DAPT for 1 month after PCI safe, effective in patients at high bleeding risk: MASTER DAPT
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In patients at high bleeding risk, dual antiplatelet therapy for 1 month after PCI lowered bleeding rates and was noninferior for ischemic events compared with 3-month DAPT, according to results of the MASTER DAPT trial.
Marco Valgimigli, MD, FESC, deputy chief of interventional cardiology at Cardiocentro Ticino Institute, Lugano, Switzerland, and colleagues randomly assigned 4,579 patients (mean age, 76 years; 69% men) at high bleeding risk who underwent PCI with a biodegradable-polymer sirolimus-eluting stent (Ultimaster, Terumo) to 1 month or at least 3 months of DAPT. Randomization occurred 1 month after PCI, after which the abbreviated therapy group stopped DAPT and the standard therapy group continued DAPT for at least 2 more months. DAPT consisted of aspirin and a P2Y12 inhibitor; single antiplatelet therapy consisted of either of those.
“If the patients were doing fine at 30 days, meaning free from ischemic events, then we randomized them, and immediately stopped dual antiplatelet therapy or continued the treatment for at least 2 additional months,” Valgimigli said at a press conference.
The study included three ranked primary outcomes: net adverse clinical events, defined as all-cause death, MI, stroke or major bleeding; MACCE, defined as all-cause death, MI or stroke; and major or clinically relevant nonmajor bleeding. The first two outcomes were analyzed for noninferiority in a per-protocol population of 4,434 patients and the third outcome was analyzed for superiority in the intention-to-treat population. Patients were followed for 335 days.
There was no difference between the groups in net adverse clinical events (abbreviated therapy, 7.5%; standard therapy, 7.7%; HR = 0.97; 95% CI, 0.78-1.2; risk difference, –0.23 percentage points; 95% CI, –1.8 to 1.33; P for noninferiority < .001) or MACCE (abbreviated therapy, 6.1%; standard therapy, 5.9%; HR = 1.02; 95% CI, 0.8-1.3; risk difference, 0.11 percentage points; 95% CI, –1.29 to 1.51; P for noninferiority < .001), according to the researchers.
However, major or clinically relevant nonmajor bleeding occurred less often in the abbreviated therapy group vs. the standard therapy group (6.5% vs. 9.4%; HR = 0.68; 95% CI, 0.55-0.94; risk difference, –2.82 percentage points; 95% CI, –4.4 to –1.24; P for superiority < .001), Valgimigli said at the press conference.
The groups did not differ in rates of all-cause death, MI or stent thrombosis, but stroke or transient ischemic attack occurred twice as often in the standard therapy group vs. the abbreviated therapy group (0.7% vs. 1.4%), according to the researchers.
“DAPT duration in excess of 1 month does not decrease the risk of heart attacks or strokes but results in greater risk of bleeding complications” in this patient population, Valgimigli said at the press conference. “Coronary stents for narrowed coronary arteries are becoming safer each year, and the drug-eluting stent, in particular the Ultimaster stent, requires only a limited duration of treatment with blood thinners, which results in lower bleeding risk ... for our patients.”
The results were simultaneously published in The New England Journal of Medicine.
In a related editorial in NEJM, E. Magnus Ohman, MB, professor of medicine and vice chair of development and innovation at Duke University School of Medicine and member in the Duke Clinical Research Institute, wrote: “The findings of Valgimigli and colleagues are
important and move us toward a shorter and simpler antithrombotic strategy after PCI. Concomitant shorter antiplatelet monotherapy in the context of chronic disease after the implantation of a drug-eluting stent represents a major shift. This news is welcome for patients at high risk for bleeding after stent placement.”
References:
- Ohman EM. N Engl J Med. 2021;doi:10.1056/NEJMe2112747.
- Valgimigli M, et al. N Engl J Med. 2021;doi:10.1056/NEJMoa2108749.
Perspective
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These findings are generally in line with prior studies showing that patients at high bleeding risk should have their dual antiplatelet regimen deescalated as soon as feasible.
Since the time this trial started, most of us have already adopted the practice of deescalating DAPT in patients at high bleeding risk and of minimizing triple antithrombotic therapy in all patients, but especially those at high bleeding risk.
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Valgimigli M, et al. Hot Line: MASTER DAPT. Presented at: European Society of Cardiology Congress; Aug. 27-30, 2021 (virtual meeting).
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