A recent study by Dr. Julinda Mehilli, M.D., published in Circulation journal, has shown that in patients undergoing elective percutaneous coronary intervention (PCI), pretreatment strategy with the intensified prasugrel loading does not differ from standard clopidogrel loading dose in terms of Safety and Efficacy. According to the trial, both strategies can be safely applied among patients undergoing elective PCI.
Periprocedural complications are one of the causes of increased morbidity and mortality in patients undergoing elective PCI. And a strategy to reduce the risks of these complications may affect the long-term post-PCI mortality among this population. The SASSICAIA (Strategies of Loading With Prasugrel Versus Clopidogrel in PCI-Treated Biomarker Negative Angina) trial investigated whether stronger platelet inhibition by an intensified oral loading strategy (ILS) with prasugrel prior to PCI would affect outcomes among biomarker-negative stable and unstable angina patients undergoing elective PCI.
In this perspective, multicenter, open-label, assessor-blinded clinical trial, a total of 781 patients with biomarker negative stable or unstable angina pectoris with an indication for PCI were randomized into two groups to receive either intensified oral loading strategy (ILS) with prasugrel 60 mg or standard loading strategy (SLS) with clopidogrel 600 mg. Also, all the participants received clopidogrel 75 mg/ daily and aspirin after the procedure. The primary endpoints were All-cause death, any myocardial infarction (MI), stent thrombosis, urgent vessel revascularization, or stroke within 30 days. Bleeding complications defined according to Bleeding Academic Research Consortium criteria ≥2 and non-CABG–related Thrombolysis in Myocardial Infarction major and minor bleeding, peri-PCI type 4a MI, all-cause death, cardiovascular death, any myocardial infarction, definite/probable stent thrombosis, urgent vessel revascularization, and stroke within 30 days after index PCI were considered the secondary endpoints of the study.
According to the results of the study, 66 patients (17.3%) of the ILS group and 74 patients (18.5%) of the SLS group showed primary endpoints of the study ((Odds Ratio (OR): 0.92 [95% Confidence Interval (CI): 0.64–1.32]; P=0.64). Bleeding Academic Research Consortium ≥2 bleeding rates were also similar between the two groups ( 4.2% in ILS versus 4.8% in SLS), (OR:0.87 [95% CI: 0.44–1.73]; P=0.70). Additionally, any myocardial infarction rates were observed in 16.2% of the ILS group versus 17.5% of the SLS group (OR: 0.91 [95% CI, 0.62–1.32]; P=0.62 ). Data from this trial did not approve the superiority of ILS with prasugrel over SLS with clopidogrel just before the elective PCI.
It is important to note that the trial does have its limitations. First, the study was terminated prematurely with a smaller number of patients per group which would result in less power. Second, treatment with clopidogrel after the PCI procedure might have affected all the event rates of the study.
Finally, premature termination of the trial as well as a smaller sample size should be taken into account while interpreting the results of this study.