| Objective: This trial is aimed at evaluating the impacts of Alprostadil on myocardial microcirculation in patients with non-ST-segment elevation myocardial infarction(NSTEMI) receiving percutaneous coronary intervention(PCI).Methods: In this randomized, single blinded, placebo-controlled test, patients who were diagnosed with NSTEMI receiving PCI in the Second Hospital of Hebei Medical University from June 2014 to December 2014 were enrolled. Eligible patients were randomly assigned to receiving Alprostadil(Prostaglandinum E1 group, PGE) or placebo(controlled group, CON). Inclusion criteria:(1) The diagnostic criteria of NSTEMI proposed by CSC in 2012;(2) Patients’ family members have signed PCI informed consent;(3) Patients were performed CAG and PCI in hospital. Exclusion criteria:(1) ST-segment elevation myocardial infarction;(2) Emergency vessel reconstruction operation;(3) Cardiac shock;(4) Allergic to prostaglandinum E1;(5) Anticoagulant or antiplatelet contraindication;(6) Severe hepatic insufficiency(transaminase is greater than 2 folds of the normal upper limit), or severe renal insufficiency required dialysis treatment;(7) History of PCI/CABG operation, or specific signs of coronary artery side branches formation;(8) The presence of autoimmune diseases, severe trauma, bleeding disorders and tumors;(9) Patients refuse to sign the informed consent. Both group received the same basic medical treatment, including anticoagulant or antiplatelet meidicine, ACEI/ARB, CCB, beta-blocker, statins and nitrates. Beyond basic medication, patients in PGE group were administered intravenous Alprostadil 20 ug with 100 ml 0.9% sodium chloride slowly, twice a day. While patients in CON group were given placebo(100 ml 0.9% sodium chloride) with the same speed and frequency of infusion. All patients enrolled were required to perform CAG and PCI in cardiology department. The baseline clinical characteristics, changes of c Tn I, medical adverse effects, the number of patients complaining about unstable angina(UA), duration of UA and the accumulating consumption doses of nitrates before/after operation were compared. During the operation, characteristic like TIMI flow grade before and after PCI procedure, corrected TIMI frame count(CTFC), TIMI myocardial perfusion grade(TMPG) were recorded. Left ventricular ejection fraction(LVEF) was calculated again after 7 days and 30 days of operation. The incidence of major adverse cardiac events(MACE) between two groups was followed in 30 days. All clinical data were analyzed with SPSS 20.0. P Value of less than 0.05(2-tailed) was considered to be statistically significant.Results: Among 62 cases in this study, 31 were randomly assigned to PGE group(26 male, average age 67.39±7.87 years old) and 31 to CON group(24 male, average age 68.84±8.44 years old).1 Comparison about baseline clinical characteristics.There were no significant differences between both groups in baseline characteristics, including gender distribution, mean age, risk factors(hypertension, diabetes millitus, hyperlipidermia, smoking history), body mass index(BMI), creatinine, hemoglobin, low density lipoprotein, TIMI score, GRACE score, CRUSADE score, and basic medication( P>0.05).2 Comparison about cases and duration of unstable angina(UA) and accumulating consumption doses of nitrates before/after operation.There were no statistical differences of cases and duration of UA between two groups before PCI(74.19% vs. 61.29%, P=0.416; 11.83±3.84 min vs.10.74±4.19 min, P=0.235). After operation, cases and durations were much less than that before procedure in both groups(All P<0.05), and there was no difference between two groups(12.90% vs. 19.35%, P=0.490; 2.88±0.80 min vs. 2.65±0.42 min, P=0.486).There was no statistical difference in the accumulating consumption doses of nitrates between two groups before PCI(34.56±23.88 mg vs 36.36±25.29 mg, P=0.816). After PCI, there was no statistical difference between two groups(11.29±6.29 mg vs 13.50±5.57 mg, P=0.816), the doses was much less than that before PCI(P<0.05).3 Changes of c Tn IThere existed no statistical difference in c Tn I value between both groups at admission(5.14±2.44μmol/L vs. 4.96±2.23μmol/L, P=0.767). There were difference between two groups about c Tn I value at different time(before PCI and 72 hours after operation)(2.99±0.69umol/L vs. 1.94±0.54umol/L; 3.16±0.79umol/L vs.2.09±0.68umol/L, P<0.05). No difference was observed between two groups 72 hours after PCI(1.94±0.54umol/L vs. 2.09±0.68umol/L, P=0.347).4 Comparison of angiographic and procedural characteristics:During PCI procedure, CAG showed there were no statistical differences between two groups in the proportion of ischemic-related artery, the average length and diameter of stents, the percentage of TIMI grade 3 before/after PCI. The CTFC of LAD, RCA in PGE group was lower than those in CON group(LAD:19.81±6.00 vs. 24.29±5.59, P=0.045; RCA:16.88±3.72 vs. 23.00±6.00, P=0.021). There was no difference between two groups in the CTFC of LCX(14.86±6.67 vs. 18.50±6.53, P=0.343). The percentage of TMPG grade 3 in PGE group was higher than CON group and the difference has no difference(P=0.071). The incidence of slow/no-reflow was similar between groups(9.7% vs. 12.9%,P=0.688).5 Evaluation of heart function.There was no significant change between two groups about LVEF when patients admitted, 7 and 30 days after PCI(45.29±4.14 vs. 45.55±3.67, P=0.796; 47.37±3.91 vs. 46.93±2.71, P=0.858; 48.87±4.30 vs. 47.63±3.46, P=0.298). After 30 days of PCI, LVEF improved within each group(45.29±4.14 vs. 48.87±4.30, P<0.05; 45.55±3.67 vs.47.63±3.46, P<0.05).6 Evaluation of the safety of AlprostadilIn PGE group, no patients claimed to develop hypotension. There were 5 patients with local phlebitis and 1 patient with headache, all patients could bear the discomfort. No patient suffered from other complications like allergic to medicine, digestive disorder, shock and so on.In the follow-up visit, one patient in PGE group and two patients in CON group were rehospitalized because of cardiac reasons in 30 days. One suffered from severe heart failure in CON group. No malignant ventricular arrhythmia and cardiac death happened to patients in both group. No significant difference was found between two groups concerning the incidence of MACE.Conclusion: Intravenous infusion of Alprostadil can improve myocardial microcirculation in patients with non-ST segment elevation myocardial infarction receiving percutaneous coronary intervention safely, without obvious adverse effects. |
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