| Objective: By comparing the early and late coronary angiography results and the frequency of major adverse cardiac events between sirolimus-eluting stent(SES)and standard stent(SS),to evaluate the efficacy and safety of SES on prevention of coronary in-stent restenosis. Method: From March 2002 to September 2003,a total of 160 in-hospital patients (139 males, 21 females) with De Novo native coronary artery lesions that stenosed from 75%~100% were randomized divided into two groups: SES group (76 cases,66 males and 10 females) and SS group (84 cases, 73 males and 11 females) according to the stent used. The MLD,DS, restenosis rates and TLR in different segment in two groups were compared by the instant and 6-month follow-up QCA. The patients in both groups were similar with respect to age, gender, history, the segment of lesion, the length and diameter of lesion. All patients were on an oral medication of 300 mg of aspirin and clopidogrel at the first time three days before PCI, then after 300 mg continue used for one month, aspirin were take 150mg q.d infinitely, clopidogrel were used 75mg q.d post-PCI. All the patients were performed Allen's test of both sides, the first access choice of patients was transradial approach in patients with positive result of Allen's test. If the patient with radial artery spasm or severe tortuous, stenosis and abnormal of radial artery demonstrate by angiography, the access was change to right femoral artery. Coronary angiography was performed in the catheterization laboratory.6 French radial or femoral artery sheath were inserted after successful Seldinger puncture. Left and right coronary angiography were performed by using 4 French angiography catheter. The size of guiding catheter was determined according to the coronary angiography result. The size of balloon and stent was based on the length and inner diameter of target lesion and reference vessel respectively (stent to artery diameter ratio is 1.0-1.1:1.0). The length of stent must be enough to cover the whole lesion and longer than that of the balloon. Aiming to insure the stent to be in full contact with the artery wall, the stent were further dilated until the residual stenosis less than 20 percent. The time of dilation was between 20 t0 30 minutes per time. A successful procedure was defined as residual stenosis lower than 20% and TIMI grade III. In most cases, another same kind of stent was implanted when dissection occurred or intimal was mangled. Treated lesion and segment 5mm pre-stent and post-stent were analyzed with QCA while the native guiding catheter was used as a reference. Identical projections to that utilized for the initial intervention were used during follow-up at 6 months. Date analysis was performed offline after completion of the follow-up studies, and the observers were blinded. The following parameters were assessed: reference vessel diameter, length of lesion, MLD, diameter stenosis percent, and late loss.Result: 112 patients were followed up, reangiography was performed in 78 patients (55 males,13 females, mean age 63.7±7.2 years).37 patients (31 males, 6 females) were in the SES group and 41 patients (34 males, 7 females) in the SS group. The median follow-up intervals were 182±25 days in the SES group and 176±32 days in the SS group. Instant coronary angiography result after the procedure: MLD in the SES group changed from 0.84±0.32 to 2.42±0.46mm, P<0.05; while that in the SS group changed from 0.86±0.36mm to 2.43±0.44mm,P<0.05.DS in the SES group diminished from 84.8±9.6% to 11.7±5.6%, P< 0.05,while the SS group diminished from 85.3±10.4% to 12.2±6.3%,P<0.05.There were no significant differences of these changes between the two groups. There was also no significant difference in maximal dilation pressure between the two groups(14.2±2.7atm vs 14.4±2.3atm).At the 6-month follow- up angiography, QCA result showed a significantly larger MLD in the SES group than that in the SS group(2.41±0.47mm vs 1.63±0.56mm,p<0.001) leading to an obvious difference fo...
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