BACKGROUND:Percutaneous coronary intervention for coronary chronic total occlusion (CTO PCI) is offered for symptom and quality of life improvement, despite the absence of blinded randomized evidence. OBJECTIVES:The aim of this study was to assess the efficacy of CTO PCI in the first randomized, placebo-controlled trial of CTO PCI. METHODS:ORBITA-CTO is a multicenter, randomized, blinded trial comparing CTO PCI with a placebo procedure. Patients had angina attributable to a single-vessel CTO, without bystander coronary disease. Angina symptoms were recorded daily using the ORBITA app. After dual-injection coronary angiography, patients were randomized to either CTO PCI or placebo. Blinding was maintained using auditory isolation and deep conscious sedation. Antianginal medications were stopped at randomization and reintroduced on a patient-initiated protocol. At the 6-month follow-up, assessments were repeated. The primary efficacy outcome was the angina symptom score, an ordinal scale combining the daily symptom burden assessed by the ORBITA app, antianginal use, and over-ride events. Secondary outcomes were symptom and quality of life questionnaires and blinding fidelity. RESULTS:Between October 19, 2021 and October 21, 2025, 50 patients were randomly assigned to CTO PCI (n = 25) or placebo (n = 25). One patient randomized to PCI was withdrawn during the procedure because of a complication. All 50 patients were included in the primary analysis. Compared with placebo, CTO PCI resulted in an immediate and sustained improvement in the angina symptom score (OR: 4.38; 95% credible interval [CrI]: 1.57-12.69; probability of benefit [Pr{Benefit}] = 0.996), arising from a clear reduction in the number of episodes of angina (OR: 4.38; 95% CrI: 1.55-11.78; Pr[Benefit] = 0.997). This resulted in an additional 30.6 days free of angina (95% CrI: 11.1-50.7; Pr[Benefit] >0.999). Improvements were also observed with the Seattle Angina Questionnaire in angina frequency (+10.7; 95% CrI: 1.4-20.2; Pr[Benefit] = 0.988), physical limitation, quality of life, and summary score and Canadian Cardiovascular Society class. Blinding of patients, staff, and researchers was maintained. CONCLUSIONS:In patients with symptomatic single-vessel CTO, CTO PCI improves angina beyond placebo. (A Placebo-controlled Trial of Chronic Total Occlusion Percutaneous Coronary Intervention for the Relief of Stable Angina [ORBITA-CTO]; NCT05142215).
OBJECTIVES:To evaluate the characteristics and outcomes of patients with a chronic total occlusion (CTO) in a Non-ST Elevation Myocardial Infarction (NSTEMI) cohort. BACKGROUND:There is limited data on the clinical characteristics, revascularisation strategies and outcomes of patients presenting with a NSTEMI and a CTO. METHODS:Retrospective analysis of a six-centre percutaneous coronary intervention (PCI) registry in the UK between January 2015 and December 2020 was performed. Patients with a NSTEMI with and without a CTO were compared for baseline characteristics and outcomes. RESULTS:There were 17,355 NSTEMI patients in total of whom 1813 patients had a CTO (10.4 %). Patients with a CTO were more likely to be older (CTO: 67.8 (±11.5) years vs. no CTO: 67.2 (±12) years, p = 0.04), male (CTO: 81.1 % vs.71.9 %, p < 0.0001) with a greater prevalence of cardiovascular risk factors. All-cause mortality at 30 days: HR 2.63, 95 % CI 1.42-4.84, p = 0.002 and at 1 year: HR: 1.87, 95 % CI 1.25-2.81, p = 0.003 was higher in the CTO cohort. CTO patients who underwent revascularisation were younger (Revascularisation 66.4 [±11.7] years vs. no revascularisation 68.4 [±11.4] years, p = 0.001). Patients with failed CTO revascularisation had lower survival (HR 0.21, 95 % CI 0.10-0.42, p < 0.0001). The mean time to revascularisation was 13.4 days. There was variation in attempt at CTO revascularisation between the 6 centres for (16 % to 100 %) with success rates ranging from 65 to 100 %. CONCLUSIONS:In conclusion, the presence of a CTO in NSTEMI patients undergoing PCI was associated with worse in-hospital and long-term outcomes.
Background Percutaneous coronary intervention (PCI) for coronary chronic total occlusion (CTO) has been performed for the improvement of symptoms and quality of life in patients with stable angina. The ORBITA study demonstrated the role of the placebo effect in contemporary PCI in non-CTO chronic coronary syndromes. However, the benefit of CTO PCI beyond that of a placebo has not been demonstrated. Aims The ORBITA-CTO pilot study will be a double-blind, placebo-controlled study of CTO PCI randomising patients who have: (1) been accepted by a CTO operator for PCI; (2) experienced symptoms due to a CTO; (3) evidence of ischaemia; (4) evidence of viability within the CTO territory; and (5) a J-CTO score ≤3. Methods Patients will undergo medication optimisation that will ensure they are on at least a minimum amount of anti-anginals and complete questionnaires. Patients will record their symptoms on an app daily throughout the study. Patients will undergo randomisation procedures, including an overnight stay, and be discharged the following day. All anti-anginals will be stopped after randomisation and re-initiated on a patient-led basis during the 6-month follow-up period. At follow-up, patients will undergo repeat questionnaires and unblinding, with a further 2-week unblinded follow-up. Results The co-primary outcomes are feasibility (blinding) in this cohort and angina symptom score using an ordinal clinical outcome scale for angina. Secondary outcomes include changes in quality-of-life measures, Seattle Angina Questionnaire (SAQ), peak VO2, and anaerobic threshold on the cardiopulmonary exercise test. Conclusion The feasibility of a placebo-controlled CTO PCI study will lead to future studies assessing efficacy. The impact of CTO PCI on angina measured using a novel daily symptom app may provide improved fidelity in assessing symptoms in patients with CTO's.
Aim: To determine the safety and feasibility of an early (12 h) waking and extubation protocol for out-of-hospital cardiac arrest (OHCA) patients receiving targeted temperature management (TTM). Methods: This was a single-centre, prospective, non-randomised, observational, safety and feasibility pilot study which included successfully resuscitated OHCA patients, of presumed cardiac cause. Inclusion criteria were: OHCA patients aged over 18 years with a return of spontaneous circulation, who were going to receive TTM33 (TTM at 33 degrees C for 24 h and prevention of hyperthermia for 72 h) as part of their post cardiac arrest care. Clinical stability was measured against physiological and neurological parameters as well as clinical assessment. Results: 50 consecutive patients were included (median age 65.5 years, 82% male) in the study. Four (8%) patients died within the first twelve hours and were excluded from the final cohort (n = 46). Twenty-three patients (46%) were considered clinically stable and suitable for early waking based on the intention to treat analysis; 12 patients were extubated early based on a variety of clinical factors (21.4 +/- 8.6 h) whilst continuing to receive TTM33 with a mean core temperature of 34.2 degrees C when extubated. Of these, five patients were discharged from the intensive care unit (ICU) <48 h after admission with a mean ICU length of stay 1.8 +/- 0.4 days. Twenty-eight patients (56%) were discharged from the ICU with a modified Rankin Score of 0-2. The overall intra-hospital mortality was 50% (n = 25). Conclusions: It is safe and feasible to wake selected comatose OHCA patients at 12 h, allowing for earlier positive neuro-prognostication and reduced ICU stay.
Controversial data exist regarding the impact of body mass index (BMI) on TAVI outcomes. Thirteen TAVI studies were included and analyzed for the incidence of procedural complications, 30-day, and long-term all-cause mortality. Three comparisons were executed: (1) underweight versus normal weight, (2) overweight versus normal weight, and (3) obese versus normal weight patients. Underweight patients (BMI <20 kg/m2) had similar 30-day all-cause mortality compared with the normal, although they displayed a significant worse survival at long-term follow-up (hazard ratio 1.68, 95% confidence interval (CI) 1.09 to 2.59, p = 0.02). Underweight patients showed a higher incidence of major and life-threatening bleedings (2,566 patients, odds ratio 1.64, 95% CI 1.10 to 2.45, p = 0.02) and of major vascular complications (2,566 patients, odds ratio 1.86, 95% CI 1.16 to 2.98, p = 0.01), compared with normal weight patients. Overweight patients (BMI ≥25 and <30 kg/m2) display similar 30-day and long-term all-cause mortality, as well as similar procedural complication rate compared with normal weight patients. Obese patients (BMI >30 kg/m2) had similar 30-day all-cause mortality rates compared with the normal weight category, whereas they displayed a significant better survival at long-term (hazard ratio 0.79, 95% CI 0.67 to 0.93, p = 0.004). Procedural complications did not differ between obese and normal body weight patients. In conclusion, a low BMI is linked to a significantly worse prognosis after TAVI. Therefore, BMI represents an important and handily tool that might be used in the risk prediction of patients to be addressed for TAVI.
Background: Accumulation of advanced glycation end products (AGEs) can be measured non-invasively by SAF, whose values are elevated in patients with CVD. OCT is a core intravascular imaging modality that could allow visualization of plaque composition. Aims: We aim to examine the relationship between skin autofluorescence (SAF) and plaque composition evaluated by frequency-domain optical coherence tomography (OCT) in patients with cardiovascular disease (CVD). Methods: We prospectively enrolled 108 patients with CVD who underwent OCT images and then percutaneous coronary intervention (PCI). We divided the population into two groups: high SAF group (greater than or equal to 2.6) and low SAF one (less than 2.6). OCT findings were then compared between high and low SAF groups. Results: The high SAF group showed much more thin cap fibroatheroma (TCFA), macrophages, microvessels, and calcified or ruptured plaques compared to the low SAF group. In multivariable analysis, low-density lipoprotein-cholesterol (LDL) (odds ratio: 1.15; 95% confidence interval: 1.00 to 1.32; p=0.043), TG (OR for 10 mg/dl increase: 1.04; 95% confidence interval: 1.01 to 1.13; p=0.016), and SAF (4.28; 1.86 to 9.84; p<0.001) were independent correlates of TCFA, whereas SAF (2.61; 1.02 to 6.70; p=0.047), female (0.18; 0.04 to 0.80; p=0.024), body mass index (1.16; 1.02 to 1.32; p=0.021), estimated glomerular filtration rate (0.68; 0.49 to 0.93; p=0.017) and LDL (1.19; 1.01 to 1.41; p=0.037) were independent predictors of ruptured plaques. SAF and medication for diabetes were independently associated with calcified plaques. Conclusion: High SAF were associated with plaque vulnerability in patients with CVD, thus suggesting the clinical utility of measurement of SAF in identifying high-risk patients for future cardiovascular events.
In STEMI patients undergoing primary PCI, optimal stent deployment is challenging due to factors like thrombus formation and vasoconstriction. In this setting stent post-dilatation with non-compliant (NC) balloons could optimise acute results, but carries a risk of distal embolization and
Mild therapeutic hypothermia (MTH 33°C) post out-of-hospital cardiac arrest (OHCA) is widely accepted as standard of care. However, uncertainty remains around the dose and therapy duration. OHCA patients are usually kept sedated±paralyzed and ventilated for the first 24-36 hours, which allows for targeted temperature management, but makes neurological prognostication challenging. The aim of this study is to investigate the feasibility and safety of assessing the unconscious OHCA patient after 12 hours for early waking/extubation while continuing to provide MTH for 24 hours, and fever prevention for 72 hours by using an intravenous temperature management (IVTM) system and established conscious MTH anti-shiver regimens. This is a single-center, prospective, non-randomized observational study that will compare the results of early awakening (at 12 hours) with historical controls. A total of 50 consecutive unconscious survivors of OHCA, treated with MTH, who meet the Therapeutic Hypothermia and eArly Waking (THAW) inclusion criteria will be enrolled. The patient will receive MTH by using IVTM. After 12 hours of MTH, patients will be assessed by using strict clinical criteria to determine suitability for early waking and extubation. Once awake and extubated, MTH will continue for 24 hours with skin counter-warming and anti-shiver regimen followed fever prevention up to 72 hours. All patients will have serial electroencephalogram (EEG), somatic sensory potential, and neuro-biomarkers performed on admission to intensive care unit, 6 and 12 hours, then every 24 hours until 72 hours. The study has been approved by the National Research Ethics Service, Health Research Authority.
The index of microcirculatory resistance (IMR) emerges as a valuable prognostic tool in ST elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronay intervention (PPCI). An IMR value more than 40 at the end of the procedure has been related with worse outcomes. In the
Coronary physiology is recommended to guide percutaneous coronary intervention (PCI) in stable coronary disease. PCI in such settings aims to relieve angina and improve exercise capacity. The aim of this study was to determine the relationship between instantaneous wave-free ratio (iFR), fractional
Background There is strong evidence of FFR guided treatment in multi-vessel disease. The presence of a concomitant CTO may influence the FFR measurement in donor vessel as suggested in previous studies and reports. This has an important implication on clinical decision making for complete revascularisation in patients with chronic total occlusion. We sought to investigate the influence of collateral regression after successful CTO recanalisation on donor vessel pressure-derived indices. Methods The study participants were patients with angina who had RCA CTO. 28 out of 34 consecutive patients underwent successful PCI to RCA CTOs during the study period and completed the follow study (at 3 months post CTO PCI) were included in this analysis. Coronary pressure-derived indices (resting PD/PA, iFR and FFR) were measured pre and post successful RCA CTO PCI in donor vessels and at follow up procedures. Results The mean age was 62.38 years. The mean estimated CTO duration was 238.72 weeks and CTO length was 32.44 mm. 25 patients had ischaemia and or viability in the RCA territory assessed with cardiac MRI. LAD was the major donor vessel in 24 patients and LCX was the minor donor vessel in 4 patients. Percent stenosis on QCA in the major and minor donor vessel were 40.6% and 35.1% respectively. The mean resting Pd/Pa, iFR and FFR pre and post RCA CTO PCI and at follow-up procedures in major donor vessel were (0.893, 0.862, 0.764), (0.907, 0.886, 0.753) and (0.918, 0.901, 0.787) respectively. The mean resting Pd/Pa, iFR and FFR pre and post RCA CTO PCI and at follow-up procedures in minor donor vessel were (0.979, 0.966, 0.890), (0.983, 0.979, 0.880) and (0.981, 0.974, 0.898) respectively. The changes in coronary pressure-derived indices pre and post RCA CTO PCI and at follow up procedures are summarised in table 1. In major donor vessel, there was significant changes in the difference between follow up and pre-CTO PCI values for Pd/Pa, iFR and FFR values (p values 0.006, 0.003 and 0.047 respectively). There was also significant change in the difference between follow up and post-CTO PCI FFR value (P value 0.002). FFR collateral reduced significantly at follow-up (p value 0.000). Conclusion Successful recanalisation of a RCA CTO results in increase in major donor vessel coronary pressure-derived indices at follow up procedure associated with the regression of collateral function. In patients with multi-vessel disease, the expected change and the optimal timing to perform PCI in donor vessel should be considered when planning multi-vessel revascularisation in this setting.