Table 5

RCTs evaluating clinical utility of phenotypic testing in the PCI setting

Studies (author/acronym)RCT design/sizePopulationAssay/cutoffPoor responders (%)Intervention in poor respondersOutcome intervention vs control
Collet et al57  Design C PCI with DES VerifyNow P2Y12 34.5 Clopidogrel (600 mg reloading, 75 or 150 maintenance), or prasugrel, or GpIIb/IIIa MACE: 
ARCTIC n = 2440 ACS 27% ≥235 U  34.6% vs 31.1% 
(no STEMI) (at 2 time points)  (HR: 1.13; 95% CI: 0.98-1.29) 
Stent thrombosis: 
 1.0% vs 0.7% 
 (HR: 1.34; 95% CI: 0.56-3.18) 
Major bleeding: 
 2.3% vs 3.3% 
 (HR:0.70; 95% CI:0.43-1.14) 
Price et al58  Design A PCI with DES VerifyNow 41 600/150 mg clopidogrel (VerifyNow) MACE: 
GRAVITAS n = 2214 ACS 10.5% P2Y12  2.3% vs 2.3%, 
≥230 U  (HR: 1.01; 95% CI: 0.58-1.76) 
Severe or moderate bleeding: 
 1.4% vs 2.3% 
 (HR: 0.59; 95% CI: 0.31-1.11) 
Trenk et al68  Design A Elective PCI with DES VerifyNow P2Y12 19 Prasugrel 10 mg maintenance (Stopped early because of futility) 
TRIGGER-PCI n = 423 ACS 0% >208 U CV death or MI: 
 0 vs 1 event 
Stent thrombosis: 
 0 vs 0 event 
Major bleeding: 
 3(1.4%) vs 1(0.5%) events 
Hazarbasanov et al99  Design C PCI MEA 18.5 Second loading dose clopidogrel 600 mg and 150 mg maintenance for 1 month MACE: 
n = 192 ACS 56.8% ≥46 U  0 (0.0%) vs 5(2.6%) P = .03 
Stent thrombosis: 
 9 (0.0%) vs 4(2.1%) P = .06 
Major bleeding: 
 1 vs 0 event 
Ari et al60  Design A n = 94 Elective PCI VerifyNow 48.9 Clopidogrel 150 mg maintenance MACE: 
EFFICIENT ACS 0% P2Y12  2(4.3%) vs 8(17%) P = .02 
<40% inhibition Major bleeding: 
 1(2.1%) vs 0 (0%) ns 
Aradi et al61  Design A n = 74 PCI LTA ≥34% max agg 38 150 mg maintenance clopidogrel MACE: 
DOSER ACS 0%  1(3.1%) vs 8(24.6%), P = .01 
Major bleeding: 
 1(2.8%) vs 0, ns 
Wang et al62  Design A PCI VASP-PRI 57 Dynamic adjustment of maintenance clopidogrel up to 375 mg daily (VASP ≤ 50%) MACE: 
n = 306 ACS 20% >50%  9.3% vs 20.4%, P = .008 
Major bleeding 
 0 vs 0 
Valgimigli et al63  Design A PCI VerifyNow P2Y12 27 Tirofiban MACE: 
n = 147 ACS 32.6% <40% inhibition  3.8% vs 10.7%, P < .05 
Major bleeding: 
 0% vs 0% 
Bonello et al64  Design A PCI VASP-PRI >50% 45 Clopidogrel 600 mg reloading, aim VASP ≤ 50% MACE: 
n = 429 ACS 52.3%  0.5% vs 8.9%, P < .001 
Major bleeding: 
 0.9% vs 0.9%, P = .1 
Bonello et al65  Design A PCI VASP-PRI >50% 52 Clopidogrel 600 mg reloading MACE: 
n = 162 ACS 48%  0% vs 8(10%), P = .007 
Major bleeding: 1.3% vs 1.3% 
Cuisset et al66  Design A PCI LTA >70% max agg 23 Abciximab MACE: 
n = 149 ACS 0%  19% vs 40%,OR = 2.8, P = .006 
Major bleeding: 
 0% vs 0% 
Studies (author/acronym)RCT design/sizePopulationAssay/cutoffPoor responders (%)Intervention in poor respondersOutcome intervention vs control
Collet et al57  Design C PCI with DES VerifyNow P2Y12 34.5 Clopidogrel (600 mg reloading, 75 or 150 maintenance), or prasugrel, or GpIIb/IIIa MACE: 
ARCTIC n = 2440 ACS 27% ≥235 U  34.6% vs 31.1% 
(no STEMI) (at 2 time points)  (HR: 1.13; 95% CI: 0.98-1.29) 
Stent thrombosis: 
 1.0% vs 0.7% 
 (HR: 1.34; 95% CI: 0.56-3.18) 
Major bleeding: 
 2.3% vs 3.3% 
 (HR:0.70; 95% CI:0.43-1.14) 
Price et al58  Design A PCI with DES VerifyNow 41 600/150 mg clopidogrel (VerifyNow) MACE: 
GRAVITAS n = 2214 ACS 10.5% P2Y12  2.3% vs 2.3%, 
≥230 U  (HR: 1.01; 95% CI: 0.58-1.76) 
Severe or moderate bleeding: 
 1.4% vs 2.3% 
 (HR: 0.59; 95% CI: 0.31-1.11) 
Trenk et al68  Design A Elective PCI with DES VerifyNow P2Y12 19 Prasugrel 10 mg maintenance (Stopped early because of futility) 
TRIGGER-PCI n = 423 ACS 0% >208 U CV death or MI: 
 0 vs 1 event 
Stent thrombosis: 
 0 vs 0 event 
Major bleeding: 
 3(1.4%) vs 1(0.5%) events 
Hazarbasanov et al99  Design C PCI MEA 18.5 Second loading dose clopidogrel 600 mg and 150 mg maintenance for 1 month MACE: 
n = 192 ACS 56.8% ≥46 U  0 (0.0%) vs 5(2.6%) P = .03 
Stent thrombosis: 
 9 (0.0%) vs 4(2.1%) P = .06 
Major bleeding: 
 1 vs 0 event 
Ari et al60  Design A n = 94 Elective PCI VerifyNow 48.9 Clopidogrel 150 mg maintenance MACE: 
EFFICIENT ACS 0% P2Y12  2(4.3%) vs 8(17%) P = .02 
<40% inhibition Major bleeding: 
 1(2.1%) vs 0 (0%) ns 
Aradi et al61  Design A n = 74 PCI LTA ≥34% max agg 38 150 mg maintenance clopidogrel MACE: 
DOSER ACS 0%  1(3.1%) vs 8(24.6%), P = .01 
Major bleeding: 
 1(2.8%) vs 0, ns 
Wang et al62  Design A PCI VASP-PRI 57 Dynamic adjustment of maintenance clopidogrel up to 375 mg daily (VASP ≤ 50%) MACE: 
n = 306 ACS 20% >50%  9.3% vs 20.4%, P = .008 
Major bleeding 
 0 vs 0 
Valgimigli et al63  Design A PCI VerifyNow P2Y12 27 Tirofiban MACE: 
n = 147 ACS 32.6% <40% inhibition  3.8% vs 10.7%, P < .05 
Major bleeding: 
 0% vs 0% 
Bonello et al64  Design A PCI VASP-PRI >50% 45 Clopidogrel 600 mg reloading, aim VASP ≤ 50% MACE: 
n = 429 ACS 52.3%  0.5% vs 8.9%, P < .001 
Major bleeding: 
 0.9% vs 0.9%, P = .1 
Bonello et al65  Design A PCI VASP-PRI >50% 52 Clopidogrel 600 mg reloading MACE: 
n = 162 ACS 48%  0% vs 8(10%), P = .007 
Major bleeding: 1.3% vs 1.3% 
Cuisset et al66  Design A PCI LTA >70% max agg 23 Abciximab MACE: 
n = 149 ACS 0%  19% vs 40%,OR = 2.8, P = .006 
Major bleeding: 
 0% vs 0% 

DES, drug eluting stent; Max agg, maximum aggregation; MEA, multiplate electrode; ns, not significant; STEMI, ST elevation myocardial infarction.

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