Biodegradable Polymer Biolimus-eluting Stent Research Articles

Biodegradable or durable polymer drug-eluting stents in patients with coronary artery disease: ten-year outcomes of the randomised NEXT Trial.

There are no randomised trials reporting clinical outcomes of biodegradable polymer biolimus-eluting stents (BP-BES) and durable polymer everolimus-eluting stents (DP-EES) at 10years. We aimed to compare the 10-year clinical outcomes between BP-BES and DP-EES. The randomised NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-eluting Stent Trial (NEXT) was originally designed to evaluate the non-inferiority of BP-BES relative to DP-EES with the primary efficacy endpoint of target lesion revascularisation (TLR) at 1year and the primary safety endpoint of death or myocardial infarction (MI) at 3years. In this extended follow-up study, clinical outcomes were compared from 1year after stent implantation up to 10years between patients with BP-BES and DP-EES. From May to October 2011, NEXT enrolled atotal of 3,241patients from 98 centres in Japan. The current study population consisted of 2,417patients (1,204patients with BP-BES and 1,213 with DP-EES) from 66 centres that agreed to participate in the extended study. Complete 10-year follow-up was achieved in 87.5% of patients. The cumulative 10-year incidence of death or MI was 34.0% in the BP-BES group and 33.1% in the DP-EES group (hazard ratio [HR] 1.04, 95% confidence interval [CI]: 0.90-1.20; p=0.58). TLR occurred in 15.9% of patients in the BP-BES group and in 14.1% of the DP-EES group (HR 1.12, 95% CI: 0.90-1.40; p=0.32). In alandmark analysis at 1year, the cumulative incidences of death or MI and TLR were not significantly different between the 2 groups. The safety and efficacy outcomes for BP-BES were not significantly different from those for DP-EES at 1year and up to 10years after stent implantation.

Biolimus-eluting vs. other limus-eluting stents in NSTE-ACS: A pooled analysis of GLASSY and TWILIGHT

BackgroundBiodegradable polymer biolimus-eluting stents (BP-BES) may be associated with better outcomes in patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI) compared to other current-generation limus-eluting stents (LES). AimsTo compare BP-BES with other current-generation LES in ACS patients undergoing PCI. MethodsWe pooled individual data of Non-ST-segment elevation (NSTE)-ACS patients from two large randomized controlled trials (GLASSY and TWILIGHT). The BP-BES groups consisted mostly of GLASSY patients, while the control group (other current-generation LES) included exclusively TWILIGHT patients. The primary outcome was major adverse cardiovascular events (MACE), including cardiovascular death, myocardial infarction, or stent thrombosis; the key secondary outcome was target-vessel failure (TVF). To account for trial design differences, outcomes were assessed at 3 months (short-term) and between 3 and 12 months (long-term) after PCI and subsequently pooled to estimate the 12-month hazards. ResultsOf 7107 and 6053 NSTE-ACS patients included in the short- and long-term analysis, 32.7% and 36.5% received a BP-BES, respectively. Risk of MACE associated with BP-BES versus other LES was similar at short-term (1.1% vs 1.3%, adjusted HR 0.86, 95%CI 0.53–1.38), lower at long-term (1.7% vs 3.1%, adjusted HR 0.49, 95%CI 0.34–0.72), and lower in the entire 12-month period (pooled adjusted HR 0.61, 95%CI 0.45–0.82). The cumulative 12-month risk of TVF was reduced with BP-BES (adjusted HR 0.52, 95%CI 0.38–0.70). ConclusionBP-BES was associated with lower 12-month risks of MACE and TVF compared to other current generation LES among NSTE-ACS patients treated with abbreviated or standard ticagrelor-based DAPT. These non-randomized findings are hypothesis-generating. Condensed abstractDifferences in clinical outcomes may exist between biodegradable polymer biolimus-eluting stents (BP-BES) and other current-generation limus-eluting stent (LES) in patients with acute coronary syndrome (ACS). We pooled individual data of about 7000 Non-ST-segment elevation ACS patients undergoing PCI and treated with ticagrelor with or without aspirin from two large randomized controlled trials (GLASSY and TWILIGHT). BP-BES patients derived very largely from GLASSY and other LES patients from TWILIGHT. In this population, BP-BES compared to other current generation LES, were associated with a lower 12-month risk of major adverse cardiovascular events and target-vessel failure.

Safety and efficacy of biodegradable polymer biolimus-eluting stents in patients with non-ST-elevation acute coronary syndrome: a pooled analysis of GLASSY and TWILIGHT

Abstract Background Biodegradable polymer (BP) drug-eluting stents (DES) have shown similar safety and efficacy compared with second-generation durable polymer (DP)-DES in several randomized trials and meta-analyses. However, study participants were generally maintained on a standard dual antiplatelet therapy (DAPT) for at least 6 months after percutaneous coronary intervention (PCI). Therefore, the differences in thrombogenicity between these two stent technologies may have been unappreciated, especially among patients with acute coronary syndrome (ACS). Purpose We aimed to compare the safety and efficacy of BP Biolimus-Eluting Stent (BP-BES) versus 2nd generation DP-DES among ACS patients undergoing PCI and receiving ticagrelor alone or in combination with aspirin. Methods We pooled individual patient-level data from two randomized controlled trials, the Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention (TWILIGHT, n=9,006) (1) and the GLOBAL LEADERS Adjudication Sub-Study (GLASSY, n=7,585) (2). In order to reduce biases related to trial design differences, only NST-ACS patients not fulfilling any exclusion criterion of both studies were included and 2 separate analysis for short (0 to 3 months after PCI) and long-term (3 to 12 months after PCI) outcomes were performed. Patients were stratified according to the stent used at index PCI (BP-BES vs 2nd generation DP-DES). In both analysis, the primary outcome was major adverse cardiovascular events (MACE, a composite of cardiovascular death, myocardial infarction and definite or probable stent thrombosis); the key secondary outcomes were target-vessel failure (TVF) and BARC 2, 3 or 5 bleeding. Events rate and risk were assessed separately for the two study periods and subsequently 12-months risk estimates were derived by pooling the results of the two analysis. Results Out of 7,729 and 6,572 NST-ACS patients included in the two analysis, 2,321 (30%) and 2,211 (33.6%) received a BP-BES, respectively. Among patients treated with BP-BES versus DP-DES, the occurrence of MACE was similar at 3 months after PCI (1.1% vs 1.4%, adjusted HR 0.81, 95% CI 0.51–1.29), while it was significantly lower in the former group between 3 and 12 months (1.7% vs 3.1%, adj. HR 0.46, 95% CI 0.32–0.67) and in the overall period (pooled adjusted HR estimate 0.58, 95% CI 0.43–0.77). Similarly, significant differences were observed for TVF and BARC 2, 3, or 5 bleeding, whose risk at 12 months was lower among BP-BES than DP-DES patients (pooled adj. HR estimate 0.49, 95% CI 0.38–0.63 and 0.79, 95% CI 0.79, 95% CI 0.65–0.97, respectively). Conclusion As compared to 2nd generation DP-DES, BP-BES was associated with a lower risk of MACE, TVF and bleeding among NST-ACS patients undergoing PCI and treated with ticagrelor with or without aspirin. The findings of this analysis are exploratory and need further confirmation. Funding Acknowledgement Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Biosensors (Singapore)

Comparison of Different Types of Drug-Eluting Stents for De Novo Long Coronary Artery Lesions.

Outcomes of percutaneous coronary intervention for diffuse long lesions remain relatively unfavorable. Prior clinical trials investigated the relative efficacy and safety of different types of drug-eluting stents (DES) in long lesions. This study sought to compare the relative performance of different types of DES for de novo long (≥25mm) coronary artery lesions. Using a pooled analysis of individual data of 1,450 patients from 3 randomized clinical trials, we compared angiographic and clinical outcomes of 5 different types of DES: 224 patients with cobalt-chromium everolimus-eluting stents (EES), 255 with platinum-chromium EES, 250 with Resolute zotarolimus-eluting stents, 245 with biodegradable polymer biolimus-eluting stents, and 476 with first-generation sirolimus-eluting stents (SES). The primary endpoint was in-segment late lumen loss at 9months. The primary endpoint was not significantly different between 4 second-generation DES and 1 first-generation SES (0.17 ± 0.41mm in cobalt-chromium EES; 0.11 ± 0.37 in platinum-chromium EES: 0.14 ± 0.38 in Resolute zotarolimus-eluting stents; 0.14 ± 0.38 in biodegradable polymer biolimus-eluting stents; or 0.10 ± 0.37 in SES, respectively, overall P = 0.38). Also, there were no significant between-group differences with respect to death, myocardial infarction, target-vessel revascularization, or stent thrombosis at 12months. In the multiple treatment propensity-score analysis, the risk of angiographic and clinical outcomes was also similar among several types of DES. In this patient-level pooled analysis, several second-generation DES showed similar angiographic and clinical outcomes in patients with de novo long coronary lesions. (Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III [LONG-DES-III]; NCT01078038; Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-IV [LONG-DES-IV]; NCT01186094; and Everolimus-eluting [PROMUS-ELEMENT] vs. Biolimus A9-Eluting [NOBORI] Stents for Long-Coronary Lesions [LONG-DES-V]; NCT01186120).

TCT-32 ABSTRACT WITHDRAWN

TCT-32 ABSTRACT WITHDRAWN

Effectiveness and Safety of Contemporary Drug-Eluting Stents in Patients With Diabetes Mellitus.

Diabetes mellitus (DM) is a well-known risk factor for adverse cardiovascular events in patients receiving percutaneous coronary intervention (PCI). Limited data are available on the relative performance of different types of contemporary drug-eluting stents (DES) for diabetic patients. The authors investigated the effectiveness and safety profiles of several contemporary DES in patients with DM in a "real-world" clinical setting. Among 24,516 patients enrolled in a multicenter, prospective registry, 7,823 patients with DM were treated with 4 contemporary DES: 2,877 with a cobalt chromium everolimus-eluting stent (EES), 789 with a biodegradable polymer biolimus-eluting stent, 2,286 with a platinum chromium-EES, and 1,871 with a Resolute zotarolimus-eluting stent. The primary outcome was target vessel failure (TVF) (a composite of cardiac death, target vessel myocardial infarction, and target vessel revascularization). The median follow-up duration was 2.9 years. Observed 3-year rates of TVF were not significantly different according to different DES types. On multigroup propensity-score analysis, the adjusted HRs for TVF were similar in between-group comparisons: biodegradable polymer biolimus-eluting stent (HR: 0.94; 95%CI: 0.76-1.16; P=0.57), platinum chromium-EES (HR: 0.94; 95%CI: 0.81-1.09; P=0.41), and Resolute zotarolimus-eluting stent (HR: 1.01; 95%CI: 0.86-1.18; P=0.93) compared with the cobalt chromium-EES (reference). This trend was maintained in patients with non-insulin- and insulin-treated DM. In this multicenter clinical-practice PCI registry, no significant between-group differences were found for a 3-year risk of TVF in patients with DM undergoing PCI with various types of contemporary DES. (Evaluation of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice [IRIS-DES]; NCT01186133).

BioMatrix versus Orsiro biodegradable polymer stents in all-comer patients with coronary artery disease: the multicentre, randomised BIODEGRADE trial.

The aim of this trial was to compare the safety and efficacy of a thin-strut biodegradable polymer sirolimus-eluting cobalt-chromium stent (Orsiro) to a thick-strut biodegradable polymer biolimus-eluting stent (BioMatrix). This randomised, open-label, non-inferiority trial was conducted among patients undergoing percutaneous coronary intervention. The primary endpoint was target lesion failure (TLF). Between July 2014 and September 2017, we randomly assigned 2,341 patients to BioMatrix stents (n=1,166) or Orsiro stents (n=1,175). We analysed 2,327 patients who completed 18-month follow-up. The mean patient age was 63.5 years, and 1,565 (67.3%) patients presented with acute coronary syndrome. At 18 months, 34 (2.9%) patients with BioMatrix stents and 24 (2.1%) with Orsiro stents experienced TLF (hazard ratio [HR] 0.70, upper limit of one-sided 95% confidence interval: 1.18, p for non-inferiority <0.0001). No significant differences were noted in rates of cardiac death (16 [1.4%] vs 12 [1.0%], p=0.558), target lesion-related myocardial infarction (0 [0%] vs 3 [0.3%], p=0.250), target lesion revascularisation (18 [1.6%] vs 10 [0.9%], p=0.124), or stent thrombosis (0 [0%] vs 2 [0.2%], p=0.50). In patients with a high prevalence of acute coronary syndrome, Orsiro stents were not inferior to BioMatrix stents. Both showed good clinical outcomes.

P3589New generation stents for primary percutaneous coronary intervention in patients with acute myocardial infarction: evidence from an individual patient data network meta-analysis of randomized clinical

Abstract Background Drug-eluting stents have shown their superiority in primary percutaneous intervention in patients with ST-segment elevation myocardial infarction (STEMI). No specific stent type has fully proven its superiority over others. Purpose We sought to compare the safety and efficacy of coronary artery stents in STEMI patients undergoing primary PCI through comprehensive network meta-analysis (NMA). Methods We performed an individual patient data (IPD) NMA of dedicated randomized trials in STEMI patients treated with coronary stents. The primary endpoint of interest was the composite outcome of cardiac death, any myocardial infarction (MI) or target lesion revascularization (TLR). Secondary outcomes were the individual component of the primary endpoint and definite or probable stent thrombosis. Outcomes were analyzed at the longest available follow-up. The primary analysis was performed using a one-stage random-effects meta-analysis. Results IPD from 15 randomized trials in STEMI patients were obtained including a total of 10,979 patients. Six different stent types were studied including bare metal stents (BMS), durable-polymer paclitaxel-eluting stents (DP-PES), durable-polymer sirolimus-eluting stents (DP-SES), durable-polymer zotarolimus-eluting stents (DP-ZES), durable-polymer everolimus-eluting stents (DP-EES) and biodegradable-polymer biolimus-eluting stent (BP-BES). Mean patient age was 60.7±11.9 years; 22.7% were female and 16.1% were diabetic. Median symptom onset to balloon time was 210 min. At a median follow-up of 3 years (interquartile range 2–4.9 years), patients treated with second-generation (DP-EES and BP-BES) or first-generation DES (DP-PES, DP-SES and DP-ZES) had significantly lower risk of the primary endpoint than patients treated with BMS (BMS vs. second-generation DES; HR 0.69, 95% CI 0.57–0.82, BMS vs. first-generation DES; HR 0.70, 95% CI 0.61–0.80). The differences were driven by the significant reduction of TLR associated with first- and second-generation DES compared with BMS. A trend towards lower risk of MI with second-generation DES compared with BMS or first-generation DES was observed (BMS vs. second-generation DES; HR 0.79, 95% CI 0.58–1.06, first- vs. second-generation DES; HR 0.75, 95% CI 0.54–1.03). Second-generation DES was associated with a significantly lower risk of definite or probable stent thrombosis compared with BMS (HR 0.62, 95% 0.40–0.97) and first-generation DES (HR 0.55, 95% CI 0.34–0.91). DP-EES and BP-BES had a similar risk of the primary endpoint, individual components of the primary endpoint, and definite or probable stent thrombosis. Conclusions In this larger-scale IPD NMA in STEMI patients, second-generation DES were superior to BMS with respect to long-term efficacy and safety outcomes. Second-generation DES were associated with a significant reduction of stent thrombosis compared with BMS and first-generation DES. Similar long-term outcomes were observed between DP-EES and BP-BES. Acknowledgement/Funding This study was funded by Biosensors International

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.

Clinical outcomes of contemporary drug-eluting stents in patients with and without diabetes mellitus: Multigroup propensity-score analysis using data from stent-specific, multicenter, prospective registries.

Whether the diabetic status differentially affects the clinical outcomes with different drug-eluting stents (DES) has been controversial. From stent-specific, prospective DES registries, we evaluated 17,184 patients (11,428 in non-diabetics and 5,756 in diabetics) who received several contemporary DES: 3570 sirolimus-eluting stents (SES), 5,023 cobalt-chromium everolimus-eluting stents (CoCr-EES), 2,985 platinum-chromium EES (PtCr-EES), 2,913 Resolute zotarolimus-eluting stents (Re-ZES), and 2,693 biodegradable-polymer biolimus-eluting stents (BP-BES). The primary outcome was patient-oriented composite endpoint (POCE, a composite of all-cause death, any myocardial infarction, and any revascularization) at 3-year follow-up and target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, and target-vessel revascularization) at 3 years was also evaluated. In non-diabetics, the rates of POCE were not significantly different (CoCr-EES 14.3%, PtCr-EES 13.0%, Re-ZES 14.3%, BP-BES 13.4%, and SES 14.6%; overall p = .39). In diabetics, similar results were revealed (CoCr-EES 18.4%, PtCr-EES 20.3%, Re-ZES 17.3%, BP-BES 17.7%, and SES 17.8%; overall p = .44). In multiple treatment propensity-score weighting analysis, regardless of the diabetic status, the hazard ratios for POCE between-individual comparison were similar. Target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, and target-vessel revascularization) was also comparable except the higher ratio of Re-ZES than PtCr-EES (hazard ratio 1.25, 1.26, 95% confidence interval 1.00-1.55, p = .048) in patients without diabetes. In this clinical-practice registry study, regardless the diabetic status, the 3-year rates of the primary outcome were similar among different types of DES, suggesting no differential clinical response between contemporary DES in patients with or without diabetes.

Everolimus-Eluting Versus Biolimus-Eluting Stents With Biodegradable Polymers in Unselected Patients Undergoing Percutaneous Coronary Intervention: A Randomized Noninferiority Trial With 1-Year Follow-Up (SORT OUT VIII Trial)

ObjectivesThe aim of this study was to compare the thin-strut biodegradable-polymer everolimus-eluting platinum-chromium stent (EES) with the biodegradable-polymer biolimus-eluting stainless-steel stent (BES). BackgroundCurrently available drug-eluting coronary stents have been refined to reduce the risk for coronary events following implantation. MethodsThis randomized, multicenter, all-comers, noninferiority trial was undertaken at 3 sites in western Denmark. Patients with clinical indications for percutaneous coronary intervention were eligible for inclusion. Patients were randomly assigned (1:1) to either EES or BES. The primary endpoint, target lesion failure, was a composite of safety (cardiac death and myocardial infarction not clearly attributable to a nontarget lesion) and efficacy (target lesion revascularization) at 12 months, analyzed using intention-to-treat principles. The trial was powered to assess target lesion failure noninferiority of the EES compared with the BES with a predetermined noninferiority margin of 3%. ResultsA total of 1,385 patients were assigned to treatment with EES and 1,369 patients to treatment with BES. The analysis showed that 55 patients (4.0%) assigned to the EES and 60 (4.4%) assigned to the BES met the primary endpoint (absolute risk difference 0.4%; upper limit of 1-sided 95% confidence interval: 1.7%; p < 0.001). ConclusionsAt 1-year follow-up, the EES was found to be noninferior to the BES with respect to target lesion failure. (Everolimus-eluting SYNERGY Stent Versus Biolimus-Eluting Biomatrix NeoFlex Stent—SORT-OUT VIII; NCT02093845)

Safety and Efficacy of Biodegradable Polymer-biolimus-eluting Stents (BP-BES) Compared with Durable Polymer-everolimus-eluting Stents (DP-EES) in Patients Undergoing Complex Percutaneous Coronary Intervention.

Background and ObjectivesThere are no data comparing clinical outcomes of complex percutaneous coronary intervention (PCI) between biodegradable polymer-biolimus-eluting stents (BP-BES) and durable polymer-everolimus-eluting stents (DP-EES). We sought to evaluate the safety and efficacy of BP-BES compared with DP-EES in patients undergoing complex PCI.MethodsPatients enrolled in the SMART-DESK registry were stratified into 2 categories based on the complexity of PCI. Complex PCI was defined as having at least one of the following features: unprotected left main lesion, ≥2 lesions treated, total stent length >40 mm, minimal stent diameter ≤2.5 mm, or bifurcation as target lesion. The primary outcome was target lesion failure (TLF), defined as a composite of cardiac death, target vessel-related myocardial infarction (TV-MI), or target lesion revascularization (TLR) at 2 years of follow-up.ResultsOf 1,999 patients, 1,145 (57.3%) underwent complex PCI: 521 patients were treated with BP-BES and 624 with DP-EES. In propensity-score matching analysis (481 pairs), the risks of TLF (3.8% vs. 5.2%, adjusted hazard ratio [HR], 0.578; 95% confidence interval [CI], 0.246–1.359; p=0.209), cardiac death (2.5% vs. 2.5%, adjusted HR, 0.787; 95% CI, 0.244–2.539; p=0.689), TV-MI (0.5% vs. 0.4%, adjusted HR, 1.128; 95% CI, 0.157–8.093; p=0.905), and TLR (1.1% vs. 2.9%, adjusted HR, 0.390; 95% CI, 0.139–1.095; p=0.074) did not differ between 2 stent groups after complex PCI.ConclusionsClinical outcomes of BP-BES were comparable to those of DP-EES at 2 years after complex PCI. Our data suggest that use of BP-BES is acceptable, even for complex PCI.

Impact of Combination Therapy with Ezetimibe/Simvastatin Treatment on the Neointimal Response to Biodegradable Polymer Biolimus-Eluting Stent Implantation in Patients with Acute Myocardial Infarction: Serial Assessment with Optical Coherence Tomography

The aim of this study was to compare the neointimal response at 12-month follow-up between ezetimibe/simvastatin (Vytorin, manufactured by Merck) 10/10 mg and Vytorin 10/40 mg after biodegradable polymer Biolimus-eluting stent (BP-BES) implantation in patients with acute myocardial infarction (AMI). A total of 20 patients requiring revascularization were randomly assigned to receive either Vytorin 10/10 mg (n = 9) or Vytorin 10/40 mg (n = 11). Baseline optical coherence tomography (OCT) was performed after stent implantation, and follow-up OCT was scheduled at 12 months. We performed follow-up OCT in 18 patients (Vytorin 10/10 mg (n = 9) or Vytorin 10/40 mg (n = 9)). A total of 842 frames and 8552 struts were analyzed at initial and follow-up OCT. At follow-up, the percentage of uncovered struts was not significantly different between both groups (6.61 ± 10.29% vs. 7.57 ± 6.45%, p = 0.815). The percentage of malapposed struts was also similar between both groups (0.69 ± 1.58% vs. 1.55 ± 2.72%, respectively, p = 0.422). Mean percent neointimal hyperplasia area was not significantly different between both groups (6.53 ± 3.26% vs. 6.37 ± 8.96%, p = 0.961). This OCT study showed that both high- and moderate-intensity dosing of Vytorin was associated with relatively lower percentages of uncovered struts and malapposed struts after Biolimus A9-eluting stent implantation in patients with AMI.

Safety and Effectiveness of Second-Generation Drug-Eluting Stents in Patients With Left Main Coronary Artery Disease

BackgroundLimited data are available on the relative performances between different types of drug-eluting stents (DES) for obstructive left main coronary artery disease (LMCAD). ObjectivesThis study sought to compare effectiveness and safety profiles of various second-generation DES for LMCAD in real-world clinical practice. MethodsAmong 4,470 patients in 3, multicenter, prospective registries (IRIS-DES [Interventional Cardiology Research Incorporation Society-Drug-Eluting Stents] registry, the IRIS-MAIN [Interventional Cardiology Research Incorporation Society-Left MAIN Revascularization] registry, and the PRECOMBAT [PREmier of Randomized COMparison of Bypass Surgery versus AngioplasTy Using Drug-Eluting Stent in Patients with Left Main Coronary Artery Disease] study) treated between July 2007 and July 2015, the authors identified 2,692 patients with significant LMCAD who received second-generation DES; 1,254 with cobalt-chromium everolimus-eluting stents (CoCr-EES), 232 with biodegradable polymer biolimus-eluting stents (BP-BES), 616 with platinum-chromium EES (PtCr-EES), and 590 with Resolute zotarolimus-eluting stent (Re-ZES). The primary outcome was target-vessel failure. ResultsThe observed 3-year rates of target-vessel failure were not significantly different for the different types of DES (16.7% for the CoCr-EES, 13.2% for the BP-BES, 18.7% for the PtCr-EES, and 14.7% for the Re-ZES; p = 0.15). In multiple treatment propensity score analysis, the adjusted hazard ratios (HRs) for target-vessel failure were similar in between-group comparisons of the different DES, except for the PtCr-EES versus the BP-BES (reference; HR: 1.60; 95% confidence interval: 1.01 to 2.54; p = 0.046). There were no significant differences in risk of composite of all-cause death, any myocardial infarction, or any revascularization and its individual components according to the different types of DES. Although the 3-year incidence of stent thrombosis was considerably low (≤1.0%) for all types of DES, between-group differences were observed, generally favoring the EES platforms. ConclusionsIn this pooled analysis of 3 prospective registries involving unrestricted use of various second-generation DES for LMCAD, we found no significant between-group differences in 3-year risk of target-vessel failure, except for a higher risk of primary outcome with PtCr-EES compared to BP-BES. (Evaluation of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice [IRIS-DES]; NCT01186133)

CRT-100.41 The Safety and Efficacy of Biodegradable-Polymer Biolimus-Eluting Stent (BP-BES) Compared with Durable-Polymer Everolimus-Eluting Stent (DP-EES) in Patients Undergoing Complex Percutaneous Coronary Intervention

The likelihood of stent failure directly correlates with the complexity of underlying coronary artery disease. The biodegradable-polymer biolimus-eluting stent (BP-BES) has a relatively thick strut (120 μm) stainless steel platform, and the unfavorable effect of thick struts may be clinically

Impact of post-dilatation on longitudinal stent elongation: An in vitro study

ObjectivesTo evaluate whether balloon inflation for post-dilatation causes longitudinal stent deformation (LSD). Methods and resultsTwo stents, sized 2.5mm×28mm and 3.5mm×28mm (Nobori®, biodegradable polymer biolimus-eluting stent; Ultimaster®, biodegradable polymer sirolimus-eluting stent; Terumo Co., Tokyo, Japan), were deployed at nominal pressure in straight and tapered silicon vessel models. Then, post-dilatation was performed in two ways: dilatation from the distal (D-P group) or proximal (P-D group) side of the stent. Microscopic findings showed that the stents were elongated during every step of the procedure regardless of the post-dilatation method and type of vessel model. The D-P group showed linear elongation during each step of post-dilatation (straight model: 28.7±0.3mm vs. 29.9±0.3mm, p=0.002; tapered model: 28.0±0.1mm vs. 29.9±0.1mm, p<0.001). In contrast, in the P-D group, the most significant change was observed in the first step of post-dilatation and only slight changes were observed thereafter (straight model: 28.6±0.1mm vs. 29.5±0.1mm, p<0.001; tapered model: 28.2±0.1mm vs. 29.5±0.1mm, p<0.001). Optical frequency domain imaging analysis showed that the frequency of stent strut malapposition was positively correlated with the percentage change in stent length (r=0.74, p<0.0001). ConclusionLSD was observed during every step of post-dilatation in both the straight and tapered vessel models. However, some differences were observed between the D-P and P-D groups. Minimizing stent strut malapposition may reduce the risk of LSD.

A comparison of the main outcomes from BP-BES and DP-DES at five years of follow-up: A systematic review and meta-analysis

Biodegradable polymer biolimus-eluting stents (BP-BES) are third-generation drug-eluting stents (DES) composed of biodegradable polymers that may improve prognosis after percutaneous coronary intervention (PCI). After five years of follow-up, BP-BES showed conflicting results compared to durable polymer drug-eluting stents (DP-DES). We performed a meta-analysis of the outcomes of studies on BP-BES and DP-DES after percutaneous coronary intervention (PCI) at five years of follow-up. Eligible studies were retrieved from PubMed, Embase and the Cochrane Library and reported the results of all-cause mortality, myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR) and stent thrombosis (ST) at five years of follow-up. Five studies of a total of 4687 patients were included in the meta-analysis. At five years of follow-up, BP-BES was associated with lower rates of major adverse cardiac events (MACE) (OR = 0.83, 95%CI = [0.71, 0.97]), TLR (OR = 0.77, 95%CI = [0.62, 0.96]) and ST (OR = 0.60, 95%CI = [0.43 to 0.84]), whereas no significant differences in mortality, MI, or TVR rates were detected. Our results demonstrated that at five years of follow-up, BP-BES can significantly reduce the risk of MACE, TLR and ST, which indicate that safety and efficacy were increased after PCI.

TCT-740 3-year Clinical Outcomes of Durable-Polymer Zotarolimus-Eluting and Biodegradable-Polymer Biolimus-Eluting Coronary Stents in Patients with Acute Coronary Syndroms (a SORT OUT VI Substudy)

Polymer materials on drug-eluting stents may trigger chronic inflammatory responses that can lead to impaired endothelialization of stent struts, malapposition, and increased risk of stent thrombosis, or may serve as corrosive barriers reducing the risk of stent thrombosis. Data indicate that a

Polymer-free amphilimus-eluting stent versus biodegradable polymer biolimus-eluting stent in patients with and without diabetes mellitus

ObjectivesThis study sought to compare clinical outcome of polymer-free amphilimus-eluting stent (PF-AES) versus biodegradable-polymer biolimus-eluting stent (BD-BES) in “all-comer” diabetes mellitus (DM) and non-DM patients who underwent percutaneous coronary intervention. BackgroundThe PF-AES has shown promising preliminary results in patients with DM. MethodsData from 2 multicentre-national registries (the ASTUTE and the INSPIRE-1) were used to analyse 1776 patients stratified in non-DM and DM. A double 1:1 propensity-score matched analysis (PF-AES vs. BD-BES) was performed in each group to adjust for clinical and procedural characteristics. Primary stent-efficacy and stent-safety endpoints were 1-year target-lesion revascularization (TLR) and target-lesion failure (TLF, composed of cardiac-death, target-vessel myocardial infarction and any TLR). ResultsAfter propensity-score matching, 850 patients were stratified as non-DM (425 PF-AES/425 BD-BES) and 480 as DM patients (240 PF-AES/240 BD-BES). Both TLF (20 of 425 [5%] vs. 24 of 425 [6%]; Plog-rank=0.527) and TLR (9 of 425 [2%] vs. 18 of 425 [4%]; Plog-rank=0.079) were similar between PF-AES and BD-BES in non-DM patients. In DM, TLF (12 of 240 [5%] vs. 31 of 240 [13%]; Plog-rank=0.002) and TLR (9 of 240 [4%] vs. 21 of 240 [9%]; Plog-rank=0.019) were significantly lower in PF-AES compared to BD-BES. Upon multivariate analysis, the most powerful predictors of TLF were chronic kidney disease in non-DM (OR 4.24, 95% CI: 2.07–8.70, p<0.001) and stent type in DM patients (OR 2.76, 1.36–5.56, p=0.005). ConclusionsThis matched-cohort study suggests that PF-AES has better safety and efficacy profile than BD-BES in patients with DM.

P3315Long-term efficacy and safety of biodegradable polymer biolimus-eluting vs. permanent polymer everolimus-eluting stents in diabetic Patients: 4-year clinical outcomes

P3315Long-term efficacy and safety of biodegradable polymer biolimus-eluting vs. permanent polymer everolimus-eluting stents in diabetic Patients: 4-year clinical outcomes