Achieving Optimal Medical Therapy: Insights From the ORBITA Trial.
Achieving Optimal Medical Therapy: Insights From the ORBITA Trial.
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DOI：
10.1161/jaha.120.017381
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发表时间：
2021-02-02
影响因子：
5.4
通讯作者：
Al-Lamee R
中科院分区：
文献类型：
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作者：
Foley M;Rajkumar CA;Shun-Shin M;Ganesananthan S;Seligman H;Howard J;Nowbar AN;Keeble TR;Davies JR;Tang KH;Gerber R;O'Kane P;Sharp ASP;Petraco R;Malik IS;Nijjer S;Sen S;Francis DP;Al-Lamee R
在稳定型冠状动脉疾病中，药物用于两个目的：降低心血管风险和改善症状。在临床试验和临床实践中，药物使用往往不是最佳的。ORBITA（稳定型心绞痛血管成形术最佳药物治疗的客观随机盲法研究）试验是第一项经皮冠状动脉介入治疗的安慰剂对照试验。ORBITA试验设计的一个关键组成部分是纳入了一个医学优化阶段，旨在确保所有患者都接受了指南指导的真正最佳药物治疗。在这项研究中，我们报告了所取得的药物治疗。入组ORBITA试验后，所有200例患者均进入为期6周的强化药物治疗优化期，开始并上调风险降低和抗心绞痛治疗。在预随机化阶段，确定的抗心绞痛药物的中位数为3（四分位数范围，2-4）。共有195例患者（97.5%）达到了预先规定的≥2种抗心绞痛药物的目标; 136例患者（68.0%）未因不良反应而停用任何抗心绞痛药物，每例患者因不良反应而停用的抗心绞痛药物中位数为0（四分位距，0-1）。安普替林和比索洛尔耐受性良好（分别有4/175 [2.3%]和9/167 [5.4%]例患者因不良反应停用）。雷诺嗪和伊伐布雷定的耐受性也良好（分别有1/20 [5.0%]和1/18 [5.6%]的患者因不良反应而停药）。分别有36/172例（20.9%）和32/141例（22.7%）患者因不良反应停用单硝酸异山梨酯和尼可地尔。他汀类药物耐受性良好，200例患者中有191例（95.5%）服用。在为期12周的ORBITA试验期间，药物治疗成功优化且耐受性良好，导致治疗停止的药物不良反应很少。在临床试验中可以实现真正最佳的药物治疗，将其转化为长期的临床实践应该是未来研究的重点。URL：https://www.clinicaltrials.gov;唯一标识符：NCT 02062593。
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. 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. 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. URL: https://www.clinicaltrials.gov; Unique identifier: NCT02062593.