Achieving Optimal Medical Therapy: Insights From the ORBITA Trial
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...
| Main Authors: | , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Wiley
2021-02-01
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| Series: | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| Subjects: | |
| Online Access: | https://www.ahajournals.org/doi/10.1161/JAHA.120.017381 |
| _version_ | 1828859186010652672 |
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| 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 Rasha Al‐Lamee |
| author_facet | 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 Rasha Al‐Lamee |
| author_sort | Michael Foley |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-13T02:13:39Z |
| format | Article |
| id | doaj.art-9a0e900eb7d640c79a4e743aad6a6da5 |
| institution | Directory Open Access Journal |
| issn | 2047-9980 |
| language | English |
| last_indexed | 2024-12-13T02:13:39Z |
| publishDate | 2021-02-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| spelling | doaj.art-9a0e900eb7d640c79a4e743aad6a6da52022-12-22T00:02:58ZengWileyJournal of the American Heart Association: Cardiovascular and Cerebrovascular Disease2047-99802021-02-0110310.1161/JAHA.120.017381Achieving Optimal Medical Therapy: Insights From the ORBITA TrialMichael Foley0Christopher A. Rajkumar1Matthew Shun‐Shin2Sashiananthan Ganesananthan3Henry Seligman4James Howard5Alexandra N. Nowbar6Thomas R. Keeble7John R. Davies8Kare H. Tang9Robert Gerber10Peter O’Kane11Andrew S. P. Sharp12Ricardo Petraco13Iqbal S. Malik14Sukhjinder Nijjer15Sayan Sen16Darrel P. Francis17Rasha Al‐Lamee18National Heart and Lung InstituteImperial College London London UKNational Heart and Lung InstituteImperial College London London UKNational Heart and Lung InstituteImperial College London London UKImperial College Healthcare NHS Trust London UKNational Heart and Lung InstituteImperial College London London UKNational Heart and Lung InstituteImperial College London London UKNational Heart and Lung InstituteImperial College London London UKEssex Cardiothoracic Centre Basildon UKEssex Cardiothoracic Centre Basildon UKEssex Cardiothoracic Centre Basildon UKEast Sussex Healthcare NHS Trust Hastings UKRoyal Bournemouth and Christchurch NHS Trust Bournemouth UKUniversity Hospital of Wales Cardiff UKNational Heart and Lung InstituteImperial College London London UKNational Heart and Lung InstituteImperial College London London UKNational Heart and Lung InstituteImperial College London London UKNational Heart and Lung InstituteImperial College London London UKNational Heart and Lung InstituteImperial College London London UKNational Heart and Lung InstituteImperial College London London UKBackground 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.https://www.ahajournals.org/doi/10.1161/JAHA.120.017381adverse effectsanginacompliance/adherencemedical therapyrandomized controlled trial |
| spellingShingle | 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 Rasha Al‐Lamee Achieving Optimal Medical Therapy: Insights From the ORBITA Trial Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease adverse effects angina compliance/adherence medical therapy randomized controlled trial |
| title | Achieving Optimal Medical Therapy: Insights From the ORBITA Trial |
| title_full | Achieving Optimal Medical Therapy: Insights From the ORBITA Trial |
| title_fullStr | Achieving Optimal Medical Therapy: Insights From the ORBITA Trial |
| title_full_unstemmed | Achieving Optimal Medical Therapy: Insights From the ORBITA Trial |
| title_short | Achieving Optimal Medical Therapy: Insights From the ORBITA Trial |
| title_sort | achieving optimal medical therapy insights from the orbita trial |
| topic | adverse effects angina compliance/adherence medical therapy randomized controlled trial |
| url | https://www.ahajournals.org/doi/10.1161/JAHA.120.017381 |
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