The Ultimaster Biodegradable-Polymer Sirolimus-Eluting Stent: An Updated Review of Clinical Evidence.

The Ultimaster coronary stent system (Terumo Corporation, Tokyo, Japan) represents a new iteration in drug-eluting stent (DES) technology that has recently received the Conformité Européenne (CE) mark approval for clinical use. The Ultimaster is a thin-strut, cobalt chromium, biodegradable-polymer, sirolimus-eluting coronary stent. The high elasticity of the biodegradable-polymer (PDLLA-PCL) and the abluminal gradient coating technology are additional novel features of this coronary device. The Ultimaster DES has undergone extensive clinical evaluation in two studies: The CENTURY I and II trials. Results from these two landmark studies suggested an excellent efficacy and safety profile of the Ultimaster DES across several lesion and patient subsets, with similar clinical outcomes to contemporary, new-generation DES. The aim of this review is to summarize the rationale behind this novel DES technology and to provide an update of available evidence about the clinical performance of the Ultimaster DES.

Upper limb ischemia from arterial thromboembolism: a comprehensive review of incidence, etiology, clinical aspects, diagnostic tools, treatment options and prognosis.

Upper limb thromboembolism is a relatively uncommon clinical syndrome that mainly affects elderly patients with cardiovascular comorbidities. Atrial fibrillation has been recognized as the main cause. However, many other cardiac and non-cardiac disorders have been identified as possible sources of upper limb thromboemboli. From a clinical point of view, upper limb thromboembolism represents a vascular emergency so that the delay in diagnosis and treatment is highly likely to imply dramatic complications. Therefore, prompt recognition and treatment is mandatory as well as identification and correction of risk factors. Despite its clinical relevance, data in literature are lacking and sparse, most likely because upper limb thromboembolism has a relatively low prevalence in the general population. We sought to write a simple but comprehensive review of this topic, thus proving cardiologists and critical care physicians with the essential tools to recognize and treat upper limb thromboembolism, identifying and correcting also its risk factors and causes.

Everolimus-eluting bioresorbable vascular scaffolds versus second generation drug-eluting stents for percutaneous treatment of chronic total coronary occlusions: Technical and procedural outcomes from the GHOST-CTO registry.

OBJECTIVES: We aimed at comparing the acute performance of bioresorbable scaffolds (BRS) and second-generation drug-eluting stents (DES) for the treatment of chronic total occlusions (CTO). BACKGROUND: There is a lack of knowledge regarding the use of BRS in CTO. METHODS: Key outcomes of interest were technical and procedural success. Technical success was defined as successful stent delivery and implantation, postprocedural residual diameter stenosis <30% within the treated segment, and restoration of thrombolysis in myocardial infarction (TIMI) grade 3 flow. Procedural success was defined as technical success with no in-hospital major adverse cardiac events (MACE). RESULTS: Between May 2013 and May 2014, 32 patients underwent CTO percutaneous coronary intervention (PCI) with the Absorb BRS (Abbott Vascular, Santa Clara, CA) and were compared with a historical control group of 54 patients who had undergone CTO PCI with second-generation DES. Baseline characteristics were similar between the BRS and DES groups, with the exception of a larger mean reference vessel diameter in the BRS group (2.92 ± 0.34 vs 2.50 ± 0.68; P < 0.001). Technical success was less likely to be achieved in the BRS group compared with the DES group (78.1% vs 96.3%, P = 0.012). Procedural success rates were 78.1% and 94.4% in the BRS and DES group, respectively (P = 0.035). CONCLUSIONS: Compared with second-generation DES for PCI of CTO lesions, BRS were associated with lower rates of technical and procedural success. © 2016 Wiley Periodicals, Inc.

Comparison between intermediate and severe coronary stenoses and clinical outcomes of an OCT-guided PCI strategy.

AIMS: We compared optical coherence tomography (OCT) features of intermediate and severe coronary stenoses in patients with stable angina and acute coronary syndrome (ACS), and tested the clinical impact of an OCT-based strategy for treating intermediate stenoses. METHODS: The study enrolled 135 consecutive patients with either ACS or stable angina and a single de-novo coronary stenosis. Patients were divided into two groups: intermediate stenosis defined as quantitative coronary angiography percentage narrowing less than 70%, or presence of angiographic vessel haziness and severe stenosis with percentage narrowing more than 70%. OCT was performed to assess features of plaque vulnerability and to measure the minimal lumen area. We also appraised the 12-month rate of major adverse event (MACE) of an OCT-guided strategy of percutaneous coronary intervention (PCI) based on the presence of thrombus and/or minimal lumen area less than 3.0 mm. RESULTS: Fifty-six patients had intermediate stenoses, whilst 79 had severe stenoses. In the 'intermediate stenosis group', patients with stable angina had a lower asymmetric index (P = 0.02) and a greater calcific arc (P = 0.0001). In the 'severe stenosis group', intermediate lesions of patients with ACS exhibited a greater lipid arc as compared with patients with stable angina (P = 0.03). A higher prevalence of thin cap fibroatheroma was seen in patients with ACS of both groups. The incidence of MACE was not significantly different between patients with an intermediate stenosis who received PCI vs. optimal medical therapy on the basis of OCT findings (P = 0.26). CONCLUSIONS: Intermediate coronary stenoses showed distinctive OCT-based features according to the initial clinical presentation. The adoption of an OCT-guided PCI strategy, based on the presence of coronary thrombus and significant vessel narrowing, led to encouraging results.

Serial optical coherence tomography imaging of ACS-causing culprit plaques.

AIMS: The aim of this study was to understand better the mechanisms of repair of plaque complications causing acute coronary syndrome. METHODS AND RESULTS: We used OCT in the acute phase and at follow-up (one to seven months) to investigate the plaque healing in 10 culprit plaques: five ruptured fibrous cap (RFC) and five intact fibrous cap (IFC) which were not treated with stent deployment and caused ST-segment elevation myocardial infarction (n=8) and non-STEMI (n=2). At follow-up OCT, the margins of the evacuated cavity in RFC plaques showed a smooth surface and a morphology similar to that of baseline images, while IFC plaques showed a smoothened intimal border and a double layering indicating organising thrombus incorporated in the superficial layers of the plaque. CONCLUSIONS: In the months following a successfully dissolved acute thrombosis, OCT revealed that the cavity of RFC plaques persists and is bordered by a smooth "neointima", while IFC plaques showed features suggesting partial incorporation of the deepest layers of thrombus in the plaque.

Suboptimal stent deployment is associated with subacute stent thrombosis: optical coherence tomography insights from a multicenter matched study. From the CLI Foundation investigators: the CLI-THRO study.

BACKGROUND: Acute or subacute stent thrombosis (ST) is a well-described complication usually causing acute coronary syndromes and, in the worst case scenario, sudden cardiac death. In this study, we aimed at exploring the potential role of optical coherence tomography (OCT) in the understanding of the mechanism of ST. METHODS: Twenty-one consecutive patients, after acute coronary syndromes due to a definite subacute ST, were assessed with OCT and matched 1:2 with 42 patients undergoing OCT for scheduled follow-up. Optical coherence tomography assessment was focused on features indicative of nonoptimal stent deployment: underexpansion, malapposition, edge dissection, and reference lumen narrowing. RESULTS: Optical coherence tomography revealed a minimum stent area sensibly smaller in the ST group (5.6 ± 2.6 vs 6.8 ± 1.7 mm(2); P = .03) with a higher incidence of stent underexpansion when compared with the control group (42.8% vs 16.7%; P = .05). Dissection at stent edges was more commonly detected in ST group (52.4% vs 9.5%; P < .01). No significant differences between the 2 groups were observed for malapposition (52.4% vs 38.1%; P = .651) and reference lumen narrowing (19.0% vs 4.8%; P = .172). At least 1 OCT finding indicative of suboptimal stent deployment was detectable in 95.2% of patients experiencing ST versus 42.9% of the control group (P < .01). CONCLUSIONS: Optical coherence tomography assessment in patients experiencing subacute ST revealed nonoptimal stent deployment in almost all cases with higher incidence of stent underexpansion and edge dissection, potentially explaining the cause of this adverse event. The adoption of an OCT-guided percutaneous coronary intervention protocol could have a potential for the prevention of ST in complex cases.

Objectifying the impact of incomplete revascularization by repeat angiographic risk assessment with the residual SYNTAX score after left main coronary artery percutaneous coronary intervention.

OBJECTIVES: We investigated the prognostic accuracy of a standardized quantification of incomplete revascularization after percutaneous coronary intervention (PCI) of the unprotected left main coronary artery (ULMCA) named residual SYNTAX score (rSS). BACKGROUND: Prognostic implications of coronary lesions left untreated after ULMCA PCI are confounded by the lack of a uniform definition of incomplete revascularization. METHODS: Baseline SYNTAX score (bSS), rSS, and the difference between bSS and rSS (ΔSS ) were assessed in predicting the risk of 2-year cardiac mortality of 400 patients undergoing ULMCA PCI. RESULTS: The rSS and bSS showed comparable discrimination (rSS area under the curve [AUC] 0.72, 95% confidence interval [95% CI] 0.61-0.83; bSS AUC 0.73, 95% CI 0.62-0.84). Hosmer-Lemeshow statistics were 0.60 for rSS (P = 0.44) and 2.45 (P = 0.12) for bSS, reflecting better calibration ability of the rSS. The ΔSS provided the worst discrimination and calibration characteristics (AUC 0.55; 95% CI 0.44-0.66; Hosmer-Lemeshow statistic 3.13, P = 0.08). The rSS was independently associated with the 2-year adjusted-risk of cardiac mortality (hazard ratio 1.07, 95% CI 1.03-1.12, P = 0.001). The risk information from both the rSS and bSS slightly improved the discrimination ability compared with risk information from each single risk assessment (AUC 0.74, 95% CI 0.62-0.86) with a net reclassification improvement of +14.2% and +13.6% over rSS and bSS alone, respectively. CONCLUSIONS: The rSS carries a prognostic value as independent predictor of 2-year cardiac mortality. Compared with a single assessment of the SYNTAX score, information coming from repeat assessment of the angiographic risk may improve the ability to discriminate and reclassify patients undergoing ULMCA PCI.

Comparative one-year effectiveness of percutaneous coronary intervention versus coronary artery bypass grafting in patients <75 versus ≥75 years with unprotected left main disease (from the CUSTOMIZE Registry).

There is a lack of knowledge on the interaction between age and left main coronary artery revascularization. The aim of this study was to investigate the comparative effectiveness of percutaneous coronary intervention (PCI) with drug-eluting stents and coronary artery bypass grafting (CABG) in patients with left main coronary artery disease aged <75 versus ≥75 years. Of a total of 894 patients included, 692 (77.4%) were aged <75 years and 202 (23.6%) ≥75 years. PCI was found to be significantly different from CABG with respect to the composite of major adverse cardiac events at 1-year follow-up in patients aged <75 years (15.5% vs 8.5%, p = 0.01) but not in those aged ≥75 years (16.4% vs 13.9%, p = 0.65). This finding was consistent after statistical adjustment for baseline confounders in the 2 groups (adjusted hazard ratio [AHR] 2.2, 95% confidence interval 1.2 to 4.1, p = 0.016 in younger patients; AHR 0.9, 95% confidence interval 0.3 to 3.0, p = 0.88 in older patients). In the 2 groups, PCI and CABG showed similar adjusted risks for all-cause death, cardiac death, and myocardial infarction. Target lesion revascularization occurred more frequently in patients aged <75 years treated with PCI compared to CABG (AHR 5.1, 95% confidence interval 1.9 to 13.6, p = 0.001) but not in those aged ≥75 years. A significant interaction between age and treatment with regard to major adverse cardiac events was identified (adjusted p for interaction = 0.034). In conclusion, compared to younger patients, elderly patients with left main disease are likely to derive the maximal gain from a less invasive procedure such as PCI.

Comparison of one-year outcomes of percutaneous coronary intervention versus coronary artery bypass grafting in patients with unprotected left main coronary artery disease and acute coronary syndromes (from the CUSTOMIZE Registry).

Uncertainty surrounds the optimal revascularization strategy for patients with left main coronary artery disease presenting with acute coronary syndromes (ACSs), and adequately sized specific comparisons of percutaneous and surgical revascularization in this scenario are lacking. The aim of this study was to evaluate the incidence of 1-year major adverse cardiac events (MACEs) in patients with left main coronary artery disease and ACS treated with percutaneous coronary intervention (PCI) and drug-eluting stent implantation or coronary artery bypass grafting (CABG). A total of 583 patients were included. At 1 year, MACEs were significantly higher in patients treated with PCI (n = 222) compared to those treated with CABG (n = 361, 14.4% vs 5.3%, p <0.001), driven by a higher rate of target lesion revascularization (8.1% vs 1.7%, p = 0.001). This finding was consistent after statistical adjustment for MACEs (adjusted hazard ratio [HR] 2.7, 95% confidence interval [CI] 1.2 to 5.9, p = 0.01) and target lesion revascularization (adjusted HR 8.0, 95% CI 2.2 to 28.7, p = 0.001). No statistically significant differences between PCI and CABG were noted for death (adjusted HR 1.1, 95% CI 0.4 to 3.0, p = 0.81) and myocardial infarction (adjusted HR 4.8, 95% CI 0.3 to 68.6, p = 0.25). No interaction between clinical presentation (ST-segment elevation myocardial infarction or unstable angina/non-ST-segment elevation myocardial infarction) and treatment (PCI or CABG) was observed (p for interaction = 0.68). In conclusion, in patients with left main coronary artery disease and ACS, PCI is associated with similar safety compared to CABG but higher risk of MACEs driven by increased risk of repeat revascularization.