DAPT for 1 month beneficial in complex PCI with biodegradable stent, high bleeding risk
Click Here to Manage Email Alerts
In patients with high bleeding risk who underwent complex PCI, dual antiplatelet therapy for approximately 1 month reduced bleeding compared with slightly longer DAPT duration, according to new data from the MASTER DAPT trial.
The 1-month DAPT strategy did not confer elevated ischemic risk compared with the 3-month DAPT strategy in patients who had complex PCI, and the results were similar in patients who had noncomplex PCI.
As Healio previously reported, in the main results of MASTER DAPT, use of DAPT for 1 month after PCI lowered bleeding rates and was noninferior for ischemic events compared with 3-month DAPT in patients at high bleeding risk. For the current prespecified substudy, presented at EuroPCR, researchers investigated the 1,196 patients from MASTER DAPT who underwent complex PCI with a sirolimus-eluting biodegradable polymer stent (Ultimaster, Terumo) and compared them with the 3,383 patients from the trial population who had noncomplex PCI.
“As we all know, patients who have to undergo complex PCI are presenting with advanced coronary artery disease and suffer from higher risk of short- and long-term ischemic events,” Marco Valgimigli, MD, FESC, deputy head of cardiology at Cardiocentro Ticino Institute in Lugano, Switzerland, said at a press conference. “Therefore, it was very important to assess the consistency of the treatment effect in complex PCI.”
The primary endpoints, all at 1 year, were net adverse clinical events, defined as all-cause death, MI, stroke and Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding; MACCE, defined as all-cause death, MI and stroke; and major or clinically relevant nonmajor bleeding, defined as BARC type 2, 3 or 5.
Complex PCI was defined as meeting at least one of the following criteria: three-vessel disease, at least three stents implanted, at least three lesions treated, bifurcation with at least two stents implanted, total stent length more than 60 mm, a target lesion with chronic total occlusion, left main stenting or graft stenting.
There was no difference between the groups in net adverse clinical events in the complex PCI population (HR = 1.03; 95% CI, 0.69-1.52; P = .9) and in the noncomplex PCI population (HR = 0.9; 95% CI, 0.71-1.15; P = .42; P for interaction = .6), Valgimigli said at the press conference.
Similarly, he said, there was no difference in MACCE in the complex PCI population (HR = 1.24; 95% CI, 0.79-1.92; P = .35) and in the noncomplex PCI population (HR = 0.91; 95% CI, 0.61-1.21; P = .52; P for interaction = .26).
The major or clinically relevant nonmajor bleeding endpoint favored the 1-month DAPT group in both the complex PCI population (HR = 0.64; 95% CI, 0.42-0.98; P = .04) and the noncomplex PCI population (HR = 0.7; 95% CI, 0.55-0.89; P < .001; P for interaction = .72), he said.
“In patients at [high bleeding risk] who had undergone implantation of a biodegradable-polymer Ultimaster stent, regardless of PCI complexity, discontinuation of DAPT at a median of 34 days compared with continuation of treatment to a median of 193 days after PCI was consistently associated with similar rates of [net adverse clinical events] and MACCE and a lower rate of major bleeding,” Valgimigli said at the press conference.
He said the results were consistent when an alternative definition of complex PCI was used as well as when ACS was or was not included as a criterion for complex PCI.
He noted that patients requiring complex PCI had once been treated with prolonged DAPT after their procedure, but data from recent trials such as MASTER DAPT suggest that was a mistake. “Retrospectively, these patients have clearly been overtreated,” Valgimigli said.
Collapse
Vranckx P, et al. New Insights from Clinical Trials in Coronary Artery Disease. Presented at: EuroPCR; May 17-20, 2022; Paris (hybrid meeting).
Click Here to Manage Email Alerts