Eurointervention最新文献

Background: Redo-transcatheter aortic valve implantation (TAVI) is the treatment of choice for failed transcatheter aortic valves. Currently, implantation of a SAPIEN 3 (S3) is indicated for redo-TAVI in degenerated CoreValve/Evolut (CV/EV) transcatheter aortic valves (TAVs) but is not well understood.

Aims: We aimed to evaluate S3 function following implantation in explanted calcified CV/EV TAVs and to assess the impact of CV/EV pathology on redo-TAVI outcomes.

Methods: Ex vivo hydrodynamic testing was performed per the International Organization for Standardization (ISO) 5840-3 standard on 4 S3 TAVs implanted at node 5 in calcified CV/EV explants. The mean gradient (MG), effective orifice area (EOA), peak velocity, regurgitant fraction (RF), geometric orifice area (GOA), leaflet overhang, leaflet pinwheeling, neoskirt height, and frame deformation were evaluated.

Results: CV/EV explants were calcified and stenotic. Following S3 implantation, the MG and peak velocity decreased. As per the ISO standard, all S3 implants showed adequate EOA, and 3 out of 4 had an RF within the accepted value (<20%). CV/EV leaflet overhang ranged from 25-37%. Calcified leaflets remained stationary throughout the cardiac cycle (difference <9%) and were not pinned in a manner that constrained S3 systolic flow or appeared to prevent selective frame cannulation. The downstream CV/EV GOA was larger than the upstream S3 GOA during systole. S3 frame underexpansion was seen, resulting in leaflet pinwheeling (range 13-30%). Above the neoskirt, calcium protrusion was observed in contact with the S3 leaflets.

Conclusions: S3 implantation at node 5 in calcified CV/EV valves resulted in satisfactory hydrodynamic performance in most configurations tested with stable leaflet overhang throughout the cardiac cycle. The long-term implications of S3 underexpansion, leaflet pinwheeling, and calcium protrusion require future studies.

Despite the use of conventional dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI), the risk of adverse events remains high among patients with increased thrombotic risk. Until recently, the optimal antiplatelet strategy to balance the ischaemic and bleeding risks in patients who are undergoing complex high-risk PCI has been unclear. The TAILored Versus COnventional AntithRombotic StratEgy IntenDed for Complex HIgh-Risk PCI (TAILORED-CHIP) trial is an investigator-initiated, multicentre, prospective randomised trial to evaluate the efficacy and safety of a time-dependent tailored antiplatelet therapy with an early (<6 months post-PCI) escalation (low-dose ticagrelor at 60 mg twice daily plus aspirin) and a late (>6 months post-PCI) de-escalation (clopidogrel monotherapy) in patients undergoing complex high-risk PCI as compared with standard DAPT (clopidogrel plus aspirin for 12 months). Eligible patients had to have at least one high-risk anatomical or procedural feature or clinical characteristic associated with an increased risk of ischaemic or thrombotic events. The primary endpoint was the net clinical outcome, a composite of death from any cause, myocardial infarction, stroke, stent thrombosis, urgent revascularisation, or clinically relevant bleeding (Bleeding Academic Research Consortium type 2, 3, or 5) at 12 months after randomisation. (ClinicalTrials.gov: NCT03465644).

Background: Calcified nodules (CNs) are an increasingly important, high-risk lesion subset.

Aims: We sought to identify the emergence of new CNs and the relation between underlying plaque characteristics and new CN development.

Methods: Patients who had undergone two optical coherence tomography (OCT) studies that imaged the same untreated calcified lesion at baseline and follow-up were included. New CNs were an accumulation of small calcium fragments at follow-up that were not present at baseline. Cardiac death, myocardial infarction (MI), or clinically driven revascularisation related to OCT-imaged, but untreated, calcified lesions were then evaluated.

Results: Among 372 untreated calcified lesions, with a median of 1.5 (first and third quartiles: 0.7-2.9) years between baseline and follow-up OCTs, new CNs were observed in 7.0% (26/372) of lesions at follow-up. Attenuated calcium representing residual lipid (odds ratio [OR] 3.38, 95% confidence interval [CI]: 1.15-9.98; p=0.03); log₁₀ calcium volume index (length×maximum arc×maximum thickness; OR 2.76, 95% CI: 1.10-6.95; p=0.03); angiographic Δangle between systole and diastole, per 10° (OR 2.30, 95% CI: 1.25-4.22; p=0.01); and time since baseline OCT, per year (OR 1.36, 95% CI: 1.05-1.75; p=0.02) were all associated with new CN development. Clinical events were revascularisation and/or MI and were more frequent in lesions with versus without a new CN (29.3% vs 15.3%; p=0.04).

Conclusions: New CNs developed in untreated, lipid-containing, severely calcified lesions with a larger angiographic hinge motion (between systole and diastole), compared with lesions without CNs, and were associated with worse clinical outcomes.

Background: Paclitaxel-coated balloons (PCB) are a viable alternative to drug-eluting stents in the treatment of de novo coronary lesions. Whether sirolimus represents an alternative to paclitaxel for drug-coated balloons remains elusive.

Aims: This randomised, controlled, multicentre, non-inferiority trial investigated a novel sirolimus-coated balloon (SCB) with a crystalline coating versus a PCB in de novo coronary lesions.

Methods: To compare a novel SCB with a clinically proven PCB, 70 patients with de novo coronary lesions were enrolled at 4 centres in Germany and Switzerland. The primary endpoint was non-inferiority regarding angiographic late lumen loss (LLL) at 6 months, with a predefined margin of δ=0.35 mm. Secondary endpoints included procedural success, major adverse cardiac events, and individual clinical endpoints.

Results: Quantitative coronary angiography revealed no differences in baseline parameters. At 6 months, in-segment LLL was 0.04±0.39 mm in the PCB group versus 0.11±0.37 mm in the SCB group (non-significant), respectively. The mean difference between SCB and PCB was 0.07 mm (95% confidence interval: -0.12 to 0.26). Non-inferiority at the predefined margin of 0.35 was shown. Clinical event rates up to 12 months were not different between the groups (3 target lesion revascularisations in the PCB group versus 2 in the SCB group, no myocardial infarctions, no deaths).

Conclusions: The novel SCB showed similar angiographic outcomes in the treatment of de novo coronary disease as compared with a clinically proven PCB (ClinicalTrials.gov: NCT03908450).

Background: Limited data exist on ultrathin-strut drug-eluting stent (ultrathin DES) performance in DES in-stent restenosis (ISR).

Aims: We aimed to assess the efficacy and safety of ultrathin DES compared to thin-strut DES and drug-eluting balloons (DEB) for DES-ISR.

Methods: Patients from the DEB Dragon (ClinicalTrials.gov: NCT04415216) and ULTRA registries (ClinicalTrials.gov: NCT05205148) were divided into ultrathin DES, thin-strut DES, or DEB groups for DES-ISR treatment. Both propensity score matching (PSM) and inverse probability weighting (IPW) were considered to adjust the distribution of patients in each class. Cox regression was applied to the following main endpoints: device-oriented composite endpoints (DOCE; including cardiac death, target lesion revascularisation [TLR] and target vessel myocardial infarction), TLR and target vessel revascularisation (TVR).

Results: A total of 269, 541, and 557 patients received an ultrathin DES, thin-strut DES, and DEB, respectively. After 3 years of follow-up, in the IPW-adjusted overall cohort, ultrathin DES were associated with a significantly reduced risk of DOCE compared to DEBs (hazard ratio [HR] 0.353, 95% confidence interval [CI]: 0.194-0.642; p<0.001), as well as thin-strut DES (HR 0.645, 95% CI: 0.457-0.911; p=0.013). Compared to DEBs, ultrathin DES also reduced the risks of both TLR (HR 0.184, 95% CI: 0.081-0.417; p<0.001) and TVR (HR 0.188, 95% CI: 0.093-0.379; p<0.001), while thin-strut DES did not (TLR: HR 0.686, 95% CI: 0.407-1.157; p=0.157; TVR: HR 0.706, 95% CI: 0.453-1.101; p=0.124). For diffuse ISR patients, ultrathin DES reduced the risk of DOCE (HR 0.364, 95% CI: 0.188-0.705; p=0.003), as did thin-strut DES (HR 0.602, 95% CI: 0.367-0.987; p=0.044), while a reduction of TLR (HR 0.220, 95% CI: 0.091-0.531; p<0.001) and TVR (HR 0.241, 95% CI: 0.113-0.513; p<0.001) was achieved only by ultrathin DES.

Conclusions: Ultrathin DES were associated with reduced DOCE, TLR and TVR risks in diffuse ISR compared to DEBs.

Background: Coronary computed tomography angiography (CCTA) and fractional flow reserve (FFR) derived from CCTA (FFR-CT) may provide a means of reducing unnecessary invasive coronary angiography (ICA) in patients with suspected non-ST-elevation acute coronary syndromes (NSTE-ACS).

Aims: The aim of this study was to evaluate the capacity of FFR-CT and CCTA to rule out significant lesions in high-risk NSTE-ACS patients, using ICA with invasive FFR as the gold standard.

Methods: High-risk NSTE-ACS patients admitted to 4 European centres were enrolled in this single-arm, prospective core lab-adjudicated study. Patients underwent CCTA with FFR-CT analysis, followed by ICA with invasive FFR.

Results: Out of the 250 initially planned NSTE-ACS patients, 168 were included, of whom 151 (92%) had sufficient CCTA image quality to undergo CCTA and FFR-CT analysis. The median high-sensitivity troponin T level at 1 hour post-hospitalisation was 5.3 (interquartile range: 1.8-18.6) times the upper reference limit. At the patient level, the diagnostic performance of FFR-CT was numerically higher as compared to CCTA though not statistically significant (sensitivity: 94% vs 93%, specificity: 63% vs 54%, positive predictive value: 83% vs 79%, negative predictive value: 85% vs 80% and accuracy: 83% vs 79%; p=0.58), suggesting an enhanced capability to avoid unnecessary ICA. At the lesion level, the ability of FFR-CT to detect significant lesions was significantly better than that of CCTA (receiver operating characteristic curves: 0.84 vs 0.65 respectively; p<0.01).

Conclusions: In patients with high-risk NSTE-ACS, FFR-CT offers better diagnostic accuracy - though not statistically significant - and a higher ability to rule out haemodynamically significant stenoses as compared to CCTA. This indicates that FFR-CT can reduce unnecessary invasive procedures by more accurately identifying patients requiring further intervention.

Cardiogenic shock (CS) is a devastating and fatal complication of acute myocardial infarction (AMI). CS can affect the pharmacokinetics and pharmacodynamics of medications. The unique properties of cangrelor make it the optimal P2Y12 inhibitor for CS-AMI, in terms of both efficacy and safety. The DAPT-SHOCK-AMI trial (ClinicalTrials.gov: NCT03551964; EudraCT: 2018-002161-19) will assess the benefits of cangrelor in patients with an initial CS-AMI undergoing primary angioplasty. This randomised, multicentre, placebo-controlled trial of approximately 550 patients (with an allowed 10% increase) in 5 countries using a double-blind design will compare initial P2Y12 inhibitor treatment strategies in patients with CS-AMI of (A) intravenous cangrelor and (B) ticagrelor administered as crushed tablets at a loading dose of 180 mg. The primary clinical endpoint is a composite of all-cause death, myocardial infarction (MI), or stroke within 30 days. The main secondary endpoints are (1) the net clinical endpoint, defined as death, MI, urgent revascularisation of the infarct-related artery, stroke, or major bleeding as defined by the Bleeding Academic Research Consortium criteria; (2) cardiovascular-related death, MI, urgent revascularisation, or heart failure; (3) heart failure; and (4) cardiovascular-related death, all (1-4) within 1 year after study enrolment. A platelet reactivity study that tests the laboratory antiplatelet benefits of cangrelor, when given in addition to standard antiplatelet therapy, will be conducted using vasodilator-stimulated phosphoprotein phosphorylation. The primary laboratory endpoints are the periprocedural rate of onset and the proportion of patients who achieve effective P2Y12 inhibition. The DAPT-SHOCK-AMI study is the first randomised trial to evaluate the benefits of cangrelor in patients with CS-AMI.

Background: Whether revascularisation (REV) improves outcomes in patients with three-vessel coronary artery disease (3V-CAD) is uncertain.

Aims: Our objective was to evaluate outcomes with REV (percutaneous coronary intervention [PCI] or coronary artery bypass graft surgery [CABG]) versus medical therapy in patients with 3V-CAD.

Methods: ISCHEMIA participants with 3V-CAD on coronary computed tomography angiography without prior CABG were included. Outcomes following initial invasive management (INV) with REV (PCI or CABG) versus initial conservative management (CON) with medical therapy alone were evaluated. Regression modelling was used to estimate the outcomes if all participants were to undergo prompt REV versus those assigned to CON. Outcomes were cardiovascular (CV) death/myocardial infarction (MI), death, CV death, and quality of life. Bayesian posterior probability for benefit (Pr [benefit]) for 1 percentage point lower 4-year rates with REV versus CON were evaluated.

Results: Among 1,236 participants with 3V-CAD (612 INV/624 CON), REV was associated with lower 4-year CV death/MI (adjusted 4-year difference: -4.4, 95% credible interval [CrI] -8.7 to -0.3 percentage points, Pr [benefit]=94.8%) when compared with CON, with similar results for PCI versus CON (-5.8, 95% CrI: -10.8 to -0.5 percentage points, Pr [benefit]=96.4%) and CABG versus CON (-3.7, 95% CrI: -8.8 to 1.5 percentage points, Pr [benefit]=84.7%). Adjusted 4-year REV versus CON differences were as follows: death -1.2 (95% CrI: -4.7 to 2.2) percentage points, CV death -2.3 (95% CrI: -5.5 to 0.8) percentage points, with similar results for PCI and for CABG. The Pr (benefit) for death with REV (PCI or CABG) versus CON was 49-63%. The adjusted 12-month Seattle Angina Questionnaire-7 summary score differences favoured REV: REV versus CON 4.6 (95% CrI: 2.7-6.4) percentage points; PCI versus CON 3.6 (95% CrI: 1.2-5.8) percentage points and CABG versus CON 4.3 (95% CrI: 1.5-6.9) percentage points with high Pr (benefit).

Conclusions: In participants with 3V-CAD, REV (either PCI or CABG) was associated with a lower 4-year CV death/MI rate and improved quality of life, with similar results for PCI versus CON and CABG versus CON. The differences in all-cause mortality between REV and CON were small with wide confidence intervals. (ClinicalTrials.gov: NCT01471522).