Myocard Infarct en Cerebrovasculair Accident keten (MICK) studie

For patients with acute coronary syndrome (ACS) and stroke prompt diagnosis and treatment is essential. Before a patient reaches the hospital he may have had contact with a general practitioner (GP), a GP cooperative (GPC), ambulance service, or Emergency Department. Optimal use and efficient functioning of the acute health care chain is imperative. The aim of the MICK study is to obtain insight into circumstances in which symptoms of patients occur, medical contacts throughout the acute care chain, delays, door-to-balloon and door-to-needle time. This is a prospective observational study including 202 patients suspected of having ACS and 239 suspected of ischemic stroke. Patients filled out a questionnaire and additional data was obtained using registries.\ud Over 40% of all patients suspected of ACS waited more than 6 hours before contacting a health care provider and over 30% of all patients suspected of having a stroke waited more than 4 hours. Patients reached the hospital through many different health care chains. Once a care provider was contacted, 45% of all patients with ACS were hospitalized within 90 minutes at the CCU and 65% of patients with stroke within 4 hours at the stroke unit.\ud Most patients first contacted the GP or GPC. For patients who immediately called 112 time to hospitalization was the shortest.\ud Overall are noticeable the long patient delays in seeking care, the various chains through which patients reach the CCU or stroke unit and the different throughput times

Micro-computed tomographic assessment following extremely oversized partial postdilatation of drug-eluting stents

AIMS: To assess the spatial geometry of drug-eluting stents (DES) following extremely oversized proximal postdilatation. Interventions of distal left main (LM) disease generally require stenting across the LM bifurcation with inherent vessel tapering along this segment and a high likelihood of stent malapposition, which can be avoided by such postdilations. METHODS AND RESULTS: Sixteen DES (four 3.5 mm-samples of Cypher Select Plus, Taxus Liberté, Endeavor Resolute, Xience V) were deployed in water; 12 samples were then proximally postdilated with noncompliant 5.0 mm balloons at 18 atm. All samples were examined by micro-computed tomography. Taxus Liberté, Endeavor Resolute, and Xience V, showed increased cell areas in the transitional region (just distal to postdilated region), while Cypher Select showed its largest cells inside the postdilated region. Overall, the largest maximum cell area was observed in Endeavor Resolute, while Cypher Select showed the smallest (p<0.001, for both). In addition, the size of the very proximal postdilated cells was relatively small in most DES except Xience V. CONCLUSIONS: Extremely oversized partial stent postdilatation demonstrated significant between-DES differences in final spatial stent configuration and maximum cell size. These data could be of practical interest with regard to coronary interventions in LM stems with stenting across the LM bifurcation

Scanning electron microscopic assessment of the biodegradable coating on expanded biolimus-eluting stents

AIMS: Biodegradable coatings on drug-eluting stents (DES) may help to avoid adverse long-term effects of DES such as late/very late stent thrombosis which is partly attributed to durable polymers. As the post-expansion morphology of biodegradable coatings is greatly unknown, we investigated the polylactic acid coating on biolimus-eluting BioMatrix stents. METHODS AND RESULTS: Scanning electron microscopy (SEM) was used to carefully examine five 3.5mm stents following expansion at 6-14atm (maximum 7% overstretch). SEM examination demonstrated only mild cracks of the coating after stent expansion at 6 atm. An increase in expansion pressure, associated with mild stent overstretch, resulted in more severe cracks. Lifting of the coating together with few sites of partial detachment of fragments was noticed after stent expansion in water at 14atm; these irregularities further increased after aggressive oversized partial postdilatation with a 5.0mm non-compliant balloon with additional secondary cracks. CONCLUSIONS: SEM assessment suggests a relatively low elasticity of the biodegradable coating on BioMatrix stents. At nominal pressure, stents showed predominantly mild cracks of the coating, while cracks increased after slight overstretch. Aggressive overexpansion of the stent, such as sometimes required in left main bifurcation stenting, worsened cracks and led to some detachment of fragments of the coating in vitro

Invasiveness of previous treatment for peripheral arterial disease and risk of adverse cardiac events after coronary stenting

Patients with peripheral arterial disease (PADs), undergoing percutaneous coronary intervention (PCI), have higher adverse event risks. The effect of invasiveness of PADs treatment on PCI outcome is unknown. This study assessed the impact of the invasiveness of previous PADs treatment (invasive or non-invasive) on event risks after PCI with contemporary drug-eluting stents. This post-hoc analysis pooled 3-year patient-level data of PCI all-comer patients living in the eastern Netherlands, previously treated for PADs. PADs included symptomatic atherosclerotic lesion in the lower or upper extremities; carotid or vertebral arteries; mesenteric arteries or aorta. Invasive PADs treatment comprised endarterectomy, bypass surgery, percutaneous transluminal angioplasty, stenting or amputation; non-invasive treatment consisted of medication and participation in exercise programs. Primary endpoint was (coronary) target vessel failure: composite of cardiac mortality, target vessel-related myocardial infarction, or clinically indicated target vessel revascularization. Of 461 PCI patients with PADs, information on PADs treatment was available in 357 (77.4%) patients; 249 (69.7%) were treated invasively and 108 (30.3%) non-invasively. Baseline and PCI procedural characteristics showed no between-group difference. Invasiveness of PADs treatment was not associated with adverse event risks, including target vessel failure (20.5% vs. 16.0%; HR: 1.30, 95%-CI 0.75–2.26, p = 0.35), major adverse cardiac events (23.3% vs. 20.4%; HR: 1.16, 95%-CI 0.71–1.90, p = 0.55), and all-cause mortality (12.1% vs. 8.3%; HR: 1.48, 95%-CI 0.70–3.13, p = 0.30). In PADs patients participating in PCI trials, we found no significant relation between the invasiveness of previous PADs treatment and 3-year outcome after PCI. Consequently, high-risk PCI patients can be identified by consulting medical records, searching for PADs, irrespective of the invasiveness of PADs treatment. Graphical abstract: (Figure presented.) Comparison of patients with non-invasive and invasive PADs treatment. PADs peripheral arterial disease, PCI percutaneous coronary intervention.</p

TCT-251 Abnormal glucose metabolism and adverse event rates 12 months after treatment with contemporary drug-eluting stents:Insights from the BIO-RESORT Silent Diabetes study

BACKGROUND: Patients with abnormal glucose metabolism, including patients with undetected and thus untreated diabetes, may have higher event risks after percutaneous coronary intervention (PCI) with contemporary drug-eluting stents (DES). We assessed the prevalence and clinical impact of abnormal glucose metabolism in allcomer patients without previously known diabetes undergoing PCI. METHODS: The BIO-RESORT Silent Diabetes study, performed at Thoraxcentrum Twente, is a substudy of the randomized BIO-RESORT trial (NCT01674803). We performed an additional analysis identifying patients with an abnormal glucose metabolism by means of oral glucose tolerance testing (OGTT), and assessment of glycated hemoglobin A1c (HbA1c) with fasting plasma glucose (FPG) and clinical outcome at 12 months. RESULTS: Assessment of glucose metabolism revealed that of the 988 participants a total 330 (33.4%) patients had an abnormal metabolism, while 658 (66.6%) patients had a normal metabolism. Patients with abnormal glucose metabolism showed higher rates of the primary endpoint Target Vessel Failure (6.4% vs. 2.7%; p0.01), a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization. Multivariate analysis demonstrated that an abnormal glucose metabolism independently predicted adverse event risk (HR 2.2, 95%-CI:1.2-4.2). CONCLUSION: Abnormal glucose metabolism was detected in one out of three PCI all-comer patients and independently associated with a more than 2-fold higher event risk. Future intervention studies should determine whether meaningful benefits may accrue from routine glycaemia testing in such patients

Long-term outcome and chest pain in patients with true versus non-true bifurcation lesions treated with second-generation drug-eluting stents in the TWENTE trial

The objective of this study is to assess 3-year clinical outcome of patients with true bifurcation lesions (TBLs) versus non-true bifurcation lesions (non-TBLs) following treatment with second-generation drug-eluting stents (DES). TBLs are characterized by the obstruction of both main vessel and side-branch. Limited data are available on long-term clinical outcome following TBL treatment with newer-generation DES. We performed an explorative sub-study of the randomized TWENTE trial among 287 patients who had bifurcated target lesions with side-branches ≥2.0 mm. Patients were categorized into TBL (Medina classes: 1.1.1; 1.0.1; 0.1.1) versus non-TBL to compare long-term clinical outcome. A total of 116 (40.4 %) patients had TBL, while 171 (59.6 %) had non-TBL only. Target-lesion revascularization rates were similar (3.5 vs. 3.5 %; p = 1.0), and definite-or-probable stent thrombosis rates were low (both <1.0 %). The target-vessel myocardial infarction (MI) rate was 11.3 versus 5.3 % (p = 0.06), mostly driven by (periprocedural) MI ≤48 h from PCI. All-cause mortality and cardiac death rates were 8.7 versus 3.5 % (p = 0.06) and 3.5 versus 1.2 % (p = 0.22), respectively. The 3-year major adverse cardiac event rate for patients with TBL versus non-TBL was 20.0 versus 11.7 % (p = 0.05). At 1-, 2-, and 3-year follow-up, 6.5, 13.0, and 11.0 % of patients reported chest pain at less than or equal moderate physical effort, respectively, without any between-group difference. Patients treated with second-generation DES for TBL had somewhat higher adverse event rates than patients with non-TBL, but dissimilarities did not reach statistical significance. Up to 3-year follow-up, the vast majority of patients of both groups remained free from chest pain

TCT-819 Prediabetes and its Impact on 1-Year Clinical Outcome After Treatment with Newer-Generation Drug-eluting Stents in 2,986 All-Comer Patients

BACKGROUND Prediabetes (Pre-DM) is a risk factor state for developing diabetes mellitus (DM). Yet it is unclear whether detection of Pre-DM by routine assessment of glycated haemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) among patients undergoing percutaneous coronary intervention (PCI) may help identify subjects with increased event risk. We assessed in all-comers who underwent PCI with contemporary drug-eluting stents (DES) the relation between glycaemia status and 1-year clinical outcome. METHODS HbA1c and FPG was determined in 2,362 non-DM participants in the multicenter, randomized, investigator-initiated TWENTE III trial, in order to identify Pre-DM (HbA1c 42-47mmol/mol; FPG 6.1- 6.9 mmol/L) and DM (HbA1c>=48mmol/mol; FPG >7 mmol/L). Another 624 patients had medically treated DM. The main clinical outcome parameter was a composite endpoint consisting of death, myocardial infarction, or revascularisation. RESULTS Glycaemic state was known in 2,986 trial participants: Pre- DM was present in 324 (11%), DM in 793 (27%), and normoglycaemia in 1,869 (63%) patients. Patients with Pre-DM and DM differed from normoglycemic patients in cardiovascular risk factors. The composite clinical endpoint in Pre-DM occurred in 11.1%, in DM in 10.5%, and in normoglycemic patients in 5.7% (

Patient preference regarding assessment of clinical follow-up after percutaneous coronary intervention: the PAPAYA study

Aims: To keep patients in long-term clinical follow-up programmes after percutaneous coronary intervention (PCI), knowledge of the patient-preferred mode for follow-up assessment is crucial. We systematically assessed patient preference, and explored potential relationships with age and gender.Methods and results: In the prospective, observational PAPAYA study (ClinicalTrials.gov: NCT02189070), 2,566 patients, treated by PCI between June 2008 and May 2012, were invited to participate in a postal survey on the patient-preferred mode (postal questionnaire, telephone or e-mail consultation) and frequency of follow-up assessment. A total of 1,797 (70.0%) patients responded. The vast majority preferred completing postal questionnaires (1,248 [69.9%]) as compared to telephone (240 [13.4%]) or e-mail-based approaches (227 [12.7%]) (p<0.001). With increasing age, there was a gradual decline in preference for e-mail (p<0.001); the youngest patients (≤60 years) preferred e-mail-based follow-up more often than the oldest (21.1% vs. 3.1%). Nevertheless, 79.9% of the youngest preferred to be approached in ways other than by e-mail. Women more often preferred approaches other than e-mail (94.1% vs. 87.3%, p<0.001).Conclusions: Patients showed a distinct preference for completing postal questionnaires rather than being approached by telephone or e-mail. Younger patients accepted e-mail-based follow-up more often, but the majority of the youngest patients still preferred approaches other than by e-mail - See more at: http://www.pcronline.com/eurointervention/ahead-of-print/201510-06/patient-preference-regarding-assessment-of-clinical-follow-up-after-percutaneous-coronary-intervention-the-papaya-study

Safety of second-generation drug-eluting stents three years after randomised use in the TWENTE trial

Aims: To assess three-year clinical outcome following randomised use of the second-generation Resolute zotarolimus-eluting stent (ZES) and the XIENCE V everolimus-eluting stent (EES). For Resolute ZES and randomised use, outcome data ≥3 years are relatively scarce. Methods and results: The TWENTE trial examined 1,391 patients with stable angina or non-ST-elevation acute coronary syndromes, of whom 21.6% were diabetics, 70.1% had complex B2 or C lesions and 77.4% had “off-label” indications for DES use. Three-year follow-up data were obtained in 1,381 patients (99.3%; 10 withdrawals). Adverse clinical events were independently adjudicated. The primary endpoint target vessel failure (TVF), a composite of cardiac death, target vessel-related myocardial infarction and clinically indicated target vessel revascularisation, was 12.1% for Resolute ZES and 13.4% for XIENCE V EES (p=0.50). Cardiac death rates were 1.9% vs. 3.5% (p=0.06); the other individual components of TVF also showed no significant between-group differences. The rates of definite-or-probable stent thrombosis (1.4% vs. 1.6%, p=0.82) and very late stent thrombosis (0.6% vs. 0.4%, p=1.0) did not differ between the groups. Conclusions: Three-year follow-up data of patients included in the randomised TWENTE trial demonstrated similar and sustained safety and efficacy of Resolute ZES and XIENCE V EE