Bare metal stents no longer advisable for high bleeding risk ACS patients

By Eleanor McDermid

A polymer-free, drug-coated stent (DCS) gives markedly better outcomes than a bare metal stent (BMS) in patients with acute coronary syndromes (ACS) and risk factors for bleeding, report researchers.

Although predefined, this subanalysis of the Leaders Free trial had insufficient statistical power to detect the expected clinical differences between the groups, so the team stresses that the findings should be "regarded as hypothesis generating".

Nonetheless, the substantial differences in favour of the DCS, given together with just 1 month of dual antiplatelet therapy, leads them to suggest that the findings "are likely to significantly impact clinical practice for high bleeding risk patients presenting with an ACS: the use of a BMS can, in our view, no longer be recommended".

As reported in the European Heart Journal, the 2466 Leaders Free participants all had at least one of 13 prespecified risk factors for bleeding, most commonly advanced age, low haemoglobin levels and reduced creatinine levels.

Of these patients, 330 presented with ACS and were randomly assigned to receive a polymer-free biolimus-A9-coated stent (Biofreedom DCS Biosensors Europe, Morges, Switzerland) plus 1 month of dual antiplatelet therapy.

After 12 months of follow-up, 3.9% of these patients had required clinically driven target-lesion revascularisation, compared with 9.0% of 329 ACS patients assigned to receive a BMS (Gazelle, Biosensors Interventional Technologies, Singapore) plus antiplatelet treatment. This equated to a significant 59% risk reduction.

Besides requiring less reintervention, patients given a DCS also had a significantly lower composite rate of cardiac death, myocardial infarction and probable/definite stent thrombosis, at 9.3% versus 18.5% in the BMS group. And the risk of the individual myocardial infarction and cardiac death endpoints was also significantly reduced.

"The fact that not only the primary efficacy endpoint but also stent thrombosis and ischaemic events are reduced in the DCS group is compelling", say Christoph Naber (Elisabeth Krankenhaus Essen, Germany) and study co-authors.

But they caution that "our findings may not be extendable to polymer-coated [drug-eluting stents] or other polymer-free drug-coated stent designs."

The rate of bleeding was similar for both groups, but the researchers note that it was high overall, at more than 20%, despite patients receiving only 1 month of dual antiplatelet treatment, with severe bleeding occurring in more than 9% of both groups.

They say this highlights that a longer course of dual antiplatelet therapy "would be expected to be poorly tolerated in this high bleeding risk cohort."

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