Randomised, non-inferiority, controlled procedural outcomes TrIal comParing reverse T And Protrusion versus double-kissing and crush stenting: protocol of the TIP TAP I randomised trial.

INTRODUCTION: To assess the impact of 'reverse T and Protrusion' (TAP) technique on the outcome after stenting of true bifurcation lesions of the left main (LM) or proximal epicardial vessels as compared with double kissing (DK)-crush technique. METHODS AND ANALYSIS: 50 consecutive patients with true coronary bifurcation lesion (Medina 1,1,1 or 0,1,1) of the LM or the proximal main vessels, requiring a two-stent technique as first-line strategy at University Medical Center Mainz, are randomised in a 1:1 ratio to reverse TAP or DK-crush stenting. As recommended by best clinical practice, final angiographic result is evaluated and optical coherence tomographic (OCT) intracoronary imaging is performed to assess and optimise the final result. The primary end point is defined as the percentage of stent expansion in the side branch. Secondary end points consist of angiographic and procedural success (assessed until patient's discharge), procedural parameters (procedural time, fluoroscopy time, use of devices, X-ray dose) and OCT parameters expressing expansion of the stents. Safety parameters include all adverse events up to 6 months after discharge. A clinical, angiographic and intracoronary imaging control at 6 months is planned. ETHICS AND DISSEMINATION: The protocol complies with good clinical practice and the ethical principles described in the Declaration of Helsinki and is approved by the local ethics committee. The results of the trial will be published as original article(s) in medical journals and/or as presentation at congresses. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT03714750).

Effectiveness of additional X-ray protection devices in reducing scattered radiation in radial intervention: the ESPRESSO randomised trial.

AIMS: We aimed to examine the impact of three different radiation protection devices in a real-world setting of radial artery catheterisation. METHODS AND RESULTS: In an all-comer randomised trial, consecutive coronary radial diagnostic and intervention procedures were assigned in a 1:1:1 ratio to shield-only protection (shield group), shield and overlapping 0.5 mm Pb panel curtain (shield+curtain group) or shield, curtain and additional 75x40 cm, 0.5 mm Pb drape placed across the waist of the patient (shield+curtain+drape group). A total of 614 radial procedures were randomised (n=193 shield, n=220 shield+curtain, n=201 shield+curtain+drape). There were no differences among the groups in patient or procedural characteristics. The primary endpoint (relative exposure ratio between the operators' exposure in µSv and the patient's exposure, dose area product in cGy·cm2) was significantly lower in the shield+curtain+drape group for both the first operator (20% reduction vs shield, 16% vs shield+curtain, p=0.025) and the assistant (39% reduction vs shield, 25% vs shield+curtain, p=0.009). CONCLUSIONS: The use of an additional drape reduced the radiation exposure of both the first operator and the second operator during routine radial procedures; a shield-attached curtain alone was only partially effective. ClinicalTrials.gov identifier: NCT03634657

Five Years Outcomes and Predictors of Events in a Single-Center Cohort of Patients Treated with Bioresorbable Coronary Vascular Scaffolds.

INTRODUCTION: We report outcome data of patients treated with coronary bioresorbable scaffolds up to 5 years and investigate predictors of adverse events. METHODS: Consecutive patients treated with at least one coronary bioresorbable scaffold (BRS, Abbott Vascular, Santa Clara, USA) between May 2012 and May 2014 in our center were enrolled. Clinical/procedural characteristics and outcome data at 1868 (1641-2024) days were collected. The incidence of scaffold thrombosis (ScT), restenosis (ScR), and target lesion failure (TLF) and their predictors were investigated using Kaplan-Meier and Cox regression analysis. RESULTS: 512 consecutive patients and 598 lesions were included in the database. A total of 30 ScT, 42 ScR, and 92 TLF were reported. The rate of ScT was 3.6% in the first year, 2.2% in the second-third year, and 0.6% in the fourth-fifth year after implantation. The corresponding rates of ScR were 2.5%, 5.7%, and 1.1%. The corresponding incidence of TLF was 8.8%, 8.0%, 3.8%. Procedural parameters (vessel size, scaffold footprint) and the technique used at implantation (including predilation, parameters of sizing, and postdilation) were predictors of ScT and TLF in the first three years after implantation. In contrast, only diabetes was predictive of events between 4-5 years (HR 6.21(1.99-19.40), p = 0.002). CONCLUSIONS: After device resorption, the incidence of very late adverse events in lesions/patients implanted with a BRS decreases. Procedural and device-related parameters are not predictors of events anymore.

QFR Predicts the Incidence of Long-Term Adverse Events in Patients with Suspected CAD: Feasibility and Reproducibility of the Method.

AIMS: We evaluate feasibility and reproducibility of post hoc quantitative flow ratio (QFR) measurements and their prognostic predictive power during long-term follow-up. METHODS AND RESULTS: Between 2010 and 2012, 167 patients without angiographic evidence of significant stenoses were enrolled in a prospective registry. Of these patients, 96% presented 7 years follow-up data. QFR was measured post hoc by three certified investigators. QFR analysis was feasible in 71% of left anterior descending (LAD), 72% of left circumflex (LCX), and 61% of right (RCA) coronaries for a total of 350 measurements repeated in triplicate. Coefficients of variation were 2.1% for RCA and LCX, and 2.8% for the LAD (quartile coefficients of dispersion respectively 1.5, 1.4, and 1.3). QFR ≤0.80 was recorded in 25 patients (27 vessels, in 74% of the cases LAD). A total of 86 major adverse cardiovascular and cerebrovascular events were observed in 76 patients. QFR ≤0.80 in at least one of the three vessels was the strongest predictor of events (HR 3.14, 95%CI 1.78-5.54, p = 0.0001). This association was maintained in several sensitivity analyses. CONCLUSIONS: QFR reproducibility is acceptable, even when analysis is performed post hoc. A pathological QFR is not rare in patients without angiographic evidence of significant stenosis and is a predictor of incident events during long-term follow-up. CONDENSED ABSTRACT: In a post hoc analysis of 167 patients without evidence of angiographic significant stenosis, the presence of QFR value ≤0.80 in at least one of the three coronary vessels showed to be the strongest predictor of major adverse cardiovascular and cerebrovascular events during long-term follow-up. QFR reproducibility have been shown to be acceptable among experienced operators.

Effectiveness of additional X-ray protection devices in reducing Scattered radiation in radial interventions: protocol of the ESPRESSO randomised trial.

BACKGROUND: A number of devices have been developed to minimise operator radiation exposure in the setting of cardiac catheterisation. The effectiveness of these devices has traditionally been explored in transfemoral coronary procedures; however, less is known for the transradial approach. We set out to examine the impact of three different radiation protection devices in a real-world setting. METHODS AND DESIGN: Consecutive coronary diagnostic and intervention procedures are randomised in a 1:1:1 ratio to a shield-only protection (shield group), shield and overlapping 0.5 mm Pb panel curtain (curtain group) or shield, curtain and additional 75×40 cm, 0.5 mm Pb drape placed across the waist of the patient (drape group).The primary outcome is the difference in relative exposure of the primary operator among groups. Relative exposure is defined as the ratio between operator's exposure (E in µSv) and patient exposure (dose area product in cGy·cm2). ETHICS AND DISSEMINATION: The protocol complies with good clinical practice and the ethical principles described in the Declaration of Helsinki and is approved by the local ethics committee. The results of the trial will be published as original article(s) in medical journals and/or as presentation at congresses. TRIAL REGISTRATION NUMBER: NCT03634657.

Incidental Finding of Strut Malapposition Is a Predictor of Late and Very Late Thrombosis in Coronary Bioresorbable Scaffolds.

Malapposition is a common finding in stent and scaffold thrombosis (ScT). Evidence from studies with prospective follow-up, however, is scarce. We hypothesized that incidental observations of strut malapposition might be predictive of late ScT during subsequent follow-up. One hundred ninety-seven patients were enrolled in a multicentre registry with prospective follow-up. Optical coherence tomography (OCT), performed in an elective setting, was available in all at 353 (0-376) days after bioresorbable scaffold (BRS) implantation. Forty-four patients showed evidence of malapposition that was deemed not worthy of intervention. Malapposition was not associated with any clinical or procedural parameter except for a higher implantation pressure (p = 0.0008). OCT revealed that malapposition was associated with larger vessel size, less eccentricity (all p < 0.01), and a tendency for more uncovered struts (p = 0.06). Late or very late ScT was recorded in seven of these patients 293 (38-579) days after OCT. OCT-diagnosed malapposition was a predictor of late and very late scaffold thrombosis (p < 0.001) that was independent of the timing of diagnosis. We provide evidence that an incidental finding of malapposition-regardless of the timing of diagnosis of the malapposition-during an elective exam is a predictor of late and very late ScT. Our data provide a rationale to consider prolonged dual antiplatelet therapy if strut malapposition is observed.

Bioresorbable vascular scaffolds for percutaneous treatment of chronic total coronary occlusions: a meta-analysis.

BACKGROUND: BRS represent a new approach to treating coronary artery disease. Beneficial properties of BRS regarding the restoration of vasomotility after resorption make them attractive devices in CTO revascularization. However, experience in this setting is limited. METHODS: We systematically searched Medline, Scholar, and Scopus for reports of at least 9 patients with CTO undergoing BRS implantation. Patients' and procedural characteristics were summarized. The primary outcome of interest was target lesion revascularization (TLR). Pooled estimates were calculated using a random-effects meta-analysis. The study protocol was registered in PROSPERO (CRD42017069322). RESULTS: Thirteen reports for a total of 843 lesions with a median follow-up of 12 months (IQR 6-12) were included in the analysis. At short-term, the summary estimate rate of TLR was 2.6% (95% CI: 1 to 4%, I2 = 0%, P = 0.887) while at mid to long-term it was 3.8% (95% CI: 2 to 6%, I2 = 0%, P = 0.803). At long-term follow-up (≥12 months), the summary estimate rate of cardiac death was 1.1% (95% CI: 0 to 2%, I2 = 0%, P = 0.887). The summary estimate rates of scaffold thrombosis and clinical restenosis were respectively 0.9% (95% CI: 0 to 2%, I2 = 0%, P = 0.919) and 1.8% (95% CI: 0 to 4%, I2 = 0%, P = 0.448). Finally, the summary estimate rate of target vessel revascularization was 6.6% (95% CI: 0 to 11%, I2 = 0%, P = 0.04). CONCLUSIONS: Implantation of BRS in a population with CTO is feasible, although further longer-term outcome studies are necessary.

Procedural Predictors for Bioresorbable Vascular Scaffold Thrombosis: Analysis of the Individual Components of the "PSP" Technique.

The technique used at the time of implantation has a central role in determining the risk of thrombosis in bioresorbable vascular scaffolds (BRS). Different definitions of the "optimal" implantation technique exist, however. The impact of individual procedural characteristics on the risk of scaffold thrombosis (ScT) was evaluated in a single-center observational study that enrolled 657 patients (79% males, mean age 63 ± 12 years) with 763 lesions who received a total of 925 BRS for de novo lesions. During a median 1076 (762⁻1206) days' follow-up there were 28 cases of thrombosis. Independent predictors of ScT included the use of predilatation balloons bigger than the nominal BRS diameter (hazard ratio (HR) = 0.4 (0.16⁻0.98), p = 0.04), sizing (implantation in vessels with reference vessel diameter >3.5 mm or <2.5 mm: HR = 5.71 (2.32⁻14.05), p = 0.0002) and the degree of vessel expansion (ratio of minimum lumen to reference vessel diameter, HR: 0.005 (0.0001⁻0.23), p = 0.007). In addition, a mild BRS oversizing (final BRS diameter to vessel diameter 1.14⁻1.28) was associated with a lower thrombosis risk, whereas undersizing and more severe oversizing (final BRS diameter to vessel diameter <1.04 and >1.35, respectively) were associated with an increased risk of ScT (HR = 0.13 (0.02⁻0.59), p = 0.0007). In conclusion, different components of the "optimal" technique have different impacts on the risk of BRS thrombosis. Besides predilatation with a balloon larger than the BRS diameter, correct vessel size selection and a mild to moderate oversizing appear to be protective.

Tako-Tsubo syndrome, spontaneous coronary dissection and microvascular disease: Sex-differences.

Up to 50% of the patients undergoing coronary angiography present no epicardial disease. Most of these patients are women. Takotsubo cardiomyopathy, coronary microvascular dysfunction, and spontaneous coronary artery dissection are the most common syndromes that affect these patients. Their mechanisms are complex, with a interplay between neurohormonal factors and a number of other systems. The present review describes how changes in the estrogen state may lead to changes in vasomotor tone and endothelial dysfunction which result in coronary epicardial and microvascular spasm and coronary arterial wall instability in these three conditions. The sex-dependent differences in prevalence, pathogenesis, and prognosis are described.

Predictors of bioresorbable scaffold failure in STEMI patients at 3 years follow-up.

BACKGROUND: Little data are available on the long-term outcomes of bioresorbable scaffold (BRS) in the setting of ST-segment elevation myocardial infarction (STEMI). The aim of this study is to investigate three-years outcomes and predictors of BRS failure in patients presenting with STEMI. METHODS AND RESULTS: Two prospective, single-arm registries were pooled. Incidence and predictors of clinical outcome were assessed with Kaplan-Meier and Cox regression analyses. From May-2012 to January-2015, 183 STEMI patients (58 ±â€¯13 years, 77% males, 29% diabetics) who received a total of 256 BRS (1.4 ±â€¯0.8 per patient) were included. 248 patients (65 ±â€¯11 years, 74% males, 27% diabetics) treated for stable coronary artery disease (SCAD) served as control. 3-years follow-up was available in 386 (90%) patients. Device-oriented composite endpoint and scaffold thrombosis (ScT) rates were similar in the two groups (STEMI: 11.5% vs SCAD: 12.9%, P = 0.84; STEMI: 3.6% vs SCAD: 3.3%, P = 0.90). While early ScT was more frequent in SCAD patients, late/very late ScT was a feature of STEMI. While in STEMI patients the incidence of ScT was higher in vessels with RVD > 3.5 mm, a RVD < 2.5 mm was a predictor of events in stable patients. Similarly, BRS undersizing predicted events in STEMI patients, while oversizing was a predictor in stable ones. Finally, the incidence of ScT was reduced in both STEMI and stable patients (from 6.3% to 0% and from 5.80% to 0.9%) when an optimized implantation technique was used. CONCLUSIONS: The incidence of events for three years follow-up was similar in STEMI and SCAD patients, although different timing and features underlie ScT in the two groups.

Three-years outcomes of diabetic patients treated with coronary bioresorbable scaffolds.

BACKGROUND: Diabetes is among the strongest predictors of outcome after coronary artery stenting and the incidence of negative outcomes is still high in this specific group. Data of long-term outcomes comparing diabetic patients with non-diabetic patients treated with bioresorbable scaffolds are still incomplete. This work evaluates the long-term outcomes after implantation of a coronary bioresorbable scaffold (BRS) in diabetic patients compared to non-diabetics. METHODS: Patients who received at least one Absorb BRS in the time of May 2012 to December 2014 were enrolled into this single-center registry. Quantitative coronary angiography (QCA) was performed. RESULTS: Six hundred fifty seven patients including 138 patients (21%, mean age 65 ± 11, 78% male) with diabetes were enrolled. Patients in the diabetic group were significantly older, were more likely to suffer from hypertension and hyperlipidemia and had more often a prior stroke or TIA as well as a reduced renal function (all P < 0.05). The initial stenosis was less severe in the diabetic group (74.8% vs. 79.6%, P = 0.036), but the residual stenosis after BRS implantation exceeded that of the control group (16.7% vs. 13.8%, P = 0.006). History of diabetes had no impact on the incidence of events within one year after BRS implantation. Beyond 1 year, diabetic patients had a higher incidence of cardiovascular death (6.9 vs. 1.4%, HR:5.37 [1.33-21.71], P = 0.001), scaffold restenosis (17.6 vs. 7.8%, HR:3.56 [1.40-9.05], P < 0.0001) and target lesion revascularization (P = 0.016). These results were confirmed in the propensity score analysis. In both diabetics and non-diabetics, there was a strong association (HR:18.6 [4.7-73.3]) between the risk of restenosis and the technique used at implantation; in contrast, the impact of vessel size was more manifest in non-diabetics than in diabetic patients, and an increased risk of restenosis was demonstrated for both large and small vessels. CONCLUSION: As for metal stents, beyond one year after implantation, diabetes was associated with an increased incidence of scaffold restenosis and related outcomes. This negative impact of diabetes was reset when an optimal implantation technique was used.

Bioresorbable everolimus-eluting vascular scaffold for patients presenting with non STelevation-acute coronary syndrome: A three-years follow-up1.

AIM: To investigate three-year outcomes of patients presenting with nonSTelevation acute coronary syndrome (NSTE-ACS) treated with bioresorbable everolimus-eluting vascular scaffolds (BRS). METHODS AND RESULTS: The study included a total of 488 consecutive patients, enrolled between May 2012 and December 2013 (median age 65 [56-74], 392 men. 269 patients presented with either NSTEMI or unstable angina at the time of enrolling, 219 patients with stable or silent angina. The primary device-oriented endpoint (Target Lesion Failure, TLF) was defined as a combination of cardiovascular death, target vessel myocardial infarction or clinically driven target lesion revascularization.Among the cardiac risk factors, NSTE-ACS patients were more frequently smokers (P = 0.028), had less frequently dyslipidemia (P = 0.003) and a history of prior PCI (P < 0.01).The median follow-up was 1070[763-1197] days. The three-years incidence of TLF was slightly higher but did not differ significantly between groups (NSTE-ACS: 16.3% vs. 15.9%, p = 0.163). Accordingly, there was no difference in any of the other endpoints. CONCLUSION: Treatment of NSTE-ACS with BRS appears to be safe and effective. In this group, risk factors for events during follow up did not differ as compared to the general population.

Characteristics and outcome of patients with complex coronary lesions treated with bioresorbable scaffolds: three-year follow-up in a cohort of consecutive patients.

AIMS: The safety of bioresorbable scaffolds (BRS) has recently been challenged. However, it is unclear whether outcomes depend on the complexity of the lesion or on the technique used to implant the device. The aim of this study was to report on the outcomes after BRS implantation in complex lesions. METHODS AND RESULTS: This investigator-initiated, single-centre, single-arm observational study recruited 657 consecutive patients (79% male, 66.7% acute coronary syndrome, age 63±12 years). Three hundred and twenty-two lesions (42.3%) in 297 (45.2%) patients with type B2 or C lesions were classified as the "complex lesions group". Post-procedural residual stenosis was slightly but significantly greater in the complex lesions group (15.7±11.3% vs. 13.5±10.2%, p=0.0109). The median follow-up was 1,076 (762-1,206) days without difference between groups. The Kaplan-Meier rates of early scaffold thrombosis (3.5% vs. 1.1%, p=0.0478, HR 3.03 [1.06-8.70]) and scaffold restenosis (9.9% vs. 9.1%, p=0.0262, HR 2.34 [1.11-4.94]) were higher in patients with complex lesions than in those with simple lesions. Late/very late thrombosis, death, repeat myocardial infarction, or repeat coronary interventions were not different. In patients in whom strict guidelines for implantation were applied, the incidence of thrombosis was reduced by 76% in complex lesions and by 92% in simple ones, such that there were no differences between groups (2.3% vs. 0.5%, p=0.3899). In contrast, the incidence of scaffold restenosis was reduced by 59% and 89%, and a difference between groups persisted (7.0% vs. 1.6%, p=0.0235). CONCLUSIONS: BRS implantation in complex lesions is, as expected, associated with higher incidence of events as compared to simple ones. The technique used at the time of the implantation, however, reduces the incidence of adverse outcomes.

Characteristics, Predictors, and Mechanisms of Thrombosis in Coronary Bioresorbable Scaffolds: Differences Between Early and Late Events.

OBJECTIVES: The study sought to investigate the incidence, characteristics, predictors, and possible mechanisms of early and 3-year coronary scaffold thrombosis (ScT). BACKGROUND: An increased incidence of both early and late ScT has been shown in randomized trials. METHODS: Consecutive patients were enrolled in a single-center registry. Quantitative coronary angiography was performed. Incidence and predictors of ScT were assessed with Kaplan-Meier and Cox regression analyses. RESULTS: A total of 657 patients (63 ± 12 years of age, 79% men, 21% diabetic, 64% acute coronary syndrome) who received 925 coronary bioresorbable scaffolds (BRS) (Abbott Vascular, Santa Clara, California) between May 2012 and January 2015 were enrolled. Clinical and procedural characteristics and outcome data at 1,076 (interquartile range: 762 to 1,206) days (3-year follow-up rate 93%) were collected. Twenty-eight ScTs were recorded: 14 early (Kaplan-Meier estimate: 2.2%), 5 late (Kaplan-Meier estimate: 0.9%), and 9 very late (Kaplan-Meier estimate: 1.7%). The incidence of ScT followed a U-shaped curve with highest incidence at the extremes of the distributions of reference vessel diameter (RVD) and the ratio of BRS nominal diameter to RVD. At quantitative coronary angiography, RVD (hazard ratio [HR]: 0.14; 95% confidence interval [CI]: 0.04 to 0.49) and BRS oversizing (ratio of BRS nominal diameter to RVD >1.15; HR: 107.40; 95% CI: 9.20 to 1,261.30) emerged as potent predictors of early ScT. RVD (HR: 9.55; 95% CI: 3.90 to 23.42) and BRS undersizing (ratio of BRS nominal diameter to RVD <0.85; HR: 0.0004; 95% CI: 0.0000 to 0.0400) predicted late or very late ScT (all p < 0.0001). The incidence of both early and late or very late ScT were lower (∼80% reduction) when an optimal implantation technique was used. The most important factor appeared to be vessel and BRS sizing. CONCLUSIONS: Different mechanisms underlie early and late ScT: although incomplete BRS deployment was a predictor of the former, the latter was associated with large vessel size and BRS undersizing. However, both phenomena are significantly less frequent with an optimized implantation technique. (Mainz Intracoronary Database. The Coronary Slow-flow and Microvascular Diseases Registry [MICAT]; NCT02180178).

Incidence, Clinical Presentation, and Predictors of Clinical Restenosis in Coronary Bioresorbable Scaffolds.

OBJECTIVES: The aim of this study was to describe the incidence and clinical characteristics, including intracoronary imaging features, of clinical restenosis in bioresorbable coronary scaffolds (BRS). Further, the authors searched for clinical and procedural predictors of scaffold restenosis (ScR) and report on the clinical outcomes after treatment of ScR in a cohort of consecutive all-comer patients. BACKGROUND: Data from randomized controlled trials demonstrate a higher rate of target lesion failure in patients treated with BRS as compared with those treated with metal drug-eluting stents. Although in-scaffold thrombosis has been thoroughly investigated, there are little data available on the incidence and characteristics of ScR. METHODS: A total of 657 consecutive patients (age 63 ± 12 years, 79% men, 21% diabetics, 67% acute coronary syndrome) who received a total of 883 BRS for the treatment of coronary artery stenoses between May 2012 and January 2015 were enrolled in a retrospective registry. RESULTS: During the median follow-up of 1,076 days (interquartile range: 762 to 1,206 days), a total of 49 cases of ScR were found in 41 patients (Kaplan-Meier incidence: 2.4%, 6.0%, and 9.0% at 12-, 24-, and 36-month follow-up, respectively). ScR presented as stable angina or as incidental finding in 73% of the cases. The angiographic pattern was complex (type II to IV) in 55% of the ScR lesions. The neointima was homogeneous with high signal intensity in all but 3 cases at optical coherence tomography. Prior revascularization (hazard ratio [HR]: 2.7; 95% confidence interval [CI]: 1.5 to 5.1; p = 0.002), diabetes (HR: 2.9; 95%CI: 1.5 to 5.4; p = 0.001), lesion types B2 or C (HR: 2.8; 95% CI: 1.5 to 5.4; p = 0.002), and implantation technique (HR: 0.3; 95% CI: 0.1 to 0.6; p = 0.001) emerged as independent predictors of ScR. Oversizing (HR: 6.29; 95% CI: 2.4 to 16.4), undersizing (HR: 5.15; 95% CI: 1.99 to 13.30), and a residual stenosis >27% (HR: 8.9; 95% CI: 3.6 to 21.8) were associated with an increased ScR risk. CONCLUSIONS: The 3-year incidence of ScR was similar to that observed in similar settings with newer-generation drug-eluting stents. It is often associated with a benign presentation and a complex angiographic pattern. Predictors of ScR match those of metallic stent restenosis, and the implantation technique used at index appears to play an important role.

The mechanisms of late scaffold thrombosis.

Coronary scaffolds have been recently developed to address the long-term limitations of metallic drug eluting stents. Concerns have however been expressed on the safety of these devices, with evidence of both early and late scaffold thrombosis. While early thrombosis has been associated with incomplete scaffold expansion, leading to flow disturbances, blood recirculation, and platelet activation, the pathophysiology of late events remains less understood. Recent cases series have shown that malapposition and scaffold dismantling might play a role in this phenomenon, an observation that further confirms the importance of an accurate implantation. Further, the role of dual antiplatelet therapy, and whether prolonging it may reduce event rates, remains to be elucidated. As well, the role of inflammatory phenomena has been proposed but never demonstrated. This brief review summarizes the current evidence on these phenomena.

Long-term outcome of bioresorbable vascular scaffolds for the treatment of coronary artery disease: a meta-analysis of RCTs.

BACKGROUND: Coronary bioresorbable scaffolds (BRS) were developed to overcome the limitations of standard metallic stents, especially to address late events after percutaneous coronary interventions. The aim of this meta-analysis was to evaluate the efficacy and safety of BRS, compared with Everolimus-eluting stents (EES), using the data available from randomized trials, with a focus on long-term outcomes. METHODS: Published randomized trials comparing BRS to EES for the treatment of coronary artery disease were searched for within PubMed, Cochrane Library and Scopus electronic databases up to April 4th 2017. The summary measure used was odds ratio (OR) with 95% confidence intervals. RESULTS: A total of 5 studies were eligible, including 5219 patients. At 2 years, BRS was associated with higher rates of target lesion failure (9.4% vs 7.2%; OR = 1.33; 95% CI 1.07 to 1.63; p = 0.008) and device thrombosis (2.3% vs 0.7%; OR = 3.22; 95% CI 1.86 to 5.57; p < 0.0001) compared with EES. The incidence of both early (within 30 days after implantation, 1.1% vs 0.5%, OR 1.97, 95% CI 1.02 to 3.81; p = 0.05) and very-late device thrombosis (>1 year, 0.6% vs 0.1%, OR 4.03, 95% CI 1.37 to 11.82; p = 0.01) was higher with BRS compared with EES. CONCLUSIONS: BRS may be associated with worse two-years clinical outcomes compared with EES in patients with coronary artery disease.

Analyzing the Release of Copeptin from the Heart in Acute Myocardial Infarction Using a Transcoronary Gradient Model.

Copeptin is the C-terminal end of pre-provasopressin released equimolar to vasopressin into circulation and recently discussed as promising cardiovascular biomarker amendatory to established markers such as troponins. Vasopressin is a cytokine synthesized in the hypothalamus. A direct release of copeptin from the heart into the circulation is implied by data from a rat model showing a cardiac origin in hearts put under cardiovascular wall stress. Therefore, evaluation of a potential release of copeptin from the human heart in acute myocardial infarction (AMI) has been done.