Myocardial Perfusion SPECT and ATTR imaging 2021 in Germany: Results of the 9th Survey.

AIM: This paper presents the results of the 9th survey of myocardial perfusion SPECT (MPS) from the reporting year 2021. METHODS: 218 questionnaires (131 practices (PR), 58 hospitals (HO), 29 university hospitals (UH)) were evaluated. Results of the last survey 2018 are set in squared brackets. RESULTS: MPS data from a total of 133,057 [145,930] patients (-8.8%) with 131,868 [143,707] stress and 106,546 [121,899] rest MPS were analysed. A comparison with official data revealed that 54% all MPS were recorded. From 2018 to 2021, official data showed a every year an increase in MPS numbers. On average, 610 [502] MPS patients (+22%) were examined in each department. 74% [69%] of the responders reported an increase or no changes in their MPS patient numbers. Ambulatory care cardiologists represented as always, the mayor referral group (68% [69%]). For the first time, pharmacological stress was more frequently applied than ergometry (42% [51]). Regadenoson was mostly used. The use of the different protocols remained nearly unchanged. Two-day protocols were predominantly applied (49% [48%]). A shift from multi-headed cameras (58% [72%]) to SPECT-CT systems (24% [17%]) was found. Attenuation correction was performed in 33% [26%] of all MPS. 88% [86%] of all stress, 88% [87%] of all rest and 87% [83%] of all stress and rest MPS were acquired as gated SPECT. 72% [67%] of all departments performed scoring by default. The number of departments without scoring decreased to 13% [16%]. CONCLUSIONS: The MPS Study 2021 shows that the long-term positive development of MPS imaging in Germany is continuing. The COVID-19 pandemia did not change this trend. The procedural and technical details of MPS imaging reveal a high level of guideline conformity.

Five-Year Clinical Outcomes of the COBRA Polyzene F NanoCoated Coronary Stent System.

BACKGROUND/PURPOSE: The COBRA Polyzene F™ NanoCoated Coronary Stent System (PzF coated stent) stent demonstrated favorable clinical outcomes at 9 months but late results have not been reported. We sought to assess the late safety and effectiveness of the PzF coated stent for treatment of de novo coronary artery lesions. METHODS: Patients with de novo coronary artery lesions meeting eligibility criteria were enrolled in a non-randomized, prospective clinical trial and followed for 5 years. The primary endpoint was target vessel failure (TVF, cardiac death, myocardial infarction [MI], or clinically-driven target vessel revascularization [TVR]) at 9 months. Secondary endpoints included major adverse clinical events (MACE, cardiac death, MI, or clinically driven TLR), clinically driven target lesion revascularization (TLR) and definite or probable stent thrombosis during 5-year follow-up. Endpoints at 5 years were analyzed as cumulative incidence accounting for competing risk of death. RESULTS: Of 296 enrolled patients, 290 (98%) were evaluable at 5 years. By 5 years, MACE had occurred in 61 (21.3%), cardiac death in 11 (4.2%), MI in 25 (8.6%), and TLR in 34 (12.0%) subjects. Between follow-up years 1 and 5, a first MACE occurred in 17 (6.2%), including 10 (4.0%) cardiac death, 4 (1.6%) MI, and 7 (2.9%) TLR events. There were no definite or probable stent thromboses. CONCLUSIONS: The PzF coated stent demonstrated continued safety and effectiveness through 5 years with low to very low incident rates of MACE, MI, TLR and stent thrombosis between 1 and 5 years after stent placement.

Five-year clinical outcomes of zotarolimus-eluting stents in coronary total occlusions.

AIMS: Reports of long-term outcomes of patients treated with drug-eluting stents in total coronary occlusions are limited. We analysed clinical outcomes of patients treated with the zotarolimus-eluting Resolute stent (R-ZES) implanted in coronary total occlusions versus non-occluded lesions. METHODS AND RESULTS: Patients treated with R-ZES and included in four trials (RESOLUTE All Comers, RESOLUTE International, RESOLUTE China RCT, and RESOLUTE China Registry) were pooled and divided into three groups - patients with chronic total occlusions (CTO), patients with total occlusions that had occurred recently (rec-TO), and patients without total occlusions (non-TO). Clinical outcomes at five years were analysed. Of 5,487 patients treated with R-ZES in these trials, 8.0% had CTOs, 8.5% rec-TOs and 83.5% non-TOs. Patients had a mean age of 62.8 years, approximately 25% were female and 30% were diabetics. TLF was similar in the three groups at five years (TLF was 13.2%, 12.5% and 13.3% in the CTO, rec-TO and non-TO groups, respectively, p=0.96). Stent thrombosis tended to occur more frequently for rec-TO compared to CTO and non-TO patients (2.6% vs 1.2% and 1.3%, respectively, p=0.11). CONCLUSIONS: In this large population of patients who had R-ZES implanted, five-year clinical outcomes were similar whether or not the stents were implanted in total occlusions.

Identification of the type of stent with three-dimensional optical coherence tomography: the SPQR study.

BACKGROUND: The ability of optical coherence tomography (OCT) to identify specific types of stent has never been systematically studied. AIMS: The aim of this study was to test the accuracy of OCT imaging to identify patterns of stent platform and subsequently identify the type of stent implanted. METHODS: Consecutive patients from six international centres were retrospectively screened, searching for OCT studies with metallic stents or scaffolds. The sample was analysed by two blinded operators, applying a dedicated protocol in four steps to identify the type of stent: 1) 3D and automatic strut detection (ASD), 2) 3D tissue view, 3) longitudinal view with ASD, 4) mode "stent only" and ASD. RESULTS: A series of 212 patients underwent OCT in the study centres, finding 294 metallic stents or scaffolds in 146 patients. The protocol correctly identified 285 stents (96.9%, kappa 0.965), with excellent interobserver agreement (kappa 0.988). The performance tended to be better in recently implanted stents (kappa 0.993) than in stents implanted ≥3 months before (kappa 0.915), and in pullback speed 18 mm/s as compared with 36 mm/s (kappa 0.969 vs 0.940, respectively). CONCLUSIONS: The type of stent platform can be accurately identified in OCT by trained analysts following a dedicated protocol, combining 3D-OCT, ASD and longitudinal view. This might be clinically helpful in scenarios of device failure and for the quantification of apposition. The blinding of analysts in OCT studies should be revisited.

The REMEDEE trial: 5­Year results on a novel combined sirolimus­eluting and endothelial progenitor cells capturing stent

OBJECTIVES: To evaluate the long-term safety and efficacy of the novel combined sirolimus-eluting endothelial progenitor cell capture Combo stent (OrbusNeich, Fort Lauderdale, FL) at 5 years in the REMEDEE (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coated bio-Engineered stEnt) trial. BACKGROUND: Drug-eluting stents have limited restenosis and reintervention but are complicated by late and very late thrombosis and accelerated neoatherosclerosis. Alternative or adjunctive technologies are needed to address these limitations. METHODS: A total of 183 patients with de novo lesions in native coronary arteries were randomized 2:1 to Combo (n = 124) or Taxus Liberté (n = 59). Primary endpoint was 9 month angiographic in-stent late lumen loss and the secondary endpoint was the occurrence of major adverse events (MACE) through 5-year follow-up. RESULTS: Compared with Taxus, after 5 years the Combo stent was associated with similar rates of MACE (18.3% vs. 16.9%, p = .89), cardiac death (0.8% vs. 5.1%, p = .07), myocardial infarction (4.1% vs. 3.4%, p = .81), target lesion (9.4% vs. 10.2%, p = .78), and target vessel revascularization (14.4% vs. 11.9%, p = .73). No cases of definite stent thrombosis were reported in the Combo group. The follow-up rate at 5 years was 97.7%. CONCLUSION: At 5-year follow-up, the Combo stent remained clinically safe and effective with an overall low rate of MACE comparable to Taxus.

Author Correction: Cardiovascular risk algorithms in primary care: Results from the DETECT study.

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

Percutaneous Coronary Intervention in Stable Coronary Heart Disease -Is Less More?

BACKGROUND: This review concerns the putative benefit of percutaneous coronary intervention (PCI) over optimal medical therapy (OMT) for symptomatic patients with stable angina pectoris, or for asymptomatic persons in whom screening tests have revealed coronary heart disease (CHD; this entity has been newly designated chronic coronary syndrome, or CCS). Moreover, it addresses the question whether the indications for which PCI is now performed in Germany on patients with CCS are consistent with current scientific knowledge. METHODS: The pathophysiological concept of CHD and ischemia induction is discussed in the light of the scientific literature. This concept implies that PCI might be beneficial in the treatment of CCS. The benefit of PCI over OMT has now been evaluated in seven randomized trials (the so-called milestone trials). The current situation in Germany is presented here as well, on the basis of the available data. RESULTS: The pathophysiological concept of CHD implies that the particular coronary artery stenoses that are likely to give rise to a myocardial infarction (the so-called vulnerable plaques) cannot be identified prospectively with current methods. Moreover, a coronary artery stenosis will not necessarily cause myocardial ischemia. All of the randomized trials carried out to date that have compared OMT to PCI-plus-OMT in patients with CCS have led to the conclusion that PCI, because it focuses on individual coronary artery stenoses, cannot prolong survival or lower the incidence of myocardial infarction over the long term. This remains the case even if a single coronary artery stenosis is known to be causing moderate or severe myocardial ischemia (a conclusion of the ISCHEMIA trial). A PCI performed only because the coronary stenosis or stenoses meet certain morphological criteria, without any demonstration of a resulting functional disturbance, is generally detrimental to the health of the patient, with rare exceptions, and is inconsistent with the recommendations of current guidelines. The number of PCIs being performed in Germany at present is high compared to other countries; this arouses concern that the indications for it may be dubious in many cases. CONCLUSION: Current data imply that PCI for CCS does not improve outcomes in a large percentage of cases. A symptomatic benefit exists only in patients with frequent angina pectoris. The selection of CCS patients for PCI needs to be more strictly bound to the recommendations of current guidelines, particularly in Germany.

The REMEDEE trial: 5-Year results on a novel combined sirolimus-eluting and endothelial progenitor cells capturing stent.

OBJECTIVES: To evaluate the long-term safety and efficacy of the novel combined sirolimus-eluting endothelial progenitor cell capture Combo stent (OrbusNeich, Fort Lauderdale, FL) at 5 years in the REMEDEE (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coated bio-Engineered stEnt) trial. BACKGROUND: Drug-eluting stents have limited restenosis and reintervention but are complicated by late and very late thrombosis and accelerated neoatherosclerosis. Alternative or adjunctive technologies are needed to address these limitations. METHODS: A total of 183 patients with de novo lesions in native coronary arteries were randomized 2:1 to Combo (n = 124) or Taxus Liberté (n = 59). Primary endpoint was 9 month angiographic in-stent late lumen loss and the secondary endpoint was the occurrence of major adverse events (MACE) through 5-year follow-up. RESULTS: Compared with Taxus, after 5 years the Combo stent was associated with similar rates of MACE (18.3% vs. 16.9%, p = .89), cardiac death (0.8% vs. 5.1%, p = .07), myocardial infarction (4.1% vs. 3.4%, p = .81), target lesion (9.4% vs. 10.2%, p = .78), and target vessel revascularization (14.4% vs. 11.9%, p = .73). No cases of definite stent thrombosis were reported in the Combo group. The follow-up rate at 5 years was 97.7%. CONCLUSION: At 5-year follow-up, the Combo stent remained clinically safe and effective with an overall low rate of MACE comparable to Taxus.

[ESC guidelines 2019 on chronic coronary syndrome (CCS, previously "stable coronary artery disease") : What is new? What is particularly important?] / ESC-Leitlinie 2019 zum chronischen Koronarsyndrom (CCS, vormals "stabile KHK") : Was ist neu? Was ist besonders wichtig?

After an unusually long period of time of 6 years, in August 2019 the updated version of the European Society of Cardiology (ESC) guidelines from 2013 on the management of stable coronary artery disease was published. The course of "stable" coronary artery disease is only assumed to be stable and pathologically is often progressive but initially goes unnoticed. In order to raise awareness for the progressive character of "stable" coronary artery disease, the term chronic coronary syndrome (CCS) was introduced. In this overview the various phenotypes of CCS are divided into three groups. 1) Suspected obstructive coronary artery disease: the emphasis here is on functional, noninvasive imaging diagnostics of ischemia and cardiac computed tomography (CT). These diagnostic options have become even more important in the light of the decreasing prevalence of coronary artery disease. 2) Known obstructive coronary artery disease: here there are many new practice-relevant recommendations, particularly in the field of pharmaceutical treatment with antithrombotic drugs. 3) Microvascular disease: in symptomatic patients the exclusion of epicardial coronary stenoses using invasive coronary angiography should not signify the end of the diagnostic procedure. Functional tests in the catheter laboratory should be initiated in order not to overlook a microvascular cause of the complaints and do an injustice to the patient.

Impact of Periprocedural Myocardial Biomarker Elevation on Mortality Following Elective Percutaneous Coronary Intervention.

OBJECTIVES: This study sought to explore the association between biomarker elevation, with creatine kinase-myocardial band (CK-MB) or cardiac troponin (cTn), following percutaneous coronary intervention (PCI) and mortality in patients undergoing PCI for stable angina with normal baseline values. BACKGROUND: Several studies have shown a strong association between post-PCI CK-MB elevation and subsequent mortality. However, the prognostic significance of troponin elevation following coronary intervention is still debated. METHODS: Patient-level data from 5 contemporary coronary stent trials and 1 large registry were pooled. Mortality of patients with stable angina, with normal baseline biomarkers, was compared between patients with and those without different cutoff values of cTn and CK-MB. RESULTS: A total of 13,452 patients were included in this pooled analysis. The overall percentage of patients with elevated biomarkers following PCI was 23.9% for CK-MB and 68.4% for cTn. In the patient cohort for whom both assays were available (n = 8,859), 2.4% had both CK-MB ≥5 × the upper limit of normal (ULN) and cTn ≥35 × ULN, while 92% had both CK-MB <5 × ULN and cTn <35 × ULN. Among patients with CK-MB ≥5 × ULN (n = 315), 212 (67.3%) also had cTn ≥35 × ULN. Conversely, 390 of patients (64.8%) who had cTn ≥35 × ULN did not have CK-MB ≥5 × ULN. A total of 259 patients (1.9%) died at 1 year; 20 (7.7%) had CK-MB ≥5 × ULN, and 23 (8.8%) had cTn ≥35 × ULN. In the Cox multivariate analysis, in which the CK-MB and cTn ratios post-procedure were forced into the model, age, prior myocardial infarction, lesion complexity, hyperlipidemia, and CK-MB ratio (≥10) post-procedure were associated with increased 1-year mortality. CONCLUSIONS: Following elective PCI in patients in stable condition treated with second-generation drug-eluting stent, CK-MB and cTn elevations remain common. After multivariate adjustment, there was an increased mortality rate with elevation of CK-MB after PCI, whereas cTn elevation was not independently associated with mortality at 1 year.