DAEDALUS study results: How stent type may affect coronary in-stent restenosis treatment
When patients with coronary in-stent restenosis (ISR) require reintervention, should specialists turn to drug-coated balloon (DCB) angioplasty or a drug-eluting stent (DES)? An international team of researchers explored this very question, sharing its findings in the Journal of the American College of Cardiology.
“Currently, it is unclear whether the relative efficacy of DCB angioplasty and repeat stenting with DES depends on the type of restenosed stent,” wrote first author Daniele Giacoppo, MD, MSc, Technical University of Munich in Germany, and colleagues. “Available evidence is of low quality and largely based on the indirect comparison of results of small, single-arm, observational studies. In addition, high-quality, large-scale datasets comparing long-term outcomes after treatment of bare-metal stent (BMS)- versus DES-ISR after percutaneous coronary intervention are still lacking.”
Giacoppo et al. launched the DAEDALUS (Difference in Antirestenotic Effectiveness of Drug-Eluting Stent and Drug-Coated Balloon Angioplasty for the Occurrence of Coronary In-Stent Restenosis) study, which pooled the findings of 10 randomized clinical trials comparing DCB angioplasty with repeat DES implantation. While the primary efficacy endpoint was target lesion revascularization (TLR) at the three-year point, the primary safety endpoint was “a composite of all-cause death, myocardial infarction or target lesion thrombosis” at three years.
The study included 710 patients with BMS-ISR and another 1,248 patients with DES-ISR. For BMS-ISR patients, researchers found “no significant difference” between DCB angioplasty and repeat DES implantation when it came to either primary endpoint. For patients with DES-ISR, the risk of TLR was 20.3% for DCB angioplasty and 13.4% for repeat DES implantation and the risk of the primary safety endpoint was 9.5% for DCB angioplasty and 13.3% for repeat DES implantation. For both treatments, the risk of TLR was lower for BMS-ISR patients (9.7%) than DES-ISR patients (17%).
“The DAEDALUS study shows for the first time in a large number of patients that DCB angioplasty and repeat stenting with DES have similar long-term efficacy in the treatment of BMS-ISR,” the authors wrote. “This result may provide a rationale for using the device that avoids an additional permanent metallic layer, with possible advantages in terms of reiteration of the mechanisms leading to recurrent ISR and more flexible application of future treatments.”
The team did emphasize, however, that repeat DES implantation performed well for patients with DES-ISR, a sign that “may provide a rationale for preference of repeat stenting with DES in this setting.”
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.