Objective: To determine in-hospital mortality and major adverse cardiac events (MACE) in acute coronary syndrome (AMI) patients with underlying severe chronic kidney disease (CKD) undergoing percutaneous coronary intervention (PCI). Methods: We conducted a retrospective cohort study from June’2013-December’2017 at Tabba Heart Institute, Karachi. Data was drawn from institutes’ database modeled after US National Cardiovascular data CathPCI registry. All AMI (STEMI: ST-elevation myocardial infarction and NSTEMI: non-ST-elevation myocardial infarction) patients undergoing PCI with creatinine clearance <30ml/min or ESRD on hemodialysis were included in the study. Results: During 54 months study period, 160 severe CKD patients underwent PCI. Mean age was 62.9±12.2 years. Men were 61.9%, hypertensive (81.3%) and diabetic (63.8%). Excluding dialysis patients, Creatinine clearance was 21.1±6.6ml/min/1.73m2. STEMI were 46.9% and 61.9% were Killip I. Mean SYNTAX score was 16.6±7.3. MACE occurred in 32.5% patients, of which 6(11.5%) had new hemodialysis and mortality: 17.5% were deceased. MACE predictor were cardiogenic shock (OR: 2.81, 95%CI: 1.17-6.74) and prior heart failure (OR: 6.84, 95%CI: 1.39-33.74), Predictor of mortality was cardiogenic shock or cardiac arrest (OR: 7.90, 95%CI: 2.95-21.17). Conclusion: Severe CKD patients undergoing PCI for AMI have drastically poor outcomes therefore individualization and patient-centric care management is mandatory. How to cite this:Sattar S, Ahmed N, Akhter Z, Aijaz S, Lakhani S, Malik R, et al. In-Hospital outcomes in acute coronary syndrome patients with concomitant severe chronic kidney disease undergoing percutaneous coronary intervention. Pak J Med Sci. 2019;35(2):---------.  doi: https://doi.org/10.12669/pjms.35.2.276 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Objectives Primary objectives: to compare radial artery occlusion rate (RAO) after cardiac catheterization between catecholamine‐chitosan pad (InnoSEAL) and pneumatic compression device (PCD) and to compare difference in hemostasis time and radial monitoring termination time between two arms. Secondary objectives: to compare radial site bleeding and ease of use of two methods by cath‐lab technicians. Background Hemostatic pads may be an effective alternative to PCD with lesser chance of access site complications with advantage of shortened compression time. Methods Patients (N = 606) undergoing trans‐radial, diagnostic or interventional procedures were randomized to either InnoSEAL arm or PCD. RAO was assessed using US Duplex; performed 6–24 hr posthemostatic device removal. Time to hemostasis was recorded as per defined protocols. Ease of use among cath‐lab technicians was assessed through 5 point Likert scale. Results Data of 597 patients was analyzed (299 InnoSEAL, 298 PCD). RAO rate was 8.5% in InnoSEAL and 9.4% in PCD arm (p value >.05). The pooled median hemostasis time and time to termination of radial monitoring was 42 versus 225 min and 50 versus 240 min in InnoSEAL and PCD arms, respectively (p value: <.01). There was no difference in Grade I/II hematoma (InnoSEAL: 1.3% vs. PCD: 3.4%). InnoSEAL was marginally acceptable compared to PCD by technicians. Conclusion Hemostasis time is significantly shorter in InnoSEAL arm with reasonable acceptability to its usage among cath lab staff. RAO and bleeding complications are comparable between the arms. Based on our findings, it seems feasible to include Chitosan based hemostasis pad routinely in cath lab.

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IntroductionAbout 2%–30% of cardiac catheterisation procedures get complicated by radial artery occlusion (RAO). Ensuring patent haemostasis appears to be an important factor in reducing RAO. Currently employed method is a radial compression device (RCD) such as transradial band (TRB) that take hours to achieve haemostasis and cause discomfort to the patients. Haemostatic pads offer an alternative to RCD with reduced time to achieve haemostasis. Our trial aims to determine the non-inferiority of the catecholamine chitosan-based pad (InnoSEAL haemostatic pad) used in conjunction with TRB (InnoSEAL +TRB) when compared with the TRB alone in reducing composite adverse access site outcomes.Methods and analysisIt will be an open-label, parallel, randomised controlled trial on 714 adult patients (325 in each arm) undergoing coronary procedure using transradial approach at a cardiac health facility over 7 months duration. InnoSEAL patch along with TRB will be used to control bleeding in intervention arm and TRB alone in control arm, which is the standard practice. Study primary outcomes include RAO and haematoma; secondary outcomes are compression time, patient discomfort, time to discharge and ease of use of the intervention technique by the healthcare staff. χ2 test will be used to compare the categorical outcomes between two arms and student’s t-test for continuous outcomes. A p value of <0.05 will be considered significant.Ethics and disseminationEthical approval for the study has been obtained from the Institutional Review Board of Tabba Heart Institute number IORG0007863. Findings will be disseminated through seminars and scientific publications.Trial registration numberNCT04380883; Pre-results.

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