Minor defects of the luminal integrity in arterial introducer eSheaths after transcatheter aortic valve implantation.

BACKGROUND: Medical devices such as implant delivery systems are commonly used during minimally invasive procedures in the cardiovascular system. These devices often have lubricious polymer coatings to reduce friction between the device and blood vessels but coatings may separate and potentially cause serious injuries to patients. METHODS: Lubricious coated eSheaths for transcatheter heart valve implantation were assessed for luminal integrity at the proximal, medial and distal part. We assessed the number, depths and area of luminal trails using environmental scanning electron microscope (ESEM), white light interferometry (WLI) and optical profilometry using area scale fractal complexity (asfc) as surface parameters. A total of 15 eSheaths were retrieved and analyzed after successful femoral transcatheter Sapien 3 implantation in patients (23 mm valve- 14F eSheath, 26 mm valve- 14F eSheath and 29 mm valve- 16F eSheath, n = 5 for each group). Unused eSheaths (14F and 16F) served as controls (n = 5 for each group). RESULTS: ESEM revealed significantly greater number of trails after TAVR passage with the 23 mm, 26 mm and 29 mm valves compared to unused control 14F and 16F eSheaths (13.9 ± 3.1, 14.2 ± 2.3, 15.8 ± 1.7 vs. 0.08 ± 0.1 and 1.0 ± 0.5 [n]; p ≤ 0.0001 for all comparisons). Similarly, WLI showed minor, but significantly greater areas of luminal defects after 23 mm, 26 mm and 29 mm valve implantation vs. 14F and 16F unused controls (7.5 ± 0.9, 10.3 ± 1.1, 10.4 ± 1.4 vs. 4.1 ± 0.4 and 2.2 ± 0.4 [µm2], p = 0.0081). Likewise, the 3D-surface-measurement showed comparable results after implantation of the 23 mm, 26 mm and 29 mm valves vs. 14F and 16F unused control eSheaths (79.5 ± 6.3, 105.9 ± 5.3, 98.8 ± 4.8 vs. 5.1 ± 2.8 and 5.6 ± 0.5 [asfc] p = 0.0001). CONCLUSION: Measurable defects of the luminal layer occur during balloon expandable TAVR using 14F and 16F eSheaths though this is likely clinically insignificant. Further clinical investigations including a prospective assessment of minor peripheral embolization are needed to fully address the impact of this luminal defects.

Long-term prognostic value of risk scores after drug-eluting stent implantation for unprotected left main coronary artery: A pooled analysis of the ISAR-LEFT-MAIN and ISAR-LEFT-MAIN 2 randomized clinical trials.

OBJECTIVES: To evaluate the long-term prognostic value of risk scores in the setting of drug-eluting stent (DES) implantation for uLMCA. BACKGROUND: Data on the prognostic value of novel risk scores developed to select the most appropriate revascularization strategy in patients undergoing DES implantation for uLMCA disease are relatively limited. METHODS: The study represents a patient-level pooled analysis of the ISAR-LEFT-MAIN (607 patients randomized to paclitaxel-eluting or sirolimus-eluting stents) and the ISAR-LEFT-MAIN-2 (650 patients randomized to everolimus-eluting or zotarolimus-eluting stents) randomized trials. The Syntax Score (SxScore) as well the Syntax Score II (SS-II), the EuroSCORE and the Global Risk Classification (GRC) were calculated. The primary outcome was all-cause mortality. RESULTS: At a mean follow-up of 3 years there were 160 deaths (12.7%). The death-incidence was significantly higher in the upper tertiles than in the intermediate or lower ones for all risk scores (log-rank test P < 0.01 for all comparisons). The discriminatory power of a multivariable model for prediction of 3-year mortality was significantly improved after the inclusion of EuroSCORE (adjusted area under the receiver operating characteristic (ROC) curve = 0.779, 95% confidence interval 0.747 to 0.810, P = 0.008), but not after the inclusion of SxScore, SS II, or GRC. CONCLUSIONS: In patients undergoing DES implantation for uLMCA disease, all evaluated risk scores were able to stratify the mortality risk at long-term follow-up. EuroSCORE was the only risk score that significantly improved the discriminatory power of a multivariable model to predict long-term mortality. © 2016 Wiley Periodicals, Inc.

Three-year efficacy and safety of new- versus early-generation drug-eluting stents for unprotected left main coronary artery disease insights from the ISAR-LEFT MAIN and ISAR-LEFT MAIN 2 trials.

BACKGROUND: In percutaneous coronary intervention (PCI) patients new-generation drug-eluting stent (DES) has reduced adverse events in comparison to early-generation DES. The aim of the current study was to investigate the long-term clinical efficacy and safety of new-generation DES versus early-generation DES for PCI of unprotected left main coronary artery (uLMCA) disease. METHODS: The patient-level data from the ISAR-LEFT MAIN and ISAR-LEFT MAIN 2 randomized trials were pooled. The clinical outcomes of PCI patients assigned to new-generation DES (everolimus- or zotarolimus-eluting stent) versus early-generation DES (paclitaxel- or sirolimus-eluting stent) were studied. The primary endpoint was the composite of death, myocardial infarction (MI), target lesion revascularization and stroke (MACCE, major adverse cardiac and cerebrovascular event). RESULTS: In total, 1257 patients were available. At 3 years, the risk of MACCE was comparable between patients assigned to new-generation DES or early-generation DES (28.2 versus 27.5 %, hazard ratio-HR 1.03, 95 % confidence intervals-CI 0.83-1.26; P = 0.86). Definite/probable stent thrombosis was low and comparable between new-generation DES and early-generation DES (0.8 versus 1.6 %, HR 0.52, 95 % CI 0.18-1.57; P = 0.25); in patients treated with new-generation DES no cases occurred beyond 30 days. Diabetes increased the risk of MACCE in patients treated with new-generation DES but not with early-generation DES (P interaction = 0.004). CONCLUSIONS: At 3-year follow-up, a PCI with new-generation DES for uLMCA disease shows comparable efficacy to early-generation DES. Rates of stent thrombosis were low in both groups. Diabetes significantly impacts the risk of MACCE at 3 years in patients treated with new-generation DES for uLMCA disease. ClinicalTrials.gov Identifiers: NCT00133237; NCT00598637.

Intraprocedural reduction of the veno-arterial norepinephrine gradient correlates with blood pressure response after renal denervation.

AIMS: No intraprocedural assessment is currently available to evaluate the extent of nerve ablation by renal denervation (RDN). We prospectively evaluated the association of intraprocedural reduction of renal veno-arterial norepinephrine gradient with blood pressure (BP) response after RDN. METHODS AND RESULTS: In 46 consecutive RDN patients, the periprocedural norepinephrine veno-arterial difference was defined as veno-arterial norepinephrine gradient. We observed a reduction of the office systolic BP from 176±19 mmHg to 165±24 mmHg (p=0.02) at three months and 163±22 mmHg (p=0.02) at six months. The mean and maximum systolic ABP decreased by 5 mmHg (p=0.03) and 9 mmHg (p=0.02), respectively. There was a decrease of the norepinephrine RV-RA difference from pre- to post-procedural levels (median 186 pg/ml [54;466] vs. 81 pg/ml [0;182], p=0.02). OBP responders (office systolic BP reduction ≥10 mmHg) showed a greater reduction of the norepinephrine gradient compared to non-responders (-290±450 pg/ml vs. -4±106 pg/ml, p=0.01). Patients with a reduction of norepinephrine gradient in both kidneys showed the most pronounced decrease of the systolic OBP (-24±14 mmHg) compared to patients with a reduction of norepinephrine gradient in only one kidney (-7±15 mmHg) or patients without a norepinephrine reduction (-3±19 mmHg, p=0.03 vs. bilateral reduction). CONCLUSIONS: Measuring renal norepinephrine gradient during RDN may be a method to gauge the extent of renal nerve ablation.

Single Center Retrospective Analysis of Conventional and Radial TIG Catheters for Transradial Diagnostic Coronary Angiography.

Current guidelines favor the radial approach for coronary angiography. Therefore, specialty radial diagnostic catheters were designed to engage both coronary arteries with a single device. However, it is unclear if single catheters are superior to conventional catheters. A retrospective analysis was performed of consecutive right radial coronary angiographies to determine catheter use, fluoroscopy time, radiation dosage, and consumption of contrast. Procedures were performed with a single TIG catheter or conventional catheters (CONV). Procedures with coronary artery bypass grafts or ventricular angiographies were excluded. 273 transradial procedures were performed successfully. 95 procedures were performed with CONV and 178 procedures with a TIG. Crossover to additional catheters was higher in TIG (15.2%) compared to CONV (5.3%, p = 0.02). Fluoroscopy time was comparable between CONV and TIG, without crossover (2.2 ± 1.2 min versus 2.3 ± 1.2 min; n.s.), however, greater in the case of crossover for CONV (5.8 ± 0.7) and TIG (7.6 ± 3.0; p = 0.0001). Radiation dosage was similar in CONV and the TIG, without crossover (1419 ± 1075, cGy∗cm(2) versus 1690 ± 1138; n.s.), however, greater for CONV (2374 ± 620) and TIG (3733 ± 2281, p = 0.05) with crossover. Overall, the amount of contrast was greater in TIG (56 ± 13 mL) versus CONV (48 ± 3 mL; p = 0.0003). CONV femoral catheters may be the primary choice for radial approach.

Changes of the eSheath Outer Dimensions Used for Transfemoral Transcatheter Aortic Valve Replacement.

Innovative catheter systems with lower-profile sheaths and a dynamic expansion mechanism (DEM) were recently introduced for transcatheter aortic valve replacement (TAVR). However, the labeling of 14 F and 16 F eSheaths denote the inner nominal diameter. Exact changes of the clinically relevant outer diameters during usage are not available. eSheaths were measured every 30 mm using a digital caliper. Unused 14 F and 16 F eSheaths served as controls. Maximum eSheath diameters were measured after insertion of the Edwards Commander Delivery System (ECDS) into 14 F and 16 F eSheaths.Finally, eSheaths were retrieved and measured after TAVR. Outer diameters of control 14 F eSheaths were 5.8 mm and 6.50 mm for the 16 F eSheath. Introduction of the 23 mm and 26 mm ECDS into 14 F eSheaths showed a maximum diameter of 7.65 mm and 7.64 mm (P = NS). Introduction of the 29 mm ECDS into the 16 F eSheath showed the greatest diameter of 8.18 mm (P = 0.03). After TAVR, diameters of the 14 F eSheaths were 7.14 mm (23 mm valve) and 7.26 mm (26 mm valve) (P = NS), while 16 F eSheaths were 8.10 mm (29 mm valve) (P ≤ 0.03). Nominal 14 F and 16 F eSheaths showed a significant increase of the outer diameter during advancement of the ECDS and after TAVR implantation.

The impact of therapeutic hypothermia on on-treatment platelet reactivity and clinical outcome in cardiogenic shock patients undergoing primary PCI for acute myocardial infarction: Results from the ISAR-SHOCK registry.

INTRODUCTION: Mild therapeutic hypothermia (TH) is standard of care after cardiac arrest of any cause. However, its impact on on-treatment platelet reactivity and clinical outcome in patients with acute myocardial infarction (AMI) complicated by cardiogenic shock and undergoing PCI with P2Y12 receptor inhibitor treatment is less clear. METHODS AND RESULTS: For the ISAR-SHOCK registry, 145 patients with AMI, cardiogenic shock and primary PCI in two centers (Deutsches Herzzentrum München and Klinikum rechts der Isar, Technical University Munich) between January 2009-May 2012 were analysed. Of these, 64 (44%) patients received TH treatment. The median [IQR] ADP-induced platelet aggregation following thienopyridine loading dose administration (clopidogrel in 95 and prasugrel in 50 patients) did not differ between the two groups (419 [283-684] for TH vs. 355 [207-710] AU x min for non-TH patients, P=0.22). After 30days follow-up, no significant differences were observed between both groups for mortality (42 vs. 44 %, HR: 0.93, 95% CI [0.56-1.53], p=0.77), MI (6 vs. 6%, HR: 0.99 95% CI [0.27-3.7], p=0.99) and TIMI minor bleedings (17 vs. 17%, HR 0.99 95% CI [0.45-2.18], p=0.98). TIMI major bleedings were numerically higher in the TH vs. non-TH cohort (25 % vs. 12 %, HR: 2.1 95% CI [0.95-4.63], p=0.07). Three definite stent thrombosis (ST) were observed in this registry and all STs occurred in the TH group of patients (p=0.09). CONCLUSION: Results of this registry suggest that TH does not negatively impact on platelet reactivity in shock patients receiving either clopidogrel or prasugrel. The numerically higher rate of major bleedings and the clustering of STs in the TH cohort warrant further investigation.

ISAR-SAFE: a randomized, double-blind, placebo-controlled trial of 6 vs. 12 months of clopidogrel therapy after drug-eluting stenting.

BACKGROUND: In patients receiving aspirin, the optimal duration of clopidogrel therapy after drug-eluting stent (DES) implantation remains unclear. METHODS: This multicentre, randomized, double-blind, placebo-controlled trial tested the hypothesis that in patients undergoing DES implantation, 6 months of clopidogrel is non-inferior to 12 months in terms of clinical outcomes. At 6 months after DES implantation, patients on clopidogrel were randomly assigned to either a 6-month period of placebo or an additional 6-month period of clopidogrel. The primary endpoint was the composite of death, myocardial infarction, stent thrombosis, stroke, and thrombolysis in myocardial infarction major bleeding at 9 months after randomization. RESULTS: Owing to slow recruitment and low event rates, the trial was stopped prematurely after enrolment of 4005 of 6000 planned patients. Of 4000 patients included in the final analysis, 1997 received 6 months of clopidogrel and 2003 received 12 months. The primary endpoint occurred in 29 patients (1.5%) assigned to 6 months of clopidogrel and 32 patients (1.6%) assigned to 12 months, observed difference -0.1%, upper limit of one-sided 95% confidence interval (CI) 0.5%, limit of non-inferiority 2%, Pfor noninferiority <0.001. Stent thrombosis was observed in five patients (0.3%) assigned to 6 months of clopidogrel and three patients (0.2%) assigned to 12 months; hazard ratio (HR) 1.66, 95% CI: 0.40-6.96, P = 0.49. Thrombolysis in myocardial infarction major bleeding was observed in 4 patients (0.2%) assigned to 6 months clopidogrel and 5 patients (0.3%) assigned to 12 months; HR 0.80, 95% CI: 0.21-2.98, P = 0.74. CONCLUSIONS: In the present trial, characterized by low event rates, we did not observe a significant difference in net clinical outcome between 6 and 12 months of clopidogrel therapy after DES implantation. However, the results of the trial must be considered in view of its premature termination and lower than expected event rates. The trial is registered with ClinicalTrials.gov, Identifier: NCT00661206.

How should I treat dislocation of a TAVI SAPIEN prosthesis into the left ventricle?

BACKGROUND: Despite the technical advancements of the transcatheter aortic valve implantation (TAVI) procedure, valve embolisation into the left ventricle remains a challenging situation requiring expedited management through the Heart Team. INVESTIGATION: The advantages and pitfalls of an interventional transfemoral approach, a transapical extraction of the dislocated prosthesis or the conversion to open heart surgery have to be balanced depending on the overall situation and the specific characteristics of the patient. DIAGNOSIS: A transfemoral approach would be the first choice for most TAVI implanters. We discuss the different options and present an elegant solution solving this challenging situation, leading to a good immediate and long-term outcome. MANAGEMENT: Attempts at pulling the prosthesis out of the ventricle using a balloon remained unsuccessful. After grasping of the prosthesis with a goose-neck snare, the valve was pulled into the annulus. A second SAPIEN XT prosthesis was implanted and fixed the first prosthesis within the annulus. After post-dilatation, there was a good result without relevant gradient and minimal aortic regurgitation.

"First-in-man" MitraClip via pulmonary vein access through a right mini-thoracotomy in a patient with agenesis of the inferior vena cava.

AIMS: Transcatheter mitral valve repair has become a promising alternative treatment option for severe symptomatic mitral regurgitation in patients at high risk for open heart surgery with heart-lung bypass. METHODS AND RESULTS: We describe the first successful procedure of mitral clipping through a right lateral mini-thoracotomy via the right upper pulmonary vein in a patient with an agenesis of the inferior vena cava. The set-up of the MitraClip system on a separate table located at 70¡ on the right side of the patient and the fixation of the steerable sheath at the entry into the thorax with constant posterior pressure enabled clip implantation using the usual manoeuvres with marked reduction of the mitral insufficiency. CONCLUSIONS: The access through the right upper pulmonary vein using the usual right mini-thoracotomy enabled a successful mitral clipping even in the absence or occlusion of the inferior vena cava.

Exercise-induced arterial hypertension - an independent factor for hypertrophy and a ticking clock for cardiac fatigue or atrial fibrillation in athletes?

UNLABELLED: Background : Exercise-induced arterial hypertension (EIAH) leads to myocardial hypertrophy and is associated with a poor prognosis. EIAH might be related to the "cardiac fatigue" caused by endurance training. The goal of this study was to examine whether there is any relationship between EIAH and left ventricular hypertrophy in Ironman-triathletes. METHODS: We used echocardiography and spiroergometry to determine the left ventricular mass (LVM), the aerobic/anaerobic thresholds and the steady-state blood pressure of 51 healthy male triathletes. The main inclusion criterion was the participation in at least one middle or long distance triathlon. RESULTS: When comparing triathletes with LVM <220g  and athletes with LVM >220g there was a significant difference between blood pressure values (BP) at the anaerobic threshold (185.2± 21.5 mmHg vs. 198.8 ±22.3 mmHg, p=0.037). The spiroergometric results were: maximum oxygen uptake (relative VO 2max) 57.3 ±7.5ml/min/kg vs. 59.8±9.5ml/min/kg (p=ns). Cut-point analysis for the relationship of BP >170 mmHg at the aerobic threshold and the probability of LVM >220g showed a sensitivity of 95.8%, a specificity of 33.3%, with a positive predictive value of 56.8 %, a good negative predictive value of 90%. The probability of LVM >220g increased with higher BP during exercise (OR: 1.027, 95% CI 1.002-1.052, p= 0.034) or with higher training volume (OR: 1.23, 95% CI 1.04 -1.47, p = 0.019). Echocardiography showed predominantly concentric remodelling, followed by concentric hypertrophy. CONCLUSION: Significant left ventricular hypertrophy with LVM >220g is associated with higher arterial blood pressure at the aerobic or anaerobic threshold. The endurance athletes with EIAH may require a therapeutic intervention to at least prevent extensive stiffening of the heart muscle and exercise-induced cardiac fatigue.

Percutaneous mitral valve edge-to-edge repair: in-hospital results and 1-year follow-up of 628 patients of the 2011-2012 Pilot European Sentinel Registry.

BACKGROUND: The use of transcatheter mitral valve repair (TMVR) has gained widespread acceptance in Europe, but data on immediate success, safety, and long-term echocardiographic follow-up in real-world patients are still limited. OBJECTIVES: The aim of this multinational registry is to present a real-world overview of TMVR use in Europe. METHODS: The Transcatheter Valve Treatment Sentinel Pilot Registry is a prospective, independent, consecutive collection of individual patient data. RESULTS: A total of 628 patients (mean age 74.2 ± 9.7 years, 63.1% men) underwent TMVR between January 2011 and December 2012 in 25 centers in 8 European countries. The prevalent pathogenesis was functional mitral regurgitation (FMR) (n = 452 [72.0%]). The majority of patients (85.5%) were highly symptomatic (New York Heart Association functional class III or higher), with a high logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) (20.4 ± 16.7%). Acute procedural success was high (95.4%) and similar in FMR and degenerative mitral regurgitation (p = 0.662). One clip was implanted in 61.4% of patients. In-hospital mortality was low (2.9%), without significant differences between groups. The estimated 1-year mortality was 15.3%, which was similar for FMR and degenerative mitral regurgitation. The estimated 1-year rate of rehospitalization because of heart failure was 22.8%, significantly higher in the FMR group (25.8% vs. 12.0%, p[log-rank] = 0.009). Paired echocardiographic data from the 1-year follow-up, available for 368 consecutive patients in 15 centers, showed a persistent reduction in the degree of mitral regurgitation at 1 year (6.0% of patients with severe mitral regurgitation). CONCLUSIONS: This independent, contemporary registry shows that TMVR is associated with high immediate success, low complication rates, and sustained 1-year reduction of the severity of mitral regurgitation and improvement of clinical symptoms.

Novel mitral clipping technique overcoming extreme atrial dilatation.

The mitral clipping technique is emerging as a promising new treatment option for severe mitral regurgitation. The device was designed and assessed in intermediate risk populations, which is in contrast to the real world, where most patients are deemed to be at very high risk for open heart surgery. The cardiac anatomy of these patients often challenges the freedom grades of the current mitral clip device. In this case presentation, we describe a novel technique overcoming extreme atrial dilation in a patient with severe mitral regurgitation despite previous implantation of two mitral clips. Based on a low/anterior trans-septal puncture, this procedure relied on a counter clock-wise 90° turn of the steerable sheath and alignment of the clip delivery system to the mitral valve, thereby gaining additional longitudinal freedom. This resulted in the successful implantation of two additional clips with achievement of a mild to moderate mitral regurgitation without relevant gradient and dramatic and sustained clinical improvement of the patient.

Impact of coronary anatomy and stenting technique on long-term outcome after drug-eluting stent implantation for unprotected left main coronary artery disease.

OBJECTIVES: This study sought to evaluate the impact of anatomic and procedural variables on the outcome of the unprotected left main coronary artery (uLMCA) itself after drug-eluting stent (DES) implantation. BACKGROUND: There is a controversial debate regarding when and how to perform percutaneous coronary intervention (PCI) for an uLMCA stenosis. METHODS: This analysis is based on a randomized study of 607 patients undergoing PCI for uLMCA, randomized 1:1 to receive paclitaxel- or sirolimus-eluting stents. We evaluated the impact of the SYNTAX score, uLMCA anatomy, and stenting technique on in-stent restenosis (ISR), target lesion revascularization (TLR), and the 3-year outcomes. RESULTS: The 3-year cardiac mortality rate was 5.8%; 235 (39%) patients had a true bifurcation lesion (TBL), and the median SYNTAX score was 27. TBL was associated with a higher need for multiple stents (72% vs. 37%, p < 0.001). TBL was a significant predictor of ISR (23% vs. 14%, p = 0.008) and for TLR (18% vs. 9%, p < 0.001). The need for multiple stents was a predictor of ISR (22% vs. 13%, p = 0.005) and for TLR (16% vs. 9%, p = 0.005). Culotte stenting showed better results compared with T-stenting for ISR (21% vs. 56%, p = 0.02) and for TLR (15% vs. 56%, p < 0.001). We observed a significant association between uLMCA-TLR and SYNTAX scores (9.2% for scores ≤ 22, 14.9% for scores 23 to 32, and 13.0% for scores ≥ 33, p = 0.008). CONCLUSIONS: PCI of uLMCA lesions with DES is safe and effective out to 3 years. TBL and multiple stents were independent predictors for ISR. In the multivariate analysis, independent predictors for TLR were TBL, age, and EuroSCORE (European System for Cardiac Operative Risk Evaluation). (Drug-Eluting-Stents for Unprotected Left Main Stem Disease [ISAR-LEFT-MAIN]; NCT00133237).

Entanglement due to Delayed Removal of a Buddy Wire.

A buddy wire is often used to aid in the delivery of balloons and stents when negotiating tortuous or calcified vessels. We present a planned two-stent mini-crush intervention complicated by entanglement of the buddy wire with the second stent and subsequent distortion of the stent within the guiding catheter. Based on this case, we suggest removing the buddy wire immediately after successful positioning of the first stent, because entrapment with a second stent is possible and may lead to challenging situations in a simultaneous two-stent strategy.

Zotarolimus- versus everolimus-eluting stents for unprotected left main coronary artery disease.

OBJECTIVES: This study sought to compare the safety and efficacy of the zotarolimus-eluting stent (ZES) and the everolimus-eluting stent (EES) for treatment of unprotected left main coronary artery (uLMCA) disease. BACKGROUND: The second-generation ZES and EES have reduced the risk of restenosis in large patient cohorts. However, their comparative performance in uLMCA lesions is not known. METHODS: In this study, patients with symptomatic coronary artery disease undergoing percutaneous coronary intervention for uLMCA lesions were randomly assigned to receive either a ZES (n = 324) or an EES (n = 326). The primary endpoint was the combined incidence of death, myocardial infarction, and target lesion revascularization at 1 year. Secondary endpoints were definite or probable stent thrombosis at 1 year and angiographic restenosis based on analysis of the left main coronary artery area at follow-up angiography. RESULTS: At 1 year, the cumulative incidence of the primary endpoint was 17.5% in the ZES group and 14.3% in the EES group (relative risk: 1.26; 95% confidence interval [CI]: 0.85 to 1.85; p = 0.25). Three patients in the ZES group (0.9%) and 2 patients in the EES group (0.6%) experienced definite or probable stent thrombosis (p > 0.99). All-cause mortality at 1 year was equal in the 2 groups (5.6%; relative risk: 1.00; 95% CI: 0.52 to 1.93; p = 0.98). Angiographic restenosis occurred in 21.5% of patients in the ZES group and 16.8% in the EES group (relative risk: 1.28; 95% CI: 0.86 to 1.92; p = 0.24). CONCLUSIONS: Within the statistical limitations of the present study, treatment of uLMCA lesions with a ZES or an EES provided comparable clinical and angiographic outcomes at 1-year follow-up.

Early vascular healing with rapid breakdown biodegradable polymer sirolimus-eluting versus durable polymer everolimus-eluting stents assessed by optical coherence tomography.

BACKGROUND: Differences in early arterial healing patterns after stent implantation between biodegradable and durable polymer based new generation drug-eluting stents are not well understood. The aim of this study was to compare the healing patterns of a novel rapid breakdown (≤8 weeks) biodegradable polymer sirolimus-eluting stent (BP-SES) with a durable polymer everolimus-eluting stent (EES) using intravascular optical coherence tomography (OCT) at 4 months. METHODS: A total of 20 patients were randomly assigned to stenting with BP-SES (n=11) or EES (n=9). Overall intravascular imaging was available for 15 (75%) patients. The primary endpoint was the difference in rate of uncovered struts between BP-SES and EES. To account for strut-level clustering, the results in both treatment groups were compared using a generalized linear mixed model approach. RESULTS: Regarding the primary endpoint, BP-SES as compared to EES showed similar rates of uncovered struts (37 [6.8%] versus 167 [17.5%], odds ratio (OR) 0.45 (95% CI 0.09-2.24), p=0.33). There were no malapposed struts in BP-SES group and 14 malapposed struts in EES group (p=0.97). No difference in percent neointimal volume (14.1±8.2% vs. 11.4±6.4%, p=0.56) was observed. CONCLUSIONS: Although rapid-breakdown BP-SES as compared to EES showed signs of improved early tissue coverage, after adjustment for strut-level clustering these differences were not statistically significant. No differences in ability to suppress neointimal hyperplasia after stent implantation between 2 stents were observed.

Paclitaxel-eluting balloons, paclitaxel-eluting stents, and balloon angioplasty in patients with restenosis after implantation of a drug-eluting stent (ISAR-DESIRE 3): a randomised, open-label trial.

BACKGROUND: The best way to manage restenosis in patients who have previously received a drug-eluting stent is unknown. We investigated the efficacy of paclitaxel-eluting balloons (PEB), paclitaxel-eluting stents (PES), and balloon angioplasty in these patients. METHODS: In this randomised, open-label trial, we enrolled patients older than 18 years with restenosis of at least 50% after implantation of any limus-eluting stent at three centres in Germany between Aug 3, 2009, and Oct 27, 2011. Patients were randomly assigned (1:1:1; stratified according to centre) to receive PEB, PES, or balloon angioplasty alone by means of sealed, opaque envelopes containing a computer-generated sequence. Patients and investigators were not masked to treatment allocation, but events and angiograms were assessed by individuals who were masked. The primary endpoint was diameter stenosis at follow-up angiography at 6-8 months. Primary analysis was done by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00987324. FINDINGS: We enrolled 402 patients, of whom 137 (34%) were assigned to PEB, 131 (33%) to PES, and 134 (33%) to balloon angioplasty. Follow-up angiography at 6-8 months was available for 338 (84%) patients. PEB was non-inferior to PES in terms of diameter stenosis (38·0% [SD 21·5] vs 37·4% [21·8]; difference 0·6%, one-sided 95% CI 4·9%; p(non-inferiority)=0·007; non-inferiority margin of 7%). Findings were consistent in per-protocol analysis (p(non-inferiority)=0·011). PEB and PES were superior to balloon angioplasty alone (54·1% [25·0]; p(superiority)<0·0001 for both comparisons). Frequency of death, myocardial infarction, or target lesion thrombosis did not differ between groups. INTERPRETATION: By obviating the need for additional stent implantation, PEB could be a useful treatment for patients with restenosis after implantation of a drug-eluting stent. FUNDING: Deutsches Herzzentrum.