Abstract
Acute pulmonary embolism (PE) can diminish patient quality of life (QoL). The objective was to test whether treatment with tenecteplase has an independent effect on a measurement that reflects QoL in patients with submassive PE. This was a secondary analysis of an 8-center, prospective randomized controlled trial, utilizing multivariate regression to control for predefined predictors of worsened QoL including: age, active malignancy, history of PE or deep venous thrombosis (DVT), recurrent PE or DVT, chronic obstructive pulmonary disease and heart failure. QoL was measured with the physical component summary (PCS) of the SF-36. Analysis included 76 patients (37 randomized to tenecteplase, 39 to placebo). Multivariate regression yielded an equation f(8, 67), P < 0.001, with R2 = 0.303. Obesity had the largest effect on PCS (β = −8.6, P < 0.001), with tenecteplase second (β = 4.73, P = 0.056). After controlling for all interactions, tenecteplase increased the PCS by +5.37 points (P = 0.027). In patients without any of the defined comorbidities, the coefficient on the tenecteplase variable was not significant (−0.835, P = 0.777). In patients with submassive PE, obesity had the greatest influence on QoL, followed by use of fibrinolysis. Fibrinolysis had a marginal independent effect on patient QoL after controlling for comorbidities, but was not significant in patients without comorbid conditions.
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van Es J, den Exter PL, Kaptein AA, Andela CD, Erkens PM, Klok FA et al (2013) Quality of life after pulmonary embolism as assessed with SF-36 and PEmb-QoL. Thromb Res 132(5):500–505
Klok FA, van Kralingen KW, van Dijk AP, Heyning FH, Vliegen HW, Kaptein AA et al (2010) Quality of life in long-term survivors of acute pulmonary embolism. Chest 138(6):1432–1440
Kline JA, Nordenholz KE, Courtney DM, Kabrhel C, Jones AE, Rondina MT et al (2014) Treatment of submassive pulmonary embolism with tenecteplase or placebo: cardiopulmonary outcomes at three months (TOPCOAT): multicenter double-blind, placebo-controlled randomized trial. J Thromb Haemost 12:549–568
Montori VM, Devereaux PJ, Adhikari NK, Burns KE, Eggert CH, Briel M et al (2005) Randomized trials stopped early for benefit: a systematic review. JAMA 294(17):2203–2209
Kline JA, Hernandez-Nino J, Hogg MM, Jones AE, Courtney DM, Kabrhel C et al (2013) Rationale and methodology for a multicenter randomized trial of fibrinolysis for pulmonary embolism that includes quality of life outcomes. Emerg Med Australas 25:515–526
Hays RD, Sherbourne CD, Mazel RM (1993) The RAND 36-Item Health Survey 1.0. Health Econ 2(3):217–227
Peitz GW, Troyer J, Jones AE, Shapiro NI, Nelson RD, Hernandez J et al (2014) Association of body mass index with increased cost of care and length of stay for emergency department patients with chest pain and dyspnea. Circ Cardiovasc Qual Outcome 7(2):292–298
Meyer G, Vicaut E, Danays T et al (2014) Fibrinolysis for patients with intermediate-risk pulmonary embolism. N Engl J Med 370:1402–1411
Konstantinides SV, Meyer G, Lang I, Verschuren F, Meyer G, Meneveau N et al (2012) Single-bolus tenecteplase plus heparin compared with heparin alone for normotensive patients with acute pulmonary embolism who have evidence of right ventricular dysfunction and myocardial injury: rationale and design of the pulmonary embolism thrombolysis (PEITHO) trial. Am Heart J 163(33–38):e1
Kolotkin RL, Meter K, Williams GR (2001) Quality of life and obesity. Obes Rev 2:219–229
Stevinson BG, Hernandez-Nino J, Rose G, Kline JA (2007) Echocardiographic and functional cardiopulmonary problems 6 months after first-time pulmonary embolism in previously healthy patients. Eur Heart J 28(20):2517–2524
Kline JA, Steuerwald MT, Marchick MR, Hernandez-Nino J, Rose GA (2009) Prospective evaluation of right ventricular function and functional status six months after acute submassive pulmonary embolism: frequency of persistent or subsequent elevation in estimated pulmonary artery pressure. Chest 136(5):1202–1210
Hogg K, Kimpton M, Carrier M, Coyle D, Forgie M, Wells P (2013) Estimating quality of life in acute venous thrombosis. JAMA Int Med 173(12):1067–1072
Chatterjee S, Chakraborty A, Weinberg I, Kadakia M, Wilensky RL, Sardar P et al (2014) Thrombolysis for pulmonary embolism and risk of all-cause mortality, major bleeding, and intracranial hemorrhage: a meta-analysis. JAMA 311(23):2414–2421
Conflict of interests
JAK owns stock in CP Diagnostics LLC is a consultant for Daiichi Sankyo Inc, Donawa Lifesciences Consulting, Janssen, and Stago Diagnostica, and has received funding from the Agency for Healthcare Reform, National Institutes for Health. Study funded by an investigator initiated Grant from Genentech, Inc. (Grant #: N3944). AEJ has received funding from the National Institutes of Health. DBD serves as a consultant for Daiichi Sankyo, Beckmann Coulter, Mylan and has received research support from Radiometer, Alere, DOD and the National Institutes of Health. CK is a consultant for Diagnostica Stago, Siemens Healthcare and has received grant funding to his institution from Diagnostica Stago, Siemens Healthcare, the Harvard Milton Fund and the National Institutes of Health.
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Trial registration: NCT00680628
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Stewart, L.K., Peitz, G.W., Nordenholz, K.E. et al. Contribution of fibrinolysis to the physical component summary of the SF-36 after acute submassive pulmonary embolism. J Thromb Thrombolysis 40, 161–166 (2015). https://doi.org/10.1007/s11239-014-1155-5
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DOI: https://doi.org/10.1007/s11239-014-1155-5