Coronary Venous Pressure and Microvascular Hemodynamics in Patients With Microvascular Angina: A Randomized Clinical Trial.

Importance: The role of the coronary venous circulation in regulating myocardial perfusion and its potential in treating microvascular angina is unexplored. Objective: To evaluate whether an increase in coronary venous pressure modifies microvascular resistance in patients with microvascular angina. Design, Setting, and Participants: This was a blinded, sham-controlled, crossover, randomized clinical trial that enrolled participants between November 2021 and January 2023. Participants for this physiology end point study were recruited from the Cardiology Center of the University of Medicine in Mainz, Germany. Patients with moderate/severe angina pectoris (Canadian Cardiovascular Society class 2-4) due to microvascular dysfunction (as defined by the thermodilution-based index of microvascular resistance >25 mm Hg × s). Exclusion criteria were epicardial coronary disease, second- and third-degree atrioventricular block, severe valvular heart disease, cardiomyopathy, and pulmonary or kidney disease. Intervention: Inflation of an undersized balloon placed in the cardiac coronary sinus (CS), hereafter referred to as balloon and the deflated balloon in the right atrium, referred to as sham. Measurements were performed at rest and during maximal coronary hyperemia. Both patients and final assessors were blinded to the randomization sequence. Main Outcomes and Measures: Hemodynamic parameters, including aortic (Pa) and distal (Pd) coronary pressure, coronary sinus pressure (Pcs), right atrial pressure (Pra), and the mean transit time (inverse of blood flow [Tmn]), were measured. Results: A total of 20 patients (median [IQR] age, 69 [64-75] years; 11 female [55.0%]) were included in the study. Two patients (10%) had diabetes, 6 (30%) had hypercholesterolemia, 15 (75%) had hypertension, and 3 (15%) were active smokers. The inflation of the CS balloon caused a significant increase in CS pressure at rest and during hyperemia (300% and 317% increase, respectively, compared with sham, both P < .001), a decrease in hyperemic distal coronary pressure (median [IQR], sham: 92 [80-100] mm Hg; balloon: 79 [75-93] mm Hg; P = .01) and mean transit time (sham: 0.39 [0.23-0.62] s; balloon: 0.26 [0.17-0.46] s; P = .008). As a result, CS occlusion led to a decrease in both resting coronary resistance (median [IQR], sham: 59 [37-87] mm Hg × s; balloon: 42 [31-67] mm Hg × s; P = .005) and the primary end point hyperemic coronary resistance (mean [IQR], sham: 31 [23-53] mm Hg × s; balloon: 14 [8-26] mm Hg × s; P < .001). Conclusion and Relevance: Increased coronary venous pressure led to a reduction of microvascular resistances in patients with microvascular angina, a mechanism with potential implications for the therapy of this complex disease. Trial Registration: ClinicalTrials.gov Identifier: NCT05034224.

Six-months clinical and intracoronary imaging follow-up after reverse T and protrusion or double-kissing and crush stenting for the treatment of complex left main bifurcation lesions.

Background: There is a debate regarding the best stent strategy for unprotected distal left main (LM) bifurcation disease. Among two-stent techniques, double-kissing and crush (DKC) is favored in current guidelines but is complex and requires expertise. Reverse T and Protrusion (rTAP) was shown to be a comparable strategy regarding short-term efficacy and safety, but with reduced procedural complexity. Aim: To compare rTAP vs. DKC by optical coherence tomography (OCT) on the intermediate term. Methods: 52 consecutive patients with complex unprotected LM stenoses (Medina 0,1,1 or 1,1,1) were randomized to either DKC or rTAP and followed-up for a median of 189[180-263] days for clinical and OCT outcomes. Results: At follow-up OCT showed similar change in the side branch (SB) ostial area (primary endpoint). The confluence polygon showed a higher percentage of malapposed stent struts in the rTAP group that did not reach statistical significance (rTAP: 9.7[4.4-18.3] % vs. DKC: 3[0.07-10.9] %; p = 0.064). It also showed a trend towards larger neointimal area relative to the stent area (DKC: 8.8 [6.9 to 13.4] % vs. rTAP: 6.5 [3.9 to 8.9] %; p = 0.07), and smaller luminal area (DKC: 9.54[8.09-11.07] mm2 vs. rTAP: 11.21[9.53-12.42] mm²; p = 0.09) in the DKC group. The minimum luminal area in the parent vessel distal to the bifurcation was significantly smaller in the DKC group (DKC: 4.64 [3.64 to 5.34] mm² vs. rTAP: 6.76 [5.20 to 7.29] mm²; p = 0.03). This segment also showed a trend for smaller stent areas (p = 0.05 to 0.09), and a bigger neointimal area relative to the stent area (DKC: 8.94 [5.43 to 10.5]% vs. rTAP: 4.75 [0.08 to 8.5]%; p = 0.06) in the DKC patients. The incidence of clinical events was comparably low in both groups. Conclusion: At 6-months, OCT showed a similar change in the SB ostial area (primary endpoint) in rTAP compared to DKC. There was also a trend for smaller luminal areas in the confluence polygon and the distal parent vessel, and a larger neointimal area relative to the stent area, in DKC, along with a tendency for more malapposed stent struts in rTAP. Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT03714750, identifier: NCT03714750.

Randomized, crossover, controlled trial on the modulation of cardiac coronary sinus hemodynamics to develop a new treatment for microvascular disease: Protocol of the MACCUS trial.

Background: Microvascular angina (MVA) is a frequent condition for which our understanding of the disease pathophysiology and therapeutic perspectives remain unsatisfactory. The current study is designed to test whether an improvement in microvascular resistances could be achieved by elevating backward pressure in the coronary venous system, based on the hypothesis that an increase in hydrostatic pressure could cause a dilatation of the myocardial arterioles, resulting in a reduction of vascular resistances. This approach might have potential clinical implications, as it might suggest that interventions aimed at increasing coronary sinus (CS) pressure might result in a decrease in angina in this subset of patients. The aim of our single-center, sham-controlled, crossover randomized trial is to investigate the effect of an acute increase in CS pressure on a number of parameters of coronary physiology, including parameters of coronary microvascular resistance and conductance. Methods and analysis: A total of 20 consecutive patients with angina pectoris and coronary microvascular dysfunction (CMD) will be enrolled in the study. Hemodynamic parameters including aortic and distal coronary pressure, CS and right atrial pressure, and the coronary microvascular resistance index will be measured at rest and during hyperemia in a randomized crossover design during incomplete balloon occlusion ("balloon") and with the deflated balloon in the right atrium ("sham"). The primary end point of the study is the change in index of microvascular resistances (IMR) after acute modulation of CS pressure, while key secondary end points include changes in the other parameters. Discussion: The aim of the study is to investigate whether occlusion of the CS is associated with a decrease in IMR. The results will provide mechanistic evidence for the development of a treatment for patients with MVA. Clinical trial registration: https://clinicaltrials.gov/, identifier NCT05034224.

Ethnic discrimination and psychological stress among Hispanic emerging adults: Examining the moderating effects of distress tolerance and optimism.

Hispanic emerging adults are often exposed to ethnic discrimination, yet little is known about coping resources that may mitigate the effects of ethnic discrimination on psychological stress in this rapidly growing population. As such, this study aims to examine (1) the associations of ethnic discrimination, distress tolerance, and optimism with psychological stress and (2) the moderating effects of distress tolerance and optimism on the association between ethnic discrimination and psychological stress. Data were drawn from a cross-sectional study of 200 Hispanic adults ages 18-25, recruited from two urban counties in Arizona and Florida. Hierarchical multiple regression and moderation analyses were utilized to examine these associations and moderated effects. Findings indicated that higher optimism was associated with lower psychological stress. Conversely, higher ethnic discrimination was associated with higher psychological stress. Moderation analyses indicated that both distress tolerance and optimism moderated the association between ethnic discrimination and psychological stress. These study findings add to the limited literature on ethnic discrimination among Hispanic emerging adults and suggest that distress tolerance may be a key intrapersonal factor that can protect Hispanic emerging adults against the psychological stress often resulting from ethnic discrimination.

Quantitative Flow Ratio or Angiography for the Assessment of Non-culprit Lesions in Acute Coronary Syndromes: Protocol of the Randomized Trial QUOMODO.

Background: Approximately 50% of the patients undergoing percutaneous coronary intervention (PCI) for acute coronary syndromes (ACS) have additional stenotic lesions in non-infarct-related coronary arteries. The decision whether these stenoses require further treatment is routinely based on angiography alone. The quantitative flow ratio (QFR) is a simple non-invasive method that may help quantify the functional significance of these intermediate coronary artery lesions. The aim of our single-center, randomized superiority trial is to test the impact and efficacy of QFR, as compared to angiography, in the treatment of patients with ACS with multivessel coronary artery disease. Primary goal of the study is to investigate 1. The impact of QFR on the proportion of patients receiving PCI vs. conservative therapy and 2. whether QFR improves angina pectoris and overall cardiovascular outcomes. Methods and Analysis: After treatment of the culprit lesion(s), a total of 200 consecutive ACS patients will be randomized 1:1 to angiography- vs. QFR-guided revascularization of non-culprit stenoses. Patients and clinicians responsible are blinded to the randomization group. The primary functional endpoint is defined as the proportion of patients assigned to medical treatment in the two groups. The primary clinical endpoint is a composite of death, non-fatal myocardial infarction, revascularization and significant angina at 12 months. Secondary endpoints include changes in the SAQ subgroups, and clinical events at 3- and 12-month follow-up. Discussion: This study is designed to investigate whether QFR-based decision-making is associated with a decrease in angina and an improved prognosis in patients with multivessel disease. Trial Registration Number: ClinicalTrials.gov Registry (NCT04808310).

Culture, Empathy, and the Therapeutic Alliance.

When the therapist and patient are from different cultures, there may be impediments to the development of empathy and a therapeutic alliance. South India culture provides an example of contrasting values and customs about which patients may be reluctant to discuss. The initial case history is of a South Indian who sought treatment in the United States. The remaining cases, drawn from a village in South India with which the author has had a 55-year history of research, illustrate cultural factors potentially inhibiting or facilitating the development of empathy and a therapeutic alliance.

Randomized non-inferiority TrIal comParing reverse T And Protrusion versus double-kissing and crush Stenting for the treatment of complex left main bifurcation lesions.

BACKGROUND: The treatment of left main bifurcation stenoses remains challenging. AIMS: We compare the "Reverse T and Protrusion" (reverse-TAP) technique to Double-Kissing and crush (DK-crush). METHODS: The study was designed as non-inferiority trial, the primary endpoint was percentage stent expansion in the ostial side branch at optical coherence tomography. RESULTS: 52 consecutive patients (13 females, 17 diabetics, Syntax score 25 [22-29]) with complex coronary bifurcation lesions of the left main were randomized in a 1:1 ratio to Reverse-TAP or DK-crush stenting. The intervention was performed according to protocol in all patients in both randomization groups. Side branch stent expansion was 75 [67-90]% in the DK-crush group and 86 [75-95]% in the reverse-TAP group (one-sided 97.5% lower parametric confidence interval: - 0.28%; P < 0.01 for non-inferiority; P = 0.037 for superiority). Side branch balloon pressure during final kissing was higher in the DK-crush group (14 [12-16] vs. reverse-TAP: 13 [12-14]; P = 0.043). Procedural time was shorter with reverse-TAP (DK-crush: 32 [24-44] min vs reverse-TAP: 25 [22-33] min; P = 0.044). Other procedural parameters were not different between groups. There was no difference in any of the safety endpoints up to 1 month. CONCLUSIONS: A reverse-TAP strategy for the interventional treatment of complex coronary lesions was non-inferior and superior to DK-crush for the primary endpoint side branch expansion while requiring less time. A larger study testing long-term clinical outcomes is warranted. TRAIL REGISTRATION: NCT: NCT03714750.

Effectiveness of a Real-Time X-ray Dosimetry Monitor in Reducing Radiation Exposure in Coronary Procedures: The ESPRESSO-Raysafe Randomized Trial.

Background-Several methods to reduce radiation exposure in the setting of coronary procedures are available on the market, and we previously showed that additional radiation shields reduce operator exposure during radial interventions. We set out to examine the efficacy of real-time personal dosimetry monitoring in a real-world setting of radial artery catheterization. Methods and Results-In an all-comer prospective, parallel study, consecutive coronary diagnostic and intervention procedures were performed with the use of standard radiation shield alone (control group) or with the addition of a real-time dosimetry monitoring system (Raysafe, Billdal, Sweden, monitoring group). The primary outcome was the difference in exposure of the primary operator among groups. Additional endpoints included patient, nurse, second operator exposure and fluoroscopy time. A total of 700 procedures were included in the analysis (n = 369 in the monitoring group). There were no differences among groups in patients' body mass index (p = 0.232), type of procedure (intervention vs. diagnostic, p = 0.172), and patient sex (p = 0.784). Fluoroscopy time was shorter in the monitoring group (5.6 (5.1-6.2) min vs. 7.0 (6.1-7.7) min, p = 0.023). Radiation exposure was significantly lower in the monitoring group for the patient (135 (115-151) µSv vs. 208 (176-245) µSv, p < 0.0001) but not for the first operator (9 (7-11) µSv vs. 10 (8-11), p = 0.70) and the assistant (2 (1-2) µSv vs. 2 (1-2) µSv, p = 0.121). Conclusions-In clinical daily practice, the use of a real-time dosimetry monitoring device reduces patient radiation exposure and fluoroscopy time without an effect on operator radiation exposure.

Coronary In-Stent Restenosis: Predictors and Treatment.

BACKGROUND: Despite the use of modern drug-eluting stents (DES), in-stent restenosis (ISR) may still occur in as many as 2-10% of percutaneous coronary interventions (PCI) in certain lesion/patient subsets. ISR causes increased morbidity after stent implantation; acute myocardial infarction is a frequent correlate to a clinical ISR, arising in 5-10% of cases. Compared to de novo stenosis, patients with ISR also present more frequently with symptoms of unstable angina pectoris (45% versus 61%). In this article, we discuss the risk factors for ISR and the corresponding diagnostic measures and effective treatment strategies. METHODS: This review is based on pertinent publications retrieved by a selective search in PubMed, with special attention to current international guidelines and specialist society recommendations. RESULTS: The type of implanted stent, the presence of diabetes mellitus, previous bypass surgery, and small vessel caliber are predictors for ISR. In their guidelines, the European specialist societies (ESC/EACTS) recommend repeated PCI with DES implantation or drug-coated balloon (DCB) angioplasty as the methods of choice for the treatment of ISR. This approach is supported by evidence from meta-analyses. The RIBS-IV trial showed that revascularization treatment of the target lesion is needed less often after everolimus-eluting stent (EES) implantation than after DCB dilatation (11 [7.1%] versus 24 [15.6%]; p = 0.015; hazard ratio: 0.43; 95% confidence interval: [0.21; 0.87]). CONCLUSION: Because the pathogenesis of ISR is multifactorial, differentiated risk stratification is necessary. The identification of patient-, stent-, and lesion-related predictors is particularly important, as the most effective way to combat ISR is to prevent it.

Race, psychosocial characteristics, and treatment outcomes among individuals undergoing treatment for cannabis use disorder: A latent profile analysis based on preferred method of using cannabis.

INTRODUCTION: There are a wide variety of methods for using combustible cannabis which may impact an individual's pattern of use as well as their response to cannabis use disorder (CUD) treatment. Previous research has noted racial/ethnic differences in cannabis users' preferred method of use. METHOD: The current study examined data from a randomized placebo-controlled trial of a pharmacological intervention for adults with CUD. Latent profile analysis classified participants (N = 302) based on their primary method of combustible cannabis use. RESULTS: A four profile solution emerged which identified participants who demonstrated 1) Primarily Joint (n = 50), 2) Primarily Blunt (n = 106), 3) Mixed MoU (n = 30), and 4) Primarily Pipe (i.e., pipe or bong; n = 116) use. Profiles were compared on socio-demographic characteristics and racial differences were found among the four latent profiles as well as differences in their level of use. Cannabis users with a preference for joints were more likely to be White as compared to other racial groups. In contrast, a greater proportion of participants with a preference for blunts were African American. The Primarily Joint profile was found to have the highest cannabis relapse rate at 1-month follow-up (94%) which was significantly greater than the Mixed MoU (74%, x2 = 5.06, p < .05) and Primarily Pipe (78%, x2 = 9.24, p < .01) profiles. Interestingly, there was no difference in 1-Month Follow-up cannabis relapse rates between the Primarily Joint and Blunt profiles (87%, x2 = 9.24, p > .05). CONCLUSIONS: Findings suggest that treatment-seeking individuals who primarily use joints or blunts may face unique challenges that may impact cannabis abstinence. Along with other cannabis-related characteristics, an individual's preferred method of use may represent an important factor to consider in the treatment of CUD.

Coronary Stent Thrombosis- Predictors and Prevention.

BACKGROUND: Stent thrombosis (ST) is a dreaded complication after stent implantation and is associated with a mortality between 5% and 45%. The mechanisms by which ST arises are complex. Because of the seriousness of this situation, all phy - sicians should have at least basic knowledge of it. In this article, we present the risk factors for ST and discuss some innovative approaches to its treatment. METHODS: This review is based on pertinent articles retrieved by a selective search in PubMed, and on current international guidelines and expert recommendations. RESULTS: The frequency of ST has been markedly lowered by technical advances in coronary stenting and by the implementation of modern implantation techniques, including the introduction of coverage with dual antiplatelet therapy (DAPT). Both patient-related risk factors and procedural aspects can elevate the risk of ST. The independent risk factors for ST include premature termination of DAPT (hazard ratio [HR] 26.8; 95% confidence interval [8.4; 85.4]; p <0.0001), malignant disease (odds ratio [OR]: 17.45; [4.67; 65.26]; p <0.0001), and diabetes mellitus (OR: 3.14; [1.33; 7.45]; p = 0.0093). In comparison to angiographically guided procedures, the use of intracoronary imaging techniques in patients with acute coronary syndrome lowers the frequency of ST (0.6% versus 1.2%; p = 0.005). These techniques enable the detection of many findings in the coronary arteries that are associated with the development of ST. In such cases, countermeasures such as secondary stent dilatation or prolongation of DAPT can help prevent ST. CONCLUSION: As the pathophysiology of ST is multifactorial, research in this area presents a special challenge. Prospective clinical trials will be needed to determine whether the systematic use of imaging techniques can lower the frequency of ST.

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).

The pleiotropic effects of antiplatelet therapies.

Percutaneous coronary intervention is the most often used method for coronary revascularization. Stenting restores blood perfusion to ischemic areas, but it also causes mechanical disruption of the atheromatous plaque and the nearby endothelium, stimulating the activation of platelets. In a similar way, platelets are activated by thrombin exposure in the setting of plaque rupture. The interaction between platelets, oxidative stress and inflammation is an important factor determining the extent and severity of vascular dysfunction observed in these settings. Platelets activated by the vessel trauma release inflammatory and mitogenic mediators into the vascular microenvironment, activating leukocyte chemotaxis and switching the endothelial phenotypefrom a quiescent to an activate one. The increased bioavailability of reactive oxygen species from the vessel wall, from leukocytes and from platelets, and the subsequent decreased bioavailability of nitric oxide, further stimulates platelets, which are otherwise inhibited by this endothelial mediator. Thus, inflammation, oxidative stress and platelet activation cooperate in a feed-forward mechanism leading to vascular dysfunction and possibly compromising the effect of stenting. Inhibitors of platelet function have thus important ancillary effects beyond their antithrombotic ones, which will be discussed in the present short review.

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.

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.

Culture, Empathy, and the Therapeutic Alliance.

When the therapist and patient are from different cultures, there may be impediments to the development of empathy and a therapeutic alliance. South India culture provides an example of contrasting values and customs about which patients may be reluctant to discuss. The initial case history is of a South Indian who sought treatment in the United States. The remaining cases, drawn from a village in South India with which the author has had a 55-year history of research, illustrate cultural factors potentially inhibiting or facilitating the development of empathy and a therapeutic alliance.

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.