Comparison of Drug-Eluting Stents with Bare Metal Stents in Diabetic Patients with Acute Myocardial Infarction: A Pilot Study

Abstract

This study was done to assess the safety and efficacy of Bare metal stents Versus Drug eluting stents implantation in the Diabetic patients with acute ST-segment elevation MI (STEMI) undergoing primary PCI.

The study was conducted on 60 patients who came to the emergency room at Ain Shams University and Ain Shams University Specialized Hospitals complaining of acute chest pain and were diagnosed as having acute ST segment elevation myocardial infarction. All patients were treated by primary percutaneous coronary intervention.

The patients were divided into two groups according to the type of intracoronary stent deployed ( BMS or DES ), each group included 30 patients: Group I who received BMS, and Group II who received DES in the primary PCI . The stent type (BMS or DES), size and number as well as peri-procedural management were left to the operator’s discretion. Furthermore, choice of different kinds of DES from the 1st or 2nd generation was also an operator’s decision.

All patients were subjected to Thorough history taking and complete physical examination, 12 leads surface ECG, laboratory investigations including serial cardiac markers, emergency coronary angiography and coronary angioplasty of the infarct related artery (1ry PCI) were done, transthoracic Echocardiography, and clinical follow up during hospital stay and on outpatient basis at 1month, six months and one year.

All patients received the assigned treatment and the primary angioplasty procedure was done successfully targeting only the culprit lesion in the infarct related artery. The baseline characteristics including demographic data, risk factors, clinical status, time of chest pain, peak cardiac enzymes, door to balloon time, and ECG data were similar and statistically non -significant among the study groups. . During procedure, the angiographic data (lesion type, thrombus burden, other vessels affected, initial TIMI flow before PCI , performance of direct stenting , stent diameter and length as well as TIMI flow post PCI) were nearly similar and statistically non -significant among the study groups. Signs of successful and early reperfusion by ECG were equal in both groups, also echo cardiographic data regarding (ejection fraction, LV internal dimensions and SWMA index) were statistically non- significant among the study groups

During hospital stay, all patients were followed up for development of any cardiac event (MACE), and post MI complication (mechanical, ischemic and arrhythmogenic). Also they were followed up for development of major or minor bleeding and puncture site bleeding. This was statistically non- significant among the study groups (P>0.05). No mortality was reported in the study group.

Also duration of hospitalization was almost equal between the study groups.

All patients were followed up after discharge for development of any major adverse cardiovascular events (MACE) such as death, recurrent ischemia including target lesion revascularization (TLR) and non-target lesion revascularization (NTLR).

This was done at one month, six month and one year .

Coronary angiogram was not a routine, but done only for cases with recurrent symptoms, especially with new ECG changes or positive stress test.

Only one death was reported in groupI (sudden cardiac death with possible stent thrombosis), which was statistically non- significant between the study groups (P > 0.05).

Recurrent ischemia in the form of recurrent CP and/or ECG changes which necessitated non target lesion revascularization (NTLR) was equal in both groups (2 patients each) and this was statistically non-significant (P > 0.05).

In all the patients who needed clinically driven TLR, coronary angiography revealed in stent restenosis with variable degrees, except for one case from Group I who presented with definite stent thrombosis one week following Primary PCI , and this was statistically non -significant in-between study groups.