. 11.4%, p = 0.01; 8.4% vs. 4.6%, p < 0.01). Two-year subgroup analysis of the all-comer PANDA III trial revealed the increased safety benefit of the BuMA SES is more prominently seen in complex patient and lesion population. ClinicalTrial.gov, Identifier-NCT02017275.

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).

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.

Randomised evaluation of a novel biodegradable polymer-based sirolimus-eluting stent in ST-segment elevation myocardial infarction: the MASTER study.

The MASTER study was designed to compare the performance of a new biodegradable polymer sirolimus-eluting stent (BP-SES) with a bare metal stent (BMS) in patients with ST-segment elevation myocardial infarction (STEMI). The study was a prospective, randomised (3:1), controlled, single-blind multicentre trial that enrolled 500 STEMI patients within 24 hours of symptom onset during 2013-2015. Three hundred and seventy-five patients were treated with BP-SES and 125 with BMS. One hundred and four (104) randomised patients underwent angiographic follow-up at six months. The primary clinical endpoint was target vessel failure (TVF), defined as cardiac death, MI not clearly attributable to a non-target vessel, or clinically driven target vessel revascularisation (TVR) at 12 months. The primary angiographic endpoint was in-stent late lumen loss (LLL) at six months in the angiographic cohort. The major secondary endpoint for safety was a composite of all-cause death, recurrent MI, unplanned infarct-related artery revascularisation, stroke, definite stent thrombosis (ST) or major bleeding at one month. At 12 months, TVF had occurred in 6.1% of BP-SES and 14.4% of BMS patients (pnon-inferiority=0.0004), mainly driven by a higher rate of repeat revascularisation in BMS patients. The safety endpoint occurred in 3.5% of BP-SES and 7.2% of BMS patients (p=0.127). In-stent LLL demonstrated the superiority (p=0.0125) of BP-SES (0.09±0.43 mm) over BMS (0.79±0.67 mm). The study showed clinical non-inferiority and angiographic superiority of BP-SES versus a comparator BMS, suggesting that this novel DES may be a potential treatment option in STEMI.