Aim of the study
This study was conducted to detect the effect of HCV seropositivity on the short- and long-term outcomes in patients after PCI.
Design of the study
This was a multi-center prospective cohort study conducted on 400 patients candidate for elective PCI using drug-eluting stents, at three different University Hospitals, Cath. Lab. Unit from May 2016 to November 2018. The participants were classified into two equal groups: group 1 was seropositive for HCV and did not received antiviral treatment, and group 2 was seronegative for HCV.
All subjects provided a written informed consent to participate in the study. The study protocol was approved by the ethics committee at Universities where the study was conducted.
Patients who meet the selection criteria were subjected to the following:
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Identification of cardiovascular risk factors (age, sex, smoking, hypertension, diabetes mellitus, dyslipidemia, body mass index, and family history of CAD).
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Assessment of symptoms suggestive of coronary insufficiency as typical exertional chest pain and history of admission to coronary care unit with acute coronary syndrome whether unstable angina or MI.
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Full clinical examination.
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Resting 12 lead surface electrocardiogram to identify cardiac rhythm and signs of myocardial ischemia (ST segment and T wave abnormalities or pathological Q waves).
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Echocardiography study was done using a 2.5-MHz transducer and harmonic imaging to measure systolic and end diastolic left ventricular dimensions, segmental wall motion abnormalities at rest, and left ventricle ejection fraction (LVEF) using biplane Simpson’s rule.
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Treadmill stress electrocardiogram testing using Modified Bruce Protocol when indicated.
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Laboratory testing includes cardiac biomarkers (CK-MB and troponin) measured at baseline and 8–12 h after the procedure and if indicated during the 12 months follow-up, fasting blood sugar, hemoglobin A1c level, lipogram, HCV antibodies using the third-generation ELISA method [33], liver function, and renal function tests.
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Coronary angiography was performed by an experienced intervention cardiologist, using Seldinger’s technique where a right femoral artery puncture was done then right and left coronary angiogram was performed in multiple projections; coronary stenosis of more than 70% by visual assessment and documented ischemia was considered for inclusion [34]. The dual antiplatelet regimen consisted of aspirin in loading doses of 300 mg and maintenance of 100 mg/day maintained indefinitely and clopidogrel loading dose of 300–600 mg, followed by 75 mg/day for at least 1 year. After insertion of the arterial sheath to the right femoral artery, patients were administered 10,000 IU or 100–200 IU heparin/kg. PCI was performed using drug-eluting stents by an experienced interventionist who was blinded to clinical and demographic data. After 24-h hospital follow-up, the patient was discharged (if no complication occurred) with prescription of aspirin, clopidogrel, B-blockers, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, statin therapy, and other medications if indicated as anti-glycemics. Some patients received modified drug regimens due to associated different co-morbid conditions.
The primary end point was MACEs that include TLR, TVR, CABG, MI, CVS, stent thrombosis, major bleeding, and cardiac and non-cardiac death immediately and over a period of 12 months. The secondary end point was clinical in-stent restenosis indicated by the recurrence of ischemic chest pain, positive stress electrocardiogram, and new motion wall abnormality by echocardiography. Clinical in-stent restenosis was documented by coronary angiography if not contraindicated. The patients were followed up by clinic visits, at 3 months, 6 months, and 12 months to detect either the primary or secondary end points. Also, telephone communication was available for the patients at any time during the 12 months follow-up. Clinical in-stent restenosis is assessed as a requirement for ischemia-driven repeat revascularization; it was proposed by the Academic Research Consortium, this definition requires both an assessment of luminal narrowing and the patient’s clinical context.
The following formula was used to calculate the minimum size of the required sample:
$$ n={(z)}^2\ p\ \left(1-p\right)/{d}^2 $$
where n indicates the sample size, z indicates the level of confidence according to the standard normal distribution (for a level of confidence of 95%, z = 1.96), p indicates the estimated proportion of the population that presents the characteristic (about 10%), and d indicates the tolerated margin of error (for example, we want to know the real proportion within 5%).
Using the previous formula for the sample size calculation (n) = (1.96)2 × 0.10 (1 − 0.10)/(0.05)2 = 138.3. So, the minimum sample size is 139 participants.
Participant characteristics
Patients aged ≥ 18 years who have symptomatic CAD and showed significant de novo stenotic lesions (≥ 70%) of native coronary arteries that were amenable to elective PCI using drug-eluting stents and who agreed and consented to participate in the study were included. We excluded patients who had any of the following criteria: target lesion in the left main coronary artery, patients with chronic total occlusion lesion, patients treated by primary PCI, patients who need bifurcation stenting technique, patients with previous history of CABG, known hypersensitivity to aspirin and clopidogrel, decompensated liver and kidney disease, congenital heart disease, chronic infections other than HCV infection, HCV-infected patients who received antiviral treatment, hematological or oncological disorders, and pregnancy.
Analysis of data
Data was analyzed using SPSS version 20. Quantitative data were analyzed using the Student t test to compare means of two groups. Qualitative data were compared using Chi square test. Fisher’s exact correction was used when the expected cell count is less than 5. Univariate and multivariate Cox hazard regression analyses for MACEs and clinical in-stent restenosis at 12 months after adjustment for confounding factors were performed. p value was considered significant at or below 0.05.
The outcome variables were MACEs (TLR, TVR, CABG, MI, CVS, stent thrombosis, major bleeding, cardiac and non-cardiac death) as a primary end point and clinical in-stent restenosis as a secondary end point.
