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Benefit of vorapaxar may be greater with BMS than DES in NSTEACS
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Among patients with non-ST-segment elevation ACS, new data suggest a trend toward greater ischemic benefit and lower bleeding risk in those receiving vorapaxar with bare-metal stents vs. those receiving the drug with drug-eluting stents.
Researchers of the study, which was published in the American Journal of Cardiology, suggested that there is uncertainty as to whether vorapaxar (Zontivity, Merck Sharp & Dohme) has therapeutic potential in patients with non-ST-segment elevation ACS (NSTEACS) who are undergoing PCI.
The current study was a pre-specified analysis of a post-randomization subgroup of the international, prospective, randomized, double blind TRACER study, which included 12,944 patients. The researchers compared the study drug with placebo. Specific focus was placed on DES compared with BMS.
A composite of CV death, MI, stroke, recurrent ischemia with rehospitalization or urgent coronary revascularization served as the primary outcome measure, while CV death, MI or stroke served as the secondary endpoint.
PCI was performed during index hospitalization in 7,479 patients, which comprised 57.8% of the initial group. Of that group, 3,060 received BMS and 4,015 received DES.
The researchers defined the median duration of thienopyridine therapy as that which fell between the 25th and 75th percentiles. That duration was 133 days (47-246 days) for BMS and 221 days (88-341 days) for DES.
In the PCI cohort, no difference was reported at 2 years between the study drug and placebo groups. This finding was consistent with the effect of the therapy reported for the full study population (P=.540).
Among patients in the BMS group, a trend toward a greater treatment effect occurred for vorapaxar vs. placebo (P=.069). Similarly, bleeding risk with vorapaxar was attenuated in the study drug group vs. the placebo group among patients receiving BMS. However, after adjusting for confounding variables, the interaction failed to reach significance (P=.301).
Duration of clopidogrel therapy was the variable that drove the stent-type-by-treatment-interaction factor, according to the findings.
“Among PCI patients, the effect of vorapaxar is consistent with the overall TRACER results,” the researchers concluded. “BMS patients underwent shorter courses of clopidogrel therapy and displayed trends toward greater ischemic benefit from vorapaxar and lower bleeding risk, compared with DES patients.”
Disclosure: The researchers report financial disclosures with Abbott, AstraZeneca, Athera Biotechnologies, Bayer, Boehringer Ingelheim, Cordis, CID, Daiichi Sankyo, Eli Lilly, Evolva, GlaxoSmithKline, Iroko, Johnson & Johnson, Merck, Merck Sharpe & Dohme, Pfizer, Portola, Regado Biosciences, Roche, Sanofi Aventis, Servier, Terumo and The Medicines Company. The study was funded by Merck.
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