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In Sunday’s late-breaking science session on the Spotlight Stage, ESC delegates heard presentations on the latest research on percutaneous coronary intervention (PCI), receiving fresh data from the EARLY-MYO and RE-DUAL trials, as well as a new sub-analysis of the FAME 1 and 2 trials.
Doctor Ben He (Shanghai, China) presented data on behalf of the EARLY-MYO investigators indicating that in STEMI patients presenting within six hours of symptom onset and for whom the expected PCI-related delay is ≥60 minutes, a pharmacoinvasive strategy with half-dose alteplase and timely PCI is safe and shows more complete epicardial and myocardial reperfusion than routine primary PCI. “Primary PCI, within the guideline-recommended time window, cannot be offered to all STEMI patients,” Dr. He said. “A pharmacoinvasive strategy has, in the STREAM study and registries, been shown to be a valid alternative to primary PCI within one hour of first medical contact.”
A total of 350 patients were enrolled (175 patients in each group), and the study had an 80% power to show non-inferiority of the pharmacoinvasive strategy vs. primary PCI (to exclude a 30% worse relative outcome of the primary endpoint). The pharmacoinvasive group received half-dose alteplase (8mg bolus followed by 42mg in 90 minutes) followed by coronary angiography within 3–24 hours of randomisation or rescue PCI.
The primary PCI group underwent routine PCI without fibrinolytic therapy. The primary endpoint for the study was complete epicardial and myocardial reperfusion after PCI, defined as TIMI flow grade 3 and TIMI myocardial perfusion grade 3 with ST-segment resolution ≥70%. Core labs were allocated to blind treatment. ST-segment resolution ≥70% was reported in 51% (n=82) of the pharmacoinvasive group compared with 45.5% (n=76) in the primary PCI group (p=0.377). TIMI flow grade 3 was reported in 91.3% (n=147) of the pharmacoinvasive group compared with 89.2% (n=149) in the primary PCI group (p=0.58), while TIMI perfusion grade 3 was seen in 65.8% (n=106) of the pharmacoinvasive group compared with 62.9% (n=105) in the primary PCI group (p=0.73). Complete reperfusion was more common in the pharmacoinvasive group at 34.2% (n=54) compared with primary PCI at 22.8% (n=39) (p value for non-inferiority <0.05, p value for superiority=0.022).
In terms of safety outcomes, minor non-ICH bleeding was reported in 26.9% (n=47) of the pharmacoinvasive group and 11% (n=18) of the primary PCI group (p<0.001). Major non-ICHU bleeding was reported in just one pharmacoinvasive patient (0.6%) and no primary PCI patients (p=0.497). There was no ICH bleeding in any patients.
“More clinical outcome data must be obtained to confirm the reperfusion benefit observed in this study,” Dr. He concluded. “If confirmed, a pharmacoinvasive treatment could be beneficial for eligible STEMI patients, particularly in countries without well-organised STEMI networks or with significant system delays.”
Resources of the presentation: Efficacy and Safety of a Pharmaco-Invasive Strategy versus Primary Angioplasty in ST-Elevation Myocardial Infarction: The EARLY-MYO Trial
In atrial fibrillation (AF) patients who have undergone PCI, dual therapy with dabigatran and a P2Y12 antagonist has significantly reduced the risk of bleeding compared with warfarin triple therapy, with non-inferiority for overall thromboembolic events. In data published by the RE-DUAL PCI study group and presented yesterday by Doctor Christopher Cannon (Boston, USA), dabigatran demonstrated absolute risk reductions of 11.5% and 5.5% in ISTH major or clinically-relevant non-major bleeding at the 110mg and 150mg doses, compared with warfarin triple therapy.
The RE-DUAL PCI trial enrolled 2,725 patients with A F who had undergone PCI. They were randomly assigned to one of three groups; the first—the triple-therapy group—began triple therapy with warfarin plus a P2Y12 inhibitor (clopidogrel or ticagrelor) and aspirin (for one to three months); the second and third groups—the 110mg and 150mg dual-therapy groups—received either 110mg or 150mg of dabigatran twice daily plus a P2Y12 inhibitor (clopidogrel or ticagrelor) and no aspirin. Due to regulatory constraints, some elderly patients (≥80 years old in the USA or ≥70 years old in Japan) were randomly assigned only to the 110mg dual-therapy group or the triple-therapy group.
At an average follow-up of 14 months, Dr. Cannon reported that the incidence of primary endpoint—major or clinically-relevant non-major bleeding event during follow-up—was 15.4% for 110mg dual-therapy group as compared with 26.9% in the triple-therapy group (p<0.001 for non-inferiority and p<0.001 for superiority). The primary endpoint incidence in the 150mg dual-therapy group was 20.2% as compared with 25.7% in the corresponding triple-therapy group, which did not include elderly patients outside of the USA (p<0.001 for non-inferiority).
The incidence of the composite efficacy endpoint—thromboembolic events (myocardial infarction, stroke, or systemic embolism), death, or unplanned revascularisation—was 13.7% in the two dual-therapy groups combined, as compared with 13.4% in the triple- therapy group (p=0.005 for non-inferiority). The rate of serious adverse events did not differ significantly among the groups.
“The 110mg and 150mg dabigatran dual-therapy regimens offer all of us two additional options, with evidence, for managing post-PCI AF patents, with both doses approved for stroke prevention,” Dr. Cannon told the audience.
Resources of the presentation: RE-DUAL PCI : Dual Antithrombotic Therapy with Dabigatran After Percutaneous Coronary Intervention in Patients with Atrial Fibrillation
New subanalysis of the FAME 1 and FAME 2 trials suggests that improvement in fractional flow reserve (FFR) predicts two-year outcome after PCI, according to Doctor Stephane Fournier (Aalst, Belgium). “The higher the post-PCI FFR value, the lower the event rate, but the likelihood ratio for the occurrence of events is weak,” Dr. Fournier explained. “The larger the improvement in FFR, the lower the event rate will be.”
Dr. Fournier and colleagues investigated whether the difference between FFR at baseline and post-PCI—ΔFFR—impacts the two-year vessel-oriented clinical events (VOCE) rate, comprised of vessel-related cardiovascular death, vessel-related revascularisation, and vessel-related myocardial infarction.
The FAME 1 and FAME 2 studies provided the raw data for the analysis, in which 1,499 lesions were treated (pre-PCI FFR ≤0.8) including 838 lesions with post-PCI FFR measurements. Of the patients with recorded post-PCI FFR, 277 were in the ΔFFR lower tertile (FFR ≤0.18), 282 were in the middle tertile (FFR >0.19 and ≤0.31), while 278 were in the upper tertile (FFR >0.31). Dr. Fournier and colleagues identified several predictors of ΔFFR, namely male gender (p=0.003), diabetes (p=0.024), previous PCI (p<0.001), and pre-PCI FFR (p<0.001).
The VOCE rate of these patients improved as ΔFFR increased. For the lower ΔFFR tertile the rate was 9% (n=25), for the middle tertile was 7.1% (n=20), and for the upper tertile was 4.7% (n=13) (p=0.13). While differences in the rates of death and myocardial infarction were not significant between the two groups, the difference in the rates of vessel-related revascularisation—7.2% (n=20) in the lower tertile, 5% (n=14) in the middle tertile, and 2.5% (n=7) in the upper tertile—were (p=0.037). “These data indicate that the reduction in ischaemic burden is an independent predictor of vessel-oriented clinical events at two years of follow-up,” Dr. Fourier concluded. “The reason for this relationship remains speculative.”
Resources of the presentation: Improvement in FFR predicts 2 years outcome after PCI. A FAME 2 Sub-Analysis.
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