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Summary Background Current guidelines recommend potent platelet inhibition with prasugrel or ticagrelor for 12 months after an acute coronary syndrome managed with percutaneous coronary intervention (PCI). However, the greatest anti-ischaemic benefit of potent antiplatelet drugs over the less potent clopidogrel occurs early, while most excess bleeding events arise during chronic treatment. Hence, a stage-adapted treatment with potent platelet inhibition in the acute phase and de-escalation to clopidogrel in the maintenance phase could be an alternative approach. We aimed to investigate the safety and efficacy of early de-escalation of antiplatelet treatment from prasugrel to clopidogrel guided by platelet function testing (PFT). Methods In this investigator-initiated, randomised, open-label, assessor-blinded, multicentre trial (TROPICAL-ACS) done at 33 sites in Europe, patients were enrolled if they had biomarker-positive acute coronary syndrome with successful PCI and a planned duration of dual antiplatelet treatment of 12 months. Enrolled patients were randomly assigned (1:1) using an internet-based randomisation procedure with a computer-generated block randomisation with stratification across study sites to either standard treatment with prasugrel for 12 months (control group) or a step-down regimen (1 week prasugrel followed by 1 week clopidogrel and PFT-guided maintenance therapy with clopidogrel or prasugrel from day 14 after hospital discharge; guided de-escalation group). The assessors were masked to the treatment allocation. The primary endpoint was net clinical benefit (cardiovascular death, myocardial infarction, stroke or bleeding grade 2 or higher according to Bleeding Academic Research Consortium [BARC]) criteria) 1 year after randomisation (non-inferiority hypothesis; margin of 30%). Analysis was intention to treat. This study is registered with ClinicalTrials.gov, number NCT01959451, and EudraCT, 2013-001636-22. Findings Between Dec 2, 2013, and May 20, 2016, 2610 patients were assigned to study groups; 1304 to the guided de-escalation group and 1306 to the control group. The primary endpoint occurred in 95 patients (7%) in the guided de-escalation group and in 118 patients (9%) in the control group (p non-inferiority =0·0004; hazard ratio [HR] 0·81 [95% CI 0·62–1·06], p superiority =0·12). Despite early de-escalation, there was no increase in the combined risk of cardiovascular death, myocardial infarction, or stroke in the de-escalation group (32 patients [3%]) versus in the control group (42 patients [3%]; p non-inferiority =0·0115). There were 64 BARC 2 or higher bleeding events (5%) in the de-escalation group versus 79 events (6%) in the control group (HR 0·82 [95% CI 0·59–1·13]; p=0·23). Interpretation Guided de-escalation of antiplatelet treatment was non-inferior to standard treatment with prasugrel at 1 year after PCI in terms of net clinical benefit. Our trial shows that early de-escalation of antiplatelet treatment can be considered as an alternative approach in patients with acute coronary syndrome managed with PCI. Funding Klinikum der Universitat Munchen, Roche Diagnostics, Eli Lilly, and Daiichi Sankyo.

The HERA Registry investigates logistics, adherence to standards, time intervals, and mortality in a regional network for primary percutaneous coronary intervention (PPCI) in ST-elevation myocardial infarction (STEMI) in a mixed urban and rural area.We included 826 consecutive patients (pts) within the HERA network with its dedicated PPCI strategy (female n = 243, mean age 64 years, range 25-98 years) with acute STEMI (May 2007 until January 2010). 680 pts (82 %) received PPCI and 45 (5.4 %) acute bypass surgery. Of 512 pts seen by an emergency physician (EP) as first medical contact (FMC) 87 % received on-scene 12-lead ECG. ECG transmission rate to the PPCI center was 29 %. Median FMC-to-balloon time (CBT) was 135 min and door-to-balloon time (DBT) 70 min. With EP FMC DBT was 38 min with direct transfer to cath lab (n = 70), 69 min via ICU (n = 240), and 132 min via ER (n = 91, p0.01). Out of 826 pts, 143(17.3 %) presented in cardiogenic shock. In-hospital mortality was 8.8 % (n = 73), 35.7 % for shock pts versus 3.2 % for non-shock pts (p0.01). For pts receiving PPCI, in-hospital mortality was 6.2 %, for shock pts (n = 107) 28.0 %, and for non-shock pts (n = 573) 2.1 % (p0.01).Prehospital management, CBT and DBT compare favourably to data from studies and registries, but do not yet fulfill strict guideline requirements. Real world mortality in non-shock pts is very low. Direct transfer to cath lab reduces DBTs by 49 %. For this crucial improvement, transmission of a 12-lead ECG to the PPCI center is mandatory.