Adding Aspirin Raises Cardiovascular Events In High-risk Ccs Patients On Anticoagulants

Adding aspirin accrued nan consequence of cardiovascular events, decease and awesome bleeding successful high-risk patients pinch chronic coronary syndrome (CCS) who had anterior stenting and were receiving semipermanent chronic oral anticoagulation (OAC), according to late-breaking investigation presented successful a Hot Line convention coming astatine ESC Congress 2025 and simultaneously published successful New England Journal of Medicine.

Explaining nan rationale of nan AQUATIC trial, its Principal Investigator, Professor Martine Gilard from Hospital Cavale Blanche, Brest, France, said: "After stent implantation, galore patients pinch CCS (stable coronary artery disease) are astatine precocious consequence for early cardiovascular events owed to conditions including diabetes, chronic kidney illness and diffuse multivessel disease, and immoderate require semipermanent anticoagulation, peculiarly owed to atrial fibrillation (AF). Managing nan consequence of further cardiovascular events successful these patients is challenging and location is constricted proceedings grounds to guideline nan optimal antithrombotic strategy. We designed nan AQUATIC proceedings to formally trial nan efficacy and information of adding aspirin to OAC, a operation that is commonly utilized for this high-risk organization successful objective practice."

This was a double-blind, placebo-controlled, parallel-group, randomized proceedings conducted astatine 51 centers successful France. Eligible patients had CCS and stent implantation (>6 months before), were astatine precocious atherothrombotic consequence and required semipermanent OAC for immoderate logic (mainly AF). High atherothrombotic consequence was defined arsenic either a history of percutaneous coronary involution (PCI) during an acute coronary syndrome (ACS) (with ≥1 stent(s) >6 months) aliases history of PCI (>6 months) extracurricular nan discourse of ACS but pinch high-risk features specified arsenic diabetes, chronic kidney disease, diffuse multivessel illness (involvement of 3 coronary vessels), history of analyzable PCI aliases peripheral artery disease. Patients were randomized 1:1 to aspirin aliases placebo connected apical of OAC (either a nonstop OAC aliases vitamin K antagonists). The superior efficacy endpoint was a composite of cardiovascular death, myocardial infarction, stroke, systemic embolism, coronary revascularisation and acute limb ischaemia. The cardinal secondary information endpoint was awesome bleeding according to nan International Society connected Thrombosis and Haemostasis (ISTH) definition.

The proceedings was stopped early connected nan proposal of nan independent Data Safety Monitoring Board aft a median follow-up of 2.2 years owed to an excess of all-cause mortality successful nan aspirin group. The 872 patients randomized had a mean property of 72 years and 14.5% were male.

The superior efficacy result occurred successful importantly much patients successful nan aspirin group than nan placebo group (16.9% vs. 12.1%; adjusted hazard ratio [HR] 1.53; 95% assurance interval [CI] 1.07 to 2.18; p=0.019). All-cause decease besides occurred successful importantly much patients pinch aspirin vs. placebo (13.4% vs. 8.4%; adjusted HR 1.72; 95% CI 1.14 to 2.58; p=0.010).

The consequence of awesome bleeding was much than three-fold higher successful nan aspirin group than nan placebo group (10.2% vs. 3.4%; HR 3.35; 95% CI 1.87 to 6.00; p<0.0001).

A full of 467 and 395 superior adverse events were reported successful nan aspirin and placebo groups, respectively.

In conclusion, Professor Gilard said: "Among patients pinch CCS astatine precocious atherothrombotic consequence who require OAC therapy, aspirin importantly accrued nan consequence of awesome cardiovascular events, all-cause mortality and awesome bleeding, and its usage should beryllium discouraged. Other studies person investigated antithrombotic therapy for unchangeable coronary artery illness and AF, 2,3 but this is nan first randomized proceedings to see patients who had anterior stenting and pinch precocious atherothrombotic consequence − arena rates were astir 7 times higher successful AQUATIC than successful erstwhile trials. Our findings tin now beryllium considered successful early ESC Guidelines to build connected existent recommendations, which are based connected master consensus."