Sirolimus-eluting stent versus paclitaxel-eluting stent in coronary angioplasty six months angiographic follow up

ABSTRACT

Over the last few years drug-eluting stent implantation emerged as new therapeutic option for the prevention restenosis. After completion of the RAVEL study a steadily growing number of clinical trials is addressing the efficacy of a variety of drug coating combinations. This study aimed at assessing and comparing the feasibility, safety, immediate and short term results of deploying two different types of drug-eluting stents in diseased coronary arteries of both diabetic and non diabetic patients. The study was conducted on 66 patients between March 2005 and June 2006 who were scheduled for elective PCI for a significant angiographic stenosis [more than 50%] in a native coronary vessel. The patients were randomly distributed to receive a Sirolimus-Eluting stent, SES, [Cypher, Cordis, Johnson and Johnson] or a Paclitaxel-eluting stent, PES, [Taxus, Boston Scientific] and then all patients were classified into 2 groups Group A 33 patients received Sirolimus-Eluting stent [SES]. Group B 33 patients received Paclitaxel-eluting stent [PES]. Patients with NYHA class IV or congestive heart failure patients, patients with serious arrhythmias or conduction defects, type "C" lesions according to AHA and ACC classification, lesions in left main trunk, lesions of arterial or venous grafts and total occlusions, lesions of instent restenosis and patients with acute myocardial infarction were excluded from the study. Patients included in the study were subjected to Full history taking, complete general and local examination, resting 12 lead ECG, echocardiographic examination including LV dimensions and ejection fraction and angiographic assessment of the lesions. The patients were followed up during their hospital stay for 24 hours and follow-up angiography was done for all asymptomatic patients electively after 6 months and earlier if any patient developed chest pain or acute coronary event before 6 months. There was no significant difference between the two groups regarding the lesion length, reference vessel diameter, minimal lumen diameter before and after angioplasty, diameter stenosis before and after angioplasty, acute gain, stent diameter and stent length [p>0.05] no complications as symptoms or signs of acute stent thrombosis as acute chest pain or new ECG changes or occurrence of any neurological or vascular complications were recorded in any patient during the 24 hours of hospital stay after intervention. After 6 months of follow-up 64 patients. In both groups [32 patients in each group] were asymptomatic during the 6 months follow-up period with no major adverse cardiac events [MACE] and these patients underwent a follow-up angiography after 6 months of the intervention. Only 2 patients one in group "A" after 70 days of angioplasty and one in group "B" after 75 days of angioplasty developed major adverse cardiac event in the form of unstable angina with chest pain and recent ECG changes. Those 2 patients immediately underwent a diagnostic coronary catheterization immediately after hospital admission with the following results. Both types of drug illuting stents gave a good immediate and at 6 months follow up results. In spite of the lack of significant difference between the two types of stents it is more preferable to use Sirolimus stents but not to the degree to recommend its use over the Paclitaxel stents. Larger number of patients and a longer follow-up period to obtain more statistically significant results between the two types of stents