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1. Impact of Bleeding and Myocardial Infarction on Mortality in All-Comer Patients Undergoing Percutaneous Coronary Intervention

Author

Hara, Hironori, Takahashi, Kuniaki, Kogame, Norihiro, Tomaniak, Mariusz, Kerkmeijer, Laura S.M., Ono, Masafumi, Kawashima, Hideyuki, Wang, Rutao, Gao, Chao, Wykrzykowska, Joanna J., de Winter, Robbert J., Neumann, Franz-Josef, Plante, Sylvain, Lemos Neto, Pedro Alves, Garg, Scot, Jüni, Peter, Vranckx, Pascal, Windecker, Stephan, Valgimigli, Marco, Hamm, Christian, Steg, Philippe Gabriel, Onuma, Yoshinobu, and Serruys, Patrick W.

Published
2020
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2. Ticagrelor Monotherapy or Dual Antiplatelet Therapy After Drug‐Eluting Stent Implantation: Per‐Protocol Analysis of the GLOBAL LEADERS Trial

Author

Gragnano, Felice, primary, Zwahlen, Marcel, additional, Vranckx, Pascal, additional, Heg, Dik, additional, Schmidlin, Kurt, additional, Hamm, Christian, additional, Steg, Philippe Gabriel, additional, Gargiulo, Giuseppe, additional, McFadden, Eugene P., additional, Onuma, Yoshinobu, additional, Chichareon, Ply, additional, Benit, Edouard, additional, Möllmann, Helge, additional, Janssens, Luc, additional, Leonardi, Sergio, additional, Zurakowski, Aleksander, additional, Arrivi, Alessio, additional, Van Geuns, Robert Jan, additional, Huber, Kurt, additional, Slagboom, Ton, additional, Calabrò, Paolo, additional, Serruys, Patrick W., additional, Jüni, Peter, additional, Valgimigli, Marco, additional, Windecker, Stephan, additional, Abdellaoui, Mohamed, additional, Adlam, David, additional, Akin, Ibrahim, additional, Gonzalez‐Trevilla, Agustin Albarran, additional, Almeida, Manuel, additional, Neto, Pedro Alves Lemos, additional, Aminian, Adel, additional, Anderson, Richard, additional, Andreae, Rick, additional, Angioi, Michael, additional, Asano, Taku, additional, Barbato, Emanuele, additional, Barlis, Peter, additional, Barraud, Pascal, additional, Bertrand, Olivier, additional, Beygui, Farzin, additional, Bolognese, Leonardo, additional, Botelho, Roberto, additional, Bouwman, Coby, additional, Bressers, Marco, additional, Brunel, Philippe, additional, Buszman, Pawel, additional, Buysschaert, Ian, additional, da Silva, Pedro Canas, additional, Carrie, Didier, additional, Cequier, Angel, additional, Chang, Chun Chin, additional, Chowdhary, Saqib, additional, Collet, Carlos, additional, Colombo, Antonio, additional, Cotton, James, additional, Ferreira, Rui Cruz, additional, Curello, Salvatore, additional, Curzen, Nick, additional, de Bot, Judith, additional, de Vreede, Tone, additional, Karth, Georg Delle, additional, Dijksma, Lynn, additional, Dominici, Marcello, additional, Édes, István, additional, Eeckhout, Eric, additional, Eitel, Ingo, additional, Faluközy, József, additional, Fath‐Ordoubadi, Farzin, additional, Ferrario, Maurizio, additional, Fontos, Geza, additional, Diaz, Jose Francisco, additional, Quintella, Edgard Freitas, additional, Frey, Bernhard, additional, Friedrich, Guy, additional, Galasko, Gavin, additional, Galuszka, Grzegorz, additional, Ribeiro, Vasco Gama, additional, Garg, Scot, additional, Geisler, Tobias, additional, Gelev, Valeri, additional, Ghandilyan, Art, additional, Goicolea, Javier, additional, Gori, Tommaso, additional, Gragnano, Felice, additional, Guimarães, Ana, additional, Haude, Michael, additional, Heijke, Pieter, additional, Antolin, Rosa Ana Hernández, additional, Hildick‐Smith, David, additional, Hillen, Dorien, additional, Hoekman, Ina, additional, Hofma, Sjoerd, additional, Holmvang, Lene, additional, Hoole, Stephen, additional, Horváth, Iván, additional, Hugense, Annemarie, additional, Ibrahim, Karim, additional, Iñiguez, Andres, additional, Isaaz, Karl, additional, Jambrik, Zoltán, additional, Jasionowicz, Pawel, additional, Jonk, Judith, additional, Jung, Werner, additional, Katagiri, Yuki, additional, Kogame, Norihiro, additional, Koh, Tian Hai, additional, Koning, René, additional, Konteva, Mariana, additional, Kőszegi, Zsolt, additional, Krackhardt, Florian, additional, Kreuger, Yvonne, additional, Kukreja, Neville, additional, Ladan, Boudijn, additional, Lantelme, Pierre, additional, Leandro, Sergio, additional, Leibundgut, Gregor, additional, Liebetrau, Christoph, additional, Lindeboom, Wietze, additional, Miguel, Carlos Macaya, additional, Mach, François, additional, Magro, Michael, additional, Maillard, Luc, additional, Manavifar, Negar, additional, Mauri, Laura, additional, McFadden, Eugene, additional, Merkely, Bela, additional, Miyazaki, Yosuke, additional, Młodziankowski, Adam, additional, Moccetti, Tiziano, additional, Modolo, Rodrigo, additional, Möllman, Helge, additional, Morelle, Jean‐François, additional, Moschovitis, Aris, additional, Ottesen, Michael Munndt, additional, Muurling, Martin, additional, Naber, Christoph Kurt, additional, Neumann, Franz‐Josef, additional, Oldroyd, Keith, additional, Ong, Paul, additional, Palsrok, Sanne, additional, Petrov, Ivo, additional, Plante, Sylvain, additional, Prokopczuk, Janusz, additional, Rademaker‐Havinga, Tessa, additional, Raffel, Christopher, additional, Rensing, Benno, additional, Roffi, Marco, additional, Royaards, Kees‐Jan, additional, Sabate, Manel, additional, Schächinger, Volker, additional, Seidler, Tim, additional, Peñaranda, Antonio Serra, additional, Serruys, Patrick, additional, Sikarulidze, Lali, additional, Soliman, Osama I, additional, Sousa, Amanda, additional, Spitzer, Ernest, additional, Stables, Rod, additional, Steg, Gabriel, additional, Steinwender, Clemens, additional, Subkovas, Eduardas, additional, Suryapranata, Harry, additional, Takahashi, Kuniaki, additional, Talwar, Suneel, additional, Teiger, Emmanuel, additional, Weele, Addy Ter, additional, Teurlings, Eva, additional, Thury, Attila, additional, Tijssen, Jan, additional, Tonev, Gincho, additional, Trendafilova‐Lazarova, Diana, additional, Tumscitz, Carlo, additional, Umans, Victor, additional, Ungi, Imre, additional, Valkov, Veselin, additional, van der Harst, Pim, additional, van Geuns, Robert Jan, additional, van Meijeren, Cokky, additional, Vassilev, Dobrin, additional, Velchev, Vasil, additional, Velthuizen, Esther, additional, Verheugt, Freek, additional, Vlcek, Natalia, additional, Dahl, Jürgen Vom, additional, Vrolix, Mathias, additional, Walsh, Simon, additional, Werner, Nikos, additional, Witsenburg, Maarten, additional, Zaman, Azfar, additional, Żmudka, Krzysztof, additional, Zrenner, Bernhard, additional, and Zweiker, Robert, additional

Published
2022
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3. A novel fiber-optic based 0.014 ' pressure wire: Designs of the OptoWire (TM), development phases, and the O-2 first-in-man results

Author

Ulacia Paola, Rimac Goran, Lalancette Sebastien, Belleville Claude, Mongrain Rosaire, Plante Sylvain, Ruzsa Zoltán, Matsuo Hitoshi, and Bertrand Olivier F.

Subjects
03.04.04. Bioanyagok (orvosi implantátumok, eszközök, szenzorok)
Abstract

Objectives To review the technical limitations of available pressure-wires, present the design evolution of a nitinol fiber-optic pressure wire and to summarize the First-in-Man (FIM) O-2 pilot study results. Background Despite increasing use of physiology assessment of coronary lesions, several technical limitations persist. We present technical details, design evolution and early clinical results with a novel 0.014 '' nitinol fiber-optic based pressure-wire. Methods and Results The 0.014' OptoWire (TM) (Opsens Medical, Quebec, Canada) was designed to combine improved handling properties compared to standard pressure-wires and to offer extremely reliable pressure recording and transmission due to fiber-optic properties compared to piezo-electric sensors and electrical wires. In vitro assessment showed that OptoWire (TM) steerability, pushability and torquability properties were closer to regular PCI wires than standard electrical pressure wires. In the First-in-Man O(2)study, 60 patients were recruited at 2 centers in Canada. A total of 103 lesions were assessed with the OptoWire (TM) and OptoMonitor (TM), 75 lesions at baseline and 28 lesions post-PCI (without disconnection). In all crossed lesions (n = 100, 97%), mean Pd/Pa and FFR could be adequately measured. In 11 cases assessed successively with OptoWire (TM) and Aegis (TM) (Abbott Vascular, USA) bland-Altman analysis showed a mean difference of 0.002 +/- 0.052 mmHg (p = .91) for Pd/Pa and 0.01 +/- 0.06 for FFR calculation (p= .45). There was no device-related complication. Upon these initial results, several design changes aimed to improve overall performance including torquability, stiffness, resistance to kink and pressure drift were completed. Conclusion The novel 0.014 '' fiber-optic OptoWire (TM) provides superior wire handling with reduced risk of pressure drift allowing reliable pre- and post-PCI physiology assessment.

Published
2022

4. Benefit and Risks of Aspirin in Addition to Ticagrelor in Acute Coronary Syndromes: A Post Hoc Analysis of the Randomized GLOBAL LEADERS Trial

Author

Tomaniak, Mariusz, Chichareon, Ply, Onuma, Yoshinobu, Deliargyris, Efthymios N., Takahashi, Kuniaki, Kogame, Norihiro, Modolo, Rodrigo, Chang, Chun Ching, Rademaker-Havinga, Tessa, Storey, Robert F., Dangas, George D., Bhatt, Deepak L., Angiolillo, Dominick J., Hamm, Christian, Valgimigli, Marco, Windecker, Stephan, Steg, Philippe Gabriel, Vranckx, Pascal, Serruys, Patrick W., Bertrand, Olivier F., Plante, Sylvain, Van Geuns, Robert-Jan, Hofma, Sjoerd H., Royaards, Kees-Jan, Slagboom, Ton, Suryapranata, Harry, Umans, Victor A. W. M., Rensing, Benno, van der Harst, Pim, Magro, Michael, Barbato, Emanuel, Aminian, Adel, Benit, Edouard, Janssens, Luc, Vrolix, Mathias, Buysschaert, Ian, Carrie, Didier, Barraud, Pascal, Teiger, Emmanuel, Koning, Ren, Farzin, Beygui, Morelle, Jean-francois, Isaaz, Karl, Maillard, Luc, Abdellaoui, Mohamed, Brunel, Philippe, Angioi, Michael, Lantelme, Pierre, Sabate, Manel, Albarran Gonzalez-Trevilla, Agustin, Cardiology, Graduate School, ACS - Atherosclerosis & ischemic syndromes, ACS - Microcirculation, ACS - Heart failure & arrhythmias, and Cardiovascular Centre (CVC)

Subjects
Male, Ticagrelor, Internationality, Time Factors, medicine.medical_treatment, 030204 cardiovascular system & hematology, Severity of Illness Index, Tertiary Care Centers, Coronary artery disease, 0302 clinical medicine, Cause of Death, 030212 general & internal medicine, 610 Medicine & health, Original Investigation, Aspirin, DUAL ANTIPLATELET THERAPY, Continuity of Patient Care, Clopidogrel, Treatment Outcome, CLOPIDOGREL, Platelet aggregation inhibitor, Drug Therapy, Combination, Female, Cardiology and Cardiovascular Medicine, INTERVENTION, medicine.drug, Acute coronary syndrome, medicine.medical_specialty, Hemorrhage, Risk Assessment, Drug Administration Schedule, 03 medical and health sciences, Percutaneous Coronary Intervention, Internal medicine, medicine, Humans, Acute Coronary Syndrome, Dose-Response Relationship, Drug, RECEPTOR, business.industry, Percutaneous coronary intervention, IN-VITRO, medicine.disease, Survival Analysis, PLATO, Conventional PCI, business, Platelet Aggregation Inhibitors, Follow-Up Studies
Abstract

Key PointsQuestionWhat are the benefits and risks of continuing aspirin in addition to P2Y12 receptor inhibition with ticagrelor among patients with acute coronary syndrome between 1 month and 12 months after percutaneous coronary intervention? FindingsIn this nonprespecified, post hoc analysis of the GLOBAL LEADERS randomized clinical trial, beyond 1 month after percutaneous coronary intervention in acute coronary syndrome, aspirin was associated with increased bleeding risk and appeared not to add to the benefit of ticagrelor on ischemic events. MeaningThe findings of this hypothesis-generating analysis pave the way for further trials evaluating aspirin-free antiplatelet strategies after percutaneous coronary intervention.ImportanceThe role of aspirin as part of antiplatelet regimens in acute coronary syndromes (ACS) needs to be clarified in the context of newer potent P2Y12 antagonists. ObjectiveTo evaluate the benefit and risks of aspirin in addition to ticagrelor among patients with ACS beyond 1 month after percutaneous coronary intervention (PCI). Design, Setting, and ParticipantsThis is a nonprespecified, post hoc analysis of GLOBAL LEADERS, a randomized, open-label superiority trial comparing 2 antiplatelet treatment strategies after PCI. The trial included 130 secondary/tertiary care hospitals in different countries, with 15991 unselected patients with stable coronary artery disease or ACS undergoing PCI. Patients had outpatient visits at 1, 3, 6, 12, 18, and 24 months after index procedure. InterventionsThe experimental group received aspirin plus ticagrelor for 1 month followed by 23-month ticagrelor monotherapy; the reference group received aspirin plus either clopidogrel (stable coronary artery disease) or ticagrelor (ACS) for 12 months, followed by 12-month aspirin monotherapy. In this analysis, we examined the clinical outcomes occurring between 31 days and 365 days after randomization, specifically in patients with ACS who, within this time frame, were assigned to receive either ticagrelor alone or ticagrelor and aspirin. Main Outcomes and MeasuresThe primary outcome was the composite of all-cause death or new Q-wave myocardial infarction. ResultsOf 15968 participants, there were 7487 patients with ACS enrolled; 3750 patients were assigned to the experimental group and 3737 patients to the reference group. Between 31 and 365 days after randomization, the primary outcome occurred in 55 patients (1.5%) in the experimental group and in 75 patients (2.0%) in the reference group (hazard ratio [HR], 0.73; 95% CI, 0.51-1.03; P=.07); investigator-reported Bleeding Academic Research Consortium-defined bleeding type 3 or 5 occurred in 28 patients (0.8%) in the experimental group and in 54 patients (1.5%) in the reference arm (HR, 0.52; 95% CI, 0.33-0.81; P=.004). Conclusions and RelevanceBetween 1 month and 12 months after PCI in ACS, aspirin was associated with increased bleeding risk and appeared not to add to the benefit of ticagrelor on ischemic events. These findings should be interpreted as exploratory and hypothesis generating; however, they pave the way for further trials evaluating aspirin-free antiplatelet strategies after PCI. Trial RegistrationClinicalTrials.gov identifier: NCT01813435.This secondary analysis of the GLOBAL LEADERS randomized clinical trial evaluates the benefit and risks of aspirin in addition to ticagrelor among patients with acute coronary syndrome beyond 1 month after percutaneous coronary intervention.

Published
2019

13. Acute complications of percutaneous transluminal coronary angioplasty for total occlusion

Author

Plante, Sylvain, Laarman, GertJan, De Feyter, Pim J., Samson, Michel, Rensing, Benno J., Umans, Victor, Supyapranta, Harry, Van den Brand, Marcel, and Serruys, Patrick W.

Subjects
Arterial occlusions -- Complications, Angina pectoris -- Care and treatment, Transluminal angioplasty -- Risk factors, Arterial occlusions -- Care and treatment, Health
Abstract

Percutaneous transluminal coronary angioplasty (PTCA), a therapeutic technique that uses balloon dilation to open up narrow sections of diseased coronary arteries, can be an alternative to coronary artery bypass surgery (CABG). A retrospective study of the medical records of 90 patients who underwent PTCA for a totally occluded artery was performed to evaluate the frequency of major complications due to PTCA. None of the occlusions were considered to be a complication of heart attack or restenosis. After further review, the 90 patients were subdivided into a stable angina (44 patients) or an unstable angina group (46 patients). Angina (pectoris) is a steady, severe pain with a feeling of pressure in region of the heart; the pain usually travels to the left shoulder down the left arm. It is caused by insufficient blood supply to the heart. For this study, unstable angina was categorized as progressive angina, angina at rest, or early angina after infarction. The two groups averaged 56 years of age and the majority of subjects were men. The occurrence of major complications such as embolization, reocclusion during PTCA, coronary intimal dissection, and occlusion of the side arteries was more frequent in patients with unstable angina (about 20 percent) than for those with stable angina (2.5 percent). The only significantly different observation was reocclusion during PTCA, which only happened in unstable angina patients (17 percent). Limitations of this study include the fact that (1) a relatively low number of patients were evaluated; (2) the age of the occlusion may not correlate with duration of patients symptoms, and (3) the sensitivity of angioplasty may be low compared with angioscopy and histopathology observations, making it possible that the frequency of blood clots were underestimated. PTCA is regarded as a safe and effective procedure to treat a totally occluded coronary artery, but this study suggests that patients with unstable angina represent a high-risk subgroup who might be better off with a different treatment approach such as thrombolytic therapy. (Consumer Summary produced by Reliance Medical Information, Inc.)

Published
1991

14. PTCA of chronically occluded coronary arteries

Author

Laarman, GertJan, Plante, Sylvain, and de Feyter, Pim J.

Subjects
Balloon dilatation -- Evaluation, Arterial occlusions, Transluminal angioplasty -- Statistics, Health
Abstract

At first glance it might seem that a completely blocked coronary artery must lead to the death and necrosis of the area of heart muscle supplied by that artery. But this is not necessarily the case, as there is some degree of overlap of coronary circulation. If the area supplied by the blocked artery is not large, the tissue oxygen demand may be satisfied by a collateral artery. However, under conditions of increased oxygen demand, this partial blood supply may no longer be adequate, and symptoms of ischemia (inadequate oxygen supply) may develop. PTCA, or percutaneous transluminal coronary angioplasty, may be used to open totally occluded arteries as well as those only partially blocked. PTCA has a success rate over 90 percent in partially occluded arteries; the success rate is roughly 60 percent for totally occluded arteries. The duration of time in which the occlusion has existed is a major determinant of PTCA success, and the chances of success are substantially reduced if the occlusion is older than two months. The length of the occluded segment is also significant; a 78 percent success rate has been reported for segments less than 1.5 centimeters, but it falls to 42 percent for longer segments. In addition, occlusions in straight segments are more amenable to PTCA than are those in curved segments. Although there are serious potential complications of PTCA for totally occluded arteries, there is no evidence that they are any worse than the complications of PTCA for partially occluded arteries. However, restenosis, or recurrence of arterial narrowing after PTCA, is more frequent among totally occluded arteries, occurring roughly 40 percent of the time, in contrast to a restenosis rate of 30 percent for partially occluded arteries treated by PTCA. (Consumer Summary produced by Reliance Medical Information, Inc.)

Published
1990

15. LONG-TERM SAFETY OF TICAGRELOR MONOTHERAPY IN PATIENTS UNDERGOING PCI FOR STABLE CORONARY ARTERY DISEASE IN THE GLOBAL LEADERS STUDY: IMPACT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE

Author

Tomaniak, Mariusz, primary, Chichareon, Ply, additional, Takahashi, Kuniaki, additional, Kogame, Norihiro, additional, Modolo, Rodrigo, additional, Chang, Chun Chin, additional, Katagiri, Yuki, additional, Cano, Ernest Spitzer, additional, Neumann, Franz-Joseph, additional, Plante, Sylvain, additional, Antolin, Rosana Hernandez, additional, Gelev, Valeri, additional, Brunel, Philippe, additional, Beygui, Farzin, additional, Filipiak, Krzysztof, additional, van Geuns, Robert, additional, Hamm, Christian, additional, Storey, Robert, additional, Soliman, Osama, additional, Onuma, Yoshinobu, additional, Vranckx, Pascal, additional, Windecker, Stephan, additional, Valgimigli, Marco, additional, and Serruys, Patrick, additional

Published
2019
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16. Ticagrelor plus aspirin for 1 month, followed by ticagrelor monotherapy for 23 months vs aspirin plus clopidogrel or ticagrelor for 12 months, followed by aspirin monotherapy for 12 months after implantation of a drug-eluting stent: a multicentre, open-label, randomised superiority trial

Author

Vranckx, Pascal, primary, Valgimigli, Marco, additional, Jüni, Peter, additional, Hamm, Christian, additional, Steg, Philippe Gabriel, additional, Heg, Dik, additional, van Es, Gerrit Anne, additional, McFadden, Eugene P, additional, Onuma, Yoshinobu, additional, van Meijeren, Cokky, additional, Chichareon, Ply, additional, Benit, Edouard, additional, Möllmann, Helge, additional, Janssens, Luc, additional, Ferrario, Maurizio, additional, Moschovitis, Aris, additional, Zurakowski, Aleksander, additional, Dominici, Marcello, additional, Van Geuns, Robert Jan, additional, Huber, Kurt, additional, Slagboom, Ton, additional, Serruys, Patrick W, additional, Windecker, Stephan, additional, Abdellaoui, Mohamed, additional, Adlam, David, additional, Akin, Ibrahim, additional, Albarran Gonzalez-Trevilla, Agustin, additional, Almeida, Manuel, additional, Alves Lemos Neto, Pedro, additional, Aminian, Adel, additional, Anderson, Richard, additional, Andreae, Rick, additional, Angioi, Michael, additional, Asano, Taku, additional, Barbato, Emanuele, additional, Barlis, Peter, additional, Barraud, Pascal, additional, Bertrand, Olivier, additional, Beygui, Farzin, additional, Bolognese, Leonardo, additional, Botelho, Roberto, additional, Bouwman, Coby, additional, Bressers, Marco, additional, Brunel, Philippe, additional, Buszman, Pawel, additional, Buysschaert, Ian, additional, Canas da Silva, Pedro, additional, Carrie, Didier, additional, Cequier, Angel, additional, Chin Chang, Chun, additional, Chowdhary, Saqib, additional, Collet, Carlos, additional, Colombo, Antonio, additional, Cotton, James, additional, Cruz Ferreira, Rui, additional, Curello, Salvatore, additional, Curzen, Nick, additional, de Bot, Judith, additional, de Vreede, Tone, additional, Delle Karth, Georg, additional, Dijksma, Lynn, additional, Édes, István, additional, Eeckhout, Eric, additional, Eitel, Ingo, additional, Faluközy, József, additional, Fath-Ordoubadi, Farzin, additional, Fontos, Geza, additional, Francisco Diaz, Jose, additional, Freitas Quintella, Edgard, additional, Frey, Bernhard, additional, Friedrich, Guy, additional, Galasko, Gavin, additional, Galuszka, Grzegorz, additional, Gama Ribeiro, Vasco, additional, Garg, Scot, additional, Gargiulo, Giuseppe, additional, Geisler, Tobias, additional, Gelev, Valeri, additional, Ghandilyan, Art, additional, Goicolea, Javier, additional, Gori, Tommaso, additional, Gragnano, Felice, additional, Guimarães, Ana, additional, Haude, Michael, additional, Heijke, Pieter, additional, Hernández Antolin, Rosa Ana, additional, Hildick-Smith, David, additional, Hillen, Dorien, additional, Hoekman, Ina, additional, Hofma, Sjoerd, additional, Holmvang, Lene, additional, Hoole, Stephen, additional, Horváth, Iván, additional, Hugense, Annemarie, additional, Ibrahim, Karim, additional, Iñiguez, Andres, additional, Isaaz, Karl, additional, Jambrik, Zoltán, additional, Jasionowicz, Pawel, additional, Jonk, Judith, additional, Jung, Werner, additional, Katagiri, Yuki, additional, Kogame, Norihiro, additional, Koh, Tian Hai, additional, Koning, René, additional, Konteva, Mariana, additional, Kőszegi, Zsolt, additional, Krackhardt, Florian, additional, Kreuger, Yvonne, additional, Kukreja, Neville, additional, Ladan, Boudijn, additional, Lantelme, Pierre, additional, Leandro, Sergio, additional, Leibundgut, Gregor, additional, Liebetrau, Christoph, additional, Lindeboom, Wietze, additional, Macaya Miguel, Carlos, additional, Mach, François, additional, Magro, Michael, additional, Maillard, Luc, additional, Manavifar, Negar, additional, Mauri, Laura, additional, McFadden, Eugene, additional, Merkely, Bela, additional, Miyazaki, Yosuke, additional, Młodziankowski, Adam, additional, Moccetti, Tiziano, additional, Modolo, Rodrigo, additional, Möllman, Helge, additional, Morelle, Jean-François, additional, Munndt Ottesen, Michael, additional, Muurling, Martin, additional, Naber, Christoph Kurt, additional, Neumann, Franz-Josef, additional, Oldroyd, Keith, additional, Ong, Paul, additional, Palsrok, Sanne, additional, Petrov, Ivo, additional, Plante, Sylvain, additional, Prokopczuk, Janusz, additional, Rademaker-Havinga, Tessa, additional, Raffel, Christopher, additional, Rensing, Benno, additional, Roffi, Marco, additional, Royaards, Kees-Jan, additional, Sabate, Manel, additional, Schächinger, Volker, additional, Seidler, Tim, additional, Serra Peñaranda, Antonio, additional, Serruys, Patrick, additional, Sikarulidze, Lali, additional, Soliman, Osama I, additional, Sousa, Amanda, additional, Spitzer, Ernest, additional, Stables, Rod, additional, Steg, Gabriel, additional, Steinwender, Clemens, additional, Subkovas, Eduardas, additional, Suryapranata, Harry, additional, Takahashi, Kuniaki, additional, Talwar, Suneel, additional, Teiger, Emmanuel, additional, ter Weele, Addy, additional, Teurlings, Eva, additional, Thury, Attila, additional, Tijssen, Jan, additional, Tonev, Gincho, additional, Trendafilova-Lazarova, Diana, additional, Tumscitz, Carlo, additional, Umans, Victor, additional, Ungi, Imre, additional, Valkov, Veselin, additional, van der Harst, Pim, additional, van Geuns, Robert Jan, additional, Vassilev, Dobrin, additional, Velchev, Vasil, additional, Velthuizen, Esther, additional, Verheugt, Freek, additional, Vlcek, Natalia, additional, vom Dahl, Jürgen, additional, Vrolix, Mathias, additional, Walsh, Simon, additional, Werner, Nikos, additional, Witsenburg, Maarten, additional, Zaman, Azfar, additional, Żmudka, Krzysztof, additional, Zrenner, Bernhard, additional, and Zweiker, Robert, additional

Published
2018
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17. Ticagrelor plus aspirin for 1 month, followed by ticagrelor monotherapy for 23 months vsaspirin plus clopidogrel or ticagrelor for 12 months, followed by aspirin monotherapy for 12 months after implantation of a drug-eluting stent: a multicentre, open-label, randomised superiority trial

Author

Vranckx, Pascal, Valgimigli, Marco, Jüni, Peter, Hamm, Christian, Steg, Philippe Gabriel, Heg, Dik, van Es, Gerrit Anne, McFadden, Eugene P, Onuma, Yoshinobu, van Meijeren, Cokky, Chichareon, Ply, Benit, Edouard, Möllmann, Helge, Janssens, Luc, Ferrario, Maurizio, Moschovitis, Aris, Zurakowski, Aleksander, Dominici, Marcello, Van Geuns, Robert Jan, Huber, Kurt, Slagboom, Ton, Serruys, Patrick W, Windecker, Stephan, Abdellaoui, Mohamed, Adlam, David, Akin, Ibrahim, Albarran Gonzalez-Trevilla, Agustin, Almeida, Manuel, Alves Lemos Neto, Pedro, Aminian, Adel, Anderson, Richard, Andreae, Rick, Angioi, Michael, Asano, Taku, Barbato, Emanuele, Barlis, Peter, Barraud, Pascal, Benit, Edouard, Bertrand, Olivier, Beygui, Farzin, Bolognese, Leonardo, Botelho, Roberto, Bouwman, Coby, Bressers, Marco, Brunel, Philippe, Buszman, Pawel, Buysschaert, Ian, Canas da Silva, Pedro, Carrie, Didier, Cequier, Angel, Chichareon, Ply, Chin Chang, Chun, Chowdhary, Saqib, Collet, Carlos, Colombo, Antonio, Cotton, James, Cruz Ferreira, Rui, Curello, Salvatore, Curzen, Nick, de Bot, Judith, de Vreede, Tone, Delle Karth, Georg, Dijksma, Lynn, Dominici, Marcello, Édes, István, Eeckhout, Eric, Eitel, Ingo, Faluközy, József, Fath-Ordoubadi, Farzin, Ferrario, Maurizio, Fontos, Geza, Francisco Diaz, Jose, Freitas Quintella, Edgard, Frey, Bernhard, Friedrich, Guy, Galasko, Gavin, Galuszka, Grzegorz, Gama Ribeiro, Vasco, Garg, Scot, Gargiulo, Giuseppe, Geisler, Tobias, Gelev, Valeri, Ghandilyan, Art, Goicolea, Javier, Gori, Tommaso, Gragnano, Felice, Guimarães, Ana, Hamm, Christian, Haude, Michael, Heg, Dik, Heijke, Pieter, Hernández Antolin, Rosa Ana, Hildick-Smith, David, Hillen, Dorien, Hoekman, Ina, Hofma, Sjoerd, Holmvang, Lene, Hoole, Stephen, Horváth, Iván, Huber, Kurt, Hugense, Annemarie, Ibrahim, Karim, Iñiguez, Andres, Isaaz, Karl, Jambrik, Zoltán, Janssens, Luc, Jasionowicz, Pawel, Jonk, Judith, Jung, Werner, Jüni, Peter, Katagiri, Yuki, Kogame, Norihiro, Koh, Tian Hai, Koning, René, Konteva, Mariana, Kőszegi, Zsolt, Krackhardt, Florian, Kreuger, Yvonne, Kukreja, Neville, Ladan, Boudijn, Lantelme, Pierre, Leandro, Sergio, Leibundgut, Gregor, Liebetrau, Christoph, Lindeboom, Wietze, Macaya Miguel, Carlos, Mach, François, Magro, Michael, Maillard, Luc, Manavifar, Negar, Mauri, Laura, McFadden, Eugene, Merkely, Bela, Miyazaki, Yosuke, Młodziankowski, Adam, Moccetti, Tiziano, Modolo, Rodrigo, Möllman, Helge, Morelle, Jean-François, Moschovitis, Aris, Munndt Ottesen, Michael, Muurling, Martin, Naber, Christoph Kurt, Neumann, Franz-Josef, Oldroyd, Keith, Ong, Paul, Onuma, Yoshinobu, Palsrok, Sanne, Petrov, Ivo, Plante, Sylvain, Prokopczuk, Janusz, Rademaker-Havinga, Tessa, Raffel, Christopher, Rensing, Benno, Roffi, Marco, Royaards, Kees-Jan, Sabate, Manel, Schächinger, Volker, Seidler, Tim, Serra Peñaranda, Antonio, Serruys, Patrick, Sikarulidze, Lali, Slagboom, Ton, Soliman, Osama I, Sousa, Amanda, Spitzer, Ernest, Stables, Rod, Steg, Gabriel, Steinwender, Clemens, Subkovas, Eduardas, Suryapranata, Harry, Takahashi, Kuniaki, Talwar, Suneel, Teiger, Emmanuel, ter Weele, Addy, Teurlings, Eva, Thury, Attila, Tijssen, Jan, Tonev, Gincho, Trendafilova-Lazarova, Diana, Tumscitz, Carlo, Umans, Victor, Ungi, Imre, Valkov, Veselin, van der Harst, Pim, van Geuns, Robert Jan, van Meijeren, Cokky, Vassilev, Dobrin, Velchev, Vasil, Velthuizen, Esther, Verheugt, Freek, Vlcek, Natalia, vom Dahl, Jürgen, Vrolix, Mathias, Walsh, Simon, Werner, Nikos, Windecker, Stephan, Witsenburg, Maarten, Zaman, Azfar, Żmudka, Krzysztof, Zrenner, Bernhard, Zurakowski, Aleksander, and Zweiker, Robert

Abstract

We hypothesised that ticagrelor, in combination with aspirin for 1 month, followed by ticagrelor alone, improves outcomes after percutaneous coronary intervention compared with standard antiplatelet regimens.

Published
2018
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20. Response to Letter Regarding Article, “The sPLA 2 Inhibition to Decrease Enzyme Release After Percutaneous Coronary Intervention (SPIDER-PCI) Trial”

Author

Džavík, Vladimír, primary, Lavi, Shahar, additional, Thorpe, Kevin, additional, Yip, Paul M., additional, Plante, Sylvain, additional, Ing, Douglas, additional, Overgaard, Christopher B., additional, Osten, Mark D., additional, Lan, Julie, additional, Robbins, Kim, additional, Miner, Steve, additional, Horlick, Eric, additional, and Cantor, Warren J., additional

Published
2011
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21. The sPLA 2 Inhibition to Decrease Enzyme Release After Percutaneous Coronary Intervention (SPIDER-PCI) Trial

Author

Džavík, Vladimír, primary, Lavi, Shahar, additional, Thorpe, Kevin, additional, Yip, Paul M., additional, Plante, Sylvain, additional, Ing, Douglas, additional, Overgaard, Christopher B., additional, Osten, Mark D., additional, Lan, Julie, additional, Robbins, Kim, additional, Miner, Steven E., additional, Horlick, Eric M., additional, and Cantor, Warren J., additional

Published
2010
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22. THE SPLA2 INHIBITION TO DECREASE ENZYME RELEASE AFTER PERCUTANEOUS CORONARY INTERVENTION (SPIDER-PCI) TRIAL.

Author

Dzavik, Vladimir, primary, Cantor, Warren J., additional, Overgaard, Christopher B., additional, Thorpe, Kevin E., additional, Lavi, Shahar, additional, Lan, Julie, additional, Horlick, Eric, additional, Ross, John R., additional, Daly, Paul, additional, Barolet, Alan, additional, Ing, Douglas, additional, Plante, Sylvain, additional, Robbins, Kim, additional, Goldman, Lorne, additional, Harsdorf, Rudiger von, additional, Atchison, Deborah, additional, Schwartz, Leonard, additional, and Seidelin, Peter H., additional

Published
2010
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33. Myocardial infarction patients in the 1990s—their risk factors, stratification and survival in Canada: The Canadian assessment of myocardial infarction (CAMI) study

Author

Rouleau, Jean L., primary, Talajic, Mario, additional, Sussex, Bruce, additional, Potvin, Louise, additional, Warnica, Wayne, additional, Davies, Richard F., additional, Gardner, Martin, additional, Stewart, Duncan, additional, Plante, Sylvain, additional, Dupuis, Robert, additional, Lauzon, Claude, additional, Ferguson, John, additional, Mikes, Etel, additional, Balnozan, Vidoslav, additional, and Savard, Pierre, additional

Published
1996
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40. Does Hormonal Status Influence the Clinical Presentation of Acute Coronary Syndromes in Women?

Author

Méthot, Julie, Hamelin, Bettina A., Bogaty, Peter, Arsenault, Marie, Plante, Sylvain, and Poirier, Paul

Subjects
HORMONE therapy for menopause, CORONARY disease, ENDOCRINE diseases, SYMPTOMS, HORMONE therapy, MEDICAL care
Abstract

Background: Previous studies suggest that the clinical presentation of acute coronary syndromes (ACS) may differ between women and men. It is not known if different clinical presentations may be explained by hormonal status in women with ACS. Our objective was to compare the clinical presentation of ACS between premenopausal (PRE) women and post- menopausal women with hormone replacement therapy (HRT) and without (POST). Methods: This was a prospective study of consecutive women admitted with a diagnosis of ACS (myocardial infarction [MI] or unstable angina). All women answered a detailed questionnaire that included a list of 27 clinical symptoms. Symptom results were adjusted for age and current coronary event diagnosis. Results: Seventy-three Caucasian women were studied. No differences were found in terms of the frequency of reported typical symptoms of ACS between PRE (n = 23), HRT (n = 32), and POST (n = 18). However, PRE more often reported atypical chest symptoms than HRT and POST women (57% vs. 31% vs. 22%, PRE vs. HRT vs. POST, respectively, p = 0.05). HRT and POST women experienced substernal chest pain more frequently than PRE (44% vs. 78% vs. 83%, p = 0.03). In contrast, PRE more frequently tended to experience chest pressure (57% vs. 31% vs. 39%, p = 0.2) or chest pain in other locations (22% vs. 3% vs. 6%, p = 0.06). HRT and POST groups reported more frequent indigestion-like pain/discomfort (22% vs. 50% vs. 56%, p = 0.04) and midback pain (35% vs. 63% vs. 72%, p = 0.04) during ACS compared with PRE women. POST experienced sudden fatigue more frequently than PRE and HRT (61% vs. 53% vs. 89%,p = 0.03). Conclusions: Our results suggest that almost all women admitted with ACS experienced typical chest symptoms but frequently reported both typical and atypical symptoms. Independently of age, atypical chest symptoms occurred more frequently in premenopausal women than in postmenopausal women with or without HRT. [ABSTRACT FROM AUTHOR]

Published
2004

41. Attenuation of myocardial ischemia with repeated exercise in subjects with chronic stable angina Relation to myocardial contractility, intensity of exercise and the adenosine triphosphate–sensitive potassium channel

Author

Bogaty, Peter, Kingma, John G, Robitaille, N-Michelle, Plante, Sylvain, Simard, Serge, Charbonneau, Lyne, and Dumesnil, Jean G

Abstract

Objectives. This study characterized the attenuation of myocardial ischemia observed with re-exercise to determine whether: 1) a differing exercise intensity modifies this attenuation; 2) it could be explained by contractile down-regulation or stunning; 3) it is mediated by activation of ATP-sensitive potassium channels (K+-ATP).Background. Subjects with ischemic heart disease (IHD) frequently note less angina with re-exercise after a brief rest. Potential mechanisms of this ‘warm-up’ phenomenon have been little explored.Methods. IHD subjects with a positive exercise test were studied. Groups I and II (12 subjects each) underwent 2 successive Naughton protocol exercise echocardiography tests (with 1 min instead of 2 min stages for Group II). Group D (10 subjects) had type II diabetes, were on ≥10 mg daily of the K+-ATP blocker, glibenclamide, and underwent the group I exercise protocol. The ischemic threshold or rate-pressure product at 1 mm ST segment depression, ST depression corresponding to the peak rate-pressure product of the first exercise (maximum ST depression equivalent), and left ventricular wall motion indexes before and immediately after each exercise were analyzed.Results. Exercise-induced myocardial ischemia with re-exercise was similarly attenuated in groups I, II, and D. The ischemic threshold was raised by nearly 20% with re-exercise (p = 0.001, p = 0.02, and p = 0.02, respectively) and the maximum ST depression equivalent was nearly halved on re-exercise (p = 0.005, p = 0.006, and p = 0.001, respectively). Exercise-induced wall motion dysfunction was attenuated with re-exercise. In group I, wall motion returned to the initial baseline score prior to exercise 2, whereas in the more intense protocol of group II, wall motion dysfunction persisted prior to exercise 2.Conclusions. Thus, the attenuation of myocardial ischemia observed with re-exercise appears to be independent of the intensity of the exercise protocol and is not explained by down-regulation of myocardial contractility induced by the initial ischemic stimulus. Since results were similar in diabetic subjects on robust doses of glibenclamide, this phenomenon does not appear to be mediated by K+-ATP activation.

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42. THE SPLA2 INHIBITION TO DECREASE ENZYME RELEASE AFTER PERCUTANEOUS CORONARY INTERVENTION (SPIDER-PCI) TRIAL

Author

Dzavik, Vladimir, Cantor, Warren J., Overgaard, Christopher B., Thorpe, Kevin E., Lavi, Shahar, Lan, Julie, Horlick, Eric, Ross, John R., Daly, Paul, Barolet, Alan, Ing, Douglas, Plante, Sylvain, Robbins, Kim, Goldman, Lorne, Harsdorf, Rudiger von, Atchison, Deborah, Schwartz, Leonard, and Seidelin, Peter H.

Subjects
Cardiology and Cardiovascular Medicine
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44. A novel fiber-optic based 0.014″ pressure wire: Designs of the OptoWire™, development phases, and the O 2 first-in-man results.

Author

Ulacia P, Rimac G, Lalancette S, Belleville C, Mongrain R, Plante S, Rusza Z, Matsuo H, and Bertrand OF

Abstract

Objectives: To review the technical limitations of available pressure-wires, present the design evolution of a nitinol fiber-optic pressure wire and to summarize the First-in-Man (FIM) O 2 pilot study results., Background: Despite increasing use of physiology assessment of coronary lesions, several technical limitations persist. We present technical details, design evolution and early clinical results with a novel 0.014" nitinol fiber-optic based pressure-wire., Methods and Results: The 0.014' OptoWire™ (Opsens Medical, Quebec, Canada) was designed to combine improved handling properties compared to standard pressure-wires and to offer extremely reliable pressure recording and transmission due to fiber-optic properties compared to piezo-electric sensors and electrical wires. In vitro assessment showed that OptoWire™ steerability, pushability and torquability properties were closer to regular PCI wires than standard electrical pressure wires. In the First-in-Man O 2 study, 60 patients were recruited at 2 centers in Canada. A total of 103 lesions were assessed with the OptoWire™ and OptoMonitor™, 75 lesions at baseline and 28 lesions post-PCI (without disconnection). In all crossed lesions (n = 100, 97%), mean Pd/Pa and FFR could be adequately measured. In 11 cases assessed successively with OptoWire™ and Aegis™ (Abbott Vascular, USA) bland-Altman analysis showed a mean difference of 0.002 ± 0.052 mmHg (p = .91) for Pd/Pa and 0.01 ± 0.06 for FFR calculation (p = .45). There was no device-related complication. Upon these initial results, several design changes aimed to improve overall performance including torquability, stiffness, resistance to kink and pressure drift were completed., Conclusion: The novel 0.014" fiber-optic OptoWire™ provides superior wire handling with reduced risk of pressure drift allowing reliable pre- and post-PCI physiology assessment., (© 2020 Wiley Periodicals LLC.)

Published
2020
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45. Impact of chronic obstructive pulmonary disease and dyspnoea on clinical outcomes in ticagrelor treated patients undergoing percutaneous coronary intervention in the randomized GLOBAL LEADERS trial.

Author

Tomaniak M, Chichareon P, Takahashi K, Kogame N, Modolo R, Chang CC, Spitzer E, Neumann FJ, Plante S, Hernández Antolin R, Jambrik Z, Gelev V, Brunel P, Konteva M, Beygui F, Morelle JF, Filipiak KJ, van Geuns RJ, Soliman O, Tijssen J, Rademaker-Havinga T, Storey RF, Hamm C, Steg PG, Windecker S, Onuma Y, Valgimigli M, and Serruys PW

Subjects
Aged, Coronary Artery Disease diagnosis, Coronary Artery Disease mortality, Drug Administration Schedule, Dual Anti-Platelet Therapy, Dyspnea chemically induced, Dyspnea diagnosis, Dyspnea mortality, Female, Humans, Incidence, Male, Middle Aged, Platelet Aggregation Inhibitors adverse effects, Prospective Studies, Pulmonary Disease, Chronic Obstructive diagnosis, Pulmonary Disease, Chronic Obstructive mortality, Risk Assessment, Risk Factors, Ticagrelor adverse effects, Time Factors, Treatment Outcome, Coronary Artery Disease therapy, Dyspnea epidemiology, Percutaneous Coronary Intervention adverse effects, Percutaneous Coronary Intervention mortality, Platelet Aggregation Inhibitors administration & dosage, Pulmonary Disease, Chronic Obstructive epidemiology, Ticagrelor administration & dosage
Abstract

Aims: To evaluate long-term safety and efficacy of ticagrelor monotherapy in patients undergoing percutaneous coronary interventions (PCIs) in relation to chronic obstructive pulmonary disease (COPD) at baseline and the occurrence of dyspnoea reported as adverse event (AE) that may lead to treatment non-adherence., Methods and Results: This is a non-prespecified, post hoc analysis of the randomized GLOBAL LEADERS trial (n = 15 991), comparing the experimental strategy of 23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT) after PCI with the reference strategy of 12-month DAPT followed by 12-month aspirin monotherapy. Impact of COPD and dyspnoea AE (as a time-dependent covariate) on clinical outcomes was evaluated up to 2 years. The primary endpoint was a 2-year all-cause mortality or non-fatal, centrally adjudicated, new Q-wave myocardial infarction. The presence of COPD (n = 832) was the strongest clinical predictor of 2-year all-cause mortality after PCI [hazard ratio (HR) 2.84; 95% confidence interval (CI) 2.21-3.66; P adjusted = 0.001] in this cohort (n = 15 991). No differential treatment effects on 2-year clinical outcomes were found in patients with and without COPD (primary endpoint: HR 0.88; 95% CI 0.58-1.35; P = 0.562; P int = 0.952). Overall, at 2 years dyspnoea was reported as an AE in 2101 patients, more frequently among COPD patients, irrespective of treatment allocation (27.2% in experimental arm vs. 14.5% in reference arm, P = 0.001). Its occurrence was not associated with a higher rate of the primary endpoint (P adjusted = 0.640) in the experimental vs. the reference arm., Conclusion: In this exploratory analysis, COPD negatively impacted long-term prognosis after PCI. Despite higher incidence of dyspnoea in the experimental arm, in particular among COPD patients, the safety of the experimental treatment strategy appeared not to be affected., Clinical Trial Registration Unique Identifier: NCT01813435., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissions@oup.com.)

Published
2020
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46. The sPLA2 Inhibition to Decrease Enzyme Release after Percutaneous Coronary Intervention (SPIDER-PCI) trial.

Author

Džavík V, Lavi S, Thorpe K, Yip PM, Plante S, Ing D, Overgaard CB, Osten MD, Lan J, Robbins K, Miner SE, Horlick EM, and Cantor WJ

Subjects
Acetates pharmacology, Acute Coronary Syndrome blood, Acute Coronary Syndrome drug therapy, Aged, Biomarkers blood, Enzyme Inhibitors pharmacology, Enzyme Inhibitors therapeutic use, Female, Humans, Indoles pharmacology, Keto Acids, Male, Middle Aged, Phospholipases A2, Secretory blood, Acetates therapeutic use, Acute Coronary Syndrome enzymology, Angioplasty adverse effects, Indoles therapeutic use, Phospholipases A2, Secretory antagonists & inhibitors, Phospholipases A2, Secretory metabolism
Abstract

Background: Secretory phospholipase A(2) (sPLA(2)) may play a role in myonecrosis after elective percutaneous coronary intervention (PCI). Inhibition of this enzyme may have a beneficial effect. The central hypothesis of this study was that treatment with varespladib, a small-molecule inhibitor of sPLA(2) would reduce postprocedural release of cardiac biomarkers after elective percutaneous coronary intervention., Methods and Results: Between October 2007 and June 2009, 144 stable patients were randomized in a phase II trial to receive varespladib 500 mg PO BID or placebo 3 to 5 days before and for 5 days after elective percutaneous coronary intervention. The primary end point was elevation of troponin I or creatine kinase-MB above the upper limit of normal at 6 to 8 or 18 to 24 hours after percutaneous coronary intervention. Mean age was 63±10 and 64±10 years, with 38% and 42% with diabetes mellitus and 29% and 28% with prior myocardial infarction for the varespladib and placebo groups, respectively. The primary end point occurred in 75% of varespladib and 63% of placebo patients (P=0.14). Troponin I 3 times the upper limit of normal was observed in 57% and 50% (P=0.39) and creatine kinase-MB 2 times the upper limit of normal in 14% and 3% (P=0.018). Median (first and third quartiles) change in high-sensitivity C-reactive protein in these 2 groups was 0.65 mg/L (-0.18 and 1.48) and 0.70 mg/L (0.00 and 1.50) at 18 to 24 hours (P=0.81) and 0.20 mg/L (-0.70 and 1.40) and 0.60 mg/L (-0.12 and 1.72) at 3 to 5 days (P=0.23), whereas change in sPLA(2) activity at 3 to 5 days in a subset was -2.85 ng/ml (-3.40 and -1.85) and 0.25 ng/ml (-0.20 and 0.85) (P<0.001)., Conclusions: Inhibition of sPLA(2) by varespladib administered for 3 to 5 days before the procedure does not reduce periprocedural myonecrosis associated with elective percutaneous coronary intervention., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00533039.

Published
2010
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47. Effects of long term cholesterol lowering on coronary atherosclerosis in patient risk factor subgroups: the Simvastatin/enalapril Coronary Atherosclerosis Trial (SCAT).

Author

Burton JR, Teo KK, Buller CE, Plante S, Catellier D, Tymchak W, Taylor D, Dzavik V, and Montague TJ

Subjects
Aged, Alberta, Anticholesteremic Agents administration & dosage, Cholesterol blood, Cholesterol, HDL blood, Cholesterol, LDL blood, Coronary Angiography, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease pathology, Double-Blind Method, Enalapril administration & dosage, Enalapril therapeutic use, Female, Humans, Male, Middle Aged, Quebec, Severity of Illness Index, Simvastatin administration & dosage, Treatment Outcome, Triglycerides blood, Anticholesteremic Agents therapeutic use, Coronary Artery Disease drug therapy, Simvastatin therapeutic use
Abstract

This study examined the effects of long term cholesterol lowering therapy with simvastatin on progression and regression of coronary atherosclerosis, as determined by quantitative angiographic end points, in subgroups of patients with known coronary risk factors. In this randomized, placebo controlled clinical trial, the effect of simvastatin on coronary atherosclerosis was compared with that of placebo in 394 patients who had paired coronary angiograms taken an average of four years apart. The effects of treatment on the following prespecified subgroups were examined: sex, age (less than 65 years versus at least 65 years), smoking status (current or previous/never), history of diabetes mellitus or hypertension, and severity of coronary artery lesions (diameter at least 50% versus less than 50%). There were significantly smaller decreases in the average minimum diameters, between closeout and baseline angiograms, in all simvastatin-treated subgroups, compared with placebo. Trends toward or significantly smaller decreases in the average of the mean diameters, and similar smaller increases in percentage diameter stenosis were also seen in all subgroups. The slowing of angiographically demonstrable coronary atherosclerotic narrowing supports the contention that this treatment effect is causally related to the reduction of coronary events repeatedly seen in large outcome clinical trials of lipid lowering therapy. Also, this treatment effect occurs in the presence or absence of the traditional coronary risk factors.

Published
2003

48. Thrombus formation on guide wires during routine PTCA procedures: a scanning electron microscopic evaluation.

Author

Gobeil F, Juneau C, and Plante S

Subjects
Aged, Aspirin therapeutic use, Coated Materials, Biocompatible adverse effects, Coated Materials, Biocompatible therapeutic use, Coronary Thrombosis diagnosis, Equipment Design, Equipment Safety, Female, Fibrinolytic Agents therapeutic use, Humans, Male, Microscopy, Electron, Scanning, Middle Aged, Phosphorylcholine therapeutic use, Polytetrafluoroethylene adverse effects, Prevalence, Quebec epidemiology, Severity of Illness Index, Silicones adverse effects, Ticlopidine therapeutic use, Time Factors, Treatment Outcome, Angioplasty, Balloon, Coronary adverse effects, Angioplasty, Balloon, Coronary instrumentation, Coronary Thrombosis etiology
Abstract

Background: Various coatings are used on catheters and guide wires to improve resistance to surface thrombus formation. However, little is known about the thrombogenicity of 0.014" angioplasty guide wires and the protection offered by these coatings., Objectives: To evaluate the thrombogenicity of five different guide wires used in coronary angioplasty., Methods: Five different 0.014" guide wire types were evaluated in 50 consecutive angioplasty procedures. At the end of the procedure, the distal part of the guide wire was cut, put in formalin and prepared for scanning electron microscopic evaluation. The condition of each guide wire was then classified into one of three predefined categories: no thrombus, limited thrombus and significant thrombus formation., Results: Silicone (n=10, Guidant, USA), phosphorylcholine polymer (n=8, Biocompatibles, Ireland), hydrophilic polymer (n=8, Scimed, USA) and two Teflon-based coatings (n=16, Schneider, USA; n=8, Cordis, USA) were evaluated. On microscopic examination, 48% of guide wires had a significant amount of thrombus, 18% had limited thrombus formation and 34% had no thrombus. The results were very dissimilar among the groups. Significant thrombus was found on 80% of Guidant guide wires, 69% of Schneider guide wires, 38% of Scimed guide wires and 25% of Cordis guide wires, while none was found on Biocompatibles guide wires (P<0.0001)., Conclusions: Significant thrombus formation on angioplasty guide wires was a frequent finding, occurring in 48% of cases. Resistance to thrombus formation was very dissimilar among coatings, with only the Biocompatibles phosphorylcholine-coated guide wires showing no thrombus formation at all. Whether subclinical thromboembolization occurred in some patients is unknown, and the clinical implications of this study remain to be defined.

Published
2002

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