Background: Even among biomarker-negative patients undergoing elective percutaneous
coronary intervention (PCI), periprocedural thrombotic and bleeding complications
can lead to increased morbidity and mortality. Whether stronger platelet inhibition
by an intensified oral loading strategy (ILS) before PCI impacts on outcomes among
these patients in contemporary practice remains unclear. Methods: This multicenter,
randomized, assessor-blinded trial tested the hypothesis that in elective PCI prasugrel
60 mg (ILS) is superior to standard loading strategy with clopidogrel 600 mg regarding
a composite primary end point of all-cause death, any myocardial infarction, definite/probable
stent thrombosis, stroke, or urgent vessel revascularization. After PCI, all patients
were on clopidogrel 75 mg/day and aspirin. The trial was terminated prematurely because
of slower-than-expected recruitment and funding discontinuation. Results: Of 781 patients
included in the final analysis, 382 were assigned to ILS and 399 to standard loading
strategy. At 30 days, the primary end point occurred in 66 patients (17.3%) assigned
to ILS and 74 patients (18.6%) assigned to standard loading strategy (odds ratio,
0.92 [95% CI, 0.63-1.32];P=0.64). Any myocardial infarction and Bleeding Academic
Research Consortium >= 2 bleeding rates were similar among ILS and standard loading
strategy groups 16.2% versus 17.5%, odds ratio, 0.91 (95% CI, 0.62-1.32),P=0.62 and
4.2% versus 4.8%, odds ratio 0.87 (95% CI, 0.44-1.73),P=0.70, respectively. Conclusions:
In biomarker-negative stable and unstable angina patients undergoing elective PCI,
the trial did not find a conclusive difference in efficacy or safety. This observation
should be interpreted in the context of wide CIs and premature termination of the
trial. Registration: URL:. Unique identifier: NCT02548611.
