Objective Randomised Blinded Investigation With Optimal Medical Therapy of Angioplasty in Stable Angina (ORBITA)

Objective Randomised Blinded Investigation With Optimal Medical Therapy of Angioplasty in Stable Angina

Defining a Gold Standard for Ischaemia: Effects of Interventional Revascularisation Versus Optimum Medical Therapy on Exercise Capacity in Patients With Stable Coronary Artery Disease

In this study the investigators will use careful scientific blinding of patient and their subsequent healthcare staff so that the investigators can determine exactly how much difference coronary angioplasty makes to symptoms and blood supply to the heart. After the 6 weeks blinded phase, all patients will be unblinded and the patients who had undergone sham procedure will be offered the active therapy.

The investigators will perform a multi-centre prospective randomised double-blinded comparison of the treatment of stable angina with percutaneous coronary intervention (PCI) and optimal medical therapy (OMT) versus a sham procedure and OMT. Two hundred patients with stable angina and one or more angiographically significant coronary stenosis of 70% or more in a single vessel that is suitable for angioplasty will be recruited. Baseline investigation of functional capacity and myocardial ischaemic burden will be performed. This will be followed by a coronary angiogram and invasive physiological investigation followed by randomisation to PCI or a sham procedure. Follow-up investigation of functional capacity and myocardial ischaemic burden at 6 weeks will then be performed.

Placebo percutaneous coronary intervention and optimal medical therapy with risk factor modification and anti-anginal therapy

Inclusion Criteria: Stable angina and at least 1 lesion with angiographic stenosis ≥70% in a single vessel suitable for stent implantation Exclusion Criteria: Acute coronary syndrome Previous coronary artery bypass graft surgery Left main stem disease Contraindications to PCI or drug-eluting stent (DES) implantation Heavily calcified or tortuous vessels Chronic total occlusion in target vessel Life expectancy <2yr Pregnancy Age <18yr or >85yr Angiographic stenosis ≥ 50% in non-target vessel Inability to consent

Rajkumar CA, Wereski R, Parsonage W, Cullen L, Khamis R, Foley M, Harrell FE Jr, Shun-Shin MJ, Mills NL, Al-Lamee RK. Association Between High-Sensitivity Cardiac Troponin, Myocardial Ischemia, and Revascularization in Stable Coronary Artery Disease. J Am Coll Cardiol. 2022 May 31;79(21):2185-2187. doi: 10.1016/j.jacc.2022.03.369. No abstract available.

Rajkumar CA, Shun-Shin M, Seligman H, Ahmad Y, Warisawa T, Cook CM, Howard JP, Ganesananthan S, Amarin L, Khan C, Ahmed A, Nowbar A, Foley M, Assomull R, Keenan NG, Sehmi J, Keeble TR, Davies JR, Tang KH, Gerber R, Cole G, O'Kane P, Sharp ASP, Khamis R, Kanaganayagam G, Petraco R, Ruparelia N, Malik IS, Nijjer S, Sen S, Francis DP, Al-Lamee R. Placebo-Controlled Efficacy of Percutaneous Coronary Intervention for Focal and Diffuse Patterns of Stable Coronary Artery Disease. Circ Cardiovasc Interv. 2021 Aug;14(8):e009891. doi: 10.1161/CIRCINTERVENTIONS.120.009891. Epub 2021 Aug 3.

McCreanor V, Nowbar A, Rajkumar C, Barnett AG, Francis D, Graves N, Boden WE, Weintraub WS, Al-Lamee R, Parsonage WA. Cost-effectiveness analysis of percutaneous coronary intervention for single-vessel coronary artery disease: an economic evaluation of the ORBITA trial. BMJ Open. 2021 Feb 9;11(2):e044054. doi: 10.1136/bmjopen-2020-044054.

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. Achieving Optimal Medical Therapy: Insights From the ORBITA Trial. J Am Heart Assoc. 2021 Feb 2;10(3):e017381. doi: 10.1161/JAHA.120.017381. Epub 2021 Jan 26.

Al-Lamee RK, Shun-Shin MJ, Howard JP, Nowbar AN, Rajkumar C, Thompson D, Sen S, Nijjer S, Petraco R, Davies J, Keeble T, Tang K, Malik I, Bual N, Cook C, Ahmad Y, Seligman H, Sharp ASP, Gerber R, Talwar S, Assomull R, Cole G, Keenan NG, Kanaganayagam G, Sehmi J, Wensel R, Harrell FE Jr, Mayet J, Thom S, Davies JE, Francis DP. 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. Circulation. 2019 Dec 10;140(24):1971-1980. doi: 10.1161/CIRCULATIONAHA.119.042918. Epub 2019 Nov 11.

Al-Lamee R, Howard JP, Shun-Shin MJ, Thompson D, Dehbi HM, Sen S, Nijjer S, Petraco R, Davies J, Keeble T, Tang K, Malik IS, Cook C, Ahmad Y, Sharp ASP, Gerber R, Baker C, Kaprielian R, Talwar S, Assomull R, Cole G, Keenan NG, Kanaganayagam G, Sehmi J, Wensel R, Harrell FE, Mayet J, Thom SA, Davies JE, Francis DP. Fractional Flow Reserve and Instantaneous Wave-Free Ratio as Predictors of the Placebo-Controlled Response to Percutaneous Coronary Intervention in Stable Single-Vessel Coronary Artery Disease. Circulation. 2018 Oct 23;138(17):1780-1792. doi: 10.1161/CIRCULATIONAHA.118.033801.

Al-Lamee R, Thompson D, Dehbi HM, Sen S, Tang K, Davies J, Keeble T, Mielewczik M, Kaprielian R, Malik IS, Nijjer SS, Petraco R, Cook C, Ahmad Y, Howard J, Baker C, Sharp A, Gerber R, Talwar S, Assomull R, Mayet J, Wensel R, Collier D, Shun-Shin M, Thom SA, Davies JE, Francis DP; ORBITA investigators. Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial. Lancet. 2018 Jan 6;391(10115):31-40. doi: 10.1016/S0140-6736(17)32714-9. Epub 2017 Nov 2. Erratum In: Lancet. 2018 Jan 6;391(10115):30.