BioMime Sirolimus-eluting Coronary Stent System
time-point, which involved an angiographic study to assess the late luminal loss by quantitative coronary angiographic (QCA) method, the rest are clinical end-points. A hospital visit was required for the 30- day time-point and the rest of the follow-up sessions were carried out via telephone interview.
Quantitative Coronary Angiographic Evaluation A diagnostic angiogram was obtained for each patient at eight-month follow-up, with target vessel cine views captured in at least two orthogonal views or the one in which maximum stented length was easily discernable. At least two cardiac cycles were recorded and the arteries were filmed while having maximum contrast passage to maximise understanding of the QCA study.
All such recordings were obtained at three distinct time-points – pre- stenting, post-stenting (also known as baseline) and at eight-month follow-up. Each CD was labelled and sent to an independent core laboratory, in this case the Cardiovascular Research Centre in Sao Paulo, Brazil. QCA was performed using leading software and edge-detection techniques. The advanced understanding of the experts was used to characterise the lesions. In-stent and in-segment morphologies were measured. The target lesion was defined as the stented segment that could clearly be seen on the software. The 5mm segments immediately pre- and post-stented length were considered to be the in-segment portion.
Study End-points
The primary safety end-point was MACE at 30 days. MACE comprised hard end-points, such as: death (cardiac or non-cardiac); MI (Q-wave or non-Q-wave); and ischaemia-driven revascularisation, either via repeat PCI or CABG. The primary efficacy end-point was in-stent late luminal loss, as calculated by QCA method at eight months angiographic follow-up.
The secondary safety end-points included the occurrence of ARC-defined definite stent thrombosis at acute, subacute, late and very late time-points, and MACE at six months, eight months, one year and two years. Secondary efficacy end-points included percentage of angiographic stenosis and binary restenosis as understood from the eight-month angiographic follow-up.
Results Characteristics of the Patients
Between March 2009 and February 2010, 30 patients who met the eligibility criteria were treated with a single BioMime stent. All patients were Indian in origin and belonged to the Asian race. Overall, 83% patients were male, with a mean age of 50.5 ± 8.0 years. A high prevalence of diabetes (30%), hypertension (57%) and high blood pressure (67%) was noted in these patients. Most of the patients had a high body mass index of 24.3 (considered overweight in Indians). Seventy per cent of patients presented with acute coronary syndrome, which was a mixture of stable and unstable angina along with a past MI episode.
The target lesion site was the left anterior descending coronary artery in 40% of cases and the right coronary artery in 37% of cases. Left circumflex artery disease was seen in 10% of patients. Lesions in the remaining patients involved the right posterior descending artery and the obtuse marginal artery, which accounted for 3 and 10% of cases, respectively. Seventy-three per cent of patients presented with thrombolysis in MI flows I and II and 73% of patients had lesion
INTERVENTIONAL CARDIOLOGY
classification of type B1 and B2 (with type B1 lesion dominating in 70% of the treatment settings). As severe calcification was an angiographic exclusion criterion, 33% of mild to moderate calcification patients were treated. Two patients had undergone a previous PCI and a CABG procedure.
Procedural Characteristics
All patients were treated with standard arterial puncture methods and routine prescription of in-process anticoagulants. An antiplatelet regimen was administered, along with other cardiac drugs, as deemed necessary. While the maximum stent diameters used were 3mm (47%), in 43% of the cases the stented lengths were 24mm, which is representative of clinical practice.
Intra- and Post-procedural Details
All patients successfully received a single BioMime stent. Physician experience of stent acute performance, such as stent trackability,
41
Table 2: Baseline Treatment Details Baseline Demographics
Number of patients
Number of Diseased Coronary Arteries Single-vessel disease Two-vessel disease Three-vessel disease
Number of coronary arteries treated
Thrombolysis in Myocardial Infarction Flow Pre-procedure TIMI flow 0 TIMI flow I TIMI flow II TIMI flow III
Details 30
28 2 0
30 0 (0%)
9 (30%) 13 (43%) 8 (27%)
American College of Cardiology/American Heart Association Lesion Type Type A Type B1 Type B2 Type C
8 (27%) 21 (70% 1 (3%) 0 (0%)
Degree of Calcification None Mild
Moderate Severe
Lesion Site Location Right coronary artery
Left anterior descending artery Left circumflex artery
Right posterior descending artery Obtuse marginal artery
BioMime Stent Deployment Details Average stented diameter (mm) Average stented length (mm)
Stent Diameters (mm) 2.5 3.0 3.5
Stent Lengths (mm) 13 16 19 24
TIMI = thrombolysis in myocardial infarction.
20 (67%) 9 (30%) 1 (3%) 0 (0%)
11 (37%) 12 (40%) 3 (10%) 1 (3%)
3 (10%)
3 ± 0.3 20 ± 4
4 (13%) 14 (47%) 12 (40%)
4 (13%) 7 (23%) 6 (20%) 3 (43%)
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