The effect of CTCA guided selective invasive graft assessment on coronary angiographic parameters and outcomes: Insights from the BYPASS-CTCA trial.

BACKGROUND: Computed tomography cardiac angiography (CTCA) is recommended for the evaluation of patients with prior coronary artery bypass graft (CABG) surgery. The BYPASS-CTCA study demonstrated that CTCA prior to invasive coronary angiography (ICA) in CABG patients leads to significant reductions in procedure time and contrast-induced nephropathy (CIN), alongside improved patient satisfaction. However, whether CTCA information was used to facilitate selective graft cannulation at ICA was not protocol mandated. In this post-hoc analysis we investigated the influence of CTCA facilitated selective graft assessment on angiographic parameters and study endpoints. METHODS: BYPASS-CTCA was a randomized controlled trial in which patients with previous CABG referred for ICA were randomized to undergo CTCA prior to ICA, or ICA alone. In this post-hoc analysis we assessed the impact of selective ICA (grafts not invasively cannulated based on the CTCA result) following CTCA versus non-selective ICA (imaging all grafts irrespective of CTCA findings). The primary endpoints were ICA procedural duration, incidence of CIN, and patient satisfaction post-ICA. Secondary endpoints included the incidence of procedural complications and 1-year major adverse cardiac events. RESULTS: In the CTCA cohort (n â€‹= â€‹343), 214 (62.4%) patients had selective coronary angiography performed, whereas 129 (37.6%) patients had non-selective ICA. Procedure times were significantly reduced in the selective CTCA â€‹+ â€‹ICA group compared to the non-selective CTCA â€‹+ â€‹ICA group (-5.82min, 95% CI -7.99 to -3.65, p â€‹< â€‹0.001) along with reduction of CIN (1.5% vs 5.8%, OR 0.26, 95% CI 0.10 to 0.98). No difference was seen in patient satisfaction with the ICA, however procedural complications (0.9% vs 4.7%, OR 0.21, 95% CI 0.09-0.87) and 1-year major adverse cardiac events (13.1% vs 20.9%, HR 0.55, 95% CI 0.32-0.96) were significantly lower in the selective group. CONCLUSIONS: In patients with prior CABG, CTCA guided selective angiographic assessment of bypass grafts is associated with improved procedural parameters, lower complication rates and better 12-month outcomes. Taken in addition to the main findings of the BYPASS-CTCA trial, these results suggest a synergistic approach between CTCA and ICA should be considered in this patient group. REGISTRATION: ClinicalTrials.gov, NCT03736018.

Computed Tomography Cardiac Angiography Before Invasive Coronary Angiography in Patients With Previous Bypass Surgery: The BYPASS-CTCA Trial.

BACKGROUND: Patients with previous coronary artery bypass grafting often require invasive coronary angiography (ICA). However, for these patients, the procedure is technically more challenging and has a higher risk of complications. Observational studies suggest that computed tomography cardiac angiography (CTCA) may facilitate ICA in this group, but this has not been tested in a randomized controlled trial. METHODS: This study was a single-center, open-label randomized controlled trial assessing the benefit of adjunctive CTCA in patients with previous coronary artery bypass grafting referred for ICA. Patients were randomized 1:1 to undergo CTCA before ICA or ICA alone. The co-primary end points were procedural duration of the ICA (defined as the interval between local anesthesia administration for obtaining vascular access and removal of the last catheter), patient satisfaction after ICA using a validated questionnaire, and the incidence of contrast-induced nephropathy. Linear regression was used for procedural duration and patient satisfaction score; contrast-induced nephropathy was analyzed using logistic regression. We applied the Bonferroni correction, with P<0.017 considered significant and 98.33% CIs presented. Secondary end points included incidence of procedural complications and 1-year major adverse cardiac events. RESULTS: Over 3 years, 688 patients were randomized with a median follow-up of 1.0 years. The mean age was 69.8±10.4 years, 108 (15.7%) were women, 402 (58.4%) were White, and there was a high burden of comorbidity (85.3% hypertension and 53.8% diabetes). The median time from coronary artery bypass grafting to angiography was 12.0 years, and there were a median of 3 (interquartile range, 2 to 3) grafts per participant. Procedure duration of the ICA was significantly shorter in the CTCA+ICA group (CTCA+ICA, 18.6±9.5 minutes versus ICA alone, 39.5±16.9 minutes [98.33% CI, -23.5 to -18.4]; P<0.001), alongside improved mean ICA satisfaction scores (1=very good to 5=very poor; -1.1 difference [98.33% CI, -1.2 to -0.9]; P<0.001), and reduced incidence of contrast-induced nephropathy (3.4% versus 27.9%; odds ratio, 0.09 [98.33% CI, 0.04-0.2]; P<0.001). Procedural complications (2.3% versus 10.8%; odds ratio, 0.2 [95% CI, 0.1-0.4]; P<0.001) and 1-year major adverse cardiac events (16.0% versus 29.4%; hazard ratio, 0.4 [95% CI, 0.3-0.6]; P<0.001) were also lower in the CTCA+ICA group. CONCLUSIONS: For patients with previous coronary artery bypass grafting, CTCA before ICA leads to reductions in procedure time and contrast-induced nephropathy, with improved patient satisfaction. CTCA before ICA should be considered in this group of patients. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03736018.

Comparing Outcomes Between Surgical and Transcatheter Aortic Valve Replacement in Classical Low-Flow Low-Gradient Aortic Stenosis.

Patients with classic low-flow low-gradient (cLFLG) aortic stenosis (AS) have a poor prognosis but still benefit from aortic valve replacement. There is a paucity of evidence to guide the choice between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). This study compared procedural and midterm outcomes in patients with cLFLG AS between TAVR and SAVR. Patients with cLFLG AS, defined as an aortic valve area ≤1 cm2, mean gradient <40 mm Hg, and left ventricular ejection fraction <50%, were selected from a single center between 2015 and 2020. Inverse probability weighting and regression were used to adjust for differences in baseline characteristics, the nonrandom assignment of treatment modalities, and procedural differences. The primary end point was all-cause mortality. A total of 322 patients (220 TAVR and 102 SAVR) were included. At a follow-up of 4.4 ± 1.5 years, the adjusted hazard ratio (HR) for mortality after inverse probability weighting with SAVR was 0.66, 95% confidence interval (CI) 0.31 to 1.35; p = 0.24. Worse renal function at baseline (per 10 ml/min/m2 increase HR 0.92, 95% CI 0.84 to 1.00, p = 0.04) and multiple valve interventions (HR 5.39, 95% CI 2.62 to 11.12, p <0.001) independently predicted mortality. There was no difference in stroke and permanent pacemaker implantation, but the rates of renal replacement therapy were higher among the SAVR cohort: 13.7% versus 0%; p <0.001. In conclusion, among patients with cLFLG AS, there was no difference in midterm mortality between TAVR and SAVR, supporting the use of either treatment. However, in patients with poor renal function or at risk of renal failure, TAVR may be the preferred option.

Predictors of post-TAVI conduction abnormalities in patients with bicuspid aortic valves.

OBJECTIVES: This study evaluates predictors of conduction abnormalities (CA) following transcatheter aortic valve implantation (TAVI) in patients with bicuspid aortic valves (BAV). BACKGROUND: TAVI is associated with CA that commonly necessitate a permanent pacemaker. Predictors of CA are well established among patients with tricuspid aortic valves but not in those with BAV. METHODS: This is a single-centre, retrospective, observational study of patients with BAV treated with TAVI. Pre-TAVI ECG and CT scans and procedural characteristics were evaluated in 58 patients with BAV. CA were defined as a composite of high-degree atrioventricular block, new left bundle branch block with a QRS >150 ms or PR >240 ms and right bundle branch block with new PR prolongation or change in axis. Predictors of CA were identified using regression analysis and optimum cut-off values determined using area under the receiver operating characteristic curve analysis. RESULTS: CA occurred in 35% of patients. Bioprosthesis implantation depth, the difference between membranous septum (MS) length and implantation depth (δMSID) and device landing zone (DLZ) calcification adjacent to the MS were identified as univariate predictors of CA. The optimum cut-off for δMSID was 1.25 mm. Using this cut-off, low δMSID and DLZ calcification adjacent to MS predicted CA, adjusted OR 8.79, 95% CI 1.88 to 41.00; p=0.01. Eccentricity of the aortic valve annulus, type of BAV and valve calcium quantity and distribution did not predict CA. CONCLUSIONS: In BAV patients undergoing TAVI, short δMSID and DLZ calcification adjacent to MS are associated with an increased risk of CA.

Getting the best from the Heart Team: guidance for cardiac multidisciplinary meetings.

The purpose of this document is to update the existing joint British Societies recommendations on multidisciplinary meetings (MDMs) published in 2015 to reflect changes in practice. We aim to provide guidance on the structure and function of MDMs which should be taking place in every cardiac surgical centre. Out of scope are MDMs that do not require the routine presence of a cardiac surgeon such as electrophysiology MDMs and those which are not provided in every centre, such as complex aortic surgery.

Safety and Efficacy of Myval Implantation in Patients with Severe Bicuspid Aortic Valve Stenosis-A Multicenter Real-World Experience.

Bicuspid aortic valve (BAV) is the most common valvular congenital anomaly and is apparent in nearly 50% of candidates for AV replacement. While transcatheter aortic valve implantation (TAVI) is a recommended treatment for patients with symptomatic severe aortic stenosis (AS) at all surgical risk levels, experience with TAVI in severe bicuspid AS is limited. TAVI in BAV is still a challenge due to its association with multiple and complex anatomical considerations. A retrospective study has been conducted to investigate TAVI's procedural and 30-day outcomes using the Myval transcatheter heart valve (THV) (Meril Life Sciences Pvt. Ltd. Vapi, Gujarat, India) in patients with severe bicuspid AS. Data were collected on 68 patients with severe bicuspid AS who underwent TAVI with the Myval THV. Baseline characteristics, procedural, 30-day echocardiographic and clinical outcomes were collected. The mean age and STS PROM score were 72.6 ± 9.4 and 3.54 ± 2.1. Procedures were performed via the transfemoral route in 98.5%. Major vascular complications (1.5%) and life-threatening bleeding (1.5%) occurred infrequently. No patient had coronary obstruction, second valve implantation or conversion to surgery. On 30-day echocardiography, the mean transvalvular gradient and effective orifice area were 9.8 ± 4.5 mmHg and 1.8 ± 0.4 cm2, respectively. None/trace aortic regurgitation occurred in 76.5%, mild AR in 20.5% and moderate AR in 3%. The permanent pacemaker implantation rate was 8.5% and 30-day all-cause death occurred in 3.0% of cases. TAVI with the Myval THV in selected BAV anatomy is associated with favorable short-term hemodynamic and clinical outcomes.

Quantitative Flow Ratio to Predict Nontarget Vessel-Related Events at 5 Years in Patients With ST-Segment-Elevation Myocardial Infarction Undergoing Angiography-Guided Revascularization.

Background In ST-segment-elevation myocardial infarction, angiography-based complete revascularization is superior to culprit-lesion-only percutaneous coronary intervention. Quantitative flow ratio (QFR) is a novel, noninvasive, vasodilator-free method used to assess the hemodynamic significance of coronary stenoses. We aimed to investigate the incremental value of QFR over angiography in nonculprit lesions in patients with ST-segment-elevation myocardial infarction undergoing angiography-guided complete revascularization. Methods and Results This was a retrospective post hoc QFR analysis of untreated nontarget vessels (any degree of diameter stenosis [DS]) from the randomized multicenter COMFORTABLE AMI (Comparison of Biolimus Eluted From an Erodible Stent Coating With Bare Metal Stents in Acute ST-Elevation Myocardial Infarction) trial by assessors blinded for clinical outcomes. The primary end point was cardiac death, spontaneous nontarget vessel myocardial infarction, and clinically indicated nontarget vessel revascularization (ie, ≥70% DS by 2-dimensional quantitative coronary angiography or ≥50% DS and ischemia) at 5 years. Of 1161 patients with ST-segment-elevation myocardial infarction, 946 vessels in 617 patients were analyzable by QFR. At 5 years, the rate of the primary end point was significantly higher in patients with QFR ≤0.80 (n=35 patients, n=36 vessels) versus QFR >0.80 (n=582 patients, n=910 vessels) (62.9% versus 12.5%, respectively; hazard ratio [HR], 7.33 [95% CI, 4.54-11.83], P<0.001), driven by higher rates of nontarget vessel myocardial infarction (12.8% versus 3.1%, respectively; HR, 4.38 [95% CI, 1.47-13.02], P=0.008) and nontarget vessel revascularization (58.6% versus 7.7%, respectively; HR, 10.99 [95% CI, 6.39-18.91], P<0.001) with no significant differences for cardiac death. Multivariable analysis identified QFR ≤0.80 but not ≥50% DS by 3-dimensional quantitative coronary angiography as an independent predictor of the primary end point. Results were consistent, including only >30% DS by 3-dimensional quantitative coronary angiography. Conclusions Our study suggests incremental value of QFR over angiography-guided percutaneous coronary intervention for nonculprit lesions among patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention.

Diagnostic accuracy of quantitative flow ratio (QFR) and vessel fractional flow reserve (vFFR) estimated retrospectively by conventional radiation saving X-ray angiography.

BACKGROUND: Angiography derived FFR reveals good performance in assessing intermediate coronary stenosis. However, its performance under contemporary low X-ray frame and pulse rate settings is unknown. We aim to validate the feasibility and performance of quantitative flow ratio (QFR) and vessel fractional flow reserve (vFFR) under such angiograms. METHODS: This was an observational, retrospective, single center cohort study. 134 vessels in 102 patients, with angiograms acquired under 7.5fps and 7pps mode, were enrolled. QFR (fQFR and cQFR) and vFFR were validated with FFR as the gold standard. A conventional manual and a newly developed algorithmic exclusion method (M and A group) were both evaluated for identification of poor-quality angiograms. RESULTS: Good agreement between QFR/vFFR and FFR were observed in both M and A group, except for vFFR in the M group. The correlation coefficients between fQFR/cQFR/vFFR and FFR were 0.6242, 0.5888, 0.4089 in the M group, with rvFFR significantly lower than rfQFR (p = 0.0303), and 0.7055, 0.6793, 0.5664 in the A group, respectively. AUCs of detecting lesions with FFR ≤ 0.80 were 0.852 (95% CI 0.722-0.913), 0.858 (95% CI 0.778-0.917), 0.682 (95% CI 0.586-0.768), for fQFR/cQFR/vFFR in the M group, while vFFR performed poorer than fQFR (p = 0.0063) and cQFR (p = 0.0054). AUCs were 0.898 (95% CI 0.811-0.945), 0.892 (95% CI 0.803-0.949), 0.843 (95% CI 0.746-0.914) for fQFR/cQFR/vFFR in the A group. AUCvFFR was significantly higher in the A group than that in the M group (p = 0.0399). CONCLUSIONS: QFR/vFFR assessment is feasible under 7.5fps and 7pps angiography, where cQFR showed no advantage compared to fQFR. Our newly developed algorithmic exclusion method could be a better method of selecting angiograms with adequate quality for angiography derived FFR assessment.

In-hospital stroke after transcatheter aortic valve implantation: A UK observational cohort analysis.

OBJECTIVES: We sought to identify baseline demographics and procedural factors that might independently predict in-hospital stroke following transcatheter aortic valve implantation (TAVI). BACKGROUND: Stroke is a recognized, albeit infrequent, complication of TAVI. Established predictors of procedure-related in-hospital stroke; however, remain poorly defined. METHODS: We conducted an observational cohort analysis of the multicenter UK TAVI registry. The primary outcome measure was the incidence of in-hospital stroke. RESULTS: A total of 8,652 TAVI procedures were performed from 2007 to 2015. There were 205 in-hospital strokes reported by participating centers equivalent to an overall stroke incidence of 2.4%. Univariate analysis showed that the implantation of balloon-expandable valves caused significantly fewer strokes (balloon-expandable 96/4,613 [2.08%] vs. self-expandable 95/3,272 [2.90%]; p = .020). After multivariable analysis, prior cerebrovascular disease (CVD) (odds ratio [OR] 1.51, 95% confidence interval [CI 1.05-2.17]; p = .03), advanced age at time of operation (OR 1.02 [0.10-1.04]; p = .05), bailout coronary stenting (OR 5.94 [2.03-17.39]; p = .008), and earlier year of procedure (OR 0.93 [0.87-1.00]; p = .04) were associated with an increased in-hospital stroke risk. There was a reduced stroke risk in those who had prior cardiac surgery (OR 0.62 [0.41-0.93]; p = .01) and a first-generation balloon-expandable valve implanted (OR 0.72 [0.53-0.97]; p = .03). In-hospital stroke significantly increased 30-day (OR 5.22 [3.49-7.81]; p < .001) and 1-year mortality (OR 3.21 [2.15-4.78]; p < .001). CONCLUSIONS: In-hospital stroke after TAVI is associated with substantially increased early and late mortality. Factors independently associated with in-hospital stroke were previous CVD, advanced age, no prior cardiac surgery, and deployment of a predominantly first-generation self-expandable transcatheter heart valve.

Pharmacodynamic Comparison of Ticagrelor Monotherapy Versus Ticagrelor and Aspirin in Patients After Percutaneous Coronary Intervention: The TEMPLATE (Ticagrelor Monotherapy and Platelet Reactivity) Randomized Controlled Trial.

Background To assess differences in platelet inhibition during ticagrelor monotherapy (TIC) or dual therapy with ticagrelor and aspirin (TIC+ASP) in patients after percutaneous coronary intervention using a comprehensive panel of functional tests. Methods and Results In a single-center parallel group, open label, randomized controlled trial, 110 participants were randomized to receive either TIC (n=55) or TIC+ASP (n=55) for 4 weeks. The primary outcome was the platelet aggregation response with 10 µmol/L thrombin receptor activation peptide-6 (TRAP-6). The secondary outcomes were platelet aggregation responses and binding of surface activation markers with a panel of other activators. The mean percentage aggregation for 10 µmol/L TRAP-6 was similar for the TIC and TIC+ASP groups (mean difference+4.29; 95% CI, -0.87 to +9.46). Aggregation was higher in the TIC group compared with the TIC+ASP group with 1 µg/mL (+6.47; +2.04 to +10.90) and 0.5 µg/mL (+14.00; +7.63 to +20.39) collagen related peptide. Aggregation responses with 5 µmol/L TRAP-6, 5 µmol/L or 2.5 µmol/L thromboxane A2 receptor agonist and surface activation marker binding with 5 µmol/L TRAP-6 or 0.5 µg/mL collagen related peptide were the same between the treatment groups. Conclusions Patients with PCI show similar levels of inhibition of most platelet activation pathways with TIC compared with dual therapy with TIC + ASP. However, the greater aggregation response with collagen related peptide during TIC indicates incomplete inhibition of glycoprotein VI (collagen) receptor-mediated platelet activation. This difference in pharmacodynamic response to anti-platelet medication may contribute to the lower bleeding rates observed with TIC compared with dual antiplatelet therapy in recent clinical trials. Registration Information URL: https://www.isrctn.com; Unique Identifier ISRCTN84335288.

Predictors of Outcomes Following Transcatheter Edge-to-Edge Mitral Valve Repair.

Transcatheter edge-to-edge mitral valve repair is a viable alternative to surgery in patients with severe mitral regurgitation and high surgical risk. Yet the specific group of patients who would optimally benefit from this therapy remains to be determined. Selection of patients for transcatheter strategy is currently based on surgical prognostic scores and technical feasibility. Meanwhile, various clinical, anatomic, and procedural factors have been recently recognized as predictors of adverse outcomes following transcatheter edge-to-edge mitral valve repair, including device failure, recurrent mitral regurgitation, and mortality. Integration of these prognostic factors in the decision-making process of the heart team might improve patient management and outcomes. Herein, the authors review the different factors related to symptomatic status, comorbidity, serum biomarkers, echocardiographic findings, and procedural technique that have been identified as independent predictors of adverse outcome following transcatheter edge-to-edge mitral valve repair and discuss their potential application in everyday clinical practice.

Computerised Methodologies for Non-Invasive Angiography-Derived Fractional Flow Reserve Assessment: A Critical Review.

Fractional flow reserve is the gold standard for assessing the haemodynamic significance of intermediate coronary artery stenoses. Cumulative evidence has shown that FFR-guided revascularisation reduces stent implantations and improves patient outcomes. However, despite the wealth of evidence and guideline recommendations, its use in clinical practice remains minimal. Patient and technical limitations of FFR as well as the need for intracoronary instrumentation, use of adenosine, and increased costs have limited FFR's applicability in clinical practice. Over the last decade, several angiography-derived FFR software packages have been developed which do not require intracoronary pressure assessment with a guidewire or need for administration of hyperaemic agents. At present, there are 3 commercially available software packages and several other non-commercial technologies that have been described in the literature. These technologies have been validated against invasive FFR showing good accuracy and correlation. However, the methodology behind these solutions is different-some algorithms are based on solving the governing equations of fluid dynamics such as the Navier-Stokes equation while others have opted for a more simplified mathematical formula approach. The aim of this review is to critically appraise the methodology behind all the known angiography-derived FFR technologies highlighting the key differences and limitations.

Routine aspiration thrombectomy is associated with increased stroke rates during primary percutaneous coronary intervention for myocardial infarction.

BACKGROUND: Recent studies have suggested that the routine use of aspiration thrombectomy catheters during primary percutaneous coronary intervention (PCI) do not result in improved mortality and may be associated with an increased stroke rate. This study sought to investigate this hypothesis. METHODS: This was an observational study analysing data from a prospective database of 6366 patients undergoing primary PCI between August 2003 and May 2015 at a UK cardiac centre. Patients' details were collected from the hospital electronic database. Primary outcome was thirty-day stroke rates. RESULTS: 3989 (62.7%) patients underwent PCI alone and 2,377 (37.3%) patients underwent PCI with adjuctive thrombus aspiration. PCI alone group had an older demographic (63 (± 14) years vs 60.7 (± 14)), a lower proportion of male participants 75% vs 79% (P=0.001) and cardiovascular risk factors such as hypertension 22.4% vs 25.3% (P=0.007), hypercholesterolemia 18.5% vs 22.6% (P<0.0001) and a history of smoking 33.5% vs 44.3% (P<0.0001). Thrombus aspiration was associated with a higher 30-day stroke rate [16 (0.7%) vs 11 (0.3%) (HR 2.51; 95% CI 1.03-6.08, P 0.03). Multivariate analysis suggested that this increased risk of stroke was maintained following adjustment for confounders (HR: 1.86; 95% CI 1.02-4.38). There was 379 deaths of which 114 (4.8%) were in the thrombus aspiration cohort vs 265 (6.6%) in PCI only cohort over the follow-up period (60 months). This resulted in a significantly lower rate of all-cause-mortality HR 0.70 (95% CI 0.52-0.94; P 0.02). There was no statistically significant difference in observed myocardial infarction rates HR 0.76 (95% CI 0.47-1.23; P 0.27) and the rates of unscheduled revascularisations HR 0.70 (95% CI 0.43-1.13; P 0.14) between the two groups. CONCLUSIONS: Our data series of STEMI patients, suggest that routine thrombus aspiration during primary PCI is associated with a significantly higher stroke, rate however, thrombus aspiration reduced mortality rate. This is consistent with current guidelines which don't recommend the routine use of thrombus aspiration for primary PCI. A possible mortality reduction in patients with high thrombus grades was seen which may warrant further study.

Adjunctive Antithrombotic Therapy for Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement.

Importance: Transcatheter aortic valve replacement (TAVR) is an established alternative to surgery for patients with severe symptomatic aortic stenosis. Adjunctive antithrombotic therapy used to mitigate thrombotic risks in patients undergoing TAVR must be balanced against bleeding complications, since both are associated with increased mortality. Observation: Stroke risk associated with TAVR is lower than that associated with surgical aortic valve replacement in recent trials including patients at intermediate or low risk, but it is constant beginning at the time of implant and accrues over time based on patient risk factors. Patients with aortic stenosis undergoing TAVR also have a sizable risk of life-threatening or major bleeding. Although dual antiplatelet therapy for 3 to 6 months after TAVR is the guideline-recommended regimen, this practice is not well supported by current evidence. In patients with no indication for oral anticoagulation, current registry-based evidence suggests that single antiplatelet therapy may be safer than dual antiplatelet therapy. Similarly, oral anticoagulation monotherapy appears superior to anticoagulation plus antiplatelet therapy in those where oral anticoagulant use is indicated. To date, no risk prediction models have been established to guide antithrombotic therapy. Conclusions and Relevance: Despite the growing volume of TAVR procedures to treat patients with severe aortic stenosis, evidence for adjunctive antithrombotic therapy remains rather scarce. Ongoing clinical trials will provide better understanding to guide antithrombotic therapy.

Safety and effectiveness of the self-aPposing, bAlloon-delivered, siRolimus-eluting stent for the Treatment of the coronary Artery disease: SPARTA, a multicenter experience.

AIMS: To assess the long-term outcomes of patients treated with sirolimus-eluting Stentys stent in a real-life setting. BACKGROUND: Few data regarding the safety and effectiveness of self-apposing sirolimus-eluting Stentys stent are available. METHODS: 278 patients (30% stable coronary artery disease, 70% acute coronary syndromes, and 54% on unprotected left main) treated with sirolimus eluting Stentys stent were retrospectively included in the self-aPposing, bAlloon-delivered, siRolimus-eluting stent for the Treatment of the coronary Artery disease multicenter registry. Major adverse cardiovascular events (MACE, a composite of cardiac death, myocardial infarction, target lesion revascularization, stent thrombosis) were the primary end-point, single components of MACE were the secondary ones. RESULTS: After 13 months (interquartile range 5-32), MACE was 14%. Stent thrombosis occurred in 3.9% of the patients (2.5% definite stent thrombosis and 1.4% probable stent thrombosis), 66% of them presenting with ST-segment elevation myocardial infarction (STEMI) at admission. Cardiovascular death, target lesion revascularization and myocardial infarction was 4.7%, 8.3%, and 7.2%, respectively. At multivariate analysis, risk of MACE was increased by diabetes (hazard ratios 4.76; P = 0.002) but was not affected by the indication leading to sirolimus-eluting Stentys stent implantation (marked vessel tapering vs. coronary ecstasies, hazard ratios 0.74, P = 0.71). CONCLUSION: Sirolimus-eluting Stentys stent may represent a potential solution for specific coronary anatomies such as bifurcation, ectasic, or tapered vessels. Risk of stent thrombosis appears related to clinical presentation with STEMI and to anatomic features, stressing the importance of the use of intracoronary imaging for self-expandable stents implantation.

Microvascular dysfunction determines infarct characteristics in patients with reperfused ST-segment elevation myocardial infarction: The MICROcirculation in Acute Myocardial Infarction (MICRO-AMI) study.

BACKGROUND: In patients with reperfused ST-elevation myocardial infarction (STEMI) both invasive and non-invasive assessments of microvascular dysfunction, the index of microcirculatory resistance (IMR), and microvascular obstruction (MVO) by cardiovascular magnetic resonance (CMR), independently predict poor long-term outcomes. AIMS: The aims of this study were to investigate whether an invasive parameter (IMR), assessed at the time of primary percutaneous intervention (PPCI), could predict the extent of MVO in proportion to infarct size (MVO index). METHODS: 50 patients presenting with STEMI and TIMI flow ≤ I in the infarct related artery were prospectively recruited to the study, before undergoing PPCI. All patients underwent invasive IMR assessment at maximal hyperaemia using adenosine, and following stent insertion. CMR was performed on day 2 following STEMI, MVO was assessed both on first-pass rest perfusion (early MVO) and in the late gadolinium enhancement (LGE) images (late MVO) along with infarct size. The MVO index was calculated as the ratio of late MVO/infarct size. Differences between IMR quartiles and the MVO index were investigated. RESULTS: The median IMR was 38.5 (range 9 to 202). The median size of late MVO was 1.9% LV (range 0 to 21.0% LV). IMR predicted late MVO (p<0.01) and as IMR increased, the MVO index increased (r = 0.70, [95% CI 0.53, 0.82], p<0.001). An IMR cut-off of 40 significantly predicted the presence of late MVO on CMR (p<0.001). CONCLUSION: IMR measured at the time of PPCI in acutely reperfused STEMI is associated with the presence and severity of infarct damage as measured by the MVO index. TRIAL REGISTRATION: The Microcirculation in Acute Myocardial Infarction (MICRO-AMI). Clinicaltrials.gov NCT01552564. Registered 9th March 2012.

Platelet inhibition during ticagrelor monotherapy versus ticagrelor plus aspirin in patients with coronary artery disease (TEMPLATE study): study protocol for a randomised controlled trial.

BACKGROUND: Dual antiplatelet therapy (DAPT) with aspirin (ASP) and a P2Y12 blocker is currently standard care after percutaneous coronary intervention (PCI) with stent insertion, and aims to inhibit platelet function in order to prevent stent thrombosis. The P2Y12 blocker ticagrelor (TIC) has greater antiplatelet effect than the previously used members of this class, such as clopidogrel. In healthy volunteers, TIC is sufficient to cause strong platelet inhibition, with little additional effect from ASP. Omission of ASP may improve the safety of antiplatelet regimes by reducing bleeding. However, the effect of single antiplatelet treatment with TIC, compared to DAPT with TIC + ASP, has not been studied in detail in patients with coronary artery disease. METHODS: To compare TIC with TIC + ASP, we have initiated a single centre, open-label randomised controlled trial (TEMPLATE study) in adults receiving DAPT following PCI with a sample size of 110 patients. Patients are invited to join the study when, as part of standard care, they are due to switch from DAPT (ASP + any P2Y12 blocker) to single antiplatelet treatment with ASP alone after 6-12 months. Patients are randomised to receive either TIC or TIC + ASP for 4 weeks. All patients then revert to standard care with ASP alone. Blood samples and clinical data are collected at three study visits: at baseline during treatment with ASP + any P2Y12 blocker (visit 1); approximately 4 weeks after visit 1 during treatment with either TIC or TIC + ASP (visit 2); and approximately 8 weeks after visit 1 when treatment has reverted to ASP alone (visit 3). The primary outcome is the extent of platelet inhibition, measured by light transmission aggregation, flow cytometry, flow chamber and plasma biomarker tests. The primary analysis will compare the extent of platelet inhibition between the TIC and TIC + ASP groups at visit 2, adjusted for baseline platelet reactivity. Secondary analyses will compare the extent of platelet inhibition at visit 2 with that at visit 3. DISCUSSION: This is the first study to compare in detail the extent of platelet inhibition in patients who are receiving TIC compared with TIC + ASP. The study findings will complement larger-scale trials of the clinical efficacy and safety of TIC compared to TIC + ASP. TRIAL REGISTRATION: ISRCTN registry, identifier ISRCTN84335288 . Registered on 23 June 2014.