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5. Mortality following cardiovascular and bleeding events occurring beyond 1 year after coronary stenting: A secondary analysis of the Dual Antiplatelet Therapy (DAPT) Study.

Author

Hopkins J., McGarry T., Nygaard T., Pow T., Larkin T., Caulfield T., Stys T., Lee T., Mansouri V., Srinivas V., Gupta V., Marquardt W., Ballard W., Bachinsky W., Colyer W., Dillon W., Felten W., French W., Kuehl W., Nicholas W., Nicholson W., Phillips W., Khatib Y., Al-Saghir Y., Hawa Z., Masud Z., Jafar Z., Muller D., Meredith I., Rankin J., Worthley M., Jepson N., Thompson P., Hendriks R., Whitbourn R., Duffy S., Stasek J., Novobilsky K., Naplava R., Coufal Z., Vaquette B., Bressollette E., Teiger E., Coste P., Rihani R., Darius H., Bergmann M.W., Radke P., Sebastian P., Strasser R., Hoffmann S., Behrens S., Moebius-Winkler S., Rutsch W., Lupkovics G., Horvath I., Kancz S., Forster T., Koszegi Z., Devlin G., Hart H., Elliott J., Ormiston J., Abernathy M., Fisher N., Kay P., Harding S., Jaffe W., Hoffmann A., Sosnowski C., Trebacz J., Buszman P., Dobrzycki S., Kornacewicz-Jach Z., Iancu A.C., Ginghina C.D., Matei C., Dobreanu D., Bolohan F.R., Dorobantu M., Jacques A., Jain A., Bakhai A., Gershlick A., Adamson D., Newby D., Felmeden D., Purcell I., Edmond J., Irving J., De Belder M., Pitt M., Kelly P., O'Kane P., Clifford P., Suresh V., Secemsky E.A., Yeh R.W., Kereiakes D.J., Cutlip D.E., Cohen D.J., Steg P.G., Cannon C.P., Apruzzese P.K., D'Agostino R.B., Massaro J.M., Mauri L., Kaplan A., Ahmed A., Ahmed A.-H., Albirini A., Moreyra A., Rabinowitz A., Shroff A., Moak A., Jacobs A., Kabour A., Gupta A., Irimpen A., Rosenthal A., Taussig A., Ferraro A., Chhabra A., Pucillo A., Spaedy A., White A., Pratsos A., Shakir A., Ghitis A., Agarwal A., Chawla A., Tang A., Barker B., Bertolet B., Uretsky B., Erickson B., Rama B., McLaurin B., Dearing B., Negus B., Price B., Brott B., Bhambi B., Bowers B., Watt B., Donohue B., Hassel C.D., Croft C., Lambert C., O'Shaughnessy C., Shoultz C., Kim C., Caputo C., Nielson C., Scott C., Wolfe C., McKenzie C., Brachfeld C., Thieling C., Fisher D., Simon D., Churchill D., Dobies D., Eich D., Goldberg D., Griffin D., Henderson D., Kandzari D., Lee D., Lewis D., Mego D., Paniagua D., Rizik D., Roberts D., Safley D., Abbott D., Shaw D., Temizer D., Canaday D., Myears D., Westerhausen D., Ebersole D., Netz D., Baldwin D., Letts D., Harlamert E., Kosinski E., Portnay E., Mahmud E., Korban E., Hockstad E., Rivera E., Shawl F., Shamoon F., Kiernan F., Aycock G.R., Schaer G., Kunz G., Kichura G., Myers G., Pilcher G., Tadros G., Kaddissi G.I., Ramadurai G., Eaton G., Elsner G., Mishkel G., Simonian G., Piegari G., Chen H., Liberman H., Aronow H., Tamboli H.P., Dotani I., Marin J., Fleischhauer J.F., Leggett J., Mills J., Phillips J., Revenaugh J., Mann J.T., Wilson J., Pattanayak J., Aji J., Strain J., Patel J., Carr J., Moses J., Chen J.-C., Williams J., Greenberg J., Cohn J., Douglas J., Gordon J., Griffin J., Hawkins J., Katopodis J., Lopez J., Marshall J., Wang J., Waltman J., Saucedo J., Galichia J., McClure M., Kozina J., Stella J., Tuma J., Kieval J., Giri K., Ramanathan K., Allen K., Atassi K., Baran K., Khaw K., Clayton K., Croce K., Skelding K., Patel K., Garratt K., Harjai K., Chandrasekhar K., Kalapatapu K., Lin L., Dean L., Barr L., MacDonald L., Cannon L., Satler L., Gruberg L., Tami L., Bikkina M., Shah M., Atieh M., Chauhan M., Litt M., Unterman M., Lechin M., Zughaib M., Fisch M., Grabarczyk M., Greenberg M., Lurie M., Rothenberg M., Stewart M., Purvis M., Hook M., Leesar M., Buchbinder M., Weiss M., Guerrero M., Abu-Fadel M., Ball M., Chang M., Cunningham M., Del Core M., Jones M., Kelberman M., Lim M., Ragosta M., Rinaldi M., Rosenberg M., Savage M., Tamberella M., Kellett M., Vidovich M., Effat M., Mirza M.A., Khan M., Dib N., Laufer N., Kleiman N., Farhat N., Amjadi N., Schechtmann N., Bladuell N., Quintana O., Gigliotti O., Best P., Flaherty P., Hall P., Gordon P., Gurbel P., Ho P., Luetmer P., Mahoney P., Mullen P., Teirstein P., Tolerico P., Ramanathan P., Kerwin P., Lee P.V., Kraft P., Wyman R.M., Gonzalez R., Kamineni R., Dave R., Sharma R., Prashad R., Aycock R., Quesada R., Goodroe R., Magorien R., Randolph R., Bach R., Kettelkamp R., Paulus R., Waters R., Zelman R., Ganim R., Bashir R., Applegate R., Feldman R., Frankel R., Hibbard R., Jobe R., Jumper R., Maholic R., Siegel R., Smith R., Stoler R., Watson R., Wheatley R., Gammon R., Hill R., Sundrani R., Caputo R., Jenkins R., Stella R., Germanwala S., Hadeed S., Ledford S., Dube S., Gupta S., Davis S., Martin S., Waxman S., Dixon S., Naidu S., Potluri S., Cook S., Crowley S., Kirkland S., McIntyre S., Thew S., Lin S., Marshalko S., Guidera S., Hearne S., Karas S., Manoukian S., Rowe S., Yakubov S., Pollock S., Banerjee S., Allaqaband S., Choi S., Mulukutla S., Papadakos S., Bajwa T., Addo T., Schreiber T., Haldis T., Mathew T., Hopkins J., McGarry T., Nygaard T., Pow T., Larkin T., Caulfield T., Stys T., Lee T., Mansouri V., Srinivas V., Gupta V., Marquardt W., Ballard W., Bachinsky W., Colyer W., Dillon W., Felten W., French W., Kuehl W., Nicholas W., Nicholson W., Phillips W., Khatib Y., Al-Saghir Y., Hawa Z., Masud Z., Jafar Z., Muller D., Meredith I., Rankin J., Worthley M., Jepson N., Thompson P., Hendriks R., Whitbourn R., Duffy S., Stasek J., Novobilsky K., Naplava R., Coufal Z., Vaquette B., Bressollette E., Teiger E., Coste P., Rihani R., Darius H., Bergmann M.W., Radke P., Sebastian P., Strasser R., Hoffmann S., Behrens S., Moebius-Winkler S., Rutsch W., Lupkovics G., Horvath I., Kancz S., Forster T., Koszegi Z., Devlin G., Hart H., Elliott J., Ormiston J., Abernathy M., Fisher N., Kay P., Harding S., Jaffe W., Hoffmann A., Sosnowski C., Trebacz J., Buszman P., Dobrzycki S., Kornacewicz-Jach Z., Iancu A.C., Ginghina C.D., Matei C., Dobreanu D., Bolohan F.R., Dorobantu M., Jacques A., Jain A., Bakhai A., Gershlick A., Adamson D., Newby D., Felmeden D., Purcell I., Edmond J., Irving J., De Belder M., Pitt M., Kelly P., O'Kane P., Clifford P., Suresh V., Secemsky E.A., Yeh R.W., Kereiakes D.J., Cutlip D.E., Cohen D.J., Steg P.G., Cannon C.P., Apruzzese P.K., D'Agostino R.B., Massaro J.M., Mauri L., Kaplan A., Ahmed A., Ahmed A.-H., Albirini A., Moreyra A., Rabinowitz A., Shroff A., Moak A., Jacobs A., Kabour A., Gupta A., Irimpen A., Rosenthal A., Taussig A., Ferraro A., Chhabra A., Pucillo A., Spaedy A., White A., Pratsos A., Shakir A., Ghitis A., Agarwal A., Chawla A., Tang A., Barker B., Bertolet B., Uretsky B., Erickson B., Rama B., McLaurin B., Dearing B., Negus B., Price B., Brott B., Bhambi B., Bowers B., Watt B., Donohue B., Hassel C.D., Croft C., Lambert C., O'Shaughnessy C., Shoultz C., Kim C., Caputo C., Nielson C., Scott C., Wolfe C., McKenzie C., Brachfeld C., Thieling C., Fisher D., Simon D., Churchill D., Dobies D., Eich D., Goldberg D., Griffin D., Henderson D., Kandzari D., Lee D., Lewis D., Mego D., Paniagua D., Rizik D., Roberts D., Safley D., Abbott D., Shaw D., Temizer D., Canaday D., Myears D., Westerhausen D., Ebersole D., Netz D., Baldwin D., Letts D., Harlamert E., Kosinski E., Portnay E., Mahmud E., Korban E., Hockstad E., Rivera E., Shawl F., Shamoon F., Kiernan F., Aycock G.R., Schaer G., Kunz G., Kichura G., Myers G., Pilcher G., Tadros G., Kaddissi G.I., Ramadurai G., Eaton G., Elsner G., Mishkel G., Simonian G., Piegari G., Chen H., Liberman H., Aronow H., Tamboli H.P., Dotani I., Marin J., Fleischhauer J.F., Leggett J., Mills J., Phillips J., Revenaugh J., Mann J.T., Wilson J., Pattanayak J., Aji J., Strain J., Patel J., Carr J., Moses J., Chen J.-C., Williams J., Greenberg J., Cohn J., Douglas J., Gordon J., Griffin J., Hawkins J., Katopodis J., Lopez J., Marshall J., Wang J., Waltman J., Saucedo J., Galichia J., McClure M., Kozina J., Stella J., Tuma J., Kieval J., Giri K., Ramanathan K., Allen K., Atassi K., Baran K., Khaw K., Clayton K., Croce K., Skelding K., Patel K., Garratt K., Harjai K., Chandrasekhar K., Kalapatapu K., Lin L., Dean L., Barr L., MacDonald L., Cannon L., Satler L., Gruberg L., Tami L., Bikkina M., Shah M., Atieh M., Chauhan M., Litt M., Unterman M., Lechin M., Zughaib M., Fisch M., Grabarczyk M., Greenberg M., Lurie M., Rothenberg M., Stewart M., Purvis M., Hook M., Leesar M., Buchbinder M., Weiss M., Guerrero M., Abu-Fadel M., Ball M., Chang M., Cunningham M., Del Core M., Jones M., Kelberman M., Lim M., Ragosta M., Rinaldi M., Rosenberg M., Savage M., Tamberella M., Kellett M., Vidovich M., Effat M., Mirza M.A., Khan M., Dib N., Laufer N., Kleiman N., Farhat N., Amjadi N., Schechtmann N., Bladuell N., Quintana O., Gigliotti O., Best P., Flaherty P., Hall P., Gordon P., Gurbel P., Ho P., Luetmer P., Mahoney P., Mullen P., Teirstein P., Tolerico P., Ramanathan P., Kerwin P., Lee P.V., Kraft P., Wyman R.M., Gonzalez R., Kamineni R., Dave R., Sharma R., Prashad R., Aycock R., Quesada R., Goodroe R., Magorien R., Randolph R., Bach R., Kettelkamp R., Paulus R., Waters R., Zelman R., Ganim R., Bashir R., Applegate R., Feldman R., Frankel R., Hibbard R., Jobe R., Jumper R., Maholic R., Siegel R., Smith R., Stoler R., Watson R., Wheatley R., Gammon R., Hill R., Sundrani R., Caputo R., Jenkins R., Stella R., Germanwala S., Hadeed S., Ledford S., Dube S., Gupta S., Davis S., Martin S., Waxman S., Dixon S., Naidu S., Potluri S., Cook S., Crowley S., Kirkland S., McIntyre S., Thew S., Lin S., Marshalko S., Guidera S., Hearne S., Karas S., Manoukian S., Rowe S., Yakubov S., Pollock S., Banerjee S., Allaqaband S., Choi S., Mulukutla S., Papadakos S., Bajwa T., Addo T., Schreiber T., Haldis T., and Mathew T.

Abstract

Importance: Early cardiovascular and bleeding events after coronary stenting are associated with high risk of morbidity and mortality. Objective(s): To assess the prognosis of cardiovascular and bleeding events occurring beyond 1 year after coronary stenting. Design, Setting, and Participant(s): This secondary analysis is derived from data from the Dual Antiplatelet Therapy (DAPT) Study, a multi center trial involving 220 US and in ternational clinical sites from 11 countries. The study dateswere August 2009 to May 2014. Individuals who underwent coronary stenting and completed 12 months of thienopyridine plus aspirin therapy without ischemic or bleeding events remained on an aspirin regimen and were randomized to continued thienopyridine therapy vs placebo for 18 additional months. Individuals were then followed up for 3 additional months while receiving aspirin therapy alone. The analysis began in August 2015. Exposures: Ischemic events (myocardial infarction not related to stent thrombosis, stent thrombosis, and ischemic stroke) and bleeding events (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries [GUSTO] classification moderate or severe bleeding). Main Outcomes and Measures: Ischemic events (myocardial infarction not related to stent thrombosis, stent thrombosis, and ischemic stroke) and bleeding events (GUSTO classification moderate or severe bleeding). Death at 21 months after randomization (33 months after coronary stenting). Result(s): Intotal, 25 682 individuals older than 18 years with an indication for coronarystentingwere enrolled, and 11 648(meanage,61.3 years; 25.1%female)were randomized. After randomization, 478 individuals (4.1%) had 502 ischemic events (306 with myocardial infarction, 113 with stent thrombosis, and 83 with ischemic stroke), and 232 individuals (2.0%) had 235 bleeding events (155 with moderate and 80 with severe bleeding). Among individuals with ischemic events, 52(10.9%) died. The annualize

Published
2017

6. Varespladib and cardiovascular events in patients with an acute coronary syndrome: the VISTA-16 randomized clinical trial

Author

Nicholls, Stephen J., Kastelein, John J. P., Schwartz, Gregory G., Bash, Dianna, Rosenson, Robert S., Cavender, Matthew A., Brennan, Danielle M., Koenig, Wolfgang, Jukema, J. Wouter, Nambi, Vijay, Wright, R. Scott, Menon, Venu, Lincoff, A. Michael, Nissen, Hennekens C, Steven E., Brown, Wv, Demets, D, Pfeffer, M, Roleau, J, Abraham, J, Gebel, J, Huff, C, Katzan, I, Shishehbor, M, Rassi, A, Uchino, K, Vest, A, Zishiri, E, Heckman, Mj, Balog, C, Dart, A, Amerena, J, Prasad, C, Farshid, A, Gunalingam, B, Thompson, P, Collins, N, Arstall, M, van Gaal, W, Aroney, C, Mahar, L, Youssef, G, Horowitz, J, Anand, D, Rodes-Cabau, J, Polasek, P, Lai, C, Huynh, T, Hubacek, J, Kokis, A, Paradis, Jm, Mukherjee, A, Senaratne, M, Constance, C, Gosselin, G, Lavi, S, Parker, J, Zadra, R, Abramson, B, Della-Siega, A, Spinar, J, Pudil, R, Motovska, Z, Maly, M, Hutyra, M, Pleva, L, Mayer, O, Semenka, J, Klimovic, T, Horak, D, Cervinka, P, Klimsa, Z, Hulinsky, V, Reichert, P, Monhart, Z, Rotterova, H, Kobulia, B, Shaburishvili, T, Mamatsashvili, M, Chapidze, G, Chumburidze, V, Megreladze, I, Khintibidze, I, Leithäuser, B, Voehringer, Hf, Wachter, R, Nogai, K, Lapp, H, Haltern, G, Gielen, S, Dorsel, T, Möllmann, H, Stellbrink, C, Hengstenberg, C, Dengler, T, Heuer, H, Kreuzer, J, Leschke, M, Mudra, H, Werner, N, Braun-Dullaeus, R, Rosenberg, M, Frey, N, Koenig, W, Strasser, R, Genth-Zotz, S, Kiss, R, Nagy, A, Kovacs, Z, Csapo, K, Edes, I, Sereg, M, Vertes, A, Ronaszeki, A, Kancz, S, Benczur, B, Polgar, P, Muller, G, Simonyi, G, Dezsi, C, Merkely, B, Dinnyes, J, Lupkovics, G, Kahali, D, Banker, D, Trivedi, S, Rajput, R, Premchand, R, Dani, S, Vadaganelli, P, Gupta, S, Chandra, S, Fulwani, M, Chawla, K, Parikh, K, Prati, F, Speciale, G, Valgimigli, M, Suriano, P, Sangiorgi, G, Fineschi, M, Merenda, R, Marenzi, G, Berti, S, Corrada, E, Cuccia, C, Testa, R, Moretti, L, Mennuni, M, Biasucci, Lm, Lioy, E, Auguadro, C, Magagnini, E, Fedele, F, Piscione, F, Azar, R, Trip, Md, Liem, A, den Hartoog, M, Lenderink, T, van de Wetering ML, Lok, D, Oei, F, Tans, Jg, Ilmer, B, Keijzers, M, Monraats, P, Kedhi, E, Breedveld, Rw, Herrman, J, van Wijk, L, Ronner, E, Nierop, P, Bosschaert, M, Hermans, W, Doevendans, P, Troquay, R, van der Heijden, R, Veen, G, Bokern, Mj, Bronzwaer, Pn, Kie, Sh, Den Hartog, F, Elliott, J, Wilkins, G, Hart, H, Devlin, G, Harding, S, Ponikowski, P, Madej, A, Kochmanski, M, Witkowski, A, Pluta, W, Bronisz, M, Kornacewicz-Jach, Z, Wysokinski, A, Ujda, M, Drozdz, J, Derlaga, B, Gessek, J, Dabrowski, M, Miekus, P, Kozlowski, A, Gniot, J, Musial, W, Dobrzycki, S, Rynkiewicz, A, Psuja, P, Rekosz, J, Drzewiecki, A, Kuznetsov, V, Gordeev, I, Goloshchekin, B, Markov, V, Barbarich, V, Belenky, D, Mikhin, V, Volkova, E, Timofeev, A, Ermoshkina, L, Barbarash, O, Klein, G, Libis, R, Vishnevsky, A, Linev, K, Khaisheva, L, Ruda, M, Dovgalevskiy, Y, Shvarts, Y, Zateyshchikov, D, Kostenko, V, Shalnev, V, Simanenkov, V, Arkhipov, M, Ovcharenko, E, Guseva, G, Akhunova, S, Ortiz, Ai, Navarro, Mj, Romero, Aj, Goya, Il, Peñaranda, As, Cendon, Aa, Rubio, Am, Zubiri, Jj, Soriano, Fr, Sanz, Rr, Genís, Ab, Lago, Vn, Fernández, Jd, Romo, Ai, Franco, Sn, Martin, Ih, Montero, Js, Martin Mde, M, González, Mj, Antolin, Jm, Areses, El, Miranda, Jm, Alonso-Pulpón, L, Esquivias, Gb, Jarne, Ef, Cortés, Jm, Pérez, Mb, Gormaz, Cl, Alegret, Jm, Nava, Js, Ingelmo, Jm, Urbano, Rh, Sanmartín, M, Katerenchuk, O, Vakaliuk, I, Karpenko, O, Prokhorov, O, Koval, O, Faynyk, A, Kopytsya, M, Karpenko, Y, Kraiz, I, Feskov, O, Rudenko, L, Kozhukhov, S, Goloborodko, B, Rivera, E, Broadwater, S, Crowley, S, Vijay, N, Goswami, R, Ferrier, L, Blanchard, A, Mccullum, K, Chernick, R, Bertolet, B, Battaglia, J, Richardson, J, Lochridge, S, Lieberman, S, Amkieh, A, Cavender, Jb, Denning, S, Treasure, C, Kmetzo, J, Stillabower, M, Brilakis, E, Schwartz, G, Acheatel, R, Kukuy, E, Ashchi, M, Skelding, K, Martin, L, Gillespie, E, French, W, Pollock, S, Polk, D, Black, R, Drenning, D, Anderson, J, Sanz, M, Korban, E, Wiley, M, Rezkalla, S, Minisi, A, Shah, A, Silverman, P, Amlani, M, Eaton, G, Brown, A, Jay, D, Loussararian, A, Lamas, G, Lauer, M, Williams, J, Asfour, A, Runquist, L, Robertson, R, Blonder, R, Davies, C, Downes, T, Chronos, N, Marso, S, Haldis, T, Eich, D, Ahmed, M, East, C, Macdonald, L, Seigel, P, White, M, Camp, A, Kleiman, N, Burtt, D, Strain, J, Go, B, Henry, P, Sultan, P, Delafontaine, P, Kashou, H, Lambert, C, Movahed, M, Saucedo, J, Thadani, U, Chandrashekhar, Y, Lu, D, Chandna, H, Mann, J, Ramaswamy, G, Browne, K, Janik, M, Cannon, K, Tolerico, P., Berni, Andrea, ACS - Amsterdam Cardiovascular Sciences, Vascular Medicine, and Cardiology

Subjects
Male, Indoles, Acetates, Acute Coronary Syndrome, Aged, Angina, Unstable, Atherosclerosis, Double-Blind Method, Early Termination of Clinical Trials, Female, Heptanoic Acids, Humans, Middle Aged, Phospholipases A, Phospholipases A2, Secretory, Pyrroles, Risk, Stroke, Survival Analysis, Treatment Outcome, Myocardial Infarction, law.invention, chemistry.chemical_compound, Randomized controlled trial, law, Atorvastatin, Clinical endpoint, Medicine (all), General Medicine, Angina, Keto Acids, medicine.medical_specialty, Acute coronary syndrome, Placebo, Unstable, Internal medicine, Multicenter trial, medicine, Atorvastatin Calcium, Unstable angina, business.industry, Secretory, medicine.disease, Interim analysis, Surgery, Phospholipases A2, chemistry, Varespladib, business
Abstract

Importance Secretory phospholipase A 2 (sPLA 2 ) generates bioactive phospholipid products implicated in atherosclerosis. The sPLA 2 inhibitor varespladib has favorable effects on lipid and inflammatory markers; however, its effect on cardiovascular outcomes is unknown. Objective To determine the effects of sPLA 2 inhibition with varespladib on cardiovascular outcomes. Design, Setting, and Participants A double-blind, randomized, multicenter trial at 362 academic and community hospitals in Europe, Australia, New Zealand, India, and North America of 5145 patients randomized within 96 hours of presentation of an acute coronary syndrome (ACS) to either varespladib (n = 2572) or placebo (n = 2573) with enrollment between June 1, 2010, and March 7, 2012 (study termination on March 9, 2012). Interventions Participants were randomized to receive varespladib (500 mg) or placebo daily for 16 weeks, in addition to atorvastatin and other established therapies. Main Outcomes and Measures The primary efficacy measure was a composite of cardiovascular mortality, nonfatal myocardial infarction (MI), nonfatal stroke, or unstable angina with evidence of ischemia requiring hospitalization at 16 weeks. Six-month survival status was also evaluated. Results At a prespecified interim analysis, including 212 primary end point events, the independent data and safety monitoring board recommended termination of the trial for futility and possible harm. The primary end point occurred in 136 patients (6.1%) treated with varespladib compared with 109 patients (5.1%) treated with placebo (hazard ratio [HR], 1.25; 95% CI, 0.97-1.61; log-rank P = .08). Varespladib was associated with a greater risk of MI (78 [3.4%] vs 47 [2.2%]; HR, 1.66; 95% CI, 1.16-2.39; log-rank P = .005). The composite secondary end point of cardiovascular mortality, MI, and stroke was observed in 107 patients (4.6%) in the varespladib group and 79 patients (3.8%) in the placebo group (HR, 1.36; 95% CI, 1.02-1.82; P = .04). Conclusions and Relevance In patients with recent ACS, varespladib did not reduce the risk of recurrent cardiovascular events and significantly increased the risk of MI. The sPLA 2 inhibition with varespladib may be harmful and is not a useful strategy to reduce adverse cardiovascular outcomes after ACS. Trial Registration clinicaltrials.gov Identifier:NCT01130246

Published
2014

9. Time course analysis of gene expression identifies multiple genes with differential expression in patients with in-stent restenosis

Author

Gudnason Thorarinn, Thorgeirsson Gudmundur, Andersen Karl, Helgadottir Anna, Billings Eric M, O'Neill Kathleen, Zheng Gang, Mehta Laxmi, Skelding Kimberly, Joo Jungnam, Ganesh Santhi K, Geller Nancy L, Simari Robert D, Holmes David R, O'Neill William W, and Nabel Elizabeth G

Subjects
Internal medicine, RC31-1245, Genetics, QH426-470
Abstract

Abstract Background The vascular disease in-stent restenosis (ISR) is characterized by formation of neointima and adverse inward remodeling of the artery after injury by coronary stent implantation. We hypothesized that the analysis of gene expression in peripheral blood mononuclear cells (PBMCs) would demonstrate differences in transcript expression between individuals who develop ISR and those who do not. Methods and Results We determined and investigated PBMC gene expression of 358 patients undergoing an index procedure to treat in de novo coronary artery lesions with bare metallic stents, using a novel time-varying intercept model to optimally assess the time course of gene expression across a time course of blood samples. Validation analyses were conducted in an independent sample of 97 patients with similar time-course blood sampling and gene expression data. We identified 47 probesets with differential expression, of which 36 were validated upon independent replication testing. The genes identified have varied functions, including some related to cellular growth and metabolism, such as the NAB2 and LAMP genes. Conclusions In a study of patients undergoing bare metallic stent implantation, we have identified and replicated differential gene expression in peripheral blood mononuclear cells, studied across a time series of blood samples. The genes identified suggest alterations in cellular growth and metabolism pathways, and these results provide the basis for further specific functional hypothesis generation and testing of the mechanisms of ISR.

Published
2011
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10. Association of an INSIG2 obesity allele with cardiovascular phenotypes is gender and age dependent

Author

Erdman Robert, Chu Xin, Kelsey Sheryl F, Selzer Faith, Vlachos Helen, Gerhard Glenn S, Skelding Kimberly A, Williams David O, and Kip Kevin E

Subjects
Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Abstract Background The INSIG2 gene has been implicated in cholesterol metabolism and a single nucleotide polymorphism (SNP) near INSIG2 has been shown to be associated with obesity. We sought to determine the relationship of the INSIG2 SNP to cardiovascular disease (CVD) related phenotypes. Methods and Results Nine hundred forty six patients undergoing percutaneous coronary intervention (PCI) in wave 5 of the multicenter NHLBI Dynamic Registry were genotyped using RT-PCR/TaqMan/allelic discrimination for the rs7566605 SNP near the INSIG2 gene. Clinical variables analyzed include demographics, medical history, and procedural details. The prevalence of peripheral vascular disease (PVD) was significantly higher in older men (≥65 years) who were either homozygous or carriers of the obesity/lipid risk allele ("C") compared to non-carriers (odds ratio 3.4, p = 0.013) using a logistic regression model incorporating history of hypercholesterolemia, history of hypertension, cerebrovascular disease, history of diabetes, and BMI. A similar relationship with cerebrovascular disease was found in older (>65) women (odds ratio 3.4, p = 0.013). The INSIG2 SNP was not associated with BMI, nor with other clinical variables. Conclusion Age and gender may influence the association of the INSIG2 obesity SNP with PVD and cerebrovascular disease in patients with pre-existing CVD.

Published
2010
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11. Knowledge and attitudes of primary care physicians in the management of patients at risk for cardiovascular events

Author

Turakhia Mintu P, Foster Elyse, Foster Jill A, Abdolrasulnia Maziar, Doroodchi Hamidreza, Skelding Kimberly A, Sagar Kiran, and Casebeer Linda L

Subjects
Medicine (General), R5-920
Abstract

Abstract Background Adherence to clinical practice guidelines for management of cardiovascular disease (CVD) is suboptimal. The purposes of this study were to identify practice patterns and barriers among U.S. general internists and family physicians in regard to cardiovascular risk management, and examine the association between physician characteristics and cardiovascular risk management. Methods A case vignette survey focused on cardiovascular disease risk management was distributed to a random sample of 12,000 U.S. family physicians and general internists between November and December 2006. Results Responses from a total of 888 practicing primary care physicians who see 60 patients per week were used for analysis. In an asymptomatic patient at low risk for cardiovascular event, 28% of family physicians and 37% of general internists made guideline-based preventive choices for no antiplatelet therapy (p < .01). In a patient at high risk for cardiovascular event, 59% of family physicians and 56% of general internists identified the guideline-based goal for serum fasting LDL level (< 100 mg/dl). Guideline adherence was inversely related to years in practice and volume of patients seen. Cost of medications (87.7%), adherence to medications (74.1%), adequate time for counseling (55.7%), patient education tools (47.1%), knowledge and skills to recommend dietary changes (47.8%) and facilitate patient adherence (52.0%) were cited as significant barriers to CVD risk management. Conclusion Despite the benefits demonstrated for managing cardiovascular risks, gaps remain in primary care practitioners' management of risks according to guideline recommendations. Innovative educational approaches that address barriers may facilitate the implementation of guideline-based recommendations in CVD risk management.

Published
2008
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15. SCAI expert consensus update on best practices in the cardiac catheterization laboratory: This statement was endorsed by the American College of Cardiology (ACC), the American Heart Association (AHA), and the Heart Rhythm Society (HRS) in April 2021.

Author

Naidu SS, Abbott JD, Bagai J, Blankenship J, Garcia S, Iqbal SN, Kaul P, Khuddus MA, Kirkwood L, Manoukian SV, Patel MR, Skelding K, Slotwiner D, Swaminathan RV, Welt FG, and Kolansky DM

Subjects
Angiography, Cardiac Catheterization, Consensus, Humans, Laboratories, Treatment Outcome, United States, American Heart Association, Cardiology
Abstract

The current document commissioned by the Society for Cardiovascular Angiography and Interventions (SCAI) and endorsed by the American College of Cardiology, the American Heart Association, and Heart Rhythm Society represents a comprehensive update to the 2012 and 2016 consensus documents on patient-centered best practices in the cardiac catheterization laboratory. Comprising updates to staffing and credentialing, as well as evidence-based updates to the pre-, intra-, and post-procedural logistics, clinical standards and patient flow, the document also includes an expanded section on CCL governance, administration, and approach to quality metrics. This update also acknowledges the collaboration with various specialties, including discussion of the heart team approach to management, and working with electrophysiology colleagues in particular. It is hoped that this document will be utilized by hospitals, health systems, as well as regulatory bodies involved in assuring and maintaining quality, safety, efficiency, and cost-effectiveness of patient throughput in this high volume area., (© 2021 Wiley Periodicals LLC.)

Published
2021
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16. Cardiovascular disease risk unmasked by pregnancy complications.

Author

Jasper R and Skelding K

Subjects
Abortion, Spontaneous, American Heart Association, Cardiovascular Diseases prevention & control, Female, Humans, Practice Guidelines as Topic, Pregnancy, Pregnancy Complications, Cardiovascular prevention & control, Risk Factors, United States, Women's Health, Cardiovascular Diseases epidemiology, Heart physiopathology, Pregnancy Complications, Cardiovascular epidemiology
Abstract

Pregnancy related complications indicate a propensity for atherosclerotic disease. Epidemiologic data demonstrate early onset cardiovascular disease in women with a history of pregnancy loss, preterm pregnancy or pregnancy complicated by intrauterine growth restriction. Early onset diabetes, increased rates of MI and increased rates of stroke are more prevalent after gestational diabetes. In addition, hypertensive disorders of pregnancy mark significant pathophysiologic changes, including vascular dysfunction and immunologic changes, which induce atherogenesis and result in a substantial increase in rates of stroke, ischemic heart disease and cardiac mortality. Metabolic, endothelial and inflammatory changes are responsible for either the early onset or early recognition of cardiovascular disease propensity in patients who experience a complicated pregnancy. Therefore, the American Heart Association guidelines recognize pregnancy related complications as an independent risk factor for heart disease. This review informs physicians of epidemiologic data and, guideline recommendations and is meant to guide physicians in early interventions including provider education, routine post-partum multidisciplinary (primary care, obstetrics, cardiology) evaluation, risk factor monitoring and control after a complicated pregnancy., (Copyright © 2018 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.)

Published
2018
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17. Effect of Access Site Choice on Acute Kidney Injury After Percutaneous Coronary Intervention.

Author

Pancholy MS, Skelding K, Scott T, Blankenship J, and Pancholy SB

Subjects
Acute Kidney Injury epidemiology, Aged, Catheterization, Peripheral methods, Contrast Media adverse effects, Female, Femoral Artery, Follow-Up Studies, Humans, Incidence, Male, Middle Aged, Pennsylvania epidemiology, Percutaneous Coronary Intervention methods, Postoperative Complications epidemiology, Propensity Score, Radial Artery, Retrospective Studies, Risk Factors, Acute Coronary Syndrome surgery, Acute Kidney Injury etiology, Catheterization, Peripheral adverse effects, Percutaneous Coronary Intervention adverse effects, Postoperative Complications etiology
Abstract

Acute kidney injury (AKI) after percutaneous coronary intervention (PCI) is associated with worse outcomes. Consecutive patients undergoing PCI between 2005 and 2013 were retrospectively analyzed. Patients undergoing PCI using transfemoral access (TFA) were categorized as the TFA Group, and those using transradial access (TRA) were categorized as the TRA Group. Post-PCI AKI was defined as an increase in serum creatinine >0.5 mg/dl or >25% increase from baseline 48 to 72 hours after the procedure. Independent predictors of post-PCI AKI were identified using inverse probability weighted multivariable analysis. There were 7,529 patients included in the analysis, 5,353 (71%) in the TFA Group and 2,176 (29%) in the TRA Group. Patients in the TRA Group were younger, more likely to be female, taller, heavier and have acute coronary syndrome (ACS) and were less likely to have previous coronary artery bypass graft surgery, cardiogenic shock, and intra-aortic balloon pump use and had shorter fluoroscopy time and less contrast use. Bleeding Academic Research Consortium type 3 or 5 was significantly less frequent in the TRA Group. The primary end point of post-PCI AKI was observed significantly less frequently in the TRA Group compared with the TFA Group (1.1% vs 2.4%, p = 0.001). TRA was independently associated with a lower incidence of post-PCI AKI (odds ratio 0.57, 95% confidence interval 0.35 to 0.91, p = 0.018). In conclusion, access site choice is an independent predictor of post-PCI AKI with a significant risk reduction associated with TRA compared with TFA., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Published
2017
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18. Middle-of-the-night PCI does not affect subsequent day PCI success and complication rates by the same operator.

Author

Crudu V, Sartorius J, Berger P, Scott T, Skelding K, and Blankenship J

Subjects
Aged, Chi-Square Distribution, Female, Hemorrhage etiology, Hospital Mortality, Humans, Logistic Models, Male, Middle Aged, Multivariate Analysis, Odds Ratio, Pennsylvania, Prospective Studies, Registries, Risk Assessment, Risk Factors, Task Performance and Analysis, Time Factors, Treatment Outcome, After-Hours Care, Clinical Competence, Percutaneous Coronary Intervention adverse effects, Percutaneous Coronary Intervention mortality, Personnel Staffing and Scheduling, Sleep Deprivation
Abstract

Objective: To determine the impact of percutaneous coronary interventions (PCI) performed during late-night hours on next day PCI performance by the same interventional cardiologist., Background: There is little data regarding the effects of sleep deprivation on interventional cardiologists performing PCIs., Methods: All primary PCIs from January 1, 2005 to December 31, 2009 between 11 PM and 7 AM were identified. All PCIs performed during the subsequent work day by the same interventionists were included in the sleep-deprived group. All other PCIs were included in the non-sleep-deprived group. Data were entered prospectively into the American College of Cardiology National Cardiovascular Data Registry (NCDR). The two groups were compared with respect to efficacy and safety endpoints., Results: During the 5-year period, 3,944 PCIs were performed by four operators, including 3,644 non-sleep-deprived cases and 167 sleep-deprived cases. The two groups were similar with respect to demographics, comorbidities, and procedural characteristics. There were more intraprocedural deaths in the sleep-deprived group (1.2% vs. 0.2%, P = 0.04); however, the adjusted odds ratio (OR) was nonsignificant (OR = 6.83, 95% confidence interval [CI] = 0.66-39.63, P = 0.11). Excessive bleeding at the arterial access site in the non-sleep-deprived group was more frequent (2.7% vs. 0%, P = 0.02). There were no differences in the combined safety or efficacy endpoints between the two groups., Conclusion: In this single-center study, we found no evidence that middle-of-the night procedures adversely affect safety or efficacy of procedures done the next day by the same operator., (Copyright © 2012 Wiley Periodicals, Inc.)

Published
2012
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19. Clinical presentation and predictors of target vessel revascularization after drug-eluting stent implantation.

Author

Al Muradi H, Mehra A, Okolo J, Vlachos H, Selzer F, Marroquin OC, Skelding K, Holper EM, Williams DO, and Abbott JD

Subjects
Adult, Age Factors, Aged, Aged, 80 and over, Coronary Angiography methods, Female, Humans, Incidence, Male, Middle Aged, Percutaneous Coronary Intervention, Predictive Value of Tests, Retrospective Studies, Risk Factors, Treatment Outcome, Coronary Restenosis epidemiology, Drug-Eluting Stents adverse effects, Myocardial Infarction epidemiology, Myocardial Revascularization statistics & numerical data
Abstract

Background: Drug eluting stent (DES) failure including restenosis and stent thrombosis, or disease progression may result in target vessel revascularization (TVR) but the relative contribution of these mechanisms in the DES era is not well described. We sought to examine the predictors and presentations of patients with clinically driven TVR after DES., Methods: Patients with all lesions treated with a DES in the Dynamic Registry from 2004 to 2006 were analyzed. Included were 2691 patients with 3401 lesions. Patients with and without incident clinically driven TVR at 2years were compared according to baseline clinical, procedural, and angiographic characteristics and independent predictors of TVR and target lesion revascularization (TLR) were determined by multivariate analysis., Results: By 2-years, TVR occurred in 7.2% of patients and TLR in 3.8%, with 71.6% and 82.5% of repeat revascularization events occurring in the first year, respectively. The indication for first TVR was myocardial infarction in 18.6% (n=34), unstable angina in 42.6% (n=78), stable coronary disease in 25.7% (n=47) and other/unknown in 13.1% (n=24). Disease progression was responsible for 47% of TVR. Among patients with TLR, restenosis was the mechanism in 86.6% and stent thrombosis in 13.4%. Independent predictors of TVR included younger age, diabetes, attempted graft lesion, lesion length >30mm and prior lesion intervention. Independent predictors of TVR and TLR were similar., Conclusion: The incidence of clinically driven TVR is low in patients treated with DES and nearly half is attributable to disease progression, which along with the low rate of in-stent restenosis explains why the mode of presentation is often an acute coronary syndrome., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Published
2012
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20. Transradial arterial access for coronary and peripheral procedures: executive summary by the Transradial Committee of the SCAI.

Author

Caputo RP, Tremmel JA, Rao S, Gilchrist IC, Pyne C, Pancholy S, Frasier D, Gulati R, Skelding K, Bertrand O, and Patel T

Subjects
Angioplasty, Balloon, Coronary adverse effects, Angioplasty, Balloon, Coronary standards, Cardiac Catheterization adverse effects, Cardiac Catheterization standards, Catheterization, Peripheral adverse effects, Catheterization, Peripheral standards, Clinical Competence, Coronary Angiography adverse effects, Coronary Angiography standards, Credentialing, Endovascular Procedures adverse effects, Endovascular Procedures standards, Humans, Patient Selection, Risk Assessment, Risk Factors, Societies, Medical, Treatment Outcome, Angioplasty, Balloon, Coronary methods, Cardiac Catheterization methods, Cardiovascular Diseases diagnostic imaging, Cardiovascular Diseases therapy, Catheterization, Peripheral methods, Coronary Angiography methods, Endovascular Procedures methods, Radial Artery
Abstract

In response to growing U.S. interest, the Society for Coronary Angiography and Interventions recently formed a Transradial Committee whose purpose is to examine the utility, utilization, and training considerations related to transradial access for percutaneous coronary and peripheral procedures. With international partnership, the committee has composed a comprehensive overview of this subject presented here-with., (Copyright © 2011 Wiley Periodicals, Inc.)

Published
2011
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21. Complications related to access site after percutaneous coronary interventions: are the adverse events underreported?

Author

Crudu V, Blankenship J, Berger P, Scott T, and Skelding K

Subjects
Aged, Aneurysm, False mortality, Angioplasty, Balloon, Coronary mortality, Arteriovenous Fistula mortality, Cardiac Catheterization mortality, Chi-Square Distribution, Databases as Topic, Female, Hemorrhage mortality, Hospital Mortality, Humans, Incidence, Male, Middle Aged, Pennsylvania epidemiology, Punctures, Quality Improvement, Quality Indicators, Health Care, Registries, Risk Assessment, Risk Factors, Time Factors, Aneurysm, False etiology, Angioplasty, Balloon, Coronary adverse effects, Arteriovenous Fistula etiology, Blood Transfusion mortality, Cardiac Catheterization adverse effects, Hemorrhage etiology
Abstract

Objectives: The primary objective was to compare the NCDR rate of four access site related complications (arteriovenous fistula, pseudoaneurysm, retroperitoneal bleed, and blood transfusion) with that obtained independently within a Quality Improvement (QI) Database. The secondary objective was to determine the in-hospital mortality related to these complications., Background: NCDR is the most comprehensive database of post-PCI patients and a method by which hospitals are compared for quality of care and outcomes. The collected data include in-hospital events only, therefore reporting for same day and/or early discharges may fail to capture adverse events. We hypothesized that the actual rate of complications post-PCI may be higher than the rate reported in NCDR., Methods: Adverse events following PCIs were collected in a QI database. We compared the rate of four above mentioned complications between NCDR and our QI database for the time period between January 1, 2005 and December 31, 2008., Results: A total of 3,940 PCIs were performed on 3,430 patients in the four-year interval. The incidence of the combined endpoint of the four adverse events was 4.1% (161 events) in NCDR, vs. 4.7% (186 events) in QI database, a 13% higher yield. There was significantly higher in-hospital mortality in the complication group with regards to both all cause (4.7% vs. 1.1%, P < 0.0001) and cardiovascular mortality (2.7% vs. 1%, P = 0.046)., Conclusions: Access site related complications occurred 13% more than what was reported in NCDR and were associated with a greater than fourfold increase in in-hospital mortality., (Copyright © 2011 Wiley-Liss, Inc.)

Published
2011
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22. Time course analysis of gene expression identifies multiple genes with differential expression in patients with in-stent restenosis.

Author

Ganesh SK, Joo J, Skelding K, Mehta L, Zheng G, O'Neill K, Billings EM, Helgadottir A, Andersen K, Thorgeirsson G, Gudnason T, Geller NL, Simari RD, Holmes DR, O'Neill WW, and Nabel EG

Subjects
Aged, Blood Cells metabolism, Cell Adhesion Molecules, Neuronal genetics, Cell Adhesion Molecules, Neuronal metabolism, Coronary Restenosis metabolism, Female, GPI-Linked Proteins genetics, GPI-Linked Proteins metabolism, Gene Expression Regulation, Humans, Male, Middle Aged, Repressor Proteins genetics, Repressor Proteins metabolism, Software, Time Factors, Coronary Restenosis genetics, Stents
Abstract

Background: The vascular disease in-stent restenosis (ISR) is characterized by formation of neointima and adverse inward remodeling of the artery after injury by coronary stent implantation. We hypothesized that the analysis of gene expression in peripheral blood mononuclear cells (PBMCs) would demonstrate differences in transcript expression between individuals who develop ISR and those who do not., Methods and Results: We determined and investigated PBMC gene expression of 358 patients undergoing an index procedure to treat in de novo coronary artery lesions with bare metallic stents, using a novel time-varying intercept model to optimally assess the time course of gene expression across a time course of blood samples. Validation analyses were conducted in an independent sample of 97 patients with similar time-course blood sampling and gene expression data. We identified 47 probesets with differential expression, of which 36 were validated upon independent replication testing. The genes identified have varied functions, including some related to cellular growth and metabolism, such as the NAB2 and LAMP genes., Conclusions: In a study of patients undergoing bare metallic stent implantation, we have identified and replicated differential gene expression in peripheral blood mononuclear cells, studied across a time series of blood samples. The genes identified suggest alterations in cellular growth and metabolism pathways, and these results provide the basis for further specific functional hypothesis generation and testing of the mechanisms of ISR.

Published
2011
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23. The use of radiographic contrast media during PCI: a focused review: a position statement of the Society of Cardiovascular Angiography and Interventions.

Author

Klein LW, Sheldon MW, Brinker J, Mixon TA, Skelding K, Strunk AO, Tommaso CL, Weiner B, Bailey SR, Uretsky B, Kern M, and Laskey W

Subjects
Evidence-Based Medicine, Humans, Patient Selection, Risk Assessment, Risk Factors, Angioplasty, Balloon, Coronary adverse effects, Angioplasty, Balloon, Coronary standards, Contrast Media adverse effects, Contrast Media standards, Radiography, Interventional adverse effects, Radiography, Interventional standards
Published
2009
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24. Predictors of long-term major adverse cardiac events and clinical restenosis following elective percutaneous coronary stenting.

Author

Cai Q, Skelding K, Armstrong A Jr, Desai D, Wood GC, and Blankenship J

Subjects
Angioplasty, Balloon, Coronary methods, Coronary Angiography, Coronary Restenosis diagnostic imaging, Coronary Restenosis etiology, Female, Follow-Up Studies, Humans, Incidence, Male, Middle Aged, Postoperative Complications, Prognosis, Retrospective Studies, Risk Factors, Time Factors, United States epidemiology, Angioplasty, Balloon, Coronary adverse effects, Coronary Restenosis epidemiology, Elective Surgical Procedures adverse effects, Stents
Abstract

Limited data exist regarding the predictors of long-term clinical outcomes following elective percutaneous coronary intervention (PCI) in the current era of stenting. The authors investigated the predictors of major adverse cardiac events (MACE) and clinical restenosis in 740 consecutive patients who underwent successful elective PCI with bare metal stents (BMSs) or drug-eluting stents (DESs). At 30-month follow-up, compared with BMS recipients, DES recipients had a significantly lower rate of MACE, which was mainly driven by a decreased repeat target vessel PCI. The rate of 30-month clinical restenosis was significantly lower in DES recipients. The authors conclude that baseline clinical, angiographic, and procedural characteristics determine long-term MACE and clinical restenosis after elective PCI, with DES being the independent predictor for both.

Published
2009
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26. Bone marrow-derived myofibroblasts are present in adult human heart valves.

Author

Deb A, Wang SH, Skelding K, Miller D, Simper D, and Caplice N

Subjects
Adult, Antigens, CD analysis, Antigens, Differentiation, Myelomonocytic analysis, Aortic Valve pathology, Bone Marrow Transplantation, Female, Heart Valve Diseases metabolism, Heart Valve Diseases therapy, Humans, Immunohistochemistry, In Situ Hybridization, Fluorescence, Male, Microfilament Proteins analysis, Middle Aged, Muscle Proteins analysis, Aortic Valve metabolism, Bone Marrow Cells metabolism, Myocytes, Smooth Muscle metabolism
Abstract

Background and Aim of the Study: Endothelial, smooth muscle and cardiomyocyte chimerism has been shown to occur in the human heart. It is currently unknown whether the bone marrow contributes to cellular components of adult human heart valves. Here, it was determined whether bone marrow-derived smooth muscle-like cells (SMLC) are present in the heart valves of adult subjects., Methods: By combining immunofluorescence staining and fluorescence in-situ hybridization (FISH) for X and Y chromosomes, the heart valves of gender-mismatched bone marrow transplant patients were examined for the presence of chimeric cells expressing calponin, a smooth muscle-specific protein. Concomitant staining for CD68 antigen was carried out to exclude cells of a monocytic lineage., Results: The mean percentage of bone marrow-derived SMLC in valves was 0.28 +/- 0.03%, with the total proportion of chimeric cells estimated at 0.71 +/- 0.05%. The mean proportion of CD68+ cells was 0.33 +/- 0.05%. Not a single cell stained doubly for calponin and CD68 antigen., Conclusion: These data establish, for the first time, human bone marrow as a source of progenitor cells contributing to SMLC in adult human heart valves.

Published
2005

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