Explore the vast range of titles available.

BackgroundIn the PREPARE-CALC trial, severely calcified lesion preparation with rotational atherectomy (RA) before biodegradable polymer sirolimus-eluting stent (SES) implantation demonstrated higher procedural success and comparable rates of acute lumen gain and late lumen loss compared to modified balloons (MB) (scoring/cutting). We aimed to analyze the 5-year outcomes of both lesion preparation strategies.MethodsPREPARE-CALC randomly assigned 200 patients 1:1 to MB or RA, followed by SES implantation. The principal endpoint of the current analysis was target vessel failure (TVF) at 5 years.ResultsAt 5 years, MB had comparable rates of TVF to RA (19% vs. 21%, HR 1.14, 95% CI 0.60–2.16, p = 0.687). Subgroup analysis showed a lesion length treatment interaction, favoring MB for short lesions and RA for long ones (p for interaction = 0.042). Target lesion revascularization (TLR) was significantly less common with RA (12 vs. 3%, HR 0.28, 95% CI 0.08–0.98, p = 0.048). In a multivariate analysis, RA was independently protective against TLR (adj. HR 0.17, 95% CI 0.04–0.78, p = 0.022), while ostial lesions were associated with higher TLR independent of treatment strategy (adj. HR 11.3, 95% CI 2.98–42.6, p < 0.001).ConclusionIn patients with severely calcified coronary lesions, using MB or RA for lesion preparation followed by biodegradable polymer SES implantation was associated with comparable rates of TVF at 5 years. However, a significant reduction of TLR was observed after RA. PREPARE-CALC is the first randomized trial showing potential clinical advantages of RA over MB during long-term follow-up.Clinical Trial RegistrationURL: https://www.clinicaltrials.gov. Unique identifier: NCT02502851.

ObjectiveTo compare Orsiro biodegradable-polymer sirolimus-eluting stent (Orsiro BP-SES) with durable-polymer everolimus-eluting stent (DP-EES) regarding target lesion failure (TLF) after rotational atherectomy (RA), with a focus on small stents (diameter ≤ 3 mm) where Orsiro BP-SES has 60 µm strut thickness, while DP-EES remains with 81 µm strut thickness.BackgroundNew-generation drug-eluting stent (DES) is superior to early-generation DES in all percutaneous coronary intervention (PCI) settings including RA. Recently, the Orsiro BP-SES was superior to a DP-EES in an all comer’s population.MethodsAmong patients who underwent RA at a single center, 121 were treated with Orsiro BP-SES and 164 with DP-EES (Promus and Xience). Those treated with other stent types, presenting with acute myocardial infarction or had a chronic total occlusion were excluded. Incidence of TLF was assessed.ResultsAfter 2 years, the TLF rate in Orsiro BP-SES and DP-EES groups was 10% and 18%, respectively (adjusted HR 0.55, 95%CI 0.26–1.16, p = 0.115). The rate of TLF was significantly lower in small Orsiro BP-SES with ultra-thin struts as compared to DP-EES with the same diameters (adjusted HR 0.19, 95% CI 0.04–0.87, p = 0.032), driven by lower rates of clinically driven target lesion revascularization (log-rank p = 0.022). Age (p = 0.035), total stent length (p = 0.007) and diabetes mellitus (p = 0.011) emerged as independent predictors of TLF in the whole population.ConclusionIn the whole cohort, Orsiro BP-SES and DP-EES had comparable rates of long-term TLF after RA. In the small stent subgroup, the Orsiro BP-SES with ultra-thin struts showed significant lower rate of TLF at 2 years.Graphic abstract

Objectives. To analyze the impact of different techniques of lesion preparation of severely calcified coronary bifurcation lesions. Background. The impact of different techniques of lesion preparation of severely calcified coronary bifurcation lesions is poorly investigated. Methods. We performed an as-treated analysis on 47 calcified bifurcation lesions treated with scoring/cutting balloons (SCB) and 68 lesions treated with rotational atherectomy (RA) in the PREPARE-CALC trial. Compromised side branch (SB) as assessed in the final angiogram was the primary outcome measure and was defined as any significant stenosis, dissection, or thrombolysis in myocardial infarction flow <3. Results. True bifurcation lesions were present in 49% vs. 43% of cases in the SCB and RA groups, respectively. After stent implantation, SB balloon dilatation was necessary in around one-third of cases (36% vs. 38%; p=0.82), and a two-stent technique was performed in 21.3% vs. 25% (p=0.75). At the end of the procedure, the SB remained compromised in 15 lesions (32%) in the SCB group and 5 lesions (7%) in the RA group (p=0.001). Large coronary dissections were more frequently observed in the SCB group (13% vs. 2%; p=0.02). Postprocedural levels of cardiac biomarkers were significantly higher in patients with a compromised SB at the end of the procedure. Conclusions. In the PREPARE-CALC trial, side branch compromise was more frequently observed after lesion preparation with SCB as compared with RA. Consequently, in calcified bifurcation lesions, an upfront debulking with an RA-based strategy might optimize the result in the side branch.

ObjectivesTo assess the feasibility and safety of minimal-contrast percutaneous coronary intervention (PCI) using rotational atherectomy (RA) in patients with severe coronary calcification at high-risk of contrast-associated acute kidney injury (AKI).MethodsTwenty-six patients with advanced chronic kidney disease undergoing PCI with RA at three high-volume centres were included. Baseline intravascular ultrasound (IVUS) was performed to assess lesion morphology, and to guide burr-, balloon-, and stent-selection. Final result was assessed by IVUS and angiographically. Feasibility and safety were determined by procedural and in-hospital complications, and efficacy was assessed by freedom from contrast-associated AKI after PCI. Procedural and in-hospital outcome was compared to a propensity-matched population of standard RA PCI.ResultsMean glomerular filtration rate was 32 ± 17 ml/min/1.73 m2. In seven cases PCI was performed in the setting of acute coronary syndrome. The left main coronary artery was treated in 27.8% and a two-stent bifurcation technique in 44.4%. RA was more often performed electively compared to the standard RA cohort (92.3 vs. 50%; p = 0.0016). Angiographic success was achieved in 100% and documented with a median contrast amount of 12.5 ml [Range 4–43]. No in-hospital death or myocardial infarction was reported. Contrast-associated AKI occurred in one patient versus five patients in standard RA group (p = 0.19). Shorter fluoroscopy time and lower radiation dose were achieved as compared to standard RA.ConclusionA minimal-contrast RA approach with IVUS-guidance for treatment of complex calcified coronary lesions is feasible and safe with high success rate.Graphic abstract

AimsTo compare the outcomes of patients undergoing non-cardiac surgery (NCS) after PCI with either a drug-coated stent (DCS) or a bare-metal stent (BMS), followed by 1-month dual antiplatelet therapy and to explore the impact of the timing of NCS.MethodsThis is a subgroup analysis of the LEADERS FREE trial. The primary safety end point was a composite of cardiac death, myocardial infarction, or stent thrombosis, and the primary efficacy end point was clinically driven target lesion revascularization (TLR).ResultsOut of 2432 patients included in the LEADERS FREE trial, 278 (11.4%) underwent NCS within 1 year after PCI. Among NCS patients, the 1-year safety end point was numerically lower with DCS; however, this difference was not significant as compared to BMS (4.7% vs. 10.1%, HR: 0.459 [0.178–1.183], p = 0.099), clinically driven TLR was significantly lower after DCS (2.4% vs. 8.3%, HR: 0.281 [0.079—0.996], p = 0.036), and BARC 3–5 bleeding was similar with DCS vs. BMS (10.2% vs. 7.5%, p = 0.438). In patients treated with BMS, NCS within 3 months after PCI was associated with higher incidence of the safety end point than NCSs performed later: 14.9% vs. 4.4%, HR: 3.586 [1.012–12.709], p = 0.034. The timing of surgery had no impact on patients treated with DCS (4.7% vs. 4.7%, p = 0.947).ConclusionsAmong patients undergoing NCS after PCI, DCS-treated patients had a lower probability of clinically driven TLR compared with BMS. However, there was no significant difference in the occurrence of the primary composite safety end point or bleeding complications. Early NCS after BMS-PCI was associated with impaired safety, while the timing of NCS had no such influence after DCS implantation.Graphic abstract

BackgroundThe HFA-PEFF score may help in predicting long-term outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) for severe aortic stenosis and preserved left ventricular ejection fraction (EF).MethodsWe retrieved data from 1,332 patients undergoing TAVI between 2010 and 2019 from the Prospective Segeberg TAVI Registry (ClinicalTrials.gov Identifier: NCT03192774). We calculated the HFA-PEFF score for 1,022 patients who had preserved EF (≥50%). To assess the prognostic value of the HFA-PEFF score in predicting adverse events, we dichotomised the patients according to a cut-off score of five (score <5 group: n=528 (51.6%), score ≥5 group: n=494 (48.3%)).ResultsThe HFA-PEFF score ≥5 groups were older (81.9±6.3 years vs. 80.3±6.9 years; p<0.001) and had a higher prevalence of atrial fibrillation (35.1% vs 20.8%; p<0.001) and chronic kidney disease (30.1% vs 26.1%; p<0.001). Kaplan-Meier survival analyses over 24 months showed increased cardiovascular (CV) mortality (12.5% vs. 7.7%, log-rank; p=0.028) and first heart failure-related rehospitalisation (7.7% vs. 4.0%, log-rank p=0.014) in the HFA-PEFF score ≥5 groups compared with those of lower scores. No significant difference in all-cause mortality between both groups was observed (22.0% vs. 17.9%, log-rank p=0.127). In multivariate analysis, HFA-PEFF score ≥5 failed to predict CV mortality (aHR 1.37, 95% CI: 0.90-2.08, p=0.140) and time to first heart failure-related rehospitalisation (aHR 1.49, 95% CI: 0.83-2.65, p=0.181).ConclusionThe HFA-PEFF score showed limited value in predicting long-term mortality and adverse heart failure-related events in patients with preserved EF undergoing TAVI. Clinical variables specific to this population could complement the HFA-PEFF score for better risk prediction.

IntroductionRotational atherectomy (RA) historically was contraindicated in patients with impaired left ventricular (LV) function due to inherent cardio-depressive effects. Contemporary RA practice is less aggressive than traditional RA and no longer withheld from patients with reduced ejection fraction (EF). The aim of this analysis is to explore the outcomes of rotational atherectomy (RA) in patients with reduced left ventricular ejection fraction (LVEF).MethodsPatients undergoing RA (n = 644) were divided into three groups according to LVEF (severely reduced ≤ 35%, n = 82; moderately reduced 36–54%, n = 170; and preserved LVEF ≥ 55%, n = 392).ResultsCompared to patients with preserved LVEF, those with severely reduced LVEF had higher rates of angiographic failure (12.2 vs. 3.3%, p = 0.003) and in-hospital major adverse cardiac events (MACE: 9.8 vs. 2.3%, p = 0.004) driven by more peri-procedural myocardial infarction (MI: 6.1 vs. 1.5%, p = 0.049). In-hospital outcomes were similar between patients with preserved and moderately reduced LVEF. At 5-year follow-up, a stepwise increase in all-cause death was observed with lower LVEF (preserved: 15%, moderately reduced: 23%, severely reduced: 43%; p < 0.001). On the other hand, revascularization and MI rates at 5 years were not affected by LVEF.ConclusionsCompared to patients with preserved LVEF, those with severely reduced LVEF have worse acute outcomes after RA, whereas a moderate reduction of LVEF poses no additional acute hazard after RA. Up to 5 years, the extent of left ventricular dysfunction was associated with a stepwise increase in mortality.

Background: Personalized prognosis plays a vital role in deciding between percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) in patients with three-vessel disease (3VD). The aim of this study is to compare the modality of revascularization chosen by the local heart team to that recommended by using individualized predictions of medium, and long-term all-cause mortality amongst patients with 3VD screened in the Multivessel TALENT trial. Methods: The SYNTAX score II (SS-II) and SS-2020 were evaluated in 200 consecutive patients by a core laboratory and compared to the decision of the “on site” heart team. Results: According to the SS-II, CABG was the recommended treatment in 51 patients (25.5%) however 34 (66.6%) of them received PCI. According to SS-2020 the predicted absolute risk differences (ARD) between PCI and CABG were significantly higher in patients receiving CABG compared to those treated by PCI for major adverse cardiovascular and cerebrovascular events, a composite of all-cause mortality, stroke or myocardial infarction at 5-years (8.8 ± 4.6% vs 6.0 ± 4.0%, p < 0.001) and all-cause mortality at 5- (5.2 ± 3.5% vs 3.7 ± 3.0%, p = 0.008) and 10-years (9.3 ± 4.8% vs 6.2 ± 4.2%, p < 0.001). Based on the novel threshold of equipoise (individual absolute risk differences [ARD] <4.5%), 133 patients were eligible for PCI however 23 of them underwent CABG; conversely, amongst the 67 patients where CABG was recommendation (individual ARD >4.5%), only 19 received it. Conclusions: Despite the robustness of the risk models proposed for screening, several deviations from the recommended mode of revascularization were observed by the core laboratory among the first 200 patients with 3VD screened in the Multivessel TALENT trial. Clinical Trial Registration: ClinicalTrials.gov reference: NCT04390672.

A randomized trial involving patients with acute coronary syndromes showed that prasugrel was superior to ticagrelor with regard to the incidence of death, myocardial infarction, or stroke within 1 year, with no increased risk of bleeding.

BackgroundQuantitative flow ratio (QFR) and target-vessel SYNTAX score (tvSS) are novel indices used to assess lesion physiology and morphology in percutaneous coronary intervention (PCI). Their prognostic implication after successful recanalization of coronary chronic total occlusion (CTO) is unknown.ObjectivesTo investigate the prognostic value of QFR measured immediately after successful CTO-recanalization in predicting vessel-oriented adverse events, and to compare it with the pre-procedural morphological tvSS.MethodsQFR was measured offline after successful CTO-PCIs in a single center. We grouped the patients according to a cut-off value of post-PCI QFR (0.91). The primary outcome was target-vessel failure (TVF) at 2 years.ResultsAmong 470 CTO lesions performed during the study period, 324 were eligible for QFR analysis (258 with QFR ≥ 0.91 and 66 with QFR < 0.91). The mean age of the study population was 68.3 ± 10.7 years. The low QFR group had a lower left ventricular ejection fraction (45.8 ± 13.9% vs. 49.8 ± 12.4%, p = 0.025) and a higher rate of atrial fibrillation (19.7% vs. 11.2%, p = 0.020). The mean tvSS was 12.8 ± 4.8, and it showed no significant difference in both groups (13.6 ± 5.1 vs. 12.6 ± 4.6, p = 0.122). Patients with low post-CTO QFR had a trend to develop more TVF at 2 years (21.2% vs. 12.4%, HR 1.74; 95% CI 0.93–3.25, p = 0.086). Low post-CTO QFR failed to predict 2-year TVF (aHR 1.67; 95% CI 0.85–3.29, p = 0.136), while pre-procedural tvSS was an independent predictor for 2-year TVF (aHR 1.06; 95% CI 1.01–1.13, p = 0.030).ConclusionWe found a limited prognostic value of immediate physiological assessment using QFR after successful CTO intervention. Pre-procedure morphological characteristics of CTO lesions using tvSS can play a role in predicting long-term adverse events.