Coronary vasomotor function and myocardial flow with bioresorbable vascular scaffolds or everolimus-eluting metallic stents: a randomised trial.

AIMS: The aim of this study was to compare the hyperaemic flow and vasomotor response to endothelium-dependent stimuli between bioresorbable vascular scaffolds (BVS) and metallic everolimus-eluting stents (EES) at 13 months. METHODS AND RESULTS: Seventy non-diabetic patients aiming to achieve complete revascularisation were randomised 1:1 to BVS or EES implantation. At 13 months, invasive coronary angiography was performed using intracoronary pressure and Doppler ultrasound measurements at rest and maximal hyperaemia. A vasomotor test to endothelium-dependent (acetylcholine) and independent (nitroglycerine) stimuli and optical coherence tomography (OCT) were also performed. Fifty-nine patients (30 BVS and 29 EES) underwent 13-month examination. Doppler ultrasound average peak velocity (49.0±17.5 vs 49.3±18.3 cm/sec; p=0.95), coronary blood flow (97.4±53.5 vs 88.3±46.7 ml/min; p=0.51), coronary flow reserve (2.6±0.9 vs 2.7±0.8; p=0.84) and fractional flow reserve (0.92±0.06 vs 0.94±0.04; p=0.17) were similar between the groups. The vasomotor test showed vasoconstriction response to acetylcholine in 75.6% proximal and 72.2% distal peri-scaffold segments without differences between study devices. BVS had larger in-scaffold vasoconstriction than EES (60.0% vs 27.6%; p=0.01) despite similar neointima response as assessed by OCT. CONCLUSIONS: BVS and EES had similar microcirculatory response to hyperaemia and predominant vasoconstrictive response in the peri-scaffold segments to endothelium-dependent stimuli. However, BVS exhibited larger vasoconstriction to endothelium-dependent stimuli in the scaffold segment.

Ticagrelor versus clopidogrel for recovery of vascular function immediately after successful chronic coronary total occlusion recanalization: A randomized clinical trial.

Coronary vascular function of a chronic coronary total occlusion (CTO) immediately after recanalization is known to be poor. We sought if ticagrelor may augment adenosine-induced coronary blood flow vs. clopidogrel immediately after successful CTO percutaneous coronary intervention (PCI).

One-year optical coherence tomography findings in patients with late and very-late stent thrombosis treated with intravascular imaging guided percutaneous coronary intervention.

Patients with late/very-late stent thrombosis (ST) are at high risk of recurrent-ST. The mechanisms of recurrent-ST are largely unknown. The objective is to describe the 1-year optical coherence tomography (OCT) findings of patients suffering from late/very-late ST treated with intravascular imaging guided percutaneous coronary intervention (PCI). All consecutive patients with late/very-late ST undergoing intravascular imaging guided PCI were screened to undergo coronary angiography and OCT examination at 1 year. Patients were classified according to the observation of stent malapposition as most contributing cause of the ST. Thirty-four patients were included. Stent malapposition was observed in 17 (50%) and the remaining 17 cases were classified as: neoatherosclerosis (n = 9), underexpansion (n = 3) and unknown mechanism (n = 5). Patients with malapposition had a remarkable reduction of the malapposition volume (from 6.4 to 1.3 mm3; p = 0.02) during the ST procedure, but this was not fully corrected in 13 (76.5%). At 12 months, two patients of the malapposition group presented with uneventful target vessel re-occlusion. Persistent malapposition was observed in nine patients (60.0%). Major coronary evaginations (46.7 vs. 0%; p = 0.001) and uncovered struts (6.3 vs. 1.0%; p < 0.001) were also more frequent in patients with malapposition than without malapposition. None of the patients had thin-cap fibroatheroma neoatherosclerosis. Contributing causes of late/very-late ST are diverse and have different healing patterns at 12 months. Patients with stent malapposition treated with intravascular imaging guided PCI showed poor re-healing; but patients with other causes of the ST showed optimal stent healing as assessed by OCT.

Temporal trends in frequency, management and outcomes of coronary perforations.

BACKGROUND: Coronary perforations (CP) have been described as a rare but potentially fatal complication in percutaneous coronary interventions (PCI). Our aim is to compare temporal trends in frequency, management and outcomes of coronary perforations (CP). METHODS: All cases of CP recorded in our prospective institutional percutaneous coronary intervention (PCI) registry from 2003 to 2015 were included. Patients were divided in 2 groups according to the time frame in which the CP occurred: the early period (before 2009, when the chronic total occlusions and primary PCI programs started) and the current period. The primary endpoint was the composite of in-hospital serious adverse events, including final TIMI flow 0-1, cardiac tamponade, emergent cardiac surgery or death. RESULTS: Overall, 88 CP occurred in 17,566 procedures (0.50%). Of these, 17 (0.26%) occurred during the early period and 71 (0.64%) during the current period (P<0.001). CP management differed between groups, with less CP sealed by intracoronary devices in the early period than in the current one (23.5% vs. 47.9%, P=0.068). Moreover, patients with CP during the early period experienced more in-hospital serious adverse events (69% vs. 31% respectively, OR 3.18, 95% CI: 1.07-9.45, P=0.037). CONCLUSIONS: Expansion of indications and complexity of PCI in the current era may be associated with an increased frequency of CP. However, progress in technical and device management of CP have led to an improvement in the prognosis of this feared complication.

TIcaGrEloR and Absorb bioresorbable vascular scaffold implantation for recovery of vascular function after successful chronic total occlusion recanalization (TIGER-BVS trial): Rationale and study design.

OBJECTIVES: To explore the role of ticagrelor versus clopidogrel in coronary blood flow normalization immediately after chronic coronary total occlusion (CTO) recanalization. BACKGROUND: Coronary vascular function of a CTO immediately after recanalization is demonstrated to be poor. METHODS: The TIGER BVS is a prospective, double-randomized, open-label, two parallel-group controlled clinical trial to evaluate efficacy of ticagrelor versus clopidogrel in improving vascular function of coronary segment distal to CTO immediately after CTO recanalization. A total of 50 patients who receive CTO PCI will be randomized 1:1 to receive ticagrelor versus clopidogrel at least 3 days before the procedure. Immediately after CTO recanalization with Absorb BVS implantation, a specific study of vascular function under adenosine infusion will be performed. Patients will be therefore randomized 1:1 to receive angiographic follow-up with vascular function and optical coherence tomography analyses at 1- or 3-year follow-up. This study is registered on ClinicalTrials.gov with number NCT02211066. CONCLUSIONS: The TIGER BVS trial will provide the first randomized comparison between ticagrelor versus clopidogrel in recovering vascular function in CTO patients. It will also provide important data on vascular restoration therapy of Absorb BVS in this scenario.

Association between coronary atherosclerosis progression and in-stent neoatherosclerosis in patients with ST-elevation myocardial infarction at five-year follow-up.

AIMS: The aim of the study was to investigate the association between in-stent neoatherosclerosis (NA) and atherosclerosis progression (AP) in non-culprit segments in patients with ST-elevation myocardial infarction at five years. METHODS AND RESULTS: Sixty-two out of 169 consecutive patients included in the EXAMINATION study underwent optical coherence tomography (OCT) at five years. NA plaques were observed in 13 (21.0%), signal-rich bands (SRB) in 22 (35.5%) and AP in 11 (17.7%). NA plaques were more frequently observed in patients treated with two stents (53.8% vs. 20.4%; p=0.02). SRB were more frequently observed with longer stent length (29.8±11.6 vs. 22.5±9.1 mm; p<0.01), larger stent size (3.4±0.4 vs. 3.1±0.4 mm; p<0.01) and with bare metal stents (BMS) (68.2% vs. 40.0%; p=0.03). Patients with AP had higher levels of LDL-cholesterol (108.3±27.1 vs. 86.3±27.6 mg/dl; p=0.02). QCA of 744 non-culprit segments showed no association between NA plaques or SRB and reduction of lumen diameters. By multivariate analysis, NA plaques were associated with stent length; SRB were associated with stent length and BMS. AP was associated with mean LDL-cholesterol levels. CONCLUSIONS: NA and SRB had no association with AP or with LDL-cholesterol. NA and SRB were associated with stent-related factors such as stent length and BMS. AP was associated with LDL-cholesterol levels.

Five-Year Optical Coherence Tomography in Patients With ST-Segment-Elevation Myocardial Infarction Treated With Bare-Metal Versus Everolimus-Eluting Stents.

BACKGROUND: The main causes of late (>1 month) stent thrombosis (ST) are stent uncoverage, malapposition, and neoatherosclerosis. First-generation drug-eluting stents were associated with higher rate of late ST compared with bare-metal stents (BMS), especially in patients with ST-segment-elevation myocardial infarction. Second-generation everolimus-eluting stents (EES) have shown similar rate of late ST than BMS. The aims of the study are to compare the ratio of uncovered to total struts per cross-section ≥30% and other optical coherence tomographic findings associated with ST between EES and BMS in patients with ST-segment-elevation myocardial infarction at 5 years. METHODS AND RESULTS: One hundred and sixty-nine consecutive event-free patients of the randomized EXAMINATION study (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-Segment Elevation Myocardial Infarction) were screened for optical coherence tomographic imaging at 5 years. Patients with target vessel-related events or life-threatening comorbidities were excluded. Finally, 64 patients (32 EES and 32 BMS) underwent optical coherence tomographic imaging. At 5 years, uncovered struts (4.1% versus 1.0%; P<0.01), length of uncoverage (3.4 versus 1.4 mm; P=0.02), and ratio of uncovered to total struts per cross-section ≥30% (35.5% versus 9.7%; P=0.02) were larger with EES than that with BMS. Malapposed struts (1.2% versus 0.3%; P=0.02) and malapposition length (1.3 versus 0.4 mm; P=0.06) were also larger with EES. Neoatherosclerotic plaques (16.1% versus 25.8%; P=0.35) and macrophage accumulations (19.4% versus 48.4%; P=0.02) were numerically more frequent with BMS. CONCLUSIONS: Despite substantial dropout of patients, the healing pattern in event-free ST-segment-elevation myocardial infarction patients differs between EES and BMS at 5 years. EES presented with larger amount of uncovered and malapposed struts and similar rate of neoatherosclerosis as compared with BMS. The clinical relevance of these findings warrants longer follow-up. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00828087.

Impacto pronóstico del intervencionismo coronario percutáneo primario en el paciente muy anciano: datos del registro Codi Infart / Prognostic impact of primary percutaneous coronary intervention in the very elderly stemi patient: insights from the codi infart registry

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Predictive ability of bleeding risk scores in the routine clinical practice.

BACKGROUND: Previous predictive models of bleeding in acute coronary syndromes (ACSs) used different definitions of bleeding and some of them come from populations lacking important predictors of haemorrhagic complications. Our group previously developed a predictive model of bleeding (PMB), including clinically meaningful variables, providing an optimal predictive ability. We aimed to compare the ability of this PMB with the main available bleeding risk scores for predicting major bleeding according to different definitions in non-selected ACS patients from daily clinical practice. METHODS: All ACS patients admitted to the Coronary Care Unit were prospectively included. CRUSADE, Mehran and ACTION bleeding risk scores were calculated for each patient. In-hospital bleeding was recorded using the CRUSADE, TIMI, Mehran, ACTION and BARC definitions. For reasons of clinical relevance, BARC 3 and 5 categories were considered severe BARC bleeding for this study. The predictive ability of the PMB and other bleeding risk scores was assessed by binary logistic regression, ROC curves and areas under the curves (AUCs). RESULTS: We included 1976 patients. Mean age was 62.1 years. Almost all patients underwent angiography, 65% of them by the radial approach. The incidence of major bleeding was: CRUSADE bleeding 3.9% (77/1976); Mehran bleeding 4.8% (94/1976); ACTION bleeding 3.9% (78/1976); and BARC 3/5 bleeding 2.4% (48/1976). The PMB showed the best ability for predicting major bleeding regardless of the definition used. The differences were specially significant for predicting BARC 3/5 bleeding (AUC: PMB 0.87, Mehran score 0.68, CRUSADE score 0.70 and ACTION score 0.70). The predictive ability of CRUSADE, ACTION and Mehran scores was similar for all the definitions analysed. CONCLUSIONS: Current bleeding risk scores showed a similar predictive ability for major bleeding regardless of the definitions used. Including other clinically meaningful predictors of bleeding into the new PMB significantly improved its predictive ability in the clinical scenario of ACS.

Body mass index and acute coronary syndromes: paradox or confusion?

BACKGROUND: A better prognosis in obese patients has been described in acute coronary syndromes (ACS). However, this evidence is mostly based on retrospective studies and has provided conflicting results. No study reported cause-specific mortality according to body mass index (BMI) in ACS. We aimed to prospectively assess the impact of BMI on mortality and its specific causes in ACS patients. METHODS: We included non-selected ACS patients admitted in a tertiary care coronary unit, collecting baseline characteristics, management and clinical course. Patients were stratified into five clinically meaningful BMI subgroups of <20, 20-24.9, 25-29.9, 30-35, >35 kg/m(2). The primary outcome was 1 year mortality, its causes and its association with BMI. This association was assessed by the Cox regression method. RESULTS: We included 2040 patients in our study with a mean age of 62.1 years. Low weight patients (BMI <20) were older, with less cardiovascular risk factors, higher prevalence of chronic obstructive pulmonary disease and worse renal function. Mean follow up was 334 days. The unadjusted analysis showed lower all-cause mortality in all subgroups as compared to low weight patients. After adjusting for potential confounders, this association remained significant for patients with a BMI 20-24.9. Cardiac mortality was similar across BMI subgroups. In contrast, the adjusted analysis showed a significantly lower non-cardiac mortality in patients with a BMI 20-24.9, 25-29.9 and 30-35 as compared to low weight patients. CONCLUSIONS: Baseline characteristics in ACS patients significantly differ according to their BMI status. The prognostic impact of BMI seems mostly related to extra-cardiac causes in low weight patients.