340 results on '"Toth, Gabor G."'
Search Results
102. TCT-294 Contrast-induced microvascular dilatation: implications for fractional flow reserve measurements
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Adjedj, Julien, primary, Toth, Gabor G., additional, Johnson, Nils P., additional, Pellicano, Mariano, additional, Ferrara, Angela, additional, Di-Gioia, Giuseppe, additional, Floré, Vincent, additional, Barbato, Emanuele, additional, Muller, Olivier, additional, and De Bruyne, Bernard, additional
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- 2015
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103. TCT-307 Validation of a novel catheter for thermodilution-derived measurement of absolute coronary blood flow and microvascular resistances
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Adjedj, Julien, primary, Toth, Gabor G., additional, Ferrara, Angela, additional, Pellicano, Mariano, additional, Floré, Vincent, additional, Barbato, Emanuele, additional, and De Bruyne, Bernard, additional
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- 2015
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104. TCT-293 Intracoronary Adenosine: Dose-Response Relationship with Hyperemia
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Adjedj, Julien, primary, Toth, Gabor G., additional, Johnson, Nils P., additional, Pellicano, Mariano, additional, Ferrara, Angela, additional, Floré, Vincent, additional, Di-Gioia, Giuseppe, additional, Barbato, Emanuele, additional, Muller, Olivier, additional, and De Bruyne, Bernard, additional
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- 2015
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105. TCT-308 Continuous intracoronary infusion of saline at room temperature induces steady state maximal hyperemia
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Adjedj, Julien, primary, Floré, Vincent, additional, Toth, Gabor G., additional, Ferrara, Angela, additional, Pellicano, Mariano, additional, Barbato, Emanuele, additional, and De Bruyne, Bernard, additional
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- 2015
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106. Intracoronary Adenosine
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Adjedj, Julien, primary, Toth, Gabor G., additional, Johnson, Nils P., additional, Pellicano, Mariano, additional, Ferrara, Angela, additional, Floré, Vincent, additional, Di Gioia, Giuseppe, additional, Barbato, Emanuele, additional, Muller, Olivier, additional, and De Bruyne, Bernard, additional
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- 2015
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107. Reply
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Fearon, William F., primary, Yong, Andy S., additional, Lenders, Guy, additional, Toth, Gabor G., additional, Dao, Catherine, additional, Daniels, David V., additional, Pijls, Nico H.J., additional, and De Bruyne, Bernard, additional
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- 2015
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108. Invasive Measures of Myocardial Perfusion and Ischemia
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Adjedj, Julien, primary, Toth, Gabor G., additional, and De Bruyne, Bernard, additional
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- 2015
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109. Response to Letter Regarding Article, “Revascularization Decisions in Patients With Stable Angina and Intermediate Lesions: Results of the International Survey on Interventional Strategy”
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Toth, Gabor G., primary, Toth, Balint, additional, De Vroey, Frederic, additional, Di Serafino, Luigi, additional, Pyxaras, Stylianos, additional, Rusinaru, Dan, additional, Di Gioia, Giuseppe, additional, Pellicano, Mariano, additional, Barbato, Emanuele, additional, Van Mieghem, Carlos, additional, Heyndrickx, Guy R., additional, De Bruyne, Bernard, additional, Wijns, William, additional, and Johnson, Nils P., additional
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- 2015
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110. Revascularization Decisions in Patients With Stable Angina and Intermediate Lesions
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Toth, Gabor G., primary, Toth, Balint, additional, Johnson, Nils P., additional, De Vroey, Frederic, additional, Di Serafino, Luigi, additional, Pyxaras, Stylianos, additional, Rusinaru, Dan, additional, Di Gioia, Giuseppe, additional, Pellicano, Mariano, additional, Barbato, Emanuele, additional, Van Mieghem, Carlos, additional, Heyndrickx, Guy R., additional, De Bruyne, Bernard, additional, and Wijns, William, additional
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- 2014
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111. Fractional flow reserve to guide and to assess coronary artery bypass grafting.
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Pellicano, Mariano, De Bruyne, Bernard, Toth, Gabor G., Casselman, Filip, Wijns, William, and Barbato, Emanuele
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The aim of this review is to highlight the role of invasive functional evaluation in patients in whom coronary artery bypass graft (CABG) is indicated, and to examine the clinical evidence available in favour of fractional flow reserve (FFR) adoption in these patients, outline appropriate use, as well as point out potential pitfalls. FFR after CABG will also be reviewed, highlighting its correct interpretation and adoption when applied to both native coronary arteries and bypass grafts. Practice European guidelines support the use of FFR to complement coronary angiography with the highest degree of recommendation (Class IA) for the assessment of coronary stenosis before undertaking myocardial revascularization when previous non-invasive functional evaluation is unavailable or not conclusive. As a result, FFR has been adopted in routine clinical practice to guide clinicians decision as to whether or not perform a revascularization. Of note, due to the increasing confidence of the interventional cardiologists, FFR guidance is also being implemented to indicate or guide CABG. This is in anticipation of supportive clear-cut evidence, since recommendations for FFR adoption were based on randomized clinical trials investigating percutaneous coronary intervention (PCI) strategies in which patients with typical indications for CABG were excluded (e.g. left main disease, valvular disease, and coronary anatomy unsuitable for PCI). Based on the critical appraisal of the literature, FFR can play an important role in risk stratification and determining management strategy of patients either before or after CABG. [ABSTRACT FROM AUTHOR]
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- 2017
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112. Anatomical and functional assessment of Tryton bifurcation stent before and after final kissing balloon dilatation: Evaluations by three-dimensional coronary angiography, optical coherence tomography imaging and fractional flow reserve.
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Pyxaras, Stylianos A., Toth, Gabor G., Di Gioia, Giuseppe, Ughi, Giovanni J., Tu, Shengxian, Rusinaru, Dan, Adriaenssens, Tom, Reiber, Johan H.C., Leon, Martin B., Bax, Jeroen J., and Wijns, William
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- 2017
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113. TCT-619 ABSORB Cohort B Trial: Five Year Angiographic Results Of The ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold
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De Bruyne, Bernard, primary, Toth, Gabor G., additional, Onuma, Yoshinobu, additional, and Serruys, Patrick W., additional
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- 2014
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114. TCT-332 Relation Between Fractional Flow Reserve And Coronary Bifurcation Anatomy: A Novel Quantitative Model To Assess The Stenotic Severity Of Bifurcation Lesions
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Tu, Shengxian, primary, Echavarria-Pinto, Mauro, additional, von Birgelen, Clemens, additional, Holm, Niels R., additional, Pyxaras, Stylianos A., additional, Kumsars, Indulis, additional, Lam, Ming Kai, additional, Valkenburg, Ilona, additional, Toth, Gabor G., additional, Li, Yingguang, additional, Escaned, Javier, additional, Wijns, William C., additional, and Reiber, Johan H., additional
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- 2014
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115. Will this trial change my practice? PRAMI - treatment of bystander coronary lesions in patients undergoing primary PCI for acute STEMI
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Toth, Gabor G., primary, Kala, Petr, additional, Lansky, Alexandra, additional, and Baumbach, Andreas, additional
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- 2014
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116. Reply: True Fractional Flow Reserve of Left Main Coronary Artery Stenosis in the Presence of Downstream Coronary Stenoses
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Fearon, William F., Yong, Andy S., Lenders, Guy, Toth, Gabor G., Dao, Catherine, Daniels, David V., Pijls, Nico H.J., and De Bruyne, Bernard
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- 2015
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117. Transition of pemphigus vulgaris into pemphigus foliaceus confirmed by antidesmoglein ELISA profile
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Toth, Gabor G., primary, Pas, Hendri H., additional, and Jonkman, Marcel F., additional
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- 2002
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118. Intracoronary Adenosine Dose–Response Relationship With Hyperemia
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Adjedj, Julien, Toth, Gabor G., Johnson, Nils P., Pellicano, Mariano, Ferrara, Angela, Floré, Vincent, Di Gioia, Giuseppe, Barbato, Emanuele, Muller, Olivier, and De Bruyne, Bernard
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coronary flow measurements ,dose-response curve ,intracoronary adenosine ,Doppler-derived flow velocity ,hyperemia ,fractional flow reserve - Abstract
ObjectivesThe present study sought to establish the dosage of intracoronary (IC) adenosine associated with minimal side effects and above which no further increase in flow can be expected.BackgroundDespite the widespread adoption of IC adenosine in clinical practice, no wide-ranging, dose-response study has been conducted. A recurring debate still exists regarding its optimal dose.MethodsIn 30 patients, Doppler-derived flow velocity measurements were obtained in 10 right coronary arteries (RCAs) and 20 left coronary arteries (LCAs) free of stenoses >20% in diameter. Flow velocity was measured at baseline and after 8 ml bolus administrations of arterial blood, saline, contrast medium, and 9 escalating doses of adenosine (4 to 500 μg). The hyperemic value was expressed in percent of the maximum flow velocity reached in a given artery (Q/Qmax, %).ResultsQ/Qmax did not increase significantly beyond dosages of 60 μg for the RCA and 160 μg for LCA. Heart rate did not change, whereas mean arterial blood pressure decreased by a maximum of 7% (p < 0.05) after bolus injections of IC adenosine. The incidence of transient A-V blocks was 40% after injection of 100 μg in the RCA and was 15% after injection of 200 μg in the LCA. The duration of the plateau reached 12 ± 13 s after injection of 100 μg in the RCA and 21 ± 6 s after the injection of 200 μg in the LCA. A progressive prolongation of the time needed to return to baseline was observed. Hyperemic response after injection of 8 ml of contrast medium reached 65 ± 36% of that achieved after injection of 200 μg of adenosine.ConclusionsThis wide-ranging, dose-response study indicates that an IC adenosine bolus injection of 100 μg in the RCA and 200 μg in the LCA induces maximum hyperemia while being associated with minimal side effects.
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119. The Impact of Downstream Coronary Stenosis on Fractional Flow Reserve Assessment of Intermediate Left Main Coronary Artery Disease Human Validation
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Fearon, William F., Yong, Andy S., Lenders, Guy, Toth, Gabor G., Dao, Catherine, Daniels, David V., Pijls, Nico H.J., and De Bruyne, Bernard
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left main coronary artery ,fractional flow reserve ,coronary artery disease - Abstract
ObjectivesThe aim of this study was to determine the impact of downstream coronary stenosis in the left anterior descending coronary artery (LAD) or left circumflex coronary artery (LCx) on the assessment of fractional flow reserve (FFR) across an intermediate left main coronary artery (LMCA) stenosis in humans with the pressure wire positioned in the nondiseased downstream vessel.BackgroundAccurate assessment of intermediate LMCA disease is critical for guiding decisions regarding revascularization. In theory, FFR across an intermediate LMCA stenosis will be affected by downstream disease, even if the pressure wire is positioned in the nondiseased downstream vessel.MethodsAfter percutaneous coronary intervention of the LAD, LCx, or both, an intermediate LMCA stenosis was created with a deflated balloon catheter. FFR was measured in the LAD and LCx coronary arteries before and after creation of downstream stenosis by inflating an angioplasty balloon within the newly placed stent. The true FFR (FFRtrue) of the LMCA, measured in the nondiseased downstream vessel in the absence of stenosis in the other vessel, was compared with the apparent FFR (FFRapp) measured in the presence of stenosis.ResultsIn 25 patients, 91 pairs of measurements were made, 71 with LAD stenosis and 20 with LCx stenosis. FFRtrue of the LMCA was significantly lower than FFRapp (0.81 ± 0.08 vs. 0.83 ± 0.08, p < 0.001), although the numerical difference was small. This difference correlated with the severity of the downstream disease (r = 0.35, p < 0.001). In all cases in which FFRapp was >0.85, FFRtrue was >0.80.ConclusionsIn most cases, downstream disease does not have a clinically significant impact on the assessment of FFR across an intermediate LMCA stenosis with the pressure wire positioned in the nondiseased vessel.
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120. Microaxial Flow Pump in Infarct-Related Cardiogenic Shock.
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Thiele, Holger, Desch, Steffen, Zeymer, Uwe, Mallidi, Jaya, Lotfi, Amir, From, Aaron M., Elkaryoni, Ahmed, Hyder, Omar, Saad, Marwan, Baldetti, Luca, Pieri, Marina, Scandrogiio, Anna Mara, von Lewinski, Dirk, Herold, Lukas, and Toth, Gabor G.
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CARDIOGENIC shock , *EXTRACORPOREAL membrane oxygenation , *ST elevation myocardial infarction - Published
- 2024
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121. Five-Year Outcomes with PCI Guided by Fractional Flow Reserve
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Xaplanteris, Panagiotis, Fournier, Stephane, Pijls, Nico H J, Fearon, William F, Barbato, Emanuele, Tonino, Pim A L, Engstrøm, Thomas, Kääb, Stefan, Dambrink, Jan-Henk, Rioufol, Gilles, Toth, Gabor G, Piroth, Zsolt, Witt, Nils, Fröbert, Ole, Kala, Petr, Linke, Axel, Jagic, Nicola, Mates, Martin, Mavromatis, Kreton, Samady, Habib, Irimpen, Anand, Oldroyd, Keith, Campo, Gianluca, Rothenbühler, Martina, Jüni, Peter, De Bruyne, Bernard, and Investigators, FAME 2
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3. Good health - Abstract
Background We hypothesized that fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) would be superior to medical therapy as initial treatment in patients with stable coronary artery disease. Methods Among 1220 patients with angiographically significant stenoses, those in whom at least one stenosis was hemodynamically significant (FFR, ≤0.80) were randomly assigned to FFR-guided PCI plus medical therapy or to medical therapy alone. Patients in whom all stenoses had an FFR of more than 0.80 received medical therapy and were entered into a registry. The primary end point was a composite of death, myocardial infarction, or urgent revascularization. Results A total of 888 patients underwent randomization (447 patients in the PCI group and 441 in the medical-therapy group). At 5 years, the rate of the primary end point was lower in the PCI group than in the medical-therapy group (13.9% vs. 27.0%; hazard ratio, 0.46; 95% confidence interval [CI], 0.34 to 0.63; P
122. Reply True Fractional Flow Reserve of Left Main Coronary Artery Stenosis in the Presence of Downstream Coronary Stenoses
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Fearon, William F., Yong, Andy S., Lenders, Guy, Toth, Gabor G., Dao, Catherine, Daniels, David V., Pijls, Nico H.J., and De Bruyne, Bernard
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123. Angiography Versus Hemodynamics to Predict the Natural History of Coronary Stenoses: Fractional Flow Reserve Versus Angiography in Multivessel Evaluation 2 Substudy.
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Ciccarelli, Giovanni, Barbato, Emanuele, Toth, Gabor G, Gahl, Brigitta, Xaplanteris, Panagiotis, Fournier, Stephane, Milkas, Anastasios, Bartunek, Jozef, Vanderheyden, Marc, Pijls, Nico, Tonino, Pim, Fearon, William F, Jüni, Peter, and De Bruyne, Bernard
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- 2017
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124. Outcomes of ECLS-SHOCK Eligibility Criteria Applied to a Real-World Cohort.
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von Lewinski, Dirk, Herold, Lukas, Bachl, Eva, Bugger, Heiko, Glantschnig, Theresa, Kolesnik, Ewald, Verheyen, Nicolas, Benedikt, Martin, Wallner, Markus, von Lewinski, Friederike, Schmidt, Albrecht, Harb, Stefan, Ablasser, Klemens, Sacherer, Michael, Scherr, Daniel, Manninger-Wünscher, Martin, Pätzold, Sascha, Gollmer, Johannes, Zirlik, Andreas, and Toth, Gabor G.
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EXTRACORPOREAL membrane oxygenation , *CARDIOGENIC shock , *ARTIFICIAL blood circulation , *HOSPITAL mortality , *CARDIOPULMONARY resuscitation - Abstract
Background: Cardiogenic shock (CS) exhibits high (~50%) in-hospital mortality. The recently published Extracorporeal life Support in Cardiogenic Shock (ECLS-SHOCK) trial demonstrated the neutral effects of the use of veno-arterial extracorporeal membrane oxygenation (VA-ECMO) on all-cause death, as well as on all secondary outcomes in subjects presenting with myocardial-infarction (MI)-related CS. Here, we compared ECLS-SHOCK eligibility criteria with a real-world cohort of CS patients. Methods and Results: ECLS-SHOCK eligibility criteria were applied to a prospective single-center CS registry (the PREPARE CS registry) consisting of 557 patients who were consecutively admitted to the catheterization laboratory (cath lab) of the Medical University of Graz, Austria, due to CS (SCAI C-E). Overall use of mechanical circulatory support (MCS) in this cohort was 19%. Sixty-nine percent of the entire cohort had MI-related CS, 38% of whom would have met ECLS-SHOCK eligibility criteria, thus representing only 27% of the PREPARE CS registry. Exclusion from the ECLS-SHOCK trial was based on patients with initial lactate values below 3 mmol/L (n = 168; 43.6%), aged over 80 years (n = 65; 16.9%), and with a duration of cardiopulmonary resuscitation (CPR) exceeding 45 min (n = 22; 5.7%). The 30-day mortality of patients of the PREPARE CS registry who met the ECLS-SHOCK eligibility criteria was 57.0%, compared to 48.4% of patients in the ECLS-SHOCK trial. The patients' baseline characteristics, however, differed considerably with respect to type of infarction, age, and gender. Conclusions: In a real-world cohort of patients with MI-related CS, only 38% of patients met the eligibility criteria of the ECLS-SHOCK trial. Thus, the impact of the use of VA-ECMO on outcome parameters in MI-related CS, as observed in the ECLS-SHOCK trial, may differ in a more heterogeneous real-world CS population of the PREPARE CS registry. [ABSTRACT FROM AUTHOR]
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- 2023
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125. Machine-learning-based prediction of fractional flow reserve after percutaneous coronary intervention.
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Hamaya, Rikuta, Goto, Shinichi, Hwang, Doyeon, Zhang, Jinlong, Yang, Seokhun, Lee, Joo Myung, Hoshino, Masahiro, Nam, Chang-Wook, Shin, Eun-Seok, Doh, Joon-Hyung, Chen, Shao-Liang, Toth, Gabor G., Piroth, Zsolt, Hakeem, Abdul, Uretsky, Barry F., Hokama, Yohei, Tanaka, Nobuhiro, Lim, Hong-Seok, Ito, Tsuyoshi, and Matsuo, Akiko
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PERCUTANEOUS coronary intervention , *CORONARY angiography , *MACHINE learning , *RANK correlation (Statistics) , *STATISTICAL correlation - Abstract
Post-percutaneous coronary intervention (PCI) fractional flow reserve (FFR) reflects residual atherosclerotic burden and is associated with future events. How much post-PCI FFR can be predicted based on baseline basic information and the clinical relevance have not been investigated. We compiled a multicenter registry of patients undergoing pre- and post-PCI FFR. Machine-learning (ML) algorithms were designed to predict post-PCI FFR levels from baseline demographics, quantitative coronary angiography, and pre-PCI FFR. FFR deviation was defined as actual minus ML-predicted post-PCI FFR levels, and its association with incident target vessel failure (TVF) was evaluated. Median (IQR) pre- and post-PCI FFR values were 0.71 (0.61, 0.77) and 0.88 (0.84, 0.93), respectively. The Spearman correlation coefficient of the actual and predicted post-PCI FFR was 0.54 (95% CI: 0.52, 0.57). FFR deviation was non-linearly associated with incident TVF (HR [95% CI] with Q3 as reference: 1.65 [1.14, 2.39] in Q1, 1.42 [0.98, 2.08] in Q2, 0.81 [0.53, 1.26] in Q4, and 1.04 [0.69, 1.56] in Q5). A model with polynomial function of continuous FFR deviation indicated increasing TVF risk for FFR deviation ≤0 but plateau risk with FFR deviation >0. An ML-based algorithm using baseline data moderately predicted post-PCI FFR. The deviation of post-PCI FFR from the predicted value was associated with higher vessel-oriented event. [Display omitted] • A machine-learning algorithm moderately predicted post-PCI FFR. • Discrepancy of actual and predicted post-PCI FFR was associated with TVF. • No additional benefit would be expected by achieving higher than the predicted FFR. [ABSTRACT FROM AUTHOR]
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- 2023
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126. Angiography versus hemodynamics to predict the natural history of coronary stenoses
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Emanuele Barbato, Giovanni Ciccarelli, Pim A. L. Tonino, Panagiotis Xaplanteris, Jozef Bartunek, Marc Vanderheyden, William F. Fearon, Stephane Fournier, Nico H.J. Pijls, Bernard De Bruyne, Peter Jüni, Brigitta Gahl, Gabor G. Toth, Anastasios Milkas, Ciccarelli, Giovanni, Barbato, Emanuele, Toth, Gabor G, Gahl, Brigitta, Xaplanteris, Panagioti, Fournier, Stephane, Milkas, Anastasio, Bartunek, Jozef, Vanderheyden, Marc, Pijls, Nico, Tonino, Pim, Fearon, William F, Jüni, Peter, De Bruyne, Bernard, Soft Tissue Biomech. & Tissue Eng., and Cardiovascular Biomechanics
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Male ,medicine.medical_specialty ,Fractional Flow Reserve, Myocardial/physiology ,medicine.medical_treatment ,Hemodynamics ,Fractional flow reserve ,Kaplan-Meier Estimate ,030204 cardiovascular system & hematology ,Revascularization ,Coronary Angiography ,Coronary artery disease ,03 medical and health sciences ,0302 clinical medicine ,Risk Factors ,Physiology (medical) ,Internal medicine ,medicine ,Clinical endpoint ,Humans ,angiography ,030212 general & internal medicine ,Myocardial infarction ,Myocardial/physiology ,Coronary Stenosis/mortality ,Proportional Hazards Models ,Aged ,medicine.diagnostic_test ,business.industry ,percutaneous coronary intervention ,Coronary Stenosis ,Percutaneous coronary intervention ,Middle Aged ,medicine.disease ,Fractional Flow Reserve ,Fractional Flow Reserve, Myocardial ,Angiography ,Cardiology ,Female ,Cardiology and Cardiovascular Medicine ,business ,coronary artery disease ,Follow-Up Studies - Abstract
Background: Among patients with documented stable coronary artery disease and in whom no revascularization was performed, we compared the respective values of angiographic diameter stenosis (DS) and fractional flow reserve (FFR) in predicting natural history. Methods: The present analysis included the 607 patients from the FAME 2 trial (Fractional Flow Reserve Versus Angiography in Multivessel Evaluation 2) in whom no revascularization was performed. FFR varied from 0.20 to 1.00 (average 0.74±0.16), and DS (by quantitative coronary analysis) varied from 8% to 98% (average 53±15). The primary end point, defined as vessel-oriented clinical end point (VOCE) at 2 years, was a composite of prospectively adjudicated cardiac death, vessel-related myocardial infarction, vessel-related urgent, and not urgent revascularization. The stenoses were divided into 4 groups according to FFR and %DS values: positive concordance (FFR≤0.80; DS≥50%), negative concordance (FFR>0.80; DS0.80; DS≥50%). Results: The rate of VOCE was highest in the positive concordance group (log rank: X 2 =80.96; P =0.001) and lowest in the negative concordance group. The rate of VOCE was higher in the positive mismatch group than in the negative mismatch group (hazard ratio, 0.38; 95% confidence interval, 0.21–0.67; P =0.001). There was no significant difference in VOCE between the positive concordance and positive mismatch groups (FFR≤0.80; hazard ratio, 0.77; 95% confidence interval, 0.57–1.09; P =0.149) and no significant difference in rate of VOCE between the negative mismatch and negative concordance groups (FFR>0.80; hazard ratio, 1.89; 95% confidence interval, 0.96–3.74; P =0.067). Conclusions: In patients with stable coronary disease, physiology (FFR) is a more important determinant of the natural history of coronary stenoses than anatomy (DS). Clinical Trial Registration: URL: https://clinicaltrials.gov . Unique identifier: NCT01132495.
- Published
- 2018
127. Graft patency after FFR-guided versus angiography-guided coronary artery bypass grafting: the GRAFFITI trial
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Gabor G. Toth, Martin Mates, Petr Kala, Frank Van Praet, Ivan Degriek, Ruben Ramos, Flavio Ribichini, Zsolt Piroth, Emanuele Barbato, Martin Penicka, Anna Piccoli, Bernard Stockman, Petr Nemec, Bernard De Bruyne, Stephane Fournier, Carlos Van Mieghem, Filip Casselman, Toth, Gabor G, De Bruyne, Bernard, Kala, Petr, Ribichini, Flavio L, Casselman, Filip, Ramos, Ruben, Piroth, Zsolt, Fournier, Stephane, Piccoli, Anna, Van Mieghem, Carlo, Penicka, Martin, Mates, Martin, Nemec, Petr, Van Praet, Frank, Stockman, Bernard, Degriek, Ivan, and Barbato, Emanuele
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medicine.medical_specialty ,Coronary Stenosi ,Fractional flow reserve ,Coronary Artery Disease ,030204 cardiovascular system & hematology ,Anastomosis ,Coronary Angiography ,03 medical and health sciences ,multiple vessel disease ,0302 clinical medicine ,Internal medicine ,Clinical endpoint ,Humans ,Myocardial ,Medicine ,Prospective Studies ,030212 general & internal medicine ,Myocardial infarction ,Coronary Artery Bypass ,fractional flow reserve ,Prospective cohort study ,Stroke ,medicine.diagnostic_test ,business.industry ,Coronary Artery Bypa ,Coronary Stenosis ,medicine.disease ,Fractional Flow Reserve, Myocardial ,Stenosis ,Prospective Studie ,Treatment Outcome ,Angiography ,Cardiology ,Cardiology and Cardiovascular Medicine ,business ,Human - Abstract
Aims The aim of this study was to assess prospectively the clinical benefits of fractional flow reserve (FFR) in guiding coronary artery bypass grafting (CABG). Methods and results GRAFFITI is a single-blinded, prospective, multicentre, randomised controlled trial of FFR-guided versus angiography-guided CABG. We enrolled patients undergoing coronary angiography, having a significantly diseased left anterior descending artery or left main stem and at least one more major coronary artery with intermediate stenosis, assessed by FFR. Surgical strategy was defined based on angiography, blinded to FFR values prior to randomisation. After randomisation, patients were operated on either following the angiography-based strategy (angiography-guided group) or according to FFR, i.e., with an FFR ≤0.80 as cut-off for grafting (FFR-guided group). The primary endpoint was graft patency at 12 months. Between March 2012 and December 2016, 172 patients were randomised either to the angiography-guided group (84 patients) or to the FFR-guided group (88 patients). The patients had a median of three [3; 4] lesions; diameter stenosis was 65% (50%; 80%), FFR was 0.72 (0.50; 0.82). Compared to the angiography-guided group, the FFR-guided group received fewer anastomoses (3 [3; 3] vs 2 [2; 3], respectively; p=0.004). One-year angiographic follow-up showed no difference in overall graft patency (126 [80%] vs 113 [81%], respectively; p=0.885). One-year clinical follow-up, available in 98% of patients, showed no difference in the composite of death, myocardial infarction, target vessel revascularisation and stroke. Conclusions FFR guidance of CABG has no impact on one-year graft patency, but it is associated with a simplified surgical procedure. ClinicalTrials.gov Identifier: NCT01810224.
- Published
- 2019
128. Standardization of Fractional Flow Reserve Measurements
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Morton J. Kern, Pascal Vranckx, Allen Jeremias, Nils P. Johnson, Emanuele Barbato, Bernard De Bruyne, William F. Fearon, Mariano Pellicano, Gabor G. Toth, Nico H.J. Pijls, Toth, Gabor G, Johnson, Nils P, Jeremias, Allen, Pellicano, Mariano, Vranckx, Pascal, Fearon, William F, Barbato, Emanuele, Kern, Morton J, Pijls, Nico H. J, and De Bruyne, Bernard
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medicine.medical_specialty ,Standardization ,medicine.medical_treatment ,Fractional flow reserve ,030204 cardiovascular system & hematology ,Revascularization ,Coronary artery disease ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,medicine ,Humans ,Medical physics ,030212 general & internal medicine ,business.industry ,percutaneous coronary intervention ,Percutaneous coronary intervention ,Data interpretation ,Reference Standards ,medicine.disease ,Coronary Vessels ,Fractional Flow Reserve, Myocardial ,Conventional PCI ,Cardiology ,coronary artery disease ,functional assessment ,Core laboratory ,Cardiology and Cardiovascular Medicine ,business ,Blood Flow Velocity - Abstract
Pressure wire-based fractional flow reserve is considered the standard of reference for evaluation of the ischemic potential of coronary stenoses and the expected benefit from revascularization. Accordingly, its application in daily practice or for research purposes has to be as standardized as possible to avoid technical or operator-related artifacts in pressure recordings. This document proposes a standardized way of acquiring, recording, interpreting, and archiving the pressure tracings for daily practice and for the purpose of clinical research involving a core laboratory. Proposed standardized steps enhance the uniformity of clinical practices and data interpretation. (C) 2016 by the American College of Cardiology Foundation. Dr. Toth has a consultancy agreement with St. Jude Medical. Dr. Johnson has received internal funding from the Weatherhead PET Center for Preventing and Reversing Atherosclerosis; has received significant institutional research support from St. Jude Medical and Volcano/Philips outside of the submitted work; and has an institutional licensing and consulting agreement with Boston Scientific. Dr. Jeremias has reported speaker and consultant fees from Volcano Inc. and St. Jude Medical Inc. outside of the submitted work. Dr. Pellicano has been supported by a research grant provided by the Cardiopath PhD program. Dr. Vranckx has received speaking or consulting fees from AstraZeneca, Bayer, Boehringer Ingelheim, Daiichi-Sankyo, and The Medicines Co. outside of the submitted work. Dr. Fearon has received research support from Medtronic and St. Jude Medical outside of the submitted work; and has received consultant fees from Medtronic, HeartFlow, and Cathworks. Dr. Barbato has received institutional research grants and speakers fees from St. Jude Medical outside of the submitted work. Dr. Kern has received consultant and speaker fees from St. Jude Medical, Volcano, Opsens, ACIST Medical, and Heartflow outside of the submitted work. Dr. Pijls is a consultant for St. Jude Medical, Opsens, and Boston Scientific outside of the submitted work; has received research grants from Medtronic; and is a shareholder for Philips, ASML, General Electric, and Heartflow. Dr. De Bruyne is a shareholder for Siemens, GE, Bayer, Philips, HeartFlow, Edwards Life Sciences, Sanofi, and Omega Pharma; and his institution has received grant support from Abbott, Boston Scientific, Biotronik, and St. Jude Medical and receives consulting fees on his behalf from St. Jude Medical, Opsens, and Boston Scientific outside of the submitted work.
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- 2016
129. Clinical Outcome of Patients with Aortic Stenosis and Coronary Artery Disease Not Treated According to Current Recommendations
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Emanuele Barbato, Bruno Trimarco, Julien Adjedj, Giuseppe Di Gioia, William Wijns, Bernard De Bruyne, Filip Casselman, Gabor G. Toth, Ivan Degrieck, Frank Van Praet, Bernard Stockman, Mariano Pellicano, Di Gioia, Giuseppe, Pellicano, Mariano, Toth, Gabor G, Casselman, Filip, Adjedj, Julien, Van Praet, Frank, Stockman, Bernard, Degrieck, Ivan, Trimarco, Bruno, Wijns, William, De Bruyne, Bernard, and Barbato, Emanuele
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Male ,Time Factors ,medicine.medical_treatment ,Pharmaceutical Science ,Coronary Artery Disease ,Kaplan-Meier Estimate ,030204 cardiovascular system & hematology ,Severity of Illness Index ,Coronary artery disease ,0302 clinical medicine ,Aortic valve replacement ,Risk Factors ,Medicine ,Registries ,Coronary Artery Bypass ,Practice Patterns, Physicians' ,Genetics (clinical) ,Aged, 80 and over ,Heart Valve Prosthesis Implantation ,Treatment Outcome ,surgical procedures, operative ,medicine.anatomical_structure ,Practice Guidelines as Topic ,Cardiology ,Molecular Medicine ,Female ,Guideline Adherence ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,Artery ,medicine.medical_specialty ,Aortic valve disease ,Lesion ,03 medical and health sciences ,Percutaneous Coronary Intervention ,Internal medicine ,Genetics ,Humans ,cardiovascular diseases ,Aged ,Proportional Hazards Models ,Retrospective Studies ,Coronary bypass graft ,Chi-Square Distribution ,business.industry ,Proportional hazards model ,Percutaneous coronary intervention ,Cardiovascular Agents ,Aortic Valve Stenosis ,medicine.disease ,Surgery ,Stenosis ,030228 respiratory system ,Conventional PCI ,business ,Delivery of Health Care - Abstract
We evaluated the clinical outcome of patients with moderate/severe aortic stenosis and significant coronary disease not treated according to guidelines, recommending combined aortic valve replacement (AVR) and coronary artery bypass grafting (CABG). From 2002 to 2010, we assessed death up to 5 years in 650 patients with moderate/severe aortic stenosis and at least one coronary lesion (>50 %): 23 % were treated conservatively (MT), 17 % with percutaneous coronary intervention (PCI), 11 % with AVR, and 49 % with combined CABG and AVR. At a median follow-up of 58 months, overall death decreased over the groups (MT, 68 % vs. PCI, 44 % vs. AVR, 34 % vs. CABG and AVR, 23 %, p
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- 2016
130. Targeted therapy with a localised abluminal groove, low-dose sirolimus-eluting, biodegradable polymer coronary stent (TARGET All Comers): a multicentre, open-label, randomised non-inferiority trial
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Karin Arkenbout, Christian M. Valina, Paul Knaapen, Henning Kelbæk, Gabor G. Toth, Salvatore Brugaletta, Paweł Buszman, Georgios J. Vlachojannis, Volker Schächinger, Marie-Angèle Morel, Harald Rittger, Andreas Baumbach, Andrzej Ochała, Christoph Naber, Luc Maillard, Ton Slagboom, Lene Holmvang, Richard Anderson, Thomas W Johnson, Alexandra J. Lansky, Luc Janssens, Bo Xu, Sergio Berti, Niels van Royen, William Wijns, Ming Zheng, Emanuele Barbato, Holger Thiele, Cardiology, ACS - Diabetes & metabolism, AGEM - Endocrinology, metabolism and nutrition, ACS - Atherosclerosis & ischemic syndromes, Lansky, Alexandra, Wijns, William, Xu, Bo, Kelbæk, Henning, van Royen, Niel, Zheng, Ming, Morel, Marie-Angèle, Knaapen, Paul, Slagboom, Ton, Johnson, Thomas W, Vlachojannis, Georgio, Arkenbout, Karin E, Holmvang, Lene, Janssens, Luc, Ochala, Andrzej, Brugaletta, Salvatore, Naber, Christoph K, Anderson, Richard, Rittger, Harald, Berti, Sergio, Barbato, Emanuele, Toth, Gabor G, Maillard, Luc, Valina, Christian, Buszman, Paweł, Thiele, Holger, Schächinger, Volker, and Baumbach, Andreas
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Target lesion ,Male ,medicine.medical_specialty ,medicine.medical_treatment ,Population ,Myocardial Ischemia ,Equivalence Trials as Topic ,030204 cardiovascular system & hematology ,Prosthesis Design ,Coronary artery disease ,03 medical and health sciences ,0302 clinical medicine ,Coronary stent ,Absorbable Implants ,Clinical endpoint ,Medicine ,Humans ,030212 general & internal medicine ,Myocardial infarction ,Everolimus ,Prospective Studies ,education ,Aged ,Sirolimus ,education.field_of_study ,business.industry ,Vascular damage Radboud Institute for Molecular Life Sciences [Radboudumc 16] ,Stent ,Percutaneous coronary intervention ,Drug-Eluting Stents ,General Medicine ,Middle Aged ,medicine.disease ,Surgery ,Intention to Treat Analysis ,Treatment Outcome ,Female ,business ,Immunosuppressive Agents - Abstract
Item does not contain fulltext BACKGROUND: The FIREHAWK is a drug-eluting stent with a fully biodegradable sirolimus-containing polymer coating localised to recessed abluminal grooves on the stent surface. We investigated clinical outcomes with this targeted, low-dose, biodegradable polymer, sirolimus-eluting stent compared with XIENCE durable polymer, everolimus-eluting stents in an all-comers population. METHODS: The TARGET All Comers study was a prospective, multicentre, open-label randomised non-inferiority trial done at 21 centres in ten European countries. Patients with symptomatic or asymptomatic coronary artery disease and objective evidence of myocardial ischaemia who qualified for percutaneous coronary intervention were randomised 1:1 to undergo implantation of a FIREHAWK or XIENCE. Randomisation was web-based, with random block allocation and stratification by centre and ST elevation myocardial infarction. Outcome assessors were masked to treatment allocation, but treating physicians and patients were not. The primary endpoint was target lesion failure at 12 months, a composite of cardiac death, target vessel myocardial infarction, or ischaemia-driven target lesion revascularisation. The control event rate for XIENCE was assumed to be 7%, the non-inferiority margin was 3.5%, and the primary analysis was in the intention-to-treat population, censoring patients who did not have either an event before 365 days or contact beyond 365 days. Late lumen loss was the primary endpoint of an angiographic substudy designed to investigate the non-inferiority of the FIREHAWK compared with the XIENCE stent. This trial is registered with ClinicalTrials.gov, number NCT02520180. FINDINGS: From Dec 17, 2015, to Oct 14, 2016, 1653 patients were randomly assigned to implantation of the FIREHAWK (n=823) or XIENCE (n=830). 65 patients in the FIREHAWK group and 66 in the XIENCE group had insufficient follow-up data and were excluded from the analyses. At 12 months, target lesion failure occurred in 46 (6.1%) of 758 patients in the FIREHAWK group and in 45 (5.9%) of 764 patients in the XIENCE group (difference 0.2%, 90% CI -1.9 to 2.2, pnon-inferiority=0.004, 95% CI -2.2 to 2.6, psuperiority=0.88). There were no differences in ischaemia-driven revascularisation or stent thrombosis rates at 12 months. 176 patients were included in the angiographic substudy, in which in-stent late lumen loss was 0.17 mm (SD 0.48) in the FIREHAWK group and 0.11 mm (0.52) in the XIENCE group (p=0.48), with an absolute difference of 0.05 mm (95% CI -0.09 to 0.18, pnon-inferiority=0.024). INTERPRETATION: In a broad all-comers population of patients requiring stent implantation for myocardial ischaemia, the FIREHAWK was non-inferior to the XIENCE as assessed with the primary endpoint of target lesion failure at 12 months and in-stent late lumen loss at 13 months. The FIREHAWK is a safe and effective alternative stent to treat patients with ischaemic coronary artery disease in clinical practice. FUNDING: Shanghai Microport Medical.
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- 2018
131. Six-Year Follow-Up of Fractional Flow Reserve-Guided Versus Angiography-Guided Coronary Artery Bypass Graft Surgery
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Gabor G. Toth, Panagiotis Xaplanteris, Nils P. Johnson, Eric Wyffels, Emanuele Barbato, Teresa Strisciuglio, Jozef Bartunek, Stephane Fournier, Bernard De Bruyne, Filip Casselman, Marc Vanderheyden, Ivan Degrieck, Frank Van Praet, Anastasios Milkas, Giovanni Ciccarelli, Bernard Stockman, Fournier, Stephane, Toth, Gabor G, De Bruyne, Bernard, Johnson, Nils P, Ciccarelli, Giovanni, Xaplanteris, Panagioti, Milkas, Anastasio, Strisciuglio, Teresa, Bartunek, Jozef, Vanderheyden, Marc, Wyffels, Eric, Casselman, Filip, Van Praet, Frank, Stockman, Bernard, Degrieck, Ivan, and Barbato, Emanuele
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Male ,medicine.medical_specialty ,Cardiac Catheterization ,coronary stenosi ,Time Factors ,Fractional flow reserve ,Coronary stenosis ,030204 cardiovascular system & hematology ,Anastomosis ,Coronary Angiography ,Risk Assessment ,Coronary artery disease ,03 medical and health sciences ,0302 clinical medicine ,Predictive Value of Tests ,Risk Factors ,Medicine ,Humans ,angiography ,030212 general & internal medicine ,Myocardial infarction ,Coronary Artery Bypass ,fractional flow reserve ,Vascular Patency ,Aged ,Retrospective Studies ,medicine.diagnostic_test ,business.industry ,coronary artery bypa ,Coronary Stenosis ,Graft Occlusion, Vascular ,Middle Aged ,medicine.disease ,Coronary Vessels ,Surgery ,Fractional Flow Reserve, Myocardial ,medicine.anatomical_structure ,Treatment Outcome ,myocardial infarction ,Angiography ,Female ,Cardiology and Cardiovascular Medicine ,business ,coronary artery disease ,Artery - Abstract
Background— Fractional flow reserve (FFR)-guided coronary artery bypass graft (CABG) surgery has been associated with lower number of graft anastomoses, lower rate of on-pump surgery, and higher graft patency rate as compared with angiography-guided CABG surgery. However, no clinical benefit has been reported to date. Methods and Results— Consecutive patients (n=627) treated by CABG between 2006 and 2010 were retrospectively included. In 198 patients, at least 1 stenosis was grafted according to FFR (FFR-guided group), whereas in 429 patients all stenoses were grafted based on angiography (angiography-guided group). The 2 coprimary end points were overall death or myocardial infarction and major adverse cardiovascular events (composite of overall death, myocardial infarction, and target vessel revascularization) up to 6-year follow-up. In the FFR-guided group, patients were significantly younger (66 [57–73] versus 70 [63–76]; P P =0.008), and less often diabetic (21% versus 30%; P =0.023). Clinical follow-up (median, 85 [66–104] months) was analyzed in 396 patients after 1:1 propensity-score matching for these 3 variables. The rate of overall death or myocardial infarction was significantly lower in the FFR-guided (n=31 [16%] versus n=49 [25%]; hazard ratio, 0.59 [95% confidence interval, 0.38–0.93]; P =0.020) as compared with the angiography-guided group. Major adverse cardiovascular events rate was also numerically lower in the FFR-guided than in the angiography-guided group (n=42 [21%] versus n=52 [26%]; hazard ratio, 0.77 [95% confidence interval, 0.51–1.16]; P =0.21). Conclusions— FFR-guided CABG is associated with a significant reduction in the rate of overall death or myocardial infarction at 6-year follow-up as compared with angiography-guided CABG.
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- 2018
132. Study Design of the Graft Patency After FFR-Guided Versus Angiography-Guided CABG Trial (GRAFFITI)
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Martin Mates, Zsolt Piroth, Gabor G. Toth, Emanuele Barbato, Ivan Degriek, Frank Van Praet, Martin Penicka, Filip Casselman, Bernard De Bruyne, Stephane Fournier, Carlos Van Mieghem, Ruben Ramos, Petr Kala, Flavio Ribichini, Toth, Gabor G, De Bruyne, Bernard, Kala, Petr, Ribichini, Flavio L, Casselman, Filip, Ramos, Ruben, Piroth, Zsolt, Fournier, Stephane, Van Mieghem, Carlo, Penicka, Martin, Mates, Martin, Van Praet, Frank, Degriek, Ivan, and Barbato, Emanuele
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Male ,medicine.medical_specialty ,medicine.medical_treatment ,Pharmaceutical Science ,Fractional flow reserve ,Coronary artery bypass graft surgery ,Coronary Artery Disease ,030204 cardiovascular system & hematology ,Revascularization ,Coronary Angiography ,HSM CAR ,Coronary artery disease ,03 medical and health sciences ,0302 clinical medicine ,Blood vessel prosthesis ,Internal medicine ,Genetics ,medicine ,Humans ,Single-Blind Method ,030212 general & internal medicine ,Myocardial infarction ,Prospective Studies ,Coronary Artery Bypass ,Genetics (clinical) ,Vascular Patency ,Coronary angiography ,Graft patency ,medicine.diagnostic_test ,business.industry ,Percutaneous coronary intervention ,medicine.disease ,Coronary Vessels ,Blood Vessel Prosthesis ,Fractional Flow Reserve, Myocardial ,Stenosis ,Treatment Outcome ,Surgery, Computer-Assisted ,Angiography ,Cardiology ,Molecular Medicine ,Female ,Cardiology and Cardiovascular Medicine ,business ,Follow-Up Studies - Abstract
Clinical benefit of invasive functionally guided revascularization has been mostly investigated and proven for percutaneous coronary intervention. It has never been prospectively evaluated whether a systematic fractional flow reserve (FFR) assessment is also beneficial in guiding coronary artery bypass graft surgery (CABG). The objective of the GRAft patency after FFR-guided versus angiography-guIded CABG (GRAFFITI) trial was to compare an FFR-guided revascularization strategy to the traditional angiography-guided revascularization strategy for patients undergoing CABG. Patients were enrolled with significantly diseased left anterior descending or left main stem and at least one major coronary artery with angiographically intermediate stenosis (30-90% diameter stenosis) that was assessed by FFR. Thereafter, while the FFR values were kept concealed, cardiac surgeons decided their intended procedural strategy based on the coronary angiography alone. At this point, patients underwent 1:1 randomization to either an FFR-guided or an angiography-guided CABG strategy. In case the patient was randomized to angiography-guided arm, cardiac surgeons kept their intended procedural strategy, i.e., CABG was guided solely on the basis of the coronary angiography. In case the patient was randomized to the FFR-guided arm, FFR values were disclosed to the surgeons who revised the surgical protocol according to the functional significance of each coronary stenosis. The primary endpoint of the trial was the rate of graft occlusion at 12 months, assessed by coronary computed tomography or coronary angiography. The secondary endpoints were (1) length of postoperative hospital stay; (2) changes in surgical strategy depending upon FFR results (in FFR-guided group only); and (3) rate of major adverse cardiac and cerebrovascular events, i.e., composite of death, myocardial infarction, stroke, and any revascularization during the follow-up period. This study is the first prospective randomized trial investigating potential clinical benefits, associated with FFR-guided surgical revascularization. info:eu-repo/semantics/publishedVersion
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- 2018
133. Prognostic value of fractional flow reserve measured immediately after drug-eluting stent implantation
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Nico H.J. Pijls, Zsolt Piroth, Bernard De Bruyne, Gabor G. Toth, William F. Fearon, Nick Curzen, Soheila Aghlmandi, Peter Jüni, Pim A.L. Tonino, Gilles Rioufol, Emanuele Barbato, Medical University Graz, Catharina Hospital Eindhoven, 'Federico II' University of Naples Medical School, Institute of Social and Preventive Medicine [Bern] (ISPM), Universität Bern [Bern], University Hospital Basel [Basel], Southampton University Hospitals, Hôpital Cardiovasculaire Louis Pradel, Hospices Civils de Lyon (HCL), Cardiovasculaire, métabolisme, diabétologie et nutrition (CarMeN), Institut National de la Recherche Agronomique (INRA)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM), Department of Biomedical Engineering [Eindhoven], Technische Universiteit Eindhoven (TU/e), Stanford University School of Medicine [Stanford], Stanford University [Stanford], St. Michael's Hospital, Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Institut National des Sciences Appliquées (INSA)-Université de Lyon-Institut National des Sciences Appliquées (INSA)-Université de Lyon-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Institut National de la Recherche Agronomique (INRA), Stanford School of Medicine [Stanford], Stanford Medicine, Stanford University-Stanford University, Piroth, Zsolt, Toth, Gabor G, Tonino, Pim A L, Barbato, Emanuele, Aghlmandi, Soheila, Curzen, Nick, Rioufol, Gille, Pijls, Nico H J, Fearon, William F, Jüni, Peter, De Bruyne, Bernard, and Cardiovascular Biomechanics
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medicine.medical_specialty ,Acute coronary syndrome ,medicine.medical_treatment ,[SDV]Life Sciences [q-bio] ,610 Medicine & health ,Fractional flow reserve ,030204 cardiovascular system & hematology ,SDG 3 – Goede gezondheid en welzijn ,acute coronary syndrome ,03 medical and health sciences ,0302 clinical medicine ,SDG 3 - Good Health and Well-being ,360 Social problems & social services ,Internal medicine ,medicine ,drug-eluting stent ,030212 general & internal medicine ,Myocardial infarction ,ComputingMilieux_MISCELLANEOUS ,business.industry ,Hazard ratio ,percutaneous coronary intervention ,Percutaneous coronary intervention ,medicine.disease ,Confidence interval ,Surgery ,Stenosis ,myocardial infarction ,Drug-eluting stent ,Cardiology ,Cardiology and Cardiovascular Medicine ,business ,hospitalization - Abstract
Background— The predictive value of fractional flow reserve (FFR) measured immediately after percutaneous coronary intervention (PCI) with drug-eluting stent placement has not been prospectively investigated. We investigated the potential of post-PCI FFR measurements to predict clinical outcome in patients from FAME 1 and 2 trials (Fractional Flow Reserve or Angiography for Multivessel Evaluation). Methods and Results— All patients of FAME 1 and FAME 2 who had post-PCI FFR measurement were included. The primary outcome was vessel-oriented composite end point at 2 years, defined as vessel-related cardiovascular death, vessel-related spontaneous myocardial infarction, and ischemia-driven target vessel revascularization. Eight hundred thirty-eight vessels in 639 patients were analyzed. Baseline FFR values did not differ between vessels with versus without vessel-oriented composite end point (0.66±0.11 versus 0.63±0.14, respectively; P =0.207). Post-PCI FFR was significantly lower in vessels with vessel-oriented composite end point (0.88±0.06 versus 0.90±0.06, respectively; P =0.019). Comparing the 2-year outcome of lower and upper tertiles of post-PCI FFR significant difference was found favoring upper tertile in terms of overall vessel-oriented composite end point (9.2% versus 3.8%, respectively; hazard ratio, 1.46; 95% confidence interval, 1.02–2.08; P =0.037) and target vessel revascularization (7.0% versus 2.4%, respectively; hazard ratio, 1.59; 95% confidence interval, 1.03–2.46; P =0.037). When adjusted to sex, hypertension, diabetes mellitus, target vessel, serial stenosis, and baseline percentage diameter stenosis, a strong trend was preserved in terms of target vessel revascularization (harzard ratio, 1.55; 95% confidence interval, 0.97–2.46; P =0.066), favoring the upper tertile. Post-PCI FFR of 0.92 was found to have the highest diagnostic accuracy; however, the positive likelihood ratio remained low ( Conclusions— A higher post-PCI FFR value is associated with a better vessel-related outcome. However, its predictive value is too low to advocate its use as a surrogate clinical end point.
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- 2017
134. Fractional flow reserve to guide and to assess coronary artery bypass grafting
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Mariano Pellicano, Gabor G. Toth, Filip Casselman, Emanuele Barbato, Bernard De Bruyne, William Wijns, Pellicano, Mariano, De Bruyne, Bernard, Toth, Gabor G, Casselman, Filip, Wijns, William, and Barbato, Emanuele
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medicine.medical_specialty ,medicine.medical_treatment ,Heart Valve Diseases ,left main coronary disease ,Fractional flow reserve ,Internal thoracic artery ,Coronary Artery Disease ,030204 cardiovascular system & hematology ,Revascularization ,multivessel disease ,03 medical and health sciences ,0302 clinical medicine ,Percutaneous Coronary Intervention ,coronary artery bypass graft ,medicine.artery ,Internal medicine ,medicine ,Myocardial Revascularization ,Humans ,030212 general & internal medicine ,cardiovascular diseases ,Radial artery ,saphenous-vein-grafts ,Coronary Artery Bypass ,fractional flow reserve ,disease ,business.industry ,Coronary Stenosis ,Percutaneous coronary intervention ,5-year follow-up ,radial-artery ,Coronary arteries ,internal thoracic artery ,Fractional Flow Reserve, Myocardial ,Critical appraisal ,mammary artery ,medicine.anatomical_structure ,surgical procedures, operative ,Coronary Occlusion ,aortic-stenosis ,Conventional PCI ,Cardiology ,revascularization ,multivessel evaluation ,syntax score ,Cardiology and Cardiovascular Medicine ,business ,functional severity - Abstract
The aim of this review is to highlight the role of invasive functional evaluation in patients in whom coronary artery bypass graft (CABG) is indicated, and to examine the clinical evidence available in favour of fractional flow reserve (FFR) adoption in these patients, outline appropriate use, as well as point out potential pitfalls. FFR after CABG will also be reviewed, highlighting its correct interpretation and adoption when applied to both native coronary arteries and bypass grafts. Practice European guidelines support the use of FFR to complement coronary angiography with the highest degree of recommendation (Class IA) for the assessment of coronary stenosis before undertaking myocardial revascularization when previous non-invasive functional evaluation is unavailable or not conclusive. As a result, FFR has been adopted in routine clinical practice to guide clinicians decision as to whether or not perform a revascularization. Of note, due to the increasing confidence of the interventional cardiologists, FFR guidance is also being implemented to indicate or guide CABG. This is in anticipation of supportive clear-cut evidence, since recommendations for FFR adoption were based on randomized clinical trials investigating percutaneous coronary intervention (PCI) strategies in which patients with typical indications for CABG were excluded (e.g. left main disease, valvular disease, and coronary anatomy unsuitable for PCI). Based on the critical appraisal of the literature, FFR can play an important role in risk stratification and determining management strategy of patients either before or after CABG.
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- 2016
135. Significance of Intermediate Values of Fractional Flow Reserve in Patients With Coronary Artery Disease
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Gabor G. Toth, Vincent Floré, Jozef Bartunek, Julien Adjedj, Guy R. Heyndrickx, Giuseppe Di Gioia, Emanuele Barbato, Marc Vanderheyden, Angela Ferrara, Mariano Pellicano, William Wijns, Bernard De Bruyne, Adjedj, Julien, De Bruyne, Bernard, Floré, Vincent, Di Gioia, Giuseppe, Ferrara, Angela, Pellicano, Mariano, Toth, Gabor G, Bartunek, Jozef, Vanderheyden, Marc, Heyndrickx, Guy R, Wijns, William, and Barbato, Emanuele
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Male ,medicine.medical_specialty ,coronary artery disease ,fractional flow reserve ,mortality ,myocardial revascularization ,patient outcome assessment ,aged ,female ,follow-up studies ,myocardial ,humans ,male ,middle aged ,retrospective studies ,medicine.medical_treatment ,Fractional flow reserve ,Coronary Artery Disease ,030204 cardiovascular system & hematology ,Revascularization ,Follow-Up Studie ,Coronary artery disease ,03 medical and health sciences ,0302 clinical medicine ,Clinical decision making ,Physiology (medical) ,Internal medicine ,medicine ,Humans ,In patient ,030212 general & internal medicine ,Myocardial infarction ,Aged ,Retrospective Studies ,business.industry ,Retrospective cohort study ,Middle Aged ,medicine.disease ,Surgery ,Fractional Flow Reserve, Myocardial ,Editorial ,Cardiology ,Female ,Cardiology and Cardiovascular Medicine ,business ,Medical therapy ,Follow-Up Studies ,Human - Abstract
Background— The fractional flow reserve (FFR) value of 0.75 has been validated against ischemic testing, whereas the FFR value of 0.80 has been widely accepted to guide clinical decision making. However, revascularization when FFR is 0.76 to 0.80, within the so-called gray zone, is still debatable. Methods and Results— From February 1997 to June 2013, all patients with single-segment disease and an FFR value within the gray zone or within the 2 neighboring FFR strata (0.70–0.75 and 0.81–0.85) were included. Study end points consisted of major adverse cardiovascular events (death, myocardial infarction, and any revascularization) up to 5 years. Of 17 380 FFR measurements, 1459 patients were included. Of them, 449 patients were treated with revascularization and 1010 patients were treated with medical therapy. In the gray zone, the major adverse cardiovascular events rate was similar (37 [13.9%] versus 21 [11.2%], respectively; P =0.3) between medical therapy and revascularization, whereas a strong trend toward a higher rate of death or myocardial infarction (25 [9.4] versus 9 [4.8], P =0.06) and overall death (20 [7.5] versus 6 [3.2], P =0.059) was observed in the medical therapy group. Among medical therapy patients, a significant step-up increase in major adverse cardiovascular events rate was observed across the 3 FFR strata, especially with proximal lesion location. In revascularization patients, the major adverse cardiovascular events rate was not different across the 3 FFR strata. Conclusions— FFR in and around the gray zone bears a major prognostic value, especially in proximal lesions. These data confirm that FFR≤0.80 is valid to guide clinical decision making.
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- 2016
136. Fractional Flow Reserve-Guided Revascularization in Patients With Aortic Stenosis
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Gabor G. Toth, Julien Adjedj, Bruno Trimarco, Bernard De Bruyne, Giuseppe Di Gioia, Bernard Stockman, Angela Ferrara, Ivan Degrieck, Frank Van Praet, William Wijns, Emanuele Barbato, Jozef Bartunek, Mariano Pellicano, Filip Casselman, DI GIOIA, Giuseppe, Pellicano, Mariano, Toth, Gabor G, Casselman, Filip, Adjedj, Julien, Van Praet, Frank, Ferrara, Angela, Stockman, Bernard, Degrieck, Ivan, Bartunek, Jozef, Trimarco, Bruno, Wijns, William, De Bruyne, Bernard, and Barbato, Emanuele
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Male ,medicine.medical_specialty ,medicine.medical_treatment ,Coronary Artery Disease ,Kaplan-Meier Estimate ,Fractional flow reserve ,030204 cardiovascular system & hematology ,Coronary Angiography ,Revascularization ,Coronary artery disease ,03 medical and health sciences ,Percutaneous Coronary Intervention ,0302 clinical medicine ,Aortic valve replacement ,Internal medicine ,medicine ,Humans ,030212 general & internal medicine ,Myocardial infarction ,Coronary Artery Bypass ,Aged ,Retrospective Studies ,Aged, 80 and over ,business.industry ,Percutaneous coronary intervention ,Aortic Valve Stenosis ,Middle Aged ,medicine.disease ,Surgery ,Fractional Flow Reserve, Myocardial ,Stenosis ,Treatment Outcome ,Aortic valve stenosis ,Cardiology ,Female ,Cardiology and Cardiovascular Medicine ,business - Abstract
Fractional flow reserve (FFR) has never been investigated in patients with aortic stenosis (AS). From 2002 to 2010, we identified 106 patients with AS and coronary artery disease with at least one intermediate lesion treated according to FFR guidance. We matched 212 contemporary control patients with AS in which revascularization was decided on angiography only. More patients in the FFR-guided group underwent percutaneous coronary intervention (24% vs 13%; p = 0.019), whereas there was a trend toward less coronary artery bypass grafting (CABG) performed. After FFR, the number of diseased vessels was downgraded within the FFR-guided group (from 1.85 ± 0.97 to 1.48 ± 1; p
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- 2016
137. Austrian consensus statement on the diagnosis and management of hypertrophic cardiomyopathy.
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Verheyen N, Auer J, Bonaros N, Buchacher T, Dalos D, Grimm M, Mayr A, Rab A, Reinstadler S, Scherr D, Toth GG, Weber T, Zach DK, Zaruba MM, Zimpfer D, Rainer PP, and Pölzl G
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- Austria, Humans, Cardiology standards, Practice Guidelines as Topic, Genetic Testing, Cardiomyopathy, Hypertrophic therapy, Cardiomyopathy, Hypertrophic diagnosis
- Abstract
Hypertrophic cardiomyopathy (HCM) is the most common inherited heart disease that is characterized by left ventricular hypertrophy unexplained by secondary causes. Based on international epidemiological data, around 20,000-40,000 patients are expected to be affected in Austria. Due to the wide variety of clinical and morphological manifestations the diagnosis can be difficult and the disease therefore often goes unrecognized. HCM is associated with a substantial reduction in quality of life and can lead to sudden cardiac death, especially in younger patients. Early and correct diagnosis, including genetic testing, is essential for comprehensive counselling of patients and their families and for effective treatment. The latter is especially true as an effective treatment of outflow tract obstruction has recently become available in the form of a first in class cardiac myosin ATPase inhibitor, as a noninvasive alternative to established septal reduction therapies. The aim of this Austrian consensus statement is to summarize the recommendations of international guidelines with respect to the genetic background, pathophysiology, diagnostics and management in the context of the Austrian healthcare system and resources, and to present them in easy to understand algorithms., (© 2024. The Author(s).)
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- 2024
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138. Vascular response following implantation of the third-generation drug-eluting resorbable coronary magnesium scaffold: an intravascular imaging analysis of the BIOMAG-I first-in-human study.
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Seguchi M, Aytekin A, Xhepa E, Haude M, Wlodarczak A, van der Schaaf RJ, Torzewski J, Ferdinande B, Escaned J, Iglesias JF, Bennett J, Toth GG, Toelg R, Wiemer M, Olivecrona G, Vermeersch P, Waksman R, Garcia-Garcia HM, and Joner M
- Subjects
- Humans, Male, Female, Middle Aged, Aged, Treatment Outcome, Neointima, Tissue Scaffolds, Tomography, Optical Coherence methods, Magnesium, Ultrasonography, Interventional methods, Drug-Eluting Stents, Coronary Artery Disease therapy, Coronary Artery Disease diagnostic imaging, Percutaneous Coronary Intervention methods, Percutaneous Coronary Intervention instrumentation, Coronary Vessels diagnostic imaging, Absorbable Implants
- Abstract
Background: The 12-month outcomes of BIOMAG-I - the first-in-human study investigating the third-generation drug-eluting resorbable magnesium scaffold (DREAMS 3G) - showed promising results regarding clinical outcomes and late lumen loss., Aims: The current study aimed to investigate vascular healing parameters assessed by optical coherence tomography (OCT) and intravascular ultrasound (IVUS), focusing on strut visibility, vessel and scaffold areas, and neointimal growth patterns., Methods: This is a BIOMAG-I substudy including patients with available serial OCT and IVUS data. We conducted a frame-based analysis of OCT findings in conjunction with IVUS-derived vessel and scaffold areas, evaluating the qualitative and quantitative aspects of vascular healing., Results: Among the 116 patients enrolled in this trial, 56 patients treated with DREAMS 3G were included in the analysis. At 12 months, OCT imaging revealed that 99.0% of the struts were invisible, and no malapposed struts were depicted. While the vessel area showed no significant difference between the timepoints, the minimum lumen area significantly decreased from post-percutaneous coronary intervention to 6 months (6.88 mm
2 to 4.75 mm2 ; p<0.0001), but no significant changes were observed between 6 and 12 months. Protruding neointimal tissue (PNT) - a unique neointimal presentation observed following resorbable magnesium scaffold implantation - was observed in 89.3% of the study patients at 12 months, and its area exhibited a 47.4% decrease from 6 to 12 months., Conclusions: This imaging substudy revealed that, at 12-month follow-up, virtually all struts of the DREAMS 3G scaffold became invisible, without evident malapposition. The vascular healing response to DREAMS 3G implantation also appeared favourable up to 12 months, which is indicated by advanced strut degradation and spontaneous regressing PNT between 6 and 12 months.- Published
- 2024
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139. Expanding our understanding on stent expansion.
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Toth GG and Stankovic G
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- Humans, Coronary Artery Disease therapy, Coronary Artery Disease surgery, Drug-Eluting Stents, Prosthesis Design, Stents, Percutaneous Coronary Intervention instrumentation, Percutaneous Coronary Intervention methods
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- 2024
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140. Correction: Intentional coronary revascularization versus conservative therapy in patients after peripheral artery revascularization due to critical limb ischemia: the INCORPORATE trial.
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Toth GG, Brodmann M, Schnur SSK, Bartus S, Vrsalovic M, Krestianinov O, Kala P, Bil J, Gil R, Kanovsky J, Di Serafino L, Paolucci L, Barbato E, Mangiacapra F, and Ruzsa Z
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- 2024
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141. Intentional coronary revascularization versus conservative therapy in patients after peripheral artery revascularization due to critical limb ischemia: the INCORPORATE trial.
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Toth GG, Brodmann M, Kanoun Schnur SS, Bartus S, Vrsalovic M, Krestianinov O, Kala P, Bil J, Gil R, Kanovsky J, Di Serafino L, Paolucci L, Barbato E, Mangiacapra F, and Ruzsa Z
- Abstract
Objectives: INCORPORATE trial was designed to evaluate whether default coronary-angiography (CA) and ischemia-targeted revascularization is superior compared to a conservative approach for patients with treated critical limb ischemia (CLI). Registered at clinicaltrials.gov (NCT03712644) on October 19, 2018., Background: Severe peripheral artery disease is associated with increased cardiovascular risk and poor outcomes., Methods: INCORPORATE was an open-label, prospective 1:1 randomized multicentric trial that recruited patients who had undergone successful CLI treatment. Patients were randomized to either a conservative or invasive approach regarding potential coronary artery disease (CAD). The conservative group received optimal medical therapy alone, while the invasive group had routine CA and fractional flow reserve-guided revascularization. The primary endpoint was myocardial infarction (MI) and 12-month mortality., Results: Due to COVID-19 pandemic burdens, recruitment was halted prematurely. One hundred eighty-five patients were enrolled. Baseline cardiac symptoms were scarce with 92% being asymptomatic. Eighty-nine patients were randomized to the invasive approach of whom 73 underwent CA. Thirty-four percent had functional single-vessel disease, 26% had functional multi-vessel disease, and 90% achieved complete revascularization. Conservative and invasive groups had similar incidences of death and MI at 1 year (11% vs 10%; hazard ratio 1.21 [0.49-2.98]). Major adverse cardiac and cerebrovascular events (MACCE) trended for hazard in the Conservative group (20 vs 10%; hazard ratio 1.94 [0.90-4.19]). In the per-protocol analysis, the primary endpoint remained insignificantly different (11% vs 7%; hazard ratio 2.01 [0.72-5.57]), but the conservative approach had a higher MACCE risk (20% vs 7%; hazard ratio 2.88 [1.24-6.68])., Conclusion: This trial found no significant difference in the primary endpoint but observed a trend of higher MACCE in the conservative arm., (© 2024. The Author(s).)
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- 2024
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142. In-hospital Outcomes of Rotational Atherectomy in ST-Elevation Myocardial Infarction: Results From the Multicentre ROTA-STEMI Network.
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Hemetsberger R, Mankerious N, Muntané-Carol G, Temporal J, Sulimov D, Gaede L, Woitek F, Grau EF, Scalamogna M, Olschewski M, Mitsis A, Ruzsa Z, Toth GG, Heyer H, Toelg R, Gómez-Hospital JA, Mügge A, Hengstenberg C, Mangner N, Gori T, Cassese S, Suárez XC, Abdel-Wahab M, Johnson T, Richardt G, and Allali A
- Subjects
- Humans, Male, Female, Aged, Retrospective Studies, Treatment Outcome, Coronary Angiography methods, Europe epidemiology, Follow-Up Studies, Shock, Cardiogenic etiology, Shock, Cardiogenic surgery, Atherectomy, Coronary methods, ST Elevation Myocardial Infarction surgery, ST Elevation Myocardial Infarction diagnosis, Hospital Mortality trends, Percutaneous Coronary Intervention methods
- Abstract
Background: Although the use of rotational atherectomy (RA) is off-label in the setting of ST-elevation myocardial infarction (STEMI), it can be the only option in severely calcified culprit lesions to achieve procedural success. We sought to investigate the safety and feasibility of RA during primary percutaneous coronary intervention (PPCI)., Methods: This was a retrospective observational study of patients who underwent RA during PPCI from 12 European centres. The main outcomes were procedural success (defined as successful stent implantation with final thrombolysis in myocardial infarction [TIMI] flow 3 and residual stenosis < 30%) and in-hospital mortality. A comparison of patients presenting with and without shock was performed., Results: In 104 patients with RA during STEMI, the mean age was 72.8 ± 9.1 years, and 35% presented with cardiogenic shock. Bailout RA was performed in 76.9% of cases. Mean burr size was 1.42 ± 0.21 mm. Procedural success was achieved in 86.5% of cases, with no difference between shocked and nonshocked patients (94.4% vs 82.4%; P = 0.13). In-hospital stent thrombosis occurred in 0.96%, perforation in 1.9% and burr entrapment in 2.9% of cases. In spite of equally high procedural success, in-hospital mortality was higher in shocked (50%) compared with nonshocked patients (1.5%; P < 0.0001)., Conclusions: Patients presenting with STEMI requiring RA, represent a high-risk population, frequently presenting with cardiogenic shock. In this analysis of selected patients, RA was performed as a bailout strategy in the majority, and, as such, RA seems to be feasible with a high procedural success rate. In the absence of cardiogenic shock, RA-facilitated PCI seems to be associated with low in-hospital mortality., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2024
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143. Microaxial Flow Pump in Infarct-Related Cardiogenic Shock.
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von Lewinski D, Herold L, and Toth GG
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- Humans, Male, Heart-Assist Devices, Myocardial Infarction complications, Shock, Cardiogenic etiology, Shock, Cardiogenic mortality, Shock, Cardiogenic surgery, ST Elevation Myocardial Infarction complications
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- 2024
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144. Temporal changes in coronary plaque as assessed by an artificial intelligence-based optical coherence tomography: from the first-in-human trial on DREAMS 3G scaffold.
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Garcia-Garcia HM, Waksman R, Melaku GD, Garg M, Beyene S, Wlodarczak A, Kerai A, Levine MB, van der Schaaf RJ, Torzewski J, Ferdinande B, Escaned J, Iglesias JF, Bennett J, Toth GG, Joner M, Toelg R, Wiemer M, Olivecrona G, Vermeersch P, and Haude M
- Subjects
- Humans, Absorbable Implants, Artificial Intelligence, Coronary Angiography, Coronary Vessels, Lipids, Tomography, Optical Coherence methods, Treatment Outcome, Coronary Artery Disease, Drug-Eluting Stents, Percutaneous Coronary Intervention, Plaque, Atherosclerotic
- Abstract
Aims: The aim of the study is to assess the impact of the baseline plaque composition on the DREAMS 3G luminal late loss and to compare the serial plaque changes between baseline and 6 and 12 months (M) follow-up., Methods and Results: A total of 116 patients were enrolled in the BIOMAG-I trial. Patients were imaged with optical coherence tomography (OCT) pre- and post-DREAMS 3G implantation and at 6 and 12 M. OCTPlus software uses artificial intelligence to assess composition (i.e. lipid, calcium, and fibrous tissue) of the plaque. The differences between the OCT-derived minimum lumen area (MLA) post-percutaneous coronary intervention and 12 M were grouped into three terciles. Patients with larger MLA differences at 12 M (P = 0.0003) had significantly larger content of fibrous tissue at baseline. There was a reduction of 24.8% and 20.9% in lipid area, both P < 0.001, between the pre-DREAMS 3G OCT and the 6 and 12 M follow-up. Conversely, the fibrous tissue increased by 48.4% and 36.0% at 6 and 12 M follow-up, both P < 0.001., Conclusion: The larger the fibrous tissue in the lesion at baseline, the larger the luminal loss seen at 6 and 12 M. Following the implantation of DREAMS 3G, favourable healing of the vessel coronary wall occurs as shown by a decrease in the lipid area and an increase in fibrous tissue., Competing Interests: Conflict of interest: H.M.G.-G., R.W., G.D.M., M.G., S.B., A.K., and M.B.L. were core laboratory members, and the remaining authors were investigators of the trial. H.M.G.-G. has grants or contracts from Medtronic, Biotronik, Abbott, Neovasc, Corflow, Alucentbio, Philips, and Chiesi (paid to institution), received consulting fees from Boston Scientific and ACIST, and participates in DSMB/advisory board of the VIVID study. R.W. has grants or contracts from Amgen, Biotronik, Boston Scientific, Medtronic, and Philips IGT; received consulting fees from Abbott Vascular, Biotronik, Boston Scientific, Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd, Swiss Interventional Systems/SIS Medical AG, Transmural Systems Inc, and Venous MedTech; received honoraria from AstraZeneca; participates in DSMB/advisory boards of Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, and Pi-Cardia Ltd; and is an investor in MedAlliance and Transmural Systems Inc. J.T. reports grants and contracts from Abbott paid to his institution, speaker honoraria and support for attending meetings from Biotronik, and is an associate editor of Cardiovascular Biologics and Regenerative Medicine and Frontiers in Cardiovascular Medicine. J.E. reports personal fees/speaker honoraria from Abbott, Boston Scientific, Philips, and Shockwave, patents from Shared, and participation in advisory boards of Abbott and Phillips. The institution of J.F.I. receives grants or contracts from Terumo Corp, Biosensors, Concept Medical, Biotronik, Abbott Vascular, and Philips Volcano. J.F.I. reports consulting fees from Biotronik, Medtronic, Cordis, Terumo Corp., and ReCor Medical; speaker fees/honoraria from Terumo Corp, Biosensors, Medalliance, OrbusNeich, Concept Medical, Bristol Myers Squibb/Pfizer, Novartis, Cordis, AstraZeneca, and Philips Volcano; and support to attend meetings from Biotronik and Amgen. The institution of J.B. receives grants or contracts from Shockwave IVLS. J.B. receives consulting fees from Biotronik AG and Boston Scientific and speaker fees/honoraria from Biotronik AG, Boston Scientific, and Abbott Vascular, participates in the DSMB of Boston Scientific, and has a leadership or fiduciary role for Biotronik. G.G.T. reports consulting fees from Biotronik, Medtronic, Abbott, and Terumo and honoraria from Biotronik, Medtronic, Abbott, and Terumo. M.J. reports grant support from Boston Scientific, Cardiac Dimensions, Edwards Lifesciences, and Infraredx; consulting fees from AlchiMedics SAS, Biotronik, TriCares, Veryan, and Shockwave; speaker fees/honoraria from Abbott Vascular, Biotronik, Boston Scientific, Edwards Lifesciences, Cardiac Dimensions, AstraZeneca, Recor Medical, and Shockwave; travel support from SIS Medical, Edwards Lifesciences, Boston Scientific, and Cardiac Dimensions; and participation in Steering Committees of Biotronik and Edwards Lifesciences. R.T. reports lecture fees from Biotronik. M.W. reports speaker honoraria and conference attendance support from Biotronik. G.O. reports lecturer honoraria from Abbott Vascular, Biotronik, and Cordis and is a DSMB member of the SCIENCE trial and a CEC-member of the BIOFREEDOM STEMI trial. M.H. reports grants/contracts from Biotronik, Cardiac Dimensions, OrbusNeich, and Philips; consulting fees from Biotronik, Cardiac Dimensions, Shockwave Medical, and OrbusNeich; honoraria/speaker fees from Biotronik, Cardiac Dimensions, Shockwave Medical, OrbusNeich, and Philips; and support to attend meetings/travel support from Biotronik, is a steering committee member of the BIOSOLVE and BIOMAG trials, and is a past president of EAPCI. All other authors have no conflict of interest to declare., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2024
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145. Impact of the Timing of Mechanical Circulatory Support on the Outcomes in Myocardial Infarction-Related Cardiogenic Shock: Subanalysis of the PREPARE CS Registry.
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Prunea DM, Bachl E, Herold L, Kanoun Schnur SS, Pätzold S, Altmanninger-Sock S, Sommer GA, Glantschnig T, Kolesnik E, Wallner M, Ablasser K, Bugger H, Buschmann E, Praschk A, Fruhwald FM, Schmidt A, von Lewinski D, and Toth GG
- Abstract
(1) Background : Mechanical circulatory support (MCS) in myocardial infarction-associated cardiogenic shock is subject to debate. This analysis aims to elucidate the impact of MCS's timing on patient outcomes, based on data from the PREPARE CS registry. (2) Methods : The PREPARE CS prospective registry includes patients who experienced cardiogenic shock (SCAI classes C-E) and were subsequently referred for cardiac catheterization. Our present analysis included a subset of this registry, in whom MCS was used and who underwent coronary intervention due to myocardial infarction. Patients were categorized into an Upfront group and a Procedural group, depending on the timing of MCS's introduction in relation to their PCI. The endpoint was in-hospital mortality. (3) Results : In total, 71 patients were included. MCS was begun prior to PCI in 33 (46%) patients (Upfront), whereas 38 (54%) received MCS during or after the initiation of PCI (Procedural). The groups' baseline characteristics and hemodynamic parameters were comparable. The Upfront group had a higher utilization of the Impella
® device compared to extracorporeal membrane oxygenation (67% vs. 33%), while the Procedural group exhibited a balanced use of both (50% vs. 50%). Most patients suffered from multi-vessel disease in both groups (82% vs. 84%, respectively; p = 0.99), and most patients required a complex PCI procedure; the latter was more prevalent in the Upfront group (94% vs. 71%, respectively; p = 0.02). Their rates of complete revascularization were comparable (52% vs. 34%, respectively; p = 0.16). Procedural CPR was significantly more frequent in the Procedural group (45% vs. 79%, p < 0.05); however, in-hospital mortality was similar (61% vs. 79%, respectively; p = 0.12). (4) Conclusions : The upfront implantation of MCS in myocardial infarction-associated CS did not provide an in-hospital survival benefit.- Published
- 2024
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146. Operator decision-making in angiography-only guided revascularization for lesions not indicated for FFR: a QFR-based functional assessment in chronic coronary syndrome.
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Kanoun Schnur SS, Pranevičius R, Stark C, Prunea D, Andreka J, Schmidt A, Harb S, Ruzsa Z, Zweiker R, Kane J, and Toth GG
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Background: Discordance between coronary angiographic findings and invasive functional significance is well-established. Yet, the prevalence of this mismatch in an era increasingly utilizing invasive functional assessments, such as fractional flow reserve (FFR), remains unclear. This study examines the extent of such discrepancies in current clinical practice., Methods: This single-center prospective registry included consecutive patients with chronic coronary syndrome (CCS) who underwent elective coronary angiography, with or without revascularization. Coronary angiograms deemed not requiring FFR due to clear anatomical distinctions, either anatomically severe indicating a need for revascularization or mild suggesting no need for intervention, were selected for evaluation. These were then subjected to post-hoc analysis by three independent operators who were blinded to the definitive treatment strategies. Importantly, the post-hoc analysis was conducted in two distinct phases: firstly, a re-evaluation of coronary stenosis, and secondly, a separate functional assessment, each carried out independently. Coronary stenosis severity was assessed visually, while functional relevance was determined by quantitative flow ratio (QFR), calculated using a computational fluid dynamics algorithm applied to angiographic images. Analysis focused on discrepancies between QFR-based functional indications and revascularization strategies actually performed., Results: In 191 patients, 488 vessels were analyzed. Average diameter stenosis (DS) was 37 ± 34%, and QFR was 0.87 ± 0.15, demonstrating a moderate correlation ( r = -0.84; 95% CI: -0.86 to -0.81, p < 0.01). Agreement with QFR at conventional anatomical cutoffs was 88% for 50% DS and 91% for 70% DS. Mismatches between revascularization decisions and QFR indications occurred in 10% of cases. Discrepancies were more frequent in the left anterior descending artery (14%) compared to the left circumflex (6%) and the right coronary artery (9%; p = 0.07)., Conclusion: In a cardiac-center where FFR utilization is high, discordance between coronary angiography and functional significance persists, even when operators are confident in their decisions not to use functional interrogation. This gap, most evident in the left anterior descending artery, highlights the potential need for integrated angiography-based functional assessments to refine revascularization decisions in CCS., Competing Interests: GT receives personal fees from Abbott, Medtronic, Biotronik and Boston Scientific, outside the present work. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2024 Kanoun Schnur, Pranevičius, Stark, Prunea, Andreka, Schmidt, Harb, Ruzsa, Zweiker, Kane and Toth.)
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- 2024
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147. Special Issue "Coronary Artery Disease Interventions".
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Herold L, Toth GG, and von Lewinski D
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The treatment and burden of patients with severe ischemic heart disease, whether acute or chronic, remain some of the greatest challenges in cardiology [...].
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- 2024
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148. Two-year results from Onyx ONE clear in patients with high bleeding risk on one-month DAPT with and without intracoronary imaging.
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Toth GG, Kandzari DE, Kirtane AJ, Windecker S, Latib A, Kedhi E, Mehran R, Price MJ, Choi JW, Caputo R, Troquay R, Diderholm E, Singh S, Brar SS, Loussararian A, Chetcuti S, Tulli M, Stone GW, Lung TH, and Mylotte D
- Subjects
- Humans, Coronary Angiography adverse effects, Coronary Angiography methods, Platelet Aggregation Inhibitors adverse effects, Treatment Outcome, Prospective Studies, Drug-Eluting Stents adverse effects, Myocardial Infarction therapy, Myocardial Infarction drug therapy, Percutaneous Coronary Intervention adverse effects, Percutaneous Coronary Intervention methods
- Abstract
Background: Patients with high bleeding risk (HBR) are often treated with abbreviated dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) to reduce bleeding risk, however this strategy is associated with an increase in ischemic events, especially if the acute PCI result is suboptimal. We compared clinical outcomes among patients with HBR treated with 1-month DAPT who underwent intravascular ultrasound (IVUS)- or optical coherence tomography (OCT)-guided PCI versus those who underwent angiography-guided PCI without intravascular imaging., Methods: The Onyx ONE Clear study includes patients with HBR from the Onyx ONE US/Japan and Onyx ONE randomized studies who were treated with the Resolute Onyx zotarolimus-eluting stent. The primary endpoint was the composite of cardiac death (CD) or myocardial infarction (MI) between 1 month and 2 years after PCI. Propensity-score adjustments and matching were performed for differences in baseline and procedural characteristics between groups., Results: Among the 1507 patients in Onyx ONE Clear, 271 (18.0 %) had IVUS or OCT used during PCI (Imaging-guided group) and 1236 (82.0 %) underwent Angiography-guided PCI (Angio-guided group). Imaging-guided patients were less likely to present with atrial fibrillation, acute coronary syndrome, and left ventricle ejection fraction ≤35 %. Conversely, Imaging-guided patients were more likely to have complex (ACC/AHA type B2/C), longer, and heavily calcified lesions. Between 1 month and 2 years, the composite rate of CD or MI was similar between Imaging-guided and Angio-guided patients (9.9 % vs. 12.4 %, P = 0.33). There was also no difference between groups after adjustment; (P = 0.56). However, CD was significantly lower among Imaging-guided patients (2.7 % vs. 6.1 %, P = 0.048). There were no between-group differences in MI or stent thrombosis. Propensity score matching results were similar., Conclusion: Despite higher lesion complexity, using intravascular imaging guidance for PCI between 1-month and 2-years follow-up had comparable outcomes with angiographic guidance alone in patients with HBR treated with 1-month DAPT. (ClinicalTrials.gov: Identifier: NCT03647475 and NCT03344653)., Non-Standard Abbreviations and Acronyms: BARC: Bleeding Academic Research Consortium; DAPT: dual antiplatelet therapy; DES: drug-eluting stent; HBR: high bleeding risk; IVUS: intravascular ultrasound; OCT: optical coherence tomography; SAPT: single antiplatelet therapy., Competing Interests: Declaration of competing interest G.G.T. reports consultancy fees and unrestricted research supports from Medtronic, Biotronik, Terumo and Abbott, outside of this project. D.E.K. reports institutional research/grant support from Biotronik, Boston Scientific, Cardiovascular Systems, Inc., Orbus Neich, Teleflex, Medtronic and Ablative Solutions; and personal consulting honoraria from Ablative Solutions, Cardiovascular Systems, Inc., Magenta Medical, Medtronic, and Terumo. A.J.K. reports institutional funding to Columbia University and/or Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, ReCor Medical, Neurotronic. In addition to research grants, institutional funding includes fees paid to Columbia University and/or Cardiovascular Research Foundation for consulting and/or speaking engagements in which Dr. Kirtane controlled the content. Personal: Consulting from IMDS; Travel Expenses/Meals from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, ReCor Medical, Chiesi, OpSens, Zoll, and Regeneron. S.W. reports research and educational grants to the institution from Abbott, Abiomed, Amgen, Astra Zeneca, Bayer, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, CardioValve, Corflow Therapeutics, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Guerbet, InfraRedx, Janssen-Cilag, Johnson & Johnson, Medicure, Medtronic, Merck Sharp & Dohm, Miracor Medical, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pfizer, Polares, Regeneron, Sanofi-Aventis, Servier, Sinomed, Terumo, Vifor, V-Wave. He serves as unpaid advisory board member and/or unpaid member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, Astra Zeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, Janssen, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, V-Wave and Xeltis, but has not received personal payments by pharmaceutical companies or device manufacturers. He is also member of the steering/executive committee group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration. A. Latib reports consulting fees from Medtronic, Abbott Vascular, and Boston Scientific. E.K. has speaker honoraria from Medtronic, Abbott, Aortic Lab, and has received institutional grants from Abbott and Medtronic. R.M. reports institutional research payments from Abbott, Abiomed, Alleviant Medical, AM-Pharma, Applied Therapeutics, Arena, AstraZeneca, BAIM, Bayer, Beth Israel Deaconess, Biosensors, Biotronik, Boston Scientific, Bristol-Myers Squibb, CardiaWave, CellAegis, CeloNova, CERC, Chiesi, Concept Medical, CSL Behring, Cytosorbents, DSI, Duke University, Element Science, Faraday, Humacyte, Idorsia, Insel Gruppe AG, Magenta, Medtronic, Novartis, OrbusNeich, Philips, RenalPro, Vivasure, Zoll; personal fees from Cine-Med Research, WebMD; consulting fees paid to the institution from Abbott, Janssen, Medtronic, Novartis; Equity <1 % in Applied Therapeutics, Elixir Medical, STEL, CONTROLRAD (spouse); Scientific Advisory Board for AMA, ACC (BOT Member), SCAI (Women in Innovations Committee Member), JAMA Associate Editor; Faculty CRF (no fee). M.J.P. reports consulting and speaker's honoraria from Abbott Vascular, Baylis Medical, Boston Scientific, Medtronic, Shockwave Medical, and W.L. Gore and consulting honoraria from Biotronik, InnovHeart, and Philips. J.W.C. is an advisory board member for Medtronic and is on the speaker bureau for Shockwave Medical. R.C. has nothing to disclose. R.T. reports institutional grant/support from Medtronic, Biotronik, Micell Technologies, B/Braun, Sahajanand Medical Technologies, Abbot Vascular, Pfizer, Amgen, Regeneron, Novartis, Bayer, Medicins Company, Esperion, Daiichi Sankyo, CLS Behring, Boehringer Ingelheim, and Celecor Therapeutics. E.D. has nothing to disclose. S.S. has nothing to disclose. S.S.B. reports institutional research/grant support from Medtronic, Boston Scientific, and Edwards Lifesciences. A. Loussararian has nothing to disclose. S.C. is a consultant for CoreValve and Medtronic. M.T. has nothing to disclose. G.W.S. has received speaker honoraria from Medtronic, Pulnovo, Infraredx; has served as a consultant to Valfix, TherOx, Robocath, HeartFlow, Ablative Solutions, Vectorious, Miracor, Neovasc, Abiomed, Ancora, Elucid Bio, Occlutech, CorFlow, Apollo Therapeutics, Impulse Dynamics, Vascular Dynamics, Shockwave, V-Wave, Cardiomech, Gore, Amgen; and has equity/options from Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, Xenter. Dr. Stone's daughter is an employee at Medtronic. Institutional disclosure: Dr. Stone's employer, Mount Sinai Hospital, receives research support from Abbott, Bioventrix, Cardiovascular Systems Inc., Phillips, Biosense-Webster, Shockwave, Vascular Dynamics and V-wave. T.L. is an employee and shareholder of Medtronic. D.M. reports proctor and consultation fees from Medtronic, Boston Scientific, and Microport., (Copyright © 2023. Published by Elsevier Inc.)
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- 2024
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149. Differential Impact of Fractional Flow Reserve Measured After Coronary Stent Implantation by Left Ventricular Dysfunction.
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Choi KH, Kwon W, Shin D, Lee SH, Hwang D, Zhang J, Nam CW, Shin ES, Doh JH, Chen SL, Kakuta T, Toth GG, Piroth Z, Hakeem A, Uretsky BF, Hokama Y, Tanaka N, Lim HS, Ito T, Matsuo A, Azzalini L, Leesar MA, Daemen J, Collison D, Collet C, De Bruyne B, Koo BK, Park TK, Yang JH, Song YB, Hahn JY, Choi SH, Gwon HC, and Lee JM
- Abstract
Background: Both left ventricular systolic function and fractional flow reserve (FFR) are prognostic factors after percutaneous coronary intervention (PCI). However, how these prognostic factors are inter-related in risk stratification of patients after PCI remains unclarified., Objectives: This study evaluated differential prognostic implication of post-PCI FFR according to left ventricular ejection fraction (LVEF)., Methods: A total of 2,965 patients with available LVEF were selected from the POST-PCI FLOW (Prognostic Implications of Physiologic Investigation After Revascularization with Stent) international registry of patients with post-PCI FFR measurement. The primary outcome was a composite of cardiac death or target-vessel myocardial infarction (TVMI) at 2 years. The secondary outcome was target-vessel revascularization (TVR) and target vessel failure, which was a composite of cardiac death, TVMI, or TVR., Results: Post-PCI FFR was independently associated with the risk of target vessel failure (per 0.01 decrease: HR
adj : 1.029; 95% CI: 1.009-1.049; P = 0.005). Post-PCI FFR was associated with increased risk of cardiac death or TVMI (HRadj : 1.145; 95% CI: 1.025-1.280; P = 0.017) among patients with LVEF ≤40%, and with that of TVR in patients with LVEF >40% (HRadj : 1.028; 95% CI: 1.005-1.052; P = 0.020). Post-PCI FFR ≤0.80 was associated with increased risk of cardiac death or TVMI in the LVEF ≤40% group and with that of TVR in LVEF >40% group. Prognostic impact of post-PCI FFR for the primary outcome was significantly different according to LVEF ( Pinteraction = 0.019)., Conclusions: Post-PCI FFR had differential prognostic impact according to LVEF. Residual ischemia by post-PCI FFR ≤0.80 was a prognostic indicator for cardiac death or TVMI among patients with patients with LVEF ≤40%, and it was associated with TVR among patients with patients with LVEF>40%. (Prognostic Implications of Physiologic Investigation After Revascularization with Stent [POST-PCI FLOW]; NCT04684043)., Competing Interests: Dr Joo Myung Lee has received an institutional research grant from Abbott Vascular, Boston Scientific, Philips Volcano, Terumo Corporation, Donga-ST, and Zoll Medical. Dr Bon-Kwon Koo has received an institutional research grant from St. Jude Medical (Abbott Vascular) and Philips Volcano. Dr Joon Hyung Doh has received a research grant from Philips Volcano. Dr Shao-Liang Chen is a consultant for Microport and Boston Scientific International; and has received a grant from the National Natural Scientific Foundation of China. Dr Toth receives consultancy fees and unrestricted research grants from Abbott, Medtronic, and Terumo. Dr Johnson has received institutional research support from Volcano/Philips (DEFINE-FLOW, NCT02328820), Abiomed (for study of Impella-related coronary physiology) and St. Jude Medical (CONTRAST, NCT02184117); has an institutional licensing agreement with Boston Scientific for the smart-minimum FFR algorithm commercialized under 510(k) K191008; and has pending patents on diagnostic methods for quantifying aortic stenosis and TAVR physiology, and also algorithms to correct pressure tracings from fluid-filled catheters. Dr Leesar has received an institutional research grant from ACIST. Dr Azzalini has received honoraria from Teleflex, Abiomed, GE Healthcare, Asahi Intecc, Philips, Abbott Vascular, and Cardiovascular System, Inc. Dr Diletti has received an institutional research grant to Erasmus University Medical Center; and has served as a consultant to ACIST Medical Systems. Dr Collison has received consultancy/speaker fees from Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2024 The Authors.)- Published
- 2023
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150. Targeted therapy with a localised abluminal groove, low-dose sirolimus-eluting, biodegradable-polymer coronary stent - five-year results of the TARGET All Comers randomised clinical trial.
- Author
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Lansky AJ, Xu B, Baumbach A, Kelbæk H, van Royen N, Zheng M, Knaapen P, Slagboom T, Johnson TW, Vlachojannis GJ, Arkenbout KE, Holmvang L, Janssens L, Brugaletta S, Naber CK, Schmitz T, Anderson R, Rittger H, Berti S, Barbato E, Toth GG, Maillard L, Valina CM, Buszman PE, Thiele H, Schächinger V, and Wijns W
- Subjects
- Humans, Sirolimus, Prospective Studies, Treatment Outcome, Absorbable Implants, Everolimus, Polymers, Drug-Eluting Stents adverse effects, Percutaneous Coronary Intervention adverse effects, Myocardial Infarction etiology
- Abstract
Background: In the prospective, multicentre, randomised TARGET All Comers study, percutaneous coronary intervention (PCI) with the FIREHAWK biodegradable-polymer sirolimus-eluting stent (BP-SES) was non-inferior to the durable-polymer everolimus-eluting stent (DP-EES) for the primary endpoint of target lesion failure (TLF) at 12 months., Aims: We aimed to report the final study outcomes at 5 years., Methods: Patients referred for PCI were randomised to receive either a BP-SES or DP-EES in a 1:1 ratio in 10 European countries. Randomisation was stratified by centre and ST-elevation myocardial infarction (STEMI) presentation, and clinical follow-up extended to 5 years. The primary endpoint was TLF (composite of cardiac death, target vessel myocardial infarction [MI], or ischaemia-driven target lesion revascularisation). Secondary endpoints included patient-oriented composite events (POCE; composite of all-cause death, all MI, or any revascularisation and its components)., Results: From December 2015 to October 2016, 1,653 patients were randomly assigned to the BP-SES or DP-EES groups, of which 93.8% completed 5-year clinical follow-up or were deceased. At 5 years, TLF occurred in 17.1% of the BP-SES group and in 16.3% of the DP-EES group (p=0.68). POCE occurred in 34.0% of the BP-SES group and 32.7% of the DP-EES group (p=0.58). Revascularisation was the most common POCE, occurring in 19.3% of patients receiving BP-SES and 19.2% receiving DP-EES, of which less than one-third was ischaemia-driven target lesion-related. In the landmark analysis, there were no differences in the rates of TLF and POCE between groups from 1 to 5 years, and these results were consistent across all subgroups., Conclusions: In an all-comers population requiring stent implantation for myocardial ischaemia, the BP-SES was non-inferior to the DP-EES for the primary endpoint of TLF at 12 months, and results were sustained at 5 years, confirming the long-term safety and efficacy of the FIREHAWK BP-SES.
- Published
- 2023
- Full Text
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