Predictive value of Systematic Coronary Risk Evaluation 2-Diabetes risk model and arterial stiffness for cardiovascular events in the Asian population with type 2 diabetes mellitus.

AIMS/INTRODUCTION: Individuals with diabetes are at high risk of developing cardiovascular events. The present study investigated the predictive value of the cardio-ankle vascular index (CAVI) when added to the Systematic Coronary Risk Evaluation 2-Diabetes (SCORE2-Diabetes) risk algorithm to predict cardiovascular events in the Asian population. MATERIALS AND METHODS: The SCORE2-Diabetes risk was assessed in 1,502 patients with diabetes, aged 40-69 years. Then, we further stratified each 10-year risk category with a CAVI value of 9.0. The primary outcomes (composite of all causes of death, myocardial infarction, stroke and hospitalization for heart failure) were assessed over 5 years. RESULTS: The mean age of the population was 59.8 ± 6.4 years. The proportion of 10-year risk according to the SCORE2-Diabetes risk of low, moderate, high and very high risk identified at 7.2, 30.0, 27.2 and 35.6%, respectively. The mean CAVI value was 8.4 ± 1.4, and approximately 35.4% of the patients had CAVI ≥9.0. The SCORE2-Diabetes risk algorithm independently predicted the primary outcomes in patients with diabetes (hazard ratio 1.18, 95% confidence interval [CI] 1.13-1.22), whereas CAVI did not (hazard ratio 1.03, 95% CI 0.89-1.18). The C-index for the primary outcomes of the SCORE2-Diabetes risk algorithm alone was 0.72 (95% CI 0.67-0.77). The combination of SCORE2-Diabetes and CAVI, both in the continuous value and risk groups, did not improve discrimination (C-index 0.72, 95% CI 0.67-0.77 and 0.68, 95% CI 0.64-0.74, respectively). CONCLUSIONS: Adding the CAVI to the SCORE2-Diabetes risk algorithm did not improve individual risk stratification in patients with diabetes.

Updated CRUSADE score to predict in-hospital bleeding: External validation in the Thai percutaneous coronary intervention registry.

BACKGROUND: The Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the ACC/AHA Guidelines (CRUSADE) score has been recommended to predict in-hospital bleeding risk in non-ST segment elevation myocardial infarction (NSTEMI) patients. The evaluation of the CRUSADE risk score in Asian patients undergoing contemporary percutaneous coronary intervention (PCI) for NSTEMI is necessary. AIMS: We aimed to validate and update the CRUSADE score to predict in-hospital major bleeding in NSTEMI patients treated with PCI. METHOD: The Thai PCI registry is a large, prospective, multicenter PCI registry in Thailand enrolling patients between May 2018 and August 2019. The CRUSADE score was calculated based on 8 predictors including sex, diabetes, prior vascular disease (PVD), congestive heart failure (CHF), creatinine clearance (CrCl), hematocrit, systolic blood pressure, and heart rate (HR). The score was fitted to in-hospital major bleeding using the logistic regression. The original score was revised and updated for simplification. RESULTS: Of 19,701 patients in the Thai PCI registry, 5976 patients presented with NSTEMI. The CRUSADE score was calculated in 5882 patients who had all variables of the score available. Thirty-five percent were female, with a median age of 65.1 years. The proportion of diabetes, PVD, and CHF was 46%, 7.9%, and 11.2%, respectively. The original and revised models of the CRUSADE risk score had C-statistics of 0.817 (95% CI: 0.762-0.871) and 0.839 (95% CI: 0.789-0.889) respectively. The simplified CRUSADE score which contained only four variables (hematocrit, CrCl, HR, and CHF), had C-statistics of 0.837 (0.787-0.886). The calibration of the recalibrated, revised, and simplified model was optimal. CONCLUSIONS: The full and simplified CRUSADE scores performed well in NSTEMI treated with PCI in Thai population.

Coronary artery calcium (CAC) score for cardiovascular risk stratification in a Thai clinical cohort: A comparison of absolute scores and age-sex-specific percentiles.

Purposes: Coronary artery calcium (CAC) score provides a quantification of atherosclerotic plaque within the coronary arteries. This study aimed to examine the prevalence and CAC score distribution and to evaluate the association of each CAC score classifications with major adverse cardiovascular events (MACE) in a Thai clinical cohort. Methods: This study was a retrospective observational cohort. We included patients aged above 35 years who underwent CAC score testing. The absolute and age-sex specific percentile classifications were categorized as 0, 1 to 10, 11 to 100, 101 to 400, and >400 and 0, <75th, 75th - 90th, and >90th, respectively. The endpoint was MACE, including cardiovascular death, myocardial infarction, heart failure hospitalization, coronary artery revascularization procedure, and stroke. Multivariable Cox regression was used to estimate the hazard ratios. The discriminative performance between classifications were compared using Harrell's C-statistics. The agreement was assessed via Cohen's Kappa. Results: This study included 440 patients, with approximately 70% of Thai patients exhibiting a CAC score. CAC score distributed higher in male than female and increased with age. Both CAC score classification demonstrated the acceptable predictive performance. However, fair agreement was observed between classifications (Cohen's kappa 0.51, 95%CI 0.42-0.59). Within the absolute classification, a higher CAC score was associated with increased hazard ratios for MACE across stratified age-sex-specific percentile levels. In contrast, the hazard ratios for MACE did not consistently rise with higher age-sex-specific percentile CAC score when stratified by absolute CAC score levels. Conclusions: Both absolute and age-sex-specific percentile CAC score demonstrated acceptable performance in predicting MACE. However, the absolute CAC score classification may be more suitable for risk stratification within the Thai clinical cohort. Our findings offer supportive information that could inform future recommendations for CAC score testing criteria within national clinical practice guidelines.

Aspirin for primary prevention in patients with high cardiovascular risk: insights from CORE-Thailand registry.

Aspirin may be considered for primary prevention in non-elderly patients with high cardiovascular risk. However, contemporary management aimed at aggressive cardiovascular risk factor control may alter benefit-risk ratio of aspirin. Therefore, we aimed to examine the effect of aspirin for primary prevention on the long-term MACEs in a large cohort registry. Cohort Of patients with high Risk for cardiovascular Events (CORE-Thailand) registry is a prospective, multicenter, observational, longitudinal study of Thai patients with high atherosclerotic risk. Patients with established atherosclerotic cardiovascular diseases were excluded. Among 4259 patients with multiple cardiovascular risk factors, 1945 (45.7%) patients used aspirin. After propensity score matching, there were 3228 patients remained in post-matching analysis. During the median follow-up period of 58.2 months, we demonstrated that aspirin use increased risk of long-term MACEs in pre-matching cohort (unadjusted HR 1.76, 95% CI 1.43-2.17, P < 0.001) and post-matching cohort (HR 1.66 (1.31-2.10), P < 0.001). In addition, patients taking aspirin had a higher risk of bleeding than non-aspirin users in pre-matching cohort (unadjusted HR 2.28, 95% CI 1.09-4.75, P = 0.028). We demonstrated that aspirin was associated with increased risk of long-term MACEs in patients with multiple cardiovascular risk factors. Due to the non-randomized design, our results should be interpreted with caution.

Validation of the academic research consortium high bleeding risk definition in Thai PCI registry.

BACKGROUND: Bleeding following percutaneous coronary intervention (PCI) has important prognostic implications. The Academic Research Consortium (ARC) have identified a set of clinical criteria to standardize the definition of a high bleeding risk (HBR). Current study sought to externally validate the ARC definition for HBR patients in a contemporary real-world cohort. METHOD: This post hoc analysis included 22,741 patients undergoing PCI between May 2018 and August 2019 enrolled in Thai PCI Registry. The primary endpoint was the incidence of major bleeding at 12 months post index PCI. RESULTS: In total, 8678 (38.2%) and 14,063 (61.8%) patients were stratified to the ARC-HBR and non-ARC-HBR groups, respectively. Incidence of major bleeding was 3.3 and 1.1 per 1000 patients per month in the ARC-HBR group and the non-ARC-HBR group (HR 2.84 [95% CI: 2.39-3.38]; p < 0.001). Advanced age and heart failure met the 1-year major criteria performance goal of ≥4% major bleeding. The impact of HBR risk factors was incremental. HBR patients also experienced significantly higher rates of all-cause mortality (19.1% versus 5.2%, HR 4.00 [95% CI: 3.67-4.37]; p < 0.001) and myocardial infarction. The ARC-HBR score fairly performed in discriminating bleeding with C-statistic (95% CI) of 0.674 (0.649, 0.698). Updating the ARC-HBR by adding heart failure, prior myocardial infarction, non-radial access, female in the model significantly improved C-statistic of 0.714 (0.691, 0.737). CONCLUSIONS: The ARC-HBR definition could identify patients at increased risk not only for bleeding but also for thrombotic events, including all-cause mortality. Coexistence of multiple ARC-HBR criteria unveiled additive prognostic value.

Cardiac wall rupture in systemic lupus erythematosus: a case report and review of the literature.

Cardiac wall rupture (CWR) is a serious and often fatal complication of myocardial infarction (MI). Despite an increase in the incidence of MI in patients with systemic lupus erythematosus (SLE), cases of CWR in these patients have been reported rarely. This study reports an SLE patient with CWR and pseudoaneurysm formation and reviews previously reported cases of CWR in SLE patients. An English language literature review of from the PubMed, EMBASE, and Scopus databases on published cases of CWR in SLE, up until January 2023, was performed and analyzed. The search identified 4 patients, including the present one, 5 cases altogether. All of them were female aged 27-40 years, and 3 of them had had SLE for 10 years or more. Chest pain and dyspnea were the common presentations. All had left ventricular (LV) wall rupture. Three patients had LV wall rupture with pseudoaneurysm formation (one had MI with normal coronary artery, one myocardial necrosis secondary from small coronary artery vasculitis and one MI from uncertain cause). The other 2 patients had LV free wall rupture (one had MI with extensive coronary atherosclerosis with coronary arteritis, and the other septic myocarditis with septic coronary arteritis) and these 2 patients died before the diagnosis was made. Three patients with pseudoaneurysm received surgical correction with good clinical outcomes in all. Cardiac wall rupture is a serious and often fatal cardiac complication. Emergency diagnosis and appropriate management with an experienced cardiology team is crucial. Surgical correction is the treatment of choice. Key Points • Cardiac wall rupture, a serious and often fatal cardiac complication, has rarely been described in SLE patients. • Emergency diagnosis and appropriate management with an experienced cardiology team is crucial. Surgical correction is the treatment of choice.

Impact of the adjunctive use criteria for intravascular ultrasound-guided percutaneous coronary intervention and clinical outcomes.

The impact of the adherence to the adjunctive use criteria (AUC) for intravascular ultrasound (IVUS) guided percutaneous coronary intervention (PCI) and clinical outcomes in low IVUS volume countries are limited. The current study compared the procedural success and complication rates between used and not used IVUS catheter in the patients who were met (C +) and were not met (C-) the AUC for IVUS-guided PCI. From June 2018 through June 2019, a total of 21,066 patients were included in the Thai PCI registry. Among the study population, 15,966 patients (75.8%) have met the IVUS-AUC. The IVUS-guided PCI rates were 14.5% and 11.3% in the C + and C - groups, respectively. After adjusting for covariables by propensity model, IVUS-guided PCI was identified as an independent predictor of the procedural success rate regardless of whether the AUC were met with the relative risk [RR (95% confidence interval (CI)] of 1.033(1.026-1.040) and 1.012(1.002-1.021) in C + and C- groups, respectively. IVUS-guided PCI increased the procedural complication risks in both groups but were not significant with corresponding RRs of 1.171(0.915-1.426) and 1.693(0.959-2.426). Procedural success was achieved with IVUS-guided PCI regardless of whether the AUC were met. IVUS-guided PCI did not lead to an increase in procedural complications.

External Validation of the ACUITY/HORIZON Bleeding Risk Score among Acute Coronary Syndrome Patients in Thai PCI Registry.

BACKGROUND: External validation is essential before implementing a predictive model in clinical practice. This analysis validated the performance of the ACUITY/HORIZON risk score in the most contemporary Thai PCI registry. METHODS: The ACUITY/HORIZON model was applied and validated externally in 12,268 ACS (acute coronary syndrome) patients. For revision and updating models, the regression coefficientd of all predictors were re-estimated and then additional predictors were stepwise selected from multivariate analysis. RESULTS: In-hospital bleeding defined by the BARC (Bleeding Academic Research Consortium) criteria was 1.3% (161 patients) and 2.3% (285 patients) by the ACUITY criteria. The calibration of both scales demonstrated overestimation of the original model with C-statistic values of 0.704 for ACUITY major bleeding and 0.793 for BARC 3 or 5 bleeding. For ACUITY major bleeding, the discriminatory power of the update model improved substantially when congestive heart failure (CHF), prior vascular disease as well as body mass index were considered. The update model demonstrated good calibration and C-statistic of 0.747 and 0.745 with no white blood cell (WBC) count. For BARC 3 or 5 bleeding, good calibration and discriminatory capacity could be observed when CHF and prior vascular disease were added in the update models, with an excellent C-statistic of 0.838, and a lower C-statistic value of 0.835 was obtained in the absence of WBC count. CONCLUSION: The ACUITY/HORIZON score was successfully validated in contemporary predictive and risk-adjustment models for PCI-related bleeding. The update models had good operating characteristics in patients from a real-world ACS population irrespective of bleeding definitions.

Prognostic Value of Ankle-Brachial Index in Prediction of Cardiovascular Events in an Asian Population with Multiple Atherosclerotic Risk Factors.

We aimed to evaluate the incremental prognostic value after incorporation of the ankle-brachial index (ABI) into the 10-year pool cohort equation (PCE) risk model in patients with multiple risk factors (MRFs). A total of 4332 MRFs patients were divided into 2 groups as ABI ≤.9 or >.9. The primary outcome was hard cardiovascular events (hCVE: including cardiovascular death, myocardial infarction, or ischemic stroke) over a median follow-up of 36 months. The Cox proportional hazards survival model, C-statistic, and net reclassification indices (NRI) were used. The occurrence of the primary outcome in the ABI ≤.9 group (3.7%) was significantly greater than in the ABI > .9 group (1.3%), P < .001. ABI is an independent predictor of hCVE in addition to the variables in the standard risk model (age, gender, and smoking status). ABI modestly improved the C-index when added to the PCE risk model (PCE .70 vs ABI+PCE .74). The addition of ABI to the PCE risk model did not significantly improve the classification of patients (NRI -.029; 95% CI: -.215 to .130). Despite ABI being one of the independent predictors of hCVE, integration of ABI into the PCE model did not improve the efficacy of risk reclassification in patients with MRFs.

Coil embolization to giant left anterior descending artery and left circumflex artery coronary artery aneurysm after failed coronary aneurysmal repair in IgG4-related disease: a case report.

BACKGROUND: IgG4-related disease (IgG4-RD) is a chronic fibroinflammatory condition with multiple-organ involvement. Rupture of coronary artery aneurysms (CAAs) in IgG4-RD is rare. CASE SUMMARY: A 65-year-old man with IgG4-RD has suffered from recurrent episodes of arterial aneurysms since 2003. He presented with chest pain and hypotension caused by localized cardiac tamponade at right ventricle free wall due to the rupture of coronary artery aneurysm (CAA) of left anterior descending artery (LAD). An urgent LAD aneurysm repaired with bovine pericardium and obliterated aneurysmal sac with cryo-acrylate glue was done together with coronary artery bypass grafting (CABG) using saphenous vein graft (SVG) to LAD and SVG to posterior descending artery. Three-month after surgery, the follow-up coronary computed tomography angiography (CCTA) revealed a growing in size of LAD and the second obtuse marginal (OM) branch aneurysm. Heart team discussion agreed to schedule the patient for double coil embolization to LAD and second OM aneurysm under intravascular ultrasound guidance. Both aneurysms were successfully obliterated with vascular coils. Two-week follow-up coronary angiogram showed complete occlusion of LAD aneurysm and near occlusion of the second OM branch aneurysm. DISCUSSION: Coronary artery aneurysm rupture is a life-threatening condition that required prompt detection and treatments. In IgG4-RD patients, acute cardiac tamponade suggesting the rupture of CAA. Coil embolization is an alternative treatment in patients who suffered from recurrent CAA after surgical repair. Serial CCTA is important for early detection of aneurysm in IgG4-RD patients who had vascular involvement.

Clinical outcomes of an ultrathin-strut sirolimus-eluting stent in all-comers population: Thailand Orsiro registry.

BACKGROUND: Despite numerous studies supporting the outperformance of ultrathin-strut bioresorbable polymer sirolimus-eluting stent (Orsiro SES, Biotronik AG), the generalizability of the study results remains unclear in the Asian population. We sought to evaluate the clinical outcomes of the Orsiro SES in unselected Thai population. METHODS: The Thailand Orsiro registry was a prospective, open-label clinical study evaluating all patients with obstructive coronary artery disease implanted with Orsiro SES. The primary endpoint was target lesion failure (TLF) at 12 months. TLF is defined as a composite of cardiac death, target vessel myocardial infarction (TVMI), emergent coronary artery bypass graft (CABG), and clinically driven target lesion revascularization (CD-TLR). Patients with diabetes, small vessels (≤ 2.75 mm), chronic total occlusions (CTOs), and acute myocardial infarction (AMI) were pre-specified subgroups for statistical analysis. RESULT: A total of 150 patients with 235 lesions were included in the analysis. Half of the patients (53.3%) presented with AMI, and 24% had diabetes. Among 235 lesions, 93(39.4%) were small vessels, and 24(10.2%) were chronic total occlusions. The primary endpoint, TLF at 12 months, occurred in eight patients (5.3%), predominately caused by cardiac death. By contrast, the incidences of TVMI and CD-TLR were null. The outcomes in pre-specified subgroup were not different from the overall population (all p > 0.05). One definite late stent thrombosis(0.7%) was incidentally observed during primary percutaneous coronary intervention to the non-target vessel. CONCLUSION: The safety and efficacy of the ultrathin strut sirolimus-eluting stent in unselected cases are confirmed in the Thailand Orsiro registry. Despite the high proportion of pre-specified high-risk subgroups, the excellent stent performance was consistent with the overall population. Trial Registration TCTR20190325001.

Five-year clinical efficacy and safety of contemporary thin-strut biodegradable polymer versus durable polymer drug-eluting stents: a systematic review and meta-analysis of 9 randomized controlled trials.

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.

Fractional Flow Reserve Derived From Computed Tomographic Angiography in Patients With Multivessel CAD.

BACKGROUND: The functional SYNTAX score (FSS) has been shown to improve the discrimination for major adverse cardiac events compared with the anatomic SYNTAX score (SS) while reducing interobserver variability. However, evidence supporting the noninvasive FSS in patients with multivessel coronary artery disease (CAD) is scarce. OBJECTIVES: The purpose of this study was to assess the feasibility of and validate the noninvasive FSS derived from coronary computed tomography angiography (CTA) with fractional flow reserve (FFRCT) in patients with 3-vessel CAD. METHODS: The CTA-SS was calculated in patients with 3-vessel CAD included in the SYNTAX II (SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery II) study. The noninvasive FSS was determined by including only ischemia-producing lesions (FFRCT ≤0.80). SS derived from different imaging modalities were compared using the Bland-Altman and Passing-Bablok method, and the agreement on the SS tertiles was investigated with Cohen's Kappa. The risk reclassification was compared between the noninvasive and invasive physiological assessment, and the diagnostic accuracy of FFRCT was assessed by the area under the receiver-operating characteristic curve using instantaneous wave-free ratio as a reference. RESULTS: The CTA-SS was feasible in 86% of patients (66 of 77), whereas the noninvasive FSS was feasible in 80% (53 of 66). The anatomic SS was overestimated by CTA compared with conventional angiography (27.6 ± 6.4 vs. 25.3 ± 6.9; p < 0.0001) whereas the calculation of the FSS yielded similar results between the noninvasive and invasive imaging modalities (21.6 ± 7.8 vs. 21.2 ± 8.8; p = 0.589). The noninvasive FSS reclassified 30% of patients from the high- and intermediate-SS tertiles to the low-risk tertile, whereas invasive FSS reclassified 23% of patients from the high- and intermediate-SS tertiles to the low-risk tertile. The agreement on the classic SS tertiles based on Kappa statistics was slight for the anatomic SS (Kappa = 0.19) and fair for the FSS (Kappa = 0.32). The diagnostic accuracy of FFRCT to detect functional significant stenosis based on an instantaneous wave-free ratio ≤0.89 revealed an area under the receiver-operating characteristics curve of 0.85 (95% CI: 0.79 to 0.90) with a sensitivity of 95% (95% CI: 89% to 98%), specificity of 61% (95% CI: 48% to 73%), positive predictive value of 81% (95% CI: 76% to 86%), and negative predictive value of 87% (95% CI: 74% to 94%). CONCLUSIONS: Calculation of the noninvasive FSS is feasible and yielded similar results to those obtained with invasive pressure-wire assessment. The agreement on the SYNTAX score tertile classification improved with the inclusion of the functional component from slight to fair agreement. FFRCT has good accuracy in detecting functionally significant lesions in patients with 3-vessel CAD. (A Trial to Evaluate a New Strategy in the Functional Assessment of 3-Vessel Disease Using SYNTAX II Score in Patients Treated With PCI; NCT02015832).

Imaging assessment of bioresorbable vascular scaffolds.

Vascular reparative therapy has become a reality with bioresorbable scaffolds (BRSs). To assess acute and long-term performance of the device, multimodality imaging would be essential. Radiopacity of metal hinders the imaging assessment, whereas radiolucent polymeric scaffolds allow for a precise imaging assessment with either invasive or non-invasive modality at baseline and at follow-up, which is one of the advantages of polymeric BRSs. Recent large trials evaluating clinical results of the first-generation BRS technology raised concerns about the safety and efficacy of these devices, namely, scaffold thrombosis. Intensive research with multimodality imaging in the field is being conducted to have in-depth understanding of the issues, which will facilitate the improvement of implantation techniques and the development of the next-generation BRSs. The current review focuses on the clinical application of the imaging modalities to assess the short- and long-term performance of the Absorb BVS.

First-in-Man Trial of SiO2 Inert-Coated Bare Metal Stent System in Native Coronary Stenosis　- The AXETIS FIM Trial.

BACKGROUND: A novel bare metal stent with an SiO2coating was developed to prevent excessive neointimal hyperplasia by inertization of the metallic stent surface. The efficacy of the device was demonstrated in a preclinical model. The aim of this first-in-man trial was to assess the safety and feasibility of the new device.Methods and Results:This prospective non-randomized single-arm trial was designed to enroll 35 patients with a de novo coronary lesion. Quantitative coronary angiography and optical coherence tomography (OCT) were performed at the baseline procedure and at the 6-month follow-up. Stent implantation was performed with OCT guidance according to optimal stent implantation criteria. The trial was terminated upon the advice of the data safety monitoring board after enrolling 14 patients due to the high incidence of re-intervention. Optimal OCT implantation criteria were achieved in only 8.3% of lesions. At 6 months, angiographic in-stent late lumen loss as the primary endpoint was 0.77±0.44 mm, and binary restenosis occurred in 33.3% of lesions. At the 6-month OCT, neointimal volume obstruction was 32.8±15.6% with a neointimal thickness of 237±117 µm. At 12 months, the device-oriented composite endpoint (defined as cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization rate) was 33.3%. CONCLUSIONS: In contrast with the preclinical study, the Axetis stent did not efficiently suppress neointimal hyperplasia in humans in this trial.

Vascular access site complication in transfemoral coronary angiography between uninterrupted warfarin and heparin bridging.

BACKGROUND: Warfarin discontinuation with heparin bridging is a common practice in patients receiving warfarin prior to elective coronary angiography (CAG). The uninterrupted warfarin strategy has been suggested to be alternative option for patients with high thromboembolic risk. Therefore, we aimed to assess the safety of elective transfemoral CAG during uninterrupted warfarin therapy compared to heparin bridging. METHODS: This study was a randomized open-label design with blinded event evaluation. The 110 consecutive patients (age ≥ 18 years) receiving warfarin before the planned transfemoral CAG were randomly assigned to either heparin bridging or uninterrupted warfarin with targeted INR (2.0-3.0). The primary outcome was the incidence of major vascular access site complications. RESULTS: The baseline characteristics were comparable between two groups (mean age was 60.1 ± 7.8 years, 49 males). The mean INR on the day of CAG of heparin bridging and uninterrupted warfarin groups was 1.2 ± 0.3 and 2.2 ± 0.5 (P < 0.001). The major vascular access site complications occurred in 3 of 55 (5.5%) heparin-bridging patients and in none of 55 uninterrupted warfarin patients (P = 0.243). The total vascular access site complications occurred in 6 (10.9%) heparin-bridging and one (1.8%) uninterrupted warfarin patients (P = 0.113). No patient developed either other bleeding or thromboembolic events during 7 days after CAG. CONCLUSIONS: We demonstrated that an uninterrupted warfarin strategy did not increase vascular access site complications in patients undergoing transfemoral CAG compared to heparin bridging therapy. Due to the safety and the ease of uninterrupted warfarin strategy, this approach should be encouraged in patients receiving long-term warfarin who undergo elective transfemoral CAG.

Difference in haemodynamic microenvironment in vessels scaffolded with Absorb BVS and Mirage BRMS: insights from a preclinical endothelial shear stress study.

AIMS: In silico studies have provided robust evidence that stent design affects local haemodynamic forces, which appear as a major determinant of clinical outcomes following stent implantation. However, the implications of different stent/scaffold configurations on local haemodynamic forces have not yet been investigated in vivo in a comparative fashion. The aim of this study was to compare the ESS distribution in two differently shaped scaffolds using OCT-based modelling. METHODS AND RESULTS: Eight healthy mini pigs were implanted with six Absorb everolimus-eluting bioresorbable vascular scaffolds (Absorb BVS) and five Mirage sirolimus-eluting bioresorbable microfibre scaffolds (Mirage BRMS). Optical coherence tomography (OCT) was performed and strut protrusion was assessed post scaffold implantation. Following the reconstruction of coronary anatomy, blood flow simulation was performed and endothelial shear stress (ESS) was estimated on top of the struts and at luminal surface between the struts in each scaffold. The thicker struts in Absorb (152±140 µm) resulted in an increased protruded distance compared to Mirage (117±123 µm) (p=0.003). This had an effect on the local haemodynamic microenvironment. ESS at the top of the struts was higher in Absorb (1.69±1.20 Pa) than in Mirage (1.53±0.91 Pa) (p<0.001), but lower at inter-strut zones (0.60±0.51 Pa vs. 0.63±0.50 Pa; p<0.01) compared to Mirage. Both scaffold types revealed comparable percentages of vessel luminal surface exposed to recirculation. CONCLUSIONS: Absorb demonstrated higher shear stress on top of the struts compared to Mirage. However, in the inter-strut zones shear stress was higher in Mirage than in Absorb. Further research is required to examine the potential value of in vivo computational modelling in optimising scaffold configuration and clinical outcomes.

Serial Assessment of Tissue Precursors and Progression of Coronary Calcification Analyzed by Fusion of IVUS and OCT: 5-Year Follow-Up of Scaffolded and Nonscaffolded Arteries.

OBJECTIVES: The aim of this study was to assess calcium growth with fused grayscale intravascular ultrasound (IVUS), IVUS-virtual histology, and optical coherence tomography (OCT) from baseline to 5-year follow-up in patients treated with bioresorbable vascular scaffolds. BACKGROUND: IVUS and OCT have individual strengths in assessing plaque composition and volume. Fusion of images obtained using these methods could potentially aid in coronary plaque assessment. METHODS: Anatomic landmarks and endoluminal radiopaque markers were used to fuse OCT and IVUS images and match baseline and follow-up. RESULTS: Seventy-two IVUS-virtual histology and OCT paired matched cross-sectional in- and out-scaffold segments were fused at baseline and follow-up. In total, 46 calcified plaques at follow-up were detected using the fusion method (33 in-scaffold, 13 out-scaffold), showing either calcium progression (52.2%) or de novo calcifications (47.8%). On OCT, calcification volume increased from baseline to follow-up by 2.3 ± 2.4 mm3 (p = 0.001). The baseline virtual histologic tissue precursors of dense calcium at follow-up were necrotic core in 73.9% and fibrous or fibrofatty plaque in 10.9%. In 15.2%, calcium was already present at baseline. Precursors on OCT were lipid pool in 71.2%, fibrous plaque in 4.3%, and fibrocalcific plaque in 23.9%. CONCLUSIONS: The use of OCT and IVUS fusion imaging shows similar calcium growth in- and out-scaffold segments. Necrotic core is the most frequent precursor of calcification. The scaffold resorption process creates a tissue layer that re-caps the calcified plaques. (Absorb Clinical Investigation, Cohort B [ABSORB B]; NCT00856856).

Single or dual antiplatelet therapy after PCI.

The optimal duration and type of antiplatelet therapy after implantation of a drug-eluting stent (DES) remains uncertain. At the time of the first-in-man implantation of the sirolimus DES in 1999, the protocol-defined dual antiplatelet therapy (DAPT) duration was only 2 months. Subsequently, DAPT duration was extended to 1 year on the basis of anecdotal historical data, and this practice was then incorporated into clinical guidelines. For >1 decade, trialists have sought to compare the safety and efficacy of abbreviated (<6 months) and prolonged (>12 months) DAPT regimens. However, the body of evidence is limited by the heterogeneity of end points, time of randomization, and bleeding criteria used in each trial. Pharmaceutical advances led to the introduction of new ADP-receptor antagonists, which are thought to be more effective than clopidogrel. The ADP-receptor antagonists moved the focus from the optimal duration of DAPT to the potential efficacy of single antiplatelet therapy after DES implantation. In this Review, we summarize the current evidence on the duration of DAPT and the risk of bleeding and adverse cardiac events after DES implantation, and describe the pitfalls of trial interpretation. The ongoing, prospective trials to test single antiplatelet therapy after DES implantation are also discussed.