Acute coronary syndrome in high bleeding risk patients undergoing PCI was associated with similar rates of target lesion failure at 1 year compared to no ACS (6.8% vs 6.7%, P=0.992).
RCT (n=1,786)
Does biodegradable polymer sirolimus-eluting stent (BP-SES) compared to durable polymer zotarolimus-eluting stent (DP-ZES) improve clinical outcomes in high bleeding risk patients with or without acute coronary syndrome undergoing PCI with 1 month DAPT?
In high bleeding risk patients undergoing PCI with 1-month DAPT, clinical outcomes were consistent between biodegradable polymer sirolimus-eluting and durable polymer zotarolimus-eluting stents, though ACS patients had higher cardiac mortality than non-ACS patients.
Absolute Event Rate: 6.8% vs 6.7%
p-value: p=0.992
Abstract Aims Patients at high bleeding risk (HBR) and acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) are at high risk of adverse outcomes. We investigated the clinical outcomes and their consistency after biodegradable polymer sirolimus-eluting (BP-SES) or durable polymer zotarolimus-eluting stent (DP-ZES) implantation in HBR patients with or without ACS. Methods and results The per-protocol population of the BIOFLOW-DAPT randomized control trial (RCT) consisted of HBR patients with (n = 541) or without ACS (n = 1245) who were randomized to BP-SES or DP-ZES and underwent 1 month dual antiplatelet therapy (DAPT). The primary efficacy and safety endpoints were target lesion failure (TLF), defined as the composite endpoint of cardiac death, target vessel myocardial infarction (TV-MI), or clinically driven target lesion revascularization (cd-TLR) as well as major bleeding defined as BARC 3 or 5 (according to Bleeding Academic Research Consortium classification) and definite/probable stent thrombosis (ST). At 1 year, patients with ACS suffered from higher cardiac death rates (3.4 vs. 1.3%, log-rank P = 0.004) but similar TLF (6.8 vs. 6.7%, P = 0.992), TV-MI (2.8 vs. 4.5%, P = 0.100), cd-TLR (1.4 vs. 2.1%, P = 0.300), major bleeding (4.2 vs. 3.1%, P = 0.266), and ST (0.2 vs. 0.9%, P = 0.098) compared with no ACS patients. The rate of TLF and of all secondary endpoints was consistent with BP-SES or DP-ZES across ACS strata. Conclusion HBR patients with ACS are at higher risk of cardiac death than those without ACS and experience a consistent outcome with BP-SES or DP-ZES followed by 1 month DAPT at 1 year follow-up. Clinical Trial Registration NCT04137510.
Mankerious et al. (Tue,) conducted a rct in High bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI) (n=1,786). Acute coronary syndrome (ACS) vs. No ACS was evaluated on Target lesion failure (TLF) (p=0.992). Acute coronary syndrome in high bleeding risk patients undergoing PCI was associated with similar rates of target lesion failure at 1 year compared to no ACS (6.8% vs 6.7%, P=0.992).