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Coronary artery calcification is common among patients undergoing percutaneous coronary intervention (PCI), and severe coronary artery lesion calcification is associated with increased procedural complexity, stent under-expansion, and high rates of intraprocedural complications and out-of-hospital adverse events. Whether calcium ablation before stent implantation can mitigate these adverse events is not currently established. We aimed to prospectively compare orbital atherectomy with a balloon angioplasty-based strategy before stent implantation for the treatment of severely calcified coronary lesions. In this multicentre, open-label, randomised controlled trial conducted at 104 medical centres in the USA, patients (aged ≥18 years) with severely calcified coronary lesions were randomly assigned (1:1) to orbital atherectomy or balloon angioplasty before PCI with drug-eluting stents using a web-based system (block sizes of four and six) and stratified by intended treatment of single versus multiple lesions and enrolling site. Randomly assigned lesions were deemed by operators to be eligible for both treatment strategies. Operators and patients were not masked to treatment. The two powered coprimary study endpoints were target vessel failure at 1 year (a composite of cardiac death, target vessel myocardial infarction, or ischaemia-driven target vessel revascularisation) and post-procedural minimal stent area at the site of maximal calcification, as assessed by intravascular optical coherence tomography in an imaging patient cohort. Primary analyses were by intention-to-treat. The trial is registered at ClinicalTrials.govNCT03108456, and 2-year follow-up is ongoing. From March 27, 2017, to April 13, 2023, 2005 patients with 2492 lesions were randomly assigned to lesion preparation with orbital atherectomy (1008 patients with 1250 lesions) or balloon angioplasty (997 with 1242 lesions) before stent implantation. Median patient age was 70·0 years (IQR 64·0–76·0). 541 (27·0%) of 2005 patients were female and 1464 (73·0%) were male. Angiographically severe calcium was confirmed by the core laboratory in 1088 (97·1%) of 1120 lesions assigned to orbital atherectomy and 1068 (97·0%) of 1101 lesions assigned to balloon angioplasty. PCI was guided by intravascular imaging in 627 (62·2%) of 1008 patients in the orbital atherectomy group and 619 (62·1%) of 997 in the balloon angioplasty group. Target vessel failure events within 1 year occurred in 113 of 1008 patients in the orbital atherectomy group (1-year target vessel failure 11·5% [95% CI 9·7 to 13·7]) and in 97 of 997 patients in the balloon angioplasty group (10·0% [8·3 to 12·1]; absolute difference 1·5% [96% CI –1·4 to 4·4]; hazard ratio 1·16 [96% CI 0·87 to 1·54], p=0·28). Among those in the optical coherence tomography substudy cohort (276 patients with 286 lesions in the orbital atherectomy group and 279 patients with 292 lesions in the balloon angioplasty group), the mean minimal stent area at the site of maximal calcification was 7·67 mm2 (SD 2·27) in the orbital atherectomy group and 7·42 mm2 (2·54) in the balloon angioplasty group (mean difference 0·26 [99% CI –0·31 to 0·82]; p=0·078). Cardiac death events within 1 year occurred in 39 of 1008 patients in the orbital atherectomy group and in 26 of 997 in the balloon angioplasty group. Routine treatment with orbital atherectomy before drug-eluting stent implantation did not increase minimal stent area or reduce the rate of target vessel failure at 1 year compared with a balloon angioplasty-based approach in severely calcified lesions deemed eligible for both treatment strategies. These data support a balloon-first approach for most calcified coronary artery lesions that can be crossed and dilated before stent implantation, guided by intravascular imaging. Abbott Vascular (Abbott).

Severe coronary artery calcification has been associated with stent underexpansion, procedural complications, and increased rates of early and late adverse clinical events in patients undergoing percutaneous coronary intervention. To date, no lesion preparation strategy has been shown to definitively improve outcomes of percutaneous coronary intervention for calcified coronary artery lesions. ECLIPSE (NCT03108456) is a prospective, randomized, multicenter trial designed to evaluate two different vessel preparation strategies in severely calcified coronary artery lesions. The routine use of the Diamondback 360 Coronary Orbital Atherectomy System is compared with conventional balloon angioplasty prior to drug-eluting stent implantation. The trial aims to enroll approximately 2000 subjects with a primary clinical endpoint of target vessel failure, defined as the composite of cardiac death, target vessel-related myocardial infarction, or ischemia-driven target vessel revascularization assessed at 1 year. The co-primary endpoint is the acute post-procedural in-stent minimal cross-sectional area as assessed by optical coherence tomography in a 500-subject cohort. Enrollment is anticipated to complete in 2022 with total clinical follow-up planned for 2 years. ECLIPSE is a large-scale, prospective randomized trial powered to demonstrate whether a vessel preparation strategy of routine orbital atherectomy system is superior to conventional balloon angioplasty prior to implantation of drug-eluting stents in severely calcified coronary artery lesions.

Debulking techniques are often necessary for successful lesion preparation in percutaneous coronary intervention. The aim of this study was to compare plaque modification of severely calcified lesions by coronary intravascular lithotripsy (IVL) with that of rotational atherectomy (RA) using optical coherence tomography (OCT). ROTA.shock was a 1:1 randomized, prospective, double-arm, multicenter noninferiority trial designed to compare final minimal stent area after IVL with RA for lesion preparation in percutaneous coronary interventional treatment of severely calcified lesions. On the basis of OCT acquired before and immediately after IVL or RA in 21 of the 70 patients included, we performed a detailed analysis of the modification of the calcified plaque. After RA and IVL, calcified plaque fractures were present in 14 of the patients (67%), with a significantly greater number of fractures after IVL (3.23 ± 0.49) than after RA (1.67 ± 0.52; p < 0.001). Plaque fractures after IVL were longer than after RA (IVL: 1.67 ± 0.43 mm vs RA: 0.57 ± 0.55 mm; p = 0.01), resulting in a greater total volume of the fractures (IVL: 1.47 ± 0.40 mm3 vs RA: 0.48 ± 0.27 mm3; p = 0.003). Use of RA was associated with a greater acute lumen gain than was use of IVL (RA: 0.46 ± 0.16 mm2 vs IVL: 0.17 ± 0.14 mm2; p = 0.03). In conclusion, we were able to show differences in plaque modification of calcified coronary lesions by OCT: although RA leads to a greater acute lumen gain, IVL induces more and longer fractures of the calcified plaque.

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.

Rotational atherectomy (RA) is an effective, mature, and specific treatment for calcified lesions. However, the incidence of RA-related myocardial injury remains high and has not been adequately addressed. To assess the safety and efficacy of low-temperature RA-flush solution versus room-temperature RA-flush solution during RA. A total of 132 patients with moderate-to-severe calcified lesions who underwent RA were randomly assigned to the low-temperature RA-flush solution group or the room-temperature RA-flush solution group. The primary endpoint was RA-related myocardial injury, defined as any increase in myocardial biomarkers within 72 h after percutaneous coronary intervention (PCI). Secondary endpoints included RA-related myocardial infarction (MI), RA-related transient slow/no flow, or transient coronary spasm. A total of 78 patients (59.1%) had increased cardiac troponin I (cTnI) levels, and 60 patients (45.5%) had increased creatine kinase isoenzyme (CK-MB) levels after PCI. The number of patients with myocardial injury (primary endpoint), defined as elevated cTnI (47.0% vs. 71.2%, p  = 0.005) or elevated CK-MB (28.8% vs. 62.1%, p  < 0.001), was significantly lower in the low temperature group than in the room temperature group. The number of patients with RA-related transient slow/no flow (6.1% vs. 34.8%, p  < 0.001) and transient coronary spasm (9.1% vs. 25.8%, p  = 0.012) (secondary endpoints) was significantly lower in the low temperature group than in the room temperature group; no significant difference in the incidence of RA-related MI was observed between the two groups. Compared with room-temperature RA-flush solution, low-temperature RA-flush solution is associated with reduced RA-related myocardial injury in patients treated with RA. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03701230; first submitted registration date: 09/10/2018.

Background The purpose of this study was to evaluate the effectiveness of intravascular lithotripsy (IVL) in the treatment of severe coronary artery calcification (CAC) lesions. Methods In this study, we selected patients diagnosed with severe CAC lesions confirmed by coronary angiography (CAG) who were hospitalized in Yulin First People’s Hospital between December 2021 and December 2022 and required percutaneous coronary intervention (PCI). Using a random number table, we divided all patients into the IVL group and the PCI group in the order of interventional therapy. We compared both groups in terms of the surgical success rate, intraoperative manipulation characteristics, procedural complication, and cumulative incidence of major adverse cardiovascular events (MACE). Results (1) There were no differences in the surgical success rate, incidence of MACE, and occurrence of procedural complication between the two groups; (2) Compared with the conventional PCI group, patients in the IVL group used fewer predilatation balloons, and the difference was statistically significant (all P  < 0.05); (3) Compared with the conventional PCI group, patients in the IVL group had lesser surgery time and lesser radiation time, with lesser proportion of patients who were assisted with stent implantation using coronary artery rotational atherectomy, and this difference was statistically significant ( P  < 0.05); (4) The mean stent diameter and length in the IVL group was greater than those in the conventional PCI group but the difference was not statistically significant ( P  > 0.05). Conclusion In this study, we found that IVL was a highly safe and effective procedure in the treatment of severe CAC lesions that did not increase the surgery and radiation time, and it could also reduce the use of predilatation balloons, thus improving the management of CAC lesions. Thus, IVL can be a novel choice in treating severe CAC lesions.

Background Anastomotic leakage is the most important surgical complication following esophagectomy. A major cause of leakage is ischemia of the gastric tube that is used for reconstruction of the gastrointestinal tract. Generalized cardiovascular disease, expressed by calcifications of the aorta and celiac axis stenosis on a pre-operative CT scan, is associated with an increased risk of anastomotic leakage. Laparoscopic ischemic conditioning (ISCON) aims to redistribute blood flow and increase perfusion at the anastomotic site by occluding the left gastric, left gastroepiploic and short gastric arteries prior to esophagectomy. This study aims to assess the safety and feasibility of laparoscopic ISCON in selected patients with esophageal cancer and concomitant arterial calcifications. Methods In this prospective single-arm safety and feasibility trial based upon the IDEAL recommendations for surgical innovation, a total of 20 patients will be included recruited in 2 European high-volume centers for esophageal cancer surgery. Patients with resectable esophageal carcinoma (cT1-4a, N0–3, M0) with “major calcifications” of the thoracic aorta accordingly to the Uniform Calcification Score (UCS) or a stenosis of the celiac axis accordingly to the modified North American Symptomatic Carotid Endarterectomy Trial (NASCET) score on preoperative CT scan, who are planned to undergo esophagectomy are eligible for inclusion. The primary outcome variables are complications grade 2 and higher (Clavien-Dindo classification) occurring during or after laparoscopic ISCON and before esophagectomy. Secondary outcomes include intra- and postoperative complications of esophagectomy and the induction of angiogenesis by biomarkers of microcirculation and redistribution of blood flow by measurement of indocyanine green (ICG) fluorescence angiography. Discussion We hypothesize that in selected patients with impaired vascularization of the gastric tube, laparoscopic ISCON is feasible and can be safely performed 12–18 days prior to esophagectomy. Depending on the results, a randomized controlled trial will be needed to investigate whether ISCON leads to a lower percentage and less severe course of anastomotic leakage in selected patients. Trial registration Clinicaltrials.gov, NCT03896399 . Registered 4 January 2019.

Heavily calcified unprotected left main (ULM) disease continues to be a challenging situation and represent a high-risk subset for interventional cardiologist. To date, there are limited data investigating the results after rotational atherectomy (RA) in this setting. The aim of this study was to investigate the in-hospital and 1-year outcomes after RA of heavily calcified ULM lesions. A retrospective cohort analysis was performed on all calcified patients with ULM (n = 86) enrolled in the multicenter international ROTATE registry (overall patients, n = 962). End points of the study were the in-hospital and 1-year incidence of major adverse cardiovascular events (MACE): a composite of death, myocardial infarction, and target-vessel revascularization in the ULM versus non-ULM group. Patients in the ULM group were older (p = 0.01) and more frequently with diabetes (p = 0.001) compared with the non-ULM group, whereas intravascular ultrasound guidance was higher, even if not systematic, in the ULM group (p <0.001). No difference was reported between ULM versus non-ULM groups in terms of in-hospital MACE (5.8% vs 8%). At 1 year, MACE rate was higher in ULM versus non-ULM (26.4% vs 14.9%, p = 0.002) mostly driven by target-vessel revascularization (20.3% vs 12.7%, p = 0.05). Even definite/probable stent thrombosis rate was higher in the ULM group (3.9% vs 0.8%). All these events were subacute and 2/3 (75%) were fatal. In conclusion, our multicenter experience shows that RA followed by stent implantation in patients with heavily calcified ULM narrowing is feasible and associated with good in-hospital results. Patient (age and diabetes) and procedural aspects (relatively low intravascular ultrasound guidance) may affect the worse subacute mid-term prognosis in the more complex ULM group.

The treatment of calcified coronary lesions by percutaneous coronary intervention has been shown to be associated with poor outcomes and an increased rate of complications. However, the impact of coronary calcification in patients undergoing coronary artery bypass grafting (CABG) is unknown. A total of 755 patients presenting with acute coronary syndrome in the Acute Catheterization and Urgent Intervention Triage Strategy trial underwent CABG. Patients were divided into 3 groups according to the presence and extent of coronary calcifications (lesion level: severe, moderate, none to mild) as assessed by an independent angiographic core laboratory. Major ischemic and bleeding outcomes were assessed at 30 days and 1 year. Severe calcification was found in 103 patients (13.6%), moderate calcification in 249 patients (33.0%), and none-to-mild calcification in 403 patients (53.4%). The presence of severe calcification compared with moderate or none to mild was associated with a significantly higher unadjusted rate of death (11.8% vs 3.7% vs 4.5%, p = 0.006), death or myocardial infarction (MI; 31.1% vs 19.7% vs 16.4%, p = 0.006), and major adverse cardiac event (MACE; 32.0% vs 22.6% vs 20.8%, p = 0.059) at 1 year. By multivariate analysis, severe calcification (vs nonsevere calcification) was identified as an independent predictor of 1-year MACE (hazard ratio 1.49, 95% confidence interval 1.01 to 2.21, p = 0.04) and death or MI (hazard ratio 1.77, 95% confidence interval 1.18 to 2.66, p = 0.006). In conclusion, the presence of severe coronary calcification was associated with worse outcomes after CABG, including an increased risk of death. The presence of severe coronary calcification was identified as an independent predictor of MACE and death or MI 1 year after CABG.