PCI for stable angina : Sham trials are welcome, but not OMT shaming trials !

September 23, 2024 by dr s venkatesan

*Caution : Language -Harsh. Likely-hood of truth : High

The flamboyant genius of Andreas Roland Gruntzig, from Zurich gifted us the path-breaking treatment modality for coronary stenosis five decades ago. After a series of experiments in animals and peripheral vessels, he proved with a single patient N-1 study that effectively treated refractory LAD angina in a 38-year-old man in 1977. (Ref 1)

That’s when PTCA/PCI arrived in the clinical cardiology arena. After some initial hiccups, it was non stop success story supported by metal scaffold. Within a span of five to ten years, the concept spread globally. No one has questioned the efficacy of PCI for true angina with a critical lesion.

The costly aftermath

Over the last three decades, PCI armed with a variety of technologies and expanded with explosive indications, has grown into a monster intervention (including the life-saving primary PCI). In the process, the abuse prevailed over the use, causing considerable damage. So, we desperately required to break this inappropriate menace with evidence base like COURAGE, ISCHEMIA, BARI-2D, These studies tried to apply some breaks, but the force was weak and couldn’t abolish a pseudo-academic vice. Something happened in 2018 , the ORBITA trial .It sent real shock waves to the Interventional community. Contrary to the usual behavior of such studies, the ghost of ORBITA appeared to roam longer in the cardiology academia than expected. We needed a quick fix.

What happened ? ORBITA-2 came in 2023 . It said in no unequivocal terms , that PCI also can be a first option in CSA. It is no way inferior to OMT. What was the necessity to do ORIBTIA 2 so soon ? When do you do a placebo controlled sham study ?

We do such studies when we suspect ,the very efficacy of the modality. What we really wanted to know for a long time , was whether PCI really beats medical therapy in stable angina of moderate or severe intensity with at least one critical lesion. ORBITA-1 was an excellent and Innovative trial, that answered the above query without any doubt, that PCI has no add on value over medical therapy in chronic CAD.

In whatever angle we look , ORBITA-2 looks a redundant one (EuroIntervention. 2022 the rationale for ORBITA- 2 ) It appears to my crooked mind, the primary aim of the ORBITA -2 is to neutralize the negative publicity (positive for the patient) the original ORBITA did. There seems to be a non-academic indication for doing this study to undo the damage done by ORBITA-1 .The irony is, almost the same team has done this study, that diluted the positive impact of the original ORBITA. If my utterances are true, such studies have no place in academia .Not only it is proving a redundant point but also let loose a wrong message , that PCI and medical therapy have equivalent effect and one can choose whatever they wish.

Final message

In an important sense, ORIBITA 2 is one among the same old study to defame the OMT. Unfortunately, the power of mis-communication is always greater than power of right-communication. ORBITA 2 looks a redundant study and serves no new purpose except to say PCI can also relieve angina in a tight lesion, which Gruentzig proved 50 years ago.

Post-amble

I wrote this post a year ago, was hesitant to post. Come September 2024. Surprised to read this defiant article against ORBITA-2 from this Impactful journal of Circulation Cardiovascular Quality Outcomes.