Intracoronary EnalaPrilat to Reduce MICROvascular Damage During Percutaneous Coronary Intervention (ProMicro) study.

Intracoronary angiotensin-converting enzyme inhibitors have been shown to relieve myocardial ischemia in stable patients and to improve epicardial flow in patients with ST-segment elevation myocardial infarction. Yet, it is still unclear whether these effects are mediated by a modulation of the coronary microcirculation. Methods We randomly assigned 40 patients to receive either an intracoronary bolus of enalaprilat (50 g) or placebo before elective PCI. The index of microvascular resistance was measured at baseline, 10 minutes after study drug administration, and after PCI. High-sensitivity cardiac troponin T was measured as a marker of myocardial injury. Results Infusion of enalaprilat resulted in a significant reduction in index of microvascular resistance (27 11 at baseline vs. 19 9 after drug vs. 15 8 after PCI), whereas a significant post-procedural increase in index of microvascular resistance levels was observed in the placebo group (24 15 at baseline vs. 24 15 after drug vs. 33 19 after PCI). Index of microvascular resistance levels after PCI were significantly lower in the enalaprilat group (p 0.001). Patients pre-treated with enalaprilat also showed lower peak values (mean: 21.7 ng/ml, range: 8.2 to 34.8 ng/ml vs. mean: 32.3 ng/ml, range: 12.6 to 65.2 ng/ml, p 0.048) and peri-procedural increases of high-sensitivity cardiac troponin T (mean: 9.9 ng/ml, range: 2.7 to 19.0 ng/ml vs. mean: 26.6 ng/ml, range: 6.3 to 60.5 ng/ml, p 0.025). Conclusions Intracoronary enalaprilat improves coronary microvascular function and protects myocardium from procedurerelated injury in patients with coronary artery disease undergoing PCI. Larger studies are warranted to investigate whether these effects of enalaprilat could result into a significant clinical benefit. (J Am Coll Cardiol 2013;61:615–21) © 2013 by the American College of Cardiology Foundatio

Cardiovascular Outcomes Following Rotational Atherectomy: A UK Multicentre Experience

Objectives: To identify factors associated with outcomes following rotational atherectomy (RA). Background: RA is an effective way to mechanically modify heavily calcified lesions before stenting; however its outcomes are not well defined. Methods and Results: Retrospective evaluation of all patients who underwent RA in three large UK centers (Leeds General Infirmary (LGI), Royal Infirmary of Edinburgh (RIE) and University Hospital of North Staffordshire (UHNS)) from March 2005 to January 2013. Five hundred and eighteen patients had RA with median follow-up period of 22 months. About 68.3% were male, 28.7% had DM and 34.6% were treated because of ACS. Stents were deployed in 97.3% of the patients while 30.7% of the procedures were performed transradially. Maximum burr was ≤1.75 mm in 85.5% and the mean SYNTAX score was 19.5 ± 11.6. Peri-procedural complications occurred in 6.4% and vascular access complications in 1.9%. Outcomes in the follow-up period were: MACE 17.8%, cardiac death 7.1%, MI 11.7%, TVR 7.5%, all-cause death 13.7%, definite stent thrombosis (ST) 1.4% and stroke 2.9%. Patients with intermediate and high SYNTAX scores were more likely to suffer MACE, cardiac death, MI, all-cause death and ST. Patients with a SYNTAX score >32 were also more likely to have a peri-procedural complication. Multiple logistic regression analysis showed that the presence of PVD (P = 0.026, OR = 2.0), DM (P = 0.008, OR = 2.1), ACS presentation (P = 0.011, OR = 2.1) and SYNTAX score ≥23 (P = 0.02, OR = 1.9) had a significant association with MACE. Conclusions: RA is safe and effective, with high rate of procedural success and relatively low incidence of MACE. PVD, DM, ACS presentation and SYNTAX score were significant predictors for MACE. © 2016 Wiley Periodicals, Inc

Prevalence and Prognostic Impact of Coronary Chronic Total Occlusions in Patients With Cardiogenic Shock

Background: Mortality in patients with cardiogenic shock (CS) remains high despite advanced treatment strategies in CS patients, underlining the need for the identification of predictors of prognosis in CS patients. Therefore, the present study investigates the prognostic impact of coronary chronic total occlusions (CTO) in patients with CS. Methods: All consecutive patients being acutely admitted with CS to an intensive care unit (ICU) and undergoing invasive coronary angiography (ICA) from 2019 to 2021 were included, irrespective of the etiology of CS. Patients with at least one CTO were compared to non-CTO patients with regard to the risk of all-cause mortality at 30 days. Further risk stratification was performed according to the extent of coronary artery disease (CAD). Results: A total of 192 CS patients undergoing ICA during index hospitalization were included. At least one CTO was present in 24% of CS patients. Patients with CTO were older (median 78 vs. 68; p = 0.001) and presented more frequently with non-ST-elevated myocardial infarction (21% vs. 12%; p = 0.048). The presence of a CTO was associated with higher rates of 30-days all-cause mortality (70.2% vs. 47.6%; HR = 1.783, 95% CI 1.176-2.702; p = 0.009), even after multivariable adjustment (adjusted HR = 1.898; 95% CI 1.116-3.229; p = 0.018). Patients with CTO were accompanied by an even higher 30-days all-cause mortality as compared to patients with multi-vessel CAD without CTO (adjusted HR = 1.723; 95% CI 1.058-2.805; p = 0.029). Conclusion: Coronary CTO are common in patients with CS and represent an independent predictor of all-cause mortality at 30 days

Coronary Chronic Total Occlusions Affect Long-Term Prognosis in Heart Failure With Mildly Reduced Ejection Fraction

Background: This study investigates the prevalence and prognostic impact of coronary chronic total occlusions (CTO) in patients with heart failure with mildly reduced ejection fraction (HFmrEF). Although coronary artery disease (CAD) represents the leading HF etiology in HFmrEF, data about CTO in this population are rare. Methods: All consecutive patients with HFmrEF (ie, left ventricular ejection fraction 41%-49% with signs and/or symptoms of heart failure) undergoing invasive coronary angiography from 2016 to 2022 were included retrospectively. Patients with at least one CTO were compared to patients without CTO, further risk stratification was performed according to the extend of CAD. The primary end point was long-term all-cause mortality at 30 months (ie, median follow-up). Secondary end points comprised of major adverse cardiac and cerebrovascular events (MACCE), HF-related and cardiac rehospitalization at 30 months. Furthermore, the association of percutaneous coronary intervention (PCI) with long-term outcomes was investigated. Results: 71% of patients with HFmrEF (1545/2184, primary cohort) underwent invasive coronary angiography. In patients undergoing invasive coronary angiography related to the index hospitalization, CAD was present in 81% (836/1037, final cohort), with a corresponding rate of CTO at 17% (n=141). Coronary CTO was associated with the highest rate of the primary end point (33%) compared with non-CTO (19%), single-vessel (12%) and multivessel CAD (21%) in HFmrEF (P=0.001). Accordingly, HFmrEF patients with CTO had the highest rates of various secondary endpoints, including long-term MACCE compared to non-CTO patients (60% versus 32%, P=0.001). Successful CTO-PCI was associated with improved long-term survival (21% versus 38%; hazard ratio, 0.49 [95% CI, 0.24-0.99]; P=0.046). Conclusions: Coronary CTO are common in HFmrEF with a significant impact on long-term prognosis

Drug-Coated Balloons in the European Registry of Chronic Total Occlusion:The ERCTO Registry

Background: Drug-coated balloons (DCBs) are increasingly used in percutaneous coronary intervention (PCI). Their application for chronic total occlusions (CTOs) is a promising option to limit stent length in diffuse disease and avoid stent underexpansion and malapposition in negatively remodeled distal vessel segments. Objectives: The aim of this study was to analyze CTO PCI procedures recorded in ERCTO (European Registry of Chronic Total Occlusion) to investigate frequency of use, patient and lesion characteristics, and in-hospital outcomes of DCBs. Methods: CTO cases entered into the database from 2016 to 2023 were examined and categorized according to DCB use. DCB-treated patients were further divided into 2 groups: DCBs only and DCBs in association with drug-eluting stents. To minimize the potential impact of confounding factors, 1:1 propensity score matching was applied. Results: Of 40,449 CTO PCIs performed at 184 centers, DCBs were used in 2,506 (6.2%), increasing from 3.4% (n = 185 of 5,498) in 2016 to 14.9% (n = 705 of 4,722) in 2023. In-hospital complications were infrequent, but DCB-treated CTOs had significantly lower rates of pericardial tamponade (0.1% [n = 2 of 2,506] vs 0.4% [n = 169 of 37,943]; P = 0.006). After propensity score matching, DCB use led to reduced drug-eluting stent length (44.2 ± 36.9 mm [95% CI: 42.7-45.7 mm] vs 58.1 ± 35.9 mm [95% CI: 56.7-59.5] mm; P &lt; 0.001). Contrast volume was lower in the DCB-treated patients (202.4 ± 109.8 mL [95% CI: 198.1-206.7 mL] vs 211.6 ± 123 mL [95% CI: 206.8-216.4 mL]; P = 0.005). Conclusions: The use of DCBs in CTO recanalization is increasing and is associated with a reduction in the length of stents implanted, as well as a decrease in contrast volume and a lower rate of pericardial tamponade.</p

Procedural Impact of Advanced Calcific Plaque Modification Devices Within Percutaneous Revascularization of Chronic Total Occlusions

Background: Significant calcifications within a coronary chronic total occlusion (CTO) increase procedural complexity and the risk for complications. Expert consensus documents recommend the use of advanced calcific plaque modification devices (ACPMDs) for calcified CTO percutaneous coronary intervention (PCI), whereas data on their procedural impact are limited. Objectives: The aim of this study was to describe trends, settings, and outcomes of PCI of severely calcified CTO performed with and without ACPMDs. Methods: Data from 15,329 CTO PCIs enrolled in the ERCTO (European Registry of Chronic Total Occlusion) between 2021 and 2023 were analyzed. On the basis of the presence of severe calcifications within the CTO, the study population was divided into 2 groups: nonsevere (n = 12,289) and severe (n = 3,040) calcium. Then, the severe group was divided into non-ACPMD (n = 2,253) and ACPMD (n = 787), according to the use of ACPMDs. Results: Compared with the non-ACPMD group, the ACPMD group had higher rates of antegrade wiring (77.9% vs 49.2%; P &lt; 0.001) and technical success (97.6% vs 79.1%; P = 0.001) and lower rates of periprocedural and in-hospital major adverse cardiac and cerebrovascular events (MACCE) (1.8% vs 3.5%; P = 0.001). A severe amount of calcium was independently associated with technical failure (OR: 3.13; 95% CI: 2.43-4.09; P &lt; 0.001) but not with MACCE (OR: 0.88; 95% CI: 0.58-1.35; P = 0.15). Furthermore, extraplaque crossing was independently associated with MACCE (antegrade dissection and re-entry without retrograde contribution: OR: 3.12; 95% CI: 1.79-4.20; P &lt; 0.001; antegrade dissection and re-entry with retrograde contribution: OR: 3.12; 95% CI: 1.67-4.11; P = 0.049; retrograde dissection and re-entry: OR: 1.90; 95% CI: 1.25-2.86; P = 0.002). Conclusions: Applying ACPMDs in severely calcified CTO to PCI was associated with higher technical success and lower MACCE rates. The presence of severe coronary calcification on coronary angiography was a marker of clinical and procedural complexity and was associated with technical failure but not with MACCE.</p

Reclassification of CTO Crossing Strategies in the ERCTO Registry According to the CTO-ARC Consensus Recommendations

Background: The CTO-ARC (Chronic Total Occlusion Academic Research Consortium) recognized that a nonstandardized definition of chronic total occlusion (CTO) percutaneous coronary intervention approaches can bias the complications' attribution to each crossing strategy. Objectives: The study sought to describe the numbers, efficacy, and safety of each final CTO crossing strategy according to CTO-ARC recommendations. Methods: In this cross-sectional study, data were retrieved from the European Registry of Chronic Total Occlusions between 2021 and&nbsp;2022. Results: Out of 8,673 patients, antegrade and retrograde approach were performed in 79.2% and 20.8% of cases, respectively. The antegrade approach included antegrade wiring and antegrade dissection and re-entry, both performed with or without retrograde contribution (antegrade wiring without retrograde contribution: n = 5,929 [68.4%]; antegrade wiring with retrograde contribution: n&nbsp;=&nbsp;446 [5.1%]; antegrade dissection and re-entry without retrograde contribution: n&nbsp;=&nbsp;353 [4.1%]; antegrade dissection and re-entry with retrograde contribution: n&nbsp;=&nbsp;137 [1.6%]). The retrograde approach included retrograde wiring (n&nbsp;=&nbsp;735 [8.4%]) and retrograde dissection and re-entry (n&nbsp;=&nbsp;1,073 [12.4%]). Alternative antegrade crossing was associated with lower technical success (70% vs 86% vs 93.1%, respectively; P &lt; 0.001) and higher complication rates (4.6% vs 2.9% vs 1%, respectively; P &lt; 0.001) as compared with retrograde and true antegrade crossing. However, alternative antegrade crossing was applied mostly as a rescue strategy (96.1%). Conclusions: The application of CTO-ARC definitions allowed the reclassification of 6.7% of procedures as alternative antegrade crossing with retrograde or antegrade contribution which showed higher MACCE and lower technical success rates, as compared with true antegrade and retrograde crossing

Procedural Impact of Advanced Calcific Plaque Modification Devices Within Percutaneous Revascularization of Chronic Total Occlusions.

Background: Significant calcifications within a coronary chronic total occlusion (CTO) increase procedural complexity and the risk for complications. Expert consensus documents recommend the use of advanced calcific plaque modification devices (ACPMDs) for calcified CTO percutaneous coronary intervention (PCI), whereas data on their procedural impact are limited. Objectives: The aim of this study was to describe trends, settings, and outcomes of PCI of severely calcified CTO performed with and without ACPMDs. Methods: Data from 15,329 CTO PCIs enrolled in the ERCTO (European Registry of Chronic Total Occlusion) between 2021 and 2023 were analyzed. On the basis of the presence of severe calcifications within the CTO, the study population was divided into 2 groups: nonsevere (n = 12,289) and severe (n = 3,040) calcium. Then, the severe group was divided into non-ACPMD (n = 2,253) and ACPMD (n = 787), according to the use of ACPMDs. Results: Compared with the non-ACPMD group, the ACPMD group had higher rates of antegrade wiring (77.9% vs 49.2%; P &lt; 0.001) and technical success (97.6% vs 79.1%; P = 0.001) and lower rates of periprocedural and in-hospital major adverse cardiac and cerebrovascular events (MACCE) (1.8% vs 3.5%; P = 0.001). A severe amount of calcium was independently associated with technical failure (OR: 3.13; 95% CI: 2.43-4.09; P &lt; 0.001) but not with MACCE (OR: 0.88; 95% CI: 0.58-1.35; P = 0.15). Furthermore, extraplaque crossing was independently associated with MACCE (antegrade dissection and re-entry without retrograde contribution: OR: 3.12; 95% CI: 1.79-4.20; P &lt; 0.001; antegrade dissection and re-entry with retrograde contribution: OR: 3.12; 95% CI: 1.67-4.11; P = 0.049; retrograde dissection and re-entry: OR: 1.90; 95% CI: 1.25-2.86; P = 0.002). Conclusions: Applying ACPMDs in severely calcified CTO to PCI was associated with higher technical success and lower MACCE rates. The presence of severe coronary calcification on coronary angiography was a marker of clinical and procedural complexity and was associated with technical failure but not with MACCE

Crystalline sirolimus-coated balloon (cSCB) angioplasty in an all-comers, patient population with stable and unstable coronary artery disease including chronic total occlusions: rationale, methodology and design of the SCORE trial

Background A decade ago, the iopromide-paclitaxel coated balloon (iPCB) was added to the cardiologist‘s toolbox to initially treat in-stent restenosis followed by the treatment of de novo coronary lesions. In the meantime, DES technologies have been substantially improved to address in-stent restenosis and thrombosis, and shortened anti-platelet therapy. Recently, sirolimus-coated balloon catheters (SCB) have emerged to provide an alternative drug to combat restenosis. Methods The objective of this study is to determine the safety and efficacy of a novel crystalline sirolimus-coated balloon (cSCB) technology in an unselective, international, large-scale patient population. Percutaneous coronary interventions of native stenosis, in-stent stenosis, and chronic total occlusions with the SCB in patients with stable coronary artery disease or acute coronary syndrome were included. The primary outcome variable is the target lesion failure (TLF) rate at 12 months, defined as the composite rate of target vessel myocardial infarction (TV-MI), cardiac death or ischemia-driven target lesion revascularization (TLR). The secondary outcome variables include TLF at 24 months, ischemia driven TLR at 12 and 24 months and all-cause death, cardiac death at 12 and 24 months. Discussion Since there is a wealth of patient-based all-comers data for iPCB available for this study, a propensity-score matched analysis is planned to compare cSCB and iPCB for the treatment of de novo and different types of ISR. In addition, pre-specified analyses in challenging lesion subsets such as chronic total occlusions will provide evidence whether the two balloon coating technologies differ in their clinical benefit for the patient. Trial registration number ClinicalTrials.gov Identifier: NCT04470934.Open Access funding enabled and organized by Projekt DEAL.Open Access funding enabled and organized by Projekt DEAL.B.Braun MelsungenFriedrich-Schiller-Universität Jena (1010)Friedrich-Schiller-Universität Jena (1010