Jan G. P. Tijssen

The Impact of Post-Procedural Asymmetry, Expansion, and Eccentricity of Bioresorbable Everolimus-Eluting Scaffold and Metallic Everolimus-Eluting Stent on Clinical Outcomes in the ABSORB II Trial

OBJECTIVESnThe study sought to investigate the relationship between post-procedural asymmetry, expansion, and eccentricity indices of metallic everolimus-eluting stent (EES) and bioresorbable vascular scaffold (BVS) and their respective impact on clinical events at 1-year follow-up.nnnBACKGROUNDnMechanical properties of a fully BVS are inherently different from those of permanent metallic stent.nnnMETHODSnThe ABSORB II (A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions) trial compared the BVS and metallic EES in the treatment of a de novo coronary artery stenosis. Protocol-mandated intravascular ultrasound imaging was performed pre- and post-procedure in 470 patients (162 metallic EES and 308 BVS). Asymmetry index (AI) was calculated per lesion as: (1xa0- minimum scaffold/stent diameter/maximum scaffold/stent diameter). Expansion index and optimal scaffold/stent expansion followed the definition of the MUSIC (Multicenter Ultrasound Stenting in Coronaries) study. Eccentricity index (EI) was calculated as the ratio of minimum and maximum scaffold/stent diameter per cross section. The incidence of device-oriented composite endpoint (DoCE) was collected.nnnRESULTSnPost-procedure, the metallic EES group was more symmetric and concentric than the BVS group. Only 8.0% of the BVS arm and 20.0% of the metallic EES arm achieved optimal scaffold/stent expansion (pxa0< 0.001). At 1 year, there was no difference in the DoCE between both devices (BVS 5.2% vs. EES 3.1%; pxa0= 0.29). Post-procedural devices asymmetry and eccentricity were related to higher event rates while there was no relevance to the expansion status. Subsequent multivariate analysis identified that post-procedural AI >0.30 is an independent predictor of DoCE (hazardxa0ratio: 3.43; 95% confidence interval: 1.08 to 10.92; pxa0= 0.037).nnnCONCLUSIONSnBVS implantation is more frequently associated with post-procedural asymmetric and eccentric morphology compared to metallic EES. Post-procedural devices asymmetry were independently associated with DoCE following percutaneous coronary intervention. However, this approach should be viewed as hypothesis generating duexa0toxa0low event rates. (ABSORB II Randomized Controlled Trial [ABSORB II]; NCT01425281).

Trial design: Rivaroxaban for the prevention of major cardiovascular events after transcatheter aortic valve replacement: Rationale and design of the GALILEO study

Background Optimal antithrombotic treatment after transcatheter aortic valve replacement (TAVR) is unknown and determined empirically. The direct factor Xa inhibitor rivaroxaban may potentially reduce TAVR‐related thrombotic complications and premature valve failure. Design GALILEO is an international, randomized, open‐label, event‐driven, phase III trial in more than 1,520 patients without an indication for oral anticoagulation who underwent a successful TAVR (ClinicalTrials.gov NCT02556203). Patients are randomized (1:1 ratio), 1 to 7 days after a successful TAVR, to either a rivaroxaban‐based strategy or an antiplatelet‐based strategy. In the experimental arm, subjects receive rivaroxaban (10 mg once daily [OD]) plus acetylsalicylic acid (ASA, 75‐100 mg OD) for 90 days followed by rivaroxaban alone. In the control arm, subjects receive clopidogrel (75 mg OD) plus ASA (as above) for 90 days followed by ASA alone. In case new‐onset atrial fibrillation occurs after randomization, full oral anticoagulation will be implemented with maintenance of the original treatment assignment. The primary efficacy end point is the composite of all‐cause death, stroke, myocardial infarction, symptomatic valve thrombosis, pulmonary embolism, deep venous thrombosis, and systemic embolism. The primary safety end point is the composite of life‐threatening, disabling, and major bleeding, according to the Valve Academic Research Consortium definitions. Conclusions GALILEO will test the hypothesis that a rivaroxaban‐based antithrombotic strategy reduces the risk of thromboembolic complications post‐TAVR with an acceptable risk of bleeding compared with the currently recommended antiplatelet therapy–based strategy in subjects without need of chronic oral anticoagulation.

Early mortality in prophylactic implantable cardioverter-defibrillator recipients: development and validation of a clinical risk score

AIMSnTo reduce sudden cardiac death, implantable cardioverter-defibrillators (ICDs) are indicated in patients with ischaemic and non-ischaemic dilated cardiomyopathy and a left ventricular ejection fraction (LVEF) ≤35%. Current guidelines do not recommend device therapy in patients with a life expectancy <1 year since benefit in these patients is low. In this study, we evaluated the incidence and predictors of early mortality (<1 year after implantation) in a consecutive primary prevention population.nnnMETHODS AND RESULTSnAnalysis was performed on a prediction and validation cohort. The primary endpoint was all-cause mortality at 1 year. The prediction cohort comprised 861 prophylactic ICD recipients with ischaemic cardiomyopathy or dilated cardiomyopathy from the Academic Medical Center (Amsterdam) and Thorax Center Twente (Enschede). Detailed clinical data were collected. After multivariate analysis, a risk score was developed based on age ≥75 years, LVEF ≤ 20%, history of atrial fibrillation, and estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73 m(2). Using these predictors, a low (≤1 factor), intermediate (2 factors), and high (≥3 factors) risk group could be identified with 1-year mortality of, respectively, 3.4, 10.9, and 38.9% (P< 0.01). Afterwards, the risk score was validated in 706 primary prevention patients from the Erasmus Medical Center (Rotterdam). One-year mortality was, respectively, 2.5, 13.2, and 46.3% (all P< 0.01).nnnCONCLUSIONnA simple risk score based on age, LVEF, eGFR, and atrial fibrillation can identify patients at low, intermediate, and high risk for early mortality after ICD implantation. This may be helpful in the risk assessment of ICD candidates.

Prognostic value of myocardial perfusion scintigraphy in type 2 diabetic patients with mild, stable angina pectoris

AimTo determine the prognostic value of reversible myocardial perfusion defects on myocardial perfusion scintigraphy (MPS) in patients with type 2 diabetes mellitus and mild anginal complaints.Methods and resultsIn the MERIDIAN trial, patients with diabetes mellitus type 2, stable, mild anginal symptoms (Canadian Cardiovascular Society classification (CCS) I-II/IV) and reversible perfusion defects were randomized to either continued pharmacological treatment or early invasive treatment. In this sub analysis, the severity of the myocardial perfusion defect was related to the occurrence of cardiac death and non-fatal myocardial infarction, in 319 patients (63% male, 65xa0±xa09xa0years). During follow-up (2.2xa0±xa00.6xa0years), 14 patients had a cardiac event: 3 in 171 patients without myocardial ischemia and 11 in 148 patients with myocardial ischemia. Annual event rates rose from 0.8% to 5.8% with increasing severity of myocardial ischemia. Multivariable analysis identified the presence of severe myocardial ischemia (hazard ratio (HR) 5.45, 95%CI 1.89-15.71) and insulin use (HR 4.00, 95%CI 1.25-12.75) as independent predictors of cardiac events.ConclusionsType 2 diabetics with mild anginal symptoms with no or moderate myocardial ischemia have a low annual cardiac event rate. In patients with severe myocardial ischemia event rate increased 3-6 fold.

Acute Gain in Minimal Lumen Area Following Implantation of Everolimus-Eluting ABSORB Biodegradable Vascular Scaffolds or Xience Metallic Stents: Intravascular Ultrasound Assessment From the ABSORB II Trial

OBJECTIVESnThe study compared, by intravascular ultrasound (IVUS), acute gain (AG) at the site of the pre-procedural minimal lumen area (MLA) achieved by either the Absorb (Abbott Vascular, Santa Clara, California) scaffold or the Xience stent and identified the factors contributing to the acute performance of these devices.nnnBACKGROUNDnIt is warranted that the acute performance of Absorb matches that of metallic stents; however, concern exists about acute expansion and lumen gain with the use of Absorb.nnnMETHODSnOf a total of 501 patients (546 lesions) in the ABSORB II (ABSORB II Randomized Controlled Trial) randomized trial, 445 patients with 480 lesions were investigated by IVUS pre- and post-procedure. Comparison of MLA pre- and post-procedure was performed at the MLA site by matching pre- and post-procedural IVUS pullbacks.nnnRESULTSnLower AG on IVUS (lowest tertile) occurred more frequently in the Absorb arm than in the Xience arm (3.46xa0mm(2) vs. 4.27 mm(2), respectively; pxa0< 0.001; risk ratio: 3.04; 95% confidence interval: 1.94 to 4.76). The plaque morphology at the MLA cross-section was not independently associated with IVUS acute gain. The main difference in AG in MLD by angiography was observed at the time of device implantation (Xience vs. Absorb, Δ+1.50 mm vs. Δ+1.23 mm, respectively), whereas the gain from post-dilation was similar between the 2 arms (Δ+0.16 mm vs. Δ+0.16 mm) when patients underwent post-dilation, although expected balloon diameter was smaller in the Absorb arm than in the Xience arm (pxa0= 0.003) during post-dilation.nnnCONCLUSIONSnAt the site of the pre-procedural MLA, the increase of the lumen post-procedure was smaller in the Absorb-arm than in the Xience arm. To achieve equivalent AG to Xience, the implantation of Absorb may require more aggressive strategies at implantation, pre- and post-dilation than the technique used in the ABSORB II trial. (ABSORB II Randomized Controlled Trial [ABSORB II]; NCT01425281).

Echocardiographic and angiographic assessment of paravalvular regurgitation after TAVI: optimizing inter-technique reproducibility

AIMSnAortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) is often first diagnosed by angiography and then confirmed and followed-up by transthoracic echocardiography (TTE). Consistency between both methods is important for follow-up. We sought to determine inter-technique reproducibility of the assessment of paravalvular AR after TAVI.nnnMETHODS AND RESULTSnThe study included 165 patients treated with a self-expanding bioprosthesis and had angiography and TTE performed at a median interval of 4 days. TTE parameters of AR severity included VARC score (the average AR grade determined by the echocardiographic VARC-II criteria), pressure half time (PHT), regurgitation jet features in long-axis views (LAX score) and colour Doppler (CD) score (=paravalvular AR jet circumferential extent (%) + LAX score). Using receiver-operating characteristics curves, the cut-points that best defined an angiographic >mild AR were identified.On TTE, AR was paravalvular in all cases, multi-jet in 28%, and predominantly (64%) detected in the commissural region between the right and left coronary sinuses. Using VARC-II criteria (combining at least two), TTE agreed with angiographic classification in 53% of cases (k = 0.14). Greater than mild AR could better be defined by one of the following combinations of criteria: (i) LAX score >4.25 and VARC-II score >1.33; (ii) CD score >11.5 and PHT <400 ms. The combination of the CD score with PHT gave the best sum of sensitivity, specificity, positive, and negative predictive values.nnnCONCLUSIONSnAgreement between angiography and TTE (using the VARC-II criteria) in the grading of post-TAVI AR is modest, and this might have contributed to the inconsistency of data on the rate and fate of paravalvular AR. Inter-technique reproducibility can be improved using a combination of CD and hemodynamic parameters.

Prevalence of myocardial ischaemia as assessed with myocardial perfusion scintigraphy in patients with diabetes mellitus type 2 and mild anginal symptoms

PurposeTo determine the prevalence and predictors of reversible myocardial perfusion defects, indicative of myocardial ischaemia, in patients with mild, stable anginal complaints [Canadian Cardiovascular Society classification (CCS) I–II/IV] and diabetes mellitus type 2 (T2DM).MethodsA total of 329 patients with T2DM and stable, mild anginal symptoms (CCS I–II/IV) underwent myocardial perfusion scintigraphy. Perfusion images were assessed using a five-point (semi)-quantitative scoring system according to a 17-segment myocardial model.ResultsOne-hundred and fifty-six (47%) patients showed reversible myocardial perfusion defects defined as a summed difference score of ≥3. Male gender [odds ratio (OR) 2.28, 95% CI 1.4–3.71, p=0.001], previous myocardial infarction (MI) without revascularisation (OR 3.04, 95% CI 1.28–7.24, p=0.01), and the use of two or more classes of anti-anginal medication (OR 2.36, 95% CI 1.48–3.76, p<0.001) were independent predictors for the presence of reversible defects. By contrast, lipid-lowering therapy reduced the possibility of reversible perfusion defects (OR 0.56, 95% CI 0.33–0.95, p=0.03).ConclusionApproximately half of the patients with mild, stable angina pectoris and T2DM showed evidence of myocardial ischaemia. Male gender, previous MI and the use of anti-anginal medication were positive predictors and lipid-lowering therapy was a negative predictor for the results of the scintigraphic stress test.

Pre-hospital management, procedural performance and outcomes for primary percutaneous coronary intervention in ST-elevation myocardial infarction in the Netherlands: Insights from the Dutch cohort of the APPOSITION-III trial

AimThe aim of this study was to achieve useful insights into pre-hospital management and procedural performance for ST-elevation myocardial infarction (STEMI) in the Netherlands by extrapolating patient characteristics, and procedural and clinical outcomes of the Dutch patient cohort from the APPOSITION-III trial.MethodsThis is axa0retrospective analysis from the APPOSITION-III trial with respect to the geographical borders of STEMI management. The APPOSITION-III trial was axa0European registry for the use of the STENTYS self-expandable stent in STEMI patients undergoing primary percutaneous coronary intervention (PPCI). 965 Patients were enrolled mainly in the Netherlands (nxa0= 420, 43.5u2009% of the overall study population), Germany (nxa0= 165) and France (nxa0= 131). The data from the Dutch cohort were compared with both the overall study population, and the French and German cohorts, respectively, as well as the European Society of Cardiology (ESC) STEMI guidelines.ResultsIn this trial there was axa0wide inter-country variation on symptom-to-balloon time, 165 minutes (120–318) in the Netherlands, 270 minutes (180–650) in Germany and 360 minutes (120–480) in France, respectively. In general, axa0preload of dual antiplatelet therapy (DAPT) combined with heparin was more often performed in the Dutch and French cohort than in the German cohort. DAPT at discharge was high across the whole APPOSITION-III population. No important differences were seen between the different groups according to the endpoints major adverse cardiac event and stent thrombosis.ConclusionIn the Dutch cohort of an European multicentre STEMI study (APPOSITION-III trial), the performance in terms of symptom-to-balloon time, and pre-, peri- and post-procedural medical treatment is in line with the recommendations of ESC STEMI guidelines.