Abstract
Abstract Aims To assess the frequency, clinical characteristics, and clinical outcomes of patients presenting with and without cardiogenic shock (CS) among those receiving cangrelor in the peri-percutaneous coronary intervention (PCI) phase. Methods Consecutive patients treated with cangrelor in 7 Italian institutions were retrospectively enrolled in the ICARUS (“Intravenous CAngrelor in high-bleeding Risk patients Undergoing percutaneouS coronary intervention”, NCT05505591) registry. Cardiogenic shock was defined as system hypotension (systolic blood pressure < 90 mmHg) despite adequate volume in presence of clinical or laboratory signs of hypoperfusion. The primary endpoint was net adverse clinical events (NACE), defined as a composite of cardiovascular death, myocardial infarction, stroke, definite or probable stent thrombosis and Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding, at 48 hours. Secondary endpoints were assessed at 48 hours. Major adverse cardiovascular events (MACE), defined as a composite of cardiovascular death, myocardial infarction, stroke, and definite or probable stent thrombosis were evaluated at discharge. Results Out of 551 patients undergoing PCI with cangrelor between January 2019 and August 2022, cardiogenic shock status was available in 550 (99.9%). Among those, 25 (4.5%) presented with CS. Median age was 67 (59-78) vs. 68 (59-77) years in CS vs. non-CS patients (p=0.767). Female sex (44% vs. 24%, p=0.038), presentation with ST-elevation myocardial infarction (84% vs. 42%, p<0.001) and cardiac arrest (46% vs. 4%, p<0.001) were more frequent in the CS group. Likewise, CS patients had higher rates of femoral access (36% vs. 10%, p<0.001), three-vessel PCI (17% vs. 3%, p=0.007), intra-aortic balloon pump implantation (50% vs. 3%, p<0.001) and Gp IIb/IIIa inhibitors use (16% vs. 3%, p=0.005). At 48 hours, CS patients had higher rates of NACE (44% vs. 7%, p<0.001), MACE (12% vs. 1%, p=0.008), cardiovascular death (12% vs. 0.4%, p=0.001), BARC 2, 3 or 5 bleeding (32% vs. 6%, p<0.001), and BARC 3 or 5 bleeding (16% vs. 1%, p=0.001). At multivariable logistic regression, CS independently predicted the occurrence of NACE (odds ratio [OR] 1.29, 95% CI 1.14-1.45, p<0.001) and BARC 3 or 5 bleeding (OR 1.14, 95% CI 1.08-1.21, p<0.001). In-hospital MACE were available in all but one patient, with an event rate that was higher among CS patients (32% vs. 1.3%, log-rank p<0.001). At Cox multivariable analysis, cardiogenic shock was the only independent predictor of in-hospital MACE (hazard ratio [HR] 7.13, 95% CI 1.37-36.8). Conclusions Approximately 5% of patients receiving cangrelor in real-world clinical practice presented with CS. These patients were at higher risk of both ischemic and bleeding events. CS independently predicted the occurrence of 48-hour NACE and major bleeding, as well as in-hospital MACE.
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