Quantitative coronary three-dimensional geometry and its association with atherosclerotic disease burden and composition.

BACKGROUND: Isolate features of the coronary anatomy have been associated with the pathophysiology of atherosclerotic disease. Computational methods have been described to allow precise quantification of the complex three-dimensional (3D) coronary geometry. The present study tested whether quantitative parameters that describe the spatial 3D coronary geometry is associated with the extension and composition of the underlying coronary artery disease (CAD). METHODS: Patients with CAD scheduled for percutaneous intervention were investigated with coronary computed tomography angiography (CCTA), and invasive coronary angiography, and virtual histology intravascular ultrasound (IVUS-VH). For all target vessels, 3D centerlines were extracted from CCTA images and processed to quantify 23 geometric indexes, grouped into 3 main categories as follows: (i) length-based; (ii) curvature-based, torsion-based, and curvature/torsion-combined; (iii) vessel path-based. The geometric variables were compared with IVUS-VH parameters assessing the extent and composition of coronary atherosclerosis. RESULTS: A total of 36 coronary patients (99 vessels) comprised the study population. From the 23 geometric indexes, 18 parameters were significantly (p < 0.05) associated with at least 1 IVUS-VH parameter at a univariate analysis. All three main geometric categories provided parameters significantly related with atherosclerosis variables. The 3D geometric indexes were associated with the degree of atherosclerotic extension, as well as with plaque composition. Geometric features remained significantly associated with all IVUS-VH parameters even after multivariate adjustment for clinical characteristics. CONCLUSIONS: Quantitative 3D vessel morphology emerges as a relevant factor associated with atherosclerosis in patients with established CAD.

Impact of dual antiplatelet therapy duration on clinical outcome after coronary bifurcation stenting: results from the euro bifurcation club registry

BACKGROUND: Optimal duration of Dual Antiplatelet Therapy (DAPT) following percutaneous coronary intervention (PCI) of a bifurcation stenosis is still debated. We evaluated the impact of DAPT duration on clinical outcomes in all-comers patients undergoing bifurcation PCI included in the European Bifurcation Club (EBC) registry. METHODS: We enrolled 2284 consecutive patients who completed at least 18 months follow-up. The cumulative occurrence of Major Adverse Cardiac and Cardiovascular Events (MACCE), defined as a composite of overall-death, non-fatal myocardial infarction (MI), target vessel revascularization (TVR) and stroke were evaluated. Bleedings classified as BARC ≥ 3 were evaluated too. RESULTS: Patients were divided into 3 groups: Short DAPT (<6-months, n=375); Standard DAPT (≥6-months but ≤12-months, n=636); Prolonged DAPT (>12- months, n=1273). At 24 months follow-up MACCE-free survival was significantly lower in Short DAPT patients (Log-Rank: 45.23, p for trend <0.001). MACCE occurred less frequently in the Prolonged DAPT group (148 (11.6%)) as compared with both the Short (83 (22.1%) HR:0.48 (0.37-0.63), p<0.001) and Standard DAPT groups (137 (21.5%) HR:0.51 (0.41-0.65), p<0.001). These differences remain after propensity score adjustment (respectively, HR: 0.27 (0.20-0.36) and HR: 0.44 (0.34-0.57)). Such finding was consistent in patients presenting with both acute and chronic coronary syndromes. BARC ≥ 3 bleedings were 0.3% in the Standard DAPT, 1.6% in Short and 1.9% in Prolonged DAPT groups. CONCLUSIONS: In the "real-world" EBC registry of patients undergoing PCI of coronary artery bifurcation stenosis, a prolonged DAPT duration was associated with a significantly lower risk of MACCE and a potential increased risk of major bleedings.

Mid term outcomes after percutaneous interventions in coronary bifurcations

BACKGROUND: The optimal treatment of patients undergoing percutaneous coronary interventions (PCI) for lesions located at coronary bifurcations is still debated. METHODS: Data on 5036 consecutive patients who underwent PCI on coronary bifurcation at 17 major coronary intervention centers between January 2012 and December 2014 were collected. RESULTS: Follow-up at a median 18 months (IQR 11-28) was available for 4506 patients (89%). Major Adverse Cardiac Events (MACE) occurred in 395 patients (8.8%): cardiac death in 152 (3.4%), myocardial infarction, excluding periprocedural, in 156 (3.5%) and stent thrombosis in 110 cases (2.4%). At multivariable Cox regression, left ventricular ejection fraction ≤30% (P < 0.001), bail-out stenting (beyond a planned strategy of either single or double stenting) (P < 0.001), admission for an acute coronary syndrome (P < 0.001), age >66 years (P < 0.001), multivessel disease (P < 0.001) and diabetes (P < 0.001) were independently associated with MACE. Sensitivity analysis identified premature discontinuation of dual antiplatelet therapy (DAPT) (P < 0.001) and side branch (SB) lesion length ≥9 mm (P < 0.05) as additional independent predictors of MACE. CONCLUSIONS: Beyond traditional risk factors, multivessel disease, the length of the SB lesion, "bail-out" stenting and premature DAPT discontinuation are independent predictors of mid-term MACE after PCI of coronary bifurcations. This highlights the importance of a carefully planned PCI strategy and adequate therapy adherence to improve the clinical outcomes in these patients. (AU)

Safety and clinical performance of a drug eluting absorbable metal scaffold in the treatment of subjects with de novo lesions in native coronary arteries: Pooled 12-month outcomes of BIOSOLVE-II and BIOSOLVE-III

OBJECTIVES: Based on outcomes of the BIOSOLVE-II study, a novel second generation drug eluting absorbable metal scaffold gained CE-mark in 2016. The BIOSOLVE-III study aimed to confirm these outcomes and to obtain additional 12-month angiographic data. BACKGROUND: Bioresorbable scaffolds are intended to overcome possible long-term effects of permanent stents such as chronic vessel wall inflammation, stent crushing, and fractures. METHODS: The prospective, multicenter BIOSOLVE-II and BIOSOLVE-III studies enrolled 184 patients with 189 lesions (123 patients in BIOSOLVE-II and 61 patients in BIOSOLVE-III). Primary endpoints were in-segment late lumen loss at 6 months (BIOSOLVE-II) and procedural success (BIOSOLVE-III). RESULTS: Mean patient age was 65.5 6 10.8 years and mean lesion reference diameter was 2.70 6 0.43 mm. In BIOSOLVE-III, there were significantly more type B2/C lesions than in BIOSOLVE-II (80.3% versus 43.4%, P < 0.0001) and significantly more moderate-to-severe calcifications (24.2% versus 10.7%, P 5 0.014). At 12 months, there was no difference in late lumen loss between the two studies; in the overall population, it was 0.25 6 0.31 mm in-segment and 0.396 0.34 mm in scaffold. Target lesion failure occurred in six patients (3.3%) and included two cardiac deaths, one target-vessel myocardial infarction, and three clinically driven target lesion revascularizations. No definite or probable scaffold thrombosis was observed. CONCLUSION: The pooled outcomes of BIOSOLVE-II and BIOSOLVE-III provide further evidence on the safety and performance of a novel drug-eluting absorbable metal scaffold with constant clinical and angiographic performance parameters at 12 months and no definite or probable scaffold thrombosis.

A randomised comparison of novolimus-eluting and zotarolimuselutingcoronary stents: 9-month follow-up results of the EXCELLA II study

Aims: Novolimus, a macrocyclic lactone with anti-proliferative properties, has asimilar efficacy to currently available agents; however it requires a lower dose,and less polymer, and is therefore conceivably safer.Methods and results: The EXCELLA II study was a prospective, multicentre,single-blind, non-inferiority clinical trial which randomised 210 patients with a maximum of two de novo coronary artery lesions in two different epicardialvessels in a ratio of 2:1 to treatment with either the Elixir DESyne NovolimusEluting Coronary Stent System (NES n=139, Elixir Medical, Sunnyvale, CA, USA)or the Endeavor zotarolimus eluting stent (ZES n=71, Medtronic, Santa Rosa, CA,USA). The primary endpoint was in-stent mean late lumen loss (LLL) at 9-monthsfollow-up. In-stent percent volume obstruction (%VO) was measured in asub-group of 65 patients having 9-month intravascular ultrasound (IVUS) follow-up.Clinical secondary endpoints included a device orientated composite of cardiacdeath, target vessel myocardial infarction (MI), and clinically indicated target lesionrevascularisation (CI-TLR) assessed at 9-months follow-up. At 9-months, thein-stent LLL was 0.11±0.32 mm in the NES arm, as compared to 0.63±0.42 mm inthe ZES (p<0.0001 non-inferiority, p<0.0001 superiority). In-stent%VO was4.5±5.1% and 20.9±11.3% for NES and ZES, respectively (p<0.001). There wasno significant difference between stent groups in the device orientated compositeendpoint (NES 2.9% vs. ZES 5.6%, –2.8% [-8.8%, 3.3%], p=0.45) or its individualcomponents of cardiac death, target vessel MI and CI-TLR.Conclusions: This non-inferiority randomised study not only met its primaryendpoint, but also demonstrated superiority of NES compared to the ZES in terms of in-stent LLL.