Dr. Mustafa Candemir

Name of the study:
3-month versus 12-month DAPT after PCI with biodegradable polymer sirolimus TARGET-eluting coronary stent

Published in Congress: TCT 2024

Link: https://www.tctmd.com/slide/3-month-versus-12-month-dual-antiplatelet-therapy-after-implantation-biodegradable-polymer

Introduction:
International guidelines currently recommend dual anti-platelet therapy (DAPT) with aspirin plus P2Y12 inhibitor for 6 months in patients with a chronic coronary syndrome (CCS) and 12 months for acute coronary syndrome (ACS) treated with percutaneous coronary intervention (PCI) to prevent myocardial infarction (MI) and stent thrombosis. The outcomes of 3-month DAPT treatment and 12-month DAPT treatment after coronary intervention with drug-eluting stents containing 2nd generation zotarolimus were similar. Optical Coherence Tomography (OCT) proved early healing and reendothelialization of the biodegradable polymer drug eluting Firehawk stent at 3 months post procedure. Limited data exist regarding 3 month DAPT after PCI with DES with biodegradable polymer.

Objective:
This study was aimed to determine whether 3 months of DAPT is less effective than the traditional 12 months in patients treated with Firehawk stents containing biodegradable polymers.

Methods:
This study was a large-scale, multicentre, controlled, open-label and randomized label study designed to determine whether 3 months of DAPT is less effective than the traditional 12 months in patients treated with Firehawk stents containing biodegradable polymers. The study group was randomized so that 1222 patients received DAPT treatment for 3 months and 1223 patients received DAPT treatment for 12 months. The primary endpoint was Net Adverse Clinical and Cerebral Events (NACCE) (all-cause death, myocardial infarction (MI), cerebral vascular accident (CVA), major bleeding as assessed by the Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 at month 18). The secondary endpoints were target vessel failure, major adverse cardiac and cerebrovascular events (MACCE), stent thrombosis and major bleeding.

Results:
The incidence of NACCE was 10.1% in patients receiving 3-month DAPT treatment and 10.9% in patients receiving 12-month DAPT treatment. 3-month DAPT treatment was non-inferior. There was no difference between the two groups in terms of secondary endpoints. Patients over 65 years of age or with impaired renal function had more favorable outcomes with the 3-month DAPT regimen.

Conclusions:
The present results demonstrate that in patients who underwent PCI with Firehawk stent implantation, short-term (3-month) DAPT was non-inferior to long-term (12-month) therapy in terms of all-cause death, MI, CVA, and major bleeding. Patients aged over 65 or those with renal dysfunction may particularly benefit from a 3-month DAPT regimen.

Comment:
Recent DAPT studies have shown that reducing the duration of dual antiaggregant use does not improve endpoints by reducing side effects. Nevertheless, the results must be supported by randomized controlled trials with longer follow-ups and on different stents.