Damras Tresukosol

Trial of Everolimus-Eluting Stents or Bypass Surgery for Coronary Disease

BACKGROUND Most trials comparing percutaneous coronary intervention (PCI) with coronary-artery bypass grafting (CABG) have not made use of second-generation drug-eluting stents. METHODS We conducted a randomized noninferiority trial at 27 centers in East Asia. We planned to randomly assign 1776 patients with multivessel coronary artery disease to PCI with everolimus-eluting stents or to CABG. The primary end point was a composite of death, myocardial infarction, or target-vessel revascularization at 2 years after randomization. Event rates during longer-term follow-up were also compared between groups. RESULTS After the enrollment of 880 patients (438 patients randomly assigned to the PCI group and 442 randomly assigned to the CABG group), the study was terminated early owing to slow enrollment. At 2 years, the primary end point had occurred in 11.0% of the patients in the PCI group and in 7.9% of those in the CABG group (absolute risk difference, 3.1 percentage points; 95% confidence interval [CI], -0.8 to 6.9; P=0.32 for noninferiority). At longer-term follow-up (median, 4.6 years), the primary end point had occurred in 15.3% of the patients in the PCI group and in 10.6% of those in the CABG group (hazard ratio, 1.47; 95% CI, 1.01 to 2.13; P=0.04). No significant differences were seen between the two groups in the occurrence of a composite safety end point of death, myocardial infarction, or stroke. However, the rates of any repeat revascularization and spontaneous myocardial infarction were significantly higher after PCI than after CABG. CONCLUSIONS Among patients with multivessel coronary artery disease, the rate of major adverse cardiovascular events was higher among those who had undergone PCI with the use of everolimus-eluting stents than among those who had undergone CABG. (Funded by CardioVascular Research Foundation and others; BEST ClinicalTrials.gov number, NCT00997828.).

Apolipoprotein E gene polymorphism: effects on plasma lipids and risk of type 2 diabetes and coronary artery disease

BackgroundThe most common apolipoprotein E (apoE) gene polymorphism has been found to influence plasma lipid concentration and its correlation with coronary artery disease (CAD) has been extensively investigated in the last decade. It is, however, unclear whether apoE gene polymorphism is also associated with increased risk of type 2 diabetes mellitus (T2DM). The knowledge of this study may provide the primary prevention for T2DM and CAD development before its initiation and progression. Therefore, this study was carried out to determine the association between apoE gene polymorphism and T2DM with and without CAD and its role in lipid metabolism.MethodsThe case-control study was carried out on a total of 451 samples including 149 normal control subjects, 155 subjects with T2DM, and 147 subjects with T2DM complicated with CAD. The apoE gene polymorphism was tested by polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP). Univariable and multivariable logistic regression analyses were used to identify the possible risks of T2DM and CAD.ResultsA significantly increased frequency of E3/E4 genotype was observed only in T2DM with CAD group (p = 0.0004), whereas the ε4 allele was significantly higher in both T2DM (p = 0.047) and T2DM with CAD (p = 0.009) as compared with controls. E3/E4 genotype was also the independent risk in developing CAD after adjusting with established risk factors with adjusted odds ratio (OR) 2.52 (95%CI 1.28-4.97, p = 0.008). The independent predictor of individuals carrying ε4 allele still remained significantly associated with both CAD (adjusted OR 2.32, 95%CI 1.17-4.61, p = 0.016) and T2DM (adjusted OR 2.04, 95%CI 1.07-3.86, p = 0.029). After simultaneously examining the joint association of E3/E4 genotype combined with either obesity or smoking the risk increased to approximately 5-fold in T2DM (adjusted OR 4.93, 95%CI 1.74-13.98, p = 0.003) and 10-fold in CAD (adjusted OR 10.48, 95%CI 3.56-30.79, p < 0.0001). The association between apoE genotypes on plasma lipid levels was compared between E3/E3 as a reference and E4-bearing genotypes. E4-bearing genotypes showed lower HDL-C and higher VLDL-C and TG, whereas other values of plasma lipid concentrations showed no significant difference.ConclusionsThese results indicate that ε4 allele has influence on lipid profiles and is associated with the development of both T2DM with and without CAD, and furthermore, it increased the risk among the subjects with obesity and/or smoking, the conditions associated with high oxidative stress.

Clinical safety and efficacy of a novel thin-strut cobalt–chromium coronary stent system: Results of the real world Coroflex Blue Registry†

Objectives: The aim of this registry was to evaluate the clinical efficacy and safety of the Coroflex Blue cobalt–chromium stent in real‐world practice. Background: The development of cobalt–chromium bare‐metal stents (BMS) with thinner struts has lead to better deliverability and lower target‐lesion revascularization rates compared with stainless steel BMS. Methods: The Coroflex Blue Registry was an international, prospective, multicenter registry enrolling patients with symptomatic ischemic heart disease attributable to single de novo or restenotic nonstented lesions of a single vessel amenable for percutaneous stenting. The primary end point was clinically driven target‐lesion revascularisation (TLR) 6 months after enrolment, secondary endpoints were technical/procedural success, in‐hospital outcome, definite stent thrombosis and major adverse cardiac events (death, myocardial infarction, or TLR) after 6 months. Results: The registry included 2,315 patients (mean age 64.3 ± 11.1 years, 19.8% diabetes, 37.3% acute myocardial infarction). Although a complex lesion cohort with 60.3% Typ B2/C‐lesions, the technical success rate was 99.1% and the procedural success rate 98.5%. The incidence of TLR after 6 months was 5.5% and the cumulative 6‐month acute/subacute stent thrombosis rate was 1.6%. After 6 months cumulative event‐free survival was 90.8% in all patients and 87% in patients with acute PCI for acute myocardial infarction. Conclusions: This registry demonstrates the safety and efficacy of the Coroflex Blue cobalt–chromium stent platform in real‐world practice. In the era of drug‐eluting stents (DES), these results raise the serious question if the use of DES for primary prevention of restenosis and TLR is really justified.

Bioresorbable Vascular Scaffolds for the Treatment of Chronic Total Occlusions: An International Multicenter Registry

Background— There are only limited studies reporting clinical outcomes after bioresorbable vascular scaffold (BVS; Absorb; Abbott Vascular, Santa Clara, CA) implantation for coronary chronic total occlusions (CTO). The aim of this study was to evaluate the real-world feasibility and safety of BVS implantation for the treatment of CTO. Methods and Results— We retrospectively evaluated CTO cases treated with BVS from a multicenter registry. The primary end point was target lesion failure defined as a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization. From September 2012 to November 2015, 65 patients with CTO were successfully treated with BVS. The mean age of patients was 60.8±11.0 years; 89.2% were male and 40.0% diabetic. The mean ejection fraction was 57.7±10.8%. The mean reference vessel diameter and CTO lesion length were 3.0±0.4 and 20.2±3.0 mm, respectively. The mean number of BVS deployed per patient was 1.8±0.7, of which mean diameter and total length were 3.0±0.4 and 47.6±19.9 mm, respectively. Postdilatation with noncompliant balloons (mean diameter 3.3±0.3 mm) was performed at high pressures (18.6±5.3 atm) in all cases. Intravascular ultrasound (n=34) or optical coherence tomography (n=31) was performed in all cases. During the follow-up period (median: 453 days, 25th and 75th percentiles: 230 and 703), there were no occurrences of target lesion failure or scaffold thrombosis. Conclusions— BVS implantation for the treatment of CTO seems feasible and safe. Appropriate lesion preparation, high-pressure postdilatation, and the use of intravascular imaging are recommended to obtain the best possible final result.

Reducing system delays in treatment of ST elevation myocardial infarction and confronting the challenges of late presentation in low and middle-income countries

Optimal treatment of acute ST-elevation myocardial infarction (STEMI) in developing countries may require a novel approach on account of the numerous infrastructure, personnel, financial and logistic constraints. The prevalent pathways of STEMI care, which exist in North America and in Europe, face hurdles in low and middle-income countries.TheAmericanCollegeofCardiologyFoundation/American Heart Association (ACCF/AHA) and the Stent for Life STEMI Guidelines recommendation to develop regional systems of STEMI care (Fig. 1) is extremely challenging to adopt in developing countries. This occurs due to numerous reasons – hospitals have not been clearly identified as PCI and non-PCI institutions and the network and transfer policies between these hospitals have not been wellestablished. Another important drawback is the general lack of ambulance-based emergency medical services in many developing countries, which means that a major component of regional STEMI networks are completely missing. In a similar manner, the recommendations ofMission: Lifeline, anAHA initiative launched in 2007, to improve health system readiness and response to STEMI, with the focus on the continuum of care from EMS activation to primaryPCI, cannot functioninenvironments that lack sophisticated prehospital care. The endorsements of the other remarkable ACCF initiative, the D2B Alliance, whose goal was for participating PCIcapable hospitals to achieve a D2B time of <90min, is also a major challenge in developing countries related to resource constraints that have been listed above. Most importantly, there are no guidelines for late presenters with in countries with system delays and non-existent STEMI networks. This manuscript is specifically designed to offer pragmatic solutions for improving STEMI care in low and middle-income countries.[47_TD

Erratum to: Third generation drug eluting stent (DES) with biodegradable polymer in diabetic patients: 5 years follow-up

DIFF] Delayed presentation is the single biggest global challenge for patients presenting with STEMI and this issue is far worse in developing countries for a variety of reasons. These include the traditionalpatient-relateddelays thatarealso seen inNorthAmerica and in Europe and which include women, the elderly and the diabetics. In lowandmiddle-incomecountries, there are additional and distinctive process delays, such as stoppages as a result of payment and consent issues. Alexander and Mullasari reported a timetopresentationinIndiaof300min, instarkcontrastto intheU.S. where patients calling 9-1-1nowhave EMSpersonnel arrive at their sides in less than 50min after symptom onset. The delayed presentation in India (and in several other low and middle-income countries) has critical implications for instituting pragmatic guidelines. Delayedpresentation is theAchilles heel of STEMI care in these countries and a rethink of this subject is critical. Specifically, the delayed presentation affects the STEMI pathways in three possible manners:

Acute and long-term clinical and angiographic outcome after S-Stent implantation: S-Stent multicenter safety and efficacy trial.

© The Author(s) 2017. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/ publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Erratum to: Cardiovasc Diabetol (2017) 16:23 DOI 10.1186/s12933‐017‐0500‐3 After publication of the original article [1], it came to the authors’ attention that there was a typo within the author list. The family name of Sinisa Stojkovic was incorrectly spelled ‘Stoikovic’. The author’s name appears in its correct form in this erratum.

Treatment effects of systematic two-stent and provisional stenting techniques in patients with complex coronary bifurcation lesions: rationale and design of a prospective, randomised and multicentre DEFINITION II trial

The purpose of this study is to demonstrate safety and effectiveness of the S‐Stent in de novo coronary lesions treated with conventional percutaneous coronary balloon angioplasty. Between January 2000 and June 2001, 120 patients were prospectively enrolled at four study centers. Patients were treated with coronary stenting in a total of 137 lesions. Procedural success was achieved in 100% of 137 attempted lesions. Clinical success was 99.8%. In‐hospital mortality was 0.8%; myocardial infarction occurred in 0.8% and stent thrombosis in 0.8%. After stent implantation, the minimal lumen diameter increased from 0.92 ± 0.43 to 2.74 ± 0.36 mm (P < 0.0001) and the percent diameter stenosis decreased from 68.0 ± 16.2 to 4.5 ± 12.0 (P < 0.0001). At 6‐month follow‐up, the percent diameter stenosis was 33.5 ± 21.3 and the angiographic restenosis rate was 16.5%. Target lesion revascularization was required in 12 patients (10.1%). We conclude that the use of S‐Stent for coronary intervention resulted in a high procedural success rate and low angiographic restenosis at 6 months after implantation. Catheter Cardiovasc Interv 2004;62:439–444.

CRT-200.92 Gender Disparities in ST-Elevation Myocardial Infarction Care and Outcomes in Emerging Countries: A Global Lumen Organization for Women (GLOW) Initiative and Call to Action

Introduction Provisional stenting (PS) for simple coronary bifurcation lesions is the mainstay of treatment. A systematic two-stent approach is widely used for complex bifurcation lesions (CBLs). However, a randomised comparison of PS and two-stent techniques for CBLs has never been studied. Accordingly, the present study is designed to elucidate the benefits of two-stent treatment over PS in patients with CBLs. Methods and analysis This DEFINITION II study is a prospective, multinational, randomised, endpoint-driven trial to compare the benefits of the two-stent technique with PS for CBLs. A total of 660 patients with CBLs will be randomised in a 1:1 fashion to receive either PS or the two-stent technique. The primary endpoint is the rate of 12-month target lesion failure defined as the composite of cardiac death, target vessel myocardial infarction (MI) and clinically driven target lesion revascularisation. The major secondary endpoints include all causes of death, MI, target vessel revascularisation, in-stent restenosis, stroke and each individual component of the primary endpoints. The safety endpoint is the occurrence of definite or probable stent thrombosis. Ethics and dissemination The study protocol and informed consent have been approved by the Institutional Review Board of Nanjing First Hospital, and accepted by each participating centre. Written informed consent was obtained from all enrolled patients. Findings of the study will be published in a peer-reviewed journal and disseminated at conferences. Trial registration number NCT02284750; Pre-results.

Response by Mitomo et al to Letter Regarding Article, “Bioresorbable Vascular Scaffolds for the Treatment of Chronic Total Occlusions: An International Multicenter Registry”

Over the past decade, outcomes for patients with acute ST-segment-elevation myocardial infarction (STEMI) have been improving in the developed world - mainly, USA and Europe. This is as a result of an organized revolution in AMI (Acute Myocardial Infarction)-care in general and STEMI-care in