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4. Coronary Stenting in High Bleeding Risk Patients With Small Coronary Arteries Followed by One-Month Dual Antiplatelet Therapy: Onyx ONE Clear

Author

Moreno, Raúl, Kandzari, David E., Kirtane, Ajay J., Windecker, Stephan, Latib, Azeem, Kedhi, Elvin, Mehran, Roxana, Price, Matthew J., Simon, Daniel I., Worthley, Stephen G., Spriggs, Douglas, Tolleson, Thaddeus, Nazif, Tamim, Golwala, Harsh, Kander, Nathan H., Liew, Houng B., Sardella, Gennaro, Tamburino, Corrado, Lung, Te-Hsin, Mahoney, Cecile, and Stone, Gregg W.

Published
2022
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7. One-Month Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention With Zotarolimus-Eluting Stents in High-Bleeding-Risk Patients

Author

Kandzari, David E., Kirtane, Ajay J., Windecker, Stephan, Latib, Azeem, Kedhi, Elvin, Mehran, Roxana, Price, Matthew J., Abizaid, Alexandre, Simon, Daniel I., Worthley, Stephen G., Zaman, Azfar, Choi, James W., Caputo, Ronald, Kanitkar, Mihir, McLaurin, Brent, Potluri, Srinivasa, Smith, Timothy, Spriggs, Douglas, Tolleson, Thaddeus, Nazif, Tamim, Parke, Maria, Lee, Lilian C., Lung, Te-Hsin, and Stone, Gregg W.

Published
2020
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9. Predictors of Paravalvular Regurgitation After Implantation of the Fully Repositionable and Retrievable Lotus Transcatheter Aortic Valve (from the REPRISE II Trial Extended Cohort)

Author

Blackman, Daniel J., Meredith, Ian T., Dumonteil, Nicolas, Tchétché, Didier, Hildick-Smith, David, Spence, Mark S., Walters, Darren L., Harnek, Jan, Worthley, Stephen G., Rioufol, Gilles, Lefèvre, Thierry, Houle, Vicki M., Allocco, Dominic J., and Dawkins, Keith D.

Published
2017
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11. First-in-Human Evaluation of a Novel Polymer-Free Drug-Filled Stent: Angiographic, IVUS, OCT, and Clinical Outcomes From the RevElution Study

Author

Worthley, Stephen, Shetty, Sharad, Sinhal, Ajay, Meredith, Ian, Abizaid, Alexandre, Jepson, Nigel, Bhindi, Ravinay, Lim, Soo Teik, Stewart, Peter, Barlis, Peter, Walters, Darren, Muller, David, Cox, Stephen, Bhagwandeen, Rohan, Worthley, Stephen G., Kirtane, Ajay J., Simon, Daniel I., Windecker, Stephan, Brar, Sandeep, Meredith, Ian T., Almonacid, Alexandra Popma, Chamié, Daniel, Maehara, Akiko, and Stone, Gregg W.

Published
2017
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15. Thirty-Day Clinical Outcomes of a Self-Expanding Transcatheter Aortic Valve: The International PORTICO NG Study

Author

Reardon, Michael J., primary, Chehab, Bassem, additional, Smith, Dave, additional, Walton, Antony S., additional, Worthley, Stephen G., additional, Manoharan, Ganesh, additional, Sultan, Ibrahim, additional, Yong, Gerald, additional, Harrington, Katherine, additional, Mahoney, Paul, additional, Kleiman, Neal, additional, Makkar, Raj R., additional, Fontana, Gregory, additional, DeLago, Augustin, additional, Ramana, Ravi K., additional, Bates, Nicholas, additional, and Sondergaard, Lars, additional

Published
2023
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16. 30-Day Clinical Outcomes of a Self-Expanding Transcatheter Aortic Valve:The International PORTICO NG Study

Author

Reardon, Michael J., Chehab, Bassem, Smith, Dave, Walton, Antony S., Worthley, Stephen G., Manoharan, Ganesh, Sultan, Ibrahim, Yong, Gerald, Harrington, Katherine, Mahoney, Paul, Kleiman, Neal, Makkar, Raj R., Fontana, Gregory, DeLago, Augustin, Ramana, Ravi K., Bates, Nicholas, Søndergaard, Lars, Reardon, Michael J., Chehab, Bassem, Smith, Dave, Walton, Antony S., Worthley, Stephen G., Manoharan, Ganesh, Sultan, Ibrahim, Yong, Gerald, Harrington, Katherine, Mahoney, Paul, Kleiman, Neal, Makkar, Raj R., Fontana, Gregory, DeLago, Augustin, Ramana, Ravi K., Bates, Nicholas, and Søndergaard, Lars

Abstract

Background: The self-expanding, intra-annular Navitor (Abbott Structural Heart) valve includes an outer cuff to reduce paravalvular leak (PVL) and large stent cells for future coronary access. Objectives: The purpose of the PORTICO NG (Evaluation of the Portico NG [Next Generation] Transcatheter Aortic Valve in High and Extreme Risk Patients With Symptomatic Severe Aortic Stenosis) study is to evaluate the safety and effectiveness of the Navitor valve in patients with symptomatic, severe aortic stenosis who are at high or extreme surgical risk. Methods: PORTICO NG is a prospective, multicenter, global study with follow-up at 30 days, 1 year, and annually through 5 years. The primary endpoints are all-cause mortality and moderate or greater PVL at 30 days. Valve Academic Research Consortium-2 events and valve performance are assessed by an independent clinical events committee and echocardiographic core laboratory. Results: A total of 260 subjects were treated at 26 clinical sites across Europe, Australia, and the United States between September 2019 and August 2022. The mean age was 83.4 ± 5.4 years, 57.3% were female, and the average Society of Thoracic Surgeons score was 3.9% ± 2.1%. At 30 days, the rate of all-cause mortality was 1.9%, and no subjects had moderate or greater PVL. The rate of disabling stroke was 1.9%, life-threatening bleeding was 3.8%, stage 3 acute kidney injury was 0.8%, major vascular complications were 4.2%, and new permanent pacemaker implantation was 19.0%. Hemodynamic performance included a mean gradient of 7.4 ± 3.5 mm Hg and an effective orifice area of 2.00 ± 0.47 cm2. Conclusions: The Navitor valve is safe and effective for the treatment of subjects with severe aortic stenosis who are at high or greater risk for surgery, which is supported by low rates of adverse events and PVL. (Evaluation of the Portico NG [Next Generation] Transcatheter Aortic Valve in High and Extreme Risk Patients With Symptomatic Severe Aortic Sten

Published
2023

17. Thirty-day and one-year outcomes of the Navitor transcatheter heart valve in patients with aortic stenosis:the prospective, multicentre, global PORTICO NG Study

Author

Sondergaard, Lars, Walton, Antony S., Worthley, Stephen G., Smith, Dave, Chehab, Bassem, Manoharan, Ganesh, Yong, Gerald, Bedogni, Francesco, Bates, Nicholas, Reardon, Michael J., Sondergaard, Lars, Walton, Antony S., Worthley, Stephen G., Smith, Dave, Chehab, Bassem, Manoharan, Ganesh, Yong, Gerald, Bedogni, Francesco, Bates, Nicholas, and Reardon, Michael J.

Abstract

Background: The Navitor transcatheter heart valve (THV) is a self-expanding valve, with an intra-annular leaflet position and an outer cuff intended to reduce paravalvular leak (PVL). Aims: The aim of the PORTICO NG Study is to assess the safety and performance of the Navitor THV in patients with symptomatic, severe aortic stenosis who are at high or extreme surgical risk. Methods: PORTICO NG is a prospective, multicentre, global, single-arm, investigational study with follow- up at 30 days, 1 year, and annually up to 5 years. The primary endpoints are all-cause mortality and moderate or greater PVL at 30 days. Valve Academic Research Consortium-2 events and valve performance are assessed by an independent clinical events committee and echocardiographic core laboratory. Results: A total of 120 high- or extreme-risk subjects (age 83.5±5.4 years; 58.3% female; Society of Thoracic Surgeons score 4.0±2.0%) were enrolled in the European conformity (CE) mark cohort. Procedural success was high at 97.5%. At 30 days, the rate of all-cause mortality was 0%, and no subjects had moderate or greater PVL. The rate of disabling stroke was 0.8%, life-threatening bleeding was 2.5%, stage 3 acute kidney injury 0%, major vascular complications 0.8%, and new pacemaker implantation 15.0%. At 1 year, the rates of all-cause mortality and disabling stroke were 4.2% and 0.8%, respectively. The rate of moderate PVL was 1.0% at 1 year. Haemodynamic performance with a mean gradient of 7.5±3.2 mmHg and effective orifice area of 1.9±0.4 cm2 was sustained up to 1 year. Conclusions: The PORTICO NG Study demonstrates low rates of adverse events and PVL up to 1 year in patients at high or extreme surgical risk, confirming the safety and efficacy of the Navitor THV system. © Europa Digital & Publishing 2023. All rights reserved., Background: The Navitor transcatheter heart valve (THV) is a self-expanding valve, with an intra-annular leaflet position and an outer cuff intended to reduce paravalvular leak (PVL). Aims: The aim of the PORTICO NG Study is to assess the safety and performance of the Navitor THV in patients with symptomatic, severe aortic stenosis who are at high or extreme surgical risk. Methods: PORTICO NG is a prospective, multicentre, global, single-arm, investigational study with follow- up at 30 days, 1 year, and annually up to 5 years. The primary endpoints are all-cause mortality and moderate or greater PVL at 30 days. Valve Academic Research Consortium-2 events and valve performance are assessed by an independent clinical events committee and echocardiographic core laboratory. Results: A total of 120 high- or extreme-risk subjects (age 83.5±5.4 years; 58.3% female; Society of Thoracic Surgeons score 4.0±2.0%) were enrolled in the European conformity (CE) mark cohort. Procedural success was high at 97.5%. At 30 days, the rate of all-cause mortality was 0%, and no subjects had moderate or greater PVL. The rate of disabling stroke was 0.8%, life-threatening bleeding was 2.5%, stage 3 acute kidney injury 0%, major vascular complications 0.8%, and new pacemaker implantation 15.0%. At 1 year, the rates of all-cause mortality and disabling stroke were 4.2% and 0.8%, respectively. The rate of moderate PVL was 1.0% at 1 year. Haemodynamic performance with a mean gradient of 7.5±3.2 mmHg and effective orifice area of 1.9±0.4 cm2 was sustained up to 1 year. Conclusions: The PORTICO NG Study demonstrates low rates of adverse events and PVL up to 1 year in patients at high or extreme surgical risk, confirming the safety and efficacy of the Navitor THV system.

Published
2023

18. 1-Year Outcomes With the Fully Repositionable and Retrievable Lotus Transcatheter Aortic Replacement Valve in 120 High-Risk Surgical Patients With Severe Aortic Stenosis: Results of the REPRISE II Study

Author

Meredith, Ian T., Walters, Darren L., Dumonteil, Nicolas, Worthley, Stephen G., Tchétché, Didier, Manoharan, Ganesh, Blackman, Daniel J., Rioufol, Gilles, Hildick-Smith, David, Whitbourn, Robert J., Lefèvre, Thierry, Lange, Rüdiger, Müller, Ralf, Redwood, Simon, Feldman, Ted E., Allocco, Dominic J., and Dawkins, Keith D.

Published
2016
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19. Catheter-based renal denervation for resistant hypertension: Twenty-four month results of the EnligHTN™ I first-in-human study using a multi-electrode ablation system

Author

Tsioufis, Costas P., Papademetriou, Vasilios, Dimitriadis, Kyriakos S., Kasiakogias, Alexandros, Tsiachris, Dimitrios, Worthley, Matthew I., Sinhal, Ajay R., Chew, Derek P., Meredith, Ian T., Malaiapan, Yuvi, Thomopoulos, Costas, Kallikazaros, Ioannis, Tousoulis, Dimitrios, and Worthley, Stephen G.

Published
2015
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27. Treatment of Aortic Stenosis With a Self-Expanding, Resheathable Transcatheter Valve: One-Year Results of the International Multicenter Portico Transcatheter Aortic Valve Implantation System Study

Author

Linke, Axel, Holzhey, David, Möllmann, Helge, Manoharan, Ganesh, Schäfer, Ulrich, Frerker, Christian, Worthley, Stephen G., van Boven, A.J., Redwood, Simon, Kovac, Jan, Butter, Christian, Søndergaard, Lars, Lauten, Alexander, Schymik, Gerhard, and Walther, Thomas

Published
2018
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30. Renal denervation in hypertensive patients not on blood pressure lowering drugs

Author

De Jager, Rosa L., Sanders, Margreet F., Bots, Michiel L., Lobo, Melvin D., Ewen, Sebastian, Beeftink, Martine M. A., Böhm, Michael, Daemen, Joost, Dörr, Oliver, Hering, Dagmara, Mahfoud, Felix, Nef, Holger, Ott, Christian, Saxena, Manish, Schmieder, Roland E., Schlaich, Markus P., Spiering, Wilko, Tonino, Pim. A. L., Verloop, Willemien L., Vink, Eva E., Vonken, Evert-Jan, Voskuil, Michiel, Worthley, Stephen G., and Blankestijn, Peter J.

Published
2016
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31. Clinical Outcomes of PCI With a Zotarolimus-Eluting Stent Followed by One-Month DAPT in High-Bleeding-Risk Patients With Small (≤2.5 mm) Coronary Arteries: One-Year Analysis From the Onyx ONE Clear Study

Author

Moreno, Raul, primary, Kandzari, David, additional, Kirtane, Ajay, additional, Windecker, Stephan, additional, Latib, Azeem, additional, Kedhi, Elvin, additional, Mehran, Roxana, additional, Price, Mathew J., additional, Simon, Daniel I., additional, Worthley, Stephen G., additional, Lung, Te-Hsin, additional, Mahoney, Cecile, additional, and Stone, Gregg W., additional

Published
2022
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32. One-Year Outcomes for an Intra-Annular Self-Expanding Transcatheter Aortic Valve and Next-Generation Low-Profile Delivery System

Author

Makkar, Raj R., primary, Groh, Mark, additional, Bedogni, Francesco, additional, Worthley, Stephen G., additional, Smith, Dave, additional, Chehab, Bassam M., additional, Waksman, Ron, additional, Monoharan, Ganesh, additional, Asch, Federico M., additional, Ramana, Ravi K., additional, and Fontana, Gregory P., additional

Published
2022
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33. Polymer-Based Versus Polymer-Free Stents in High Bleeding Risk Patients

Author

Windecker, Stephan, primary, Latib, Azeem, additional, Kedhi, Elvin, additional, Kirtane, Ajay J., additional, Kandzari, David E., additional, Mehran, Roxana, additional, Price, Matthew J., additional, Abizaid, Alexandre, additional, Simon, Daniel I., additional, Worthley, Stephen G., additional, Zaman, Azfar, additional, Hudec, Martin, additional, Poliacikova, Petra, additional, Kahar bin Abdul Ghapar, Abdul, additional, Selvaraj, Kamaraj, additional, Petrov, Ivo, additional, Mylotte, Darren, additional, Pinar, Eduardo, additional, Moreno, Raul, additional, Fabbiocchi, Franco, additional, Pasupati, Sanjeevan, additional, Kim, Hyo-Soo, additional, Aminian, Adel, additional, Tie, Charles, additional, Wlodarczak, Adrian, additional, Hur, Seung-Ho, additional, Marx, Steven O., additional, Ali, Ziad A., additional, Parke, Maria, additional, Lung, Te-Hsin, additional, and Stone, Gregg W., additional

Published
2022
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35. The REMEDEE Trial: A Randomized Comparison of a Combination Sirolimus-Eluting Endothelial Progenitor Cell Capture Stent With a Paclitaxel-Eluting Stent

Author

Haude, Michael, Lee, Stephen W.L., Worthley, Stephen G., Silber, Sigmund, Verheye, Stefan, Erbs, Sandra, Rosli, Mohd Ali, Botelho, Roberto, Meredith, Ian, Sim, Kui Hian, Stella, Pieter R., Tan, Huay-Cheem, Whitbourn, Robert, Thambar, Sukumaran, Abizaid, Alexandre, Koh, Tian Hai, Den Heijer, Peter, Parise, Helen, Cristea, Ecaterina, Maehara, Akiko, and Mehran, Roxana

Published
2013
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38. Coronary atheroma composition and its association with segmental endothelial dysfunction in non-ST segment elevation myocardial infarction: novel insights with radiofrequency (iMAP) intravascular ultrasonography

Author

Puri, Rishi, Nicholls, Stephen J., Brennan, Danielle M., Andrews, Jordan, Liew, Gary Y., Carbone, Angelo, Copus, Barbara, Nelson, Adam J., Kapadia, Samir R., Tuzcu, E. Murat, Beltrame, John F., Worthley, Stephen G., and Worthley, Matthew I.

Published
2015
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40. CRT-100.52 Clinical Outcomes of PCI With a Zotarolimus-Eluting Stent Followed by One-Month DAPT in High-Bleeding-Risk Patients With Small (≤2.5 mm) Coronary Arteries: One-Year Analysis From the Onyx ONE Clear Study

Author

Moreno, Raul, primary, Kandzari, David, additional, Kirtane, Ajay, additional, Windecker, Stephan, additional, Latib, Azeem, additional, Kedhi, Elvin, additional, Mehran, Roxana, additional, Price, Mathew J., additional, Simon, Daniel I., additional, Worthley, Stephen G., additional, Lung, Te-Hsin, additional, Mahoney, Cecile, additional, and Stone, Gregg W., additional

Published
2022
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41. CRT-700.32 One-Year Outcomes for an Intra-Annular Self-Expanding Transcatheter Aortic Valve and Next-Generation Low-Profile Delivery System

Author

Makkar, Raj R., primary, Groh, Mark, additional, Bedogni, Francesco, additional, Worthley, Stephen G., additional, Smith, Dave, additional, Chehab, Bassam M., additional, Waksman, Ron, additional, Monoharan, Ganesh, additional, Asch, Federico M., additional, Ramana, Ravi K., additional, and Fontana, Gregory P., additional

Published
2022
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45. TCT-191 HighLife Trans-Septal Mitral Valve Replacement (TSMVR) System; Early and Long Term Clinical and Hemodynamic Outcomes of the First 30 Consecutive Cases; The HighLife Feasibility Studies in Europe, Australia, and the US

Author

Rottbauer, Wolfgang, primary, Schneider, Leonhard, additional, Nickenig, Georg, additional, huczek, Zenon, additional, Wojakowski, Wojciech, additional, Tchetche, Didier, additional, Dubois, Christophe, additional, Nasr, Malek, additional, Verhees, Luc, additional, Rothman, Martin, additional, Piazza, Nicolo, additional, Buithieu, Jean, additional, Yeow, Wen Loong, additional, and Worthley, Stephen G., additional

Published
2021
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46. TCT-35 One-Month Dual Antiplatelet Therapy After PCI With Resolute Onyx DES: Final 2-Year Results From Onyx ONE Clear

Author

Kandzari, David, primary, Kirtane, Ajay, additional, Mehran, Roxana, additional, Price, Matthew, additional, Simon, Daniel, additional, Latib, Azeem, additional, Kedhi, Elvin, additional, Abizaid, Alexandre, additional, Worthley, Stephen G., additional, Zaman, Azfar, additional, Parke, Maria, additional, Mahoney, Amanda, additional, Lung, Te-Hsin, additional, Windecker, Stephan, additional, and Stone, Gregg, additional

Published
2021
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48. Polymer-Based Versus Polymer-Free Stents in High Bleeding Risk Patients: Final 2-Year Results From Onyx ONE

Author

Windecker, Stephan, Latib, Azeem, Kedhi, Elvin, Kirtane, Ajay J, Kandzari, David E, Mehran, Roxana, Price, Matthew J, Abizaid, Alexandre, Simon, Daniel I, Worthley, Stephen G, Zaman, Azfar, Hudec, Martin, Poliacikova, Petra, Kahar Bin Abdul Ghapar, Abdul, Selvaraj, Kamaraj, Petrov, Ivo, Mylotte, Darren, Pinar, Eduardo, Moreno, Raul, Fabbiocchi, Franco, Pasupati, Sanjeevan, Kim, Hyo-Soo, Aminian, Adel, Tie, Charles, Wlodarczak, Adrian, Hur, Seung-Ho, Marx, Steven O, Ali, Ziad A, Parke, Maria, Lung, Te-Hsin, and Stone, Gregg W

Subjects
Percutaneous Coronary Intervention, Treatment Outcome, Polymers, Humans, Drug-Eluting Stents, Hemorrhage, Stents, 610 Medicine & health, Prosthesis Design, Platelet Aggregation Inhibitors
Abstract

BACKGROUND Resolute Onyx polymer-based zotarolimus-eluting stents (ZES) were noninferior in safety and effectiveness to BioFreedom polymer-free biolimus A9-coated stents (DCS) in high-bleeding-risk (HBR) patients treated with 1-month dual antiplatelet therapy (DAPT) followed by single antiplatelet therapy (SAPT) at 1 year. OBJECTIVES This study reports the final 2-year results of the randomized Onyx ONE trial. METHODS The Onyx ONE (A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients) trial randomly assigned HBR patients to treatment with ZES or DCS. Following 1-month DAPT, event-free patients received SAPT (either aspirin or a P2Y12 inhibitor at physician discretion). The primary safety endpoint, a composite of cardiac death, myocardial infarction, or stent thrombosis at 1 year, was determined at 1 year. Rates of primary and secondary endpoints were calculated after final follow-up at 2 years. RESULTS A total of 1,003 patients were randomly allocated to ZES and 993 patients to DCS. Follow-up was complete in 980 (97.7%) ZES patients and 962 (96.9%) DCS patients at 2 years. The primary safety endpoint occurred in 208 (21.2%) patients in the ZES group and 199 (20.7%) patients in the DCS group (risk difference: 0.5%; 95% CI: -3.1% to 4.2%; P = 0.78) at 2 years without significant differences in individual components of the composite endpoint. The secondary effectiveness endpoint occurred in 217 (22.1%) patients in the ZES group and 202 (21.0%) patients in the DCS group (risk difference: 1.1%; 95% CI: -2.5% to 4.8%; P = 0.54). CONCLUSIONS Among patients at HBR treated with 1-month DAPT followed by SAPT, the Resolute Onyx polymer-based ZES had similar 2-year outcomes for the primary safety and secondary effectiveness endpoint compared with the BioFreedom polymer-free DCS. (A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy [DAPT] for High-Bleeding Risk Patients [Onyx ONE]; NCT03344653).

Published
2021

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