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IDEAL-LM: Newer EES plus shortened DAPT similar to older EES plus 1-year DAPT in left main disease
SAN FRANCISCO — Among patients with CAD in the left main artery who underwent PCI, a biodegradable polymer everolimus-eluting stent plus 4 months of dual antiplatelet therapy conferred similar outcomes as a durable polymer EES plus 1 year of DAPT, according to results from the IDEAL-LM trial.
The primary outcome of MACE, defined as death, MI or ischemia-driven target vessel revascularization at 2 years, occurred in 14.6% of patients assigned the biodegradable EES (Synergy, Boston Scientific) and 11.4% of those assigned the durable EES (Xience, Abbott Vascular; risk difference, 3.28; 95% CI, –0.63 to 7.18; log-rank P = .152), meeting the 7.5% noninferiority margin, Robert-Jan van Geuns, MD, PhD, an interventional cardiologist at Radboud University Medical Center, Nijmegen, the Netherlands, said during a press conference at TCT 2019.
BARC grade 3 or 5 bleeding was higher in the biodegradable group at 2 years (2.7% vs. 0.5%; P = .02), he said.
However, other secondary outcomes were similar between the groups at 2 years, including all-cause mortality (P = 1), any MI (P = .13), ischemia-driven TVR (P = .14), ischemia-driven target lesion revascularization (P = .43), device-oriented composite events (P = .31) and definite or probable stent thrombosis (P = .21), although all except all-cause mortality were numerically higher in the biodegradable group.
“IDEAL-LM confirms excellent outcomes of current angioplasty techniques in the left main coronary artery,” van Geuns said during the press conference. “Short dual antiplatelet therapy is an option after PCI for left main disease with the latest DES design.”
In a landmark analysis, the primary outcome did not differ between the groups between baseline and 4 months (log-rank P = .139), between 4 months and 1 year (log-rank P = .189) and between 1 and 2 years (log-rank P = .801), van Geuns said.
For the all-comers trial, the researchers enrolled 818 patients (mean age, 66 years; 80% men; 93.2% eligible for surgery; 37.3% with ACS) with left main CAD from 29 sites in five countries. All were selected for PCI instead of CABG based on low SYNTAX score (57.9%), comorbidities (23.8%), ACS (16.8%) and other reasons (34.7%), van Geuns said.
Some experts debated the merits of the study design and interpretation during a panel discussion at the press conference.
“This is an important subset of patients and these are not easy trials to do,” said Robert A. Harrington, MD, cardiologist, the Arthur L. Bloomfield Professor of Medicine and chairman of the department of medicine at Stanford University and president of the American Heart Association. “Having said that, you need to really be careful on the interpretation. This is a potential classic type 2 error. The failure to observe a difference is not the same as there being no difference. In fact, all of the data are suggesting that there is somewhat of a doubling of risk range for the shorter DAPT group. I don’t think you can conclude that this is an option. You should conclude that this is worrisome, and that more data are needed.” – by Erik Swain
Reference:
van Geuns RJ, et al. Late-Breaking Trials 1. Presented at: TCT Scientific Symposium; Sept. 25-29, 2019; San Francisco.
Disclosures: The study was funded by Boston Scientific and sponsored by Golden Jubilee Hospital. Van Geuns reports he received speaker fees from Abbott and Boston Scientific. Harrington reports he holds equity in Element Science and received fees from SignalPath and WebMD.
Perspective
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This was a pragmatic study that tried to look for a brave strategy of reducing use of DAPT in patients with left main disease. This is not much different from the recommendations in the European Society of Cardiology guidelines of 6 months of DAPT for elective PCI regardless of lesion location. This study tested 4 months of DAPT with a biodegrabable-polymer stent. However, the study had a large noninferiority margin and to me was quite underpowered to definitively address this question, and there were signals within the secondary endpoints that there may be an increase in thrombotic events, which warrants caution. It is good that we have these data, but the results can be interpreted in two ways. Believers in short DAPT will find a way to push that concept, and proponents of longer, standard DAPT will find arguments they can make from the same trial.