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1. Comparison of Fondaparinux and Enoxaparin in Acute Coronary Syndromes

Author

Yusuf, S., Mehta, S.R., Bassand, J.P., Budaj, A., Chrolavicius, S., Fox, K.A.A., Granger, C.B., Joyner, C., Peters, R.J.G., Wallentin, L., Avezum, A., Boden, W., Cardona, E., Ceremuzynski, L., Col, J., Commerford, P.J., Diaz, R., Faxon, D., Flather, M., Fodor, G., Franzosi, M.G., Granger, C., Halon, D., Hunt, D., Karatzas, N., Keltai, M., Kenda, M., Kim, J.H., Lanas, F., Lau, C.P., Lewis, B.S., Morais, J., Moccetti, T., Pais, P., Paolasso, E., Parkhomenko, A., Petrauskiene, B., Piegas, L., Pipilis, A., Robaayah, D., Ruda, M., Rumboldt, Zoran, Rupprecht, H.J., Sitkei, E., Steg, P.G., Swahn, E., Theroux, P., Valentin, V., Varigos, J., Weitz, J., White, H., Widimsky, P., Xavier, D., Zhu, J.R., Ameriso, S., Bonilla, C., Braekken, S., Chan, Y.K., Chen, W., Chenniappan, M., Cohen, E., Cottin, Y., Csiba, L., Czepiel, A., de Raedt, H., Finet, G., Gardinale, E., Gaxiola, E., Gorecki, A., Gregor, P., Happola, O., Heras, M., Himbert, D., Irkin, O., Isaaz, K., Iyengar, S.S., Kalvach, P., Kevers, L., Klosiewicz-Wasek , B., Laine, M., Leys, D., Lundstrom, E., Lušić, Ivo, Lutay, Y., Maggioni, A., Massaro, A., Mayosi, B.M., Moulin, T., Narendra, J., Naslund, U., Peeters, A., Penicka, M., Perakis, A., Petersen, P., Polić, S., Radhakrishnan, S., Renkin, J., Stockins, B., Sundararajan, R., Thygesen, K., Turazza, F., van Belle, E., Vik-Mo, H., Zaborski, J., Sleight, P., Anderson , J.L., Johnstone D., Hirsh, J., de Mets, D., Holmes, D.R., Meeks, B., Afzal, R., Pogue, J., Boccalon, S., Chrysler, K., Cracknell, B., Horsman, C., Hoskin, T., Jedrzejowski. B., Johnson, J., Kotlan, S., Lawrence, M., Smiley, M., Stevens, C., Yallup, R., Connolly, S., Demers, C., Devereaux, P.J., Healey, J., Lonn, E., Magloire, P., McKelvie, R., Morillo, C., Natarajan, M., Rokoss, M., Teo, K., Valettas, N., Velianou, J., Bakula, Miro, Bergovec, M, Lukin Ajvor, Miličević, Goran, Padovan, Milko, and Raguž, M.

Subjects
ST-segment elevation, high-risk patients, unfractionated heparin, myocardial infarction, collaborative metaanalysis, randomized trials, initial treatment, american-college, task-force, prevention
Abstract

The combined use of anticoagulants, antiplatelet agents, and invasive coronary procedures reduces ischemic coronary events but also increases bleeding in patients with acute coronary syndromes. We therefore assessed whether fondaparinux would preserve the anti-ischemic benefits of enoxaparin while reducing bleeding. We randomly assigned 20, 078 patients with acute coronary syndromes to receive either fondaparinux (2.5 mg daily) or enoxaparin (1 mg per kilogram of body weight twice daily) for a mean of six days and evaluated death, myocardial infarction, or refractory ischemia at nine days (the primary outcome) ; major bleeding ; and their combination. Patients were followed for up to six months. The number of patients with primary-outcome events was similar in the two groups (579 with fondaparinux [5.8 percent] vs. 573 with enoxaparin [5.7 percent] ; hazard ratio in the fondaparinux group, 1.01 ; 95 percent confidence interval, 0.90 to 1.13), satisfying the noninferiority criteria. The number of events meeting this combined outcome showed a nonsignificant trend toward a lower value in the fondaparinux group at 30 days (805 vs. 864, P=0.13) and at the end of the study (1222 vs. 1308, P=0.06). The rate of major bleeding at nine days was markedly lower with fondaparinux than with enoxaparin (217 events [2.2 percent] vs. 412 events [4.1 percent] ; hazard ratio, 0.52 ; P

Published
2006

2. Comparison of fondaparinux and enoxaparin in acute coronary syndromes

Author

Yusuf, S., Mehta, S. R., Bassand, J. P., Budaj, A., Chrolavicius, S., Fox, K. A. A., Granger, C. B., Joyner, C., Peters, R. J. G., Wallentin, L., Avezum, A., Boden, W., Cardona, E., Ceremuzynski, L., Col, J., Commerford, P. J., Diaz, R., Faxon, D., Flather, M., Fodor, G., Franzosi, M. G., Granger, C., Halon, D., Hunt, D., Karatzas, N., Keltai, M., Kenda, M., Kim, J. H., Lanas, F., Lau, C. P., Lewis, B. S., Morais, J., Moccetti, T., Pais, P., Paolasso, E., Parkhomenko, A., Petrauskiene, B., Piegas, L., Pipilis, A., Robaayah, D., Ruda, M., Rumboldt, Z., Rupprecht, H. J., Sitkei, E., Steg, P. G., Swahn, E., Theroux, P., Valentin, V., Varigos, J., Weitz, J., White, H., Widimsky, P., Xavier, D., Zhu, J. R., Ameriso, S., Bonilla, C., Braekken, S., Chan, Y. K., Chen, W., Chenniappan, M., Cohen, E., Cottin, Y., Csiba, L., Czepiel, A., Raedt, H., Finet, G., Gardinale, E., Gaxiola, E., Gorecki, A., Gregor, P., Happola, O., Heras, M., Himbert, D., Irkin, O., Isaaz, K., Iyengar, S. S., Kalvach, P., Kevers, L., Klosiewicz-Wasek, B., Laine, M., Leys, D., Lundstrom, E., Lusic, I., Lutay, Y., Maggioni, A., Massaro, A., Mayosi, B. M., Moulin, T., Narendra, J., Naslund, U., Peeters, A., Penicka, M., Perakis, A., Petersen, P., Polic, S., Radhakrishnan, S., Renkin, J., Stockins, B., Sundararajan, R., Thygesen, K., Turazza, F., Belle, E., Vik-Mo, H., Zaborski, J., Sleight, P., Anderson, J. L., Johnstone, D. E., Hirsh, J., Demets, D., Holmes, D. R., Meeks, B., Afzal, R., Pogue, J., Boccalon, S., Chrysler, K., Cracknell, B., Horsman, C., Hoskin, T., Jedrzejowski, B., Johnson, J., Kotlan, S., Lawrence, M., Smiley, M., Stevens, C., Yallup, R., Connolly, S., Demers, C., Devereaux, P. J., Healey, J., Lonn, E., Magloire, P., Mckelvie, R., Morillo, C., Natarajan, M., Rokoss, M., Teo, K., Valettas, N., Velianou, J., Albisu, J. P., Amuchastegui, M., Bello, F. A., Bluguermann, J. J., Bono, J. O., Caccavo, A., Carlevaro, O. O., Cassettari, A., Cuneo, C., Farras, H. A., Fuselli, J., Garrido, M., Guerrero, R., Hasbani, E., Hominal, M. A., Hrabar, A., Marquez, L. L., Luciardi, H. L., Riera, L. M., Marzetti, E. M., Memoli, R., Nordaby, R., Orlandini, A. D., Perez, M., Piasentin, J. A., Ramos, H. R., Risolo, A. M., Sala, J., Salomone, O., Schygiel, P. O., Ubaldini, J., Vico, M., Amerena, J., Arnolda, L., Aroney, G., Boyd, P., Cahill, P., Chew, D., Counsell, J. T., Cross, D., Edington, J., Fitzpatrick, D., Hicks, P., Horowitz, J. D., Horrigan, M. C. G., New, G., Owensby, D., Schoeman, M., Thompson, P., Tulloch, G., Waites, J., Whelan, A., Ziffer, R., Huber, K., Jordanova, N., Al Shawafi, K., Convens, C., Coussement, P., Meester, A., El Allaf, D., Janssens, L., Marcovitch, O., Muyldermans, L., Roosen, J., Soeur, F., Lierde, J., Vrolix, M., Leaes, P., Carvalho, A. C., Schramm, E. C., Mora, R. D., Amino, J. D., Dutra, O., Manenti, E. R. F., Gun, C., Saraiva, J. F. K., Hayashi, E. K., Lichter, A., Lima, A., Marin-Neto, J. A., Teixeira, S. P. M., Abrantes, J. A. M., Baracioli, L. M., Nicolau, J. C., Maia, L. N., Jaeger, C. P., Esteves, J. P., Rabelo, A., Ramos, R. F., Reis, G., Rossi, P., Dos Santos, F. R., Teixeira, M. S., Silveira, D. S., Lemos, Mabt, Timerman, A., Greque, G. V., Vaz, R., Bhargava, R., Brons, S., Colclough, M., Constance, C., Costi, P., Dacyk, A., Davies, T., Diodati, J., Dupuis, R., Elliott, H., Fell, D. A., Fung, A. Y., Gladstone, P. J. S., Gosselin, G., Grondin, F., Huynh, T., Janzen, I., Kalaparambath, T., Kornder, J., Kouz, S., Kuritzky, R., Labelle-Stimac, S., Lamothe, M., Lauzon, C., Lemay, M., Ma, P., Maccallum, G. C., Mccallum, A., Mitchell, D., Montigny, M., Nguyen, N., Pearce, M., Pistawka, K. J., Rebane, T., Roy, M., Senaratne, M., Smith, J., Stimac, J., Traboulsi, M., Vizel, S., Weeks, A., Zadra, R., Zimmerman, R. H., Alcaino, M. E., Castro, P., Chen, J., Chen, J. L., Fan, W., Ge, J., Hu, D., Huang, J., Jingxuan, G., Ke, Y., Ma, H., Wu, Y., Yingxian, S., Yu, B., Zhu, W., Bakula, M., Bergovec, M., Lukin, A., Milicevic, G., Padovan, M., Raguz, M., Aschermann, M., Belohlavek, J., Bocek, P., Branny, M., Budesinsky, T., Groch, L., Holm, F., Jansky, P., Jelinek, P., Jirka, V., Kaislerova, M., Konecny, P., Lisa, L., Maly, M., Marcinek, G., Oscipovsky, M., Stumar, J., Vacha, M., Nielsen, T., Vigholt, E., Laanmets, P., Soopold, U., Voitk, J., Naveri, H., Niemela, M., Peuhkurinen, K., Tuomainen, P., Ylitalo, A., Py, A., Amat, G., Bessede, G., Boschat, J., Carrie, D., Charbonnier, B., Coliet, J. P., Dambrine, P., Dubois-Rande, J. L., Ferrari, E., Fouche, R., Grollier, G., Jaboureck, O., Ketelers, R., Khalife, K., Leroy, F., Lognone, T., Macquin-Mavier, I., Montalescot, G., Pacouret, G., Poulard, J. E., Puel, J., Richard, M., Schiele, F., Bischoff, K. O., Buerke, M., Buerke, U., Dominick, K., Drexler, H., Feiler, A., Guelker, H., Haltern, G., Katus, H. A., Klauss, V., Klutmann, M., Koeth, O., Meinhardt, G., Muenzel, T. M., Nitschke, T., Offterdinger, M., Rieber, J., Schieffer, B., Stangl, K., Stangl, V., Vom Dahl, J., Witzenbichler, B., Zeymer, U., Alexopoulos, D., Blassopoulou, N., Christon, A., Fotiadis, I., Foussas, S., Grapsas, N., Moschos, N., Papasteriadis, E., Symeonidis, D., Tyrologos, A., Leung, W. S., Li, S. K., Arabadzisz, H., Csikazs, J., Dancs, T., Davidovits, Z., Edes, I., Farkas, E., Herczeg, B., Janos, S., Janosi, A., Kadar, A., Kis, E., Kristof, E., Lupkovics, G., Mark, L., Nagy, A., Nagy, L., Poor, F., Regos, L., Sebo, J., Tomcsanyi, J., Toth, K., Bharani, A., Chidambaram, N., Haridas, K. K., Jain, A., Jain, P. R. K., Jaison, T. M., Kerkar, P. G., Naik, S., Nambiar, A., Panwar, R. B., Parikh, K., Puri, V. K., Rajesh, T., Ramesh, M., Singh, B., Thanikachalam, S., Tongia, R. K., Varma, S., Barbiero, M., Bardelli, G., Bernardi, D., Bolognese, L., Capponi, L., Ferrari, G., Fanelli, R., Frediani, L., Galli, M., Izzo, A., Lombardi, A., Maresta, A., Martinoni, A., Melloni, C., Meneghetti, P., Mennuni, M., Moretti, L., Orlandi, M., Pancaldi, L. G., Petronzelli, S., Piovaccari, G., Salvioni, A., Severini, D., Terrosu, P., Zanini, R., Erglis, A., Kalnins, U., Verboenko, J., Zakke, I., Kugiene, R., Zaliunas, R., Bin Othman, A., Chee, K. H., Hian, S. K., Gutierrez, A. C., Diaz, A. C., Garcia-Castillo, A., Guerrero, M. C., Morales, C. L., Ramos-Lopez, G., Baldew, S. C., Basart, D. C. G., Clappers, N., Daniels, M. C. G., Weerd, G. J., Den Hartog, F. R., Hendriks, Ihgm, Herrman, J. P. R., Kofflard, M., Krasznai, K., Michels, H. R., Stoel, I., Ten Berg, J. M., Umans, Vawn, Beek, G. J., Daele, Merm, Den Berg, B. J., Hessen, M. W. J., Kalmthout, P. M., Rossum, P., Verheugt, F. W. A., Viergever, E. P., Withagen, Ajam, Achremczyk, P., Arasimowicz, P., Baranowska, T., Biegayto, J., Bronisz, M., Buszman, P., Dalkowski, M., Dluzniewski, M., Gessek, J., Goch, J. H., Janik, K., Janion, M., Kawecki, D., Kleinrok, A., Komorowski, P., Krasowski, W., Krauze-Wielicka, M., Malinowski, S., Nowak, T., Nowakowski, P., Ogorek, M., Piepiorka, M., Pluta, W., Puzio, E., Puzniak, M., Rekosz, J., Rybka, P., Sendrowski, D., Siminiak, T., Skura, M., Stopinski, M., Szetemej, R., Szolkiewicz, M., Szpajer, M., Trusz-Gluza, M., Waszyrowski, T., Wita, K., Wodniecki, J., Wojewoda, P., Zambrzycki, J., Zielinski, Z., Cardoso, P., Carrageta, D. M., Ferreira, D., Gomes, M. V., Santos, L., Arkhipov, M., Belousov, Y., Charchoglyan, R., Gordeev, I. G., Gratsiansky, N. A., Grinshtein, Y., Khrustalev, O., Kokorin, V. A., Komarov, A., Kozulin, V., Minushkina, L. O., Panchenko, E., Panov, A., Petrik, E. S., Shakhnovich, R. M., Shalaev, S. V., Sukhinina, T. S., Trifonov, I. R., Zateyshchikov, D. A., Khoo, B. C. H., Tan, H. C., Tan, R. S., Hricak, V., Motovska, Z., Poliacik, P., Kanic, V., Kovacic, D., Kranjec, I., Voga, G., Bayat, J., Essop, M. R., Maritz, F., Marx, J. D., Ntsekhe, M., Pretorius, M. P., Ranjith, N., Theron, H., Chae, I. H., Chae, S. C., Choe, K. H., Chung, N. S., Jeong, M. H., Kim, C. J., Kim, H. S., Kim, W., Rhim, C. Y., Shin, E. K., Shin, G. J., Alameda, M., Alonso-Orcajo, N., Bethencourt, A., Calvo, F., Avellaneda, J. L. C., Delgado, V., Diaz-Castro, O., Esplugas, E., Faus, R., Antonio Fernandez-Ortiz, Frutos, A., Goirena, P., Iglesias, F. C., Llorian, A. R., Macaya, C., Mancisidor, X., Melgares, R., Pascual, C., Ruiz-Nodar, J. M., Simon, J. M., Agewall, S., Ahlstrom, P., Ali, M., Andersson, L., Bandh, S., Digerfeldt, C., Ericsson, H., Forsgren, M., Jabro, J., Janzon, M., Joborn, H., Johnston, N., Karlsson, J. E., Larsson, L. E., Linderfalk, C., Lonnberg, I., Mooe, T., Oldgren, J., Pihl, E., Risenfors, M., Sjolund, E., Soderberg, I., Stjerna, A., Svennberg, L., Wodlin, P., Pagnamenta, A., Pieper, M., Rossi, M. G., Weber, K., Peng, M. C., Cheng, J. J., Chiang, F. T., Kuo, C. T., Tseng, C. D., Andreyeshcheva, I., Dzyak, G. V., Fedtchouk, L., Gontar, A., Karpenko, O., Kononenko, L., Koval, E. A., Kovalsky, I., Kraitz, I., Netiazhenko, V., Polyvoda, S., Prokopenko, Y., Prudkiy, I., Rudenko, L., Serediuk, N., Zolotaykina, V., Adgey, J., Ahsan, A., Brack, M., Bridges, A. B., Burton, J., Findlay, I., Fluck, D. S., Radford, L., Robson, R. H., Senior, R., Starkey, I. R., Alexander, J., Baber, Z., Campbell, M., Caputo, R., Chandna, H., Chandrashekhar, Y., Chu, A., Deraad, R. E., Druken, B., Goyal, A., Holly, D., Kemp, A., Kotlaba, D., Levine, M. J., Miller, G. P., Nygaard, T., Parikh, D. K., Ramos, C., Rivera, E., Rodriguez, R., Sangani, B., Walder, J. S., and Oasis

3. Radial versus femoral access for elderly patients with acute coronary syndrome undergoing coronary angiography and intervention: insights from the RIVAL trial.

Author

Cantor WJ, Mehta SR, Yuan F, Džavík V, Worthley M, Niemelä K, Valentin V, Fung A, Cheema AN, Widimsky P, Natarajan M, Jedrzejowski B, and Jolly SS

Subjects
Acute Coronary Syndrome surgery, Aged, Female, Femoral Artery, Humans, Male, Radial Artery, Treatment Outcome, Acute Coronary Syndrome diagnostic imaging, Catheterization, Peripheral methods, Coronary Angiography methods, Percutaneous Coronary Intervention methods
Abstract

Background: Radial access for percutaneous coronary intervention is associated with lower rates of access site complications and bleeding. However, elderly patients have more complex vascular anatomy and radial access may be more challenging in this population. There remains uncertainty regarding the role of radial access in elderly patients undergoing cardiac catheterization., Methods and Results: The RIVAL trial randomized patients with acute coronary syndromes undergoing cardiac catheterization to radial versus femoral access. In this analysis, the rates of access site complications and access site cross-over were compared across different age groups. Among the 7,021 patients, 1035 (15%) were ≥75 years of age. Across all age categories, radial access was consistently associated with higher rates of access site cross over and lower rates of major access site complications, with no significant interaction between age and access site. Radial access was associated with lower rates of major vascular access site complications in patients ≥75 years of age (3.6% vs 6.6%; P = .03) and in patients <75 years of age (1.0% vs 3.2%; P < .001; P value for interaction = .2). The rates of access site crossover were higher with radial access among patients ≥75 (12.5% vs 2.6%; P < .001) and <75 (6.7% vs 1.9%; P < .001; P value for interaction = .9). There were no significant differences in the primary composite outcome (death, myocardial infarction, stroke or non coronary artery bypass graft major bleeding) or its individual components in either age group. In patients ≥75 years of age undergoing primary percutaneous coronary intervention, there was no significant difference in procedure time (120 vs 115 minutes; P = .3)., Conclusions: Consistent with the overall RIVAL trial population, elderly patients undergoing cardiac catheterization have lower rates of major bleeding or access site complications and higher rates of access site crossover with radial access compared to femoral access., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Published
2015
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4. Effect of radial versus femoral access on radiation dose and the importance of procedural volume: a substudy of the multicenter randomized RIVAL trial.

Author

Jolly SS, Cairns J, Niemela K, Steg PG, Natarajan MK, Cheema AN, Rao SV, Cantor WJ, Džavík V, Budaj A, Sheth T, Valentin V, Fung A, Widimsky P, Ferrari E, Gao P, Jedrzejowski B, and Mehta SR

Subjects
Aged, Angina, Unstable diagnostic imaging, Clinical Competence, Female, Fluoroscopy, Humans, Learning Curve, Linear Models, Male, Middle Aged, Multivariate Analysis, Myocardial Infarction diagnostic imaging, Prospective Studies, Radiation Monitoring, Time Factors, Angina, Unstable therapy, Femoral Artery diagnostic imaging, Hospitals, High-Volume, Hospitals, Low-Volume, Myocardial Infarction therapy, Percutaneous Coronary Intervention methods, Radial Artery diagnostic imaging, Radiation Dosage, Radiography, Interventional methods
Abstract

Objectives: The authors sought to compare the radiation dose between radial and femoral access., Background: Small trials have shown an increase in the radiation dose with radial compared with femoral access, but many were performed during the operators' learning curve of radial access., Methods: Patients were randomized to radial or femoral access, as a part of the RIVAL (RadIal Vs. femorAL) trial (N = 7,021). Fluoroscopy time was prospectively collected in 5740 patients and radiation dose quantified as air kerma in 1,445 patients and dose-area product (DAP) in 2,255 patients., Results: Median fluoroscopy time was higher with radial versus femoral access (9.3 vs. 8.0 min, p < 0.001). Median air kerma was nominally higher with radial versus femoral access (1,046 vs. 930 mGy, respectively, p = 0.051). Median DAP was not different between radial and femoral access (52.8 Gy-cm(2) vs. 51.2 Gy·cm(2), p = 0.83). When results are stratified according to procedural volume, air kerma was increased only in the lowest tertile of radial volume centers (low 1,425 vs. 1,045 mGy, p = 0.002; middle 987 vs. 958 mGy, p = 0.597; high 652 vs. 621 mGy, p = 0.403, interaction p = 0.026). Multivariable regression showed procedural volume was the greatest independent predictor of lower air kerma dose (ratio of geometric means 0.55; 95% confidence interval 0.49 to 0.61 for highest-volume radial centers)., Conclusions: Radiation dose as measured by air kerma was nominally higher with radial versus femoral access, but differences were present only in lower-volume centers and operators. High-volume centers have the lowest radiation dose irrespective of which access site approach that they use. (A Trial of Trans-radial Versus Trans-femoral Percutaneous Coronary Intervention (PCI) Access Site Approach in Patients With Unstable Angina or Myocardial Infarction Managed With an Invasive Strategy [RIVAL]; NCT01014273)., (Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Published
2013
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