Eugenio Martuscelli

Stent implantation versus balloon angioplasty in chronic coronary occlusions : Results from the GISSOC Trial

OBJECTIVES In this multicenter, randomized trial we evaluated whether stent implantation after successful recanalization of a chronic coronary occlusion reduced the incidence of restenosis. BACKGROUND Percutaneous transluminal coronary angioplasty (PTCA) in chronic total occlusions is associated with a higher rate of angiographic restenosis and reocclusion than PTCA in subtotal stenoses. Preliminary reports have suggested a decreased restenosis rate after stent implantation in coronary total occlusions. METHODS We randomly assigned 110 patients with recanalized total occlusion to Palmaz-Schatz stent implantation, followed by 1 month of anticoagulant therapy versus no other treatment. The primary end point was the minimal lumen diameter (MLD) of the treated segment at follow-up, as determined by quantitative angiography at a core laboratory. RESULTS Repeat coronary angiography was performed 9 months after the procedure in 88% of patients. The MLD (mean +/- SD) at follow-up was 1.74 +/- 0.88 mm in patients assigned to stent implantation and 0.85 +/- .75 mm in patients assigned to PTCA (p < 0.001). Stent implantation was associated with a lower incidence of restenosis (defined as diameter stenosis > or =50% at follow-up) (32% vs. 68%, p < 0.001) and reocclusion (8% vs. 34%, p = 0.003) than balloon PTCA. Likewise, stent-treated patients had less recurrent ischemia (14% vs. 46%, p = 0.002) and target lesion revascularization (5.3% vs. 22%, p = 0.038), but experienced a longer hospital stay. CONCLUSIONS Palmaz-Schatz stent implantation after successful balloon PTCA of chronic total occlusions improves the midterm angiographic and clinical outcome and could be the preferred treatment option in selected patients with occluded vessels.

Image Quality and Radiation Exposure With a Low Tube Voltage Protocol for Coronary CT Angiography: Results of the PROTECTION II Trial

OBJECTIVES The purpose of this study was to evaluate image quality and radiation dose using a 100 kVp tube voltage scan protocol compared with standard 120 kVp for coronary computed tomography angiography (CTA). BACKGROUND Concerns have been raised about radiation exposure during coronary CTA. The use of a 100 kVp tube voltage scan protocol effectively lowers coronary CTA radiation dose compared with standard 120 kVp, but it is unknown whether image quality is maintained. METHODS We enrolled 400 nonobese patients who underwent coronary CTA: 202 patients were randomly assigned to a 100 kVp protocol and 198 patients to a 120 kVp protocol. The primary end point was to demonstrate noninferiority in image quality with the 100 kVp protocol, which was assessed by a 4-point grading score (1 = nondiagnostic, 4 = excellent image quality). For the noninferiority analysis, a margin of -0.2 image quality score points for the difference between both scan protocols was pre-defined. Secondary end points included radiation dose and need for additional diagnostic tests during follow-up. RESULTS The mean image quality scores in patients scanned with 100 kVp and 120 kVp were 3.30 ± 0.67 and 3.28 ± 0.68, respectively (p = 0.742); image quality of the 100 kVp protocol was not inferior, as demonstrated by the 97.5% confidence interval of the difference, which did not cross the pre-defined noninferiority margin of -0.2. The 100 kVp protocol was associated with a 31% relative reduction in radiation exposure (dose-length product: 868 ± 317 mGy × cm with 120 kVp vs. 599 ± 255 mGy × cm with 100 kVp; p < 0.0001). At 30-day follow-up, the need for additional diagnostic studies did not differ (13.4% vs. 19.2% for 100 kVp vs. 120 kVp, respectively; p = 0.114). CONCLUSIONS A coronary CTA protocol using 100 kVp tube voltage maintained image quality, but reduced radiation exposure by 31% as compared with the standard 120 kVp protocol. Thus, 100 kVp scan protocols should be considered for nonobese patients to keep radiation exposure as low as reasonably achievable. (Prospective Randomized Trial on Radiation Dose Estimates of Cardiac CT Angiography in Patients Scanned With a 100 kVp Protocol [PROTECTION II]; NCT00611780).

Image quality and radiation exposure with prospectively ECG-triggered axial scanning for coronary CT angiography: The multicenter, multivendor, randomized PROTECTION-III Study

OBJECTIVES The purpose of this study was to evaluate image quality and radiation dose using a prospectively electrocardiogram (ECG)-triggered axial scan protocol compared with standard retrospective ECG-gated helical scanning for coronary computed tomography angiography. BACKGROUND Concerns have been raised regarding radiation exposure during coronary computed tomography angiography. Although the use of prospectively ECG-triggered axial scan protocols may effectively lower radiation dose compared with helical scanning, it is unknown whether image quality is maintained in a clinical setting. METHODS In a prospective, multicenter, multivendor trial, 400 patients with low and stable heart rates were randomized to either an axial or a helical coronary computed tomography angiography scan protocol. The primary endpoint was to demonstrate noninferiority in image quality with the axial scan protocol, which was assessed on a 4-point scale (1 = nondiagnostic, 4 = excellent image quality). Secondary endpoints included radiation dose and the rate of downstream testing during 30-day follow-up. RESULTS Image quality in patients scanned with the axial scan protocol (score 3.36 ± 0.59) was not inferior compared with helical scan protocols (3.37 ± 0.59) (p for noninferiority <0.004). Axial scanning was associated with a 69% reduction in radiation exposure (dose-length product [estimated effective dose] 252 ± 147 mGy · cm [3.5 ± 2.1 mSv] vs. 802 ± 419 mGy · cm [11.2 ± 5.9 mSv] for axial vs. helical scan protocols, p < 0.001). The rate of downstream testing did not differ (13.8% vs. 15.9% for axial vs. helical scan protocols, p = 0.555). CONCLUSIONS In patients with stable and low heart rates, the prospectively ECG-triggered axial scan protocol maintained image quality but reduced radiation exposure by 69% compared with helical scanning. Axial computed tomography data acquisition should be strongly recommended in suitable patients to avoid unnecessarily high radiation exposure.

Pharmacological modulation of β-adrenoceptor function in patients with coexisting chronic obstructive pulmonary disease and chronic heart failure ☆

Pharmacological modulation of beta-adrenoceptor function is one of the critical issues in the treatment of patients with concurrent chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF). A volume of published evidence sustains the role of long-acting beta(2)-agonists in the treatment of stable COPD, but beta-agonists seem to be detrimental when used for long term in CHF. beta(2)-agonists may exacerbate heart failure and, in any case, they induce adverse cardiac effects in COPD patients with pre-existing cardiovascular disease. The adverse effects of beta(2)-agonists are likely to be exacerbated in COPD patients with coexistent CHF. beta-Blockers are the standard treatment in CHF, but they can worsen FEV(1) and airway hyperresponsiveness and reluctance exists to prescribe these agents to COPD patients, despite the anticipated beneficial cardiovascular effects. Although the literature is reassuring, there are currently no prospective long-term studies on the safety of beta-blockers in COPD. Therefore, although beta-blockers can be introduced in any medical setting for treating patients with concurrent COPD and CHF, it still seems appropriate to only use those beta-blockers that are more selective for the beta(1)-AR but without ISA at the lowest dose and to titrate them slowly with attention to lung function and symptoms, adding an inhaled antimuscarinic agent when bronchodilation is needed.

Regression and shift in composition of coronary atherosclerotic plaques by pioglitazone: insight from an intravascular ultrasound analysis.

Background Plaque reduction with the use of pioglitazone and statin combination therapy has been observed in carotid plaque. We sought to investigate the effect of combination therapy with statins and pioglitazone on coronary plaque regression and composition with the use of intravascular ultrasound (IVUS) and intravascular ultrasound-virtual histology (IVUS-VH). Methods We analysed 29 plaques in 25 diabetic patients with angiographic evidence of nonsignificant coronary lesions with IVUS-VH. Patients were treated with 80 mg of atorvastatin and 30 mg of pioglitazone daily for 6 months. After 6 months of therapy, IVUS-VH of each lesion was reacquired. Results Mean elastic external membrane volume was significantly reduced between baseline and follow-up (343.9 vs. 320.5 mm3; P < 0.05) as was mean total atheroma volume (179.3 vs. 166.6 mm3; P < 0.05). Change in total atheroma volume showed a 6.3% mean reduction. Areas of fibrous tissue, fibrolipidic tissue and calcium decreased over the 6 months of follow-up, although not significantly. On the other hand, the necrotic core increased from 9 to 14% (P < 0.05). Conclusion Our data demonstrated that atorvastatin/pioglitazone association is able to induce significant regression of coronary atherosclerosis, acting on plaque composition. Our findings are preliminary results and will be confirmed in an ongoing randomized placebo-controlled multicenter trial (PIPER; Pioglitazone for Prevention of Restenosis in Diabetics with Complex Lesion; trial registration: clinical trials.gov. Identifier: NCT 00376870).

Effects of chronic treatment with the new ultra-long-acting β2-adrenoceptor agonist indacaterol alone or in combination with the β1-adrenoceptor blocker metoprolol on cardiac remodelling

The ability of a chronic treatment with indacaterol, a new ultra‐long‐acting β2‐adrenoceptor agonist, to reverse cardiac remodelling and its effects in combination with metoprolol, a selective β1‐adrenoceptor antagonist, were investigated on myocardial infarction in a rat model of heart failure (HF).

Individual patient data meta-analysis for the clinical assessment of coronary computed tomography angiography: protocol of the Collaborative Meta-Analysis of Cardiac CT (CoMe-CCT)

BackgroundCoronary computed tomography angiography has become the foremost noninvasive imaging modality of the coronary arteries and is used as an alternative to the reference standard, conventional coronary angiography, for direct visualization and detection of coronary artery stenoses in patients with suspected coronary artery disease. Nevertheless, there is considerable debate regarding the optimal target population to maximize clinical performance and patient benefit. The most obvious indication for noninvasive coronary computed tomography angiography in patients with suspected coronary artery disease would be to reliably exclude significant stenosis and, thus, avoid unnecessary invasive conventional coronary angiography. To do this, a test should have, at clinically appropriate pretest likelihoods, minimal false-negative outcomes resulting in a high negative predictive value. However, little is known about the influence of patient characteristics on the clinical predictive values of coronary computed tomography angiography. Previous regular systematic reviews and meta-analyses had to rely on limited summary patient cohort data offered by primary studies. Performing an individual patient data meta-analysis will enable a much more detailed and powerful analysis and thus increase representativeness and generalizability of the results. The individual patient data meta-analysis is registered with the PROSPERO database (CoMe-CCT, CRD42012002780).Methods/DesignThe analysis will include individual patient data from published and unpublished prospective diagnostic accuracy studies comparing coronary computed tomography angiography with conventional coronary angiography. These studies will be identified performing a systematic search in several electronic databases. Corresponding authors will be contacted and asked to provide obligatory and additional data. Risk factors, previous test results and symptoms of individual patients will be used to estimate the pretest likelihood of coronary artery disease. A bivariate random-effects model will be used to calculate pooled mean negative and positive predictive values as well as sensitivity and specificity. The primary outcome of interest will be positive and negative predictive values of coronary computed tomography angiography for the presence of coronary artery disease as a function of pretest likelihood of coronary artery disease, analyzed by meta-regression. As a secondary endpoint, factors that may influence the diagnostic performance and clinical value of computed tomography, such as heart rate and body mass index of patients, number of detector rows, and administration of beta blockade and nitroglycerin, will be investigated by integrating them as further covariates into the bivariate random-effects model.DiscussionThis collaborative individual patient data meta-analysis should provide answers to the pivotal question of which patients benefit most from noninvasive coronary computed tomography angiography and thus help to adequately select the right patients for this test.

Clinical recommendations on Cardiac-CT in 2015: a position paper of the Working Group on Cardiac-CT and Nuclear Cardiology of the Italian Society of Cardiology.

We worked out a position paper on cardiac-computed tomography (CCT) endorsed by the Working Group on CCT and Nuclear Cardiology of the Italian Society of Cardiology. The CCT clinical indications were discussed and formulated according to the following two modalities: a brief paragraph dedicated to each indication, with the description of clinical usefulness of different indications; and each indication was rated by the technical panel for appropriateness, using a score assessing whether the use of CCT for each indication is appropriate, uncertain, or inappropriate. All conventional CCT clinical indications, regarding coronary and noncoronary evaluation, were discussed and rated. Moreover, we wrote specific sections regarding the newest CCT applications, such as stress perfusion computed tomography, noninvasive evaluation of fractional flow reserve, and CCT use in athletes. The present study has the following two main objectives: because the diagnostic performance of coronary computed tomography angiography (CCTA) is strictly dependent on adequate technology and local expertise, we strove to provide clinical recommendations on CCTA that may help Italian physicians involved with this diagnostic tool; and to give an update on new indications of CCTA, such as its use for safely discharging patients with suspected acute coronary syndromes from the emergency department, and latest clinical results that have been made possible by the remarkable technology developments of the scanners.

Role of 64-slice cardiac computed tomography in the evaluation of patients with non-ST-elevation acute coronary syndrome

PurposeThis study was done to evaluate the feasibility, sensitivity and specificity of 64-slice computed tomography (CT) in identifying haemodynamically significant (>50%) coronary artery stenoses in patients with suspected acute coronary syndrome (ACS) by correlating the CT findings with the clinical event and data provided by conventional coronary angiography (CCA).Materials and methodsSixty-four patients (38 men and 26 women; mean age 65 years; range±10 years) presenting to our hospital’s emergency department with a clinical suspicion of ACS were studied with 64-slice CT followed by CCA within 24 h of arrival.ResultsTwo patients (3.1%) were excluded from the analysis due to artefacts. Per-patient analysis in the remaining 62 patients identified 24 cases (38.7%) of negative CT findings (no stenoses or stenoses <50%), 35 cases of positive CT findings (56.4%) with identification of the culprit lesion, two cases in which the culprit lesion was not identified and one patient with unconfirmed stenosis. Sensitivity and specificity were 94.6% and 96%, respectively. Per-vessel analysis (186 vessels) revealed 17 non-evaluable vessels (9.1%) due to motion artefacts, 61 vessels (32.8%) with stenosis >50%, seven overestimated vessels (3.7%) due to extensive calcifications, three vessels (1.6%) with underestimated stenosis and 98 vessels (52.6%) without stenosis. Sensitivity and specificity were 95.3% and 93.3%, respectively.ConclusionsIn this type of emergency, coronary CT angiography could lead to considerably lower healthcare costs by identifying patients without coronary disease and allowing immediate discharge without any need for further diagnostic procedures.RiassuntoObiettivoScopo di questo lavoro è stato valutare fattibilità, sensibilità e specificità della tomografia computerizzata (TC)-volumetrica a 64 strati nell’identificazione di stenosi emodinamicamente significative (>50%) delle arterie coronarie in soggetti con sospetta sindrome coronarica acuta (SCA), correlando il reperto TC con l’evento clinico del paziente e confrontando successivamente i dati ottenuti con quelli della coronarografia convenzionale (CC).Materiali e metodiSessantaquattro pazienti (38 maschi e 26 femmine, età 65±10 anni) pervenuti presso il Pronto Soccorso (PS) del nostro policlinico universitario con sospetta SCA sono stati sottoposti a TC-volumetrica a 64strati e a successiva CC entro 24 ore dalla presentazione in PS.RisultatiDue pazienti (3,1%) sono stati totalmente esclusi per artefatti. L’analisi per paziente dei rimanenti 62 ha visto 24 pazienti (38,7%) negativi allo studio TC (stenosi assenti o <50%), 35 pazienti (56,4%) positivi, con identificazione della lesione culprit, 2 pazienti dove non è stato possibile identificare la lesione culprit ed 1 paziente con stenosi non confermata; sensibilità e specificità sono risultate del 94,6% e del 96%. L’analisi globale per coronaria (186 vasi) ha evidenziato 17 vasi (9,1% non valutabili per artefatti da movimento, 61 vasi (32,8%) con stenosi>50%, 7 vasi (3,7%) sovrastimati per presenza di estese calcificazioni, 3 vasi (1,6%) sottostimati circa la significatività della stenosi e 98 vasi (52,6%) privi di stenosi. I valori della sensibilità e della specificità sono risultati del 95,3% e del 93,3%.ConclusioniL’utilizzo della coronaro-TC nella pratica clinica, in questo tipo di emergenze, potrebbe incidere in maniera ragguardevole sui costi del Sistema Sanitario, stratificando i pazienti privi di patologia coronarica o di altra patologia e consentendone la dimissione in tempi immediati, senza necessità di ulteriori indagini diagnostiche.

Coronary-to-bronchial artery fistula in a patient with multivessel coronary disease treated by percutaneous coronary intervention.

We describe the case of a 78-year-old patient, admitted to our hospital with an acute coronary syndrome. Coronary angiography showed multivessel coronary artery disease and an anomalous coronary vessel branching from the right coronary artery. After successful percutaneous revascularization and discharge, the anomalous vessel was diagnosed by contrast enhanced 64-multidetector computed tomography as a coronary-to-bronchial fistula. Since the patient was asymptomatic, conservative treatment was selected.