Neoatherosclerosis: A Distinctive Pathological Mechanism of Stent Failure.

With the development of drug-eluting stents, intimal re-endothelialisation is significantly inhibited by antiproliferative drugs, and stent restenosis transforms from smooth muscle cell proliferation to neoatherosclerosis (NA). As a result of the development of intravascular imaging technology, the incidence and characteristics of NA can be explored in vivo, with some progress made in illustrating the mechanisms of NA. Experimental studies have shed light on the molecular characteristics of NA. More critically, sufficient evidence proves NA as a significant cause of late stent failure. Treatments for NA are still being explored. In this review, we summarise the histopathological characteristics of different types of stent NA, explore the potential relationship of NA with native atherosclerosis and discuss the clinical significance of NA in late stent failure and the promising present and future prevention and treatment strategies.

Long-term outcomes after coronary intervention with biodegradable polymer stents in patients with acute coronary syndromes.

BACKGROUND: Patients with acute coronary syndromes (ACS) may have worse outcomes after percutaneous coronary intervention compared to patients without ACS. AIMS: To compare 5-year efficacy and safety outcomes in patients with and without ACS treated with biodegradable polymers, the ultrathin strut sirolimus-eluting Orsiro stent (O-SES) or the biolimus-eluting Nobori stent (N-BES). METHODS: The Scandinavian Organisation for Randomized Trials with Clinical Outcome VII is a randomized trial comparing O-SES and N-BES in an all-comer setting. Of 2525 patients, 1329 (53%) patients had ACS and 1196 (47%) patients were without ACS. Endpoints were target lesion failure (TLF) (a composite of cardiac death, target lesion myocardial infarction, or target lesion revascularization) and definite stent thrombosis within 5 years. RESULTS: At 5-year follow-up, TLF did not differ significantly between patients with and without ACS (12.3% vs. 13.2%; rate ratio (RR) 1.00; 95% confidence interval (CI): 0.70-1.44), whereas the risk of definite stent thrombosis was increased in patients with ACS (2.3% vs. 1.3; RR: 2.01 [95% CI: 1.01-3.98]). In patients with ACS, the rate of TLF was similar between O-SES and N-BES (12.4% vs. 12.3%; RR: 1.02; 95% CI: 0.74-1.40). The reduced risk of definite stent thrombosis in O-SES treated ACS patients within the first year (0.2% vs. 1.6%; RR: 0.12; 95% CI: 0.02-0.93) was not maintained after 5 years (1.8% vs. 2.7%; RR: 0.77; 95% CI: 0.37-1.63). CONCLUSION: Patients with ACS had an increased risk of stent thrombosis regardless of the stent type used. Long-term outcomes were similar for ACS patients treated with O-SES or N-BES at 5 years.

Influence of stent strut and its associated injury on thrombus formation: A dissipative particle dynamics study.

Vascular stent intervention is a pivotal treatment for coronary atherosclerosis, though in-stent thrombosis remains a significant postoperative complication with an unclear underlying mechanism. This study utilized dissipated particle dynamics analysis to investigate the impact of stent and its injury on platelet behavior. The findings suggest that thrombus formation upstream of the stent is mainly initiated by upstream arterial injury, which leads to increased platelet accumulation and activation in that area. While thrombosis downstream of the stent is more directly influenced by the stent itself. The morphology and size of in-stent thrombosis can vary significantly due to the different contributions of the stent and underlying injuries. Additionally, the volume of in-stent thrombosis is affected by the extent of the injury and the viscosity of platelets, showing a notable increase in volume with the lengthening of the injury area and rise in platelet viscosity. This study provides a novel theoretical framework for optimizing stent placement strategies and structural designs by examining the effects of stent struts and associated injuries on thrombus formation.

Modelling of the in-stent thrombus formation by dissipative particle dynamics.

BACKGROUND: Stent implantation is a highly efficacious intervention for the treatment of coronary atherosclerosis. Nevertheless, stent thrombosis and other post-operative complications persist, and the underlying mechanism of adverse event remains elusive. METHODS: In the present study, a dissipative particle dynamics model was formulated to simulate the motion, adhesion, activation, and aggregation of platelets, with the aim of elucidating the mechanisms of in-stent thrombosis. FINDINGS: The findings suggest that stent thrombosis arises from a complex interplay of multiple factors, including endothelial injury resulting from stent implantation and alterations in the hemodynamic milieu. Furthermore, the results suggest a noteworthy association between in-stent thrombosis and both the length of the endothelial injured site and the degree of stent malposition. Specifically, the incidence of stent thrombosis appears to rise in tandem with the extent of the injured site, while moderate stent malposition is more likely to result in in-stent thrombosis compared to severe or minor malposition. INTERPRETATION: This study offers novel research avenues for investigating the plasticity mechanism of stent thrombosis, while also facilitating the clinical prediction of stent thrombosis formation and the development of more precise treatment strategies.

One-Month Dual Antiplatelet Therapy Followed by P2Y12 Inhibitor Monotherapy After Biodegradable Polymer Drug-Eluting Stent Implantation　- The REIWA Region-Wide Registry.

BACKGROUND: The safety and feasibility of using 1-month dual antiplatelet therapy (DAPT) followed by P2Y12inhibitor monotherapy for patients after percutaneous coronary intervention (PCI) with thin-strut biodegradable polymer drug-eluting stents (BP-DES) in daily clinical practice remain uncertain. METHODS AND RESULTS: The REIWA region-wide registry is a prospective study conducted in 1 PCI center and 9 local hospitals in northern Japan. A total of 1,202 patients who successfully underwent final PCI using BP-DES (Synergy: n=400; Ultimaster: n=401; Orsiro: n=401), were enrolled in the registry, and received 1-month DAPT followed by P2Y12inhibitor (prasugrel 3.75 mg/day or clopidogrel 75 mg/day) monotherapy. The primary endpoint was a composite of cardiovascular and bleeding events at 12 months, including cardiovascular death, myocardial infarction (MI), definite stent thrombosis (ST), ischemic or hemorrhagic stroke, and Thrombolysis in Myocardial Infarction (TIMI) major or minor bleeding. Based on the results of a previous study, we set the performance goal at 5.0%. Over the 1-year follow-up, the primary endpoint occurred in 3.08% of patients, which was lower than the predefined performance goal (Pnon-inferiority<0.0001). Notably, definite ST occurred in only 1 patient (0.08%) within 1 year (at 258 days). No differences were observed in the primary endpoint between stent types. CONCLUSIONS: The REIWA region-wide registry suggests that 1-month DAPT followed by P2Y12inhibitor monotherapy is safe and feasible for Japanese patients with BP-DES.

Subacute in-stent thrombosis after carotid artery stenting in a patient with gene polymorphisms associated with aspirin and clopidogrel resistance: a case report.

BACKGROUND: Carotid artery stenting (CAS) is a key treatment option for moderate to severe carotid artery stenosis. Carotid stent thrombosis (CST), a rare complication of CAS, has gained significant attention because of its catastrophic nature. More evidences are needed to guide the diagnosis and treatment of CST. CASE PRESENTATION: This study reports a rare case of sub-acute CST following CAS in a 50-year-old male patient who had experienced repeated cerebrovascular events on the premise of taking antiplatelet drugs. He also suffered an occlusion of the left middle cerebral artery (MCA) in the M2 segment, likely caused by an embolus detached from the stent thrombus. The cause of CST in this patient was presumed to be dual antiplatelet resistance (AR), as indicated by genetic testing. After treated with guide catheter-directed thrombolysis, thrombus aspiration, and a second round of thrombolysis, his in-stent thrombus was basically cleared. His M2 occlusion was resolved by mechanical thrombectomy using the Solitaire FR/Stent with Intermediate Catheter Assisting technique. The patient recovered well after replacement of antiplatelet drugs, and no new thromboembolic event occurred during the 13-month follow-up period. CONCLUSIONS: The occurrence rate of AR-related CST may be underestimated as the cause of majority CST cases remains unclear. Implementation of genetic test for aspirin and clopidogrel resistance may be helpful to find the possible cause of CST and to avoid future repeated cerebrovascular events by replacement of antiplatelet drugs.

Intravascular Ultrasound-Guided versus Angiography-Guided Percutaneous Coronary Intervention for Stent Thrombosis Elevation Myocardial Infarction: An Updated Systematic Review and Meta-Analysis.

INTRODUCTION: Intravascular ultrasound (IVUS) provides intra-procedural guidance in optimizing percutaneous coronary interventions (PCI) and has been shown to improve clinical outcomes in stent implantation. However, current data on the benefit of IVUS during PCI in ST-elevation myocardial infarction (STEMI) patients is mixed. We performed meta-analysis pooling available data assessing IVUS-guided versus angiography-guided PCI in STEMI patients. METHODS: We conducted a systematic search on PubMed and Embase for studies comparing IVUS versus angiography-guided PCI in STEMI. Mantel-Haenszel random effects model was used to calculate risk ratios (RRs) with 95% confidence intervals (CIs) for outcomes of major adverse cardiovascular events (MACEs), death, myocardial infarction (MI), target vessel revascularization (TVR), stent thrombosis (ST) and in-hospital mortality. RESULTS: A total of 8 studies including 336,649 individuals presenting with STEMI were included for the meta-analysis. Follow-up ranged from 11 to 60 months. We found significant association between IVUS-guided PCI with lower risk for MACE (RR 0.82, 95% CI 0.76-0.90) compared with angiography-guided PCI. We also found significant association between IVUS-guided PCI with lower risk for death, MI, TVR, and in-hospital mortality but not ST. CONCLUSION: In our meta-analysis, IVUS-guided compared with angiography-guided PCI was associated with improved long-term and short-term clinical outcomes in STEMI patients.

A Case of Coronary Artery Perforation Caused by Manual Cardiopulmonary Resuscitation in the Catheterization Laboratory.

Cardiopulmonary resuscitation (CPR) is essential for the survival of cardiac arrest patients, but it can cause severe traumatic complications. In the catheterization laboratory, various physical constraints complicate the appropriate performance of CPR. However, we are not aware of reports of CPR complications in this setting. Here, we report a case of coronary artery perforation (CAP) caused by manual CPR in the catheterization laboratory. The patient, a 68-year-old woman, initially underwent successful percutaneous coronary intervention (PCI) for unstable angina. Back in the ward, the patient experienced acute stent thrombosis, which resulted in cardiac arrest, and another PCI was performed under ongoing manual CPR. Although revascularization was successful, sudden CAP occurred, leading to cardiac tamponade. Despite extensive treatment efforts, the patient died 18 hours later.Initially, the compression site of CPR was on the midline of the sternum; however, the compression site shifted to the left, to just above the left anterior descending artery, by the time that CAP was detected via angiography. This corresponded to the area where rib fractures were observed upon computed tomography, suggesting the possibility of traumatic CAP due to manual CPR. The physical constraints in the catheterization laboratory can lead to an inappropriate CPR technique and severe traumatic complications.

[Research progress in coatings with active compounds and extracts of traditional Chinese medicines for coronary intervention devices].

In recent years, the incidence and mortality rates of cardiovascular diseases in China have kept rising, with no significant reduction in disease burden observed. Percutaneous coronary intervention(PCI) is an effective approach for treating coronary artery disease. Drug-eluting stents and drug-coated balloons are currently the most common PCI devices used in clinical practice. However, challenges with restenosis and late-stage thrombotic events persist. Inhibiting the proliferation of vascular smooth muscle cells while enhancing endothelial cell activity is crucial for reducing restenosis and preventing thrombosis, and it remains a challenge in research. The active compounds and extracts of traditional Chinese medicine(TCM), particularly the combinations of active compounds in coatings, possess multi-target potential and serve as a supplement to coatings prepared from synthetic compounds. This review elucidates the application of TCM active compounds(such as arsenic trioxide, paclitaxel, hirudin, tetramethylpyrazine, emodin, oxymatrine, and curcumin), combinations of TCM active compounds(paclitaxel/hirudin, geniposide/baicalin), and TCM extracts(such as Curcumae Rhizoma extract and Tripterygium hypoglaucum extract) in the coatings for PCI devices in recent years. Furthermore, this review expounds the current challenges and future prospects in this field, giving insights into the innovation of PCI devices.

Long-term cardiovascular outcomes of biodegradable polymer drug eluting stents in patients with diabetes versus non-diabetes mellitus: a meta-analysis.

BACKGROUND: Today, diabetes mellitus (DM) has become a worldwide concern. DM is a major risk factor for the development of cardiovascular diseases (CVD). Eligible patients with CVD are treated invasively by percutaneous coronary intervention (PCI) whereby a stent is implanted inside the coronary vessel with the particular lesion to allow sufficient blood flow. Newer scientific research have shown that even though associated with a lower rate of re-stenosis, first-generation drug eluting stents (DES) were associated with a higher rate of late stent thrombosis. Recently, newer stents, namely biodegradable polymer DES (BP-DES) have been developed to overcome the safety issues of earlier generation DES. In this analysis we aimed to systematically compare the long term (≥ 12 months) adverse cardiovascular outcomes observed in DM versus non-DM patients who were implanted with BP-DES. METHODS: Cochrane central, MEDLINE (Subset PubMed), EMBASE, Web of Science, http://www. CLINICALTRIALS: gov and Google scholar were searched for relevant publications involving BP-DES in patients with DM versus non-DM and their associated adverse cardiovascular outcomes. The mean follow-up time period ranged from 12 to 120 months. Data analysis was carried out with the latest version of the RevMan software (version 5.4). Based on the Mantel-Haenszel test, risk ratios (RR) with 95% confidence intervals (CI) were calculated and used to represent the results following analysis. RESULTS: Seven (7) studies with a total number of 10,246 participants were included in this analysis. Stents which were implanted during PCI were BP-DES. Participants were enrolled from the year 2006 to 2013. Our current results showed that in patients who were implanted with BP-DES, the risks of major adverse cardiac events (RR: 1.30, 95% CI: 1.18-1.43; P = 0.00001), myocardial infarction (RR: 1.48, 95% CI: 1.14-1.93; P = 0.003), all-cause mortality (RR: 1.70, 95% CI: 1.29-2.23; P = 0.0002), cardiac death (RR: 1.93, 95% CI: 1.28-2.93; P = 0.002), target vessel revascularization (RR: 1.35, 95% CI: 1.03-1.77; P = 0.03), target lesion revascularization (RR: 1.28, 95% CI: 1.07-1.54; P = 0.007) and target lesion failure (RR: 1.79, 95% CI: 1.52-2.12; P = 0.00001) were significantly higher in the DM group. Definite and probable stent thrombosis (RR: 1.80, 95% CI: 1.28-2.55; P = 0.0009) were also significantly higher in the DM group. CONCLUSIONS: Diabetes mellitus was an independent risk factor associated with long term adverse cardiovascular outcomes following PCI with BP-DES.

Trends in Off-Label Indications of Non-Vitamin K Antagonist Oral Anticoagulants in Acute Coronary Syndrome.

Acute coronary syndrome (ACS) is a leading cause of mortality worldwide. Despite optimal antiplatelet therapy recommendation after ischemic events, recurrent thrombotic complications rate remains high. The recurrent events maybe in part due to increased thrombin levels during ACS which may underscore the need for an additional anticoagulation therapy. Given the advantages of non-vitamin K antagonist oral anticoagulants (NOACs) over warfarin, they have the potential to prevent thrombus formation, in the presence or absence of atrial fibrillation, but at the cost of increased risk of bleeding. NOACs have also shown a promising efficacy in managing left ventricular thrombus and a potential benefit in avoiding stent thrombosis after percutaneous coronary revascularization. Taken as a whole, NOACs are increasingly used for off-licence indications, and continue to evolve as essential therapy in preventing and treating thrombotic events. Herein, this review discusses NOACs off-label indications in the setting of ischemic coronary disease.

Management of failed stenting of the unprotected left main coronary artery.

Percutaneous coronary intervention (PCI) is increasingly accepted as treatment for unprotected left main coronary artery (ULMCA) disease especially in those patients who are unsuitable for cardiac surgery. Treatment of any stent failure is associated with increased complexity and worse clinical outcomes when compared with de novo lesion revascularization. Intracoronary imaging has provided new insight into mechanisms of stent failure and treatment options have developed considerably over the last decade. There is paucity of evidence on the management strategy for stent failure in the specific setting of ULMCA. Treating any left main with PCI requires careful consideration and consequently treatment of failed stents in ULMCA is complex and provides unique challenges. Consequently, we provide an overview of ULMCA stent failure, proposing a tailored algorithm to guide best management and decision in daily clinical practice, with a special focus on intracoronary imaging characterization of causal mechanisms and specific technical and procedural considerations.

Computational Fluid Dynamics for the Prediction of Endograft Thrombosis in the Superficial Femoral Artery.

PURPOSE: Contemporary diagnostic modalities, including contrast-enhanced computed tomography (CTA) and duplex ultrasound, have been insufficiently able to predict endograft thrombosis. This study introduces an implementation of image-based computational fluid dynamics (CFD), by exemplification with 4 patients treated with an endograft for occlusive disease of the superficial femoral artery (SFA). The potential of personalized CFD for predicting endograft thrombosis is investigated. MATERIALS AND METHODS: Four patients treated with endografts for an occluded SFA were retrospectively included. CFD simulations, based on CTA and duplex ultrasound, were compared for patients with and without endograft thrombosis to investigate potential flow-related causes of endograft thrombosis. Time-averaged wall shear stress (TAWSS) was computed, which highlights areas of prolonged residence times of coagulation factors in the graft. RESULTS: CFD simulations demonstrated normal TAWSS (>0.4 Pa) in the SFA for cases 1 and 2, but low levels of TAWSS (<0.4 Pa) in cases 3 and 4, respectively. Primary patency was achieved in cases 1 and 2 for over 2 year follow-up. Cases 3 and 4 were complicated by recurrent endograft thrombosis. CONCLUSION: The presence of a low TAWSS was associated with recurrent endograft thrombosis in subjects with otherwise normal anatomic and ultrasound assessment and a good distal run-off.

Predicting Features of Visceral Stent Failure in Fenestrated Endovascular Aortic Aneurysm Repair.

PURPOSE: Visceral stents in fenestrated endovascular aortic repair (FEVAR) have a significant risk of complications and carry a considerable burden of reinterventions. The aim of this study is to identify preoperative and intraoperative predictors of visceral stent failure. MATERIALS: A retrospective review of 75 consecutive FEVARs in a single center from 2013 to 2021 was undertaken. Data on mortality, stent failure, and reintervention pertaining to 226 visceral stents were collected. METHODS: Anatomical features including aortic neck angulation, aneurysm diameter, and angulation of target viscerals were obtained from preoperative computed tomography (CT) scans. Stent oversizing and intraprocedural complications were recorded. Postoperative CT scans were analyzed to determine the length of cover of target vessels. RESULTS: Only bridging stents through fenestrations to visceral vessels were considered; 28 (37%) cases had 4 visceral stents, 24 (32%) had 3, 19 (25%) had 2, 4 (5%) had 1. Thirty day mortality was 8%, a third of which was related to visceral stent complications. Intraprocedural complexity was documented during the cannulation of 8 (3.5%) target vessels, with a technical success rate of 98.7%. A significant endoleak or visceral stent failure was identified in 22 stents (9.8%) postoperatively, of which 7 (3%) had in-patient reintervention within 30 days. Further reinterventions at 1, 2, and 3 years were 12 (5.4%), 2 (1%), and 1 (0.4%), respectively. Most reinterventions were for renal stents (n=19, 86%). A smaller stent diameter and a shorter length of visceral stent were significant predictors of failure. No other anatomical feature or stent choice was found to be a significant predictor of failure. CONCLUSIONS: The modality of visceral stent failures varies, but renal stents with a smaller diameter and/or shorter length are more likely to fail over time. Their complications and reinterventions are common and carry a significant burden; therefore, close surveillance must be continued long term. CLINICAL IMPACT: With this work we share the methodology adopted at our centre to treat juxtarenal aneurysm with FEVAR. Thanks to this detailed review of anatomical and technical features we provide guidance for endovascular surgeons to face hostile aneurysm with peculiar visceral vessels anatomy. With our findings will also motivate industries in their attempt to produce improved technologies able to overcome issues identified in this paper.

Revascularization of acute stent thrombosis caused by diarrhea after carotid artery stenting in an intermediate clopidogrel metabolizer.

Carotid artery stenting (CAS) is an alternative treatment to carotid endarterectomy for carotid artery stenosis. Acute stent thrombosis (ACST) is an extremely rare complication but can have devastating consequences. Although many cases have been reported, the best treatment is still uncertain. In this study, we report the treatment of ACST caused by diarrhea in an intermediate clopidogrel metabolizer. We also review the literature and discuss appropriate treatment strategies for this rare event.

Association between cancer history and second-generation drug-eluting stent thrombosis: insights from the REAL-ST registry.

BACKGROUND: Cancer-associated thrombosis is a frequent complication of cancer; however, little evidence is available regarding the association between cancer history and coronary artery stent thrombosis (ST). We aimed to investigate the relationship between cancer history and second-generation drug-eluting stent thrombosis (G2-ST). METHODS: From the REAL-ST (Retrospective Multicenter Registry of ST After First- and Second-Generation Drug-Eluting Stent Implantation) registry, this study evaluated 1265 patients (G2- ST cases, n = 253; controls, n = 1012) with cancer-related information available. RESULTS: The prevalence of patients with cancer history was higher (12.3% vs. 8.5%, p = 0.065), and that of currently diagnosed and currently treated cancer was significantly higher in ST cases than controls (3.6% vs. 1.4%, p = 0.021; 3.2% vs. 1.3%, p = 0.037, respectively). Multivariable logistic regression analysis revealed that cancer history was associated with late ST (odds ratio [OR]: 2.80, 95% confidence intervals [CI]: 0.92-8.55, p = 0.071) and very late ST (OR: 2.40, 95% CI: 1.02-5.65, p = 0.046), but not with early ST (OR: 1.01, 95% CI: 0.51-2.00, p = 0.97). During the median follow-up period of 872 days after the index ST events, patients with cancer history showed a higher mortality than those without, among both ST cases (hazard ratio [HR]: 1.93, 95% CI: 1.06-3.51, p = 0.031) and controls (HR: 1.93, 95% CI: 1.09-3.40, p = 0.023). CONCLUSION: A post hoc analysis of REAL-ST registry revealed that patients with G2-ST had a higher prevalence of currently diagnosed and currently treated cancer. Notably, cancer history was associated with the occurrence of late and very late ST, but not with early ST.

An elderly case with late carotid stent thrombosis: possible role of antiphospholipid antibodies.

The case study speculates that the antiphospholipid antibodies acquired during the follow-up period of carotid artery stenting may cause late stent thrombosis that is resistant to direct oral anticoagulants. A 73-year-old man was hospitalized with complaints of weakness in the right lower extremity. The patient had undergone carotid artery stenting for symptomatic stenosis of the left internal carotid artery 6 years prior and had received antiplatelet therapy with clopidogrel 75 mg/day. As the patient had developed atrial fibrillation without stent stenosis at the age of 70 years, anticoagulation therapy with rivaroxaban15 mg/day was initiated while discontinuing clopidogrel. On admission, diffusion weighted imaging (DWI) revealed acute brain infarcts in the territory of the left middle cerebral artery. Contrast-enhanced computed tomography and cerebral angiography exposed severe stenosis in the left carotid artery accompanied by a filling defect caused by a floating thrombus. Laboratory examination revealed the presence of three types of antiphospholipid antibodies, with marked prolongation of activated partial thromboplastin time (APTT). Replacement of rivaroxaban with warfarin eliminated the thrombus without recurrent stroke. In conclusion, late stent thrombosis may be associated with antiphospholipid antibodies acquired during the follow-up period of carotid artery stenting.

One-year outcomes of polymer-free amphilimus-eluting stents versus durable polymer zotarolimus-eluting stents in patients with diabetes mellitus: a meta-analysis.

BACKGROUND: Diabetes mellitus (DM) and cardiovascular diseases often co-exist. Today, percutaneous coronary intervention (PCI) is the preferred revascularization procedure for majority of patients with coronary artery disease. Polymer-free amphilimus-eluting stents (AES) represent a novel elution technology in the current era of drug-eluting stents. In this analysis, we aimed to systematically compare the cardiovascular outcomes which are associated with polymer-free amphilimus-eluting stents (AES) versus the durable polymer zotarolimus-eluting stents (ZES) for the treatment of patients with DM. METHODS: Http://www. CLINICALTRIALS: gov, EMBASE, Web of Science, MEDLINE, Cochrane database and Google Scholar were searched for publications comparing polymer-free AES versus durable polymer ZES in patients with DM. Selective cardiovascular outcomes were assessed. Statistical analysis was carried out by the latest version of the RevMan software. Risk ratio (RR) with 95% confidence interval (CI) was used to represent the data analysis. RESULTS: Four studies with a total number of 1795 participants with DM whereby 912 patients were assigned to be revascularized by the polymer-free AES and 883 patients were assigned to be revascularized by the durable polymer ZES were included in this analysis. In patients with DM, at one year, polymer-free AES were associated with significantly lower risk of major adverse cardiac events (MACEs) (RR: 0.69, 95% CI: 0.54-0.88; P = 0.002) and target lesion failure (TLF) (RR: 0.66, 95% CI: 0.48-0.91; P = 0.01) compared to durable polymer ZES. However, there was no significant change in all-cause mortality (RR: 0.79, 95% CI: 0.51-1.22; P = 0.28), cardiac death and the other cardiovascular outcomes. Similar risk of total stent thrombosis (RR: 1.13, 95% CI: 0.60-2.13; P = 0.70), including definite stent thrombosis (RR: 1.12, 95% CI: 0.38-3.31; P = 0.84), probable stent thrombosis (RR: 0.87, 95% CI: 0.37-2.09; P = 0.76), possible stent thrombosis (RR: 1.19, 95% CI: 0.50-2.87; P = 0.69) and late stent thrombosis (RR: 1.00, 95% CI: 0.17-5.72; P = 1.00) as between polymer-free AES and durable polymer ZES in patients with DM. CONCLUSIONS: At 1 year follow-up, polymer-free AES were associated with significantly lower MACEs and TLF compared to durable polymer ZES in these patients with DM, without any increase in mortality, stent thrombosis and other cardiovascular outcomes. However, this analysis is only based on a follow-up time period of one year, therefore, future research should focus on the long term follow-up time period.

Diabetes mellitus is independently associated with early stent thrombosis in patients undergoing drug eluting stent implantation: Analysis from the Victorian cardiac outcomes registry.

BACKGROUND: Diabetes mellitus (DM) is a predictor of restenosis and late stent thrombosis (ST) in patients undergoing percutaneous coronary intervention (PCI) with drug-eluting-stents (DES). Real-world data on rates of early ST is lacking. We compared clinical outcomes of patients with and without DM from the Victorian cardiac outcomes registry. METHODS: Consecutive patients undergoing PCI with DES were analyzed with primary outcome being ST at 30-days. Secondary outcomes including major adverse cardiovascular events (MACE) and all-cause mortality. RESULTS: Of 43,209 patients included, 9730 (22.5%) had DM. At 30 days, DM was independently associated with higher rates of early ST (0.7% vs. 0.5%) OR 1.41 (95% confidence interval; 1.05-1.87, p = 0.02), MACE (4.1% vs. 3.5%, p = 0.004) and mortality (1.9% vs. 1.5%, p = 0.01). Increased risk was not simply due to treatment. Patients with DM requiring insulin were equally affected in regard to MACE (4.7% vs. 3.9%, p = 0.069) and mortality (1.9%, vs. 1.8%, p = 0.746). On National Death Index linkage, patients with DM had increased all-cause mortality over five-year follow-up (OR 1.69 CI 1.55-1.83, p = < 0.001). CONCLUSION: In this large real-world-registry, DM was an independent predictor of early ST, MACE and mortality at 30 days. These data suggest additional therapeutic strategies are required to reduce the risk of early complications in patients with DM undergoing PCI with DES.

Five-year angiographic, OCT and clinical outcomes of a randomized comparison of everolimus and biolimus-eluting coronary stents with everolimus-eluting bioresorbable vascular scaffolds.

AIMS: To compare 5-year angiographic, optical coherence tomography (OCT), and clinical outcomes between patients treated with bioresorbable vascular scaffolds (BVS) and drug-eluting stents (DES). METHODS: The EverBio-2 trial (Comparison of Everolimus- and Biolimus-Eluting Coronary Stents with Everolimus-Eluting Bioresorbable Vascular Scaffold) was a single-center, assessor-blinded, randomized controlled trial in which 240 patients were randomly allocated (1:1:1) to BVS, everolimus-eluting (EES) or biolimus-eluting (BES) DES. Clinical follow-up was scheduled up to 5 years. All patients, alive and who did not have repeat revascularization of the target lesion during follow-up were asked to return for angiographic follow-up at 5 years. RESULTS: Five-year angiographic follow-up was completed in 122 patients (51%) and OCT analysis was performed in 86 (36%) patients. In-stent late lumen loss was similar in both groups with 0.50 ± 0.38 mm in BVS versus 0.58 ± 0.36 mm in EES/BES, p = 0.20. Clinical follow-up was complete in 232 patients (97%) at 5 years. The rate of the device-oriented endpoint was 22% in the BVS and 18% in the EES/BES group (p = 0.49). The patient-oriented composite endpoint occurred in 40% of BVS- and 43% of EES/BES-treated patients (p = 0.72) at 5 years. No acute coronary syndrome due to stent thrombosis was detected after 2 years. Complete BVS strut resorption was observed at 5 years in the OCT subgroup. CONCLUSION: Five-year clinical outcomes were similar between BVS and DES patients as well as angiographic outcomes in a selected subgroup. However, a definitive conclusion cannot be drawn because the EverBio-2 trial was not powered for clinical and angiographic endpoints at 5 years of follow-up.