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1. Coronary flow reserve and cardiovascular outcomes: a systematic review and meta-analysis.

Author

Kelshiker, Mihir, Seligman, Henry, Howard, James, Rahman, Haseeb, Foley, Michael, Nowbar, Alexandra, Rajkumar, Christopher, Shun-Shin, Matthew, Ahmad, Yousif, Sen, Sayan, Al-Lamee, Rasha, and Petraco, Ricardo more...

Subjects
Cardiology, Cardiovascular risk, Coronary flow reserve, Interventional, Microvascular disease, Acute Coronary Syndrome, Cardiovascular System, Coronary Artery Disease, Fractional Flow Reserve, Myocardial, Humans, Myocardial Ischemia, Prognosis, Proportional Hazards Models
Abstract

AIMS: This meta-analysis aims to quantify the association of reduced coronary flow with all-cause mortality and major adverse cardiovascular events (MACE) across a broad range of patient groups and pathologies. METHODS AND RESULTS: We systematically identified all studies between 1 January 2000 and 1 August 2020, where coronary flow was measured and clinical outcomes were reported. The endpoints were all-cause mortality and MACE. Estimates of effect were calculated from published hazard ratios (HRs) using a random-effects model. Seventy-nine studies with a total of 59 740 subjects were included. Abnormal coronary flow reserve (CFR) was associated with a higher incidence of all-cause mortality [HR: 3.78, 95% confidence interval (CI): 2.39-5.97] and a higher incidence of MACE (HR 3.42, 95% CI: 2.92-3.99). Each 0.1 unit reduction in CFR was associated with a proportional increase in mortality (per 0.1 CFR unit HR: 1.16, 95% CI: 1.04-1.29) and MACE (per 0.1 CFR unit HR: 1.08, 95% CI: 1.04-1.11). In patients with isolated coronary microvascular dysfunction, an abnormal CFR was associated with a higher incidence of mortality (HR: 5.44, 95% CI: 3.78-7.83) and MACE (HR: 3.56, 95% CI: 2.14-5.90). Abnormal CFR was also associated with a higher incidence of MACE in patients with acute coronary syndromes (HR: 3.76, 95% CI: 2.35-6.00), heart failure (HR: 6.38, 95% CI: 1.95-20.90), heart transplant (HR: 3.32, 95% CI: 2.34-4.71), and diabetes mellitus (HR: 7.47, 95% CI: 3.37-16.55). CONCLUSION: Reduced coronary flow is strongly associated with increased risk of all-cause mortality and MACE across a wide range of pathological processes. This finding supports recent recommendations that coronary flow should be measured more routinely in clinical practice, to target aggressive vascular risk modification for individuals at higher risk. more...

Published
2022

2. Therapeutic options for neurocardiogenic syncope: a meta-analysis of randomised trials with and without blinding

Author

Darrel P Francis, James Howard, Matthew J Shun-Shin, Ahran Arnold, Phang Boon Lim, Alexandra Nowbar, Bradley Porter, Philip Eardley, Zachary I Whinnett, Daniel Keene, Melanie Dani, Monika Johal, Michela Sorbini, Nandita Kaza, Zhuang Liu, Shuli Levy, Patricia Taraborelli, and Mohamed Zuhair more...

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

Background Neurocardiogenic syncope is a common condition with significant associated psychological and physical morbidity. The effectiveness of therapeutic options for neurocardiogenic syncope beyond placebo remains uncertain.Methods The primary endpoint was the risk ratio (RR) of spontaneously recurring syncope following any therapeutic intervention. We also examined the effect of blinding on treatment efficacy. We identified all randomised trials which evaluated the effect of any pharmacological, device-based or supportive intervention on patients with a history of syncope. A systematic search was conducted on Medline, Embase, PubMed databases and Cochrane Central Register for Controlled Trials from 1950 to 25 April 2023. Event rates, their RRs and 95% CIs were calculated, and a random-effects meta-analysis was conducted for each intervention. Data analysis was performed in R using RStudio.Results We identified 47 eligible trials randomising 3518 patients. Blinded trials assessing syncope recurrence were neutral for beta blockers, fludrocortisone and conventional dual-chamber pacing but were favourable for selective serotonin reuptake inhibitors (SSRIs) (RR 0.40, 95% CI 0.26 to 0.63, p more...

Published
2024
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4. A randomized controlled trial to investigate the use of acute coronary syndrome therapy in patients hospitalized with COVID-19: the COVID-19 Acute Coronary Syndrome trial

Author

Kanagaratnam, Prapa, Francis, Darrel P., Chamie, Daniel, Coyle, Clare, Marynina, Alena, Katritsis, George, Paiva, Patricia, Szigeti, Matyas, Cole, Graham, de Andrade Nunes, David, Howard, James, Esper, Rodrigo, Khan, Masood, More, Ranjit, Barreto, Guilherme, Meneguz-Moreno, Rafael, Arnold, Ahran, Nowbar, Alexandra, Kaura, Amit, Mariveles, Myril, March, Katherine, Shah, Jaymin, Nijjer, Sukhjinder, Lip, Gregory Y.H., Mills, Nicholas, Camm, A. John, Cooke, Graham S., Corbett, Simon J., Llewelyn, Martin J., Ghanima, Waleed, Toshner, Mark, Peters, Nicholas, Petraco, Ricardo, Al-Lamee, Rasha, Boshoff, Ana Sousa Marcelino, Durkina, Margarita, Malik, Iqbal, Ruparelia, Neil, Cornelius, Victoria, and Shun-Shin, Matthew more...

Published
2023
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7. N-of-1 Trial of Angina Verification Before Percutaneous Coronary Intervention

Author

Rajkumar, Christopher A., primary, Foley, Michael J., additional, Ahmed-Jushuf, Fiyyaz, additional, Simader, Florentina A., additional, Mohsin, Muhammad, additional, Ganesananthan, Sashiananthan, additional, Nowbar, Alexandra N., additional, Chotai, Shayna, additional, Sen, Sayan, additional, Petraco, Ricardo, additional, Nijjer, Sukhjinder S., additional, Sehmi, Joban, additional, Ruparelia, Neil, additional, Dungu, Jason N., additional, Kabir, Alamgir, additional, Tang, Kare, additional, Gamma, Reto, additional, Davies, John R., additional, Kotecha, Tushar, additional, Cole, Graham D., additional, Howard, James P., additional, Keeble, Thomas R., additional, Clesham, Gerald, additional, O’Kane, Peter D., additional, Harrell, Frank E., additional, Francis, Darrel P., additional, Shun-Shin, Matthew J., additional, and Al-Lamee, Rasha K., additional more...

Published
2024
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8. Symptoms as a Predictor of the Placebo-Controlled Efficacy of PCI in Stable Coronary Artery Disease

Author

Simader, Florentina A., primary, Rajkumar, Christopher A., additional, Foley, Michael J., additional, Ahmed-Jushuf, Fiyyaz, additional, Chotai, Shayna, additional, Bual, Nina, additional, Khokhar, Arif, additional, Gohar, Aisha, additional, Lampadakis, Ioannis, additional, Ganesananthan, Sashiananthan, additional, Pathimagaraj, Rachel H., additional, Nowbar, Alexandra, additional, Davies, John R., additional, Keeble, Tom R., additional, O’Kane, Peter D., additional, Haworth, Peter, additional, Routledge, Helen, additional, Kotecha, Tushar, additional, Spratt, James C., additional, Williams, Rupert, additional, Nijjer, Sukhjinder S., additional, Sen, Sayan, additional, Curzen, Nick, additional, Sinha, Manas, additional, Howard, James P., additional, Cole, Graham, additional, Harrell, Frank E., additional, Francis, Darrel P., additional, Shun-Shin, Matthew J., additional, and Al-Lamee, Rasha K., additional more...

Published
2024
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9. The Placebo-Controlled Effect of Percutaneous Coronary Intervention on Exercise Induced Changes in Anti-Malondialdehyde-LDL Antibody Levels in Stable Coronary Artery Disease: A Substudy of the ORBITA Trial

Author

Adam Hartley, Matthew Shun-Shin, Mikhail Caga-Anan, Christopher Rajkumar, Alexandra N. Nowbar, Michael Foley, Darrel P. Francis, Dorian O. Haskard, Ramzi Y. Khamis, and Rasha K. Al-Lamee

Subjects
atherosclerosis, percutaneous coronary intervention (PCI), exercise, LDL-cholesterol, oxidised LDL (oxLDL), malondialdehyde-modified LDL (MDA-LDL), Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Aim: Malondialdehyde-modified low-density lipoprotein (MDA-LDL) forms a significant component of oxidised LDL. The effects of exercise on levels of MDA-LDL and anti-MDA-LDL antibodies are not well-understood. Furthermore, it is not known whether these can be modified in patients with coronary artery disease by percutaneous coronary intervention (PCI).Methods: The Objective Randomised Blinded Investigation with optimal medical Therapy of Angioplasty in stable angina (ORBITA) trial was the first blinded, multi-centre randomised trial of PCI vs. placebo procedure for angina relief. Serum samples were available at four time-points: pre-randomisation pre- (P1) and post- (P2) exercise and post-randomisation (6-weeks following the PCI or placebo procedure), pre- (P3) and post- (P4) exercise. ELISAs were performed using laboratory-developed assays for MDA-LDL (adjusted for Apolipoprotein B) and anti-MDA-LDL antibodies.Results: One hundred ninety-six of the 200 patients (age 66.1 [SD 8.99] years, 28% female) with severe single vessel coronary artery disease suitable for PCI enrolled in the ORBITA trial had blood available for analysis. With exercise at pre-randomisation (P2–P1) there was no significant change in adjusted MDA-LDL (−0.001, 95% CI −0.004 to 0.001; p = 0.287); however, IgG and IgM anti-MDA-LDL significantly declined (−0.022, 95% CI −0.029 to −0.014, p < 0.0001; −0.016, 95% CI −0.024 to −0.008, p = 0.0002, respectively). PCI did not have a significant impact on either the pre-exercise values (P3 controlling for P1) of MDA-LDL (p = 0.102), IgG (p = 0.444) or IgM anti-MDA-LDL (p = 0.909). Nor did PCI impact the exercise induced changes in these markers (P4 controlling for P1, P2, and P3) for MDA-LDL (p = 0.605), IgG (p = 0.725) or IgM anti-MDA-LDL (p = 0.171). Pre-randomisation ischaemia on stress echo did not impact these interactions.Conclusions: Exercise results in an acute reduction in anti-oxLDL antibodies in patients with severe single vessel coronary disease, possibly indicating an induction in homoeostatic clearance via the innate immune system. However, PCI did not ameliorate this effect. more...

Published
2021
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10. Placebo-Controlled Efficacy of Percutaneous Coronary Intervention for Focal and Diffuse Patterns of Stable Coronary Artery Disease

Author

Rajkumar, Christopher A., Shun-Shin, Matthew, Seligman, Henry, Ahmad, Yousif, Warisawa, Takayuki, Cook, Christopher M., Howard, James P., Ganesananthan, Sashiananthan, Amarin, Laura, Khan, Caitlin, Ahmed, Ayesha, Nowbar, Alexandra, Foley, Michael, Assomull, Ravi, Keenan, Niall G., Sehmi, Joban, Keeble, Thomas R., Davies, John R., Tang, Kare H., Gerber, Robert, Cole, Graham, O’Kane, Peter, Sharp, Andrew S.P., Khamis, Ramzi, Kanaganayagam, Gajen, Petraco, Ricardo, Ruparelia, Neil, Malik, Iqbal S., Nijjer, Sukhjinder, Sen, Sayan, Francis, Darrel P., and Al-Lamee, Rasha more...

Published
2021
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11. Achieving Optimal Medical Therapy: Insights From the ORBITA Trial

Author

Michael Foley, Christopher A. Rajkumar, Matthew Shun‐Shin, Sashiananthan Ganesananthan, Henry Seligman, James Howard, Alexandra N. Nowbar, Thomas R. Keeble, John R. Davies, Kare H. Tang, Robert Gerber, Peter O’Kane, Andrew S. P. Sharp, Ricardo Petraco, Iqbal S. Malik, Sukhjinder Nijjer, Sayan Sen, Darrel P. Francis, and Rasha Al‐Lamee more...

Subjects
adverse effects, angina, compliance/adherence, medical therapy, randomized controlled trial, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Background In stable coronary artery disease, medications are used for 2 purposes: cardiovascular risk reduction and symptom improvement. In clinical trials and clinical practice, medication use is often not optimal. The ORBITA (Objective Randomised Blinded Investigation With Optimal Medical Therapy of Angioplasty in Stable Angina) trial was the first placebo‐controlled trial of percutaneous coronary intervention. A key component of the ORBITA trial design was the inclusion of a medical optimization phase, aimed at ensuring that all patients were treated with guideline‐directed truly optimal medical therapy. In this study, we report the medical therapy that was achieved. Methods and Results After enrollment into the ORBITA trial, all 200 patients entered a 6‐week period of intensive medical therapy optimization, with initiation and uptitration of risk reduction and antianginal therapy. At the prerandomization stage, the median number of antianginals established was 3 (interquartile range, 2–4). A total of 195 patients (97.5%) reached the prespecified target of ≥2 antianginals; 136 (68.0%) did not stop any antianginals because of adverse effects, and the median number of antianginals stopped for adverse effects per patient was 0 (interquartile range, 0–1). Amlodipine and bisoprolol were well tolerated (stopped for adverse effects in 4/175 [2.3%] and 9/167 [5.4%], respectively). Ranolazine and ivabradine were also well tolerated (stopped for adverse effects in 1/20 [5.0%] and 1/18 [5.6%], respectively). Isosorbide mononitrate and nicorandil were stopped for adverse effects in 36 of 172 (20.9%) and 32 of 141 (22.7%) of patients, respectively. Statins were well tolerated and taken by 191 of 200 (95.5%) patients. Conclusions In the 12‐week ORBITA trial period, medical therapy was successfully optimized and well tolerated, with few drug adverse effects leading to therapy cessation. Truly optimal medical therapy can be achieved in clinical trials, and translating this into longer‐term clinical practice should be a focus of future study. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02062593. more...

Published
2021
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12. A Placebo-Controlled Trial of Percutaneous Coronary Intervention for Stable Angina

Author

Rajkumar, Christopher A., primary, Foley, Michael J., additional, Ahmed-Jushuf, Fiyyaz, additional, Nowbar, Alexandra N., additional, Simader, Florentina A., additional, Davies, John R., additional, O’Kane, Peter D., additional, Haworth, Peter, additional, Routledge, Helen, additional, Kotecha, Tushar, additional, Gamma, Reto, additional, Clesham, Gerald, additional, Williams, Rupert, additional, Din, Jehangir, additional, Nijjer, Sukhjinder S., additional, Curzen, Nick, additional, Ruparelia, Neil, additional, Sinha, Manas, additional, Dungu, Jason N., additional, Ganesananthan, Sashiananthan, additional, Khamis, Ramzi, additional, Mughal, Lal, additional, Kinnaird, Tim, additional, Petraco, Ricardo, additional, Spratt, James C., additional, Sen, Sayan, additional, Sehmi, Joban, additional, Collier, David J., additional, Sohaib, Afzal, additional, Keeble, Thomas R., additional, Cole, Graham D., additional, Howard, James P., additional, Francis, Darrel P., additional, Shun-Shin, Matthew J., additional, and Al-Lamee, Rasha K., additional more...

Published
2023
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13. Safety and Efficacy of Renal Denervation in Patients Taking Antihypertensive Medications

Author

Kandzari, David E., primary, Townsend, Raymond R., additional, Kario, Kazuomi, additional, Mahfoud, Felix, additional, Weber, Michael A., additional, Schmieder, Roland E., additional, Pocock, Stuart, additional, Tsioufis, Konstantinos, additional, Konstantinidis, Dimitrios, additional, Choi, James, additional, East, Cara, additional, Lauder, Lucas, additional, Cohen, Debbie L., additional, Kobayashi, Taisei, additional, Schmid, Axel, additional, Lee, David P., additional, Ma, Adrian, additional, Weil, Joachim, additional, Agdirlioglu, Tolga, additional, Schlaich, Markus P., additional, Shetty, Sharad, additional, Devireddy, Chandan M., additional, Lea, Janice, additional, Aoki, Jiro, additional, Sharp, Andrew S.P., additional, Anderson, Richard, additional, Fahy, Martin, additional, DeBruin, Vanessa, additional, Brar, Sandeep, additional, Böhm, Michael, additional, Wang, Yale, additional, Jay, Desmond, additional, McLaurin, Brent, additional, Lomboy, Carl, additional, Allaqaband, Suhail, additional, Jan, Fuad, additional, Gummadi, Bharat, additional, Litt, Marc, additional, Garcia, Fidel, additional, Singh, Jasvindar, additional, Brown, Angela, additional, Paul, Ashley, additional, Sharp, Andrew, additional, Coulson, James, additional, Nanjundappa, Aravinda, additional, Thakker, Ganpat, additional, Campbell, James, additional, Honton, Benjamin, additional, Farah, Bruno, additional, Patel, Manesh, additional, Gutierrez, Antonio, additional, Tyson, Crystal, additional, Svetkey, Laura, additional, Fudim, Marat, additional, Pagidipati, Neha, additional, Jones, Schuyler, additional, Vemulapalli, Sreekanth, additional, Devireddy, Chandan, additional, Kulshreshtha, Ambar, additional, Wells, Bryan, additional, Batson, Bryan, additional, Wilkins, Robert, additional, Sharif, Faisal, additional, Khair, Abdullahi Mohamed, additional, Pallippattu, Abhishek Wilson, additional, Alhmoudi, Aishah Matar, additional, Gaffney, Brian, additional, Cawley, Christian, additional, Gorry, Colin, additional, Hamed, Hanan, additional, Carron, Jennifer, additional, Birrane, John, additional, Rosseel, Liesbeth, additional, Lunardi, Mattia, additional, Cronin, Michael, additional, McKittrick, Myles, additional, Almagal, Naeif, additional, Khalid, Noman, additional, Shehahd, Qussai, additional, Shahzad, Shirjeel, additional, Fezzi, Simone, additional, Tyulkin, Stanislav, additional, Bel, Xavier Armario, additional, Jolly, Sanjit, additional, Yip, Gordon, additional, Schwalm, Jon-David, additional, Tsang, Michael, additional, Mehta, Shamir, additional, Lurz, Philipp C., additional, Binner, Christian, additional, Obradovic, Danilo, additional, Fahr, Florian, additional, Richter, Ines, additional, Rotta detto Loria, Johannes, additional, Fengler, Karl, additional, Rommel, Karl-Philipp, additional, Cuartas, Mateo Marin, additional, Lerche, Matthias, additional, Hartung, Philipp, additional, Münch, Phillip, additional, Höllriegel, Robert, additional, John, Silke, additional, Otsuji, Satoru, additional, Kusumoto, Hirofumi, additional, Tamaru, Hiroto, additional, Ishibuchi, Kasumi, additional, Hasegawa, Katsuyuki, additional, Sugimoto, Ken, additional, Kakishita, Mikio, additional, Ishii, Rui, additional, Takiuchi, Shin, additional, Yasuda, Shingo, additional, Nakabayashi, Sho, additional, Yamamoto, Wataru, additional, Higashino, Yorihiko, additional, Shimatani, Yuji, additional, Taniguchi, Yusuke, additional, Kasiakogias, Alexandros, additional, Konstantinidis, Dimitris, additional, Andrikou, Eirini, additional, Konstantinou, Konstantinos, additional, Dimitriadis, Kyriakos, additional, Kalos, Theodoros, additional, Cohen, Debbie, additional, Rene, Garvey, additional, Cohen, Jordana, additional, Bonanni, Maria, additional, Denker, Matthew, additional, Wickramisinghe, Rasi, additional, Wilensky, Robert, additional, Kobayashi, Tai, additional, Anjan, Venkatesh, additional, Huan, Yonghong, additional, Haught, Walter Herbert, additional, Krasnow, Joshua, additional, Vasquez, Alejandro, additional, Gessler, Carl, additional, Roth, Christopher, additional, Drenning, David, additional, Velasquez, Enrique, additional, Soliman, George, additional, Murphy, James, additional, Jain, Kaushik, additional, Butler, Michael, additional, Kanitkar, Mihir, additional, Laney, Phillip, additional, Hunter, Ross, additional, Cheng, Shi-Chi, additional, Wright, Thomas, additional, Chapman, Neil, additional, Arnold, Ahran, additional, Nowbar, Alexandra, additional, Janmohamed, Azara, additional, Corden, Ben, additional, Cook, Christopher, additional, Rajkumar, Christopher, additional, Keene, Daniel, additional, Thompson, David, additional, Seligman, Henry, additional, Howard, James, additional, Davies, Justin, additional, Sweeney, Mark, additional, Shun-Shin, Matthew, additional, Foley, Michael, additional, Quaife, Nicholas, additional, Al-Lamee, Rasha, additional, Hadjiphilippou, Savvas, additional, Sen, Sayan, additional, Ahmad, Yousif, additional, Shimizu, Hayato, additional, Waki, Hirotaka, additional, Narita, Keisuke, additional, Shimpo, Masahisa, additional, Hoshide, Satoshi, additional, Komori, Takahiro, additional, Ogoyama, Yukako, additional, Ogata, Yukiyo, additional, Oba, Yusuke, additional, Bisharat, Mohanned, additional, Lishmanov, Anton, additional, Jeffords, Travis, additional, Ghali, Magdi, additional, Chia, Beth, additional, Onsrud, Rachel, additional, Rough, Randolph, additional, Tomii, Daijiro, additional, Mori, Fumiko, additional, Kikushima, Hosei, additional, Ninomiya, Kai, additional, Yahagi, Kazuyuki, additional, Tanabe, Kengo, additional, Nakamura, Kosuke, additional, Komiyama, Kota, additional, Nakase, Masaaki, additional, Asami, Masahiko, additional, Setoguchi, Naoto, additional, Tanaka, Tetsu, additional, Horiuchi, Yu, additional, Watanabe, Yusuke, additional, Feldman, Dmitriy, additional, Bergman, Geoffrey, additional, Sherifi, Ines, additional, Kim, Luke, additional, Amin, Nivee, additional, Minutello, Robert, additional, Wong, S. Chiu, additional, McCullough, Stephen, additional, D'Souza, Richard, additional, Kurdi, Hibba, additional, Statton, Sarah, additional, Watkinson, Tony, additional, Bertolet, Barry, additional, Gupta, Amit, additional, Blossom, Benjamin, additional, Bell, Chris, additional, Hill, Douglas, additional, Sierra, Francisco, additional, Johnson, James, additional, Estess, John, additional, Adams, Joseph, additional, McDuffie, Katie, additional, Ferguson, Lee, additional, Little, Nelson, additional, Ballard, Richard Dane, additional, Williams, Roger, additional, Ikeda, Wanda, additional, Calhoun, William, additional, Carroll, William, additional, Singh, Avneet, additional, Hirsh, Benjamin, additional, Meraj, Perwaiz, additional, Jauhar, Rajiv, additional, Golwala, Harsh, additional, Rueda, Jose, additional, Graham, Kellie, additional, Al-Hakim, Ramsey, additional, Rope, Robert, additional, Kandzari, David, additional, Bahrami, Dariush, additional, Reedus, Denise, additional, David, Shukri, additional, Rehman, Iram, additional, Zakaria, Khalid, additional, Choksi, Nishit, additional, Kazziha, Samer, additional, Kumar, Sarwan, additional, Saba, Souheil, additional, Steigerwalt, Susan, additional, Sirajeldin, Yassir, additional, Hyder, Omar, additional, Aronow, Herbert, additional, Connors, Andrea, additional, Shemin, Douglas, additional, Bent, Clare, additional, Levy, Terry, additional, Kodoth, Vivek, additional, Schlaich, Markus, additional, Kiuchi, Marcio, additional, Carnagarin, Revathy, additional, Torre, Sabino, additional, Levitt, Howard, additional, Chen, Lin, additional, Fan, Sarah, additional, Waxman, Sergio, additional, Porr, Wendy, additional, Mangos, George, additional, Smyth, Brendan, additional, Lane, Cathie, additional, Sader, Mark, additional, Patel, Kirit Kumar, additional, Rao, Anjani, additional, Milford, Brett, additional, Ahluwalia, Guneet, additional, Sennott, Jaqueline, additional, Field, Justin, additional, Jena, Nihar, additional, Loree, Stacy, additional, Graham, John, additional, Al-Hesayen, Abdul, additional, Bagai, Akshay, additional, Shite, Junya, additional, Kozuki, Amane, additional, Suzuki, Atsushi, additional, Masuko, Eri, additional, Soga, Fumitaka, additional, Asada, Hiroyuki, additional, Shibata, Hiroyuki, additional, Nagoshi, Ryoji, additional, Fujiwara, Ryudo, additional, Kyo, Shokan, additional, Miyata, Tomohiro, additional, Kijima, Yoichi, additional, Griesinger, Lena, additional, Hafer, Lukas, additional, Starick, Rene-Alexander, additional, Keil, Sebastian, additional, Desch, Udo, additional, Saito, Shigeru, additional, Koyama, Eiji, additional, Yamanaka, Futoshi, additional, Yokoyama, Hiroaki, additional, Tobita, Kazuki, additional, Shishido, Koki, additional, Yamaguchi, Masashi, additional, Murakami, Masato, additional, Moriyama, Noriaki, additional, Takahashi, Saeko, additional, Mizuno, Shingo, additional, Yokota, Shohei, additional, Hayashi, Takahiro, additional, Yamada, Takashi, additional, Yamagishi, Tamiharu, additional, Sugiyama, Yoichi, additional, Mashimo, Yuka, additional, Tamaki, Yusuke, additional, Tanaka, Yutaka, additional, Lee, David, additional, Yeung, Alan, additional, Noel, Thomas, additional, Umana, Ernesto, additional, Katopodis, John, additional, Dixon, William, additional, Walton, Tony, additional, Rischin, Adam, additional, Chee, Adrian, additional, Leaney, Alexandra, additional, Fernando, Himavan, additional, Hopper, Ingrid, additional, Bloom, Jason, additional, Fairley, Jessica, additional, Stehli, Julia, additional, Segan, Julian, additional, Sharma, Meenal, additional, Fitzgerald, Melissa, additional, Papandony, Michelle, additional, Whyler, Naomi, additional, Noaman, Samer, additional, Ali, Shazeea, additional, Jefferson, Brian, additional, Reyes, David, additional, Johnston, Thomas, additional, Höfling, Alexander, additional, Berger, Ann-Kathrin, additional, Cremers, Bodo, additional, Millenaar, Dominic, additional, Zivanovic, Ina, additional, Lucic, Jelena, additional, Dederer, Juliane, additional, Fischer, Patrick, additional, Kulenthiran, Saarraangan, additional, Ewen, Sebastian, additional, Bewarder, Yvonne, additional, Schmieder, Roland, additional, Bosch, Agnes, additional, Ott, Christian, additional, Kannenkeril, Dennis, additional, Akarca, Ertan, additional, Kistner, Iris, additional, Kolwelter, Julie, additional, Bihlmaier, Karl, additional, Striepe, Kristina, additional, Karg, Marina, additional, Günes-Altan, Merve, additional, Anna Friedrich, Stefanie Sofia, additional, Jung, Susanne, additional, Dienemann, Thomas, additional, Ziakas, Antonios, additional, Kouparanis, Antonios, additional, Pagiantza, Areti, additional, Peteinidou, Emmanouela, additional, Didagelos, Matthaios, additional, Psochias, Polykarpos Akis, additional, Shishehbor, Mehdi, additional, Meade, Ashley, additional, Linetsky, Elena, additional, Robinson, Monique, additional, Kotter, John, additional, Ziada, Khaled, additional, Bachinsky, William, additional, Garton, Alex, additional, Stuck, Jason, additional, Papademetriou, Vasilios, additional, Chung, Annise, additional, Li, Ping, additional, Nagpal, Sameer, additional, Remetz, Michael, additional, Shah, Samit, additional, and Lynch, Shannon, additional more...

Published
2023
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22. Dobutamine Stress Echocardiography Ischemia as a Predictor of the Placebo-Controlled Efficacy of Percutaneous Coronary Intervention in Stable Coronary Artery Disease: The Stress Echocardiography–Stratified Analysis of ORBITA

Author

Al-Lamee, Rasha K., Shun-Shin, Matthew J., Howard, James P., Nowbar, Alexandra N., Rajkumar, Christopher, Thompson, David, Sen, Sayan, Nijjer, Sukhjinder, Petraco, Ricardo, Davies, John, Keeble, Thomas, Tang, Kare, Malik, Iqbal, Bual, Nina, Cook, Christopher, Ahmad, Yousif, Seligman, Henry, Sharp, Andrew S.P., Gerber, Robert, Talwar, Suneel, Assomull, Ravi, Cole, Graham, Keenan, Niall G., Kanaganayagam, Gajen, Sehmi, Joban, Wensel, Roland, Harrell, Frank E., Jr, Mayet, Jamil, Thom, Simon, Davies, Justin E., and Francis, Darrel P. more...

Published
2019
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25. Development of artificial intelligence tools for invasive Doppler-based coronary microvascular assessment.

Author

Seligman, H., Patel, S.B., Alloula, A., Howard, J.P., Cook, C.M., Ahmad, Y., Waard, G.A. de, Pinto, M.E., Hoef, T.P. van de, Rahman, H., Kelshiker, M.A., Rajkumar, C.A., Foley, M., Nowbar, A.N., Mehta, S., Toulemonde, M., Tang, M.X., Al-Lamee, R., Sen, S., Cole, G., Nijjer, S., Escaned, J., Royen, N. van, Francis, D.P., Shun-Shin, M.J., Petraco, R., Seligman, H., Patel, S.B., Alloula, A., Howard, J.P., Cook, C.M., Ahmad, Y., Waard, G.A. de, Pinto, M.E., Hoef, T.P. van de, Rahman, H., Kelshiker, M.A., Rajkumar, C.A., Foley, M., Nowbar, A.N., Mehta, S., Toulemonde, M., Tang, M.X., Al-Lamee, R., Sen, S., Cole, G., Nijjer, S., Escaned, J., Royen, N. van, Francis, D.P., Shun-Shin, M.J., and Petraco, R. more...

Abstract

01 augustus 2023, Contains fulltext : 295922.pdf (Publisher’s version ) (Open Access), AIMS: Coronary flow reserve (CFR) assessment has proven clinical utility, but Doppler-based methods are sensitive to noise and operator bias, limiting their clinical applicability. The objective of the study is to expand the adoption of invasive Doppler CFR, through the development of artificial intelligence (AI) algorithms to automatically quantify coronary Doppler quality and track flow velocity. METHODS AND RESULTS: A neural network was trained on images extracted from coronary Doppler flow recordings to score signal quality and derive values for coronary flow velocity and CFR. The outputs were independently validated against expert consensus. Artificial intelligence successfully quantified Doppler signal quality, with high agreement with expert consensus (Spearman's rho: 0.94), and within individual experts. Artificial intelligence automatically tracked flow velocity with superior numerical agreement against experts, when compared with the current console algorithm [AI flow vs. expert flow bias -1.68 cm/s, 95% confidence interval (CI) -2.13 to -1.23 cm/s, P < 0.001 with limits of agreement (LOA) -4.03 to 0.68 cm/s; console flow vs. expert flow bias -2.63 cm/s, 95% CI -3.74 to -1.52, P < 0.001, 95% LOA -8.45 to -3.19 cm/s]. Artificial intelligence yielded more precise CFR values [median absolute difference (MAD) against expert CFR: 4.0% for AI and 7.4% for console]. Artificial intelligence tracked lower-quality Doppler signals with lower variability (MAD against expert CFR 8.3% for AI and 16.7% for console). CONCLUSION: An AI-based system, trained by experts and independently validated, could assign a quality score to Doppler traces and derive coronary flow velocity and CFR. By making Doppler CFR more automated, precise, and operator-independent, AI could expand the clinical applicability of coronary microvascular assessment. more...

Published
2023

26. Therapeutic options for syncope: a meta-analysis of trials with and without placebo control

Author

Kaza, N, primary, Sorbini, M, additional, Johal, M, additional, Liu, Z, additional, Porter, B, additional, Nowbar, A, additional, Levy, S, additional, Dani, M, additional, Taraborelli, P, additional, Eardley, P, additional, Whinnett, Z I, additional, Francis, D P, additional, Shun-Shin, M, additional, Lim, P B, additional, and Keene, D, additional more...

Published
2023
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27. Development of artificial intelligence tools for invasive Doppler-based coronary microvascular assessment

Author

Seligman, Henry, primary, Patel, Sapna B, additional, Alloula, Anissa, additional, Howard, James P, additional, Cook, Christopher M, additional, Ahmad, Yousif, additional, de Waard, Guus A, additional, Pinto, Mauro Echavarría, additional, van de Hoef, Tim P, additional, Rahman, Haseeb, additional, Kelshiker, Mihir A, additional, Rajkumar, Christopher A, additional, Foley, Michael, additional, Nowbar, Alexandra N, additional, Mehta, Samay, additional, Toulemonde, Mathieu, additional, Tang, Meng-Xing, additional, Al-Lamee, Rasha, additional, Sen, Sayan, additional, Cole, Graham, additional, Nijjer, Sukhjinder, additional, Escaned, Javier, additional, Van Royen, Niels, additional, Francis, Darrel P, additional, Shun-Shin, Matthew J, additional, and Petraco, Ricardo, additional more...

Published
2023
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28. Cardiopulmonary exercise testing and efficacy of percutaneous coronary intervention: a substudy of the ORBITA trial

Author

Sashiananthan Ganesananthan, Christopher A Rajkumar, Michael Foley, David Thompson, Alexandra N Nowbar, Henry Seligman, Ricardo Petraco, Sayan Sen, Sukhjinder Nijjer, Simon A Thom, Roland Wensel, John Davies, Darrel Francis, Matthew Shun-Shin, James Howard, Rasha Al-Lamee, and Medical Research Council more...

Subjects
Cardiac & Cardiovascular Systems, Chronic coronary syndrome, Coronary Artery Disease, Ischaemia, MEDICAL THERAPY, Oxygen Consumption, Percutaneous Coronary Intervention, Oxygen pulse, ARTERY-DISEASE, Humans, Angina, Stable, ANGIOPLASTY, 1102 Cardiorespiratory Medicine and Haematology, Peak oxygen uptake, Science & Technology, ANAEROBIC THRESHOLD, VE/VCO2 SLOPE, 1103 Clinical Sciences, Angina, CHRONIC HEART-FAILURE, Cardiopulmonary exercise testing, VENTILATION, Fractional Flow Reserve, Myocardial, Oxygen, Cardiovascular System & Hematology, Cardiovascular System & Cardiology, UPTAKE EFFICIENCY SLOPE, Exercise Test, Quality of Life, Stable coronary artery disease, OXYGEN-UPTAKE, STABLE ANGINA, Cardiology and Cardiovascular Medicine, Life Sciences & Biomedicine
Abstract

Aims Oxygen-pulse morphology and gas exchange analysis measured during cardiopulmonary exercise testing (CPET) has been associated with myocardial ischaemia. The aim of this analysis was to examine the relationship between CPET parameters, myocardial ischaemia and anginal symptoms in patients with chronic coronary syndrome and to determine the ability of these parameters to predict the placebo-controlled response to percutaneous coronary intervention (PCI). Methods and results Patients with severe single-vessel coronary artery disease (CAD) were randomized 1:1 to PCI or placebo in the ORBITA trial. Subjects underwent pre-randomization treadmill CPET, dobutamine stress echocardiography (DSE) and symptom assessment. These assessments were repeated at the end of a 6-week blinded follow-up period. A total of 195 patients with CPET data were randomized (102 PCI, 93 placebo). Patients in whom an oxygen-pulse plateau was observed during CPET had higher (more ischaemic) DSE score [+0.82 segments; 95% confidence interval (CI): 0.40 to 1.25, P = 0.0068] and lower fractional flow reserve (−0.07; 95% CI: −0.12 to −0.02, P = 0.011) compared with those without. At lower (more abnormal) oxygen-pulse slopes, there was a larger improvement of the placebo-controlled effect of PCI on DSE score [oxygen-pulse plateau presence (Pinteraction = 0.026) and oxygen-pulse gradient (Pinteraction = 0.023)] and Seattle angina physical-limitation score [oxygen-pulse plateau presence (Pinteraction = 0.037)]. Impaired peak VO2, VE/VCO2 slope, peak oxygen-pulse, and oxygen uptake efficacy slope was significantly associated with higher symptom burden but did not relate to severity of ischaemia or predict response to PCI. Conclusion Although selected CPET parameters relate to severity of angina symptoms and quality of life, only an oxygen-pulse plateau detects the severity of myocardial ischaemia and predicts the placebo-controlled efficacy of PCI in patients with single-vessel CAD. more...

Published
2022
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29. Mechanical thrombectomy with retrievable stents and aspiration catheters for acute ischaemic stroke: a meta-analysis of randomised controlled trials

Author

Alexandra N. Nowbar, Matthew J. Shun-Shin, Iqbal S. Malik, Rasha Al-Lamee, George D Thornton, Iris Q. Grunwald, Henry Seligman, Darrel P. Francis, Sashiananthan Ganesananthan, James P. Howard, Michael Foley, Yousif Ahmad, Christopher Rajkumar, and Thomas R. Keeble more...

Subjects
medicine.medical_specialty, Catheters, medicine.medical_treatment, Brain Ischemia, Modified Rankin Scale, Ischaemic stroke, medicine, Clinical endpoint, Humans, Stroke, Ischemic Stroke, Randomized Controlled Trials as Topic, Thrombectomy, business.industry, Endovascular Procedures, Stent, Bayes Theorem, Thrombolysis, medicine.disease, Surgery, Mechanical thrombectomy, Treatment Outcome, Meta-analysis, Stents, Cardiology and Cardiovascular Medicine, business, Meta-Analysis
Abstract

Background: Retrievable stents and aspiration catheters have been developed to provide more effective arterial recanalisation in acute ischaemic stroke. Aims: The aim of this analysis was to test the effect of mechanical thrombectomy on mortality and longterm neurological outcome in patients presenting with acute large-vessel anterior circulation ischaemic stroke. Methods: A structured search identified randomised controlled trials of thrombectomy (using a retrievable stent or aspiration catheter) versus control on a background of medical therapy which included intravenous thrombolysis if appropriate. The primary endpoint was disability at 90-day follow-up as assessed by the modified Rankin scale (mRS). Secondary endpoints included all-cause mortality and symptomatic intracranial haemorrhage. A Bayesian mixed-effects model was used for analysis. Results: Twelve (12) trials met the inclusion criteria, comprising a total of 1,276 patients randomised to thrombectomy and 1,282 patients to control. Randomisation to thrombectomy significantly reduced disability at 90 days (OR 0.52, 95% credible interval 0.46 to 0.61, probability(control better)2 (OR 0.44, CrI 0.37 to 0.52, pr more...

Published
2022
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30. Development of artificial intelligence tools for invasive Doppler-based coronary microvascular assessment

Author

Henry Seligman, Sapna B Patel, Anissa Alloula, James P Howard, Christopher M Cook, Yousif Ahmad, Guus A de Waard, Mauro Echavarría Pinto, Tim P van de Hoef, Haseeb Rahman, Mihir A Kelshiker, Christopher A Rajkumar, Michael Foley, Alexandra N Nowbar, Samay Mehta, Mathieu Toulemonde, Meng-Xing Tang, Rasha Al-Lamee, Sayan Sen, Graham Cole, Sukhjinder Nijjer, Javier Escaned, Niels Van Royen, Darrel P Francis, Matthew J Shun-Shin, and Ricardo Petraco more...

Subjects
General Engineering, General Earth and Planetary Sciences, General Environmental Science
Abstract

Aims Coronary flow reserve (CFR) assessment has proven clinical utility, but Doppler-based methods are sensitive to noise and operator bias, limiting their clinical applicability. The objective of the study is to expand the adoption of invasive Doppler CFR, through the development of artificial intelligence (AI) algorithms to automatically quantify coronary Doppler quality and track flow velocity. Methods and results A neural network was trained on images extracted from coronary Doppler flow recordings to score signal quality and derive values for coronary flow velocity and CFR. The outputs were independently validated against expert consensus. Artificial intelligence successfully quantified Doppler signal quality, with high agreement with expert consensus (Spearman’s rho: 0.94), and within individual experts. Artificial intelligence automatically tracked flow velocity with superior numerical agreement against experts, when compared with the current console algorithm [AI flow vs. expert flow bias −1.68 cm/s, 95% confidence interval (CI) −2.13 to −1.23 cm/s, P < 0.001 with limits of agreement (LOA) −4.03 to 0.68 cm/s; console flow vs. expert flow bias −2.63 cm/s, 95% CI −3.74 to −1.52, P < 0.001, 95% LOA −8.45 to −3.19 cm/s]. Artificial intelligence yielded more precise CFR values [median absolute difference (MAD) against expert CFR: 4.0% for AI and 7.4% for console]. Artificial intelligence tracked lower-quality Doppler signals with lower variability (MAD against expert CFR 8.3% for AI and 16.7% for console). Conclusion An AI-based system, trained by experts and independently validated, could assign a quality score to Doppler traces and derive coronary flow velocity and CFR. By making Doppler CFR more automated, precise, and operator-independent, AI could expand the clinical applicability of coronary microvascular assessment. more...

Published
2023
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31. A randomised controlled trial to investigate the use of acute coronary syndrome therapy in patients hospitalised with COVID-19: the C19-ACS trial

Author

Prapa Kanagaratnam, Darrel P. Francis, Daniel Chamie, Clare Coyle, Alena Marynina, George Katritsis, Patricia Paiva, Matyas Szigeti, Graham Cole, David de Andrade Nunes, James Howard, Rodrigo Esper, Masood Khan, Ranjit More, Guilherme Barreto, Rafael Meneguz-Moreno, Ahran Arnold, Alexandra Nowbar, Amit Kaura, Myril Mariveles, Katherine March, Jaymin Shah, Sukhjinder Nijjer, Gregory YH. Lip, Nicholas Mills, A John Camm, Graham S. Cooke, Simon J. Corbett, Martin J. Llewelyn, Waleed Ghanima, Mark Toshner, Nicholas Peters, Ricardo Petraco, Rasha Al-Lamee, Ana Sousa Marcelino Boshoff, Margarita Durkina, Iqbal Malik, Neil Ruparelia, Victoria Cornelius, and Matthew Shun-Shin more...

Subjects
Hematology
Abstract

BACKGROUND: Patients hospitalised with COVID-19 suffer thrombotic complications. Risk factors for poor outcomes are shared with coronary artery disease. OBJECTIVES: To investigate efficacy of an acute coronary syndrome regimen in patients hospitalised with COVID-19 and coronary disease risk factors. PATIENTS/METHODS: A randomised controlled open-label trial across acute hospitals (UK and Brazil) added aspirin, clopidogrel, low-dose rivaroxaban, atorvastatin, and omeprazole to standard care for 28-days. Primary efficacy and safety outcomes were 30-day mortality and bleeding. The key secondary outcome was a daily clinical status (at home, in hospital, on intensive therapy unit admission, death). RESULTS: 320 patients from 9 centres were randomised. The trial terminated early due to low recruitment. At 30 days there was no significant difference in mortality (intervention: 11.5% vs control: 15%, unadjusted OR 0.73, 95%CI 0.38 to 1.41, p=0.355). Significant bleeds were infrequent and not significantly different between the arms (intervention: 1.9% vs control 1.9%, p>0.999). Using a Bayesian Markov longitudinal ordinal model, it was 93% probable that intervention arm participants were more likely to transition to a better clinical state each day (OR 1.46, 95% CrI 0.88 to 2.37, Pr(Beta>0)=93%; adjusted OR 1.50, 95% CrI 0.91 to 2.45, Pr(Beta>0)=95%) and median time to discharge home was two days shorter (95% CrI -4 to 0, 2% probability that it was worse). CONCLUSIONS: Acute coronary syndrome treatment regimen was associated with a reduction in the length of hospital stay without an excess in major bleeding. A larger trial is needed to evaluate mortality. more...

Published
2023

32. Phasic flow patterns of right versus left coronary arteries in patients undergoing clinical physiological assessment

Author

Mauro Echavarria-Pinto, Tim P. van de Hoef, Ibrahim Danad, Matthew J. Shun-Shin, Martijn Meuwissen, Christopher Cook, Martijn A. van Lavieren, Darrel P. Francis, Takayuki Warisawa, Guus A. de Waard, Paul Knaapen, Hernán Mejía-Rentería, Yousif Ahmad, Rasha Al-Lamee, Ricardo Petraco, Sukhjinder Nijjer, Christopher Rajkumar, Justin E. Davies, Alexandra N. Nowbar, Mihir Kelshiker, Javier Escaned, Sayan Sen, James P. Howard, Vitaliy Androshchuk, Henry Seligman, Niels van Royen, Jan J. Piek, Jamil Mayet, ACS - Microcirculation, ACS - Atherosclerosis & ischemic syndromes, Cardiology, Graduate School, and ACS - Heart failure & arrhythmias more...

Subjects
medicine.medical_specialty, stable angina, Diastole, Hyperemia, Constriction, Pathologic, Hyperaemia, Clinical Research, Internal medicine, medicine.artery, Coronary Circulation, other technique, medicine, Humans, In patient, fractional flow reserve, business.industry, Vascular damage Radboud Institute for Molecular Life Sciences [Radboudumc 16], Coronary flow reserve, Blood flow, medicine.disease, Coronary Vessels, Coronary arteries, Stenosis, medicine.anatomical_structure, Right coronary artery, Cardiology, medicine.symptom, Cardiology and Cardiovascular Medicine, business, Blood Flow Velocity
Abstract

Item does not contain fulltext BACKGROUND: Coronary blood flow in humans is known to be predominantly diastolic. Small studies in animals and humans suggest that this is less pronounced or even reversed in the right coronary artery (RCA). AIMS: This study aimed to characterise the phasic patterns of coronary flow in the left versus right coronary arteries of patients undergoing invasive physiological assessment. METHODS: We analysed data from the Iberian-Dutch-English Collaborators (IDEAL) study. A total of 482 simultaneous pressure and flow measurements from 301 patients were included in our analysis. RESULTS: On average, coronary flow was higher in diastole both at rest and during hyperaemia in both the RCA and LCA (mean diastolic-to-systolic velocity ratio [DSVR] was, respectively, 1.85±0.70, 1.76±0.58, 1.53±0.34 and 1.58±0.43 for LCA(rest), LCA(hyp), RCA(rest) and RCA(hyp), p more...

Published
2022
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36. A friend in need

Author

Nowbar, Alexandra N and Francis, Darrel P

Published
2014

39. Mechanical thrombectomy with retrievable stents and aspiration catheters for acute ischaemic stroke: a meta-analysis of randomised controlled trials

Author

Rajkumar, Christopher Rajkumar, primary, Ganesananthan, Sashiananthan, additional, Ahmad, Yousif, additional, Seligman, Henry, additional, Thornton, George Thornton, additional, Foley, Michael, additional, Nowbar, Alexandra Nowbar, additional, Howard, James Howard, additional, Francis, Darrel Francis, additional, Keeble, Thomas Keeble, additional, Grunwald, Iris Grunwald, additional, Al-Lamee, Rasha Al-Lamee, additional, Malik, Iqbal, additional, and Shun-Shin, Matthew Shun-Shin, additional more...

Published
2022
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40. A double-blind randomised placebo-controlled trial of percutaneous coronary intervention for the relief of stable angina without antianginal medications: design and rationale of the ORBITA-2 trial

Author

Nowbar, Alexandra Nowbar, primary, Rajkumar, Christopher, additional, Foley, Michael, additional, Ahmed-Jushuf, Fiyyaz, additional, Howard, James Howard, additional, Seligman, Henry, additional, Petraco, Ricardo, additional, Sen, Sayan, additional, Nijjer, Sukhjinder Nijjer, additional, Shun-Shin, Matthew Shun-Shin, additional, Keeble, Thomas Keeble, additional, Sohaib, Afzal, additional, Collier, David, additional, McVeigh, Patrick, additional, Harrell, Frank Harrell, additional, Francis, Darrel Francis, additional, and Al-Lamee, Rasha Al-Lamee, additional more...

Published
2022
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43. Side Effect Patterns in a Crossover Trial of Statin, Placebo, and No Treatment

Author

Peter S. Sever, Judith A. Finegold, Frances A. Wood, Susan Connolly, James P. Howard, Matthew J. Shun-Shin, Darrel P. Francis, Christine Norton, Jaimini Cegla, Christopher Rajkumar, Alexandra N. Nowbar, Ahran D. Arnold, Chris Stride, Simon A. McG. Thom, David Thompson, British Heart Foundation, and Wellcome Trust more...

Subjects
Male, medicine.medical_specialty, Statin, Cardiac & Cardiovascular Systems, Side effect, Nocebo, medicine.drug_class, Drug intolerance, Placebo, 1117 Public Health and Health Services, statins, Double-Blind Method, Internal medicine, Atorvastatin, medicine, Humans, cardiovascular diseases, Nocebo Effect, 1102 Cardiorespiratory Medicine and Haematology, IQR, interquartile range, Aged, Original Investigation, Cross-Over Studies, Science & Technology, business.industry, nutritional and metabolic diseases, Myalgia, Middle Aged, Crossover study, nocebo, drug intolerance, CI, confidence interval, side effects, Cardiovascular System & Hematology, Cardiovascular System & Cardiology, Female, lipids (amino acids, peptides, and proteins), crossover trial, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Cardiology and Cardiovascular Medicine, business, Life Sciences & Biomedicine
Abstract

Background Most people who begin statins abandon them, most commonly because of side effects. Objectives The purpose of this study was to assess daily symptom scores on statin, placebo, and no treatment in participants who had abandoned statins. Methods Participants received 12 1-month medication bottles, 4 containing atorvastatin 20 mg, 4 placebo, and 4 empty. We measured daily symptom intensity for each using an app (scale 1-100). We also measured the “nocebo” ratio: the ratio of symptoms induced by taking statin that was also induced by taking placebo. Results A total of 60 participants were randomized and 49 completed the 12-month protocol. Mean symptom score was 8.0 (95% CI: 4.7-11.3) in no-tablet months. It was higher in statin months (16.3; 95% CI: 13.0-19.6; P < 0.001), but also in placebo months (15.4; 95% CI: 12.1-18.7; P < 0.001), with no difference between the 2 (P = 0.388). The corresponding nocebo ratio was 0.90. In the individual-patient daily data, neither symptom intensity on starting (OR: 1.02; 95% CI: 0.98-1.06; P = 0.28) nor extent of symptom relief on stopping (OR: 1.01; 95% CI: 0.98-1.05; P = 0.48) distinguished between statin and placebo. Stopping was no more frequent for statin than placebo (P = 0.173), and subsequent symptom relief was similar between statin and placebo. At 6 months after the trial, 30 of 60 (50%) participants were back taking statins. Conclusions The majority of symptoms caused by statin tablets were nocebo. Clinicians should not interpret symptom intensity or timing of symptom onset or offset (on starting or stopping statin tablets) as indicating pharmacological causation, because the pattern is identical for placebo. (Self-Assessment Method for Statin Side-effects Or Nocebo [SAMSON]; NCT02668016), Central Illustration more...

Published
2021

45. Gender-Related Differences in Clinical Presentation and Angiographic Findings in Patients with Ischemia and No Obstructive Coronary Artery Disease (INOCA): A Single-Center Observational Registry

Author

Rasha Al-Lamee, Mauro Gitto, Alexandra N. Nowbar, Alaide Chieffo, and Francesco Gentile

Subjects
education.field_of_study, medicine.medical_specialty, medicine.diagnostic_test, business.industry, Population, Ischemia, Single Center, medicine.disease, Coronary arteries, Coronary artery disease, Stenosis, medicine.anatomical_structure, Internal medicine, Angiography, medicine, Cardiology, Population study, Cardiology and Cardiovascular Medicine, education, business
Abstract

Ischemia and no obstructive coronary arteries (INOCA) is a common clinical presentation, with a variety of causes that are often not fully investigated in routine clinical practice. The goal of our study was to characterize a real-world population of patients with INOCA, with a deeper focus on symptoms and stress test findings. The study population consisted of 435 patients who underwent diagnostic coronary angiography for anginal symptoms and/or evidence of myocardial ischemia at non-invasive imaging. In all patients angiography demonstrated nonobstructive coronary artery disease (CAD, less than 30% luminal diameter stenosis or fractional flow reserve > 0.8 and/or instantaneous wave-free ratio > 0.89). Fifty-four percent of the patients were women. Atypical clinical presentation was more common in women (59.5 vs. 49.5%, p = 0.037). Women were more likely to have normal coronary arteries than men (41.8 vs. 16.2%, p more...

Published
2020
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46. Daily angina documentation versus subsequent recall: development of a symptom smartphone app

Author

Alexandra N Nowbar, James P Howard, Matthew J Shun-Shin, Christopher Rajkumar, Michael Foley, Arunima Basu, Akshit Goel, Sapna Patel, Ahmer Adnan, Catherine J Beattie, Thomas R Keeble, Afzal Sohaib, David Collier, Patrick McVeigh, Frank E Harrell, Darrel P Francis, and Rasha K Al-Lamee more...

Abstract

Aims The traditional approach to documenting angina outcomes in clinical trials is to ask the patient to recall their symptoms at the end of a month. With the ubiquitous availability of smartphones and tablets, daily contemporaneous documentation might be possible. Methods and results The ORBITA-2 symptom smartphone app was developed with a user-centred iterative design and testing cycle involving a focus group of previous ORBITA participants. The feasibility and acceptability were assessed in an internal pilot of participants in the ongoing ORBITA-2 trial. Seven days of app entries by ORBITA-2 participants were compared with subsequent participant recall at the end of the 7-day period. The design focus group tested a prototype app. They reported that the final version captured their symptoms and was easy to use. In the completion assessment group, 141 of 142 (99%) completed the app in full and 47 of 141 (33%) without reminders. In the recall assessment group, 29 of 29 (100%) participants said they could recall the previous day’s symptoms, and 82% of them recalled correctly. For 2 days previously, 88% said they could recall and of those, 87% recalled correctly. The proportion saying they could recall their symptoms fell progressively thereafter: 89, 67, 61, 50%, and at 7 days, 55% (P Conclusion Episode counts of angina are difficult to recall after a few days. For trials such as ORBITA-2 focusing on angina, daily symptom collection via a smartphone app will increase the validity of the results. more...

Published
2022

47. Phasic flow patterns of right versus left coronary arteries in patients undergoing clinical physiological assessment

Author

Seligman, H., Nijjer, S.S., Hoef, T.P. van de, Waard, G.A. de, Mejía-Rentería, H., Echavarria-Pinto, M., Shun-Shin, M.J., Howard, J.P., Cook, C.M., Warisawa, T., Ahmad, Y., Androshchuk, V., Rajkumar, C., Nowbar, A., Kelshiker, M.A., Lavieren, M.A. van, Meuwissen, M., Danad, I., Knaapen, P., Sen, S., Al-Lamee, R., Mayet, J., Escaned, J., Piek, J.J., Royen, N. van, Davies, J.E., Francis, D.P., Petraco, R., Seligman, H., Nijjer, S.S., Hoef, T.P. van de, Waard, G.A. de, Mejía-Rentería, H., Echavarria-Pinto, M., Shun-Shin, M.J., Howard, J.P., Cook, C.M., Warisawa, T., Ahmad, Y., Androshchuk, V., Rajkumar, C., Nowbar, A., Kelshiker, M.A., Lavieren, M.A. van, Meuwissen, M., Danad, I., Knaapen, P., Sen, S., Al-Lamee, R., Mayet, J., Escaned, J., Piek, J.J., Royen, N. van, Davies, J.E., Francis, D.P., and Petraco, R. more...

Abstract

Item does not contain fulltext, BACKGROUND: Coronary blood flow in humans is known to be predominantly diastolic. Small studies in animals and humans suggest that this is less pronounced or even reversed in the right coronary artery (RCA). AIMS: This study aimed to characterise the phasic patterns of coronary flow in the left versus right coronary arteries of patients undergoing invasive physiological assessment. METHODS: We analysed data from the Iberian-Dutch-English Collaborators (IDEAL) study. A total of 482 simultaneous pressure and flow measurements from 301 patients were included in our analysis. RESULTS: On average, coronary flow was higher in diastole both at rest and during hyperaemia in both the RCA and LCA (mean diastolic-to-systolic velocity ratio [DSVR] was, respectively, 1.85±0.70, 1.76±0.58, 1.53±0.34 and 1.58±0.43 for LCA(rest), LCA(hyp), RCA(rest) and RCA(hyp), p<0.001 for between-vessel comparisons). Although the type of RCA dominance affected the DSVR magnitude (RCA(dom)=1.55±0.35, RCA(co-dom)=1.40±0.27, RCA(non-dom)=1.35; standard deviation not reported as n=3), systolic flow was very rarely predominant (DSVR was greater than or equal to 1.00 in 472/482 cases [97.9%] overall), with equal prevalence in the LCA. Stenosis severity or microvascular dysfunction had a negligible impact on DSVR in both the RCA and LCA (DSVR x hyperaemic stenosis resistance R(2) =0.018, p=0.03 and DSVR x coronary flow reserve R(2) <0.001, p=0.98). CONCLUSIONS: In patients with coronary artery disease undergoing physiological assessment, diastolic flow predominance is seen in both left and right coronary arteries. Clinical interpretation of coronary physiological data should therefore not differ between the left and the right coronary systems. more...

Published
2022

48. Cardiopulmonary exercise testing and efficacy of percutaneous coronary intervention: a substudy of the ORBITA trial

Author

Ganesananthan, Sashiananthan, primary, Rajkumar, Christopher A, additional, Foley, Michael, additional, Thompson, David, additional, Nowbar, Alexandra N, additional, Seligman, Henry, additional, Petraco, Ricardo, additional, Sen, Sayan, additional, Nijjer, Sukhjinder, additional, Thom, Simon A, additional, Wensel, Roland, additional, Davies, John, additional, Francis, Darrel, additional, Shun-Shin, Matthew, additional, Howard, James, additional, and Al-Lamee, Rasha, additional more...

Published
2022
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49. Daily angina documentation versus subsequent recall: development of a symptom smartphone app

Author

Nowbar, Alexandra N, primary, Howard, James P, additional, Shun-Shin, Matthew J, additional, Rajkumar, Christopher, additional, Foley, Michael, additional, Basu, Arunima, additional, Goel, Akshit, additional, Patel, Sapna, additional, Adnan, Ahmer, additional, Beattie, Catherine J, additional, Keeble, Thomas R, additional, Sohaib, Afzal, additional, Collier, David, additional, McVeigh, Patrick, additional, Harrell, Frank E, additional, Francis, Darrel P, additional, and Al-Lamee, Rasha K, additional more...

Published
2022
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50. A double-blind randomised placebo-controlled trial of percutaneous coronary intervention for the relief of stable angina without antianginal medications: design and rationale of the ORBITA-2 trial

Author

Alexandra Nowbar Nowbar, Christopher Rajkumar, Michael Foley, Fiyyaz Ahmed-Jushuf, James Howard Howard, Henry Seligman, Ricardo Petraco, Sayan Sen, Sukhjinder Nijjer Nijjer, Matthew Shun-Shin Shun-Shin, Thomas Keeble Keeble, Afzal Sohaib, David Collier, Patrick McVeigh, Frank Harrell Harrell, Darrel Francis Francis, and Rasha Al-Lamee Al-Lamee more...

Subjects
Percutaneous Coronary Intervention, Treatment Outcome, Double-Blind Method, Quality of Life, Trial Design, Humans, Cardiovascular Agents, Angina, Stable, Cardiology and Cardiovascular Medicine, Coronary Angiography
Abstract

Percutaneous coronary intervention (PCI) is frequently performed for stable angina. However, the first blinded trial, ORBITA, did not show a placebo-controlled increment in exercise time in patients with single-vessel disease, at 6 weeks, on maximal antianginal therapy. ORBITA-2 will assess the placebo-controlled efficacy of PCI on angina frequency in patients with single- or multivessel disease, at 12 weeks, on no antianginal therapy. ORBITA-2 is a double-blind placebo-controlled trial randomising participants with (i) angina at presentation, (ii) documented angina during the 2-week pre-randomisation symptom assessment phase, (iii) objective evidence of ischaemia, (iv) single- or multivessel disease, and (v) clinical eligibility for PCI. At enrolment, antianginals will be stopped, and angina questionnaires completed. Participants will record their symptoms on a smartphone application daily throughout the trial and will undergo exercise treadmill testing and stress echocardiography at pre-randomisation. They will then undergo coronary angiography with unblinded invasive physiology assessment. Eligible participants will then be sedated to a deep level of conscious sedation and randomised 1:1 between PCI and placebo. After the 12-week blinded follow-up period, they will return for questionnaires, exercise testing and stress echocardiography assessment. If angina becomes intolerable, antianginals will be introduced using a prespecified medication protocol. The primary outcome is an angina symptom score using an ordinal clinical outcome scale for angina. Secondary outcomes include exercise treadmill time, angina frequency, angina severity and quality of life. Trial registration: ClinicalTrials.gov: NCT03742050. more...

Published
2022