JACC in a Flash

Five key trials presented at EuroPCR were simultaneously published in the Journal of the American College of Cardiology and JACC: Cardiovascular Interventions. Here we bring you our flash summaries of these trials.

Should Computed Tomography-Derived FFR Guide Clinical Decision-Making?

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The noninvasive assessment of stenosis severity by calculating the functional SYNTAX score (FSS) using computed tomography angiography-derived fractional flow reserve (FFRCT) was shown to have a high degree of accuracy in detecting functionally significant lesions in patients with three-vessel coronary artery disease (CAD). The results of this analysis of a cohort of patients from the SYNTAX trial was presented during EuroPCR and published in the Journal of the American College of Cardiology.

Using data from the SYNTAX II study, Carlos A. Collet, MD, et al., calculated the CTA-SS in 77 patients with three-vessel CAD to assess the feasibility of and validate the noninvasive functional SYNTAX score in ischemia-producing lesions. The risk reclassification was compared between the noninvasive FSS and the invasive physiological assessment. The diagnostic accuracy of FFRCT was assessed by the area under the receiver-operating characteristic curve. Read More >>>

Results showed that of the 77 patients, obtaining the CTA-SS was feasible in 86 percent and the noninvasive FSS was feasible in 80 percent. While the anatomic SYNTAX score was shown to be overestimated by CTA compared with conventional angiography, the calculation of the FSS yielded similar results between the noninvasive and invasive imaging modalities.

The authors also found that the noninvasive FSS reclassified 30 percent of patients from the high and intermediate SYNTAX score tertiles to the low risk tertile, whereas the invasive functional SYNTAX score reclassified 23 percent of patients from the high and intermediate SYNTAX score tertiles to the low risk tertile.

Furthermore, the diagnostic accuracy of FFRCT to detect functionally significant stenosis — based on an instantaneous-wave free ratio of 0.89 or less — revealed an area under the receiver-operating characteristics curve of 0.85 with a sensitivity of 95 percent, specificity of 61 percent, positive predictive value of 81 percent and negative predictive value of 87 percent.

In an accompanying editorial comment, Bjarne L. Nørgaard, MD, PhD, et al., note that this study may present a new era in the management of CAD and “the days of having patients going to the catheterization laboratory with nothing more than symptoms and a positive stress test result may be coming to an end.” They add, “This study may be signaling a shifting paradigm with CAD diagnosed and thoroughly characterized non-invasively, revascularization planning made in a collaborative fashion integrating the heart team, and a wealth of non-invasive data that will hopefully lead to more effective and cost-efficient revascularization strategies.”

Collet C, Miyazaki Y, Ryan N, et al. J Am Coll Cardiol 2018;May 22:[Epub ahead of print].

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Ticagrelor Not Associated With Improved Endothelial Function, Vascular Biomarkers

Cardiology Magazine, Jan. 2017

Treatment with ticagrelor did not improve endothelial function or increase systemic adenosine plasma levels compared with prasugrel or clopidogrel in patients with stable post acute coronary syndrome (ACS), according to results from the HI-TECH study presented at EuroPCR and published in JACC: Cardiovascular Interventions.

In the randomized, open-label, crossover study, Sara Ariotti, MD, et al., examined 54 stable post-ACS patients in five European centers to assess whether treatment with ticagrelor improves endothelium-dependent dilation. Each patient was sequentially exposed to ticagrelor, prasugrel and clopidogrel following a three-period balanced Latin square crossover design with four weeks per treatment. The investigators also measured systemic adenosine plasma levels and several markers of endothelial function. Read More >>>

Results showed that the primary endpoint of reactive hyperemia index did not differ after ticagrelor vs. prasugrel (1.970 vs. 2.007; p=0.557) or vs. clopidogrel (1.970 vs. 2.072; p=0.685). No differences were seen between the drugs for systemic adenosine plasma levels or vascular biomarkers at any time points. Additionally, P2Y12 platelet reactivity units were lower after ticagrelor vs. clopidogrel at all time points and after a maintenance dose vs. prasugrel. Flow-mediated dilatation did not differ after the maintenance dose of ticagrelor vs. clopidogrel and prasugrel.

The authors explain that further research is needed to assess the effect of ticagrelor on tissue adenosine plasma levels in humans compared with other oral P2Y12 inhibitors and its relationship with clinical outcomes.

In an accompanying editorial comment, Jay S. Giri, MD, MPH, and Ashwin Nathan, MD, note that “it is imperative to ascertain whether these medications are accessible for individual patients.” They add, “although studies will attempt to identify nuanced differences among different antiplatelet agents to maximize benefits to patients, the best antiplatelet agent in the current era is likely the one the patient can afford to obtain.”

Ariotti S, Ortega-Paz L, van Leeuwen M, et al. JACC Cardiovasc Interv:May 24:[Epub ahead of print].

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Should Patients Be Treated With BVS over EES?

Cardiology Magazine, Jan. 2017

Both endothelium-dependent and -independent vasomotion of an infarct-related artery (IRA) were more evident with bioresorbable vascular scaffolds (BVS) compared with everolimus-eluting stents (EES) at three years, while functional microcirculatory parameters were mostly adequate and similar, according to results from the TROF II trial presented at EuroPCR and published in JACC: Cardiovascular Interventions.

Using data from the randomized, controlled, multicenter study, Josep Gomez-Lara, MD, PhD, et al., screened 63 consecutive event-free patients to undergo coronary angiography with vasomotor, microcirculatory and optical coherence tomography examination to compare the IRA function between BVS and EES at three years. Vasomotion was defined as more than a 4 percent change in mean lumen diameter to acetylcholine and nitroglycerin as assessed by quantitative angiography, and microcirculatory examination was performed with pressure or thermodilution techniques. Read More >>>

Results showed that of the 38 patients included (20 BVS and 18 EES), over 60 percent exhibited paradoxical vasoconstriction to acetylcholine in the periscaffold or stent segments at three years. Vasoconstriction to acetylcholine and vasodilatation to nitroglycerin were found to be more often observed in the scaffold or stent segment with BVS than with EES (77.8 vs. 25.0 percent; p=0.008, and 61.1 vs. 18.8 percent; p=0.018).

For IRA-dependent microcirculation, the findings showed similar index of resistance (23.8 vs. 22.4; p=0.781), coronary flow reserve (2.4 vs. 1.9; p=0.523), fractional flow reserve (0.91 vs. 0.93; p=0.317) and absolute flow (135.5 ml/min vs. 147.3 ml/min; p=0.791). Optical coherence tomography showed remaining strut footprints and larger number of intraluminal scaffold dismantling (26.3 vs. 0 percent; p=0.049) in the BVS group.

The clinical implications of these findings require further investigations note the authors.

In an accompanying editorial comment, Hiroyuki Jinnouchi, MD, et al., state these data are “valuable because they enhance our knowledge of the long-term vascular responses to this technology and might serve to temper enthusiasm.” However, they add, “the promise of BVS remains more fiction than fact, and if its future is to be realized, long-term responses such as vasomotion and compensatory dilation will need to be conclusively shown.”

Gomez-Lara J, Brugaletta S, Ortega-Paz L, et al. JACC Cardiovasc Interv:May 24:[Epub ahead of print].

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Visual Assessment Favored by Many Over Invasive Coronary Physiology Assessment of ACS

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Use of coronary physiology assessment in daily practice in catheterization laboratories met current guideline recommendations in only 48 percent of cases, with operator confidence in visual assessment being the most frequent reason for not using the physiology guidance, according to results from the ERIS study presented at EuroPCR and published in JACC: Cardiovascular Interventions.

In the investigator-driven, prospective, cross-sectional study, Matteo Tebaldi, MD, et al., reviewed cases at 76 Italian catheterization laboratories. Each center included consecutive cases for which the operators either used fractional flow reserve (FFR) or instantaneous wave-free ratio (iFR) assessment (physiology assessment group; n=1,177) or did not use it although patients met the inclusion and exclusion criteria (visual estimation group; n=681). Read More >>>

Overall, 140 operators provided 1,400 decisions about stenosis significance. Of these, 52 percent were based on visual assessment only and these decisions were consistent with the intracoronary pressure measurement in 46 percent of cases. In the other 48 percent of cases, operators acknowledged the need for an additional diagnostic tool, mostly intracoronary pressure measurement.

According to the authors, this is the first study to collect operators’ rationale for not performing the physiology assessment at the time of the clinical decision-making process in real-life cases.

In an accompanying editorial comment, Nils P. Johnson, MD, FACC, et al., write this study helps us to critically evaluate potential responses to the question “‘Why don’t interventional cardiologists use coronary physiology?’... Although operators can be reluctant to admit it, the fundamental reason has received different labels: attitude, belief, local practice, ‘experience’ and culture. Put simply, we as a profession do not yet emotionally accept coronary physiology to guide treatment.”

Tebaldi M, Biscaglia S, Fineschi M, et al. JACC Cardiovasc Interv:May 23:[Epub ahead of print].

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Predictors of Procedural Success with ACURATE neo Prosthesis in TAVR

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Procedural success of transfemoral implantation of the ACURATE neo prosthesis for transcatheter aortic valve replacement (TAVR) requires careful patient selection with appropriate oversizing, according to an analysis presented at EuroPCR and published in JACC: Cardiovascular Interventions. Further, the best outcomes may be achieved in cases with only mild to moderate calcification of the device landing zone.

In this single center post hoc analysis of 500 consecutive patients with severe aortic stenosis, Won-Keun Kim, MD, et al., examined predictors of procedural success with the new-generation, self-expanding X-shaped ACURATE neo valve. Patients had transfemoral TAVR between May 2012 and September 2017. Read More >>>

Device landing zone calcification was stratified as severe, moderate or mild. Anatomic and procedural predictors of second-degree or greater paravalvular leakage (PVL) and permanent pacemaker implantation (PPI) were assessed. A stepwise logistic regression analysis (forward logistic regression) was carried out to specify independent predictors of second-degree or greater PVL and PPI.

Postprocedural second-degree or greater PVL was more frequent with increasing device landing zone calcification (mild 0.8 percent vs. moderate 5.0 percent vs. severe 13.0 percent; p<0.001). However, PPI was independent of device landing zone calcification.

Independent predictors of second-degree or greater PVL were more severe periannular calcification (odds ratio [OR], 1.007; p<0.001); less oversizing (OR, 0.867; p=0.014); presence of annular plaque protrusions (OR, 2.756; p= 0.025); aortic movement of the delivery system after full deployment (OR, 5.593; p=0.02); and sinotubular junction height (OR, 1.156; p=0.04).

Predictors of PPI were preexisting right bundle branch block (OR, 3.122; p=0.01) and more oversizing (OR, 1.111; p=0.03).

The investigators write that less aggressive predilatation may help reduce PPI rates, and maintaining forward pressure on the delivery system during deployment may decrease the likelihood of postprocedural PVL.

Validation of these results are needed in randomized studies. The comparative effectiveness of the ACURATE neo valve is being studied in two ongoing studies within the SCOPE trial program, with the balloon expandable SAPIEN 3 device and the self-expanding Evolut R device. “If results of randomized controlled trials, such as SCOPE I and II, are able to properly characterize patient- and procedure-related factors, which could predict device and procedural success as well as long-term outcome, this would represent a major step forward to precision medicine in TAVR,” write Christian Hengstenberg, MD, and Jolanta M. Siller-Matula, MD, in an accompanying editorial comment.

Kim W-K, Mollmann H, Liebetrau C, et al. JACC Cardiovasc Interv 2018;May 22;[Epub ahead of print].

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Similar Mortality for Hybrid Coronary Revascularization, CABG

Cardiology Magazine, Jan. 2017

Hybrid coronary revascularization (HCR) has similar five-year all-cause mortality when compared with conventional coronary bypass grafting in patients with multivessel coronary artery disease (CAD), according to research published in JACC: Cardiovascular Interventions.

This was a five-year follow-up analysis of the patients enrolled in the original HYBRID trial. The original trial evaluated the feasibility of a hybrid approach among patients with multivessel CAD. Two-hundred patients were randomly assigned to CABG vs. HCR (minimally invasive left internal mammary artery [LIMA] to left anterior descending artery [LAD] + PCI). This analysis focused on five-year outcomes among the cohort enrolled.

Data from 191 patients (94 in the HCR and 97 in the CABG groups) were analyzed. The baseline characteristics were similar in the two groups. All-cause mortality at five-year follow-up was similar in the two groups (6.4 percent for HCR vs. 9.2 percent for CABG; p=0.69). Also similar between the HCR and CABG groups, respectively, were the rates of myocardial infarction (4.3 vs. 7.2 percent; p=0.30), repeat revascularization (37.2 vs. 45.4 percent; p=0.38), stroke (2.1 vs. 4.1 percent; p=0.35) and major adverse cardiac and cerebrovascular events (45.2 vs. 53.4 percent; p=0.39).

The authors conclude that HCR is a promising coronary revascularization strategy in selected patients with multivessel CAD. They add that the study “warrants further validation in multicenter, adequately powered randomized studies to definitively assess the absolute benefits and risks of HCR.”

Tajstra M, Hrapkowicz T, Hawranek M, et al. JACC Cardiovasc Interv 2018;11:847-52.

Clinical Topics: Acute Coronary Syndromes, Arrhythmias and Clinical EP, Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Atherosclerotic Disease (CAD/PAD), ACS and Cardiac Biomarkers, EP Basic Science, Aortic Surgery, Cardiac Surgery and Arrhythmias, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Heart Failure and Cardiac Biomarkers, Interventions and ACS, Interventions and Coronary Artery Disease, Interventions and Imaging, Interventions and Structural Heart Disease, Interventions and Vascular Medicine, Angiography, Nuclear Imaging

Keywords: ACC Publications, Cardiology Interventions, Absorbable Implants, Acetylcholine, Acute Coronary Syndrome, Adenosine, Aneurysm, Angiography, Aortic Valve Stenosis, Arteries, Biological Markers, Blood Platelets, Bundle-Branch Block, Catheterization, Cohort Studies, Constriction, Pathologic, Coronary Angiography, Coronary Artery Bypass, Coronary Artery Disease, Cross-Over Studies, Cross-Sectional Studies, Dilatation, Drug-Eluting Stents, Endothelium, Exercise Test, Follow-Up Studies, Hyperemia, Logistic Models, Mammary Arteries, Microcirculation, Myocardial Infarction, Nitroglycerin, Odds Ratio, Pacemaker, Artificial, Patient Selection, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors, Prospective Studies, Prostheses and Implants, Research Personnel, Risk Assessment, ROC Curve, Sensitivity and Specificity, Stents, Stroke, Thermodilution, Purinergic P2Y Receptor Antagonists, Ticlopidine, Tomography, Optical Coherence, Transcatheter Aortic Valve Replacement, Vasoconstriction, Vasodilation

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