Table 2 |.
Study (year) | Design | Intervention | Patient population | Primary end points and results | Ref. |
---|---|---|---|---|---|
TAILOR-PCI (2020) | Randomized controlled trial | Genotype-guided therapy (n = 903) versus conventional therapy with clopidogrel (n = 946) in IMs and PMs | ACS or stable CAD and PCI | Cardiovascular death, MI, stroke, stent thrombosis or severe recurrent ischaemia occurred in 4.0% of the genotype-guided group and 5.9% of the conventional group (HR 0.66, 95% CI 0.43–1.02, P = 0.06) | 49 |
Hulot et al. (2020) | Multi-site observational study | Clinical genotyping with recommendations for alternative therapy in slow (for example, *1/*2) and very slow (*2/*2) metabolizers (n = 1,445 total) | STEMI and PCI | Rate of death, MI or stent thrombosis was 3.04% in slow and very slow metabolizers who received optimized therapy versus 3.31% in normal and rapid metabolizers (P = 0.82) and 15.6% in slow or very slow metabolizers without treatment adjustment (P < 0.05) | 64 |
POPular Genetics (2019) | Randomized controlled trial | Genotype-guided therapy (n = 1,242) versus standard treatment with either ticagrelor or prasugrel (n = 1,246) | STEMI and PCI | All-cause death, MI, stent thrombosis, stroke or major bleeding occurred in 5.1% of the genotype-guided group and 5.9% of the standard-treatment group (P < 0.001 for non-inferiority); major or minor bleeding occurred in 9.8% of the genotype group and 12.5% of the standard-treatment group (HR 0.78, 95% CI 0.61–0.98, P = 0.04) | 19 |
PHARMCLO (2018) | Randomized controlled trial | Genotype-guided therapy (n = 448) versus standard treatment (n = 440) | STEMI or non-STEMI and PCI (62% had PCI) | Cardiovascular death, MI, stroke or major bleeding occurred in 15.9% of the genotype group and 25.9% of the standard-treatment group (HR 0.58, 95% CI 0.43–0.78, P < 0.001) | 46 |
Cavallari et al. (2018) | Multi-site observational study | Clinical genotyping with recommendations for alternative therapy in IMs and PMs (n = 1,815 total) | ACS or stable CAD and PCI | Rate of death, MI or ischaemic stroke was 13.5 per 100 patient-years in IMs or PMs prescribed clopidogrel versus 8.7 per 100 patient-years in IMs or PMs prescribed alternative therapy (propensity score adjusted HR 2.26, 95% CI 1.18–4.32, P = 0.013) | 62 |
Deiman et al. (2016) | Single-centre, observational study | Clinical genotyping with recommendations for alternative therapy in PMs (n = 3,260 total) | Elective PCI | Occurrence of death from cardiovascular causes, MI, stent thrombosis, repeat revascularization or stroke in PMs was 31% with clopidogrel and 5% with prasugrel (P = 0.003) | 63 |
Sanchez-Ramos et al. (2016) | Intervention study versus historical controls | Genotype-guided strategy (n = 317) versus non-tailored strategy (n = 402) | PCI with stent implantation (86% with ACS) | Cardiovascular death, ACS or stroke occurred in 10% of patients in the genotype group and 14% of controls (P = 0.037) | 50 |
Shen et al. (2016) | Intervention study versus historical controls | Genotype-guided group (n = 309) versus usual care with clopidogrel (n = 319) | CAD and PCI | All-cause death, MI or target-vessel revascularization occurred at rate of 4.2% in the genotype group and 9.4% in the usual-care group (P = 0.010) | 47 |
IAC-PCI (2013) | Randomized controlled trial | Personalized therapy (n = 301) versus conventional therapy with clopidogrel (n = 299) | CAD and PCI with stent implantation | Cumulative rate of all-cause death, MI, stroke or target-vessel revascularization at 6 months was 2.6% in the genotype group and 9.0% in the conventional treatment group (P < 0.01) | 48 |
ACS, acute coronary syndrome; CAD, coronary artery disease; IM, intermediate metabolizer; MI, myocardial infarction; PCI, percutaneous coronary intervention; PM, poor metabolizer; STEMI, ST-segment elevation myocardial infarction.