Dropping dual antiplatelet therapy (DAPT) in favor of aspirin alone at 1 month after drug-eluting stent (DES) implantation for stable coronary disease patients was not worse than longer DAPT regimens, a trial suggested.
The 1-year composite of cardiac death, nonfatal MI, target-vessel revascularization, cerebrovascular accident, or major bleeding occurred in 5.9% of people treated with the short DAPT regimen after getting the BioFreedom polymer-free DES compared with 6.5% of people who got 6 to 12 months of DAPT after getting a durable-polymer BioMatrix or Ultimaster DES.
That absolute 0.7% difference between groups met criteria for non-inferiority, reported Myeong-Ki Hong, MD, PhD, of Severance Cardiovascular Hospital in Seoul, South Korea, at the American Heart Association (AHA) virtual meeting.
The same was true in a landmark analysis looking at events after 1 month and for all secondary endpoints.
A subgroup analysis suggested that the short DAPT regimen might not be safe in patients who had presented with acute coronary syndrome (primary composite event rate 7.2% vs 5.1% with longer DAPT, HR 1.43, P=0.013 for interaction), albeit based on relatively few events in the 3,020-patient randomized trial.
The multicenter, open-label trial included patients who presented for elective percutaneous coronary intervention (PCI) both with and without high bleeding risk. Acute MI, complex lesions, and cardiogenic shock were exclusion criteria.
It’s the first randomized trial to support the safety of a 1-month DAPT regimen after stenting low-risk patients, noted AHA session discussant Róisín Colleran, MB BCh, of the Cardiovascular Research Institute Dublin.
Aspirin monotherapy is cheaper and has fewer off-target side effects than ticagrelor (Brilinta), as well as less variation in treatment response than clopidogrel (Plavix) for P2Y12 inhibitor monotherapy, she noted.
However, none of the stents tested in the trial are approved for use in the U.S. Interpretation of the results was also complicated by the mix of stent types, with different strut thicknesses across the three used, and the range of longer DAPT used as a comparator, she added.
“It will be important now to see if this might be a class effect that can be extended to other more widely used stents in this country,” commented B. Hadley Wilson, MD, of Sanger Heart & Vascular Institute-Charlotte in North Carolina and a spokesperson for the American College of Cardiology.
“Is it related to this being a polymer-free stent, or is it just the design of all these late-generation stents are so much better now that you can have shorter DAPT as a class effect?” he posited in an interview with MedPage Today.
Evidence is accruing for shorter DAPT regimens, as each stent would need safety data to provide the FDA to get an indication for it, which the Resolute Onyx drug eluting stent recently did for 1-month DAPT for high bleeding risk patients.
However, the trend has been to drop aspirin rather than the more potent antiplatelet agent, noted Roxana Mehran, MD, of Icahn School of Medicine at Mount Sinai in New York City.
“At the moment we have a lot of data, especially with the LEADERS FREE evaluation in 1-month DAPT, as well as the ONYX ONE, and most recently on the Xience 28-days and 90-days evaluation…showing really really good results as far as the hard endpoints,” she told MedPage Today.
Hong and colleagues study was fairly small for looking at hard clinical endpoints, she added.
“I believe we are moving toward, if we’re looking at stent-related complications in elective PCI for stable coronary disease, that we can go even shorter,” she said. However, “we shouldn’t be so cavalier about applying these to every single patient,” she argued, especially high-risk patients like smokers or those with diabetes, multivessel disease, or acute coronary syndrome.
For such patients with low bleeding risk, “I still would like to give them either a dual antiplatelet therapy or a TWILIGHT type of strategy after PCI, which is ticagrelor monotherapy,” she said.
Longer duration antiplatelet use may have some benefit beyond just the stent-related complications, as suggested in the DAPT trial showing that an extended duration of DAPT for as much as 30 months after DES implantation held benefit.
Mehran disclosed relevant relationships with Applied Therapeutics, Claret Medical, Elixir Medical, STEL, ControlRad, Janssen Scientific Affairs, Boston Scientific, California Institute for Regenerative Medicine, Society for Cardiovascular Angiography and Interventions, American College of Cardiology, and American Medical Association.
Colleran and Wilson disclosed no relevant relationships with industry.