Sirolimus-coated balloon in all-comer population of coronary artery disease patients: the EASTBOURNE DIABETES prospective registry.

BACKGROUND: The outcomes of percutaneous coronary intervention (PCI) in diabetic patients are still suboptimal, and it is unclear if diabetic patients might derive a benefit from the use of drug-coated balloons. AIMS: To evaluate the impact of diabetes mellitus on the outcomes of patients undergoing PCI with sirolimus-coated balloon (SCB) MagicTouch (Concept Medical, India). METHODS: We conducted a subgroup analysis of the prospective, multicenter, investigator-initiated EASTBOURNE registry, evaluating the performance of MagicTouch SCB in patients with and without diabetes. The study primary endpoint was target lesion revascularization (TLR) at 12-month follow-up. Secondary clinical endpoints were major adverse clinical events (MACE), death, myocardial infarction (MI), and BARC 2-5 bleedings. RESULTS: Among 2,083 enrolled patients, a total of 864 suffered from diabetes (41.5%). Patients with diabetes had a numerically higher occurrence of TLR (6.5% vs. 4.7% HR 1.38, 95%CI 0.91-2.08), all-cause death (3.8% vs. 2.6%, HR 1.81, 95%CI 0.95-3.46), and MACE (12.2% vs. 8.9%; HR 1.26 95%CI 0.92-1.74). The incidence of spontaneous MI was significantly higher among diabetic patients (3.4% vs. 1.5%, HR 2.15 95%CI 1.09-4.25); bleeding events did not significantly differ. The overall incidence of TLR was higher among in-stent restenosis (ISR) as compared to de-novo coronary lesions, irrespectively from diabetes status. CONCLUSIONS: In the EASTBOURNE DIABETES registry, diabetic patients treated with the MagicTouch SCB did not have a significant increase in TLR when compared to non-diabetic patients; moreover, diabetic status did not affect the study device performance in terms of TLR, in both de-novo lesions and ISR.

Fifteen-Year Clinical Outcomes After Sirolimus-Eluting Stent Implantation.

BACKGROUND: Clinical outcomes after percutaneous coronary intervention have improved with the use of drug-eluting stents, but data beyond 10 years are limited. The purpose of this study was to evaluate the clinical outcomes of patients undergoing sirolimus-eluting stent implantation with follow-up beyond 10 years and to determine the impact of clinical and angiographic characteristics on long-term prognosis.Methods and Results: The clinical outcomes of 885 patients who had undergone sirolimus-eluting stent implantation at a single institution were retrospectively reviewed. Primary endpoints included in the analysis were clinically driven target lesion revascularization (cTLR) and target lesion revascularization (TLR). Univariate and multivariate nominal logistic regression was used for data analysis. The incidence rates of cTLR and TLR beyond 10 years after sirolimus-eluting stent implantation were 16.4% and 36.8%, respectively, with cTLR tending to decrease beyond 10 years. Acute coronary syndrome was a predominant trigger for cTLR. Age, statin use, and stent restenosis emerged as predictors of cTLR within 10 years, but no significant predictors other than age were identified beyond 10 years. CONCLUSIONS: Events continue to occur beyond 10 years after sirolimus-eluting stent implantation, with a trend toward an increase in acute coronary syndromes. It is important to be vigilant about the occurrence of acute coronary syndromes during long-term follow-up.

Radial and ulnar approach for carotid artery stenting with Roadsaver™ double layer micromesh stent: Early and long-term follow-up.

AIMS: We aimed to evaluate the feasibility and safety of carotid artery stenting (CAS) with a newly designed double-layer micromesh stent using wrist approach in patients with significant carotid disease. MATERIALS AND METHODS: Between January 2016 and December 2021, 105 patients undergoing CAS with Roadsaver™ stent were enrolled in a single center prospective study. Follow-up assessments included neurological exams, duplex ultrasound (DUS), and 12-lead ECG. The primary endpoint was the 30-day composite rate of stroke, death, and myocardial infarction. Secondary endpoints included procedure success, access site complications, device success, target lesion revascularization, and in-stent restenosis evaluated with DUS. Long-term outcomes up to 72 months of follow-up were assessed in all eligible patients. RESULTS: The study population was predominantly male (69.5%) with a median age of 68 ± 8 years. Patients were symptomatic in 80% of the cases, and 35% fulfilled the high-risk criteria for surgical endarterectomy. The right internal carotid artery was the target artery in 56 (53.4%), and the left in 49 (46.6%) of the cases. All procedures were successfully completed from the right wrist, with right radial access in 94 (89.5%) cases and ulnar artery access with previous radial artery occlusion in 11 (10.5%) cases. All patients were treated successfully with the study device. The primary endpoint was met with a 30-day major adverse event rate of 0.9% (1/105). Up to 72 months of follow-up (median 30 ± 20 months) there were no strokes, neurological deaths, or target lesion revascularization of the treated lesion. Doppler ultrasound examination revealed nonsignificant in-stent restenosis in two asymptomatic patients. There was no hand ischemia detected in any patient. CONCLUSION: Results from this study demonstrate the radial and ulnar access for CAS with double layer micromesh Roadsaver™ stent is safe and feasible and associated with favorable early and long-term follow-up.

Clinical and Angiographic Outcomes of Elective Paclitaxel-Coated Balloon Angioplasty in Comparison with Drug-Eluting Stents for De Novo Coronary Lesions in Large Vessels.

We retrospectively examined the feasibility of paclitaxel-coated balloon (PCB) angioplasty for de novo stenosis in large coronary vessels (LV; pre- or postprocedural reference vessel diameter ≥ 2.75 mm) in comparison with placement of drug-eluting stents (DESs).Consecutive de novo stenotic lesions in the LV electively and successfully treated with either PCB (n = 73) or DESs (n = 81) from January 2016 to December 2018 at our center were included. The primary endpoint was the incidence of target lesion failure (TLF), including cardiac death, nonfatal myocardial infarction, and target vessel revascularization. The impact of PCB on TLF was examined using Cox proportional hazards models by including 39 variables. The secondary endpoint, angiographic restenosis, defined as a follow-up percent diameter stenosis > 50, was examined in angiographic follow-up lesions after PCB angioplasty (n = 56) and DES placement (n = 53). This retrospective investigation was conducted in July 2022.The mean PCB size and length were 3.23 ± 0.42 and 18.4 ± 4.3 mm, respectively. The TLF frequency in the PCB group (6.8% during the mean observational interval of 1536 ± 538 days) was not significantly different from that in the DES group (14.6%, 1344 ± 606 days, P = 0.097). PCB was not a significant predictor of TLF in the univariate analysis (hazard ratio: 0.424; 95%CI: 0.15-1.21; P = 0.108). There was no angiographic restenosis after PCB angioplasty.The present observational single-center study showed that PCB for de novo stenosis in the LV had no significant adverse impact on TLF and had favorable angiographic outcomes.

Diabetes and restenosis.

Restenosis, defined as the re-narrowing of an arterial lumen after revascularization, represents an increasingly important issue in clinical practice. Indeed, as the number of stent placements has risen to an estimate that exceeds 3 million annually worldwide, revascularization procedures have become much more common. Several investigators have demonstrated that vessels in patients with diabetes mellitus have an increased risk restenosis. Here we present a systematic overview of the effects of diabetes on in-stent restenosis. Current classification and updated epidemiology of restenosis are discussed, alongside the main mechanisms underlying the pathophysiology of this event. Then, we summarize the clinical presentation of restenosis, emphasizing the importance of glycemic control in diabetic patients. Indeed, in diabetic patients who underwent revascularization procedures a proper glycemic control remains imperative.

Incidence and Predictors of Outcome in the Treatment of In-Stent Restenosis with Drug-Eluting Balloons, a Real-Life Single-Centre Study.

Objectives: To determine the one-year and five-year occurrence and prognosticators of major adverse cardiac events (MACE: composition of all-cause death, myocardial infarction, target vessel revascularization, and vessel thrombosis), mortality, and target lesion revascularization (TLR) in patients with in-stent restenosis (ISR) treated with drug-eluting balloons (DEBs). Background: DEBs have become an emerging therapeutic option for ISR. We report the results of a single-center retrospective study on the treatment of ISR with DEB. Methods: 94 consecutive patients with ISR treated with the paclitaxel-eluting balloon were retrospectively studied between August 2011 and December 2019. Results: The one-year MACE rate was 11.8%, and the five-year MACE rate was 39.8%. The one-year mortality was 5.3%, and the five-year mortality rate was 21.5%. The one-year TLR rate was 4.3%, and the five-year rate was 18.7%. The univariable-Cox proportional hazard models for TLR showed lesion length, and the number of DEBs per vessel is associated with adverse outcomes with H.R. of 1.038 (1.007-1.069) and 4.7 (1.6-13.8), respectively. Conclusion: Our data indicate that at one year, DEBs provide an effective alternative to stenting for in-stent restenosis. Our five-year data, representing one of the longest-term follow-ups of DEB use, demonstrate high rates of MACE. The high five-year MACE reflects all-cause mortality in a high-risk population. This is offset by a reasonable five-year rate of TLR, indicating that DEB provides both short-term and long-term benefits in ISR.

Analysis of the incidence and influencing factors associated with binary restenosis of target lesions after drug-coated balloon angioplasty for patients with in-stent restenosis.

BACKGROUND: Drug-coated balloon (DCB) is a novel and effective device for coronary artery disease patients with in-stent restenosis (ISR). However, the incidence and possible influencing factors associated with binary restenosis have not yet been adequately assessed. METHODS: The data are extracted from a prospective, multicenter, randomized controlled trial. A total of 211 patients with ISR were enrolled at 13 centers from August 2017 to October 2018 and treated with DCB. At the 9-month coronary angiographic follow-up, patients were divided into restenosis and non-restenosis groups, and demographic data, lesion features, and laboratory tests were retrospectively reviewed. Furthermore, logistic regression analysis was used to identify possible influencing factors. RESULTS: All patients successfully underwent treatment, and 166 patients with 190 lesions took part in angiography follow-ups at 9 months. Of these, 41 patients with 44 target lesions developed restenosis following treatment, and the incidence of ISR was 24.7%. There were significant differences in the average length of target lesions and the number of multivessel lesions and fasting plasma glucose (FBG) between the two groups (p < 0.05). Demographic data, cardiac risk factors, left ventricular ejection fractions (LVEF), blood routine tests, biochemical tests, and other features of devices and lesions showed no difference. Logistic regression analyses showed that FBG > 6.1 mmol/L (OR: 7.185 95% CI: 2.939-17.567 P < 0.001) and length of lesion (OR:1.046 95% CI: 1.001-1.093 P = 0.046) were associated risk factors. CONCLUSIONS: The longer length of lesions, more target lesions and FBG > 6.1 mmol/L per individual may be characteristics of patients showing ISR following treatment. Studies with larger sample size, and more complete follow-up data are needed in the future to expend on these findings. TRIAL REGISTRATION: No.: NCT04213378, first posted date (30/12/2019).

Factors Associated with Coronary In-Stent Restenosis after Drug-Eluting Stent Implantation in Patients on Chronic Hemodialysis.

AIMS: Recently, drug-eluting stents (DESs) have been widely adopted for patients on chronic hemodialysis (HD). However, whether DES implantation is associated with a reduced rate of in-stent restenosis (ISR) is unclear. We investigated the incidence of ISR and its predictors in patients on HD after DES implantation. METHODS AND RESULTS: We analyzed 194 consecutive patients (331 lesions) on HD who underwent follow-up angiography after DES implantation. ISR was observed in 74 lesions (22.4%). Angiographically, the relative incidence of AHA/ACC type C lesion was increased (47 vs. 32%; p = 0.043), the minimal lumen diameter (MLD) before DES implantation was smaller (0.82 ± 0.49 vs. 0.97 ± 0.45 mm; p < 0.01), and the lesion length (LL) was increased (30.2 ± 16.1 vs. 24.4 ± 12.1 mm; p = 0.023) in lesions with ISR compared to those without ISR. The rate of rotational atherectomy use was also increased in lesions with ISR compared to those without ISR (50% vs. 25%; p < 0.01). In a multivariate analysis, the MLD before DES implantation (odds ratio [OR] = 0.50, 95% confidence interval [CI] 0.27-0.91, p = 0.024), LL (OR = 1.02, 95% CI 1.00-1.04, p = 0.030) and the use of rotational atherectomy (OR = 2.71, 95% CI 1.55-4.72, p < 0.01) were independent predictors of ISR. The incidence of ISR was similar between lesions treated with the first-generation (25.8%) and the second-generation DESs (20.4%). CONCLUSIONS: ISR was observed in 74 lesions (22.4%). A small MLD, long LL, and the use of rotational atherectomy were independent predictors of ISR after DES implantation in patients on HD. There was no significant difference in the ISR rate between the first- and the second-generation DESs.

Is coronary artery tortuosity a predisposing factor for drug-eluting stent restenosis?

BACKGROUND: Coronary artery tortuosity (CAT) is a relatively common finding on coronary angiography and may be associated with impaired left ventricular relaxation and coronary ischemia However, the significance of CAT remains unknown. This study aimed to investigate whether the severity of tortuosity in the targeted coronary segment is a predictor of stent restenosis. METHODS: The study included a total of 637 patients undergoing drug-eluting stent implantation due to stable or unstable angina and who had no native coronary artery stenosis on their last coronary angiogram. The patients were separated into two groups: 312 patients with in-stent restenosis and 325 patients without in-stent restenosis. All patients underwent computed tomography (CT) coronary angiography after invasive angiography and CAT was calculated using the computer software. RESULTS: Patients with in-stent restenosis had higher CAT than those without restenosis (1.25 ± 0.11 vs. 1.11 + 0.07, p < 0.001). Multivariate Cox regression analysis showed that the tortuosity index (hazard ratio [HR]: 1.246 95% confidence interval [CI]: 1.127-1.376 p < 0.001) and the circumflex lesion (HR: 1.437 95% CI: 1.062-1.942 p = 0.019) were independently associated with in-stent restenosis. With the threshold value of severe tortuosity set at 1.15, the prediction of could be made with 81% sensitivity and 80% specificity. CONCLUSION: The severity of tortuosity is proportional to coronary in-stent stenosis in patients with stable and unstable angina pectoris undergoing drug-eluting stent implantation for a severe single coronary artery.

Long-Term Safety and Efficacy of Durable Polymer Cobalt-Chromium Everolimus-Eluting Stents in Patients at High Bleeding Risk: A Patient-Level Stratified Analysis From Four Postapproval Studies.

BACKGROUND: Long-term outcomes in patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention with a drug-eluting stent are unclear. Therefore, we aimed to evaluate long-term adverse events in HBR patients undergoing percutaneous coronary intervention with cobalt-chromium everolimus-eluting stent implantation. METHODS: We analyzed stratified data from 4 all-comers postapproval registries. Patients with at least 1 of the following criteria were categorized as HBR: age ≥75 years, history of major bleeding (MB), history of stroke, chronic oral anticoagulant use, chronic kidney disease, anemia, or thrombocytopenia. Additionally, in a separate analysis, patients were categorized according to the recently published Academic Research Consortium HBR criteria. The Kaplan-Meier method was used for time-to-event analyses. Coronary thrombotic events (CTE) included myocardial infarction or definite/probable stent thrombosis. MB was defined according to the TIMI (Thrombolysis in Myocardial Infarction) or GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) scales. Impact of CTE and MB on subsequent risk of mortality was assessed using multivariable Cox regression with MB and CTE included as time-updated covariates. RESULTS: Of the total 10 502 patients included, 3507 (33%) were identified as HBR. Compared with non-HBR patients, those at HBR had more comorbidities, higher lesion complexity, and a higher risk of 4-year mortality (Hazard Ratio [HR] 4.38 [95% CI, 3.76-5.11]). Results were qualitatively similar when using Academic Research Consortium criteria to define HBR. Risk of mortality was increased after CTE (HR 5.02 [95% CI, 3.93-6.41]), as well as after MB (HR 4.92 [95% CI, 3.82-6.35]). Of note, this effect was consistent across the spectrum of bleeding risk (P-interaction test 0.97 and 0.06, respectively). CONCLUSIONS: Compared with the non-HBR population, HBR patients experienced worse 4-year outcomes after percutaneous coronary intervention with cobalt-chromium everolimus-eluting stent. Both CTE and MB had a significant impact on subsequent risk of mortality irrespective of bleeding risk.

Triglyceride-glucose index is associated with in-stent restenosis in patients with acute coronary syndrome after percutaneous coronary intervention with drug-eluting stents.

BACKGROUND: The triglyceride-glucose (TyG) index is an alternative marker of insulin resistance (IR) and is closely associated with the prevalence and prognosis of atherosclerotic cardiovascular disease (ASCVD). However, the association between the TyG index and in-stent restenosis (ISR) after drug-eluting stent (DES) implantation in patients with acute coronary syndrome (ACS) remains unknown. METHODS: The present study retrospectively recruited patients who were admitted for ACS and underwent coronary angiography at 6 to 24 months after successful DES-based percutaneous coronary intervention (PCI). In addition, we calculated the TyG index with the following formula: Ln(fasting triglyceride [mg/dL] × fasting blood glucose [mg/dL]/2) and divided patients into 3 groups according to the tertile of the TyG index. Most importantly, multivariate logistic regression analysis models were also constructed to assess the association between the TyG index and DES-ISR in patients with ACS. RESULTS: A total of 1574 patients with ACS (58.4 ± 9.4 years, 77.4% male) were included in this study. At the median follow-up time of 12 (9-14) months, the prevalence of DES-ISR increased stepwise with the increasing tertile of the TyG index (11.6% vs 17.3% vs 19.4%, p = 0.002), and the TyG index was also higher in the ISR group than in the non-ISR group (9.00 ± 0.58 vs 8.84 ± 0.61, p < 0.001). In addition, the positive association between the TyG index and the prevalence of DES-ISR was also determined in the fully adjusted model (TyG, per 1-unit increase: OR 1.424, 95% CI 1.116 to 1.818, p = 0.005; tertile of TyG, the OR (95% CI) values for tertile 2 and tertile 3 were 1.454 (1.013 to 2.087) and 1.634 (1.125 to 2.374), respectively, with tertile 1 as a reference). The association was also reflected in most subgroups. Moreover, adding the TyG index to the predictive model for DES-ISR in patients with ACS could contribute to an increase in C-statistics (0.675 vs 0.659, p = 0.010), categorical net reclassification improvement (0.090, p < 0.001), and integrated discrimination improvement (0.004, p = 0.040). CONCLUSION: An elevated TyG index was independently and positively associated with DES-ISR in patients with ACS who underwent PCI. However, the incremental predictive value of the TyG index for DES-ISR was slight. To further confirm our findings, future studies are needed.

In-hospital Bleeding Outcomes of Oral Anticoagulant and Dual Antiplatelet Therapy During Percutaneous Coronary Intervention: An Analysis From the Japanese Nationwide Registry.

ABSTRACT: The type of periprocedural antithrombotic regimen that is the safest and most effective in percutaneous coronary intervention (PCI) patients on oral anticoagulant (OAC) therapy has not been fully investigated. We aimed to retrospectively investigate the in-hospital bleeding outcomes of patients receiving OAC and antiplatelet therapies during PCI using Japanese nationwide multicenter registry data. A total of 26,938 patients who underwent PCI with OAC and antiplatelet therapies between 2016 and 2017 were included. We investigated in-hospital bleeding requiring blood transfusion, mortality, and stent thrombosis according to the antithrombotic regimens used at the time of PCI: OAC + single antiplatelet therapy (double therapy) and OAC + dual antiplatelet therapy (triple therapy). The antiplatelet agents included aspirin, clopidogrel, and prasugrel. The OAC agents included warfarin and direct OACs. Adjusting the dose of OAC or intermitting OAC before PCI was at each operator's discretion. In the study population [mean age (SD), 73.5 (9.5) years; women, 21.5%], the double therapy and triple therapy groups comprised 5546 (20.6%) and 21,392 (79.4%) patients, respectively. Bleeding requiring transfusion was not significantly different between the groups [adjusted odds ratio (aOR), 0.700; 95% confidence interval (CI), 0.420-1.160; P = 0.165] (triple therapy as a reference). Mortality was not significantly different (aOR, 1.370; 95% CI, 0.790-2.360; P = 0.258). Stent thrombosis was significantly different between the groups (aOR, 3.310; 95% CI, 1.040-10.500; P = 0.042) (triple therapy as a reference). In conclusion, for patients on OAC therapy who underwent PCI, periprocedural triple therapy may be safe with respect to in-hospital bleeding risks. However, further investigations are warranted to establish the safety and efficacy of periprocedural triple therapy.

Impact of anemia on in-stent restenosis after percutaneous coronary intervention.

BACKGROUND: Anemia is a common risk factor for post-percutaneous coronary intervention (PCI) adverse events; however, data on its association with in-stent restenosis (ISR) is limited. METHODS: 538 patients who underwent PCI between January 2017 and September 2019 and follow-up angiography 9-12 months after the initial PCI were enrolled in this study. Baseline clinical and procedural characteristics were compared between the ISR and non-ISR groups, and independent predictors of ISR were determined using propensity score matching. RESULTS: The incidence of anemia was 53.5% in patients with ISR and 19.0% in those without ISR. Univariable logistic regression analyses showed that anemia (OR, 4.283; 95% CI, 1.949-9.410; P < 0.001), diabetes mellitus (OR, 2.588; 95% CI, 1.176-5.696; P = 0.018), chronic kidney disease (OR, 3.058; 95% CI, 1.289-7.252; P = 0.011), multiple stenting (OR, 2.592; 95% CI, 1.205-5.573; P = 0.015), bifurcation lesion (OR, 2.669; 95% CI, 1.236-5.763; P = 0.012), and calcification (OR, 3.529; 95% CI, 1.131-11.014; P = 0.030) were closely associated with ISR. Low-density lipoprotein cholesterol (LDL-c) levels and stent diameter were also significantly linked to ISR, as was anemia (P = 0.009) after propensity score matching. CONCLUSION: Anemia is closely associated with post-PCI ISR, and patients with lower hemoglobin levels are at a higher risk of ISR.

Risk factors of in-stent restenosis among coronary artery disease patients with syphilis undergoing percutaneous coronary intervention: a retrospective study.

BACKGROUND: The risk factors of in-stent restenosis (ISR) among coronary artery disease (CAD) patients with syphilis after percutaneous coronary intervention (PCI) are not fully understood. Therefore, this study aimed to elucidate not only the risk factors of ISR among CAD patients with syphilis after performing PCI, but also the population attributable risk percentage (PAR%), which is used to quantify the proportion of ISR that could be eliminated if particular risk factors are not present. METHODS: Evaluation of the prevalence, risk factors, and their PAR% for ISR among CAD patients with syphilis undergoing PCI was conducted retrospectively at Beijing Ditan Hospital. CAD patients with syphilis underwent PCI from August 2010 to August 2019 and received a diagnosis, coronary angiography, PCI, and periodical follow-up. The clinical, laboratory, and imaging data were reviewed and summarised anonymously from electronic medical records. The chi-square or Fisher exact test was used in data analysis. RESULTS: Among 114 CAD patients with syphilis undergoing PCI, ISR occurred in 18 patients (15.78%). The multivariate Cox regression model indicated that average stent length ≥ 35 mm (adjusted hazard ratio [HR] = 4.47, 95% confidence interval [CI] = 1.30-15.44, p = 0.018) and titres of the toluidine red unheated serum test (TRUST) > 1:16 (adjusted HR = 3.72, 95% CI = 1.22-11.36, p = 0.021) were associated with an increased risk of ISR, while successful antisyphilitic treatment (adjusted HR = 0.12, 95% CI = 0.02-0.95, p = 0.045) was protective predictor of ISR among these patients. The PAR% values of particular risk factors associated with ISR including average stent length ≥ 35 mm, titres of TRUST > 1:16, and successful antisyphilitic treatment were 12.2%, 24.0%, and -39.6%, respectively, among these patients. CONCLUSIONS: Preventing the occurrence of ISR among CAD patients with syphilis undergoing PCI requires clinical intervention. Our results indicated that carefully evaluating the length of the vessel lesion to determine whether the stent length is < 35 mm, prioritising the clinical intervention for titres of TRUST > 1:16, and providing successful antisyphilitic treatment could reduce the risk of ISR occurrence.

Factors Influencing 1st and 2nd Generation Drug-Eluting Stent Performance: Understanding the Basic Pharmaceutical Drug-in-Polymer Formulation Factors Contributing to Stent Thrombosis Do We Really Need to Eliminate the Polymer?

Drug-eluting stents (DES) have a major role in treating cardiovascular disease. The evolution of bare metal stents into 1st generation durable-polymer DES (DP-DES) reduced the rate of in-stent restenosis (ISR) and the need for repeat-revascularization. However, clinical outcomes showed similar rates of late stent thrombosis (ST<1 year) and higher rates of very late stent thrombosis (ST>1 year) necessitating the advent of 2nd generation more biocompatible polymer DES and biodegradable-polymer DES (BP-DES) that reduced ST rates with shorter dual anti-platelet therapy (DAPT). Despite the improvements in drugs and polymer biocompatibility for both durable and biodegradable polymers, stent thrombosis remains an issue. Doubts remain about the safety and efficacy of the more biocompatible 2nd generation durable polymers in respect to vessel inflammatory and thrombogenic response as compared to biodegradable polymers despite clinical trial and meta-analyses evidence indicating that 2nd generation DP-DES are non-inferior to BP-DES for stent thrombosis. A long-term presence of the polymer can cause inflammation and thrombogenesis. However, the cause of stent thrombosis is multi-factorial from a drug-in-polymer formulation perspective; e.g., drug release kinetics, drug physiochemical and pharmacological properties, degradation kinetics; polymer biocompatibility and hemocompatibility and coating properties. It appears that the focus should be on controlling burst release and developing more biocompatible, durable polymers, especially considering the cost of PCI utilizing biodegradable, polymer-free and bioresorbable scaffolds. This may give an insight into certain DP-DES effectiveness as compared to BP-DES for the existing clinical data and improve future stent development.

Clinical outcomes after percutaneous coronary intervention for early versus late and very late stent thrombosis: a systematic review and meta-analysis.

Whether the clinical outcomes of stent thrombosis (ST) are different when stratified by time of occurrence remains unclear. The objective of this study was to compare the short- and long-term clinical outcomes after percutaneous coronary intervention (PCI) for early stent thrombosis (EST) versus late stent thrombosis (LST) and very late stent thrombosis (VLST). We enrolled eligible studies searched from the main electronic databases (EMBASE, PubMed, Cochrane). The primary endpoints were in-hospital, 30-day, 1-year and long-term mortality. The secondary endpoints included recurrent stent thrombosis (RST) and target vessel/lesion revascularization (TVR/TLR) during hospitalization, at 30 days, at 1 year and at long-term follow-up. A total of 23 studies with 17,592 patients were included. Compared with mortality rates of the late and very late thrombosis (LST/VLST) group, in-hospital (P = 0.004), 30-day (P < 0.00001), 1-year (P < 0.00001) and long-term mortality rates (P = 0.04) were significantly higher in the EST group. The in-hospital TVR/TLR rates were similar between the EST group and the LST/VLST group. However, a higher trend in TVR/TLR rate at 30 days and a significantly higher TVR/TLR rate at 1 year (P = 0.002) as well as at long-term follow up (P = 0.009) were found in the EST group. EST patients also trended toward higher risk of RST in both short- and long-term follow-up than LST/VLST patients, although differences were not statistically significant. After PCI treatment, patients with EST have worse clinical outcomes in both short- and long-term follow-up than patients with LST/VLST. Further studies are warranted to determine the optimal treatment strategies for EST.

Non-Fasting Hypertriglyceridemia as an Independent Risk Factor for Coronary In-Stent Restenosis after Primary Bare Metal Stent Implantation in Patients with Coronary Artery Disease.

After a percutaneous coronary intervention (PCI) in patients with coronary artery disease (CAD), in-stent neoatherosclerosis may pose a risk of in-stent restenosis (ISR). To clarify whether non-fasting hypertriglyceridemia contributes to ISR, we examined the relationship between non-fasting hypertriglyceridemia (i.e., triglyceride (TG) level ≥ 200 mg/dL) and ISR after stenting with a bare metal stent (BMS) post-primary PCI in patients with CAD by means of a single-site retrospective analysis. A total of 1,039 patients with CAD were enrolled, and 86 patients (112 lesions) were evaluated for BMS-ISR 3-6 months post-primary PCI. The percentage of patients with non-fasting hypertriglyceridemia was significantly higher in the ISR (+) group than in the ISR (-) group (P < 0.009). The follow-up period and number of patients in the ISR (+) group were significantly smaller than those in the ISR (-) group (P < 0.001). There were no significant between-group differences in the other baseline patient characteristics before the primary PCI or at the time of the follow-up coronary angiography. However, at the follow-up period, the ISR (+) group had significantly lower diastolic blood pressure and high-density lipoprotein cholesterol levels (P = 0.015) and significantly higher TG levels (P = 0.012) than the ISR (-) group. A multiple logistic regression analysis demonstrated that non-fasting hypertriglyceridemia and a follow-up period of ≥ 6 months were independent risk factors for ISR after primary PCI in patients with BMS implantation for stenotic CAD (P = 0.006), with an adjusted odds ratio of 8.232 (1.201-56.410) and 0.006 (95% confidence interval < 0.001-0.045), respectively. Non-fasting hypertriglyceridemia may be an additional independent risk factor for BMS-ISR after primary PCI in patients with CAD.

[Analysis of the causes of repeat stenosis of the coronary arteries after elective stenting in patients with stable angina pectoris].

AIM: Coronary stenting is the evidence-based treatment approach of stable angina. The objective was to determine the incidence of restenosis or atherosclerosis progression which led to the need for coronary angiography according to a single center registry data. MATERIALS AND METHODS: The procedure and clinical data of 3732 (2897 males) consecutive stable coronary artery disease patients undergoing coronary stenting, over five years between March 2010 and September 2014, were subject of this study. Over the next 4 years, 1487 (1173 males) patients were re-evaluated due to angina reoccurrence. 699 patients demonstrated the indications for coronary angiography. RESULTS: The restenosis of the previously stented segment was detected in 84 (12%) cases, the progression of coronary atherosclerosis in 306 (44%), the combination of restenosis and atherosclerosis progression in 63 (9%), and the absence of these complications in 245 (35%) cases. The progression of coronary atherosclerosis was the leading indication for the repeat angiography and revascularization (44 and 58%, respectively); p0.05. The basal level of hsCRP2 mg/l had a prognostic significance for the development of combined event (the restenosis and atherosclerosis progression): AUC 0.65 (0.500.75), OR 3.0 (1.17.9), p0.05. CONCLUSION: The progression of coronary atherosclerosis was the leading indication for the repeat angiography and repeat revascularization during 2 years after coronary stenting. The hsCRP level 2 mg/l at baseline had a prognostic significance for the development of restenosis in previously stented segment and coronary atherosclerosis progression.

Magnesium-Based Resorbable Scaffold Versus Permanent Metallic Sirolimus-Eluting Stent in Patients With ST-Segment Elevation Myocardial Infarction: The MAGSTEMI Randomized Clinical Trial.

BACKGROUND: The use of poly-l-lactide acid-based bioresorbable scaffolds is limited in daily clinical practice because of safety concerns and lack of physiological benefit. Magnesium-based bioresorbable scaffold (MgBRS) presents a short resorption period (<1 year) and have the potential of being thromboresistant and exhibiting early restoration of vasomotor function. To date, however, no randomized clinical trial has investigated the performance of MgBRS. Therefore, this study aimed to compare the in-stent/scaffold vasomotion between MgBRS and permanent metallic sirolimus-eluting stent (SES) at 12-month follow-up in ST-segment-elevation myocardial infarction patients. METHODS: This investigator-driven, multicenter, randomized, single-blind, controlled trial randomized ST-segment-elevation myocardial infarction patients 1:1 to SES or MgBRS at 11 academic centers. The primary end point was the rate of increase (≥3%) after nitroglycerin in mean lumen diameter of the in-stent/scaffold segment at 12 months with superiority of MgBRS over SES in the as-treated population. The main secondary end points included angiographic parameters of restenosis, device-oriented composite end point, their individual components, and device thrombosis rate. Besides, endothelial-dependent vasomotor response to acetylcholine (ie, endothelial function) was also assessed in a subgroup of patients (n=69). RESULTS: Between June 2017 and June 2018, 150 ST-segment-elevation myocardial infarction patients were randomized (MgBRS, n=74; SES, n=76). At 1 year, the primary end point was significantly higher in the MgBRS arm (56.5% versus 33.8%; P=0.010). Conversely, late lumen loss was significantly lower in the SES group (in-segment: 0.39±0.49mm versus 0.02±0.27mm, P<0.001; in-device: 0.61±0.55mm versus 0.06±0.21mm; P<0.001). The device-oriented composite end point was higher in the MgBRS arm driven by an increase in ischemia-driven target lesion revascularization rate (12[16.2%] versus 4[5.2%], P=0.030). Definite thrombosis rate was similar between groups (1[1.4%] in the MgBRS arm versus 2[2.6%] in the SES group; P=1.0). Endothelial function assessment at device segment evidenced a more pronounced vasoconstrictive response to maximal dose of acetylcholine in the MgBRS arm (-8.3±3.5% versus -2.4±1.3% in the SES group, P=0.003). CONCLUSIONS: When compared to SES, MgBRS demonstrated a higher capacity of vasomotor response to pharmacological agents (either endothelium-independent or endothelium-dependent) at 1 year. However, MgBRS was associated with a lower angiographic efficacy, a higher rate of target lesion revascularization, without thrombotic safety concerns. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03234348.

Visit-to-visit HbA1c variability is associated with in-stent restenosis in patients with type 2 diabetes after percutaneous coronary intervention.

BACKGROUND: Patients with type 2 diabetes are under substantially higher risk of in-stent restenosis (ISR) after coronary stent implantation. We sought to investigate whether visit-to-visit HbA1c variability is a potential predictor of ISR in diabetic patients after stent implantation. METHODS: We consecutively enrolled type 2 diabetic patients who underwent successful elective percutaneous coronary intervention and performed follow-up coronary angiography after around 12 months. The incidence of ISR and its relationship with visit-to-visit HbA1c variability, expressed as coefficient of variation (CV), standard deviation (SD) and variability independent of the mean (VIM), were studied. Multivariable Cox proportional hazards models were constructed to analyze the predictive value of HbA1c variability for ISR. RESULTS: From September 2014 to July 2018 in Ruijin Hospital, a total of 420 diabetic patients (688 lesions) after stent implantation were included in the final analysis. During a mean follow-up of 12.8 ± 1.3 months, the incidence of ISR was 8.6%, which was significantly increased in patients with higher CV of HbA1c (P = 0.001). The mean diameter stenosis (DS), net luminal loss and net luminal gain were 22.9 ± 16.8%, 0.42 ± 0.88 mm and 1.66 ± 0.83 mm, respectively. Greater DS was observed in subjects with higher tertiles of CV of HbA1c (P < 0.001), and this trend was more prominent in patients with optimal glycemic control (HbA1c ≤ 7%) in the baseline. In multivariate analysis, HbA1c variability was independently associated with incidence of ISR after adjustment for traditional risk factors and mean HbA1c (HR: 3.00 [95% CI 1.14-7.92] for highest vs. lowest tertile). Inclusion of CV of HbA1c led to a better risk stratification accuracy. Assessing HbA1c variability by SD or VIM yielded similar findings. CONCLUSIONS: This study suggests that visit-to-visit HbA1c variability is an independent predictor of incidence of ISR in patients with type 2 diabetes after stent implantation. Trial registration NCT02089360: NCT.