- Among patients undergoing PCI using third-generation DES with ultrathin struts and advanced polymer technology, 3- to 6-month DAPT was noninferior to 12-month DAPT for net adverse clinical events (NACE; defined as the composite of cardiac death, TVMI, CD-TLR, stent thrombosis, or major bleeding) at one year (3.7% vs. 4.1%; HR, 0.93; 95% CI, 0.60 to 1.45; p=0.75).
- The rates of target lesion failure (TLR; defined as the composite of cardiac death, TVMI, or CD-TLR) were comparable (2.4% vs. 2.5%; HR, 0.98; 95% CI, 0.56 to 1.71; p=0.94).
- No significant difference in major bleeding (BARC type 3 or 5) was observed (1.5% vs. 1.9%; HR, 0.82; 95% CI, 0.41 to 1.61; p=0.56).
- NACE, TLR, or major bleeding was not affected by the mode of presentation (stable ischemic heart disease or acute coronary syndrome).
Among the general population excluding patients with STEMI, 3-month DAPT was non-inferior to 12-month DAPT with respect to net adverse clinical events (NACE; defined as the composite of cardiac death, TVMI, CD-TLR, stent thrombosis, or major bleeding) at 12 months after PCI using third-generation DES with ultrathin struts and advanced polymer technology, according to the HOST-IDEA trial presented by Hyo-Soo Kim, MD, PhD at the ACC.23/WCC.
Current guidelines for dual antiplatelet therapy (DAPT) in patients undergoing percutaneous coronary intervention (PCI) recommend a duration of 6 months for stable ischemic heart disease (SIHD) and 12 months for acute coronary syndrome (ACS). However, the use of DAPT can have both beneficial and detrimental effects, and there have been efforts to investigate the efficacy and safety of shorter durations of DAPT in order to minimize the risk of bleeding complications, particularly with the use of second-generation drug-eluting stents (DES). While shortening or prolonging the duration of DAPT based on individual clinical risk has been proposed, this approach can be complex and difficult to implement in daily practice. Therefore, third-generation DES with ultrathin struts and advanced polymer technology have been developed to reduce the risk of stent-related complications and potentially allow for a shorter default duration of DAPT.
The HOST-IDEA trial was a multicenter, open-label, non-inferiority, randomized study initiated by investigators in South Korea. The participants enrolled in the trial had de novo stenotic lesions suitable for implantation with with Orsiro, or Coroflex ISAR stent. The trial randomized participants to receive either abbreviated dual antiplatelet therapy (DAPT) lasting 3 to 6 months (60 days to 150 days) or conventional 12-month DAPT (300 days or longer). The exclusion criteria included patients with ST-segment elevation myocardial infarction (STEMI), cardiogenic shock, severe decompensated heart failure, stent thrombosis, or restenosis. Patients scheduled for elective surgery or procedure within 3 months, patients with a recent history of major surgery or gastrointestinal bleeding within 1 month, patients on anticoagulation therapy, patients with other comorbid conditions with a life expectancy of less than 1 year, patients with hypersensitivity or contraindication to aspirin, clopidogrel, prasugrel, ticagrelor, heparin, cobalt chromium, or sirolimus, and pregnant women were also excluded from the trial. The primary outcome was the occurrence of net adverse clinical event (NACE), a composite of cardiac death, target vessel myocardial infarction (TVMI), clinically driven target lesion revascularization (CD-TLR), stent thrombosis, or major bleeding defined as Bleeding Academic Research Consortium (BARC) type 3 or 5 at 12 months after the index PCI. The key secondary outcomes were 1) target lesion failure (TLF), a composite of cardiac death, TVMI, or CD-TLR as an ischemic outcome, and 2) major bleeding as a bleeding outcome.
A total of 2,013 patients were randomized to the abbreviated 3- to 6-month DAPT (1,002 patients) or the conventional 12-month DAPT (1,011 patients), with a median DAPT duration of 100 days (interquartile range [IQR] 91–151) and 360 days (IQR 360–360), respectively. Patient population included had a mean age of 65.7 years, mostly men (73.9%, and more thanpresented with acute coronary syndrome (55%). At 12 months, the primary outcome occurred in 37 (3.7%) patients in the 3- to 6-month DAPT group and 41 (4.1%) in the 12-month DAPT group (HR, 0.93; 95% CI, 0.60 to 1.45; p=0.75; p<0.001 for non-inferiority). TLF occurred in 24 (2.4%) patients in the 3- to 6-month DAPT group and 25 (2.5%) in the 12-month DAPT group (HR, 0.98; 95% CI, 0.56 to 1.71; p=0.94). There was no significant difference in major bleeding (1.5% vs. 1.9%; HR, 0.82; 95% CI, 0.41 to 1.61; p=0.56). Treatment effect on the primary endpoint was consistent across the subgroups, including the mode of presentation (stable ischemic heart disease or acute coronary syndrome).
In conclusion, the HOST-IDEA trial suggests that 3- to 6-month DAPT may be a feasible option for general patients exclusive of STEMI who are undergoing PCI using third-generation DES with ultrathin struts and advanced polymer technology.