Background:
Paclitaxel-coated balloons (PCBs) are a preferred treatment option for coronary in-stent restenosis. To date, data from randomized trials of alternative drug coatings are lacking. The aim of the randomized Malaysian and German-Swiss randomized trials was to investigate a novel sirolimus-coated balloon (SCB) compared with a PCB in in-stent restenosis.
Methods:
One hundred one patients with drug-eluting stent in-stent restenosis were enrolled in 2 identical randomized trials comparing the novel SCB (SeQuent SCB, 4 μg/mm²) with the clinically proven PCB (SeQuent Please, 3 μg/mm²). Primary end point was angiographic late lumen loss at 6 months. Secondary end points included procedural success, major adverse cardiac events, and individual clinical end points such as stent thrombosis, cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, and binary restenosis.
Results:
Quantitative coronary angiography revealed no differences in baseline parameters. After 6 months, in-segment late lumen loss was 0.25±0.57 mm in the PCB group versus 0.26±0.60 mm in the SCB group. Mean difference between SCB and PCB was 0.01 (95% CI, -0.23 to 0.24). Noninferiority at a predefined margin of 0.35 was shown. Clinical events up to 12 months did not differ between the groups.
Conclusions:
This first-in man comparison of a novel SCB with a crystalline coating showed similar angiographic and clinical outcomes in the treatment of coronary drug-eluting stent in-stent restenosis compared with PCB.
Registration:
URL:
https://www.clinicaltrials.gov
; Unique identifier: NCT02996318, NCT03242096.
Background: Cardiovascular magnetic resonance (CMR) is a rapidly emerging noninvasive imaging technique providing high resolution images without any application of radiation. It has broad range of clinical applications and is increasingly been used in clinical practice in Malaysia. A national CMR Registry is needed to assess its practice in Malaysia.Objective: To evaluate indications, safety and impact on patient management of CMR in Sarawak Heart Centre.Materials Methods: A pilot run of CMR Registry in single centre with consecutive patients who underwent clinical CMR from JanuaryJune 2015. Retrospective data collection from CMR database and case notes.Results: A total of 169 patients underwent clinical CMR, with 20 did not complete scan; 25% due to claustrophobia. 94% of patients received gadolinium-based contrast agent. Most important indications were viability assessment (54.4%), cardiomyopathy (28.2%), and risk stratification in suspected coronary artery disease (CAD) (4.7%). 6.7% of patients underwent stress MR (adenosine or dobutamine). Severe complications only occurred in 0.7% of the cases (anaphylactic reaction secondary to contrast agent). No mortality during/due to CMR. There was direct impact of CMR on the clinical management by confirming suspected diagnosis (59.1%), excluding suspected diagnosis (21.5%), providing additional information for suspected diagnosis which is confirmed or excluded (18.1%) and providing unsuspected completely new diagnosis (1.3%). Invasive coronary angiogram was avoided and diagnosis were excluded in all patients referred for risk stratification of suspected coronary artery disease. Invasive therapeutic procedures such as PCI, CABG, valve surgery were triggered in 49.6 % of patients after CMR was done, regardless of indication. Out of 81 patients who underwent CMR for viability study, 76.5% were planned for revascularisation (CABG or PCI) with the rest were planned for optimal medical therapy only after the CMR.Conclusions: The top indications of CMR in Sarawak are viability assessment, cardiomyopathy and risk stratification in suspected CAD, which differs from the EuroCMR registry results. This demonstrated the importance of establishing a national multicentre CMR registry in Malaysia, and subsequently substudy on specific conditions. With appropriate medical personnel training and patient selection, CMR is safe and has strong impact on clinical management. Introduction: Cardiovascular (CV) risk factors are highly prevalent in south east Asia and current risk scoring systems have been proven to have some drawbacks. Calcium score (CAS) has emerged as a potential marker to improve risk prediction in western population however data is lacking on its utility in Malaysia.Objective: We aim to test the diagnostic performance of CAS in comparison to Framingham risk score (FRS) in a sample of Malaysian population presented with stable chest pain to an outpatient setting.Method: This is a single-centre retrospective study of patients referred for coronary CT angiography (CTCA) for...
follow up clinics notes and via phone calls. Data interpreted by using logistic regression analysis. Results: 176 patients were studied. Mean age 54.0 years, of which 86.9% were male. 11 patients (6.3%) died within 30 days after PPCI. No significant difference in outcome for gender and age groups. Prolonged door in door out (DIDO) at primary hospital showed higher mortality rate (b30 minutes: 4.8% p=0.549, 30-60min: 5.3% p=0.708, N60min: 11.1% p=0.165). Longer door to device (DTD) duration is associated with higher mortality rate in both PCI-capable Hospital (b90minutes: 4.8% vs N90min: 12.5%, p=0.342) and non-PCI-capable hospitals (b120min: 3.6% vs N120min: 9.1% p=0.359). Systolic blood pressure(BP) is significant factor affecting patients' outcome (Odd Ratio (OR)=0.959 (0.935-0.983), p=0.001). Systolic BP b 100mmHg (OR 4.339 (1.295-14.543), p=0.045), and diastolic BP b 60mmHg (OR= 4.339 (1.295-14.543), p=0.045) are associated with high mortality. Patients presented with Killip I (OR 0.202 (0.062-6.59), p=0.008) had favorable outcome while patients presented with Killip IV (OR 6.151 (2.056-18.40), p=0.04) had poor outcome in this study. Conclusion: PPCI for acute STEMI 30 days mortality rate is 6.3%. Outcome of patients with Killip IV remained poor despite immediate intervention. Blood pressure is an important factor predicting patients' outcome. Shorter transfer time associated with better outcome but not statistically significant. As STEMI network in this region is expanding, a more comprehensive outcomes study will be obtained with longer study period and bigger sample size.
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