The trials behind the practice

Supports medical therapy first

The question

In stable coronary artery disease, does adding a stent to optimal medical therapy prevent death or heart attack?

What it found

Over a median 4.6 years, adding PCI to optimal medical therapy did not reduce death or myocardial infarction compared with optimal medical therapy alone.

What it changes

In stable disease, a stent is not a life-extending treatment. Medical therapy is not the lesser option — it is the comparator that PCI failed to beat.

Boden WE, O’Rourke RA, Teo KK, et al. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med. 2007;356(15):1503–1516.

Supports medical therapy first

The question

Do patients with type 2 diabetes and stable coronary disease live longer with prompt revascularisation?

What it found

Five-year survival and freedom from major cardiovascular events did not differ between prompt revascularisation and intensive medical therapy alone.

What it changes

Diabetes alone is not a reason to intervene early. It is a reason to treat the metabolic disease harder.

BARI 2D Study Group. A randomized trial of therapies for type 2 diabetes and coronary artery disease. N Engl J Med. 2009;360(24):2503–2515.

Defines who benefits

The question

Does measuring whether a blockage actually restricts blood flow change who benefits from a stent?

What it found

Among lesions that were physiologically significant on fractional flow reserve, PCI reduced the need for urgent revascularisation, without a reduction in death or myocardial infarction.

What it changes

The decision should rest on physiology, not on how the narrowing looks on an angiogram. A tight-looking lesion that does not restrict flow is not a target.

De Bruyne B, Pijls NHJ, Kalesan B, et al. Fractional flow reserve–guided PCI versus medical therapy in stable coronary disease. N Engl J Med. 2012;367(11):991–1001.

Supports medical therapy first

The question

When patients do not know whether they received a stent, does the stent still improve their exercise capacity?

What it found

Against a placebo procedure, PCI did not produce a statistically significant increase in exercise time in patients on antianginal medication.

What it changes

A meaningful share of the perceived benefit of stenting in stable angina is the effect of having had a procedure. That is worth knowing before consenting to one.

Al-Lamee R, Thompson D, Dehbi H-M, et al. Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial. Lancet. 2018;391(10115):31–40.

Supports medical therapy first

The question

In patients with moderate or severe ischaemia on stress testing — the group most expected to benefit — does an invasive strategy reduce events?

What it found

Over a median 3.2 years, an initial invasive strategy did not reduce ischaemic cardiovascular events or all-cause death compared with an initial conservative strategy. Patients who had angina at baseline did report better symptom relief.

What it changes

This is the strongest test of the question yet run, in the patients most likely to benefit. It reframes the conversation from “how soon do we stent” to “what are we trying to achieve”.

Maron DJ, Hochman JS, Reynolds HR, et al. Initial invasive or conservative strategy for stable coronary disease. N Engl J Med. 2020;382(15):1395–1407.

Supports medical therapy first

The question

In severe ischaemic cardiomyopathy with viable myocardium, does PCI improve survival or heart-failure outcomes?

What it found

Over a median 41 months, PCI added to optimal medical therapy did not reduce all-cause death or heart-failure hospitalisation, and did not produce a sustained improvement in ejection fraction.

What it changes

A weak heart with viable muscle is not, by itself, an indication to stent. Guideline-directed heart-failure therapy is the intervention that changes the trajectory.

Perera D, Clayton T, O’Kane PD, et al. Percutaneous revascularization for ischemic left ventricular dysfunction. N Engl J Med. 2022;387(15):1351–1360.

Qualifies the position

The question

With antianginal medication withdrawn, does PCI relieve angina better than a placebo procedure?

What it found

PCI produced a lower daily angina symptom score than the placebo procedure, and patients were substantially more likely to be free of angina at 12 weeks. It did not reduce death or myocardial infarction.

What it changes

Stents genuinely relieve symptoms. This is the honest case for PCI in stable disease — and it is a symptom case, not a survival case. Patients deserve to be told which one they are being offered.

Rajkumar CA, Foley MJ, Ahmed-Jushuf F, et al. A placebo-controlled trial of percutaneous coronary intervention for stable angina. N Engl J Med. 2023;389(25):2319–2330.