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Procedural results
Table 2 depicts related angiographic baseline characteristics and
procedural information. Stent deployment success was achieved in 141
patients (97.2%); deployment failures occurred in four patients (2.8%)
due to severe calcifications and/or tortousity of the target vessel.
Invasive 6-month follow-up data were available for 33 patients
(22.8%). 22 of the 33 patients (15.2%) had invasive follow-up due
to symptoms, 11 patients (7.6%) had re-angiography due to
additional planned interventional procedures.
Non-invasive follow-up was available in 142 patients (97.9%): One
patient got lost to follow-up, two patients died during the follow-up
period due to non-cardiac causes. Twenty-two patients (15.2%) had
typical or atypical angina pectoris during the follow-up period and were
considered for re-angiography, of whom seven patients had significant
restenosis with need for re-angioplasty (TLR 4.9%). One patient had
unstable angina pectoris 134 days after the index procedure of a 90%
stenosis of a postero-lateral bypass graft. Angiographically, a re-
occlusion in the stent with additional thrombus (not encountered as
stent thrombosis) was diagnosed. No patient required emergency
bypass surgery or experienced a procedure-related cerebral vascular
accident. Therefore the total rate of MACE was 5.6%.
Table 1. Patient characteristics.
Patients
(n)
145
Male 100 (69.0%)
Age (in years) 69.0±13.8 (41-92)
Coronary risk factors
Diabetes mellitus 40 (27.6%)
Hypertension 113 (77.9%)
Hypercholesterolaemia 110 (75.9%)
Reduced LV-function (LV-EF < 50%) 35 (24.1%)
Clinical characteristics
Stable angina pectoris (CCS I-III) 93 (64.1%)
CCS class 1 8 (5.5%)
CCS class 2 68 (46,9%)
CCS class 3 17 (11,7%)
Unstable angina pectoris 24 (16.6%)
NSTEMI / STEMI 28 (19.3%)
Number of diseased vessels
One 28 (19.3%)
Two 33 (22.8%)
Three 84 (57.9%)
Values are means ±SD (continuous data), absolute numbers and percentage,
or range in brackets (nominal data). LV-EF, echocardiographic left ventricular
ejection fraction. NSTEMI/STEMI, (Non-)ST-Elevation Myocardial Infarction
Table 2. Angiographic baseline characteristics and procedural data.
Number of lesions 161
Target vessel
Left anterior descending artery /
diagonal artery 48 (29.8%)
Left circumflex artery /
marginal artery 43 (26.7%)
Right coronary artery /
Posterior interventricular artery/
posterior descending artery 64 (39.7%)
Coronary Bypass 6 (3.7%)
Lesion type (AHA/ACC)
A 18 (11.2%)
B1 48 (29.8%)
B2 49 (30.4%)
C 46 (28.6%)
Lesion morphology
De novo
155 (96.3%)
Restenosis 6 (3.7%)
Stent parameter
Mean stent length (mm) 15.3±3.4 (8.0 - 35.0*)
Mean stent diameter (mm) 2.89±0.4 (2.5 -4.0)
Mean maximum pressure used (atm) 15.6±3.2 (8 - 25)
Stent deployment success 141 (97.2%)
Values are means ±SD (continuous data), absolute numbers and
percentage, or range in brackets (nominal data). * 3 patients (3 lesions)
with > 2 stents implanted (overlap > 2 mm)
Table 3. Angiographic data and study endpoints.
Number of patients available for follow-up 142 (97.9%)
Number of patients with angiographic follow-up 33 (22.8%)
Angiographic follow-up due to symptoms 22 (15.2%)
Angiographic follow-up for additional PCI’s 11 (7.6%)
Study endpoints
TLR 7 (4.9%)
Binary restenosis 28.1%
Late-loss (in-stent)(mm) 0.75±0,71
MACE 8 (5.6%)
Values are means ±SD (continuous data), absolute numbers and percentage,
or range in brackets (nominal data). PCI: percutaneous coronary intervention;
TLR: target lesion revascularisation; MLD: minimal lumen diameter; MACE:
major adverse cardiac event.
Table 4. QCA data.
Number of patients 33
Baseline data
Reference diameter (mm) 2.67±0.73
Lesion length (mm) 12.85±6.71
MLD (in-stent) (mm) 0.84±0.48
MLD (in-segment) (mm) 0.79±0.46
DS (in-stent) (%) 68.9±18.2
DS (in-segment) (%) 69.5±16.9
After procedure
MLD (in-stent) (mm) 2.30±0.62
MLD (in-segment) (mm) 2.54±0.75
DS (in-stent) (%) 15.72±9.6
DS (in-segment) (%) 16.70±9.5
At follow-up
MLD (in-stent) (mm) 1.58±0.87
MLD (in-segment) (mm) 1.58±0.87
DS (in-stent) (%) 41.96±23.40
DS (in-segment) (%) 41.96±23.40
Late loss (in-stent) (mm) 0.75±0,71
Late loss (in-segment) (mm) 0.79±0,72
binary stenosis (in-stent) (%) 28.1%
binary stenosis (in-segment) (%) 28.1%
Time to follow-up (days) 166±124
Values are means±SD (continuous data), absolute numbers and percentage,
or range in brackets (nominal data). MLD: minimal lumen diameter; DS:
diameter stenosis.
Clinical research