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1. 4.8 Reference Values for Submaximal Exercise Blood Pressure: the EXERcise Stress Test CollaboratION (EXERTION)

Author

Schultz Martin, Ann-Marie Kovacevic, Philip Roberts-Thomson, Tony Stanton, Christian Hamilton-Craig, Sudir Wahi, James Hare, Joseph Selvanayagam, Andrew Maiorana, Alison Venn, and James Sharman

Subjects
Specialties of internal medicine, RC581-951, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Background: Exaggerated blood pressure (BP) during submaximal exercise independently predicts cardiovascular mortality and identifies uncontrolled high BP not detected at rest. However, thresholds for submaximal exercise BP during clinical exercise testing have never been defined from a large representative sample, which was the aim of this study. Methods: Records from 13,949 people referred for a clinical exercise stress test (aged 52 ± 13 years, 61% male) using the Bruce treadmill protocol (stages 1 to 4 plus peak) were extracted from 4 Australian hospitals over the years 2000–2018. Exercise records were linked to administrative health datasets (hospital admissions and emergency presentations) to define clinical characteristics, including cardiovascular disease history. Thresholds denoting exaggerated BP were defined as > 90th centile at each exercise stage. Results: SBP and DBP thresholds across all stages were higher in males vs. females (stage-1: 180/90 vs 175/90 mmHg; stage-2: 196/94 vs 190/90 mmHg; stage-3: 204/97 vs 196/91 mmHg; stage-4: 210/100 vs 196/92 mmHg; peak: 215/100 vs 206/95 mmHg). SBP at all stages increased stepwise from the 1st to 4th age quartile (p < 0.05), whilst DBP remained similar (stage-1: 163/90 to 185/92 mmHg; stage-2: 180/90 to 204/95 mmHg; stage-3: 193/90 to 210/95 mmHg, stage-4: 200/91, to 210/96 mmHg; peak: 201/95 to 217/100 mmHg). Results were similar irrespective of cardiovascular disease history. Conclusions: This is the first study to define submaximal exercise BP thresholds during clinical exercise testing. Thresholds were higher in males compared to females and increased with age. These thresholds may help clinicians to identify people at increased high BP-related risk.

Published
2020
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2. P113 The Forgotten Black Box of Blood Pressure: Error in Oscillometric Mean Arterial Pressure is Associated with Cuff Measurement Inaccuracy

Author

Dean Picone, Martin Schultz, Matthew Armstrong, Nathan Dwyer, Philip Roberts-Thomson, Thomas Weber, and James Sharman

Subjects
Specialties of internal medicine, RC581-951, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Background: Accurate measurement of cuff systolic BP (SBP) and diastolic BP (DBP) is contingent on the assumption of oscillometric MAP being accurate. If MAP is inaccurate this is likely to impact the accuracy of cuff SBP and DBP, but this has never been determined and was the aim of the study. Methods: In five independent studies, MAP was measured by five unique cuff oscillometric BP devices at the same time as invasive aortic MAP (area under the waveform) by fluid-filled or solid-state catheters among 262 patients (61 ± 11 years, 65% male) during coronary angiography. Cuff SBP and DBP were estimated by device-specific algorithms. Measurement errors were calculated as cuff – invasive aortic BP. Results: For each BP device, MAP error was −2.6 ± 6.1, 0.76 ± 7.2, 1.4 ± 5.5, 1.5 ± 6.7 and 7.1 ± 9.2 mmHg. Corresponding SBP errors were 4.4 ± 8.7, −0.8 ± 11.2, −8.8 ± 10.4, −0.9 ± 10.5 and 1.9 ± 10.8 mmHg, whereas DBP errors were 8.8 ± 5.1, 2.0 ± 7.4, 6.7 ± 7.3, 10.3 ± 9.0 and 13.1 ± 6.4 mmHg. There was a direct relationship between errors in oscillometric MAP and SBP error in four of the five devices (B range = 0.42 to 1.04). However, MAP error was consistently related to DBP error in all devices (B range = 0.48 to 0.97). Across all devices, absolute error in MAP ≥3 mmHg corresponded to absolute error in SBP and DBP ≥5 mmHg in 56–77% and 62–88% of patients. Conclusion: Errors in oscillometric MAP are directly related to cuff SBP and DBP inaccuracy, but the magnitude of error is device-specific. Further work is required to understand algorithms used in oscillometric devices to improve cuff BP accuracy.

Published
2020
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3. P109 The Influence of Sex on Cuff Blood Pressure Accuracy

Author

Elif Stoneman, Dean Picone, Martin Schultz, Matthew Armstrong, Willem Bos, Nathan Dwyer, Peter Lacy, Esben Laugesen, Stefano Omboni, Giacomo Pucci, Philip Roberts-Thomson, George Stouffer, Kenji Takazawa, Thomas Weber, Berend Westerhof, and James Sharman

Subjects
Specialties of internal medicine, RC581-951, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Background: Cuff blood pressure (BP) is intended to approximate central aortic BP and accuracy is paramount. Sex differences in BP physiology could influence the accuracy of cuff BP as an estimate of invasive aortic BP, but this has not been explored in-depth and was the aim of this study. Methods: Cuff and invasive aortic BP were measured in 1701 subjects (31.9% female, aged 63 ± 12) during coronary angiography from the INvaSive blood PressurE ConsorTium (INSPECT) database. Cuff accuracy was defined as cuff–invasive BP. In a sub-sample (n = 376, 27% female, aged 63 ± 11), invasive brachial BP was recorded to assess systolic (SBP) amplification (invasive brachial–aortic SBP). Results: Invasive aortic SBP was higher in females compared with males (mean [95% CI]: 141.8 mmHg [137.1, 146.3] versus 132.9 mmHg [129.4, 136.4], p < 0.001). Cuff SBP significantly underestimated invasive aortic SBP in females compared with males (−3.1 mmHg [−5.9, −0.2] versus 1.4 mmHg [−1.1, 4.0], p < 0.001 for difference). Sex differences remained after adjustment for age and height. In the sub-sample, aortic-to-brachial SBP-amplification was lower in females (7.1 mmHg [3.3, 10.8] versus 10.2 mmHg [5.1, 15.4], p = 0.0070). Sex, SBP-amplification, height and age were associated with cuff BP inaccuracy, but only SBP-amplification and age remained associated in multivariable analysis (p < 0.05). Conclusion: Females have greater propensity towards cuff BP inaccuracy through underestimation of aortic SBP. Both age and the magnitude of aortic-to-brachial SBP-amplification are related to cuff BP inaccuracy, which provide greater understanding of sex differences in BP physiology and may help improve the accuracy of cuff BP methods.

Published
2020
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4. P112 Influence of Cuff Blood Pressure Accuracy on Identification of Isolated Systolic Hypertension

Author

Dean Picone, Martin Schultz, Matthew Armstrong, Willem Bos, Nathan Dwyer, Peter Lacy, Esben Laugesen, Stefano Omboni, Giacomo Pucci, Philip Roberts-Thomson, George Stouffer, Kenji Takazawa, Thomas Weber, Berend Westerhof, and James Sharman

Subjects
Specialties of internal medicine, RC581-951, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Introduction: Isolated systolic hypertension (ISH) is the most common form of hypertension in older people. However, accurate identification of ISH may be hindered because cuff blood pressure (BP) underestimates systolic BP (SBP) and overestimates diastolic BP (DBP). This study aimed to determine the influence of cuff BP accuracy on the identification of ISH. Methods: Cuff BP and invasive aortic BP were measured simultaneous (or near-simultaneously) in 1737 subjects (63 ± 12 years, 68% male) during coronary angiography. Data was derived from 32 studies, using 20 different cuff BP devices, from the Invasive Blood Pressure Consortium (INSPECT). ISH was defined as ≥140/

Published
2020
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5. P63 Accuracy (Validation) of Central Blood Pressure Measurement Using the Sphygmocor Xcel-cuff Device

Author

Martin Schultz, Dean Picone, Matthew Armstrong, Andrew Black, Nathan Dwyer, Philip Roberts-Thomson, and James Sharman

Subjects
Specialties of internal medicine, RC581-951, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Background: Numerous devices purport to measure central aortic BP as distinct from conventional brachial BP. This study aimed to determine the accuracy (validation) of the Sphygmocor Xcel-cuff device (AtCor Medical, Sydney, Australia) for measuring central BP. Methods: 330 patients (mean age 61.3 ± 10.6 years) undergoing coronary angiography had simultaneous measurement of invasive aortic BP and non-invasive cuff-derived central BP using the Xcel device (total n = 552 individual comparisons). Methods were undertaken according to Artery Society guidelines and several calibration techniques to derive central SBP were examined. Results: Central SBP was significantly underestimated, and with wide variability, when using the default calibration of brachial cuff SBP/DBP (−7.7 ± 11.0 mmHg). Similar wide variability was observed using other calibration methods (cuff 33% form-factor MAP/DBP, −4.4 ± 11.5 mmHg; cuff 40% form-factor MAP/DBP, 4.7 ± 11.9 mmHg; cuff oscillometric MAP/DBP, −18.2 ± 12.1 mmHg). Only calibration with invasive aortic integrated MAP/DBP resulted in a mean difference ± SD (3.3 ± 7.5 mmHg) within the minimum tolerable error of ≤5 ± ≤8 mmHg. The difference between brachial cuff SBP and invasive aortic SBP was 3.3 ± 10.7 mmHg. A subsample (n = 151) analysis to determine the accuracy of central-to-brachial SBP amplification, showed this to be over-estimated by the Xcel device (4.3 ± 9.1 mmHg, p = 0.02). Conclusion: Irrespective of calibration technique, the Sphygmocor Xcel-cuff device does not pass the Artery Society accuracy (validation) criteria for non-invasive measurement of central BP. Further accuracy refinements of this device are required.

Published
2020
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6. ST‐Segment–Elevation Myocardial Infarction (STEMI) Patients Without Standard Modifiable Cardiovascular Risk Factors—How Common Are They, and What Are Their Outcomes?

Author

Stephen T. Vernon, Sean Coffey, Mario D'Souza, Clara K. Chow, Jens Kilian, Karice Hyun, James A. Shaw, Mark Adams, Philip Roberts‐Thomson, David Brieger, and Gemma A. Figtree

Subjects
atherosclerosis, mortality, risk factor, ST‐segment–elevation myocardial infarction, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Background Programs targeting the standard modifiable cardiovascular risk factors (SMuRFs: hypertension, diabetes mellitus, hypercholesterolemia, smoking) are critical to tackling coronary heart disease at a community level. However, myocardial infarction in SMuRF‐less individuals is not uncommon. This study uses 2 sequential large, multicenter registries to examine the proportion and outcomes of SMuRF‐less ST‐segment–elevation myocardial infarction (STEMI) patients. Methods and Results We identified 3081 STEMI patients without a prior history of cardiovascular disease in the Australian GRACE (Global Registry of Acute Coronary Events) and CONCORDANCE (Cooperative National Registry of Acute Coronary Syndrome Care) registries, encompassing 42 hospitals, between 1999 and 2017. We examined the proportion that were SMuRF‐less as well as outcomes. The primary outcome was in‐hospital mortality, and the secondary outcome was major adverse cardiovascular events (death, myocardial infarction, or heart failure, during the index admission). Multivariate regression models were used to identify predictors of major adverse cardiovascular events. Of STEMI patients without a prior history of cardiovascular disease 19% also had no history of SMuRFs. This proportion increased from 14% to 23% during the study period (P=0.0067). SMuRF‐less individuals had a higher in‐hospital mortality rate than individuals with 1 or more SMuRFs. There were no clinically significant differences in major adverse cardiovascular events at 6 months between the 2 groups. Conclusions A substantial and increasing proportion of STEMI presentations occur independently of SMuRFs. Discovery of new markers and mechanisms of disease beyond standard risk factors may facilitate novel preventative strategies. Studies to assess longer‐term outcomes of SMuRF‐less STEMI patients are warranted.

Published
2019
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7. P20 BRACHIAL AND RADIAL SYSTOLIC BLOOD PRESSURE ARE NOT THE SAME: POTENTIAL IMPLICATIONS FOR VALIDATION PROTOCOLS INCLUDING BRACHIAL CUFF DEVICES AND WRIST-BASED WEARABLES

Author

Matthew Armstrong, Martin Schultz, Dean Picone, James Sharman, Nathan Dwyer, Philip Roberts-Thomson, and Andrew Black

Subjects
Specialties of internal medicine, RC581-951, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Introduction: Radial intra-arterial blood pressure (BP) is sometimes used as the reference standard for validation of brachial cuff BP devices, and there is an emerging ‘wearables’ market seeking to measure BP at the wrist. However, brachial systolic BP may not be a good representation of the radial systolic BP, and this could have implications for appropriate BP validation protocols. This study sought to determine the difference between brachial and radial systolic BP. Methods: Intra-arterial BP was measured consecutively at the brachial and radial arteries in 168 participants undergoing coronary angiography (aged 62 ± 10 years, 69% male). Intra-arterial BP recordings were made via fluid filled catheter according to guideline recommendations. Results: Brachial systolic BP was lower than radial systolic BP (136.5 vs 143.9 mmHg; p15 mmHg (140.3 and 161.3 mmHg; p < 0.001). Conclusion: Radial systolic BP is not representative of brachial systolic BP, with the majority of participants having a systolic BP difference greater than 5 mmHg between brachial and radial arteries. Therefore, if validation testing of BP devices is performed with intra-arterial BP as the reference standard, this should be undertaken at the same site as the brachial cuff or wrist based wearable device.

Published
2018
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8. P109 RESERVOIR-EXCESS PRESSURE CHARACTERISTICS HELP IDENTIFY PEOPLE WITH HIGH INTRA-ARTERIAL AORTIC SYSTOLIC BLOOD PRESSURE

Author

Elif Stoneman, Dean Picone, Martin Schultz, Matthew Armstrong, Andrew Black, Nathan Dwyer, Philip Roberts-Thomson, and James Sharman

Subjects
Specialties of internal medicine, RC581-951, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Background: High aortic blood pressure (BP) predicts clinical outcomes beyond peripheral BP. Aortic BP may differ according to level of systolic BP (SBP)-amplification but these differences cannot be identified using current non-invasive BP measurement methods. In this study, we sought to determine if high intra-arterial aortic BP could be detected via reservoir-excess pressure characteristics. Methods: Standard cuff BP, SphygmoCor-derived central BP (CBP), and intra-arterial aortic and brachial waveforms were recorded in 160 participants (61 ± 11 years, 68% male) during coronary angiography. SBP-amplification was defined as ≥5 mmHg increase in SBP across the aortic-to-brachial arteries, whereas no SBP-amplification was defined as 0.20 both). Aortic, but not brachial, reservoir pressure was significantly higher in participants with no SBP-amplification (2506 ± 662 versus 2239 ± 640 Pa/s, p = 0.011). This pattern was also observed for aortic excess pressure (718 ± 304 versus 624 ± 293 Pa/s, p = 0.049) and aortic diastolic rate constant (0.021 ± 0.08 versus 0.025 ± 0.09 s−1, p = 0.002). All differences remained after adjustment for age, sex and intra-arterial aortic SBP. Conclusions: Reservoir-excess pressure characteristics help identify people with high intra-arterial aortic BP that are otherwise missed using cuff BP or SphygmoCor-derived CBP. Thus, analysis of BP waveforms using reservoir-excess pressure characteristics could be used to refine accuracy of BP measurement.

Published
2018
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9. P147 ASSOCIATIONS BETWEEN RESERVOIR PRESSURE PARAMETERS AND KIDNEY FUNCTION ARE DEPENDENT ON THE ARTERIAL MEASUREMENT SITE

Author

Matthew Armstrong, Dean Picone, Martin Schultz, James Sharman, Nathan Dwyer, Philip Roberts-Thomson, and Andrew Black

Subjects
Specialties of internal medicine, RC581-951, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Introduction: Reservoir pressure parameters derived from pressure waveforms captured at various arterial sites predict adverse kidney function independently of conventional cuff blood pressure (BP). However, there has never been an analysis directly comparing if associations with kidney function may differ depending on arterial site of measurement, which was the aim of this study. Methods: Intra-arterial BP waveforms were measured via fluid filled catheter at the ascending aorta, brachial and radial arteries in 172 people undergoing coronary angiography (aged 60 ± 13 years, 67% male). Customised Matlab software was used to derive reservoir pressure and associated parameters of excess pressure, diastolic and systolic rate constants at each arterial site. Kidney function was determined by estimated glomerular filtration rate (eGFR). Results: Reservoir and excess pressure derived from BP waveforms measured at the aorta were associated with eGFR (r = −0.26, and r = −0.24, p < 0.01, respectively), but not from brachial or radial BP waveforms (r < −0.14, p > 0.07 all). However, diastolic rate constants from BP waveforms at all arterial sites were significantly associated with eGFR. These associations remained following adjustment for aortic systolic BP, heart rate, sex, and body mass index (β = −0.37, p = 0.001; β = −0.37, p = 0.003; β = −0.25, p = 0.02 respectively). Systolic rate constants were not significantly associated with eGFR at any arterial site. Conclusion: Associations between reservoir pressure parameters and kidney function are dependent on site of waveform measurement, with exception of the diastolic rate constant, which independently relates to kidney function irrespective of location. This is of clinical relevance since this variable can be derived from non-invasively recorded peripheral BP waveforms.

Published
2018
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10. 3.5 CUFF BLOOD PRESSURE IS PROGRESSIVELY MORE BIASED WITH INCREASING AGE: INDIVIDUAL PARTICIPANT LEVEL ANALYSIS FROM THE INSPECT CONSORTIUM

Author

Dean Picone, Martin Schultz, Petr Otahal, Ahmed Al-Jumaily, J. Andrew Black, Willem Bos, Chen-Huan Chen, Hao-Min Chen, Antoine Cremer, Nathan Dwyer, Ricardo Fonseca Diaz, Brian Gould, Alun Hughes, Hack-Lyoung Kim, Peter Lacy, Esben Laugesen, Sandy Muecke, Nobuyuki Ohte, Stefano Omboni, Christian Ott, Xiaoqing Peng, Telmo Pereira, Giacomo Pucci, Philip Roberts-Thomson, Niklas Rossen, Roland Schmieder, Velandai Srikanth, Ralph Stewart, George Stouffer, Daisuke Sueta, Kenji Takazawa, Ji-Guang Wang, Thomas Weber, Berend Westerhof, Bryan Williams, Hirotsugu Yamada, Eiichiro Yamamoto, and James Sharman

Subjects
Specialties of internal medicine, RC581-951, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Objectives: Accurate blood pressure (BP) measurement is critical for appropriate hypertension diagnosis and management. Aortic BP represents pressure loading on vital organs and this can be approximated using upper arm cuff BP. With advancing age, cuff systolic BP (SBP) increases and diastolic BP (DBP) decreases (widening pulse pressure [PP]), but whether age may influence cuff BP compared with invasive BP is unknown and was the aim of this study. Methods: Cuff BP was measured simultaneously, or near-simultaneously, with invasive aortic BP during catheterization in 1696 individuals within the INSPECT consortium (an international collaboration comprising data from 31 studies and 19 different cuff BP devices [17 oscillometric, 2 mercury sphygmomanometry]). Differences in cuff and invasive BP were assessed using mixed models. Results: Subjects were aged 63.3 ± 10.6 years and 32% female. Cuff SBP overestimated invasive aortic SBP in those aged 40–49, but with increasing age there was a progressive increase in the underestimation of aortic SBP (Table). Conversely, cuff DBP systematically overestimated aortic DBP, increasingly with age. Thus, there was a progressively higher error (underestimation) in cuff PP with older age. Adjusting models for sex, mean arterial pressure, heart rate and catheter type did not alter the findings, and no interactions between these parameters and age were found. Conclusion: Cuff BP is progressively more biased with increasing age, exposing older people to greater chance for misdiagnosis of risk related to BP. The findings highlight the need to improve cuff BP methods to ensure all people receive appropriate diagnosis and management of hypertension.

Published
2018
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11. P135 PRECISION CALIBRATION OF PERIPHERAL PRESSURE WAVEFORMS USING INTRA-ARTERIAL BLOOD PRESSURE REVEALS THE NEED FOR IMPROVED WAYS TO ACCURATELY ESTIMATE AORTIC BLOOD PRESSURE

Author

Dean S. Picone, Martin G. Schultz, Xiaoqing Peng, J. Andrew Black, Nathan Dwyer, Philip Roberts-Thomson, and James E. Sharman

Subjects
Specialties of internal medicine, RC581-951, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Background: Estimating aortic blood pressure (BP) non-invasively requires peripheral waveform calibration using cuff systolic (SBP) and diastolic (DBP). Accuracy of estimated aortic BP has never been determined when peripheral waveforms are precision calibrated using peripheral intra-arterial SBP/DBP. This is relevant to understanding the best methods to estimate aortic BP accurately and was the aim of this study. We also determined how other calibrations influence estimated aortic BP accuracy. Methods: Ascending aortic, brachial and radial artery intra-arterial BP was measured among 104 patients (61.8±10 years, 66% male) undergoing coronary angiography. Intra- arterial aortic SBP was compared with estimated aortic SBP by generalised transfer function (SphygmoCor) using: (1) intra-arterial brachial pressure waveforms calibrated with intra-arterial brachial SBP/DBP; (2) intra-arterial radial pressure waveforms calibrated with intra-arterial brachial SBP/DBP and (3) radial SBP/DBP and; (4) intra-arterial aortic mean arterial pressure (MAP)/DBP. Results: All intra-arterial SBP/DBP peripheral waveform calibrations significantly underestimated intra-arterial aortic SBP ((1) −4.5±7.0 mmHg; (2) −8.8±8.0 mmHg and (3) −5.4±7.6 mmHg; p < 0.0001 all). Conversely, intra-arterial aortic MAP/DBP calibration (4) accurately estimated aortic SBP (0.03±4.6 mmHg, p = 0.95). Underestimation of intra-arterial aortic SBP was related to lower aortic-to-brachial SBP amplification (r > 0.25, p < 0.009 all calibrations). Conclusion: Even when using accurate (intra-arterial) SBP/DBP for precision peripheral waveform calibration, aortic SBP was significantly underestimated. Intra-arterial aortic MAP/DBP was the most accurate calibration, but is not feasible for non-invasive use. These findings highlight the need for improved ways to accurately estimate aortic SBP.

Published
2017
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12. Lipoprotein(a) and Benefit of PCSK9 Inhibition in Patients With Nominally Controlled LDL Cholesterol

Author

Gregory G. Schwartz, Michael Szarek, Vera A. Bittner, Rafael Diaz, Shaun G. Goodman, J. Wouter Jukema, Ulf Landmesser, Patricio López-Jaramillo, Garen Manvelian, Robert Pordy, Michel Scemama, Peter R. Sinnaeve, Harvey D. White, Ph Gabriel Steg, P.h. Gabriel Steg, Deepak L. Bhatt, Robert A. Harrington, Andreas M. Zeiher, Pierluigi Tricoci, Matthew T. Roe, Kenneth W. Mahaffey, Jay M. Edelberg, Corinne Hanotin, Guillaume Lecorps, Angèle Moryusef, William J. Sasiela, Jean-François Tamby, Philip E. Aylward, Heinz Drexel, Peter Sinnaeve, Mirza Dilic, Renato D. Lopes, Nina N. Gotcheva, Juan-Carlos Prieto, Huo Yong, Ivan Pećin, Zeljko Reiner, Petr Ostadal, Steen Hvitfeldt Poulsen, Margus Viigimaa, Markku S. Nieminen, Nicolas Danchin, Vakhtang Chumburidze, Nikolaus Marx, Evangelos Liberopoulos, Pablo Carlos Montenegro Valdovinos, Hung-Fat Tse, Robert Gabor Kiss, Denis Xavier, Doron Zahger, Marco Valgimigli, Takeshi Kimura, Hyo Soo Kim, Sang-Hyun Kim, Andrejs Erglis, Aleksandras Laucevicius, Sasko Kedev, Khalid Yusoff, Gabriel Arturo Ramos López, Marco Alings, Sigrun Halvorsen, Roger M. Correa Flores, Rody G. Sy, Andrzej Budaj, Joao Morais, Maria Dorobantu, Yuri Karpov, Arsen D. Ristic, Terrance Chua, Jan Murin, Zlatko Fras, Anthony J. Dalby, José Tuñón, H. Asita de Silva, Emil Hagström, Christian Müller, Chern-En Chiang, Piyamitr Sritara, Sema Guneri, Alexander Parkhomenko, Kausik K. Ray, Patrick M. Moriarty, Robert Vogel, Bernard Chaitman, Sheryl F. Kelsey, Anders G. Olsson, Jean-Lucien Rouleau, Maarten L. Simoons, Karen Alexander, Chiara Meloni, Robert Rosenson, Eric J.G. Sijbrands, John H. Alexander, Luciana Armaganijan, Akshay Bagai, Maria Cecilia Bahit, J. Matthew Brennan, Shaun Clifton, Adam D. DeVore, Shalonda Deloatch, Sheila Dickey, Keith Dombrowski, Grégory Ducrocq, Zubin Eapen, Patricia Endsley, Arleen Eppinger, Robert W. Harrison, Connie Ng Hess, Mark A. Hlatky, Joseph Dedrick Jordan, Joshua W. Knowles, Bradley J. Kolls, David F. Kong, Sergio Leonardi, Linda Lillis, David J. Maron, Jill Marcus, Robin Mathews, Rajendra H. Mehta, Robert J. Mentz, Humberto Graner Moreira, Chetan B. Patel, Sabrina Bernardez Pereira, Lynn Perkins, Thomas J. Povsic, Etienne Puymirat, William Schuyler Jones, Bimal R. Shah, Matthew W. Sherwood, Kenya Stringfellow, Darin Sujjavanich, Mustafa Toma, Charlene Trotter, Sean F.P. van Diepen, Matthew D. Wilson, Andrew Tze-Kay Yan, Lilia B. Schiavi, Marcelo Garrido, Andrés F. Alvarisqueta, Sonia A. Sassone, Anselmo P. Bordonava, Alberto E. Alves De Lima, Jorge M. Schmidberg, Ernesto A. Duronto, Orlando C. Caruso, Leonardo P. Novaretto, Miguel Angel Hominal, Oscar R. Montaña, Alberto Caccavo, Oscar A. Gomez Vilamajo, Alberto J. Lorenzatti, Luis R. Cartasegna, Gustavo A. Paterlini, Ignacio J. Mackinnon, Guillermo D. Caime, Marcos Amuchastegui, Oscar Salomone, Oscar R. Codutti, Horacio O. Jure, Julio O.E. Bono, Adrian D. Hrabar, Julio A. Vallejos, Rodolfo A. Ahuad Guerrero, Federico Novoa, Cristian A. Patocchi, Cesar J. Zaidman, Maria E. Giuliano, Ricardo D. Dran, Marisa L. Vico, Gabriela S. Carnero, Pablo N. Guzman, Juan C. Medrano Allende, Daniela F. Garcia Brasca, Miguel H. Bustamante Labarta, Sebastian Nani, Eduardo D.S. Blumberg, Hugo R. Colombo, Alberto Liberman, Victorino Fuentealba, Hector L. Luciardi, Gabriel D. Waisman, Mario A. Berli, Ruben O. Garcia Duran, Horacio G. Cestari, Hugo A. Luquez, Jorge A. Giordano, Silvia S. Saavedra, Gerardo Zapata, Osvaldo Costamagna, Susana Llois, Jonathon H. Waites, Nicholas Collins, Allan Soward, Chris L.S. Hii, James Shaw, Margaret A. Arstall, John Horowitz, Daniel Ninio, James F. Rogers, David Colquhoun, Romulo E. Oqueli Flores, Philip Roberts-Thomson, Owen Raffel, Sam J. Lehman, Constantine Aroney, Steven G.M. Coverdale, Paul J. Garrahy, Gregory Starmer, Mark Sader, Patrick A. Carroll, Ronald Dick, Robert Zweiker, Uta Hoppe, Kurt Huber, Rudolf Berger, Georg Delle-Karth, Bernhard Frey, Dirk Faes, Kurt Hermans, Bruno Pirenne, Attilio Leone, Etienne Hoffer, Mathias C.M. Vrolix, Luc De Wolf, Bart Wollaert, Marc Castadot, Karl Dujardin, Christophe Beauloye, Geert Vervoort, Harry Striekwold, Carl Convens, John Roosen, Emanuele Barbato, Marc Claeys, Frank Cools, Ibrahim Terzic, Fahir Barakovic, Zlatko Midzic, Belma Pojskic, Emir Fazlibegovic, Azra Durak-Nalbantic, Mehmed Kulić, Dusko Vulic, Adis Muslibegovic, Boris Goronja, Gilmar Reis, Luciano Sousa, Jose C. Nicolau, Flavio E. Giorgeto, Ricardo P. Silva, Lilia Nigro Maia, Rafael Rech, Paulo R.F. Rossi, Maria José A.G. Cerqueira, Norberto Duda, Renato Kalil, Adrian Kormann, José Antonio M. Abrantes, Pedro Pimentel Filho, Ana Priscila Soggia, Mayler O.N. de Santos, Fernando Neuenschwander, Luiz C. Bodanese, Yorghos L. Michalaros, Freddy G. Eliaschewitz, Maria H. Vidotti, Paulo E. Leaes, Roberto V. Botelho, Sergio Kaiser, Euler Roberto F. Fernandes Manenti, Dalton B. Precoma, Jose C. Moura Jorge, Pedro Silva, Jose A. Silveira, Wladmir Saporito, Jose A. Marin Neto, Gilson S. Feitosa, Luiz Eduardo F. Ritt, Juliana A. de Souza, Fernando Costa, Weimar K.S.B. Souza, Helder J.L. Reis, Leandro Machado, José Carlos Aidar Ayoub, Georgi V. Todorov, Fedya P. Nikolov, Elena S. Velcheva, Maria L. Tzekova, Haralambi O. Benov, Stanislav L. Petranov, Haralin S. Tumbev, Nina S. Shehova-Yankova, Dimitar T. Markov, Dimitar H. Raev, Mihail N. Mollov, Kostadin N. Kichukov, Katya A. Ilieva-Pandeva, Raya Ivanova, Maryana Gospodinov, Valentina M. Mincheva, Petar V. Lazov, Bojidar I. Dimov, Manohara Senaratne, James Stone, Jan Kornder, Stephen Pearce, Danielle Dion, Daniel Savard, Yves Pesant, Amritanshu Pandey, Simon Robinson, Gilbert Gosselin, Saul Vizel, Gordon Hoag, Ronald Bourgeois, Anne Morisset, Eric Sabbah, Bruce Sussex, Simon Kouz, Paul MacDonald, Ariel Diaz, Nicolas Michaud, David Fell, Raymond Leung, Tycho Vuurmans, Christopher Lai, Frank Nigro, Richard Davies, Gustavo Nogareda, Ram Vijayaraghavan, John Ducas, Serge Lepage, Shamir Mehta, James Cha, Robert Dupuis, Peter Fong, Sohrab Lutchmedial, Josep Rodes-Cabau, Hussein Fadlallah, David Cleveland, Thao Huynh, Iqbal Bata, Adnan Hameed, Cristian Pincetti, Sergio Potthoff, Juan C. Prieto, Monica Acevedo, Arnoldo Aguirre, Margarita Vejar, Mario Yañez, Guillermo Araneda, Mauricio Fernandez, Luis Perez, Paola Varleta, Fernando Florenzano, Laura Huidobro, Carlos A. Raffo, Claudia Olivares, Leonardo Nahuelpan, Humberto Montecinos, Jiyan Chen, Yugang Dong, Weijian Huang, Jianzhong Wang, Shi'An Huang, Zhuhua Yao, Xiang Li, Lan Cui, Wenhua Lin, Yuemin Sun, Jingfeng Wang, Jianping Li, Xuelian Zhang, Hong Zhu, Dandan Chen, Lan Huang, Shaohong Dong, Guohai Su, Biao Xu, Xi Su, Xiaoshu Cheng, Jinxiu Lin, Wenxia Zong, Huanming Li, Yi Feng, Dingli Xu, Xinchun Yang, Yuannan Ke, Xuefeng Lin, Zheng Zhang, Zeqi Zheng, Zhurong Luo, Yundai Chen, Chunhua Ding, Yi Zhong, Yang Zheng, Xiaodong Li, Daoquan Peng, Shuiping Zhao, Ying Li, Xuebo Liu, Meng Wei, Shaowen Liu, Yihua Yu, Baiming Qu, Weihong Jiang, Yujie Zhou, Xingsheng Zhao, Zuyi Yuan, Ying Guo, Xiping Xu, Xubo Shi, Junbo Ge, Guosheng Fu, Feng Bai, Weiyi Fang, Xiling Shou, Xiangjun Yang, Jian'An Wang, Meixiang Xiang, Yingxian Sun, Qinghua Lu, Ruiyan Zhang, Jianhua Zhu, Yizhou Xu, Zhongcai Fan, Tianchang Li, Chun Wu, Nicolas Jaramillo, Gregorio Sanchez Vallejo, Diana C. 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Liew, Wan Mohd Izani Wan Mohamed, Armando García Castillo, Jorge Carrillo Calvillo, Pedro Fajardo Campos, Juan Carlos Núñez Fragoso, Edmundo Alfredo Bayram Llamas, Marco Antonio Alcocer Gamba, Jaime Carranza Madrigal, Luis Gerardo González Salas, Enrique López Rosas, Belinda González Díaz, Eduardo Salcido Vázquez, Alfredo Nacoud Ackar, Guillermo Antonio Llamas Esperón, Carlos Rodolfo Martínez Sánchez, María Guerrero De Leon, Rodrigo Suarez Otero, Guillermo Fanghänel Salmón, Jesús Antonio Pérez Ríos, José Angel Garza Ruíz, Robert W. Breedveld, Margriet Feenema-Aardema, Alida Borger-Van Der Burg, Pieter A.M. Hoogslag, Harry Suryapranata, Antonius Oomen, Paulus Van Haelst, Margriet Feenema-Aradema, Jacobijne J. Wiersma, Dirk Basart, Ruud M.A. Van Der Wal, Peter Zwart, Pascalle Monraats, Henricus Van Kesteren, Ioannis Karalis, Johan Jukema, Gerardus J.E. Verdel, Bart R.G. Brueren, Roland PTh Troquay, Eric P. Viergever, Nadea Y.Y. Al-Windy, Gerard L. Bartels, Jan H. Cornel, Walter R.M. 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Bengus, Constantin Militaru, Doina Rosu, Irinel R. Parepa, Adrian V. Matei, Tom M. Alexandru, Mihaela Malis, Ioan Coman, Rodica Stanescu-Cioranu, Doina Dimulescu, Yury Shvarts, Olga Orlikova, Zhanna Kobalava, Olga L. Barbarash, Valentin Markov, Nadezhda Lyamina, Alexander Gordienko, Konstantin Zrazhevsky, Alexander Y. Vishnevsky, Victor Gurevich, Raisa Stryuk, Nikita V. Lomakin, Igor Bokarev, Tatiana Khlevchuk, Sergey Shalaev, Larisa Khaisheva, Petr Chizhov, Inna Viktorova, Natalya Osokina, Vladimir Shchekotov, Evgenia Akatova, Galina Chumakova, Igor Libov, Mikhail I. Voevoda, Tatyana V. Tretyakova, Evgeny Baranov, Sergey Shustov, Sergey Yakushin, Ivan Gordeev, Niiaz Khasanov, Olga Reshetko, Tatiana Sotnikova, Olga Molchanova, Konstantin Nikolaev, Liudmila Gapon, Elena Baranova, Zaur Shogenov, Elena Kosmachova, Yuriy Karpov, Anton Povzun, Liudmila Egorova, Vadim V. Tyrenko, Igor G. Ivanov, Masterov Ilya, Sergey Kanorsky, Dragan Simic, Nikola Ivanovic, Goran Davidovic, Nebojsa Tasic, Milika R. Asanin, Stevo Stojic, Svetlana R. Apostolovic, Stevan Ilic, Biljana Putnikovic Tosic, Aleksandar Stankovic, Aleksandra Arandjelovic, Slavica Radovanovic, Branislava Todic, Jovan Balinovac, Dragan V. Dincic, Petar Seferovic, Ana Karadzic, Slobodan Dodic, Sinisa Dimkovic, Tamara Jakimov, Kian-Keong Poh, Hean Yee Ong, Justin Tang I-Shing, Karol Micko, Jan Nociar, Daniel Pella, Peter Fulop, Marian Hranai, Juraj Palka, Juraj Mazur, Ivan Majercák, Andrej Dzupina, František Fazekas, Jozef Gonsorcik, Viliam Bugan, Juraj Selecky, Gabriel Kamensky, Jaroslava Strbova, Rudolf Smik, Andrej Dukat, Peter Olexa, Ivan Žuran, Janez Poklukar, Nataša Černič Šuligoj, Matija Cevc, Henry P. Cyster, Naresh Ranjith, Clive Corbett, Junaid Bayat, Ellen Makoali Makotoko, Hendrik du Toit Theron, Ilse E. Kapp, Matthys M. de V Basson, Hanlie Lottering, Dina Van Aswegen, Louis J. Van Zyl, Peter J. 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De Berrazueta Fernández, José Antonio Vázquez de Prada, Jose Francisco Díaz Fernández, José Alberto García Lledó, Juan Cosín Sales, Javier Botas Rodriguez, Gabriel Gusi Tragant, Amparo Benedicto, Carlos Gonzalez-Juanatey, Mercedes Camprubí Potau, Ignacio Plaza Perez, César Morís De La Tassa, Pablo Loma-Osorio Rincon, Javier Balaguer Recena, Juan M. Escudier, Antonio Coca Payeras, Norberto Alonso Orcajo, Pedro Valdivielso, Godwin Constantine, Ruvaiz Haniffa, Nirmali Tissera, Stanley Amarasekera, Chandrike Ponnamperuma, Nimali Fernando, Kaputella Fernando, Jayanthimala Jayawardena, Santharaj Wijeyasingam, Gotabhaya Ranasinghe, Ruvan Ekanayaka, Sepalika Mendis, Vajira Senaratne, Gnanamoorthy Mayurathan, Ajantha Rajapaksha, Thilak Sirisena, Jagath I. Herath, Naomali Amarasena, Stefan Berglund, Gundars Rasmanis, Ola Vedin, Nils Witt, Georgios Mourtzinis, Peter Nicol, Ole Hansen, Stefano Romeo, Steen Agergaard Jensen, Ingemar Torstensson, Ulf Ahremark, Torbjörn Sundelin, Tiziano Moccetti, Francois Mach, Ronald Binde, Oliver Gämperli, Wei-Chuan Tsai, Kwo-Chang Ueng, Wen-Ter Lai, Ming-En Liu, Juey-Jen Hwang, Wei-Hsian Yin, I-Chang Hsieh, Ming-Jer Hsieh, Wei Hsiang Lin, Jen-Yuan Kuo, Tsuei-Yuan Huang, Chih-Yuan Fang, Pinij Kaewsuwanna, Wasant Soonfuang, Woravut Jintapakorn, Apichard Sukonthasarn, Nattawut Wongpraparut, Krisada Sastravaha, Nakarin Sansanayudh, Wirash Kehasukcharoen, Dilok Piyayotai, Paiboon Chotnoparatpat, Ahmet Camsari, Hakan Kultursay, Bulent Mutlu, Murat Ersanli, Mustafa Demirtas, Cevat Kirma, Ertan Ural, Lale Koldas, Oleksandr Karpenko, Alexander Prokhorov, Ihor Vakaluyk, Halyna Myshanych, Dmytro Reshotko, Valeriy Batushkin, Leonid Rudenko, Ihor Kovalskyi, Mykola Kushnir, Vira Tseluyko, Yuriy Mostovoy, Mykola Stanislavchuk, Yulian Kyiak, Yuriy Karpenko, Yaroslav Malynovsky, Andriy Klantsa, Oles Kutniy, Ekaterina Amosova, Viktor Tashchuk, Oleh Leshchuk, Mykola Rishko, Mykola Kopytsya, Andriy Yagensky, Mykola Vatutin, Andriy Bagriy, Olga M. Barna, Olexiy Ushakov, Georgiy Dzyak, Borys Goloborodko, Anatolii Rudenko, Volodymyr Zheleznyy, Jasper Trevelyan, Azfar Zaman, Kaeng Lee, Andrew Moriarty, Rajesh K. Aggarwal, Piers Clifford, Yuk-Ki Wong, Syed M.R. Iqbal, Eduardas Subkovas, Denise Braganza, David Sarkar, Robert Storey, Huw Griffiths, Sam Mcclure, Rangasamy Muthusamy, Simon Smith, John Kurian, Terry Levy, Craig Barr, Honer Kadr, Robert Gerber, Audrius Simaitis, Handrean Soran, Anthony Mathur, Adrian Brodison, Mohammad Ayaz, Muhammad Cheema, Richard Oliver, Simon Thackray, Telal Mudawi, Gohar Rahman, Ayyaz Sultan, Timothy Reynolds, David Sharman, null david Sprigings, Rob Butler, Peter Wilkinson, Gregory Y.H. Lip, Julian Halcox, Sean Gallagher, Nicholas Ossei-Gerning, Gil Vardi, Duccio Baldari, David Brabham, Charles Treasure, Charles Dahl, Bruce Palmer, Alan Wiseman, Abul Khan, Sanjeev Puri, Ann Elizabeth Mohart, Carlos Ince, Enrique Flores, Scott Wright, Shi-Chi Cheng, Michael Rosenberg, William Rogers, Edward Kosinski, Les Forgosh, Jonathan Waltman, Misal Khan, Mohammad Shoukfeh, Georges Dagher, Patrick Cambier, Ira Lieber, Priya Kumar, Cara East, Perry Krichmar, Mian Hasan, Lindsey White, Thomas Knickelbine, Thomas Haldis, Eve Gillespie, Thomas Amidon, David Suh, Imran Arif, Mouhamad Abdallah, Faiq Akhter, Eric Carlson, Michael D'Urso, Fadi El-Ahdab, William Nelson, Katie Moriarty, Barry Harris, Steven Cohen, Luther Carter, Daniel Doty, Kenneth Sabatino, Tariq Haddad, Amir Malik, Sunder Rao, Angel Mulkay, Ion Jovin, Kim Klancke, Vinay Malhotra, Sai K. 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O'Donnell, Dinesh Singal, Naseem Jaffrani, Sridhar Banuru, Daniel Fisher, Mark Xenakis, Neal Perlmutter, Ravi Bhagwat, James Strader, Ronald Blonder, Ayim Akyea-Djamson, Ajay Labroo, Kwan Lee, H. John Marais, Edmund Claxton, Robert Weiss, Rohr Kathryn, Martin Berk, Peter Rossi, Parag Joshi, Amit Khera, Ajit S. Khaira, Greg Kumkumian, Steven Lupovitch, Joshua Purow, Stephen Welka, David Hoffman, Stuart Fischer, Eugene Soroka, Donald Eagerton, Samir Pancholy, Michael Ray, Norman Erenrich, Michael Farrar, Stewart Pollock, William J. French, Steve Diamantis, Douglas Guy, Lawrence Gimple, Mark Neustel, Steven Schwartz, Edward Pereira, Seals Albert, Douglas Spriggs, Janet Strain, Suneet Mittal, Anthony Vo, Majed Chane, Jason Hall, Nampalli Vijay, Kapildeo Lotun, F. Martin Lester, Ahed Nahhas, Theodore Pope, Paul Nager, Rakesh Vohra, Mukesh Sharma, Riyaz Bashir, Hinan Ahmed, Michael Berlowitz, Robert Fishberg, Robert Barrucco, Eric Yang, Michael Radin, Daniel Sporn, Dwight Stapleton, Steven Eisenberg, Joel Landzberg, Martin Mcgough, Samir Turk, Michael Schwartz, P. Sandy Sundram, Diwakar Jain, Mark Zainea, Carlos Bayron, Ronald Karlsberg, Suhail Dohad, Henry Lui, William Keen, Donald Westerhausen, Sandeep Khurana, Himanshu Agarwal, Jessica Birchem, William Penny, Mark Chang, Sherrill Murphy, John Henry, Branislav Schifferdecker, John M Gilbert, Gopal Chalavarya, Charles Eaton, John F. Schmedtje, Stuart Christenson, Imran Dotani, Douglas Denham, Alexander Macdonell, Paul Gibson, Aref Rahman, Tammam Al Joundi, Nizar Assi, Gary Conrad, Purushotham Kotha, Michael Love, Gregory Giesler, Howard Rubenstein, Dawood Gamil, Laura Akright, Justine Krawczyk, Joanne Cobler, Terry Wells, James Welker, Robert Foster, Richard Gilmore, Jay Anderson, Douglas Jacoby, Bill Harris, Geraldine Gardner, Ramprasad Dandillaya, Kishor Vora, John Kostis, John Hunter, David Laxson, Eric Ball, Flavia Egydio, Anelise Kawakami, Janaina Oliveira, Julianna Wozniak, Alexander Matthews, Caroline Ratky, Janine Valiris, Lisa Berdan, Anita Hepditch, Kirby Quintero, Tyrus Rorick, Melissa Westbrook, Andrea Pascual, Carla Rovito, Madeleine Bezault, Elodie Drouet, Tabassome Simon, Caroline Alsweiler, Anne Luyten, Julie Butters, Liddy Griffith, Michelle Shaw, Lena Grunberg, Shahidul Islam, Marie-France Brégeault, Nathalie Bougon, Douglas Faustino, Sylvie Fontecave, Judith Murphy, Melanie Verrier, null Veronique Agnetti, Dorthe Andersen, Emmy Badreddine, Mhamed Bekkouche, Cecile Bouancheau, Imane Brigui, Maddy Brocklehurst, Joseph Cianciarulo, Dawn Devaul, Szilvia Domokos, Cecile Gache, Caroline Gobillot, Severine Guillou, Jan Healy, Megan Heath, Gayatri Jaiwal, Carine Javierre, Julien Labeirie, Myriam Monier, Ulises Morales, Asmaa Mrabti, Bicky Mthombeni, Betim Okan, Lucile Smith, Jennifer Sheller, Sebastien Sopena, Valerie Pellan, Fadela Benbernou, Nafissa Bengrait, Maud Lamoureux, Katarina Kralova, Raphael Bejuit, Anthony Coulange, Christelle Berthou, Jérôme Repincay, Christelle Lorenzato, Alexis Etienne, Valerie Gouet, Virginie Loizeau, Mickael Normand, Anne Ourliac, Christelle Rondel, Antony Adamo, Pascale Beltran, Pauline Barraud, Helene Dubois-Gache, Benjamin Halle, Lamia Metwally, Maxime Mourgues, Marc Sotty, Marion Vincendet, Raluca Cotruta, Zhu Chengyue, Dominique Fournie-Lloret, Christine Morrello, Aurelie Perthuis, Patrick Picault, Isabelle Zobouyan, Helen M. Colhoun, Michael A. Dempsey, Mark A. McClanahan, Masira, and Laucevičius, Aleksandras

Subjects
Male, Acute coronary syndrome, medicine.medical_specialty, Cardiac & Cardiovascular Systems, Randomization, PCSK9 inhibitor, LOW-DENSITY-LIPOPROTEIN, Antibodies, Monoclonal, Humanized, acute coronary syndrom, Placebo, Gastroenterology, lipoprotein(a), Internal medicine, medicine, Humans, Low-density lipoprotein cholesterol, Aged, Alirocumab, RISK, low-density lipoprotein cholesterol, Science & Technology, biology, business.industry, PCSK9, PCSK9 Inhibitors, Hazard ratio, ALIROCUMAB, acute coronary syndrome, Cholesterol, LDL, Lipoprotein(a), Middle Aged, EFFICACY, medicine.disease, Cardiovascular Diseases, CARDIOVASCULAR-DISEASE, SAFETY, Cardiovascular System & Cardiology, biology.protein, Female, lipids (amino acids, peptides, and proteins), STATIN, low-density lipoprotein, cholesterol PCSK9 inhibitor, CORONARY, Cardiology and Cardiovascular Medicine, business, Life Sciences & Biomedicine, Mace
Abstract

Digital, Background Guidelines recommend nonstatin lipid-lowering agents in patients at very high risk for major adverse cardiovascular events (MACE) if low-density lipoprotein cholesterol (LDL-C) remains ≥70 mg/dL on maximum tolerated statin treatment. It is uncertain if this approach benefits patients with LDL-C near 70 mg/dL. Lipoprotein(a) levels may influence residual risk. Objectives In a post hoc analysis of the ODYSSEY Outcomes (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) trial, the authors evaluated the benefit of adding the proprotein subtilisin/kexin type 9 inhibitor alirocumab to optimized statin treatment in patients with LDL-C levels near 70 mg/dL. Effects were evaluated according to concurrent lipoprotein(a) levels. Methods ODYSSEY Outcomes compared alirocumab with placebo in 18,924 patients with recent acute coronary syndromes receiving optimized statin treatment. In 4,351 patients (23.0%), screening or randomization LDL-C was 13.7 mg/dL or ≤13.7 mg/dL; corresponding adjusted treatment hazard ratios were 0.82 (95% CI: 0.72-0.92) and 0.89 (95% CI: 0.75-1.06), with Pinteraction = 0.43. Conclusions In patients with recent acute coronary syndromes and LDL-C near 70 mg/dL on optimized statin therapy, proprotein subtilisin/kexin type 9 inhibition provides incremental clinical benefit only when lipoprotein(a) concentration is at least mildly elevated. (ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab; NCT01663402), Ciencias Médicas y de la Salud

Published
2021

13. Identifying Isolated Systolic Hypertension from Upper-Arm Cuff Blood Pressure Compared with Invasive Measurements

Author

James E. Sharman, Antoine Cremer, Sho Okada, Esben Laugesen, Nobuyuki Ohte, Martin G. Schultz, Roland E. Schmieder, Christian Ott, Nathan Dwyer, Philip Roberts-Thomson, Berend E. Westerhof, Kenji Takazawa, Stefano Omboni, Bryan Williams, Chen Huan Chen, Giacomo Pucci, Manish D. Sinha, Fuyou Liang, J. Andrew Black, Ji-Guang Wang, Dean S. Picone, Hao Min Cheng, Thomas Weber, Willem Jan W Bos, Hack-Lyoung Kim, Matthew K Armstrong, Peter S. Lacy, Alun D. Hughes, Telmo Pereira, George A. Stouffer, Pulmonary medicine, ACS - Atherosclerosis & ischemic syndromes, ACS - Heart failure & arrhythmias, and ACS - Pulmonary hypertension & thrombosis

Subjects
Coronary angiography, Male, medicine.medical_specialty, hypertension, prevalence, Diastole, 030204 cardiovascular system & hematology, 03 medical and health sciences, 0302 clinical medicine, Interquartile range, Internal medicine, medicine.artery, Internal Medicine, medicine, Humans, 030212 general & internal medicine, Aged, Aorta, business.industry, blood pressure, Blood Pressure Determination, Middle Aged, aorta, Blood pressure, medicine.anatomical_structure, Isolated systolic hypertension, Cuff, Cardiology, Female, coronary angiography, business, Artery
Abstract

Isolated systolic hypertension (ISH) is the most common form of hypertension and is highly prevalent in older people. We recently showed differences between upper-arm cuff and invasive blood pressure (BP) become greater with increasing age, which could influence correct identification of ISH. This study sought to determine the difference between identification of ISH by cuff BP compared with invasive BP. Cuff BP and invasive aortic BP were measured in 1695 subjects (median 64 years, interquartile range [55–72], 68% male) from the INSPECT (Invasive Blood Pressure Consortium) database. Data were recorded during coronary angiography among 29 studies, using 21 different cuff BP devices. ISH was defined as ≥130/

Published
2021

14. Influence of Age on Upper Arm Cuff Blood Pressure Measurement

Author

Martin G. Schultz, Willem Jan W Bos, Thomas C. Weber, Dean S. Picone, Hirotsugu Yamada, Bryan Williams, Hack Lyoung Kim, Alun D. Hughes, Nobuyuki Ohte, Christian Ott, Nathan Dwyer, Ricardo Fonseca, Stefano Omboni, Hao Min Cheng, J. Andrew Black, James E. Sharman, Chen Huan Chen, Petr Otahal, Roland E. Schmieder, Telmo Pereira, Eiichiro Yamamoto, Esben Laugesen, Daisuke Sueta, Philip Roberts-Thomson, Niklas B. Rossen, Kenji Takazawa, Giacomo Pucci, Peter S. Lacy, Antoine Cremer, Berend E. Westerhof, Ji-Guang Wang, Pulmonary medicine, ACS - Pulmonary hypertension & thrombosis, ACS - Atherosclerosis & ischemic syndromes, and ACS - Heart failure & arrhythmias

Subjects
Coronary angiography, Adult, medicine.medical_specialty, Diastole, sphygmomanometers, Sphygmomanometer, Blood Pressure, 030204 cardiovascular system & hematology, Article, 03 medical and health sciences, Automation, 0302 clinical medicine, cardiovascular disease, Internal medicine, Oscillometry, Internal Medicine, Medicine, Humans, 030212 general & internal medicine, Aged, Aged, 80 and over, medicine.diagnostic_test, business.industry, aging, Blood Pressure Determination, Auscultation, Middle Aged, Pulse pressure, Cardiovascular physiology, Blood pressure, coronary angiography, risk factor, Cuff, Cardiology, Arm, business
Abstract

Blood pressure (BP) is a leading global risk factor. Increasing age is related to changes in cardiovascular physiology that could influence cuff BP measurement, but this has never been examined systematically and was the aim of this study. Cuff BP was compared with invasive aortic BP across decades of age (from 40 to 89 years) using individual-level data from 31 studies (1674 patients undergoing coronary angiography) and 22 different cuff BP devices (19 oscillometric, 1 automated auscultation, 2 mercury sphygmomanometry) from the Invasive Blood Pressure Consortium. Subjects were aged 64±11 years, and 32% female. Cuff systolic BP overestimated invasive aortic systolic BP in those aged 40 to 49 years, but with each older decade of age, there was a progressive shift toward increasing underestimation of aortic systolic BP ( P P P

Published
2020

15. P112 Influence of Cuff Blood Pressure Accuracy on Identification of Isolated Systolic Hypertension

Author

Thomas Weber, James E. Sharman, Martin G. Schultz, Dean S. Picone, Willem Jan W. Bos, Berend E. Westerhof, Stefano Omboni, George A. Stouffer, Esben Laugesen, Peter S. Lacy, Philip Roberts-Thomson, Matthew K Armstrong, Kenji Takazawa, Giacomo Pucci, and Nathan Dwyer

Subjects
medicine.medical_specialty, lcsh:Diseases of the circulatory (Cardiovascular) system, lcsh:Specialties of internal medicine, business.industry, General Medicine, lcsh:RC581-951, lcsh:RC666-701, Internal medicine, Isolated systolic hypertension, medicine, Cardiology, Identification (biology), business, Cuff blood pressure
Abstract

Introduction: Isolated systolic hypertension (ISH) is the most common form of hypertension in older people. However, accurate identification of ISH may be hindered because cuff blood pressure (BP) underestimates systolic BP (SBP) and overestimates diastolic BP (DBP). This study aimed to determine the influence of cuff BP accuracy on the identification of ISH. Methods: Cuff BP and invasive aortic BP were measured simultaneous (or near-simultaneously) in 1737 subjects (63 ± 12 years, 68% male) during coronary angiography. Data was derived from 32 studies, using 20 different cuff BP devices, from the Invasive Blood Pressure Consortium (INSPECT). ISH was defined as ≥140/

Published
2020

16. P109 The Influence of Sex on Cuff Blood Pressure Accuracy

Author

Matthew K Armstrong, Thomas Weber, Dean S. Picone, Willem Jan W. Bos, Kenji Takazawa, Martin G. Schultz, James E. Sharman, Stefano Omboni, Giacomo Pucci, Elif Stoneman, Philip Roberts-Thomson, Peter S. Lacy, Esben Laugesen, George A. Stouffer, Nathan Dwyer, and Berend E. Westerhof

Subjects
medicine.medical_specialty, lcsh:Diseases of the circulatory (Cardiovascular) system, lcsh:Specialties of internal medicine, business.industry, lcsh:RC581-951, lcsh:RC666-701, Internal medicine, Cardiology, Medicine, General Medicine, Cuff blood pressure, business, circulatory and respiratory physiology
Abstract

Background: Cuff blood pressure (BP) is intended to approximate central aortic BP and accuracy is paramount. Sex differences in BP physiology could influence the accuracy of cuff BP as an estimate of invasive aortic BP, but this has not been explored in-depth and was the aim of this study. Methods: Cuff and invasive aortic BP were measured in 1701 subjects (31.9% female, aged 63 ± 12) during coronary angiography from the INvaSive blood PressurE ConsorTium (INSPECT) database. Cuff accuracy was defined as cuff–invasive BP. In a sub-sample (n = 376, 27% female, aged 63 ± 11), invasive brachial BP was recorded to assess systolic (SBP) amplification (invasive brachial–aortic SBP). Results: Invasive aortic SBP was higher in females compared with males (mean [95% CI]: 141.8 mmHg [137.1, 146.3] versus 132.9 mmHg [129.4, 136.4], p < 0.001). Cuff SBP significantly underestimated invasive aortic SBP in females compared with males (−3.1 mmHg [−5.9, −0.2] versus 1.4 mmHg [−1.1, 4.0], p < 0.001 for difference). Sex differences remained after adjustment for age and height. In the sub-sample, aortic-to-brachial SBP-amplification was lower in females (7.1 mmHg [3.3, 10.8] versus 10.2 mmHg [5.1, 15.4], p = 0.0070). Sex, SBP-amplification, height and age were associated with cuff BP inaccuracy, but only SBP-amplification and age remained associated in multivariable analysis (p < 0.05). Conclusion: Females have greater propensity towards cuff BP inaccuracy through underestimation of aortic SBP. Both age and the magnitude of aortic-to-brachial SBP-amplification are related to cuff BP inaccuracy, which provide greater understanding of sex differences in BP physiology and may help improve the accuracy of cuff BP methods.

Published
2020

17. P113 The Forgotten Black Box of Blood Pressure: Error in Oscillometric Mean Arterial Pressure is Associated with Cuff Measurement Inaccuracy

Author

Martin G. Schultz, Matthew K Armstrong, James E. Sharman, Nathan Dwyer, Thomas Weber, Philip Roberts-Thomson, and Dean S. Picone

Subjects
Mean arterial pressure, medicine.medical_specialty, business.industry, Specialties of internal medicine, General Medicine, Blood pressure, RC581-951, Black box, Internal medicine, RC666-701, Cuff, medicine, Cardiology, Diseases of the circulatory (Cardiovascular) system, business, circulatory and respiratory physiology
Abstract

Background: Accurate measurement of cuff systolic BP (SBP) and diastolic BP (DBP) is contingent on the assumption of oscillometric MAP being accurate. If MAP is inaccurate this is likely to impact the accuracy of cuff SBP and DBP, but this has never been determined and was the aim of the study. Methods: In five independent studies, MAP was measured by five unique cuff oscillometric BP devices at the same time as invasive aortic MAP (area under the waveform) by fluid-filled or solid-state catheters among 262 patients (61 ± 11 years, 65% male) during coronary angiography. Cuff SBP and DBP were estimated by device-specific algorithms. Measurement errors were calculated as cuff – invasive aortic BP. Results: For each BP device, MAP error was −2.6 ± 6.1, 0.76 ± 7.2, 1.4 ± 5.5, 1.5 ± 6.7 and 7.1 ± 9.2 mmHg. Corresponding SBP errors were 4.4 ± 8.7, −0.8 ± 11.2, −8.8 ± 10.4, −0.9 ± 10.5 and 1.9 ± 10.8 mmHg, whereas DBP errors were 8.8 ± 5.1, 2.0 ± 7.4, 6.7 ± 7.3, 10.3 ± 9.0 and 13.1 ± 6.4 mmHg. There was a direct relationship between errors in oscillometric MAP and SBP error in four of the five devices (B range = 0.42 to 1.04). However, MAP error was consistently related to DBP error in all devices (B range = 0.48 to 0.97). Across all devices, absolute error in MAP ≥3 mmHg corresponded to absolute error in SBP and DBP ≥5 mmHg in 56–77% and 62–88% of patients. Conclusion: Errors in oscillometric MAP are directly related to cuff SBP and DBP inaccuracy, but the magnitude of error is device-specific. Further work is required to understand algorithms used in oscillometric devices to improve cuff BP accuracy.

Published
2020

18. 3.5 CUFF BLOOD PRESSURE IS PROGRESSIVELY MORE BIASED WITH INCREASING AGE: INDIVIDUAL PARTICIPANT LEVEL ANALYSIS FROM THE INSPECT CONSORTIUM

Author

Niklas B. Rossen, Sandy Muecke, Hirotsugu Yamada, Ralph A.H. Stewart, Hack-Lyoung Kim, Kenji Takazawa, Peter S. Lacy, Nobuyuki Ohte, Eiichiro Yamamoto, Ricardo Fonseca Diaz, Velandai Srikanth, Esben Laugesen, Brian Gould, Giacomo Pucci, Roland E. Schmieder, Martin G. Schultz, Christian Ott, Petr Otahal, Stefano Omboni, Ji-Guang Wang, Philip Roberts-Thomson, Bryan Williams, Berend E. Westerhof, Antoine Cremer, James E. Sharman, George A. Stouffer, Nathan Dwyer, Alun D. Hughes, Ahmed M. Al-Jumaily, Telmo Pereira, Chen Huan Chen, J. Andrew Black, Daisuke Sueta, Thomas Weber, Xiaoqing Peng, Dean S. Picone, Willem Jan W. Bos, and Hao-Min Chen

Subjects
medicine.medical_specialty, lcsh:Diseases of the circulatory (Cardiovascular) system, lcsh:Specialties of internal medicine, business.industry, lcsh:RC581-951, lcsh:RC666-701, Internal medicine, medicine, Cardiology, General Medicine, business, Cuff blood pressure
Abstract

Objectives: Accurate blood pressure (BP) measurement is critical for appropriate hypertension diagnosis and management. Aortic BP represents pressure loading on vital organs and this can be approximated using upper arm cuff BP. With advancing age, cuff systolic BP (SBP) increases and diastolic BP (DBP) decreases (widening pulse pressure [PP]), but whether age may influence cuff BP compared with invasive BP is unknown and was the aim of this study. Methods: Cuff BP was measured simultaneously, or near-simultaneously, with invasive aortic BP during catheterization in 1696 individuals within the INSPECT consortium (an international collaboration comprising data from 31 studies and 19 different cuff BP devices [17 oscillometric, 2 mercury sphygmomanometry]). Differences in cuff and invasive BP were assessed using mixed models. Results: Subjects were aged 63.3 ± 10.6 years and 32% female. Cuff SBP overestimated invasive aortic SBP in those aged 40–49, but with increasing age there was a progressive increase in the underestimation of aortic SBP (Table). Conversely, cuff DBP systematically overestimated aortic DBP, increasingly with age. Thus, there was a progressively higher error (underestimation) in cuff PP with older age. Adjusting models for sex, mean arterial pressure, heart rate and catheter type did not alter the findings, and no interactions between these parameters and age were found. Conclusion: Cuff BP is progressively more biased with increasing age, exposing older people to greater chance for misdiagnosis of risk related to BP. The findings highlight the need to improve cuff BP methods to ensure all people receive appropriate diagnosis and management of hypertension.

Published
2018

19. Discovery of new blood pressure phenotypes and relation to accuracy of cuff devices used in daily clinical practice

Author

Ji-Guang Wang, Philip Roberts-Thomson, James E. Sharman, Nathan Dwyer, Hao Min Cheng, Dean S. Picone, J. Andrew Black, Xiaoqing Peng, Giacomo Pucci, Martin G. Schultz, and Chen Huan Chen

Subjects
Male, medicine.medical_specialty, Brachial Artery, Hemodynamics, Sphygmomanometer, Blood Pressure, 030204 cardiovascular system & hematology, Catheterization, 03 medical and health sciences, 0302 clinical medicine, medicine.artery, Internal medicine, Oscillometry, Ascending aorta, Internal Medicine, Medicine, Humans, cardiovascular diseases, 030212 general & internal medicine, Brachial artery, Radial artery, Blood pressure, Phenotype, Sphygmomanometers, Aged, Blood Pressure Determination, Equipment Design, Female, Hypertension, Middle Aged, Radial Artery, Reproducibility of Results, business.industry, Cuff, cardiovascular system, Cardiology, business, circulatory and respiratory physiology
Abstract

Cuff blood pressure (BP) is the reference standard for management of high BP, but the method is inaccurate and can lead to BP misclassification. The aims of this study were to determine whether distinctive BP phenotypes exist based on BP transmission (amplification) variability from central-to-peripheral arteries and whether applying one standard cuff BP measurement approach (eg, oscillometry) to all people could discriminate the BP phenotypes. Intra-arterial BP was measured at the ascending aorta and brachial and radial arteries in 126 participants (61±10 years; 69% male) after coronary angiography. Central-to-peripheral systolic BP (SBP) transmission (SBP amplification) was defined by ≥5 mm Hg SBP increase between the aorta-to-brachial or brachial-to-radial arteries. Standard cuff BP was measured 4 different times using 3 different devices. Three independent investigators also provided data (n=255 from 4 studies) using another 3 separate cuff BP devices. Four distinct BP phenotypes were discovered based on variability in SBP amplification: phenotype 1, both aortic-to-brachial and brachial-to-radial SBP amplification; phenotype 2, only aortic-to-brachial SBP amplification; phenotype 3, only brachial-to-radial SBP amplification; and phenotype 4, neither aortic-to-brachial nor brachial-to-radial SBP amplification. Aortic SBP was significantly higher among phenotypes 3 and 4 compared with phenotypes 1 and 2 ( P =0.00074), but this was not discriminated using any standard cuff BP measures ( P =0.31). Data from independent investigators confirmed the key findings. This is the first-in-human discovery of BP phenotypes that have significantly different BPs, but which are not discriminated by standard cuff BP devices used in daily clinical practice. Improved BP device accuracy may be achieved by considering individual phenotypic BP differences.

Published
2018

20. Rivaroxaban with or without aspirin in patients with stable coronary artery disease : an international, randomised, double-blind, placebo-controlled trial

Author

Stuart J Connolly, John W Eikelboom, Jackie Bosch, Gilles Dagenais, Leanne Dyal, Fernando Lanas, Kaj Metsarinne, Martin O'Donnell, Anthony L Dans, Jong-Won Ha, Alexandr N Parkhomenko, Alvaro A Avezum, Eva Lonn, Liu Lisheng, Christian Torp-Pedersen, Petr Widimsky, Aldo P Maggioni, Camilo Felix, Katalin Keltai, Masatsugu Hori, Khalid Yusoff, Tomasz J Guzik, Deepak L Bhatt, Kelley R H Branch, Nancy Cook Bruns, Scott D Berkowitz, Sonia S Anand, John D Varigos, Keith A A Fox, Salim Yusuf, JORGELINA SALA, LUIS CARTASEGNA, MARISA VICO, MIGUEL ANGEL HOMINAL, EDUARDO HASBANI, ALBERTO CACCAVO, CESAR ZAIDMAN, DANIEL VOGEL, ADRIAN HRABAR, PABLO OMAR SCHYGIEL, CARLOS CUNEO, HUGO LUQUEZ, IGNACIO J. MACKINNON, RODOLFO ANDRES AHUAD GUERRERO, JUAN PABLO COSTABEL, INES PALMIRA BARTOLACCI, OSCAR MONTANA, MARIA BARBIERI, OSCAR GOMEZ VILAMAJO, RUBEN OMAR GARCIA DURAN, LILIA BEATRIZ SCHIAVI, MARCELO GARRIDO, ADRIAN INGARAMO, ANSELMO PAULINO BORDONAVA, MARIA JOSE PELAGAGGE, LEONARDO NOVARETTO, JUAN PABLO ALBISU DI GENNERO, LUZ MARIA IBANEZ SAGGIA, MOIRA ALVAREZ, NESTOR ALEJANDRO VITA, STELLA MARIS MACIN, RICARDO DARIO DRAN, MARCELO CARDONA, LUIS GUZMAN, RODOLFO JUAN SARJANOVICH, JESUS CUADRADO, SEBASTIAN NANI, MARCOS RAUL LITVAK BRUNO, CAROLINA CHACON, LAURA ELENA MAFFEI, DIEGO GRINFELD, NATALIA VENSENTINI, CLAUDIO RODOLFO MAJUL, HECTOR LUCAS LUCIARDI, PATRICIA DEL CARMEN GONZALEZ COLASO, FREDY ANTONI FERRE PACORA, PAUL VAN DEN HEUVEL, PETER VERHAMME, BAVO ECTOR, PHILIPPE DEBONNAIRE, PHILIPPE VAN DE BORNE, JEAN LEROY, HERMAN SCHROE, PASCAL VRANCKX, IVAN ELEGEERT, ETIENNE HOFFER, KARL DUJARDIN, CLARISSE INDIO DO BRASIL, DALTON PRECOMA, JOSE ANTONIO ABRANTES, EULER MANENTI, GILMAR REIS, JOSE SARAIVA, LILIA MAIA, MAURO HERNANDES, PAULO ROSSI, FABIO ROSSI DOS SANTOS, SERGIO LUIZ ZIMMERMANN, RAFAEL RECH, EDUARDO ABIB JR, PAULO LEAES, ROBERTO BOTELHO, OSCAR DUTRA, WEIMAR SOUZA, MARIA BRAILE, NILO IZUKAWA, JOSE CARLOS NICOLAU, LUIZ FERNANDO TANAJURA, CARLOS VICENTE SERRANO JUNIOR, CESAR MINELLI, LUIZ ANTONIO NASI, LIVIA OLIVEIRA, MARCELO JOSE DE CARVALHO CANTARELLI, RICHARD TYTUS, SHEKHAR PANDEY, EVA LONN, JAMES CHA, SAUL VIZEL, MOHAN BABAPULLE, ANDRE LAMY, KEVIN SAUNDERS, JOSEPH BERLINGIERI, BOB KIAII, RAKESH BHARGAVA, PRAVINSAGAR MEHTA, LAURIE HILL, DAVID FELL, ANDY LAM, FAISAL AL-QOOFI, CRAIG BROWN, ROBERT PETRELLA, JOSEPH A RICCI, ANTHONY GLANZ, NICOLAS NOISEUX, KEVIN BAINEY, FATIMA MERALI, MICHAEL HEFFERNAN, ANTHONY DELLA SIEGA, GILLES R DAGENAIS, FRANCOIS DAGENAIS, STEEVE BRULOTTE, MICHEL NGUYEN, MICHAEL HARTLEIB, RANDOLPH GUZMAN, RONALD BOURGEOIS, DENNIS RUPKA, YAARIV KHAYKIN, GILBERT GOSSELIN, THAO HUYNH, CLAUDE PILON, JEAN CAMPEAU, FRANCIS PICHETTE, ARIEL DIAZ, JAMES JOHNSTON, PRAVIN SHUKLE, GREGORY HIRSCH, PAUL RHEAULT, WLODZIMIERZ CZARNECKI, ANNIE ROY, SHAH NAWAZ, STEPHEN FREMES, DINKAR SHUKLA, GABRIEL JANO, JORGE LEONARDO COBOS, RAMON CORBALAN, MARCELO MEDINA, LEONARDO NAHUELPAN, CARLOS RAFFO, LUIS PEREZ, SERGIO POTTHOFF, BENJAMIN STOCKINS, PABLO SEPULVEDA, CHRISTIAN PINCETTI, MARGARITA VEJAR, HONGYAN TIAN, XUESI WU, YUANNAN KE, KAIYING JIA, PENGFEI YIN, ZHAOHUI WANG, LITIAN YU, SHULIN WU, ZONGQUI WU, SHAO WEN LIU, XIAO JUAN BAI, YANG ZHENG, PING YANG, YUN MEI YANG, JIWEI ZHANG, JUNBO GE, XIAO PING CHEN, JUNXIA LI, TAO HONG HU, RUIYAN ZHANG, ZHE ZHENG, XIN CHEN, LIANG TAO, JIANPING LI, WEIJIAN HUANG, GUOSHENG FU, CHUNJIAN LI, YUGANG DONG, CHUNSHENG WANG, XINMIN ZHOU, YE KONG, ARISTIDES SOTOMAYOR, JOSE LUIS ACCINI MENDOZA, HENRY CASTILLO, MIGUEL URINA, GUSTAVO AROCA, MARITZA PEREZ, DORA INES MOLINA DE SALAZAR, GREGORIO SANCHEZ VALLEJO, MANZUR J FERNANDO, HENRY GARCIA, LUIS HERNANDO GARCIA, EDGAR ARCOS, JUAN GOMEZ, FRANCISCO CUERVO MILLAN, FREDY ALBERTO TRUJILLO DADA, BORIS VESGA, GUSTAVO ADOLFO MORENO SILGADO, EVA ZIDKOVA, JEAN-CLAUDE LUBANDA, MARKETA KALETOVA, RADIM KRYZA, GABRIEL MARCINEK, MAREK RICHTER, JINDRICH SPINAR, JIRI MATUSKA, MARTIN TESAK, ZUZANA MOTOVSKA, MARIAN BRANNY, JIRI MALY, MARTIN MALY, MARTIN WIENDL, LENKA FOLTYNOVA CAISOVA, JOSEF SLABY, PETR VOJTISEK, JAN PIRK, LENKA SPINAROVA, MIROSLAVA BENESOVA, JULIA CANADYOVA, MIROSLAV HOMZA, JINDRICH FLORIAN, ROSTISLAV POLASEK, ZDENEK COUFAL, VLADIMIRA SKALNIKOVA, RADIM BRAT, MIROSLAV BRTKO, PETR JANSKY, JAROSLAV LINDNER, PAVEL MARCIAN, ZBYNEK STRAKA, MARTIN TRETINA, YAN CARLOS DUARTE, FREDDY POW CHON LONG, MAYRA SANCHEZ, JOSE LOPEZ, CARMITA PERUGACHI, RICARDO MARMOL, FREDDY TRUJILLO, PABLO TERAN, JAAKKO TUOMILEHTO, HENRI TUOMILEHTO, MARJA-LEENA TUOMINEN, ILKKA KANTOLA, GABRIEL STEG, VICTOR ABOYANS, FLORENCE LECLERCQ, EMILE FERRARI, FRANCK BOCCARA, EMMANUEL MESSAS, PATRICK MISMETTI, MARIE ANTOINETTE SEVESTRE, GUILLAUME CAYLA, PASCAL MOTREFF, STEFAN STOERK, HANS-DIRK DUENGEN, CHRISTOPH STELLBRINK, OSMAN GUEROCAK, CHRISTOPH KADEL, RUEDIGER BRAUN-DULLAEUS, MICHAEL JESERICH, CHRISTIAN OPITZ, HANS-FRIEDRICH VOEHRINGER, KARL-FRIEDRICH APPEL, BERNHARD WINKELMANN, THOMAS DORSEL, SIGRID NIKOL, HARALD DARIUS, JURGEN RANFT, SEBASTIAN SCHELLONG, WOLFGANG JUNGMAIR, PIROZE DAVIERWALA, MARC VORPAHL, LASZLO BAJNOK, ZOLTAN LASZLO, EBRAHIM NOORI, GABOR VERESS, ANDRAS VERTES, ANDRAS ZSARY, ERNO KIS, LASZLO KORANYI, JUDIT BAKAI, ZOLTAN BODA, FERENC POOR, ZOLTAN JARAI, VENDEL KEMENY, JOHN BARTON, BRENDAN MCADAM, ANDREW MURPHY, PETER CREAN, NIALL MAHON, RONAN CURTIN, BRIAIN MACNEILL, SEAN DINNEEN, MAJDI HALABI, REUVEN ZIMLICHMAN, DAVID ZELTSER, YOAV TURGEMAN, ELIEZER KLAINMAN, BASIL LEWIS, AMOS KATZ, SHAUL ATAR, EUGENIA NIKOLSKY, STEFANO BOSI, MONICA NALDI, POMPILIO FAGGIANO, DEBORA ROBBA, LUCIO MOS, GIANFRANCO SINAGRA, FRANCO COSMI, LUIGI OLTRONA VISCONTI, DE MATTEIS CARMINE, GIUSEPPE DI PASQUALE, MATTEO DI BIASE, SARA MANDORLA, MARINO BERNARDINANGELI, GIOVANNI CARLO PICCINNI, MICHELE MASSIMO GULIZIA, MARCELLO GALVANI, FLAVIO VENTURI, GIORGIO MOROCUTTI, MARIA GRAZIA BALDIN, CARLO OLIVIERI, GIAN PIERO PERNA, VINCENZO CIRRINCIONE, TAKAYASU KANNO, HIROYUKI DAIDA, YUKIO OZAKI, NAOMASA MIYAMOTO, SHINICHI HIGASHIUE, HIROSHI DOMAE, SHINOBU HOSOKAWA, HIROO KOBAYASHI, TAKEHIKO KURAMOCHI, KENSHI FUJII, KAZUAKI MIZUTOMI, KEIJIRO SAKU, KAZUO KIMURA, YOSHIHARU HIGUCHI, MITSUNORI ABE, HARUHITO OKUDA, TOSHIYUKI NODA, TERUAKI MITA, ATSUSHI HIRAYAMA, HARUHIKO ONAKA, MORIAKI INOKO, MITSUGU HIROKAMI, MUNENORI OKUBO, YUTAKA AKATSUKA, MIZUHO IMAMAKI, HARUO KAMIYA, MAMORU MANITA, TOSHIHARU HIMI, HIDEKI UENO, YUJI HISAMATSU, JUNYA AKO, YASUHIRO NISHINO, HIDEO KAWAKAMI, YUTAKA YAMADA, YUKIHIRO KORETSUNE, TAKAHISA YAMADA, TETSURO YOSHIDA, HIDEKI SHIMOMURA, NORIYUKI KINOSHITA, AKIHIKO TAKAHASHI, KHALID YUSOFF, WAN AZMAN WAN AHMAD, MUHAMMAD RADZI ABU HASSAN, SAZZLI KASIM, AIZAI AZAN ABDUL RAHIM, DIMON MOHD ZAMRIN, MASAHARU MACHIDA, YORIHIKO HIGASHINO, NORIAKI UTSU, AKIHIKO NAKANO, SHIGERU NAKAMURA, TETSUO HASHIMOTO, KENJI ANDO, TOMOHIRO SAKAMOTO, F.J. PRINS, DIRK LOK, JOHANNES GERT-JAN MILHOUS, ERIC VIERGEVER, FRANK WILLEMS, HENK SWART, MARCO ALINGS, ROB BREEDVELD, KEES-JAN DE VRIES, ROGER VAN DER BORGH, FANNY OEI, STIENEKE ZOET-NUGTEREN, HANS KRAGTEN, JEAN PAUL HERRMAN, PAUL VAN BERGEN, MARCEL GOSSELINK, EDUARD HOEKSTRA, ERWIN ZEGERS, EELKO RONNER, FRANK DEN HARTOG, GERARD BARTELS, PETER NIEROP, COEN VAN DER ZWAAN, JACOB VAN ECK, EDWIN VAN GORSELEN, BJORN GROENEMEIJER, PIETER HOOGSLAG, MARC ROBERT DE GROOT, ALDRIN LOYOLA, DENNIS JOSE SULIT, NANNETTE REY, MARIA TERESA ABOLA, DANTE MORALES, ELLEN PALOMARES, MARC EVANS ABAT, GREGORIO ROGELIO, PHILIP CHUA, JOSE CARLO DEL PILAR, JOHN DENNIS ALCARAZ, GERALDINE EBO, LOUIE TIRADOR, JOSEFINA CRUZ, JOHN ANONUEVO, ARTHUR PITARGUE, MARIANNA JANION, TOMASZ GUZIK, GRZEGORZ GAJOS, MACIEJ ZABOWKA, ANDRZEJ RYNKIEWICZ, MARLENA BRONCEL, ANDRZEJ SZUBA, DANUTA CZARNECKA, PAWEL MAGA, IRINA STRAZHESKO, YURY VASYUK, ZHANNA SIZOVA, YURY POZDNYAKOV, OLGA BARBARASH, MIKHAIL VOEVODA, TATIANA POPONINA, ALEXEY REPIN, IRINA OSIPOVA, ANNA EFREMUSHKINA, NINA NOVIKOVA, OLEG AVERKOV, DMITRY ZATEYSHCHIKOV, ARKADIY VERTKIN, AZA AUSHEVA, PATRICK COMMERFORD, SAADIYA SEEDAT, LOUIS VAN ZYL, JAN ENGELBRECHT, ELLEN MAKONLI MAKOTOKO, CATHARINA ELIZABETH PRETORIUS, ZAID MOHAMED, ADRIAN HORAK, THOMAS MABIN, ERIC KLUG, JANG-HO BAE, CHEOLHO KIM, CHONG-JIN KIM, DONG-SOO KIM, YONG JIN KIM, SEUNGJAE JOO, JONG-WON HA, CHUL SOO PARK, JANG YOUNG KIM, YOUNG-KWON KIM, CHRISTINA JARNERT, THOMAS MOOE, MIKAEL DELLBORG, INGEMAR TORSTENSSON, PER ALBERTSSON, LARS JOHANSSON, FARIS AL-KHALILI, HENRIK ALMROTH, TOMMY ANDERSSON, EMIL PANTEV, BENGT-OLOV TENGMARK, BO LIU, GUNDARS RASMANIS, CARL-MAGNUS WAHLGREN, TIZIANO MOCCETTI, ALEXANDER PARKHOMENKO, VIRA TSELUYKO, VOLODYMYR VOLKOV, OLENA KOVAL, LYUDMYLA KONONENKO, OLEKSANDR PROKHOROV, VALERIY VDOVYCHENKO, ANDRIY BAZYLEVYCH, LEONID RUDENKO, VADYM VIZIR, OLEKSANDR KARPENKO, YAROSLAV MALYNOVSKY, VALENTYNA KOVAL, BORYS STOROZHUK, JAMES COTTON, ASOK VENKATARAMAN, ANDREW MORIARTY, DEREK CONNOLLY, PATRICK DAVEY, ROXY SENIOR, INDERPAUL BIRDI, JOHN CALVERT, PATRICK DONNELLY, JASPER TREVELYAN, JUSTIN CARTER, AARON PEACE, DAVID AUSTIN, NEVILLE KUKREJA, THOMAS HILTON, SUNNY SRIVASTAVA, RONALD WALSH, RONALD FIELDS, JOSEPH HAKAS, EDWARD PORTNAY, HARINDER GOGIA, ABRAHAM SALACATA, JOHN J. HUNTER, J MICHAEL BACHARACH, NICOLAS SHAMMAS, DAMODHAR SURESH, RICKY SCHNEIDER, PAUL GURBEL, SUBHASH BANERJEE, PAUL GRENA, NOEL BEDWELL, STEPHEN SLOAN, STEVEN LUPOVITCH, ANAND SONI, KATHLEEN GIBSON, RENEE SANGRIGOLI, RAJENDRA MEHTA, PETER I-HSUAN TSAI, EVE GILLESPIE, STEPHEN DEMPSEY, GLENN HAMROFF, ROBERT BLACK, ELLIS LADER, JOHN B. KOSTIS, VERA BITTNER, WILLIAM MCGUINN, KELLEY BRANCH, VINAY MALHOTRA, STEPHEN MICHAELSON, MICHAEL VACANTE, MATTHEW MCCORMICK, RALUCA ARIMIE, ALAN CAMP, GEORGE DAGHER, N. MATHEW KOSHY, STEPHEN THEW, FREDERICK COSTELLO, MARK HEIMAN, ROBERT CHILTON, MICHAEL MORAN, FREDRIC ADLER, ANTHONY COMEROTA, ANDREW SEIWERT, WILLIAM FRENCH, HARVEY SEROTA, ROBERT HARRISON, FAISAL BAKAEEN, SHUAB OMER, LOKESH CHANDRA, ALAN WHELAN, ANDREW BOYLE, PHILIP ROBERTS-THOMSON, JAMES ROGERS, PATRICK CARROLL, DAVID COLQUHOUN, JAMES SHAW, PETER BLOMBERY, JOHN AMERENA, CHRIS HII, ALISTAIR ROYSE, BHUWAN SINGH, JOSEPH SELVANAYAGAM, SHIRLEY JANSEN, WINGCHI LO, CHRISTOPHER HAMMETT, ROHAN POULTER, SESHASAYEE NARASIMHAN, HENRIK WIGGERS, HENRIK NIELSEN, GUNNAR GISLASON, LARS KOBER, KIM HOULIND, VIBEKE BOENELYKKE SOERENSEN, ULRIK DIXEN, JENS REFSGAARD, ELISABETH ZEUTHEN, PETER SOEGAARD, MARIAN HRANAI, LUDOVIT GASPAR, DANIEL PELLA, KATARINA HATALOVA, ERIKA DROZDAKOVA, IOAN COMAN, DOINA DIMULESCU, DRAGOS VINEREANU, MIRCEA CINTEZA, CRINA SINESCU, CATALINA ARSENESCU, IMRE BENEDEK, ELENA BOBESCU, DAN DOBREANU, DAN GAITA, ADRIAN IANCU, ADRIANA ILIESIU, DANIEL LIGHEZAN, LUCIAN PETRESCU, OCTAVIAN PIRVU, IULIA TEODORESCU, DAN TESLOIANU, MARIUS MARCIAN VINTILA, and OVIDIU CHIONCEL

Subjects
Male, medicine.medical_treatment, Myocardial Infarction, Coronary Artery Disease, 030204 cardiovascular system & hematology, Stroke/epidemiology, Coronary artery disease, 0302 clinical medicine, Rivaroxaban, Hemorrhage/chemically induced, Carotid artery disease, 030212 general & internal medicine, Myocardial infarction, Cardiovascular Diseases/mortality, Aspirin, Atrial fibrillation, General Medicine, Stroke, ORAL RIVAROXABAN, Cardiovascular Diseases, Factor Xa Inhibitors/administration & dosage, Cardiology, Female, Drug Therapy, Combination, medicine.drug, medicine.medical_specialty, Rivaroxaban/administration & dosage, Coronary Artery Disease/drug therapy, Hemorrhage, Drug Administration Schedule, 03 medical and health sciences, Double-Blind Method, Internal medicine, Journal Article, Myocardial Infarction/epidemiology, medicine, Humans, Aspirin/administration & dosage, Platelet Aggregation Inhibitors/administration & dosage, Aged, Dose-Response Relationship, Drug, business.industry, Unstable angina, Percutaneous coronary intervention, medicine.disease, PREVENTION, Morbidity, business, Platelet Aggregation Inhibitors, Factor Xa Inhibitors
Abstract

BACKGROUND: Coronary artery disease is a major cause of morbidity and mortality worldwide, and is a consequence of acute thrombotic events involving activation of platelets and coagulation proteins. Factor Xa inhibitors and aspirin each reduce thrombotic events but have not yet been tested in combination or against each other in patients with stable coronary artery disease.METHODS: In this multicentre, double-blind, randomised, placebo-controlled, outpatient trial, patients with stable coronary artery disease or peripheral artery disease were recruited at 602 hospitals, clinics, or community centres in 33 countries. This paper reports on patients with coronary artery disease. Eligible patients with coronary artery disease had to have had a myocardial infarction in the past 20 years, multi-vessel coronary artery disease, history of stable or unstable angina, previous multi-vessel percutaneous coronary intervention, or previous multi-vessel coronary artery bypass graft surgery. After a 30-day run in period, patients were randomly assigned (1:1:1) to receive rivaroxaban (2·5 mg orally twice a day) plus aspirin (100 mg once a day), rivaroxaban alone (5 mg orally twice a day), or aspirin alone (100 mg orally once a day). Randomisation was computer generated. Each treatment group was double dummy, and the patients, investigators, and central study staff were masked to treatment allocation. The primary outcome of the COMPASS trial was the occurrence of myocardial infarction, stroke, or cardiovascular death. This trial is registered with ClinicalTrials.gov, number NCT01776424, and is closed to new participants.FINDINGS: Between March 12, 2013, and May 10, 2016, 27 395 patients were enrolled to the COMPASS trial, of whom 24 824 patients had stable coronary artery disease from 558 centres. The combination of rivaroxaban plus aspirin reduced the primary outcome more than aspirin alone (347 [4%] of 8313 vs 460 [6%] of 8261; hazard ratio [HR] 0·74, 95% CI 0·65-0·86, pINTERPRETATION: In patients with stable coronary artery disease, addition of rivaroxaban to aspirin lowered major vascular events, but increased major bleeding. There was no significant increase in intracranial bleeding or other critical organ bleeding. There was also a significant net benefit in favour of rivaroxaban plus aspirin and deaths were reduced by 23%. Thus, addition of rivaroxaban to aspirin has the potential to substantially reduce morbidity and mortality from coronary artery disease worldwide.FUNDING: Bayer AG.

Published
2018

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