ABSTRACT
BACKGROUND: Current ESC guidelines recommend the use of intra-coronary pressure guidewires for functional assessment of intermediate-grade coronary stenoses. Angiography-derived quantitative flow ratio (QFR) is a novel method of assessing these stenoses, and guiding percutaneous coronary intervention (PCI). METHODS/DESIGN: The PIONEER IV trial is a prospective, all-comers, multi-center trial, which will randomize 2,540 patients in a 1:1 ratio to PCI guided by angiography-derived physiology or usual care, with unrestricted use in both arms of the Healing-Targeted Supreme sirolimus-eluting stent (HT Supreme). The stent's fast, biologically healthy, and robust endothelial coverage allows for short dual-antiplatelet therapy (DAPT); hence the antiplatelet regimen of choice is 1-month DAPT, followed by ticagrelor monotherapy. In the angiography-derived physiology guided arm, lesions will be functionally assessed using on-line QFR, with stenting indicated in lesions with a QFR ≤0.80. Post-stenting, QFR will be repeated in the stented vessel(s), with post-dilatation or additional stenting recommended if the QFR<0.91 distal to the stent, or if the delta QFR (across the stent) is >0.05. Usual care PCI is performed according to standard clinical practice. The primary endpoint is a non-inferiority comparison of the patient-oriented composite endpoint (POCE) of all-cause death, any stroke, any myocardial infarction, or any clinically, and physiologically driven revascularization with a non-inferiority risk-difference margin of 3.2%, at 1-year post-procedure. Clinical follow-up will be up to 3 years. SUMMARY: The PIONEER IV trial aims to demonstrate non-inferiority of QFR-guided PCI to usual care PCI with respect to POCE at 1-year in patients treated with HT Supreme stents and ticagrelor monotherapy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov UNIQUE IDENTIFIER: NCT04923191 CLASSIFICATIONS: Interventional Cardiology.
Subject(s)
Coronary Artery Disease , Drug-Eluting Stents , Percutaneous Coronary Intervention , Coronary Angiography , Coronary Artery Disease/therapy , Humans , Percutaneous Coronary Intervention/methods , Prospective Studies , Stents , Ticagrelor/therapeutic use , Treatment OutcomeABSTRACT
OBJECTIVE: The Pragmatic Ischaemic Thrombectomy Evaluation (PISTE) trial was a multicentre, randomised, controlled clinical trial comparing intravenous thrombolysis (IVT) alone with IVT and adjunctive intra-arterial mechanical thrombectomy (MT) in patients who had acute ischaemic stroke with large artery occlusive anterior circulation stroke confirmed on CT angiography (CTA). DESIGN: Eligible patients had IVT started within 4.5â hours of stroke symptom onset. Those randomised to additional MT underwent thrombectomy using any Conformité Européene (CE)-marked device, with target interval times for IVT start to arterial puncture of <90â min. The primary outcome was the proportion of patients achieving independence defined by a modified Rankin Scale (mRS) score of 0-2 at day 90. RESULTS: Ten UK centres enrolled 65 patients between April 2013 and April 2015. Median National Institutes of Health Stroke Scale score was 16 (IQR 13-21). Median stroke onset to IVT start was 120â min. In the intention-to-treat analysis, there was no significant difference in disability-free survival at day 90 with MT (absolute difference 11%, adjusted OR 2.12, 95% CI 0.65 to 6.94, p=0.20). Secondary analyses showed significantly greater likelihood of full neurological recovery (mRS 0-1) at day 90 (OR 7.6, 95% CI 1.6 to 37.2, p=0.010). In the per-protocol population (n=58), the primary and most secondary clinical outcomes significantly favoured MT (absolute difference in mRS 0-2 of 22% and adjusted OR 4.9, 95% CI 1.2 to 19.7, p=0.021). CONCLUSIONS: The trial did not find a significant difference between treatment groups for the primary end point. However, the effect size was consistent with published data and across primary and secondary end points. Proceeding as fast as possible to MT after CTA confirmation of large artery occlusion on a background of intravenous alteplase is safe, improves excellent clinical outcomes and, in the per-protocol population, improves disability-free survival. TRIAL REGISTRATION NUMBER: NCT01745692; Results.
Subject(s)
Brain Ischemia/drug therapy , Brain Ischemia/surgery , Stroke/drug therapy , Stroke/surgery , Thrombectomy , Thrombolytic Therapy , Administration, Intravenous , Aged , Aged, 80 and over , Brain Ischemia/complications , Combined Modality Therapy , Female , Humans , Male , Middle Aged , Stroke/complications , Survival Analysis , Tissue Plasminogen Activator/administration & dosage , Tissue Plasminogen Activator/therapeutic use , Treatment OutcomeABSTRACT
ObjectivesThis study aimed to compare clinical outcomes for patients admitted to Hospital in the Home (HITH) and traditional (bricks-and-mortar) hospitals and explore patient and carer experiences.MethodsA mixed methods approach including triangulation of quantitative and qualitative data was used. Quantitative outcomes were compared using augmented inverse propensity weighting to adjust for differences in patient characteristics between groups. Qualitative data was collected by focus groups and interviews and analysed using reflexive thematic analysis. The study took place in metropolitan Adelaide and one adjacent regional health network in 2020-22. Participants were patients discharged from either hospital setting with 1 of 22 eligible diagnoses. Hospital administrative data informed a comparison of outcomes that included mortality, rate of emergency department re-presentations and re-admissions, length of stay and incidence of complications.ResultsPatients treated in HITH were less unwell than traditional hospital patients. There were no safety or quality concerns identified in the clinical outcomes. Of 2095 HITH patients, the in-patient mortality rate was 0.2%, and 2.3% experienced a return to a bricks-and-mortar hospital during the HITH admission. For HITH patients, the mortality rate after 30days was lower (-1.3%, 95% CI -2 to -0.5, P=0.002), as were re-presentations in 28days (-7.2%, 95% CI -9.5 to -5, P<0.0001), re-admissions in 28days (-4.9%, 95% CI -6.7 to -3.2, P<0.001) and complications (-0.6%, 95% CI -0.8 to -0.5, P<0.001). Interviews of 35 patients and six carers found that HITH was highly accepted and preferred by patients. HITH was perceived to free up resources for other, more acutely unwell patients.ConclusionsHITH was preferred by patients and at least as effective in delivering quality health care as a traditional hospital, although the potential for unobserved confounding must be acknowledged.