ObjectiveThe CYP2C19 loss-of-function (LoF) allele is present in half of the East Asian population and is associated with high on-treatment platelet reactivity (HTPR). This study aimed to investigate whether a rapid genotyping-guided approach is feasible and efficacious for selecting P2Y12 receptor blockers in Chinese patients suffering from acute coronary syndrome (ACS).MethodsThis was a single-centre, prospective, randomized, open-label study. A total of 132 patients with ACS were randomized to the rapid genotyping-guided treatment group (GG, N = 65) or the standard treatment group (SG, N = 67). Patients in the GG group were genotyped by the Verigene system. Patients with the CYP2C19 LoF allele were switched to ticagrelor and all remaining patients continued on clopidogrel. The endpoints were HTPR at 24 hours after the first loading dose of clopidogrel and 1 month afterwards.ResultsForty patients in the GG group switched to ticagrelor, while others continued on clopidogrel. The incidence of HTPR in the GG vs SG groups was 9.2% vs 40.3% at 24 hours and 6.5% vs 32.3% at 1 month, respectively. Rapid point-of-care genotyping showed 100% concordance with conventional genotyping by real-time polymerase chain reaction.ConclusionsIn Chinese patients suffering from ACS, the rapid genotyping-guided approach for selecting P2Y12 receptor blockers is feasible and reduces the incidence of HTPR.Clinical Trial RegistrationURL: http://clinicaltrials.gov. Unique identifier: NCT01994941.
M onotherapy drug-eluting stents (DES) suppress neointimal proliferation and reduce the 1-year target lesion revascularization rate better than bare-metal stents but have other issues about safety and efficacy.1,2 Inadequate endothelial strut coverage causes stent thrombosis requiring stringent dual-antiplatelet therapy. 3,4 Late catch-up with cumulative increase in the target lesion revascularization rate seems inevitable for most monotherapy DES.5 AcceleratedBackground-Current monotherapy drug-eluting stents are associated with impaired healing, neoatherosclerosis, and late stent thrombosis. The healing profile and neointimal transformation of the first dual-therapy endothelial progenitor cellcapturing sirolimus-eluting stent are unknown. Methods and Results-In this prospective, single-center study, 61 patients treated with the Combo stent had optical coherence tomography at baseline, early follow-up (4 monthly groups in a 1:2:2:1 ratio from 2 to 5 months), 9 months, and 24 months. Optical coherence tomography early strut coverage increased from 77.1% to 92.5% to 92.7% to 94.9% between 2 and 5 months. At 9 months, the major adverse cardiac event rate was 1.64%, and angiographic in-stent late loss was 0.24 mm (0.08-0.40). The 36-month major adverse cardiac event rate was 3.3%. From 9 to 24 months, neointimal regression was confirmed by optical coherence tomography: neointimal thickness (median [first quartile and third quartile]), 0.14 mm (0.08 and 0. Conclusions-With additional endothelial progenitor cell-capturing technology, the Combo stent exhibits a unique late neointimal regression (from 9 to 24 months) that has not been reported in any drug-eluting stents, translating into good 36-month clinical results with minimal restenosis and no late stent thrombosis. This is the first study testing the concept of using a longitudinal sequential optical coherence tomography protocol to continuously document early healing profile and late neointimal transformation, predicting long-term outcomes of a new novel stent platform. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifiers: NCT01274234, NCT01756807, and NCT02263313. Technology to capture endothelial progenitor cells with an anti-CD34 antibody coating has been developed as a radically different approach to promote vessel healing. [8][9][10] This technology has been combined with an abluminal sirolimus-eluting coating composed of a biodegradable polymer to form a new DES platform, the Combo stent (OrbusNeich Medical, Fort Lauderdale, FL). Sirolimus release (5 µg/mm) is completed in 30 days, and the biodegradable polymer disappears within 90 days. This dualtherapy approach aims for neointimal suppression while retaining the endothelial progenitor cell-capturing prohealing benefits enabling rapid endothelialization. [11][12][13] We have used a vigorous imaging protocol (longitudinal sequential optical coherence tomography [OCT] assessments) to evaluate this new Combo platform by monitoring its healing profile and neointimal transformati...
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