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Coronary drug-eluting stents (DES) built with either durable (DP) or biodegradable (BP) polymeric coatings have been largely tested and are extensively available for routine use. However, their comparative performance remains an open question, particularly in more complex subsets of patients. We evaluated the outcomes of patients with ST-elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (pPCI) using DP-DES versus BP-DES in a large multicenter real-world registry. The population comprised patients with STEMI treated with pPCI within 12 h of symptoms onset. Those treated with more than one DES who received different polymer types were excluded. The final cohort for analysis was selected after propensity score matching (PSM), computed to generate similar groups of DP DES versus BP DES. Primary endpoint was the incidence of major adverse cardiac events (MACE), defined as the composite of total death, myocardial infarction and target lesion revascularization at 2 years. From January 2017 to April 2022, a total of 1527 STEMI patients underwent pPCI with a single DES type (587 DP-DES; 940 BP-DES). After PSM, 836 patients (418 patients in the DP-DES and 418 patients in the BP-DES groups), comprised the final study population. Both study groups had a similar baseline profile. Patients treated with BP-DES group had similar rates of MACE (15.3 % vs. 19.4 %, HR 0.69, 95 % CI 0.50–0.94, p = 0.022). Rates of target lesion revascularization was lower in BP DES group (0.7 % vs. 3.8 %, HR 0.17, 95 % CI 0.05–0.51, p = 0.006). In a cohort of STEMI patients submitted to pPCI, BP and DP DES had similar rates of the primary outcome. Patients treated with BP DES, however, had a decreased incidence of TLR at after 2-year follow-up. • Biodegradable polymer stents enable controlled drug release and subsequent dissolution of the polymeric material, avoiding stimulus for chronic inflammation and the risk of further stent thrombosis; • This observational study evaluated biodegradable polymer stents versus durable polymer stents in a highly thrombogenic clinical scenario – ST segment elevation myocardial infarction; • Patients treated with BP-DES group similar rates of MACE but lower rates of target lesion revascularization after long-term follow up. [ABSTRACT FROM AUTHOR]

Background: The aim of this study was to compare the clinical outcomes of biodegradable polymer (BP) versus durable polymer (DP) drug eluting stents (DES) in patients with calcified coronary lesions who underwent rotational atherectomy (RA) and percutaneous coronary intervention (PCI). Methods: This study was based on a multicenter registry which enrolled patients with calcified coronary artery disease who received PCI using RA during between January 2010 and October 2019 from 9 tertiary centers in Korea. The primary outcome was 3-year all-cause mortality, and the secondary outcomes were cardiovascular death and target-lesion failure. Results: A total of 540 patients who underwent PCI using RA were enrolled with a follow-up period of median 16.1 months. From this registry, 272 patients with PCI using DP-DES and 238 patients with BP-SGDES were selected for analysis. PCI with BP-DES was associated with decreased all-cause mortality after propensity score matching (HR 0.414, CI 0.174–0.988) and multivariate Cox regression analysis (HR 0.458, HR 0.224–0.940). BP-DES was also associated with decreased cardiovascular mortality, but there was no difference in TLF between the two groups. Conclusions: BP-DES were associated with favorable outcomes compared to DP-DES in patients undergoing PCI using RA for calcified coronary lesions. [ABSTRACT FROM AUTHOR]

Background: Long-term clinical data on biodegradable-polymer (BP) drug-eluting stents (DES) are limited. The objective of this study was to assess the long-term safety and efficacy of the BP-DES SYNERGY compared to XIENCE V, a durable-polymer (DP)-DES., Methods: We compared patients treated with BP-DES or DP-DES at our center from 2008 to 2020. The primary outcome was major adverse cardiac events (MACE), defined as the composite of all-cause death, Q-wave myocardial infarction (MI), and target vessel revascularization (TVR). Secondary endpoints were all-cause death, Q-wave MI, target lesion revascularization (TLR), and stent thrombosis (ST)., Results: A total of 4255 patients underwent propensity-score matching, and 380 patients from each cohort were matched. There was no significant difference between BP-DES and DP-DES concerning MACE (5-year estimates: 21.6% vs. 26.6%, log-rank p = 0.259). Furthermore, there was no difference in the TLR rate (5-year estimates: 7.3% vs. 8.6%, log-rank p = 0.781). All-cause death (5-year estimates: 13.6% vs. 12.9%, log-rank p = 0.72) and Q-wave MI (5-year estimates: 0.53% vs. 1.7%, log-rank p = 0.427) were also comparable between the two groups. Of note, the rate of very late ST was very low and similar between the groups (5-year estimates: 0.26% vs. 0.64%, log-rank p = 0.698)., Conclusion: BP-DES and DP-DES demonstrate similar safety and efficacy at 5-year follow-up. Both can be used for the effective treatment of coronary artery disease., (© 2024 Wiley Periodicals LLC.)

Background In a previous trial, higher 5‐year mortality was observed following treatment with biodegradable polymer Orsiro sirolimus‐eluting stents (SES). We assessed 5‐year safety and efficacy of all‐comers as well as patients with diabetes treated with SES or Synergy everolimus‐eluting stents (EES) versus durable polymer Resolute Integrity zotarolimus‐eluting stents (ZES). Methods and Results The randomized BIO‐RESORT (Comparison of Biodegradable Polymer and Durable Polymer Drug‐Eluting Stents in an All Comers Population) trial enrolled 3514 all‐comer patients at 4 Dutch cardiac centers. Patients aged ≥18 years who required percutaneous coronary intervention were eligible. Participants were stratified for diabetes and randomized to treatment with SES, EES, or ZES (1:1:1). The main end point was target vessel failure (cardiac mortality, target vessel myocardial infarction, or target vessel revascularization). Five‐year follow‐up was available in 3183 of 3514 (90.6%) patients. The main end point target vessel failure occurred in 142 of 1169 (12.7%) patients treated with SES, 130 of 1172 (11.6%) treated with EES, versus 157 of 1173 (14.1%) treated with ZES (hazard ratio [HR], 0.89 [95% CI, 0.71–1.12], Plog‐rank=0.31; and HR, 0.82 [95% CI, 0.65–1.04], Plog‐rank=0.10, respectively). Individual components of target vessel failure showed no significant between‐stent difference. Very late definite stent thrombosis rates were low and similar (SES, 1.1%; EES, 0.6%; ZES, 0.9%). In patients with diabetes, target vessel failure did not differ significantly between stent‐groups (SES, 19.8%; EES, 19.2%; versus ZES, 21.1% [Plog‐rank=0.69 and Plog‐rank=0.63]). Conclusions Orsiro SES, Synergy EES, and Resolute Integrity ZES showed similar 5‐year outcomes of safety and efficacy, including mortality. A prespecified stent comparison in patients with diabetes also revealed no significant differences in 5‐year clinical outcomes. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01674803.

BackgroundThe healing response of the Firehawk stent in patients with ST-segment elevation myocardial infarction (STEMI) remains unclear.AimWe compared the vascular healing of a biodegradable polymer sirolimus-eluting stent (Firehawk) vs. a durable polymer everolimus-eluting stent (Xience) at 6 months after percutaneous coronary intervention (PCI) in patients with STEMI.MethodsIn this prospective, multicenter, randomized, non-inferiority study, patients within 12 h of STEMI onset were randomized in a ratio of 1:1 to receive Firehawk or Xience stents. Optical coherence tomography (OCT) follow-up was performed 6 months after the index procedure and assessed frame by frame. The primary endpoint was the neointimal thickness (NIT) at 6 months evaluated by OCT. The safety endpoint was target lesion failure (TLF) at 12 months.ResultsThe Firehawk stent was non-inferior to the Xience stent in terms of the neointimal thickness (73.03 ± 33.30 μm vs. 78.96 ± 33.29 μm; absolute difference: −5.94 [one-sided 95% lower confidence bound: −23.09]; Pnon−inferiority < 0.001). No significant difference was observed between the Firehawk and Xience groups regarding the percentage of uncovered struts (0.55 [0.08, 1.32]% vs. 0.40 [0.21, 1.19]%, P = 0.804), the percentage of malapposed struts (0.17 [0.00, 1.52]% vs. 0.17 [0.00, 0.69]%, P = 0.662), and the healing score (1.56 [0.23, 5.74] vs. 2.12 [0.91, 3.81], P = 0.647). At 12 months, one patient in the Firehawk group experienced a clinically indicated target lesion revascularization. No other TLF events occurred in both groups. Independent risk factors of the NIT included body mass index, hyperlipidemia, B2/C lesions, thrombus G3–G5, thrombus aspiration, and postdilation pressure.ConclusionIn patients with STEMI, Firehawk was non-inferior to Xience in vascular healing at 6 months. Both stents exhibited nearly complete strut coverage, moderate neointimal formation, and minimal strut malapposition.Clinical Trial NumberNCT04150016.

Background: Biodegradable polymer drug eluting stents (BP-DES) may offer the advantage of vascular healing in ST-segment elevation myocardial infarction (STEMI). Long-term outcome data comparing BP-DES and second-generation durable polymer drug eluting stents (DP-DES) in STEMI is lacking. This study aims to compare the long-term clinical outcomes of BP-DES versus second-generation DP-DES in STEMI.Methods: This is an observational study of consecutive patients with STEMI who received either BP-DES (n = 854) or DP-DES (n = 708) during primary percutaneous coronary intervention (PCI) from 1st February 2007 to 31st December 2016. The primary outcome was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (MI), and target lesion revascularization with follow up till 30th November 2019.Results: The baseline demographics, lesion and procedural characteristic were similar between the two groups except for more prior MI and chronic obstructive pulmonary disease in the BP-DES group. At a median follow up of 4.2 years (interquartile range: 2.6-6.2 years), the incidence of TLF was similar between BP-DES and DP-DES (adjusted hazard ratio [HR] 0.94, 95% confidence interval [CI] 0.70-1.26). Likewise, incidence of major adverse cardiovascular events (MACE: all-cause death, any MI or target vessel revascularization) and definite stent thrombosis were similar in both groups (MACE: adjusted HR 1.04, 95% CI 0.82-1.32; definite stent thrombosis: adjusted HR 1.06, 95% CI 0.31-3.64).Conclusion: Among patients with STEMI who underwent primary PCI, BP-DES and DP-DES implantation was associated with similar long-term clinical outcomes. [ABSTRACT FROM AUTHOR]

Background and Aims: Neoatherosclerosis is a leading cause of late (>1 year) stent failure following drug-eluting stent implantation. The role of biodegradable (BP) versus durable polymer (DP) drug-eluting stents on long-term occurrence of neoatherosclerosis remains unclear. Superiority of biodegradable against durable polymer current generation thin-strut everolimus-eluting stent (EES) was tested by assessing the frequency of neoatherosclerosis 3 years after primary percutaneous coronary intervention (pPCI) among patients with ST-segment elevation myocardial infarction (STEMI)., Methods: The randomized controlled, multicentre (Japan and Switzerland) CONNECT trial (NCT03440801) randomly (1:1) assigned 239 STEMI patients to pPCI with BP-EES or DP-EES. The primary endpoint was the frequency of neoatherosclerosis assessed by optical coherence tomography (OCT) at 3 years. Neoatherosclerosis was defined as fibroatheroma or fibrocalcific plaque or macrophage accumulation within the neointima., Results: Among 239 STEMI patients randomized, 236 received pPCI with stent implantation (119 BP-EES; 117 DP-EES). A total of 178 patients (75%; 88 in the BP-EES group and 90 in the DP-EES group) underwent OCT assessment at 3 years. Neoatherosclerosis did not differ between the BP-EES (11.4%) and DP-EES (13.3%; odds ratio 0.83, 95% confidence interval 0.33-2.04, p=0.69). There were no differences in the frequency of fibroatheroma (BP-EES 9.1% vs DP-EES 11.1%, p=0.66) or macrophage accumulation (BP-EES 4.5% vs DP-EES 3.3%, p=0.68), and no fibrocalcific neoatherosclerosis was observed. Rates of target lesion failure did not differ between groups (BP-EES 5.9% vs DP-EES 6.0%, p=0.97)., Conclusions: Use of BP-EES for primary PCI in patients presenting with STEMI was not superior to DP-EES regarding frequency of neoatherosclerosis at 3 years., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Background: The ideal drug-eluting stent (DES) for the treatment of unprotected left main coronary artery (ULMCA) is unknown. We compared percutaneous coronary intervention (PCI) using durable polymers versus early-generation, thicker strutted and coated bioabsorbable polymers for ULMCA disease.Methods: Patients who underwent ULMCA PCI (893 patients) from April 2008 to November 2014 were identified from the Grand-DES registry. The primary end point was 3-year target lesion failure (TLF) after propensity score matching.Results: The final analysis included 754 patients (84.4%) and 139 patients (15.6%) in the durable and bioabsorbable polymer group, respectively. The groups differed significantly in lesion and procedural characteristics. Propensity score-matched analysis revealed a trend toward a lower 3-year TLF in the durable polymer group (log rank p=0.071). Independent predictors of 3-year TLF were chronic kidney disease, presentation with acute myocardial infarction, and a two-stenting technique for ULMCA lesions. Definite/probable stent thrombosis rates at 3-years were low in both groups (0.8% vs. 0.7%, p=0.925).Conclusions: The safety of ULCMA PCI was excellent, and durable and bioabsorbable polymer DES provided similar clinical outcomes at 3-year follow-up. Landmark analysis revealed that the durable polymer group had a lower TLF rate from 9 months. Further studies are needed to confirm these results. [ABSTRACT FROM AUTHOR]

Background: Very 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. Methods: We 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. Results: This 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). Conclusion: At 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 registration: ClinicalTrials.gov, NCT00598533, Registered 10 January 2008, https://clinicaltrials.gov/ct2/show/NCT00598533?term=NCT00598533 Kaplan-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). [ABSTRACT FROM AUTHOR]

Recent clinical studies have suggested the feasibility of 1-month dual antiplatelet therapy (DAPT) for patients receiving drug-eluting stent (DES). Although our previous ex-vivo swine arteriovenous (AV) shunt studies under low dose heparin treatment suggested superior thromboresistance of fluoropolymer-coated everolimus-eluting stent (FP-EES) when compared to other polymer-based DESs, the relative thromboresistance of different DESs under single antiplatelet therapy (SAPT) has never been examined. This study aimed to evaluate platelet adhesion under SAPT in competitive DESs in the in vitro flow loop model and ex vivo swine AV shunt model. The thrombogenicity of FP-EES, BioLinx polymer zotarolimus-eluting stent (BL-ZES), and biodegradable polymer everolimus-eluting stent (BP-EES) was assessed acutely using the swine AV shunt model under aspirin or clopidogrel SAPT. Stents were immunostained using antibodies against platelets and inflammatory markers and evaluated by confocal microscopy. Also, the adhesion of platelet and albumin on the three DESs was assessed by an in-vitro flow loop model using human platelets under aspirin SAPT and fluorescent albumin, respectively. In the shunt model, FP-EES showed significantly less platelet and inflammatory cell adhesion than BL-ZES and BP-EES. In the flow loop model, FP-EES showed significantly less platelet coverage and more albumin adsorption than BL-ZES and BP-EES. These results suggest FP-EES may have particular advantage for short-term DAPT compared to other DESs. • Recent studies suggest feasibility of short-term DAPT for patients receiving DES. • The relative thromboresistance of different DESs under SAPT has never been examined. • We compared thrombogenicity in current contemporary DESs. • An in vitro flow loop model and ex vivo swine AV shunt model on SAPT were performed. • Fluoropolymer-coated DES showed superior thromboresistance than other DESs on SAPT. [ABSTRACT FROM AUTHOR]

Aims: The advantage of biodegradable-polymer drug-eluting stents (BP-DES) versus durable-polymer (DP) DES remains uncertain. We compared neointimal formation and endothelial barrier function of new BP sirolimus-eluting stents (BP-SES, BuMA Supreme®) to other contemporary BP-DES, DP-DES, and bare metal stents (BMS).Methods and Results: Light microscopic assessment in swine coronary arteries showed comparable neointimal formation between BP-SES and DP everolimus-eluting stent (DP-EES). The performance of BP-SES was compared with DP-EES (Xience Xpedition®), BP-EES (Synergy®), and BMS (Multi-Link Vision®) at 45- and 90-days in rabbit ilio-femoral arteries using Evans blue dye (EBD) followed by immunostaining for endothelial barrier proteins (p120/vascular endothelial-cadherin [VE-cad]) to evaluate endothelial barrier function and scanning electron microscopy (SEM) to determine strut tissue coverage. BMS followed by BP-SES and BP-EES exhibited smaller EBD positive areas versus that of DP-EES at 45- and 90-days. p120/VE-cad immunostaining and SEM-determined strut coverage was greater at 45- and 90-days for BMS followed by all DESs. Regardless of stent type, the lack of p120/VE-cad co-localization showed greater leukocyte and platelet aggregation.Conclusion: Three types of DES showed different endothelial healing pattern regardless their equivalent suppression of neointimal formation. [ABSTRACT FROM AUTHOR]

Introduction: Percutaneous coronary intervention (PCI) represents the most frequent procedure performed in medicine. Second generation drug eluting stents (DES) have been developed to reduce the rates of late and very late complications of first generation DES. Areas covered: To improve long-term efficacy and safety of patients undergoing PCI, second generation DES have been developed with novel stent platforms, biocompatible durable and biodegradable polymers and newer antiproliferative agents. In this review we provide an overview of second generation DES and their clinical trials, discussing safety and effectiveness of these devices, and outlining clinical indication for use. Expert commentary: Numerous clinical trials have demonstrated the safety and efficacy of second generation DES over the last decade. These devices represent the gold standard treatment in stable and acute coronary syndromes. [ABSTRACT FROM AUTHOR]

Abstract Background The Orsiro biodegradable polymer sirolimus-eluting stent (O-SES) is a new-generation biodegradable polymer drug-eluting stent with the thinnest strut thickness to date developed to improve the percutaneous treatment of patients with coronary artery disease. We perform a meta-analysis of randomized clinical trials (RCTs) comparing the efficacy and safety of an ultra-thin, Orsiro biodegradable polymer sirolimus-eluting stent (O-SES) compared with durable polymer drug-eluting stents (DP-DESs). Methods Medline, Embase, and CENTRAL databases were searched for randomized controlled trials comparing the safety and efficacy of O-SES versus DP-DES. Paired reviewers independently screened citations, assessed risk of bias of included studies, and extracted data. We used the Mantel-Haenszel method to calculate risk ratio (RR) by means of a random-effects model. Results Six RCTs with a total of 6949 patients were selected. All included trials were rated as low risk of bias. The O-SES significantly reduced the risk of myocardial infarction (RR 0.78, 95% confidence interval [CI] 0.62–0.98; I2 = 0%; 10 fewer per 1000 [from 1 fewer to 18 fewer]; high quality) compared with the DP-DES. There was no significant difference between O-SES and DP-DES in the prevention of stent thrombosis (RR: 0.75; 95% CI: 0.52–1.08), cardiac death (RR: 0.93; 95% CI: 0.63–1.36), target lesion revascularization (RR 1.10, 95% CI 0.86–1.42) and target vessel revascularization (RR 0.97, 95% CI 0.78–1.21). Conclusion Among patients undergoing percutaneous coronary intervention, O-SES resulted in significantly lower rates of myocardial infarction than DP-DES and had a trend toward reduction in stent thrombosis.

The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) has been the focus of much discussion. The risk of late stent thrombosis appears less with newer-generation stents, and polymer-free drug-coated stents (DCS) may improve clinical efficacy relative to a bare metal stent without the potential long-term hazards associated with a durable polymer. Based on the outcomes of recent clinical trials, risk stratification to identify high bleeding risk patients and appropriate selection of a polymer-free drug-coated or durable-polymer zotarolimus-eluting stent may optimize clinical outcomes in patients who require an abbreviated DAPT regimen. [ABSTRACT FROM AUTHOR]

Background: Outcome data after extended long-term follow-up of patients with coronary artery disease treated with drug-eluting stents (DES) in randomized clinical trials are scant.Objectives: Performance differences among devices may be expected to emerge over time depending on whether stenting is done with polymer-free or durable polymer DES. This study assessed the 10-year outcomes of patients enrolled in the ISAR-TEST-5 (Test Efficacy of Sirolimus- and Probucol-Eluting Versus Zotarolimus-Eluting Stents) trial.Methods: A total of 3,002 patients were randomized to treatment with either polymer-free sirolimus- and probucol-eluting stents (n = 2,002) or durable polymer zotarolimus-eluting stents (n = 1,000). The primary endpoint was the composite of cardiac death, target vessel-related myocardial infarction, or target lesion revascularization (a device-oriented composite endpoint [DOCE]). Additional endpoints of interest were the patient-oriented composite endpoint (POCE), including all-cause death, any myocardial infarction, or any revascularization; individual components of the composite endpoints; and definite or probable stent thrombosis.Results: The median age of the patients at randomization was 67.8 years. At 10 years, 63.9% of patients were alive. The rates of DOCE and POCE were high in both groups with no difference in the incidence between polymer-free sirolimus- and probucol-eluting stents and durable polymer zotarolimus-eluting stents (DOCE: 43.8% vs. 43.0%, respectively; hazard ratio: 1.01; 95% confidence interval [CI]: 0.89 to 1.14; p = 0.90; POCE: 66.2% vs. 67.7%, respectively; hazard ratio: 0.94; 95% CI: 0.86 to 1.04; p = 0.22). The rates of the individual components of the composite endpoints were comparable in both groups. The incidence of definite/probable stent thrombosis over 10 years was low and comparable in both groups (1.6% vs. 1.9%; hazard ratio: 0.85; 95% CI: 0.46 to 1.54; p = 0.58).Conclusions: At 10 years, there were no measurable differences in outcomes between patients treated with polymer-free versus durable polymer DES. The incidence of stent thrombosis was low and comparable in both groups. High overall adverse clinical event rates were observed during extended follow-up. (Test Efficacy of Sirolimus- and Probucol-Eluting Versus Zotarolimus-Eluting Stents [ISAR-TEST-5]; NCT00598533). [ABSTRACT FROM AUTHOR]

Coronary percutaneous interventions have evolved from plain old balloon angioplasty (POBA) to stent implantation, which itself evolved from bare-metal stents (BMS) to the new biodegradable stents which try to restore endothelial function. Currently, the most commonly used stent is the everolimus-eluting stent. This review will cover the current status of durable polymer everolimus-eluting stent, its history, and future perspectives. Nowadays, the everolimus-eluting stent is the most used device in the acute and chronic settings due to its safety and efficacy. Durable polymer everolimus-eluting stent, supported by much evidence, has demonstrated its efficacy and safety, not only in de novo artery lesions, but in multiples scenarios, such as the acute setting and diabetic population, becoming one of the most polyvalent stents available. Nowadays, research is focused on the reduction of antiplatelet treatment duration. Similar rates of stent thrombosis with short dual antiplatelet treatment regimens of 1 to 3 months compared to pronged treatment have been observed. However, specific studies should be performed to evaluate this possibility. [ABSTRACT FROM AUTHOR]

Very long-term data of the biodegradable polymer drug-eluting stents (BP-DES) in comparison with the contemporary durable polymer DES (DP-DES) are still to be investigated. We aimed to investigate the very long-term clinical performance of contemporary BP-DES against the DP-DES. We performed a systematic review to evaluate very long-term clinical outcomes of BP-DES versus DP-DES. Inclusion criteria were randomized design comparing BP-DES against DP-DES and follow-up duration ≥ 36 months. MEDLINE, EMBASE, and CENTRAL without restricting language or publication status were searched up to December 2018. The primary efficacy and safety endpoints were target lesion failure (TLF; a composite of cardiac death, target vessel myocardial infarction and ischemia-driven target lesion revascularization) and definite/probable stent thrombosis (ST), respectively. Primary analysis was done for the contemporary thin-strut BP- and DP-DES (strut thickness < 100 µm). A total of 9 trials comprising 10,699 patients (BP-DES, n = 6241 versus DP-DES, n = 4458) were analyzed. The mean follow-up duration was 63 months. No significant difference was found in TLF [Odds ratio (95% CI) 1.04 (0.89–1.21)] and definite/probable ST (odds ratio (95% CI) 0.78 (0.59–1.01)] between the BP- and DP-DESs. The present meta-analysis suggested that the contemporary thin-strut BP- and DP-DES have similar efficacy and safety profile at 5-year follow-up. Clinical trial registration PROSPERO; CRD42018101983 https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=101983. [ABSTRACT FROM AUTHOR]

We aimed to quantitatively assess a possible difference of the neointimal quality between biodegradable polymer- (BP-) and durable polymer drug-eluting stents (DP-DESs). We conducted a single-center all-comer prospective cohort study: the RESTORE registry (UMIN000033009). All patients who received successful OCT examination at planned 3-month follow-up after DES implantation were analyzed. Study population was divided into 2 groups, BP-DES versus DP-DES groups. We evaluated standard OCT variables, coverage percent, and the quantitative light property values including light intensity, attenuation, and backscatter. We performed OCT analyses of 121 lesions in 98 patients (BP-DES 55 lesions in 51 patients vs. DP-DES 66 lesions in DP-DES 53 patients). Lesion and procedural characteristics were overall well-balanced between both groups. At 3-month follow-up, neointimal thickness (BP-DES 49.3 [38.2, 57.7] µm versus DP-DES 54.7 [45.1, 70.7] µm, p = 0.059) and coverage percent (BP-DES 94.5 [89.8, 97.0]% vs. DP-DES 95.8 [91.1, 98.1]%, p = 0.083) did not significantly differ. Light intensity of superficial neointima in the BP-DES was lower than that in the DP-DES, whereas that of deep neointima did not differ between both groups. Both superficial and deep neointima of the BP-DES presented significantly lower light attenuation and backscatter than those of the DP-DES did. Almost complete coverage at 3 months in both contemporary BP- and DP-DES would support the ultra-short DAPT strategy in the upcoming decade. Nevertheless, there was a significant difference in the neointimal characteristics on OCT light property 3 months after BP- versus DP-DES implantation.Trial Registration UMIN000033009. [ABSTRACT FROM AUTHOR]

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Purpose: We investigated the safety and efficacy of biodegradable polymer drug-eluting stents (BP-DES) versus second-generation durable polymer drug-eluting stents (DP-DES) in a follow-up period of 5 years. Methods: A meta-analysis was performed using data from the PubMed, EMBASE, and Cochrane Library databases. The primary endpoint was target lesion failure (TLF), a composite endpoint of safety and efficacy, which included cardiac death, target vessel myocardial infarction (MI), and clinically indicated target lesion revascularization (TLR). Secondary endpoints were all-cause death, MI, TLR, definite or probable stent thrombosis (ST), and definite or probable very late ST. In addition, we performed subgroup analyses based on patient and stent characteristics. Results: Nine randomized controlled trials (RCTs) in 11,817 patients were included in the meta-analysis. Compared with second-generation DP-DES, BP-DES was not associated with increased risk of TLF (odds ratio (OR) 1.06, 95 % confidence interval [CI] 0.94–1.20; p = 0.33), all-cause death (OR 1.04, [0.92–1.18], p = 0.49), myocardial infarction (OR 0.97, [0.83–1.13], p = 0.67), target lesion revascularization (OR 1.08, [0.94–1.23], p = 0.27), definite or probable stent thrombosis (OR 0.85, [0.66–1.11], p = 0.24), or definite or probable very late stent thrombosis (OR 0.86, [0.58–1.26],p = 0.43). Furthermore, the subgroup analyses did not reveal any statistically significant differences between the stent groups. Conclusion: At 5 years of follow-up, the safety and efficacy of BP-DES are clinically comparable to those of second-generation DP-DES. [ABSTRACT FROM AUTHOR]

The purpose of this study was to evaluate the vessel healing status 3 months after stent implantation of bioresorbable-polymer drug-eluting stents (BP-DESs) in comparison with durable-polymer DESs (DP-DESs) by angioscopy. Study design was a single-center all-comer prospective cohort study: the RESTORE registry (UMIN000033009). All patients who received successful angioscopic examination at planned 3-month follow-up after the DES implantation in the native coronary artery were enrolled. We evaluated main, maximum, minimum strut coverage grades and coverage heterogeneity score defined as a difference between maximum and minimum coverage grades. All lesions were divided into three segments: proximal, mid, and distal segments. A total of 108 patients (66.6 ± 10 years) with 124 lesions were analyzed (BP-DES 57 patients 61 lesions 226 segments vs. DP-DES 57 patients 63 lesions 203 segments; six patients had both BP-DES and DP-DES). Patient and lesion demographics, procedural characteristics were well balanced. Main coverage grade (mean ± standard error; 1.08 ± 0.02 vs. 1.05 ± 0.03, p = 0.354) and minimum coverage grade (1.00 ± 0.00 vs. 1.00 ± 0.00, p > 0.999) were not significantly different between BP-DES and DP-DES groups. Maximum coverage grade was significantly higher in the BP-DES than in the DP-DES (1.45 ± 0.04 vs. 1.35 ± 0.04, p = 0.049). Coverage heterogeneity score did not differ between BP-DES and DP-DES groups (1.05 ± 0.07 vs. 0.90 ± 0.07, p = 0.162). At 3-month follow-up, the current BP-DES had higher maximum stent coverage than the contemporary DP-DES, while main and minimum coverage grades and heterogeneity of the neointimal coverage were comparable. Further prospective randomized trials should be conducted to evaluate the clinical significance of the present imaging results. [ABSTRACT FROM AUTHOR]

Abstract Aims Despite similar efficacy and safety profile in pilot studies, bioresorbable polymer drug-eluting stents (BP-DES) could have potential benefit over latest generation durable polymer (DP)-DES by facilitating vessel healing, therefore reducing inflammation and neoatherosclerosis leading to enhanced clinical safety. Therefore, we sought to perform a meta-analysis of randomized clinical trials (RCTs) comparing the safety and efficacy of everolimus-eluting BP-DES (BP-EES) to second-generation DP-DES. Methods and results We conducted a systematic review and meta-analysis to examine the safety and efficacy of BP-EES in patients treated for coronary artery disease. We searched PubMed, Scopus, and the Cochrane Library through February 2018 for RCTs that included outcome data on BP-EES. We identified four eligible studies, which included a total of 4631 patients. Three studies reported a follow-up of one year and one study of five years. The BP-EES group, included 2315 patients and the DP-DES group included 2316 patients (1143 treated with DP-EES and 1173 treated with zotarolimus eluting DP-DES). Patient's characteristics were comparable between the two groups except for higher prevalence of prior MI in the DP-DES group (25.7 vs 22.5%, respectively, p = 0.001). Procedural characteristics were comparable among groups except for slightly longer lesions in the BP-EES group compared to the DP-DES group (mean 15.1 vs 14.9 mm, p = 0.04). No significant differences were observed for cardiac mortality (p = 0.72), occurrence of MI (p = 0.64), any TLR (p = 0.93), ST (p = 0.85) or major adverse cardiac events (p = 0.43). Conclusion Overall, based on the available data BP-EES had similar one-year outcomes to contemporary DP-DES. Whether these devices could enhance clinical safety remains to be evaluated at longer follow-up. Highlights • To date, no meta-analysis focused on the safety and efficacy of biodegradable polymer everolimus-eluting stents (BP-EES) to second-generation durable polymer drug-eluting stents (DP-DES). • Overall, BP-EES had similar one-year outcomes compared to contemporary DP-DES. • Whether these devices could enhance long-term clinical efficacy remains to be evaluated at longer follow-up. [ABSTRACT FROM AUTHOR]

Purpose: Patients with high bleeding risk (HBR) who undergo percutaneous coronary intervention also have an increased risk of ischemic events and represent an overall high-risk population. The coating of durable polymer drug-eluting stents (DP-DES) may induce inflammation and delay arterial healing, which might be reduced by novel biodegradable polymer DES (BP-DES). We aimed to evaluate the safety and efficacy of treating HBR patients with very thin-strut BP-DES versus thin-strut DP-DES.Methods: Participants in BIO-RESORT (NCT01674803), an investigator-initiated multicenter, randomized all-comers trial, were treated with very thin-strut BP-DES (Synergy or Orsiro) or thin-strut DP-DES (Resolute Integrity). For the present analysis, patients were classified following HBR criteria based on previous trials. The primary endpoint was target vessel failure: a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization at 1 year.Results: Of all 3514 patients, 1009 (28.7%) had HBR. HBR patients were older (p < 0.001) and had more co-morbidities than non-HBR patients (p < 0.001). At 1-year follow-up, HBR patients had significantly higher rates of target vessel failure (6.7 vs. 4.2%, p = 0.003), cardiac death (1.9 vs. 0.4%, p < 0.001), and major bleeding (3.3 vs. 1.5%, p = 0.001). Of all 1009 HBR patients, 673 (66.7%) received BP-DES and 336 (33.3%) had DP-DES. The primary endpoint was met by 43/673 (6.5%) patients treated with BP-DES and 24/336 (7.3%) treated with DP-DES (HR 0.88 [95%CI 0.54-1.46], p = 0.63). There were no significant between-group differences in the most global patient-oriented clinical endpoint (9.7 vs. 10.5%, HR 0.92 [95%CI 0.61-1.39], p = 0.69) and other secondary endpoints.Conclusions: At 1-year follow-up, very thin-strut BP-DES showed similar safety and efficacy for treating HBR patients as thin-strut DP-DES. [ABSTRACT FROM AUTHOR]

Aims Whether biodegradable-polymer drug-eluting stents (BP-DES) induce a vascular response at follow-up more favourable than that of new-generation durable-polymer drug-eluting stents (DP-DES) remains controversial. We sought to evaluate the vascular response to percutaneous coronary intervention (PCI) with BP-DES vs. new-generation DP-DES as assessed by optical coherence tomography (OCT) imaging at follow-up. Methods and results We undertook a meta-analysis of aggregate data by searching electronic scientific databases for investigations of PCI-patients receiving BP-DES vs. new-generation DP-DES and OCT imaging at follow-up. The primary outcome was neointima hyperplasia (NIH) thickness. The co-primary outcome was the incidence of lesions with uncovered struts. The main secondary outcome was the incidence of lesions with malapposed struts. Among 10 trials, a total of 544 PCI-patients were assigned to BP-DES (n  = 282) or new-generation DP-DES (n  = 262). Of these, 447 participants with 480 treated lesions had analysable OCT imaging at a weighted median follow-up of 7 months. Lesions treated with BP-DES vs. new-generation DP-DES showed comparable NIH thickness [weighted mean difference 95% confidence intervals (CI)  = −11.37 (−29.25, 6.52); P  = 0.21]. However, thick-struts (>100 μm) BP-DES showed less NIH thickness as compared to new-generation DP-DES [−20.39 (−33.83, −6.95); P  = 0.003]. BP-DES vs. new-generation DP-DES showed a higher risk for uncovered struts [odds ratio 95% CI = 3.50 (1.69–7.26); P  = 0.0008] and a trend towards higher risk for malapposed struts [2.01 (0.98–4.12); P  = 0.06]. Conclusion In PCI-patients with available OCT imaging at follow-up, BP-DES with thicker backbones delay vascular response as compared with new-generation DP-DES. [ABSTRACT FROM AUTHOR]

Background: The Orsiro biodegradable polymer sirolimus-eluting stent (O-SES) is a new-generation biodegradable polymer drug-eluting stent with the thinnest strut thickness to date developed to improve the percutaneous treatment of patients with coronary artery disease. We perform a meta-analysis of randomized clinical trials (RCTs) comparing the efficacy and safety of an ultra-thin, Orsiro biodegradable polymer sirolimus-eluting stent (O-SES) compared with durable polymer drug-eluting stents (DP-DESs).Methods: Medline, Embase, and CENTRAL databases were searched for randomized controlled trials comparing the safety and efficacy of O-SES versus DP-DES. Paired reviewers independently screened citations, assessed risk of bias of included studies, and extracted data. We used the Mantel-Haenszel method to calculate risk ratio (RR) by means of a random-effects model.Results: Six RCTs with a total of 6949 patients were selected. All included trials were rated as low risk of bias. The O-SES significantly reduced the risk of myocardial infarction (RR 0.78, 95% confidence interval [CI] 0.62-0.98; I2 = 0%; 10 fewer per 1000 [from 1 fewer to 18 fewer]; high quality) compared with the DP-DES. There was no significant difference between O-SES and DP-DES in the prevention of stent thrombosis (RR: 0.75; 95% CI: 0.52-1.08), cardiac death (RR: 0.93; 95% CI: 0.63-1.36), target lesion revascularization (RR 1.10, 95% CI 0.86-1.42) and target vessel revascularization (RR 0.97, 95% CI 0.78-1.21).Conclusion: Among patients undergoing percutaneous coronary intervention, O-SES resulted in significantly lower rates of myocardial infarction than DP-DES and had a trend toward reduction in stent thrombosis. [ABSTRACT FROM AUTHOR]

Objectives This study sought to investigate endothelial coverage and barrier protein expression following stent implantation. Background Biodegradable polymer drug-eluting stents (BP-DES) have been purported to have biological advantages in vessel healing versus durable polymer DES (DP-DES), although clinical trial data suggest equipoise. Methods Biodegradable polymer-sirolimus-eluting stents (BP-SES), durable polymer-everolimus-eluting stents (DP-EES), and bare-metal stents (BMS) were compared. In the rabbit model (28, 45, and 120 days), stented arteries underwent light microscopic analysis and immunostaining for the presence of vascular endothelium (VE)-cadherin, an endothelial barrier protein, and were subjected to confocal microscopy and scanning electron microscopy. A cell culture study in stented silicone tubes was performed to assess cell proliferation. Results Light microscopic assessments were similar between BP-SES and DP-EES. BMS showed nearly complete expression of VE-cadherin at 28 days, whereas both DES showed significantly less with results favoring BP-SES versus DP-EES (39% coverage in BP-SES, 22% in DP-EES, 95% in BMS). Endothelial cell morphologic patterns differed according to stent type with BMS showing a spindle-like shape, DP-EES a cobblestone pattern, and BP-SES a shape in between. VE-cadherin-negative areas showed greater surface monocytes regardless of type of stent. Cell proliferation was suppressed in both DES with numerically less suppression in BP-SES versus DP-EES. Conclusions This is the first study to examine VE-cadherin expression after DES. All DES demonstrated deficient barrier expression relative to BMS with results favoring BP-SES versus DP-EES. These findings may have important implications for the development of neoatherosclerosis in different stent types. [ABSTRACT FROM AUTHOR]

Introduction: Polymers are an essential component of drug-eluting stents (DES) used to control drug release but remain the most controversial component of DES technology. There are two types of polymers employed in DES: durable polymer based DES (DP-DES) and biodegradable polymer DES (BP-DES). First-generation DES were exclusively composed of DP and demonstrated increased rates of late stent failure due in part to poor polymer biocompatibility. Newer generations DES use more biocompatible durable polymers or biodegradable polymers. Areas covered: We will cover issues identified with 1st-generation DP-DES, areas of success and failure in 2nd-generation DP-DES and examine the promise and shortcomings of BP-DES. Briefly, fluorinated polymers used in 2nd-generation DP-DES have excellent anti-thrombogenicity and better biocompatibility than 1st-generation DES polymers. However, these devices lead to persistent drug exposure to the endothelium which impairs endothelial function and predisposes towards neoatherosclerosis. Meanwhile, BP-DES has shortened the duration of drug exposure which might be beneficial for endothelial functional recovery leading to less neoatherosclerosis. However, it remains uncertain whether the long-term biocompatibility of bare metal surfaces is better than that of polymer-coated metals. Expert commentary: Each technology has distinct advantages, which can be optimized depending upon the particular characteristics of the patient being treated. [ABSTRACT FROM AUTHOR]

Introduction: Despite advances in drug-eluting stent (DES) technology, stent thrombosis (ST) remains the most feared complication with high morbidity and mortality. Areas covered: Stent related factors certainly play a role in the pathophysiology of ST and more recent data suggest coating technologies have the potential to favorable modify this risk though blood material interactions. Of the polymer coatings used in DES, fluorinated polymers in particular have shown significant promise in modifying the risk of ST through their preferential interactions with albumin which is believed to prevent the adhesion and aggregation of platelets to the stent surface and thus minimize thrombus formation. Preclinical data from the porcine arteriovenous fistula model and clinical data from large network meta-analysis support a role for fluorinated polymers in reducing ST. Expert commentary: The search for more biocompatible anti-thrombotic polymer coatings continues and it is likely that further modification of stent based surfaces will revolutionize the field of interventional cardiology by one day obviating the need for systemic anti-platelet therapies in patients receiving intravascular devices. [ABSTRACT FROM AUTHOR]

Objectives The authors sought to perform a meta-analysis of randomized clinical trials (RCTs) comparing the safety and efficacy of biodegradable polymer drug-eluting stents (BP-DES) to second-generation durable polymer drug-eluting stents (DP-DES). Background Prior meta-analyses have established the superiority of BP-DES over bare-metal stents and first-generation DP-DES; however, their advantage compared with second-generation DP-DES remains controversial. Methods The authors searched PubMed and Scopus databases for RCTs comparing BP-DES to the second-generation DP-DES. Outcomes included target vessel revascularization (TVR) as efficacy outcome and cardiac death, myocardial infarction (MI), and definite or probable stent thrombosis (ST) as safety outcomes. In addition, we performed landmark analysis for endpoints beyond 1 year of follow-up and a subgroup analysis based on the stent characteristics. Results The authors included 16 RCTs comprising 19,886 patients in the meta-analysis. At the longest available follow-up (mean duration 26 months), we observed no significant differences in TVR (p = 0.62), cardiac death (p = 0.46), MI (p = 0.98), or ST (risk ratio: 0.83, 95% confidence interval: 0.64 to 1.09; p = 0.19). Our landmark analysis showed that BP-DES were not associated with a reduction in the risk of very late ST (risk ratio: 0.87, 95% confidence interval: 0.49 to 1.53; p = 0.62). Similar outcomes were seen regardless of the eluting drug (biolimus vs. sirolimus), the stent platform (stainless steel vs. alloy), the kinetics of polymer degradation or drug release (<6 months vs. >6 months), the strut thickness of the BP-DES (thin <100 μm vs. thick >100 μm), or the DAPT duration (≥6 months vs. ≥12 months). Conclusions BP-DES have similar safety and efficacy profiles to second-generation DP-DES. [ABSTRACT FROM AUTHOR]