DAPT for 1 Month Falls Short in Acute Coronary Syndrome

The 1-month dual antiplatelet (DAPT) approach weak in the STOPDAPT-2 acute coronary syndrome (ACS) trial failed to test the security and efficacy outcomes of the conventional STOPDAPT-2 seek.

For a composite important endpoint of cardiovascular (CV) death, myocardial infarction, stroke, definite stent thrombosis, or important or minor bleeding in ACS sufferers, the cumulative match price modified into 3.2% in the 1-month DAPT community and 2.83% in the 12-month community, for a distinction that modified into no longer statistically various (HR 1.15, 95% CI 0.80-1.62), reported Hirotoshi Watanabe, MD, of Kyoto College in Japan.

Additionally, the MI price modified into very much larger with 1-month DAPT (1.59% vs 0.85% at 12 months; HR 1.91, 95% CI 1.06-3.44), even though the cumulative rates of Thrombolysis in Myocardial Infarction (TIMI) important and minor bleeding had been very much decrease (0.54% vs 1.17% at 12 months; HR 0.46, 95% CI 0.23-0.94), he mentioned in a presentation on the European Society of Cardiology (ESC) virtual assembly.

The novel STOPDAPT-2 trial confirmed both non-inferiority and superiority of 1-month DAPT adopted by clopidogrel (Plavix) monotherapy via 1 year in opposition to 12 months of DAPT submit-percutaneous coronary intervention. In the first trial, most intelligent 38% of the sufferers had ACS; all bought a eternal-polymer, cobalt-chromium, everolimus-eluting stent (Xience).

Watanabe outlined that the prespecified upper limit of the self assurance interval modified into 1.50, however the interval found in the STOPDAPT-2 ACS fell start air that limit, so non-inferiority may perhaps well per chance no longer be shown.

In addition, he famend that there “modified into a pattern in direction of an amplify in cardiovascular events regardless of a discount in important bleeding events.”

The trial’s findings had been very various than these from the MASTER DAPT seek, also offered on the assembly. ESC press conference moderator Carlos Aguiar, MD, of Nicely being facility Santa Cruz in Portugal, acknowledged that the conflicting outcomes may perhaps well per chance stagger away doctors and sufferers with whiplash. But he careworn that the patient populations in MASTER DAPT and STOPDAPT-2 ACS had been very various.

To illustrate, STOPDAPT-2 did no longer include sufferers taking oral anticoagulation while MASTER DAPT did. Additionally, MASTER DAPT sufferers bought a stent with a bioresorbable polymer (Ultimaster), and on account of it modified into the suitable stent weak in that seek, the findings can’t be applied to other devices, Aguiar advised MedPage On the present time on the time of the seek presentation.

Aguiar mentioned that the STOPDAPT-2 ACS findings would no longer replace contemporary put collectively, however that the seek “light confirms, via some info that’s prospectively and adequately light, that we fabricate peep larger rates of bleeding with prolonged DAPT.”

“Bleeding is a ingredient we want to proceed to accept in thoughts when deciding how prolonged DAPT ought to be continued in sufferers,” he mentioned.

STOPDAPT-2 ACS enrolled 2,988 sufferers with ACS and pooled the implications with these from sufferers with ACS in STOPDAPT-2, for a full seek inhabitants of 4,136 sufferers. Every trials weak the identical protocol.

Watanabe also famend that important secondary CV outcomes occurred in 2.76% of sufferers in the 1-month DAPT community and 1.86% sufferers in the 12-month community (HR 1.50, 95% CI 0.99-2.26). Fundamental secondary bleeding occurred in 0.54% and 1.17%, respectively (HR 0.46, 95% CI 0.23-0.94), indicating that bleeding stays a dispute with longer-interval of time DAPT, he reiterated.

Sarah Clarke, MD, of Royal Papworth Nicely being facility in Cambridge, England advised MedPage On the present time that STOPDAPT-2 ACS demonstrated “no merit in stopping [DAPT] early and using clopidogrel because the one agent.” But she added that “we prefer extra info sooner than we can if truth be told be run…there are other elements to [consider], such because the variability of stent weak, the variability of lesions being stented, tag, and other procedural elements … it is no longer a gloomy-or-white dedication.”