Polymer-free Sirolimus-eluting Stent Research Articles

Biodegradable Polymer Versus Polymer-Free Ultrathin Sirolimus-Eluting Stents: Analysis of the Stent Arm Registry From the HOST-IDEA Randomized Trial.

The efficacy and safety of each third-generation drug-eluting stent with ultrathin struts and advanced polymer technology remain unclear. We investigated the clinical outcomes of percutaneous coronary intervention using the Coroflex ISAR polymer-free sirolimus-eluting stent (SES) or Orsiro biodegradable polymer SES. The HOST-IDEA trial (Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis-Coronary Intervention With Next-Generation Drug-Eluting Stent Platforms and Abbreviated Dual Antiplatelet Therapy), initially designed with a 2×2 factorial approach, sought to randomize patients undergoing percutaneous coronary intervention based on dual antiplatelet therapy duration (3 versus 12 months) and stent type (Coroflex ISAR versus Orsiro). Despite randomizing 2013 patients for dual antiplatelet therapy duration, the stent arm transitioned to a registry format during the trial. Among these, 328 individuals (16.3%) were randomized for Coroflex ISAR or Orsiro SES, while 1685 (83.7%) underwent percutaneous coronary intervention without stent-type randomization. In this study, the Coroflex ISAR (n=559) and Orsiro groups (n=1449) were matched using a propensity score. The prespecified primary end point was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization at 12 months. The baseline patient and procedural characteristics were well balanced between the Coroflex ISAR and Orsiro groups after propensity score matching (n=559, each group). The Coroflex ISAR group was significantly associated with a higher rate of target lesion failure, mainly driven by clinically driven target lesion revascularization, compared with the Orsiro group (3.4% versus 1.1%; hazard ratio, 3.21 [95% CI, 1.28-8.05]; P=0.01). A higher risk of target lesion failure in the Coroflex ISAR group was consistently observed across various subgroups. The rates of any bleeding (hazard ratio, 0.85 [95% CI, 0.51-1.40]; P=0.52) and major bleeding (hazard ratio, 1.58 [95% CI, 0.61-4.08]; P=0.34) were comparable between the 2 groups. In this propensity score-matched analysis of the stent arm registry from the HOST-IDEA trial, the Orsiro SES was associated with significantly better outcomes in terms of 1-year target lesion failure, mainly driven by clinically driven target lesion revascularization, than the Coroflex ISAR SES. URL: https://www.clinicaltrials.gov; Unique identifier: NCT02601157.

1-year clinical outcomes using Polymer-Free Sirolimus-Eluting Stents: Insights from a French registry

1-year clinical outcomes using Polymer-Free Sirolimus-Eluting Stents: Insights from a French registry

The effect of gender on clinical outcomes following routine revascularizations with polymer-free sirolimus-eluting stents.

Gender-specific outcomes after percutaneous coronary interventions were studied by a number of research groups with different endpoints and cohorts of different ethnic extractions. The purpose of this report is to use propensity score matching to determine gender-specific differences in clinical outcomes after percutaneous coronary interventions with polymer-free sirolimus-coated stents. The basis for this post hoc analysis was two large all-comers studies with prospectively enrolled patients from Europe and Asia. Data were pooled and analyzed in terms of clinical outcomes to assess the impact of gender in patients with stable coronary artery disease and acute coronary syndrome. The primary endpoint was the accumulated target-lesion revascularization rate whereas secondary endpoints consisted of the event rates for major adverse cardiac events (MACE), myocardial infarction, bleeding events and death from all causes. The purpose of these post hoc analyses was to detect potential differences in clinical outcomes between females and males in unselected and propensity-score-matched cohorts. Overall, in the unmatched cohorts, accumulated target-lesion revascularization rates did not differ between both genders (2.7% vs. 2.0%; P = 0.101), however, accumulated MACE rates were higher in females than in males (5.2% vs. 3.9%; P = 0.020). After propensity-score-matching, primarily adjusting for age, hypertension and diabetes, our data revealed similar accumulated MACE in women and men (5.5% vs. 5.2%; P = 0.749). In the unmatched STEMI subgroup, all-cause mortality was significantly higher in females driven by older age (P < 0.001). In the propensity-score-matched real-world cohorts, female gender was not a predictor for increased rates of accumulated MACE. In the unmatched STEMI subgroup, all-cause mortality was significantly higher in females due to older age. Age seems to be the determining factor for increased clinical event rates and not gender.

Abstract 15324: Biodegradable Polymer Ultrathin Sirolimus-Eluting Stent is Associated With Better Outcomes Compared With Polymer-Free Ultrathin Sirulimus-Eluting Stent in Complex Percutaneous Coronary Intervention: A Post Hoc Analysis of the HOST-IDEA Randomized Clinical Trial

Introduction: Third generation drug-eluting stents with ultrathin struts and advanced polymer technology have been introduced. However, their safety and efficacy have not been fully elucidated, particularly in complex percutaneous intervention (PCI). Aim To investigate the clinical outcomes of complex PCI using the Coroflex ISAR polymer-free sirolimus-eluting stent (SES) or Orsiro biodegradable polymer SES. Methods: This study was a post-hoc analysis of the HOST-IDEA trial that randomly assigned 2,013 patients undergoing PCI with Orsiro or Coroflex ISAR into either 3-month dual antiplatelet therapy (DAPT) or 12-month DAPT arms from January 2016 to May 2021 at 37 centers in South Korea. We compared a 1:1 propensity score (PS)–matched cohort balanced by patient and procedural characteristics. The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, and clinically-driven target lesion revascularization at 1 year. Complex PCI was defined as any of the following features: ≥3 stents implanted, ≥3 lesions treated, bifurcation PCI, total stent length ≥ 60 mm, left main PCI, or heavy calcification. Results: After PS matching, baseline patient and procedural characteristics were balanced between Coroflex ISAR and Orsiro groups (n=542 in each). Complex PCI was significantly associated with a higher rate of TLF compared with non-complex PCI (5.3% vs. 1.1%, hazard ratio (HR) 5.12 [95% confidence interval (CI) 2.21-11.86], P&lt;0.001). Compared with the Coroflex ISAR SES, the better outcomes of TLF associated with the Orsiro SES was more pronounced in the complex PCI group (HR 0.14 [95% CI 0.03-0.60], P =0.008 in complex PCI; HR 0.99 [95% CI 0.25-3.98], P =0.993 in non-complex PCI; P for interaction 0.054). Conclusion In patients undergoing complex PCI with third-generation DES, the Orsiro SES was associated with significantly better outcomes in terms of TLF than the Coroflex ISAR SES.

Comparison Of 3-6 Month Versus 12 Month Dual Antiplatelet Therapy After Coronary Intervention Using the Contemporary Drug-eluting Stents With Ultrathin Struts: The HOST-IDEA Randomized Clinical Trial.

Background: Limited data are available on short-term dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) using third-generation drug-eluting stents (DES) with ultrathin struts and advanced polymer technology. We investigated whether 3-6 month DAPT was non-inferior to 12 month one after implantation of DES with ultrathin struts and advanced polymer technology. Methods: We performed an open-label, randomized trial at 37 centers in South Korea. We enrolled patients undergoing PCI using the Orsiro biodegradable-polymer sirolimus-eluting stents (SES) or the Coroflex ISAR polymer-free SES. Patients with ST-segment elevation myocardial infarction were excluded. Patients were randomized to receive either 3-6 month or 12 month DAPT after PCI. The choice of antiplatelet medications was at the physician's discretion. The primary outcome was a net adverse clinical event (NACE), a composite of cardiac death, target vessel myocardial infarction (TVMI), clinically driven target lesion revascularization (CD-TLR), stent thrombosis, or major bleeding, defined as Bleeding Academic Research Consortium type 3 or 5 at 12 months. The major secondary outcomes were target lesion failure (TLF), a composite of cardiac death, TVMI, CD-TLR, and major bleeding. Results: A total of 2,013 patients (mean age 65.7±10.5, 1,487 male [73.9%], 1,110 [55.1%] presented with acute coronary syndrome) were randomized to 3-6 month DAPT (n=1,002) or 12 month DAPT (n=1,011). The primary outcome occurred in 37 (3.7%) patients in the 3-6 month DAPT group and 41 (4.1%) in the 12 month DAPT group. The non-inferiority of the 3-6 month DAPT group to the 12 month DAPT group was met (absolute risk difference, -0.4% [1-sided 95% confidence interval (CI), -∞% to 1.1%; P<0.001 for non-inferiority]). There were no significant differences in TLF (hazard ratio [HR] 0.98, 95% CI 0.56-1.71, P=0.94) or major bleeding (HR 0.82, 95% CI 0.41-1.61, P=0.56) between the two groups. Across various subgroups, the treatment effect of 3-6 month DAPT was consistent for NACE. Conclusions: Among patients undergoing PCI using third-generation DES, 3-6 month DAPT was non-inferior to 12 month DAPT for NACE. Further research is needed to generalize this finding to other populations and to determine the ideal regimen for 3-6 month DAPT.

A novel polymer-free everolimus-eluting stent with a nitrogen-doped titanium dioxide film inhibits restenosis and thrombosis in a swine coronary model.

Short-term outcomes regarding the safety and efficacy of a polymer-free everolimus-eluting stent (EES) with a nitrogen-doped titanium dioxide (N-TiO₂) film in a swine coronary model have been reported. However, the long-term results of the use of this type of stent have not yet been evaluated or compared to those of other polymer-free coronary stents. Therefore, this study aimed to determine the mid- to long-term safety and efficacy of a polymer-free EES with an N-TiO₂ film in a swine coronary model. Polymer-free EES with N-TiO₂ films (n = 30) and polymer-free sirolimus-eluting stents (SES; n = 30) were implanted in 30 pigs. Quantitative coronary analysis and optical coherence tomography were conducted immediately and at 1 (quantitative coronary analysis only), 3, and 6 months after stenting. Histopathologic examinations were performed at 1, 3, and 6 months after stenting. The polymer-free EES group had a lower percentage of neointimal growth than the polymer-free SES group at 3 months (22.5% ± 11.4% vs. 32.1% ± 12.3%; p < 0.001). The polymer-free EES group had a lower fibrin score than the polymer-free SES group at 1 month (1.9 ± 0.45 vs. 2.5 ± 0.54; p = 0.001). The re-endothelialization rates were similar between groups. The polymer-free EES group had a lower percentage of the area of stenosis than the polymer-free SES group throughout the follow-up period. The novel polymer-free EES with an N-TiO₂ film has superior safety and efficacy than the polymer-free SES at the 6-month follow-up in a swine model.

Early vascular healing of ultra-thin strut polymer-free sirolimus-eluting stents in acute coronary syndrome: USUI-ACS study.

Ultra-thin strut polymer-free sirolimus-eluting stent (UPF-SES) have two novel characteristics, ultra-thin strut and polymer-free coating, which have the potential to achieve early re-endotherialization. However, a little is known whether early vascular healing of UPF-SES can be achieved in patients with acute coronary syndrome (ACS). The aim of this study was to evaluate the vascular healing after an implantation of UPF-SES in patients with ACS using optical coherence tomography (OCT) at 3 months after the stent implantation. From September 2020 and January 2021, a total of 31 consecutive patients presenting with ACS who underwent OCT-guided percutaneous coronary intervention (PCI) and 3 month follow-up OCT examination were enrolled in the USUI-ACS study. The endpoints of this study were neointimal strut coverage, malapposition, and mean neointimal hyperplasia (NIH) thickness at 3 month follow-up. Over a mean follow-up of 91 days after the initial PCI, the follow-up OCT was examined. The median percentage of covered struts was 98.4% and malapposed struts 0%, and the mean NIH thickness was 80 μm. UPF-SES exhibited an excellent early vascular healing at 3 months in patients with ACS.Supplementary InformationThe online version contains supplementary material available at 10.1007/s12928-022-00862-2.

Clinical outcomes in 2481 unselected real-world patients treated with a polymer-free sirolimus-eluting stent: 3\xa0years results from the NANO multicenter Registry

ObjectivesTo evaluate the 3-year clinical outcomes of a polymer-free sirolimus-eluting, Nano plus stent for the treatment of coronary artery disease in the NANO multicenter Registry.BackgroundThe long-term clinical data evaluating the safety and efficacy of the novel polymer-free sirolimus-eluting Nano plus stent (Lepu Medical, Beijing, China) is limited.MethodsThe NANO all-comers Registry trial was a prospective, multicenter clinical registry conducted in 26 centers in China between August 2016 and January 2017. A total of 2481 consecutive patients were exclusively treated with the Nano plus stent. The primary clinical endpoint, target lesion failure (TLF, defined as cardiac death, target vessel nonfatal myocardial infarction, and clinically driven target lesion revascularization [CD-TLR]), was analyzed at 3 years.ResultsAt 3 years, 2295 patients (92.5%) were followed. The incidence of TLF was 6.8% (168/2481). The rate of cardiac death was 3.8% (94/2481), target vessel nonfatal myocardial infarction 0.7% (18/2481), and CD-TLR 2.9% (68/2481). The rate of definite/probable stent thrombosis was 0.5% (13/2481). The risk factors of diabetes mellitus, acute myocardial infarction, age, chronic renal failure, in-stent restenosis, chronic total occlusion, and left ventricular ejection fraction < 40% were the independent predictors of 3-year TLF.ConclusionsAt three years, the rate of TLF was relatively low in patients treated with the polymer-free Nano plus stent. The polymer-free Nano plus stent showed a favorable safety and efficacy profile in real-world patients.Clinical trial registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT02929030.

Ten-year clinical outcomes of polymer-free versus durable polymer new-generation drug-eluting stent in patients with coronary artery disease with and without diabetes mellitus

BackgroundVery long-term outcomes according to diabetic status of patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI) with new-generation drug-eluting stents (DES) are scant. Both, the durable polymer zotarolimus-eluting stent (DP-ZES), the first DES to gain FDA-approval for specific use in patients with diabetes mellitus, and the polymer-free sirolimus- and probucol-eluting stent (PF-SES), with a unique design that enables effective drug release without the need of a polymer offer the potential to enhance clinical long-term outcomes especially in patients with diabetes mellitus.MethodsWe investigate 10-year clinical outcomes of the prespecified subgroups of patients with and without diabetes mellitus, randomly assigned to treatment with PF-SES versus DP-ZES in the ISAR-TEST 5 trial. The primary endpoint of interest was major adverse cardiac events (MACE), defined as the composite of all-cause death, any myocardial infarction or any revascularization. Further endpoints of interest were cardiac death, myocardial infarction related to the target vessel and target lesion revascularization as well as the individual components of the primary composite endpoint and the incidence of definite or probable stent thrombosis at 10 years.ResultsThis analysis includes a total of 3002 patients randomly assigned to PF-SES (n = 2002) or DP-ZES (n = 1000). Prevalence of diabetes mellitus was high and comparable, 575 Patients (28.7%) in PF-SES group and 295 patients (29.5%) in DP-ZES group (P = 0.66). At 10 years 53.5% of patients with diabetes mellitus and 68.5% of patients without diabetes mellitus were alive. Regarding major adverse cardiac events, PF-SES as compared to DP-ZES showed comparable event rates in patients with diabetes mellitus (74.8% vs. 79.6%; hazard ratio 0.86; 95% CI 0.73–1.02; P = 0.08) and in patients without diabetes (PF-SES 62.5% vs. DP-ZES 62.2%; hazard ratio 0.99; 95% CI 0.88–1.11; P = 0.88).ConclusionAt 10 years, both new-generation DES show comparable clinical outcome irrespective of diabetic status or polymer strategy. Event rates after PCI in patients with diabetes mellitus are considerable higher than in patients without diabetes mellitus and continue to accrue over time.Trial registrationClinicalTrials.gov, NCT00598533, Registered 10 January 2008, https://clinicaltrials.gov/ct2/show/NCT00598533?term=NCT00598533Graphic abstractKaplan-Meier estimates of endpoints of interest for patients with vs. without diabetes mellitus treated with PF-SES vs. DP-ZES. Bar graphs: Kaplan-Meier estimates as percentages. PF-SES: polymer-free sirolimus-eluting stent; DP-ZES: durable polymer zotarolimus-eluting stent; DM: diabetes mellitus. Comparison of event rates of individual endpoints in patients with and without diabetes mellitus treated with PF-SES vs. DP-ZES all without statistically significant differences. Comparison of event rates of individual endpoints in overall patients with vs. without diabetes mellitus significantly different (P ≤ 0.01 for all comparisons).

Nine-month angiographic and 2-year clinical outcomes of the RECOVERY trial: A randomized study of the biodegradable polymer sirolimus-eluting COMBO dual-therapy stent versus a polymer-free sirolimus-eluting stent in Chinese patients.

We evaluated the safety and efficacy of the novel dual-therapy sirolimus-eluting and endothelial progenitor cell (EPC) capture COMBO stent. (Very) late stent thrombosis (ST) and neo-atherosclerosis limit the performance of drug-eluting stents. The capture of EPCs accelerates stent re-endothelialization, thereby potentially decreasing the risk of restenosis and ST. In total, 440 patients with de novo lesions in native coronary arteries were randomized (1:1) to either receive the COMBO stent (n = 220) or Nano polymer-free sirolimus-eluting stent (n = 220). The primary endpoint was the 9-month angiographic in-segment late lumen loss (LLL). Secondary endpoints included target lesion failure (TLF), a patient-oriented composite endpoint (PoCE), and ST. At 9 months, the COMBO in-segment LLL (0.29 ± 0.46 mm) was non-inferior to that of the Nano comparator stent (0.31 ± 0.44 mm; pnon-inferiority < .0001). Clinical outcomes were also similar between the COMBO and Nano stents, with TLF rates of 9.3% and 7.9% (p = .61) at 12 months, and 9.4% and 8.0% (p = .62) at 24 months, respectively. The PoCE rate was 14.8% and 10.6% (p = .19) at 12 months, and 16.0% and 11.3% (p = .16) at 24 months, respectively. Ischemia-driven target lesion revascularization rates were 6.0% and 3.7% (p = .26) at 12 months, and 6.2% and 3.8% (p = .26) at 24 months, respectively. No case of ST occurred in either group. The RECOVERY trial has shown the COMBO stent was effective, meeting the primary non-inferiority angiographic endpoint, and safe, with an overall low rate of clinical events in both stent groups, including no ST for up to 2 years.

Impact of Coronary Stent Architecture on Clinical Outcomes: Do Minor Changes in Stent Architecture Really Matter?

IntroductionThe objective of this study was to compare the accumulated clinical outcomes of two Malaysian all-comers populations, each treated with different polymer-free sirolimus-eluting stents (PF-SES) of similar stent design.MethodsThe Malaysian subpopulation of two all-comers observational studies based on the same protocol (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were combined and compared to a Malaysian-only cohort which was treated with a later-generation PF-SES. The PF-SES’s used differed only in their bare-metal backbone architecture, with otherwise identical sirolimus coating. The primary endpoint was the accumulated target lesion revascularization (TLR) rate at 12 months. The rates of major adverse cardiac events (MACE), stent thrombosis (ST) and myocardial infarction (MI) were part of the secondary endpoints.ResultsA total of 643 patients were treated with either the first-generation PF-SES (413 patients) or second-generation PF-SES (230 patients). Patient demographics were similar in terms of age (p = 0.744), male gender (0.987), diabetes mellitus (p = 0.293), hypertension (p = 0.905) and acute coronary syndrome (ACS, 44.8% vs. 46.1%, p = 0.752) between groups. There were no differences between treatment groups in terms of lesion length (20.8 ± 7.3 mm vs. 22.9 ± 7.9, p = 0.111) or vessel diameter (2.87 ± 0.39 vs. 2.93 ± 0.40, p = 0.052) despite numerically smaller diameters in the first-generation PF-SES group. The second-generation PF-SES tended to have more complex lesions as characterized by calcification (10.3% vs. 16.2%, p = 0.022), severe tortuosity (3.5% vs. 6.9%, p = 0.041) and B2/C lesions (49.2% vs. 62.8%, p < 0.001). The accumulated TLR rates did not differ significantly between the first- and second-generation PF-SES (0.8% vs. 0.9%, p = 0.891). The accumulated MACE rates were not significantly different (p = 0.561), at 1.5% (6/413) and 2.2% (5/230), respectively.ConclusionsModifications in coronary stent architecture which enhance the radial strength and radiopacity without gross changes in strut thickness and design do not seem to impact clinical outcomes.Clinical Trial RegistrationClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214.

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.

Real-World Dual Antiplatelet Therapy Following Polymer-Free Sirolimus-Eluting Stent Implantations to Treat Coronary Artery Disease

ObjectivesThe objective of this post hoc analysis was to analyze real-world dual antiplatelet therapy (DAPT) regimens following polymer-free sirolimus-eluting stent (PF-SES) implantations in an unselected patient population.MethodsPatient-level data from two all-comers observational studies (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were pooled and analyzed in terms of their primary endpoint. During the data verification process, we observed substantial deviations from DAPT guideline recommendations. To illuminate this gap between clinical practice and guideline recommendations, we conducted a post hoc analysis of DAPT regimens and clinical event rates for which we defined the net adverse event rate (NACE) consisting of target lesion revascularization (TLR, primary endpoint of all-comers observational studies) all-cause death, myocardial infarction (MI), stent thrombosis (ST), and bleeding events. A logistic regression was utilized to determine predictors why ticagrelor was used in stable coronary artery disease (CAD) patients instead of the guideline-recommended clopidogrel.ResultsFor stable CAD, the composite endpoint of clinical, bleeding, and stent thrombosis, i.e., NACE, between the clopidogrel and ticagrelor treatment groups was not different (5.4% vs. 5.1%, p = 0.745). Likewise, in the acute coronary syndrome (ACS) cohort, the NACE rates were not different between both DAPT strategies (9.2% vs. 9.3%, p = 0.927). There were also no differences in the accumulated rates for TLR, myocardial infarction ([MI], mortality, bleeding events, and stent thrombosis in elective and ACS patients. The main predictors for ticagrelor use in stable CAD patients were age < 65 years, smaller vessels, treatment of ostial and calcified lesions, and in-stent restenosis.ConclusionWithin the framework of a post hoc analysis based on a real-world, large cohort study, there were no differences in the combined endpoint of major adverse cardiac events (MACE), bleeding and thrombotic events for clopidogrel and ticagrelor in stable CAD or ACS patients. Despite the recommendation for clopidogrel by the European Society of Cardiology (ESC), real-world ticagrelor use was observed in subgroups of stable CAD patients that ought to be explored in future trials.

One-year clinical results of the NANO registry: A multicenter, prospective all-comers registry study in patients receiving implantation of a polymer-free sirolimus-eluting stent.

We aimed to evaluate the safety and efficacy of Nano+™ (Lepu Medical, Beijing, China) stent implantation in all-comer patients at the 1-year follow-up. The Nano+™ stent is a novel polymer-free sirolimus-eluting stent polymer that employs nanoporous stent surface technology to control drug-delivery. The Nano+™ stent is one of the most widely used drug-eluting stent (DES) in China. A total of 2,481 consecutive patients were included in the multicenter and prospective NANO registry. In this study, the primary endpoint was target lesion failure (TLF) at 1-year follow-up, defined as a composite of cardiac death, target vessel nonfatal myocardial infarction (TV-MI), and clinically driven target lesion revascularization (TLR). The safety endpoint was the occurrence of definite or probable stent thrombosis (ST). Up to 40.2% of patients presented with acute myocardial infarction (AMI). A total of 63.9% of the 2,904 lesions were American College of Cardiology/American Heart Association (ACC/AHA) type B2 or C lesions. One-year follow-up data were available for 98.4% of patients. The 1-year rate of TLF was 3.1% with rates of 1.3, 1.8, and 0.4% for clinically driven TLR, cardiac death, and TV-MI, respectively. ST occurred in 0.4% of patients. Diabetes mellitus, AMI, left ventricular ejection fraction <40% and long lesions (>40 mm) were independent predictors of 1-year TLF. The 1-year clinical outcomes were excellent for Nano+™ polymer-free SES implantation in an all-comer patient population. Follow-up will be extended up to 5 years, to further elucidate the potential long-term clinical benefits. URL: https://www.clinicaltrials.gov/. Unique identifier: NCT02929030.

Polymer-free sirolimus-eluting stent use in Europe and Asia: Ethnic differences in demographics and clinical outcomes.

BackgroundThe objective of this study was to assess regional and ethnic differences in an unselected patient population treated with polymer-free sirolimus-eluting stents (PF-SES) in Asia and Europe.MethodsTwo all-comers observational studies based on the same protocol (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were combined for data analysis to assure sufficient statistical power. The primary endpoint was the accumulated target lesion revascularization (TLR) rate at 9–12 months.ResultsOf the total population of 7243 patients, 44.0% (3186) were recruited in the Mediterranean region and 32.0% (2317) in central Europe. The most prominent Asian region was South Korea (17.6%, 1274) followed by Malaysia (5.7%, 413). Major cardiovascular risk factors varied significantly across regions. The overall rates for accumulated TLR and MACE were low with 2.2% (140/6374) and 4.4% (279/6374), respectively. In ACS patients, there were no differences in terms of MACE, TLR, MI and accumulated mortality between the investigated regions. Moreover, dual antiplatelet therapy (DAPT) regimens were substantially longer in Asian countries even in patients with stable coronary artery disease as compared to those in Europe.ConclusionsPF-SES angioplasty is associated with low clinical event rates in all regions. Further reductions in clinical event rates seem to be associated with longer DAPT regimens.

Comparative preclinical evaluation of a polymer-free sirolimus-eluting stent in porcine coronary arteries.

Background:Polymer-free drug-eluting stents (DES) without permanent-polymer coating may be associated with rapid vessel healing, providing a rationale to reduce dual-antiplatelet therapy (DAPT). The aim of the current study was to compare vessel healing of a polymer-free sirolimus-eluting stent (PF-SES), its bare metal stent (BMS) analogue to a permanent polymer-based sirolimus-eluting stent (SES) with proven effectiveness in porcine coronary arteries.Material and methods:An ultrathin-strut cobalt–chromium PF-SES, its BMS analogue and an SES with a permanent polymer were used to study vessel healing and their antistenotic potential. Stents were implanted in porcine coronary arteries for histopathologic analysis at 7, 28 and 180 days.In an additional in vitro study, the thrombogenicity of PF-SES was compared with a fluoropolymer-coated everolimus-eluting stent (EES) which demonstrated low stent thrombosis rates in numerous studies.Results:In the animal study, neointimal growth and injury scores were minimal and inflammation scores were low in the neointima and adventitia in all study groups. After 28 days, neointimal area was lowest in PF-SES when compared with SES and BMS (1.48 ± 0.55 mm² versus 2.43 ± 0.69 mm² versus 1.90 ± 0.85 mm², respectively, p < 0.05) and endothelialization of luminal surfaces was nearly complete in all groups, though SES show the least coverage with occasional adherent luminal inflammatory cells (p > 0.05). At 180 days, neointimal area and thickness were most pronounced in SES (p < 0.05) and comparable with BMS implantations, which were characterized by nearly completed vessel healing. PF-SES and BMS had complete endothelialization, absence of fibrin and sustained low inflammatory reaction when compared with the permanent polymer-based SES (inflammation score: PF-SES 0.41 ± 0.74 versus SES 2.52 ± 1.72 versus BMS 0.30 ± 0.65, respectively, p < 0.05 BMS versus SES). Granuloma formation and fibrin accumulation were most pronounced in SES but did not reach statistical significance, p > 0.05). In the in vitro thrombogenicity study, the PF-SES confirmed comparable antithrombogenic properties with regard to the parameters fibrin and platelet binding, and platelet aggregation when compared with the EES.Conclusions:As compared with BMS, the ultrathin-strut cobalt–chromium PF-SES showed similar endothelialization at 28 days and comparable healing characteristics at 180 days efficacious inhibition of neointimal proliferation in porcine coronary arteries with low inflammation responses and a BMS-like endothelialization at 180 days. In addition, in an in vitro model, the PF-SES also confirmed low thrombogenicity as compared with the EES.

Open-labeled randomized controlled trial to evaluate the 1-year clinical outcomes of polymer-free sirolimus-eluting coronary stents as compared with biodegradable polymer-based sirolimus-eluting coronary stents

BackgroundHead to head trials of clinical outcomes of sirolimus eluting polymer free vs. biodegradable polymer stents are lacking. MethodsSingle centre prospective open labeled randomised controlled clinical trial. Basis for sample size calculation was the rate of MACE from the ISAR TEST 3 trial in which the absolute difference was 10.25% with a standard deviation of 0.24. Assuming null hypothesis, 80% power and 5% alpha error, to detect a 10% difference, adjusting for 10% loss of follow up, sample size was 204. Inclusion criteria: Patients with stable coronary artery disease or recent acute coronary syndrome ( >1 week from the date of STEMI), being taken up for elective angioplasty. End points: Primary end point was MACE at 1 year and secondary end points at the end of 1 year were cardiac death, urgent target lesion revascularization, acute coronary syndrome, stroke and in-stent re-stenosis. Results204 patients were enrolled between January 2013 to July 2014, 91 in the polymer-free group and 113 in the biodegradable polymer group. Baseline characteristics were comparable between both groups. 21 patients (10.29%), were lost to follow up. MACE at 1 year were comparable in both the groups 3 of 85(3.52%) in the polymer-free group and 3 of 98(3.06%) in the biodegradable polymer group, p = 0.859. The secondary end points were also comparable between the two groups- Death- 1 of 85(1.17%) vs. 2 of 98(2.04%), p = 0.646, Stroke 0 of 85 vs. 2 of 98(2.04%), p = 0.185 and acute coronary syndrome – 2 of 85(2.35%) vs. 1 of 98(1.02%), p = 0.204. There were no instances of urgent target lesion re-vascularisation or definite stent thrombosis in either groups. In stent re-stenosis was found in 7 of 85(8.2%) in the polymer-free group vs. 6 of 98(6.12%) in the biodegradable polymer group. ConclusionThe 1 year MACE rates are comparable in patients who underwent elective coronary revascularization using sirolimus eluting polymer-free and biodegradable polymer stents.

Nine-month clinical outcomes in patients with diabetes treated with polymer-free sirolimus-eluting stents and 6‑month vs. 12‑month dual-antiplatelet therapy (DAPT)

Diabetes mellitus is known to be associated with worse clinical outcomes in patients with coronary artery disease (CAD) undergoing percutaneous coronary interventions (PCI) with drug-eluting stents (DES). Defining the optimal duration of dual antiplatelet therapy (DAPT) after DES implantation is still under debate. The objective of this subgroup analysis of the all-comers ISAR 2000 registry was to assess the safety and efficacy of ashort DAPT (<6month) versus alonger DAPT (>6month) in patients with diabetes electively treated with the polymer-free sirolimus-coated ultrathin strut drug-eluting stent (PF-SES). Patients who received the PF-SES were investigated in amulticenter all-comers observational study. The primary endpoint was the 9‑month target lesion revascularization (TLR) rate, whereas secondary endpoints included the 9‑month major adverse cardiac event (MACE) and procedural success rates. In all, 167 patients were treated with DAPT for ≤6months (S-DAPT group) and 350 patients underwent DAPT treatment for 12months (L-DAPT group). There was no significant difference in the overall MACE rate (4.6% vs. 3.1%, p = 0.441), the 9‑month accumulated stent thrombosis rates (0.8% vs. 0.3%, p = 0.51), or the accumulated rate of bleeding complications (5.3% vs. 3.4%, p = 0.341). PF-SES are safe and effective in daily clinical routine with low rates of TLR and MACE in patients with diabetes and stable disease. Our data suggest that extending the duration of DAPT beyond 6months does not improve MACE or TLR at 9months in patients with stable CAD (ClinicalTrials.gov Identifier NCT02629575).

9-month results of polymer-free sirolimus eluting stents in young patients compared to a septuagenarian and octogenarian all-comer population.

To evaluate the 9-month safety and efficacy of polymer-free sirolimus eluting drug eluting stents in septuagenarians and octogenarians. An all-comer, worldwide single armed trial (ClinicalTrials.gov Identifier NCT02629575) was conducted to demonstrate the safety and efficacy of an ultra-thin strut, polymer-free sirolimus eluting stent (PF-SES). The primary endpoint was the 9-month target revascularization rate (TLR). Secondary endpoints included the rates of major adverse cardiac events (MACE), stent thrombosis (ST) and bleeding (BARC) in septuagenarians (≥70 years, <80 years), and in octogenarians (≥80 years) to be compared to the younger patient group (<70 years). A total of 1607 patients were treated with PF-SES in the sub-70-year-old age group, 694 in septuagenarians, and 371 in the octogenarian patient group. At 9 months, the MACE rates were 7.2% in octogenarians, 5.3% in septuagenarians, and 3.0% in the younger patient group (P = 0.001). These were mostly driven by all-cause mortality (4.4% vs 1.9% vs 0.6%, P < 0.001) while the TLR rates were only numerically lower in the younger age group (P = 0.080). BARC 1-5 bleeding events were more frequent in the older age group (1.9% vs 2.7% vs 4.6%, P = 0.012) whereas the rates for ST were not different (0.7% vs 0.6% vs 0.6%, P = 0.970). In octogenarians treated with PF-SES, the rates for MACE, overall mortality, and bleeding are higher as compared to the younger age groups. However, the rates for TLR and ST were not significantly different across the investigated age groups. PF-SES are safe and effective in octogenarians.

TCT-731 Nine-month clinical outcomes in patients with diabetes treated with polymer free sirolimus-eluting stents and dual-anti platelet therapy (DAPT) for 6 months versus DAPT for 12 months

TCT-731 Nine-month clinical outcomes in patients with diabetes treated with polymer free sirolimus-eluting stents and dual-anti platelet therapy (DAPT) for 6 months versus DAPT for 12 months