September 27, 2019
IDEAL-LM Supports Shortened DAPT After PCI With Biodegradable-Polymer EES in Patients With Unprotected Left Main CAD
September 26, 2019—The Cardiovascular Research Foundation (CRF) announced that results from the IDEAL-LM study were presented by coprincipal investigator Prof. Robert-Jan Van Geuns, MD, at TCT 2019, the 31st annual Transcatheter Cardiovascular Therapeutics scientific symposium, which is sponsored by CRF and held September 25–29 in San Francisco, California.
According to CRF, the IDEAL-LM trial found that a biodegradable polymer everolimus-eluting stent (BP-EES) followed by 4 months of dual antiplatelet therapy (DAPT) was safe and effective compared to a conventional durable polymer EES (DP-EES) followed by 12 months of DAPT in patients undergoing percutaneous coronary intervention (PCI) for unprotected left main coronary artery (uLMCA) disease.
In the study, the BP-EES is the Synergy platinum chromium EES with bioresorbable polymer (Boston Scientific Corporation). The DP-EES is the Xience cobalt chromium EES with durable polymer (Abbott).
As summarized in the CRF announcement, the prospective, randomized, multicenter IDEAL-LM study was conducted at 29 sites in five countries. Between December 2014 and September 2016, a total of 818 patients were randomized 1:1 to BP-EES or DP-EES. Procedural success was 99.9%, predominantly using single-stent techniques (79.6%).
In the BP-EES arm (n = 403), DAPT was stopped at 4 months. DAPT continued for 12 months after PCI in the DP-EES arm (n = 396).
The primary endpoint assessment was a noninferiority comparison of major adverse cardiovascular events (MACE) rate, including death from any cause, myocardial infarction, or ischemia-driven target vessel revascularization at 2 years after the procedure. Key secondary endpoints included ischemic and bleeding events.
Prof. Van Geuns reported that the primary endpoint of noninferiority for MACE at 24 months was met with 14.6% in the BP-EES arm and 11.4% the DP-EES arm (P = .17).
There were no differences in ischemic events, including no difference in stent thrombosis, between 4 and 12 months when the antiplatelet therapy was reduced in the BP-EES arm. However, this strategy did not result in a reduction of Bleeding Academic Research Consortium 3 or 5 bleeding in the short DAPT group, with low-bleeding occurring in both the BP-EES and the DP-EES study arms (2.7% vs 0.5%; P = .02).
In the CRF announcement, Prof. Van Geuns commented, “IDEAL-LM confirms the excellent outcomes of current angioplasty techniques in patients with left main coronary artery disease. In addition, short DAPT is an option after angioplasty for left main disease with the latest DES design.”
Additionally, IDEAL-LM Coprincipal Investigator Prof. Keith G. Oldroyd, MD, noted that the somewhat surprising data on bleeding was likely due to the use of oral anticoagulation in some of the patients who bled and pointed out that the trial was not powered for bleeding events.