In a nutshell: The hottest developments in the field of cardiology in 2020. Section 5. Coronary artery disease
5. ALPHEUS (Ticagrelor versus clopidogrel in elective percutaneous coronary intervention) trial
Ticagrelor instead of clopidogrel fared no better with respect to protection from periprocedural myocardial infarction or major myocardial injury.
Patients with stable coronary artery disease were eligible for the study if they had an indication for PCI and at least one high-risk characteristic. Eligible patients were randomly assigned (1:1) to either ticagrelor (180 mg loading dose, 90 mg twice daily thereafter for 30 days) or clopidogrel (300–600 mg loading dose, 75 mg daily thereafter for 30 days).
Ticagrelor was not superior to clopidogrel in reducing periprocedural myocardial necrosis after elective PCI and did not cause an increase in major bleeding, but did increase the rate of minor bleeding at 30 days. These results support the use of clopidogrel as the standard of care for elective PCI.
Dipti Itchhaporia, MD (Hoag Memorial Hospital Presbyterian, Newport Beach, CA), said the trial should make interventional cardiologists think, particularly since many have grown more comfortable over the years using ticagrelor and prasugrel for patients with ACS and even in stable CAD patients with high-risk, complex anatomy. In one review, almost one-third of patients without ACS undergoing PCI between 2009 to 2016 were treated with prasugrel or ticagrelor, she said.
For that reason, “ALPHEUS is a really important data. I think the data does really make you pause and ask if [more potent antiplatelet therapy] is really necessary because it is more expensive, although prasugrel is generic so that’s not as big an issue, but if you’re using ticagrelor, [cost] is an issue”, she concluded.
Source: Lancet. Silvain J, Lattuca B, Beygui F, et al. Ticagrelor versus clopidogrel in elective percutaneous coronary intervention (ALPHEUS): a randomized, open-label, phase 3b trial. Lancet 2020 https://doi.org/10.1016/S0140-6736(20)32236-4
6. COMPARE CRUSH (COMPARison of pre-hospital CRUSHed vs. uncrushed Prasugrel tablets in patients with STEMI undergoing primary percutaneous coronary intervention) trial
Crushed prasugrel did not improve TIMI 3 flow at first angiography or complete ST-segment resolution at 1 hour post-PCI compared with integral prasugrel.
Eligible patients were randomized in a 1:1 fashion to either crushed (n = 369) or integral (n = 358) tablets of 60 mg prasugrel in the ambulance. They also received aspirin and heparin.
Crushed prasugrel did not improve TIMI 3 flow at first angiography or complete ST-segment resolution at 1 hour post-PCI compared with integral prasugrel, both of which were administered as a 60 mg load in the ambulance prior to PPCI among patients with suspected STEMI.
Source: Circulation journal: Vlachojannis G, Wilschut JM, Vogel R, et al. Effect of pre-hospital crushed prasugrel tablets in patients with STEMI planned for primary percutaneous coronary intervention: the randomized COMPARE CRUSH trial. Circulation 2020;Oct 14 https://doi.org/10.1161/CIRCULATIONAHA.120.051532
Coronary artery disease (CAD) management id undoubtedly the most impactful arena of interventional cardiology. This year we witnessed several important trials that redefined the drug management as well as interventions for CAD. There was ATPCI trial that explored the benefit of trimetazidine in post PCI setup, Tailor PCI, TICO, TWILIGHT COMPLEX, ALPHEUS and COMPARE CRUSH trials will serve as landmarks for future guidelines for antiplatelet therapy in CAD.
The extended outcome of PRECOMBAT trial sheds more light on ever-debatable CABG vs. PCI for left main disease while DEFINITION II has supported DK crush for complex PCI lesions. Finally, COMPARE ACUTE supported the role of FFR in complete revascularisation during the index procedure in STEMI setting.
Page 1: ATPCI and TAILOR-PCI trials
Page 2. TICO and TWILIGHT COMPLEX trials
Page 3. ALPHEUS and COMPARE-CRUSH trials
Page 4. HOST REDUCE POLYTECH ACS and PRECOMBAT trials
Page 5. DEFINITION II, COMPARE ACUTE and ONTIME 3 trials
Long term trimetazidine is safe but not preventative of angina or adverse outcome after PCI.
The ATPCI trial followed 6007 patients receiving either trimetazidine or a placebo, following successful percutaneous coronary intervention (PCI). After a median follow-up of 47.5 months, trimetazidine did not improve either the outcome or the occurrence of angina.
The event rate in this trial was lower than expected and may have contributed to the null finding.
"It is the first study to test the value of increasing the energy status of the ischemic myocyte with trimetazidine in terms of hard end points such as cardiac death and hospitalization. This is particularly relevant considering that a recent study with ranolazine (RIVER-PCI trial), another piperazine derivative, in a similar patient setting failed to show a benefit" noted Roberto Ferrari, MD Department of Cardiology and LTTA Centre University Hospital of Ferrara ITALY (study author).
Source: The Lancet Journal: Ferrari R, Ford I, Fox K, et al. Efficacy and safety of trimetazidine after percutaneous coronary intervention (ATPCI): Lancet 2020;396:830-8.
2. The Tailor PCI (Tailored Antiplatelet Initiation to Lessen Outcomes due to Decreased Clopidogrel Response After Percutaneous Coronary Intervention) trial
A genotype-guided strategy was not superior at reducing adverse cardiovascular events compared with standard therapy after PCI.
Patients undergoing primary PCI for stable or unstable coronary artery disease were randomized to a genotype-guided strategy (n = 2,652) versus standard therapy (n = 2,650).
The primary analysis was between 903 subjects with a loss of function allele (*2 or *3) in the genotype-guided group compared with 946 subjects in the standard therapy group with a loss of function allele.
Among patients who underwent PCI for stable or unstable coronary artery disease, a genotype-guided strategy was not beneficial compared to standard therapy. The primary outcome of major adverse cardiovascular events and bleeding were similar between treatment groups at 12 months.
"Although these results fell short of the effect size that we predicted, they nevertheless provide a signal that offers support for the benefit of genetically guided therapy, with approximately one-third fewer adverse events in the patients who received genetically guided treatment compared with those who did not," said Naveen L. Pereira, MD, of Mayo Clinic, Rochester, Minnesota, co-principal investigator of the study, who presented the results.
Source: JAMA cardiology: Pereira NL, Farkouh ME, So D, et al. The TAILOR-PCI Randomized Clinical Trial. JAMA 2020;324:761-71
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