Serum lipoprotein(a) and 3-year outcomes in patients undergoing percutaneous coronary intervention.

BACKGROUND AND AIMS We aimed at addressing the association between serum lipoprotein (a) levels and clinical outcomes of consecutive patients undergoing PCI. METHODS We used consecutive patients undergoing PCI at the Heart Center University of Freiburg, Bad Krozingen in Germany between January 2005 and November 2013. A total of 6679 patients [men (n = 5391) and women (n = 1288)] mean aged 67.5 (± 11.1) years were assessed at baseline and prospectively followed for 3 years. Lp(a) measurement were performed at hospital admission as a routine laboratory parameter. RESULTS Approximately 30% of PCI patients show an elevated Lp(a) value of more than 50mg/dL. In total, 736 Patients died during the follow-up, thereof 189 (11.3%) in the first quartile, 186 (10.7%) in the second quartile, 183 (11.5%) in the third quartile and 178 (10.7%) in the last quartile (p value 0.843 from LogRank test). The MACE rate showed consistent results with 409 (24.4%), 385 (22.1%), 395 (24.7%) and 419 (25.3%) in the different respective quartiles (p value 0.125 from LogRank test). CONCLUSION In this large non-selected cohort of patients undergoing PCI followed by moderate intensity statin therapy, higher Lp(a) levels were not associated with worse clinical outcomes during a follow-up of 3 years

Feasibility and outcome of the Rotapro system in treating severely calcified coronary lesions: The Rotapro study

Background: The Rotapro study was conducted to evaluate the safety and feasibility of the new Rotapro rotational atherectomy system (RAS) for lesion preparation in calcified coronary artery stenosis. Methods: Between 2015 and 2019 consecutive patients undergoing rotational atherectomy (RA) with the new Rotapro system and the conventional rotablator (Rotablator) were included from the Bad Krozingen Rotablation Registry. The primary endpoint was the incidence of in-hospital major adverse cardiovascular and cerebral event rate (MACCE). Results: Rotablation was performed in 3.6% of all patients (n = 597) treated by percutaneous coronary intervention. Procedural outcomes were compared according to the applied RAS (n = 246 Rotapro vs. n = 351 Rotablator). Overall technical success was achieved in 98.3% of patients. The primary endpoint of in-hospital MACCE was comparable between the Rotapro- and the Rotablator-group (3.7% vs. 5.7%, respectively, p = 0.254). The Rotapro group was associated with significant reductions of fluoroscopy time (30 vs. 38 min, p < 0.0001), procedural time (82.5 vs. 96 min, p = 0.0003), applied contrast volume (210 vs. 290 mL, p < 0.0001) and radiation dose (6129 vs. 9827 cGy*cm2, p < 0.0001) compared to the Rotablator group. Conclusions: The present study demonstrates the safety and efficacy of the new Rotapro system. In-hospital MACCE rates were comparable between both RAS, whereas Rotapro was associated with less fluoroscopy time, radiation dose as well as contrast use

T and small Protrusion (TAP) vs double-kissing crush technique: Insights from in vitro models

BACKGROUND: Percutaneous coronary interventions on complex bifurcation lesions may require implantation of two stents to appropriately treat diffuse side-branch (SB) disease. Comparisons among different bifurcation stenting techniques are continuously attempted by various study designs (bench tests, computer simulations, clinical studies). Among different techniques, double kissing crush (DKC) represents the last evolution for "crushing" while T and small Protrusion (TAP) represents the evolution of "T stenting". Both techniques are actually gaining popularity, but head-to-head comparisons are lacking. METHODS AND RESULTS: Two last generation drug-eluting stents (Synergy™, Boston Scientific, MA, USA and Ultimaster™,Terumo Corp., Japan) were implanted in left main bifurcation bench models using TAP (n = 6 sets) and DKC (n = 6 sets) techniques. A peristaltic pump with fresh porcine blood was used to perfuse the blood through the silicone model at a flow rate of 200 ml/min for 4 min. Optical coherence tomography (OCT) was used to assess stent struts geometry and thrombus formation. SB cross sectional area as well as SB obstruction did not significantly differ between the two techniques. Numerical (but not statistically significant) differences were found in terms of malapposed struts (fewer with TAP) and floating struts (fewer with DKC). Thrombus formation after blood perfusion was similar between TAP and DKC technique (1.53 ± 1.12 vs. 1.20 ± 1.01 mm2, p = 0.6). CONCLUSION: The result of the present in-vitro study shows the absence of significant difference between TAP and DKC in terms of stent struts apposition and acute thrombus formation potential. Despite the completely different technical steps required, both techniques have similar performance according to such articulated pre-clinical evaluation. WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT?: Due to its limited complexity, T and Protrusion (TAP) technique is considered the to-go technique for bifurcation lesions with good long-term results. Recently, double kissing crush (DKC) technique has been gaining popularity and demonstrated promising results in randomized clinical trials. WHAT DOES THIS STUDY ADD?: This in-vitro bench test study provides a unique detailed OCT comparison and local hemodynamic environment analysis of the two techniques. HOW MIGHT THIS IMPACT ON CLINICAL PRACTICE?: New insights of acute thrombogenicity and computational flow model simulation may guide percutaneous therapeutic strategies of bifurcation lesions

Minimal information for studies of extracellular vesicles 2018 (MISEV2018):a position statement of the International Society for Extracellular Vesicles and update of the MISEV2014 guidelines

The last decade has seen a sharp increase in the number of scientific publications describing physiological and pathological functions of extracellular vesicles (EVs), a collective term covering various subtypes of cell-released, membranous structures, called exosomes, microvesicles, microparticles, ectosomes, oncosomes, apoptotic bodies, and many other names. However, specific issues arise when working with these entities, whose size and amount often make them difficult to obtain as relatively pure preparations, and to characterize properly. The International Society for Extracellular Vesicles (ISEV) proposed Minimal Information for Studies of Extracellular Vesicles (“MISEV”) guidelines for the field in 2014. We now update these “MISEV2014” guidelines based on evolution of the collective knowledge in the last four years. An important point to consider is that ascribing a specific function to EVs in general, or to subtypes of EVs, requires reporting of specific information beyond mere description of function in a crude, potentially contaminated, and heterogeneous preparation. For example, claims that exosomes are endowed with exquisite and specific activities remain difficult to support experimentally, given our still limited knowledge of their specific molecular machineries of biogenesis and release, as compared with other biophysically similar EVs. The MISEV2018 guidelines include tables and outlines of suggested protocols and steps to follow to document specific EV-associated functional activities. Finally, a checklist is provided with summaries of key points

Left Main Coronary Artery Disease and Outcomes after Percutaneous Coronary Intervention for Chronic Total Occlusions

BACKGROUND Concomitant left main coronary artery (LMCA) disease in patients with chronic total occlusions (CTO) commonly results in referral for coronary artery bypass grafting, although the impact of LMCA in CTO patients remains largely unknown. Nevertheless, patient selection for percutaneous coronary intervention of CTOs (CTO-PCI) or alternative revascularization strategies should be based on precise evaluation of the coronary anatomy to anticipate those patients that most likely benefit from a procedure and not on strict adherence to perpetual clinical practice. Therefore, the aim of this study was to assess the impact of LMCA disease on long-term outcomes in patients undergoing percutaneous coronary intervention for CTO. METHODS We enrolled 3860 consecutive patients undergoing PCI for at least one CTO lesion and investigated the predictive value of concomitant LMCA disease. All-cause mortality was defined as the primary study endpoint. RESULTS We observed that LMCA disease is significantly associated with mortality. In the Cox regression analysis, we observed a crude hazard ratio (HR) 1.59 (95% confidence interval (CI) 1.23-2.04, p < 0.001) for patients with LMCA disease as compared to patients without. Results remained unchanged after bootstrap- or clinical confounder-based adjustment. CONCLUSION LMCA disease is associated with excess mortality in CTO patients. Specifically, anatomical features such as CTO of the circumflex artery represent a high risk patient population

Three-year outcomes of percutaneous coronary intervention with next-generation zotarolimus-eluting stents for de novo coronary bifurcation lesions.

AIMS To investigate the outcomes of percutaneous coronary intervention (PCI) in bifurcation versus non-bifurcation lesions using the next-generation Resolute zotarolimus-eluting stent (R-ZES). METHODS AND RESULTS We analyzed 3-year pooled data from the RESOLUTE All-Comers trial and the RESOLUTE International registry. The R-ZES was used in 2772 non-bifurcation lesion patients and 703 bifurcation lesion patients, of which 482 were treated with a simple-stent technique (1 stent used to treat the bifurcation lesion) and 221 with a complex bifurcation technique (2 or more stents used). The primary endpoint was 3-year target lesion failure (TLF, defined as the composite of death from cardiac causes, target vessel myocardial infarction, or clinically-indicated target lesion revascularization [TLR]), and was 13.3% in bifurcation vs 11.3% in non-bifurcation lesion patients (adjusted P=.06). Landmark analysis revealed that this difference was driven by differences in the first 30 days between bifurcation vs non-bifurcation lesions (TLF, 6.6% vs 2.7%, respectively; adjusted P<.001), which included significant differences in each component of TLF and in-stent thrombosis. Between 31 days and 3 years, TLF, its components, and stent thrombosis did not differ significantly between bifurcation lesions and non-bifurcation lesions (TLF, 7.7% vs 9.0%, respectively; adjusted P=.50). CONCLUSION The 3-year risk of TLF following PCI with R-ZES in bifurcation lesions was not significantly different from non-bifurcation lesions. However, there was an increased risk associated with bifurcation lesions during the first 30 days; beyond 30 days, bifurcation lesions and non-bifurcation lesions yielded similar 3-year outcomes

Association of Prolonged Fluoroscopy Time with Procedural Success of Percutaneous Coronary Intervention for Stable Coronary Artery Disease with and without Chronic Total Occlusion

Background: In percutaneous coronary interventions (PCI), the impact of prolonged fluoroscopy time (FT) on procedural outcomes is poorly studied. Methods and Results: We analyzed the outcomes of 12,538 consecutive elective PCIs. The primary endpoint was procedure failure (PF), the composite of technical failure, and adverse in-hospital events including all-cause death, myocardial infarction, stroke, and target vessel revascularization (MACCE), as well as pericardial tamponade. We stratified the procedures as PCI for chronic total occlusion (CTO, n = 2720) and PCI for non-CTO (n = 9818). Logistic regression demonstrated a significant association between fluoroscopy time and procedural failure with a significant interaction with PCI type (both p &lt; 0.001). The odds ratios (OR) of procedural failure for a 10-min increment in FT were 1.15 (confidence interval (CI) 95% 1.12–1.18, p &lt; 0.001) in non-CTO PCI and 1.05 (CI 95% 1.03–1.06, p &lt; 0.001) in CTO PCI. The optimal cut-point for prediction of PF was 21.1 min in non-CTO PCI (procedural success in 98.4% versus 95.3%, adjusted OR for PF 2.79 (CI 95% 1.93–4.04), p &lt; 0.001) and 41 min in CTO PCI (procedural success in 92.3% versus 83.8%, adjusted OR for PF 2.18 (CI 95% 1.64–2.94), p &lt; 0.001). In CTO PCI, the increase in PF with FT was largely driven by technical failure (adjusted OR 2.25 (CI 95% 1.65–3.10), p &lt; 0.001), whereas in non-CTO PCI, it was driven by major complications (adjusted OR 2.94 (CI 95% 1.93–4.53), p &lt; 0.001). Conclusions: Prolonged FT is strongly associated with procedural failure in both non-CTO and CTO PCI. In CTO PCI, this relation is shifted towards longer FT. The mechanisms of procedural failure differ between CTO and non-CTO PCI

Clinical Outcomes after Additional Dynamic Renal® Stent Implantation for Stent Recoil in Ostial Coronary Lesions

Background: Interventional treatment of aorto-ostial coronary stenoses is limited by stent recoil and suboptimal angiographic results, leading to restenosis and frequent re-interventions. As a potential bail-out strategy for stent recoil, implantation of an additional stent to increase radial force has been reported. Thus, we sought to investigate clinical outcomes after additional implantation of a Dynamic Renal&reg; stent (DRS), a non-coronary; bare-metal stent with very high radial force, in aorto-ostial coronary stenoses. Methods: Patients treated by implantation of DRSs for stent recoil in the ostial right coronary artery or the left main stem were identified from the hospital database. Baseline clinical and procedural characteristics were compared to patients who underwent re-intervention for in-stent-restenosis in similar segments by either implantation of conventional drug-eluting stents (DES) or paclitaxel-coated balloons (PCB). Clinical follow-ups were performed up to three years following re-intervention with the assessment of death, target lesion reintervention (TLR), and major adverse cardiac events (MACE) as a combination death, myocardial infarction and target vessel revascularization. Kaplan&ndash;Meier analyses were performed for event-free survival between the three groups. Results: Between 05/2013 and 07/2019, 28 patients underwent DRS implantation of aorto-ostial coronary lesions. In comparison with 49 patients with DES implantation and 29 patients undergoing PCB treatment, no relevant differences in baseline parameters were identified. Median follow-up was 714 days, with an available follow-up of &gt;1 year after intervention in 82.1% of patients. In the entire study cohort at two years after re-intervention, the TLR rate was 16% (17 patients), the MACE rate 37% (39 patients), and all-cause mortality 9% (10 patients), with no significant differences between the three groups. Conclusions: DRS implantation for treating stent recoil of aorto-ostial coronary lesions resulted in a high rate of TLR, and was associated with similar risk for death and MACE compared to treatment of in-stent-restenosis with DES or PCB. Randomized, larger comparisons of contemporary DES in patients exclusively presenting with stent recoil are necessary to further define the efficacy and safety of this approach

Temporal changes in outcomes of women and men undergoing percutaneous coronary intervention for chronic total occlusion: 2005-2013

OBJECTIVE Percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) has undergone impressive progress during the last decade, both in strategies and equipment. It is unknown whether technical refinement has translated into improved outcomes in women undergoing CTO-PCI. METHOD AND RESULTS A total of 2002 consecutive patients (17% females, mean age 65.2 ± 10.7 years) undergoing PCI of at least one CTO lesion at our center between 01/2005 and 12/2013 were evaluated. The incidence of adverse events was compared between two time series (2005-2009 and 2010-2013). A significant increase in adverse lesion characteristics over time was noted in both, women and men (p < 0.001), while technical success rates significantly increased in men but not in women (ptrend < 0.001 in men and ptrend=0.9 in women). The incidence of procedural complications was significantly higher in women as compared to men and increased over the study period in women (p < 0.05) but not in men. Accordingly, multivariate logistic regression analysis identified female sex as a strong predictor of PCI-related complications in recent years, while this was not the case in earlier years (adjusted HR 2.03, 95% CI 0.62-6.6, p = 0.2 and adjusted HR 4.7, 95% CI 1.8-12.3, p = 0.002, respectively, p < 0.001 for log LH ratio). In addition, major adverse cardiovascular events (MACE) after a 3-year follow-up significantly declined in men (log rank = 0.046), while no changes were observed in women. CONCLUSION While higher success rates and a reduced rate of MACE have been achieved in men, the incidence of procedural complications in women undergoing CTO-PCI has increased over time