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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.

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).

BackgroundDiabetes 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.MethodsPatients 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.ResultsSix 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.ConclusionAs 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.Electronic supplementary materialThe online version of this article (10.1186/s12872-018-0811-7) contains supplementary material, which is available to authorized users.

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.

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. Graphical abstract

BackgroundApproximately 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 AnalysisAfter 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.DiscussionThis 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 NumberClinicalTrials.gov Registry (NCT04808310).