Prognostic Utility of Coronary Computed Tomography Angiography-derived Plaque Information on Long-term Outcome in Patients With and Without Diabetes Mellitus.

PURPOSE: To investigate the long-term prognostic value of coronary computed tomography angiography (cCTA)-derived plaque information on major adverse cardiac events (MACE) in patients with and without diabetes mellitus. MATERIALS AND METHODS: In all, 64 patients with diabetes (63.3±10.1 y, 66% male) and suspected coronary artery disease who underwent cCTA were matched with 297 patients without diabetes according to age, sex, cardiovascular risk factors, and statin and antithrombotic therapy. MACE were recorded. cCTA-derived risk scores and plaque measures were assessed. The discriminatory power to identify MACE was evaluated using multivariable regression analysis and concordance indices. RESULTS: After a median follow-up of 5.4 years, MACE occurred in 31 patients (8.6%). In patients with diabetes, cCTA risk scores and plaque measures were significantly higher compared with nondiabetic patients (all P <0.05). The following plaque measures were predictors of MACE using multivariable Cox regression analysis (hazard ratio [HR]) in patients with diabetes: segment stenosis score (HR=1.20, P <0.001), low-attenuation plaque (HR=3.47, P =0.05), and in nondiabetic patients: segment stenosis score (HR=1.92, P <0.001), Agatston score (HR=1.0009, P =0.04), and low-attenuation plaque (HR=4.15, P =0.04). A multivariable model showed a significantly improved C-index of 0.96 (95% confidence interval: 0.94-0.0.97) for MACE prediction, when compared with single measures alone. CONCLUSION: Diabetes is associated with a significantly higher extent of coronary artery disease and plaque features, which have independent predictive values for MACE. cCTA-derived plaque information portends improved risk stratification of patients with diabetes beyond the assessment of obstructive stenosis on cCTA alone with subsequent impact on individualized treatment decision-making.

Improved long-term prognostic value of coronary CT angiography-derived plaque measures and clinical parameters on adverse cardiac outcome using machine learning.

OBJECTIVES: To evaluate the long-term prognostic value of coronary CT angiography (cCTA)-derived plaque measures and clinical parameters on major adverse cardiac events (MACE) using machine learning (ML). METHODS: Datasets of 361 patients (61.9 ± 10.3 years, 65% male) with suspected coronary artery disease (CAD) who underwent cCTA were retrospectively analyzed. MACE was recorded. cCTA-derived adverse plaque features and conventional CT risk scores together with cardiovascular risk factors were provided to a ML model to predict MACE. A boosted ensemble algorithm (RUSBoost) utilizing decision trees as weak learners with repeated nested cross-validation to train and validate the model was used. Performance of the ML model was calculated using the area under the curve (AUC). RESULTS: MACE was observed in 31 patients (8.6%) after a median follow-up of 5.4 years. Discriminatory power was significantly higher for the ML model (AUC 0.96 [95%CI 0.93-0.98]) compared with conventional CT risk scores including Agatston calcium score (AUC 0.84 [95%CI 0.80-0.87]), segment involvement score (AUC 0.88 [95%CI 0.84-0.91]), and segment stenosis score (AUC 0.89 [95%CI 0.86-0.92], all p < 0.05). Similar results were shown for adverse plaque measures (AUCs 0.72-0.82, all p < 0.05) and clinical parameters including the Framingham risk score (AUCs 0.71-0.76, all p < 0.05). The ML model yielded significantly higher diagnostic performance compared with logistic regression analysis (AUC 0.96 vs. 0.92, p = 0.024). CONCLUSION: Integration of a ML model improves the long-term prediction of MACE when compared with conventional CT risk scores, adverse plaque measures, and clinical information. ML algorithms may improve the integration of patient's information to enhance risk stratification. KEY POINTS: • A machine learning (ML) model portends high discriminatory power to predict major adverse cardiac events (MACE). • ML-based risk stratification shows superior diagnostic performance for MACE prediction over coronary CT angiography (cCTA)-derived risk scores or clinical parameters alone. • A ML model outperforms conventional logistic regression analysis for the prediction of MACE.

Randomized Comparison of Intensified and Standard P2Y12-Receptor-Inhibition Before Elective Percutaneous Coronary Intervention: The SASSICAIA Trial.

BACKGROUND: Even among biomarker-negative patients undergoing elective percutaneous coronary intervention (PCI), periprocedural thrombotic and bleeding complications can lead to increased morbidity and mortality. Whether stronger platelet inhibition by an intensified oral loading strategy (ILS) before PCI impacts on outcomes among these patients in contemporary practice remains unclear. METHODS: This multicenter, randomized, assessor-blinded trial tested the hypothesis that in elective PCI prasugrel 60 mg (ILS) is superior to standard loading strategy with clopidogrel 600 mg regarding a composite primary end point of all-cause death, any myocardial infarction, definite/probable stent thrombosis, stroke, or urgent vessel revascularization. After PCI, all patients were on clopidogrel 75 mg/day and aspirin. The trial was terminated prematurely because of slower-than-expected recruitment and funding discontinuation. RESULTS: Of 781 patients included in the final analysis, 382 were assigned to ILS and 399 to standard loading strategy. At 30 days, the primary end point occurred in 66 patients (17.3%) assigned to ILS and 74 patients (18.6%) assigned to standard loading strategy (odds ratio, 0.92 [95% CI, 0.63-1.32]; P=0.64). Any myocardial infarction and Bleeding Academic Research Consortium ≥2 bleeding rates were similar among ILS and standard loading strategy groups 16.2% versus 17.5%, odds ratio, 0.91 (95% CI, 0.62-1.32), P=0.62 and 4.2% versus 4.8%, odds ratio 0.87 (95% CI, 0.44-1.73), P=0.70, respectively. CONCLUSIONS: In biomarker-negative stable and unstable angina patients undergoing elective PCI, the trial did not find a conclusive difference in efficacy or safety. This observation should be interpreted in the context of wide CIs and premature termination of the trial. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02548611.

Long-term follow-up and predictors of target lesion failure after implantation of everolimus-eluting bioresorbable scaffolds in real-world practice.

BACKGROUND: Bioresorbable scaffolds (BRS) have been shown to be inferior to drug-eluting stents in randomized trials. Nevertheless, patients treated during daily routine differ from those treated within randomized trials and thus need further long-term evaluation. The present investigation aims to address this lack. METHODS: Consecutive patients with coronary artery disease treated with implantation of everolimus-eluting BRS at 5 centers in Germany were included. Clinical follow-up was assessed up to 3 years. Analysis of clinical outcomes was performed by pooling of the individual patient data sets of each center. The major clinical endpoints of interest was target lesion failure (TLF) a composite of cardiac death, target vessel myocardial infarction and target lesion revascularization. Furthermore occurrence of definite scaffold thrombosis was evaluated. A multivariable Cox regression analysis was applied to identify independent predictors of TLF. RESULTS: A total of 1614 patients treated with BRS were analyzed (mean age 64.0 ± 10.9 years, 75.8% male, 28.3% diabetics). A total 1817 lesions were treated with BRS and 56.0% were considered to be complex. At 3 years, the rate of TLF was 17.1% and definite scaffold thrombosis was noted in 2.6%. Independent predictors of TLF were a higher age, diabetes, bifurcation, complex lesions and the use of small BRS. CONCLUSIONS: In this large-scale analysis of patients undergoing BRS implantation in daily routine, event rates were high, but in line with randomized studies. Predictors of TLF were identified which may optimize patient and lesion selection for BRS.

Impact of severe left ventricular outflow tract calcification on device failure and short-term mortality in patients undergoing TAVI.

BACKGROUND: To investigate the impact of left ventricular outflow tract (LVOT) calcification on the incidence of device failure and mortality in patients undergoing transcatheter aortic valve implantation (TAVI). METHODS: Of 690 consecutive patients undergoing transfemoral TAVI in our center from January 2013 to December 2015, 600 presented with non-severe (NSCALVOT) and 90 (13.0%) with severe (SCALVOT) LVOT calcification. Primary outcome of interest was device failure defined as a composite of procedural death, prosthesis dislocation, annulus rupture or significant para-valvular leakage (PVL). Secondary outcome of interest was 30-day and one-year all-cause mortality. RESULTS: Mean age of the population was 80.8 ±â€¯7.2 years, mean STS score was 5.7 ±â€¯4.6% and 50.6% of the patients were women. Patients with SCALVOT more frequently experienced device failure (10.0% vs. 3.8%, p = 0.009) and were at higher risk of 30 day (10.0% vs. 2.8%, p < 0.001) all cause mortality as compared to those with NSCALVOT. Furthermore, patients with SCALVOT were more frequently in need of post-dilation (15.6% vs. 8.5%, p = 0.032) and showed higher incidence of significant PVL (7.8% vs. 2.5%, p = 0.007). In multivariate analysis, SCALVOT (hazard ratio 2.87; 95% CI 1.20 to 6.34) and use of balloon-expandable prosthesis (hazard ratio 0.32; 95% CI 0.15 to 0.73) were identified as independent predictors of device failure. CONCLUSION: Presence of severe LVOT calcification in patients undergoing transfemoral TAVI is associated with a higher risk of device failure and short-term mortality.

Oral Anticoagulant Type and Outcomes After Transcatheter Aortic Valve Replacement.

OBJECTIVES: The purpose of the study was to investigate the impact of oral anticoagulation (OAC) type on clinical outcomes 1 year after transcatheter aortic valve replacement (TAVR). BACKGROUND: Non-vitamin K oral anticoagulants (NOACs) are superior to vitamin K antagonists (VKAs) in nonvalvular atrial fibrillation (AF), while their comparative performance among patients in need of OAC undergoing TAVR is underinvestigated. METHODS: The study enrolled 962 consecutive patients who underwent TAVR in 4 tertiary European centers and were discharged on either NOACs (n = 326) or VKAs (n = 636). By using propensity scores for inverse probability of treatment weighting (IPTW), the comparison of treatment groups was adjusted to correct for potential confounding. RESULTS: Mean age and Society of Thoracic Surgeons score of the population were 81.3 ± 6.3 years and 4.5% (interquartile range: 3.0% to 7.3%); 52.5% were women and a balloon-expandable valve was used in 62.7% of cases. The primary outcome of interest, combined incidence of all-cause mortality, myocardial infarction, and any cerebrovascular event at 1-year after TAVR, was 21.2% with NOACs versus 15.0% with VKAs (hazard ratio [HR]: 1.44; 95% confidence interval [CI]: 1.00 to 2.07; p = 0.050, IPTW-adjusted). The 1-year incidence of any Bleeding Academic Research Consortium bleeds and all-cause mortality were comparable between the NOAC and VKA groups, 33.9% versus 34.1% (HR: 0.97; 95% CI: 0.74 to 1.26; p = 0.838, IPTW-adjusted) and 16.5% versus 12.2% (HR: 1.36; 95% CI: 0.90 to 2.06; p = 0.136, IPTW-adjusted), respectively. CONCLUSIONS: Chronic use of both NOACs and VKAs among patients in need of OAC after TAVR are comparable regarding 1-year bleeding risk. The higher ischemic event rate observed with NOACs needs to be evaluated in large randomized trials.

Sex and long-term outcomes after implantation of the Absorb bioresorbable vascular scaffold for treatment of coronary artery disease.

AIMS: Women and men suffering from coronary artery disease differ in their risk profiles. We sought to investigate the impact of sex on two-year outcomes after BVS implantation in routine clinical practice. METHODS AND RESULTS: Sex-based analysis of clinical outcomes was carried out by pooling the individual patient data of the ISAR-ABSORB and KUM-ABSORB registries performed in four high-volume tertiary centres in Munich. Of the total of 1,032 patients, 259 (25.1%) were women. The primary composite endpoint of death, target vessel myocardial infarction (TV-MI) and target lesion revascularisation (TLR) up to two years occurred in 13.2% of women and 17.9% of men (p=0.12). Compared to men, women experienced numerically lower rates of TLR and definite or probable BVS thrombosis - 7.5% vs 12.4% (p=0.051) and 1.2% and 2.7% (p=0.20), respectively. Independent predictors of increased risk for TLR were use of smaller size BVS (HR 1.28, 95% CI: 1.02-1.62), while being a woman was a protective factor (HR 0.59, 95% CI: 0.35-1.00). CONCLUSIONS: BVS used in a routine setting tend to perform better among women compared to men, which might be partially related to the lower complexity of their coronary artery disease.

Hybrid-stenting with metallic and bioresorbable drug-eluting stents 2-year clinical outcomes in KUM ABSORB registry.

AIM AND OBJECTIVE: We sought to investigate and compare outcomes 2 years after Hybrid-stenting with bioresorbable vascular scaffolds (BVS) and contemporary metallic drug-eluting stents (DES) within the same coronary lesion versus BVS alone. METHODS: Between 11/2012 and 7/2015 at our institution, 134 (33.2%) were treated with Hybrid-stenting for complex or long coronary lesions, 270 patients were treated by BVS alone. The primary outcome of interest was target lesion failure (TLF) at 2-years of follow-up. RESULTS: Patients treated by Hybrid-stenting were more frequently men (80% vs. 70%, p = 0.04) had extensive multivessel disease (84% vs. 71%, p < 0.01) including more complex (89% vs. 52%, p < 0.01) and longer lesions (28.9 mm vs 16.4 ± mm, p < 0.01) resulting in longer treated segments (47.3 mm vs 21.5 mm, p < 0.01) and more residual in-segment stenosis (12.3% vs 8.5%, p < 0.01) compared to BVS alone patients. At 2 years, cumulative incidence of TLF was 9.7% of Hybrid-stenting patients and 11.5% of BVS alone patients (p = 0.62), myocardial infarction (3.0% vs 4.1%, p = 0.59) and mortality (1.5% vs 4.1%, p = 0.17), respectively. Target lesion revascularization occurred in 9 Hybrid-stenting patients (2 located in DES) and in 20 BVS alone patients, cumulative incidence 6.7% vs. 7.4% (p = 0.80). Chronic kidney disease and residual in-segment stenosis >30% were identified as independent predictors of TLF at 2-years. CONCLUSION: Despite differences in clinical and angiographic profile, Hybrid-stenting performed similar to BVS alone at 2 years after percutaneous coronary intervention.

Age-dependent impact of the SYNTAX-score on longer-term mortality after percutaneous coronary intervention in an all-comer population.

BACKGROUND: The Synergy between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery (SYNTAX)-score is a validated tool for risk stratification and revascularization strategy selection in patients with complex coronary artery disease. The aim of this study was to analyse its age-related prognostic value. METHODS: SYNTAX-score was calculated in 1331 all-comer patients undergoing percutaneous coronary intervention (PCI): 463 patients ≥ 75 years and 868 patients < 75 years. Outcomes of interest were all-cause mortality at one and two years. RESULTS: A significant interaction of age and SYNTAX-score for mortality was observed at two-year (P interaction = 0.019) but not at one-year follow-up (P interaction = 0.594). In multivariable analysis, SYNTAX-score independently predicted 1-year mortality in both age groups (< 75 years, hazard ratio (HR): 1.43, 95% confidence intervals (CI): 1.03-2.00, P = 0.034; and ≥ 75 years, HR: 1.37, 95% CI: 1.01-1.85, P = 0.042), but only two-year mortality among younger patients (< 75 years, HR: 1.33, 95% CI: 1.01-1.76, P = 0.041; and ≥ 75 years, HR: 1.11, 95% CI: 0.87-1.41, P = 0.394). SYNTAX-score tertiles were useful to stratify 1-year mortality in both, patients < 75 years (SYNTAX-score < 9, 3.8%; 9-20, 5.3%; ≥ 20, 10.3%; P = 0.004) and ≥ 75 years (SYNTAX-score < 11, 5.7%; 11-22.5, 16.1%; ≥ 22.5, 18.7%; P = 0.003), but two-year mortality only among patients < 75 years (SYNTAX-score < 9, 6.5%; 9-20, 7.6%; ≥ 20, 15%; P < 0.001) and not among ≥ 75 years old patients (SYNTAX-score < 11, 19.4%; 11-22.5, 26.3%; ≥ 22.5, 27.9%; P = 0.138). CONCLUSIONS: Age modifies the impact of the SYNTAX-score on longer-term mortality after PCI. Among patients < 75 years, the SYNTAX-score independently predicts the risk of death at one and two years after PCI, while among patients ≥ 75 years its predictive role is limited to the first year after PCI. Further studies are needed to evaluate the value of SYNTAX-score for selecting the most appropriate revascularization strategy among elderly patients.

Platelet Reactivity and Early Outcomes after Transfemoral Aortic Valve Implantation.

Beyond thromboembolic events, peri-procedural bleeding remains one of the most frequent complications after transcatheter aortic valve implantation (TAVI). The majority of TAVI patients receive a dual anti-platelet treatment (DAPT) regimen. This analysis from the EVERY-TAVI register database aimed to analyse whether the level of on-treatment adenosine diphosphate-induced platelet reactivity predicts early outcomes at 30 days after TAVI. A total of 146 consecutive TAVI patients on DAPT who underwent platelet function testing with the Multiplate analyser were included here. Definition of bleeding events was done according to the Valve Academic Research Consortium-2 (VARC-2) classification. In our cohort, a status of low platelet reactivity (LPR, ≤ 18 units) was observed in 79 patients (54%), while high platelet reactivity (HPR, ≥ 46 units) was present in 18 patients (12%). At 30-day follow-up, the incidence of VARC-2 bleeds was 45.6% (n = 36) in LPR patients and 23.9% (n = 16) in patients without LPR (hazard ratio [HR] 2.10, 95% confidence interval [CI], 1.17-3.79; p = 0.01). In age-adjusted multivariate analysis, a status of LPR was independently associated with VARC-2 bleeding events (HRadj, 2.06, 95% CI, 1.14-3.71; p = 0.02). HPR was not associated with the 30-day risk of death, stroke, or myocardial infarction (p ≥ 0.43). In summary, presence of LPR was associated with bleeding events in patients undergoing TAVI while presence of HPR was not associated with ischaemic outcomes at 30 days. The value of platelet function testing for bleeding risk prediction and for a possible guidance of anti-thrombotic treatment in the elderly TAVI population warrants further investigation.

Polymer-free drug-eluting stents for coronary artery disease.

Polymer-free drug-eluting stents (PF-DES) were designed with the expectation of avoiding late restenosis and thrombosis related to the polymer used in traditional DES platforms. Furthermore, due to similarities with bare metal stents after drug elution, PF-DES has been considered as particularly suitable for patients at high bleeding risk. A variety of PF-DES platforms have been clinically tested. Despite their theoretical advantages, PF platforms showed comparable clinical outcomes with modern permanent- or biodegradable polymer-based DES up to 5 years after implantation. Use of more biocompatible polymers on the modern DES platforms is one of the reasons therefore. Their improved safety profile allows already less intensive antithrombotic regimes after DES. Hence, nowadays PF-DES platforms can be considered as one of many DES options for percutaneous treatment of coronary artery disease.

Restenosis patterns after bioresorbable vascular scaffold implantation: Angiographic substudy of the GHOST-EU registry.

OBJECTIVES: To evaluate pattern of in-BVS-restenosis after bioresorbable vascular scaffold (BVS) implantation. BACKGROUND: In-stent restenosis morphology impacts target lesion revascularization (TLR) rates and clinical outcomes. Although several trials report on outcomes after BVS implantation, information about in-BVS restenosis pattern is still lacking. METHODS: Between November 2011 and January 2014, in 7 of 10 European centers participating in the GHOST-EU registry, 668 patients underwent BVS implantation. Of them 164 patients (200 lesions) underwent an additional angiogram 3 to 12 months after index PCI. RESULTS: Binary in-BVS restenosis (IBR) (in-segment diameter stenosis ≥50%) was observed in 12.7% (21 of 164) of patients (30 lesions), with a TLR rate of 16.5%. The IBR morphology was classified as focal margin in 50.0%, focal body in 26.7%, multifocal in 10.0%, and diffuse in 13.3% of these cases. Treatment of small vessels (OR 5.49, 95% CI 1.6-18.8, P < 0.01) was identified as independent predictor of IBR. Performing predilatation (OR 0.13, 95% CI 0.02-1.04, P = 0.06), high-pressure postdilatation (OR 3.16, 95% CI 0.90-11.18, P = 0.07) as well as treatment of acute coronary syndrome (OR 0.18, 95% CI 0.03-1.12, P = 0.07) seem to strongly influence this risk. CONCLUSIONS: The IBR morphology is mostly focal involving particularly the BVS margins suggesting association with procedural aspects in this early experience with BVS. Treatment of small vessels is the strongest predictor of higher IBR risk.

Coronary Computed Tomographic Angiography-Derived Fractional Flow Reserve for Therapeutic Decision Making.

This study investigated the performance of coronary computed tomography angiography (cCTA) with cCTA-derived fractional flow reserve (CT-FFR) compared with invasive coronary angiography (ICA) with fractional flow reserve (FFR) for therapeutic decision making in patients with suspected coronary artery disease (CAD). Seventy-four patients (62 ± 11 years, 62% men) with at least 1 coronary stenosis of ≥50% on clinically indicated dual-source cCTA, who had subsequently undergone ICA with FFR measurement, were retrospectively evaluated. CT-FFR values were computed using an on-site machine-learning algorithm to assess the functional significance of CAD. The therapeutic strategy (optimal medical therapy alone vs revascularization) and the appropriate revascularization procedure (percutaneous coronary intervention vs coronary artery bypass grafting) were selected using cCTA-CT-FFR. Thirty-six patients (49%) had a functionally significant CAD based on ICA-FFR. cCTA-CT-FFR correctly identified a functionally significant CAD and the need of revascularization in 35 of 36 patients (97%). When revascularization was deemed indicated, the same revascularization procedure (32 percutaneous coronary interventions and 3 coronary artery bypass grafting) was chosen in 35 of 35 patients (100%). Overall, identical management strategies were selected in 73 of the 74 patients (99%). cCTA-CT-FFR shows excellent performance to identify patients with and without the need for revascularization and to select the appropriate revascularization strategy. cCTA-CT-FFR as a noninvasive "one-stop shop" has the potential to change diagnostic workflows and to directly inform therapeutic decision making in patients with suspected CAD.

Predictors of cerebrovascular events at mid-term after transcatheter aortic valve implantation - Results from EVERY-TAVI registry.

BACKGROUND: Clinical relevant cerebrovascular events (CVE) following transcatheter aortic valve implantation (TAVI) still remain a devastating complication associated with mortality and severe impairments. Therefore, identification of particularly modifiable predictors of this complication is clinically relevant and an important step for planning preventive strategies. METHODS: A total of 985 patients who underwent trans-femoral TAVI for aortic valve stenosis in our institution from February 2008 to January 2015 were considered. The influence of demographics, clinical and procedural data on the occurrence of CVE was assessed with a competing risk model with death as competing event. Clinical events were defined according to VARC-2 criteria. RESULTS: At a median follow-up of 838days, 95% CI 807-892, 59 patients experienced any CVE (5.9%) and the overall cumulative mortality rate was 46.1%. CVEs mainly occur later than 30days after TAVI (47.5%), 88.1% of them were of ischemic origin and 52.5% were disabling events. Independent predictors of CVEs were age (hazard ratio 1.05; 95% CI 1.01 to 1.09), history of CVE (hazard ratio 2.54; 95% CI 1.39 to 4.63) and use of balloon post-dilation (hazard ratio 1.85; 95% CI 1.08 to 3.18). CONCLUSION: In patients undergoing TAVI incidence of clinically relevant CVEs is frequent with half of the events occurring after the first 30days post-TAVI. Identification of balloon post-dilation as the only modifiable predictor of CVE risk at mid-term, urges its cautious performance after prosthesis implantation. CLINICALTRIALS. GOV IDENTIFIER: NCT02289339.

Clinical restenosis and its predictors after implantation of everolimus-eluting bioresorbable vascular scaffolds: results from GABI-R.

AIMS: The aim of this study was to assess clinical restenosis and its predictors after implantation of bioresorbable vascular scaffolds (BVS) in everyday practice in the large-scale German-Austrian ABSORB Registry (GABI-R). METHODS AND RESULTS: Between November 2013 and January 2016, 3,264 patients underwent BVS implantation in the 93 centres of GABI-R. At six-month follow-up, 24 patients experienced clinically indicated target lesion revascularisation (cTLR) unrelated to BVS thrombosis (cumulative incidence 0.76%; angiographically, 58.3% of in-BVS restenosis of focal pattern). Compared to patients without cTLR, patients with cTLR had more lesions per patient (1.83±1.0 vs. 1.36±0.7), complex (52.3% vs. 36.2%) and mild-to-moderately calcified lesions (65.9% vs. 60.5%) treated, and more frequently had overlapping BVS (22.2% vs. 10.8%), all p<0.05. Implanted BVS length was 40.0 mm (28.0, 46.9) vs. 23.0 mm (18.0, 30.0), p<0.001, remaining in the multivariable analysis the only independent predictor of cTLR (hazard ratio 1.02, 95% CI: 1.01-1.04, p<0.001). The myocardial infarction rate was also significantly higher among patients with cTLR, 29.2% vs. 1.7%, p<0.0001. CONCLUSIONS: cTLR related to BVS restenosis at six months after BVS implantation is a rare event depending on implanted BVS length. Whether cTLR increases the myocardial infarction risk needs to be evaluated at longer-term follow-up and within the setting of adequately powered randomised trials.

Correlation and predictive value of aortic root calcification markers with coronary artery calcification and obstructive coronary artery disease.

OBJECTIVE: To evaluate the correlation between aortic root calcification (ARC) markers and coronary artery calcification (CAC) derived from coronary artery calcium scoring (CACS) and their ability to predict obstructive coronary artery disease (CAD). METHODS: We retrospectively analyzed 189 patients (47% male, age 60.3 ± 11.1 years) with an intermediate probability of CAD who underwent clinically indicated CACS and coronary CT angiography (CCTA). ARC markers [aortic root calcium score (ARCS) and volume (ARCV)] were calculated and compared to CAC markers: coronary artery calcium score (CACS), volume (CACV), and mass (CACM). CCTA datasets were visually evaluated for significant CAD (stenosis ≥ 50%) and the ability of ARC markers to predict obstructive CAD was assessed. RESULTS: ARCS (mean 67.7 ± 189.5) and ARCV (mean 67.3 ± 184.7) showed significant differences between patients with and without CAC (109.4 ± 238.6 vs 9.42 ± 31.4, p < 0.0001; 108.5 ± 232.4 vs 9.9 ± 30.5, p < 0.0001). A strong correlation was found for ARCS and ARCV with CACS, CACM, and CACV (all p < 0.0001). In a multivariate analysis, ARCS (OR 1.09, p = 0.033) and ARCV (OR 1.12, p = 0.046) were independent markers for CAC. Using a receiver-operating characteristics analysis, the AUC to detect severe CAC was 0.71 (p < 0.0001) and 0.71 (p < 0.0001) for ARCS and ARCV, respectively. ARCS (0.67, p < 0.0001) and ARCV (0.68, p < 0.0001) showed discriminatory power for predicting obstructive CAD, yielding sensitivities 61 and 78% and specificities of 62 and 80%, respectively. CONCLUSION: ARC markers are associated with and independently predict the presence of CAC and obstructive CAD. Further testing is required in patients with severe ARC and significant CAD in order to reliably obtain these markers from thoracic-CT or X-ray for proper risk classification.

Impact of Clinical Presentation on Early Vascular Healing After Bioresorbable Vascular Scaffold Implantation.

BACKGROUND: Optimal strut coverage and early vascular healing are important factors to reduce the risk of stent thrombosis. Data on early vascular healing with the new bioresorbable vascular scaffolds (BVS) are lacking. Further, healing response after BVS implantation in different clinical presentation has not been fully investigated. METHODS AND RESULTS: We assessed with optical coherence tomography (OCT) the early vascular response to BVS implantation in 26 consecutive patients presenting with acute coronary syndrome (ACS) or stable angina (SA). Images from 16 BVSs (17,166 struts) in ACS patients and 17 BVSs (23,045 struts) in SA patients were analyzed. The mean implanted BVS diameter and length was 3.1 ± 0.4 mm and 20.4 ± 5.8 mm. At mean 47.6 ± 6.3 days, overall 99% of BVS struts were covered. There were no differences between ACS and SA on the amount of tissue coverage per strut (0.09 ± 0.02 mm vs. 0.09 ± 0.01 mm; P = 0.86, respectively) and lumen area stenosis (24.2 ± 19.3% vs. 22.3 ± 22.0%; P = 0.78, respectively). However, a numerically higher proportion of protruding (ACS 1.2 ± 2.7%; SA 4.2 ± 6.5%; P = 0.11) and malapposed (ACS 0.4 ± 0.5%; SA 2.4 ± 5.8%; P = 0.18) struts were observed in SA compared to ACS, with trendy better healing score in ACS (1.87 ± 1.67 vs. 5.28 ± 7.28, P = 0.08). CONCLUSION: Early after BVS implantation almost complete scaffold strut coverage without any thrombi was observed by OCT, independent by the clinical presentation at index coronary intervention. However, BVS in ACS lesions were associated with easier strut penetration and a trendy better healing score compared with SA.

Coronary Computed Tomography Angiography-Derived Plaque Quantification in Patients With Acute Coronary Syndrome.

This study investigated the discriminatory value of quantitative atherosclerotic plaque markers derived from coronary computed tomography angiography (cCTA) in patients with first acute coronary syndrome (ACS) compared with patients with stable coronary artery disease (CAD). Forty patients (56.9 ± 9.3 years, 55% men) admitted with their first ACS and Framingham risk score-matched controls with stable CAD were retrospectively analyzed. All patients had undergone cCTA followed by invasive coronary angiography. Total plaque volume, calcified and noncalcified plaque volumes, plaque burden (in %), remodeling index, lesion length, presence of napkin-ring sign, segment involvement score, and segment stenosis score were derived from cCTA and compared between both groups on a per-lesion and per-patient level. Patients with ACS showed a significant higher number of obstructive CAD and higher values for segment stenosis score, segment involvement score, noncalcified plaque volume, lesion length, and remodeling index than the stable angina group (all p <0.05). On a per-lesion level, culprit lesions had significantly higher values for plaque burden, total plaque volume, noncalcified plaque volume, remodeling index, lesion length, and prevalence of napkin-ring sign in comparison to nonculprit lesions (all p <0.05). On receiver-operating characteristics (ROC) analysis, a stepwise model demonstrated incremental discriminatory power for identifying ACS both per-patient (area under the curve 0.92, p <0.0001) as well as per-lesion (area under the curve 0.88, p <0.0001). cCTA-derived culprit plaque markers show discriminatory value both on a per-patient and per-lesion level. A combination of markers added to the Framingham risk score yields the greatest discriminatory ability.

One-year outcomes with two suture-mediated closure devices to achieve access-site haemostasis following transfemoral transcatheter aortic valve implantation.

AIMS: In the current study we assess the impact of two different access-site suture-mediated closure devices (SMCD), ProGlide and Prostar, on vascular and bleeding complications after transfemoral transcatheter aortic valve implantation (TAVI), as well as on long-term mortality. METHODS AND RESULTS: From 2008 to 2013, 1,022 patients underwent transfemoral TAVI in two German centres using ProGlide (n=506) and Prostar (n=516) SMCD to close the access site. The primary outcome was the incidence of peri-TAVI major vascular complications according to Valve Academic Research Consortium-2 (VARC-2) definitions. Secondary outcomes were the incidence of bleeding complications and mortality. Compared to the Prostar SMCD group, patients in the ProGlide SMCD group less frequently experienced VARC-2 major vascular complications (7.5% vs. 15.9%, p<0.001), closure device failure (0.8% vs. 2.3%, p=0.04), any bleeding (BARC: 36.8% vs. 53.9%, p<0.001; VARC-2: 30.8% vs. 34.9%, p=0.59). Furthermore, one-year mortality was significantly lower in the ProGlide SMCD group, 14.8% vs. 19.5% in the Prostar SMCD group, log-rank p=0.04. However, VARC-2 major vascular complications but not ProGlide use were identified as an independent predictor of one-year mortality (adjusted odds ratio 1.54, 95% CI: 1.01-2.34 and 1.01, 95% CI: 0.65-1.55, respectively). CONCLUSIONS: In this analysis, the use of ProGlide SMCD was associated with a reduced risk of vascular and bleeding complications following TAVI compared to Prostar SMCD usage. However, major vascular complications but not ProGlide use did independently predict long-term mortality.