Shortened DAPT after PCI with third-generation DES noninferior to 12-month DAPT

ACC.23 In patients undergoing PCI (STEMI patients excluded), using a contemporary drug-eluting stent (DES), 3 to 6-month dual antiplatelet therapy (DAPT) was non-inferior to 12-month DAPT with regard to net adverse clinical events at 12 months.

Presented at the ACC.23 by: Hyo-Soo Kim, MD, PhD - Seoul, South Korea

Introduction and methods

After PCI, current guidelines recommend dual antiplatelet therapy (DAPT) for 6 months in patients with stable ischemic heart disease and 12 months in ACS patients. The use of a third-generation drug-eluting stent (DES) with ultrathin struts and advanced polymer technology has theoretical benefits that minimize the risk of stent-related complications and may allow shortening of the default duration of DAPT. However, little is known about the effects of short-term DAPT after PCI with this type of stents.

The HOST-IDEA (Harmonizing Optimal Strategy for Treatment of coronary artery diseases – coronary Intervention with next-generation Drug-Eluting stent platforms and Abbreviated dual antiplatelet therapy) trial was a multicenter, investigator-initiated, open-label, non-inferiority, adjudicator-blinded, randomized study conducted in South Korea. In this RCT, 2013 patients with de novo stenotic lesions who underwent PCI with an Orsiro bioresorbable-polymer sirolimus-eluting stent (SES) or Coroflex ISAR polymer-free SES were randomized to receive either DAPT for 3–6 months (followed by single APT) or 12 months. The APT regimen with aspirin and/or a P2Y12 i was left to the physician’s discretion. STEMI was one of the exclusion criteria.

The primary endpoint was a net adverse clinical event (NACE), a composite outcome of cardiac death, target-vessel MI, clinically driven target lesion revascularization, stent thrombosis, and major bleeding (defined as Bleeding Academic Research Consortium type 3 or 5) at 12 months. Major secondary endpoints were target lesion failure (a composite outcome of cardiac death, target-vessel MI, or clinically driven target lesion revascularization) and major bleeding.

Main results

• The primary endpoint occurred in 37 patients (3.7%) in the 3 to 6-month DAPT group and 41 (4.1%) in the 12-month DAPT group (HR: 0.93; 95%CI: 0.60–1.45; P=0.75; absolute risk difference: –0.4%; 1-sided 95%CI: -∞% to 1.1%; P for non-inferiority<0.001).
• There were no differences between the 2 groups in the incidence of target lesion failure (2.4% vs. 2.5%; HR: 0.98; 95%CI: 0.56–1.71; P=0.94) or major bleeding (1.5% vs. 1.9%; HR: 0.82; 95%CI: 0.41–1.61; P=0.56), nor in any of the other components of the primary endpoint.
• Post-hoc subgroup analyses showed similar results for the treatment effect of 3 to 6-month DAPT versus 12-month DAPT on the primary endpoint, without significant interaction.
• Per-protocol analysis results were also consistent with those from the intention-to-treat analysis.

Conclusion

In patients undergoing PCI (STEMI patients excluded) using a third-generation DES with ultrathin struts and advanced polymer technology, 3 to 6-month DAPT was non-inferior to 12-month DAPT with regard to the rate of NACE at 12 months.

- Our reporting is based on the information provided at the ACC.23 -

The results of this study were simultaneously published in Circulation .