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George Touma: Do We Really Need to Implant Metal in Every High-Bleeding-Risk Patient?
George Touma/LinkedIn
Sep 11, 2026, 16:31

George Touma: Do We Really Need to Implant Metal in Every High-Bleeding-Risk Patient?

George Touma, Interventional Cardiologist at St George Private Cardiology, posted on LinkedIn:

“Do we really need to implant metal in every high-bleeding-risk patient?

One of the ESC 2026 studies I found interesting was the SELUTION DeNovo HBR analysis.

The question was:

‘If a patient is at high bleeding risk, do we always need to leave a permanent metal scaffold behind?’

The HBR subgroup included 522 patients, comparing a sirolimus-eluting balloon strategy with provisional stenting against systematic DES.

At 1 year:

Target-vessel failure:

  • 4.9% vs 7.9%

NACE:

  • 6.8% vs 10.7% – NACE = net adverse clinical events, combining major ischaemic events with clinically important bleeding.

Only 17.1% of patients in the balloon strategy required bailout stenting.

So roughly 83% avoided a stent.

At 6 months, 27.8% of patients in the balloon group were on no antiplatelet therapy compared with 14.9% in the DES group.

For an elderly patient on anticoagulation, this could matter a lot.

But there is an important caveat when discussing SELUTION DeNovo and any associated analysis. The non-inferiority claim itself needs scrutiny.

In the overall SELUTION DeNovo trial, the 1-year ITT analysis demonstrated non-inferiority for target-vessel failure: 5.3% vs 4.4%

The prespecified non-inferiority margin was 2.44 percentage points, with an observed risk difference of 0.91% and an upper 95% CI of 2.38%. So it just cleared the margin.

But: The per-protocol sensitivity analysis did NOT confirm non-inferiority.

That is a very very important limitation. It doesn’t mean the strategy doesn’t work. It means we should be careful about saying:

‘SELUTION has been proven non-inferior to DES.’

A more accurate statement is:

‘Non-inferiority was demonstrated in the primary ITT analysis, but not confirmed in the per-protocol sensitivity analysis.’

This is important when we’re talking about changing a very established standard of care.

In essence, we cant claim that sirolimis DCB has now replaced DES.

Also, the selution denovo trial wasnt really DCB vs DES. It was a different PCI philosophy ie:

  1. Prepare the lesion properly
  2. Deliver sirolimus
  3. Assess the result
  4. Implant a stent only if you actually need one. In other words don’t put metal in simply because that’s what we have always done.

For selected HBR patients, eg those on long-term anticoagulation, with small vessels, diffuse disease or anatomy where avoiding a permanent implant is attractive this could be a useful strategy.

Remember, we shouldn’t talk about ‘DCBs’ as though they are one homogeneous technology.

Drug, dose, delivery system and drug-transfer characteristics differ.

SELUTION DeNovo HBR adds another interesting piece to the puzzle.

For me, the most interesting number isn’t 4.9% vs 7.9%.

It’s that 83% avoided a stent.

This opens up a good option if selution denovo holds some advantage in longer term follow up.

But we need more data, especially given the non inferiority claim of the inital selution denovo trial raises concern.”

Stay updated with Hemostasis Today.

ESC 2026 George Touma Health Hematology Hemostasis Hemostasis News Hemostasis Today Medicine SELUTION DeNovo HBR analysis
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