Dr. Gurbir Singh GillInterventional Cardiologist & DiabetologistContact

Clinical approach

The No-Stent Protocol

A stent is a tool, not a verdict. This is the reasoning — and the published evidence — behind treating stable coronary disease with medicine first, and reserving intervention for the patients it demonstrably helps.

Most patients arrive after an angiogram, holding a number. Seventy per cent. Eighty. The number feels like a sentence, and the next sentence they expect to hear is that a stent will be placed today.

That number describes how a narrowing looks. It does not describe whether the narrowing is restricting blood flow, whether it is causing the symptoms that brought you in, or whether opening it will make you live longer. Those are three separate questions, and the evidence answers them differently.

What the randomised evidence actually shows

Over nearly two decades, cardiology has repeatedly tested the same question in stable coronary disease: does adding a stent to good medical therapy prevent death and heart attack? The answer has been remarkably consistent.

In COURAGE (2007), 2,287 patients with stable disease were randomised to medical therapy with or without PCI. Over a median 4.6 years, adding the stent did not reduce death or myocardial infarction. BARI 2D (2009) asked the same question specifically in patients with type 2 diabetes and found the same answer.

ISCHEMIA (2020) was designed to close the remaining objection — that earlier trials had enrolled patients whose disease was not severe enough to benefit. It recruited 5,179 patients with moderate or severe ischaemia on stress testing, the group most expected to gain from intervention, across 320 sites in 37 countries. Over a median 3.2 years, an initial invasive strategy did not reduce ischaemic cardiovascular events or death from any cause.

REVIVED-BCIS2 (2022) extended the question to severely weakened hearts — ejection fraction 35% or below, with viable muscle. Across 700 patients followed a median 41 months, PCI added to medical therapy did not reduce death or heart-failure hospitalisation, and the improvement in pumping function did not materialise.

The uncomfortable trial, included deliberately

It would be easy to stop there. Honesty requires going further.

ORBITA (2018) did something unusual: it gave half of 200 patients a real stent and half a placebo procedure, and nobody — patient or assessor — knew which. The stent did not significantly improve exercise time. That finding suggested a substantial share of the benefit patients report after angioplasty comes from having undergone a procedure at all.

But ORBITA-2 (2023) refined the design. It withdrew antianginal medication first, so the stent was compared against placebo rather than against placebo-plus-drugs, and measured angina daily through a smartphone app. In 301 patients, PCI clearly reduced angina — patients were around three times more likely to be free of symptoms at twelve weeks.

So stents work. They work on symptoms. ORBITA-2 did not show a reduction in death or heart attack, and its authors did not claim one. The distinction between a treatment that makes you feel better and a treatment that makes you live longer is the single most important thing a patient facing this decision can understand — and it is the distinction most often blurred in the consultation room.

How that translates into a consultation

The protocol is not a refusal to stent. It is a sequence of questions asked before stenting, in order:

  1. Is this an emergency? If you are having a heart attack, the reasoning below stops and the catheter lab starts. See the notice on this page.
  2. Are you symptomatic, and how limiting is it? Angina that stops you climbing stairs is a different problem from an incidental finding on a screening scan.
  3. Is there objective ischaemia? Stress testing, stress echocardiography or perfusion imaging — not the angiogram alone.
  4. Does the lesion actually restrict flow? FAME 2 established that physiological assessment, such as fractional flow reserve, selects lesions differently from visual assessment.
  5. Has medical therapy been given a fair trial? In most of the trials above, the comparator was not “nothing”. It was aggressive, properly titrated medical therapy — and that is what the stent failed to beat.
  6. What does the patient want, knowing all of this? A patient who understands they are choosing symptom relief rather than survival benefit makes a different decision from one who believes the stent is saving their life.

What “medical therapy” actually means

Choosing not to stent is not choosing to do nothing, and it is not the easier path. Done properly it means high-intensity statin therapy titrated to a lipid target, blood pressure controlled to goal, antiplatelet therapy where indicated, glucose management in diabetes, structured exercise, complete tobacco cessation, and scheduled follow-up that actually happens. It asks more of the patient than a procedure does, and more of the physician than a referral does.

That regimen is the comparator in COURAGE, ISCHEMIA and REVIVED-BCIS2. The reason those trials read as they do is not that stents are ineffective. It is that well-delivered medical therapy is very effective, and the trials were fair to it.

Where a stent is clearly right

An honest protocol names its own limits. Intervention is indicated in ST-elevation myocardial infarction and high-risk acute coronary syndromes, in significant left main stem disease, in angina that persists despite genuinely optimised medical therapy, and where objective testing shows a large ischaemic burden with symptoms that are limiting daily life. Those patients are stented, without hesitation.

Written and medically reviewed by Dr. Gurbir Singh Gill — Interventional Cardiologist & Diabetologist, Oxford Hospital.

Last reviewed: 1 September 2026

Common questions

Does a stent prevent a future heart attack?
In stable coronary disease, the randomised evidence says no. COURAGE (2007), ISCHEMIA (2020) and REVIVED-BCIS2 (2022) each compared a stent-first strategy against medical therapy and found no reduction in death or heart attack. Stents are highly effective at relieving angina, and they are life-saving during an actual heart attack — but in stable disease they treat symptoms, not survival.
My angiogram shows a 70% blockage. Do I need a stent?
Not necessarily. A percentage on an angiogram describes how a narrowing looks, not whether it restricts blood flow. FAME 2 showed that decisions made on measured physiology — fractional flow reserve — identify lesions differently from decisions made on appearance alone. The relevant questions are whether you have symptoms, whether there is objective ischaemia, and whether medical therapy has been given a fair trial.
Is avoiding a stent risky?
Choosing medical therapy in stable disease is not choosing to do nothing. It means high-intensity statin therapy, blood-pressure and glucose control, antiplatelet therapy where indicated, structured exercise, tobacco cessation and scheduled follow-up. In the trials above, that regimen was the comparator that a stent-first strategy failed to outperform on death and heart attack.
When is a stent clearly the right answer?
During a heart attack, above all. Also in high-risk acute coronary syndromes, in significant left main disease, in angina that persists despite properly optimised medical therapy, and where objective testing shows a large burden of ischaemia and symptoms are limiting daily life. The protocol is not anti-stent — it is against stenting patients who will not benefit.
Can I get a second opinion before agreeing to a stent?
Yes, and in stable disease there is usually time to. Bring your angiogram images or CD, any stress test or echocardiogram reports, your current medication list and recent blood work. A second opinion consultation reviews whether the evidence supports intervention in your specific case.
What if I have already had a stent?
The same principles govern what happens next. Secondary prevention after PCI — antiplatelet therapy, lipid lowering to target, blood-pressure and diabetes control, cardiac rehabilitation — is what determines long-term outcome, and is frequently under-treated relative to the attention given to the procedure itself.

The trials, in full

Every citation below links to the primary publication on PubMed. Read them.

COURAGE

2007 · n = 2,287

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.

Read on PubMed →

BARI 2D

2009 · n = 2,368

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.

Read on PubMed →

FAME 2

2012 · n = 888

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.

Read on PubMed →

ORBITA

2018 · n = 200

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.

Read on PubMed →

ISCHEMIA

2020 · n = 5,179

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.

Read on PubMed →

REVIVED-BCIS2

2022 · n = 700

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.

Read on PubMed →

The evidence that complicates the picture

Included because leaving it out would misrepresent the field.

ORBITA-2

2023 · n = 301

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.

Read on PubMed →