Real-world five-year outcomes of FlexyRap® cobalt-chromium rapamycin-eluting stents with biodegradable polymer in patients with de-novo coronary artery disease

Table 1 Demographic baseline and clinical characteristics

Characteristics	FlexyRap® cobalt chromium rapamycin eluting coronary stent system; Number of patients, (n = 500)
Patient demographics
Age, yr (mean ± SD)	59.30 ± 11.27
Male, n (%)	351 (70.2)
Female, n (%)	149 (29.8)
Heart rate (mean ± SD)	86.36 ± 11.34
Systolic blood pressure (mean ± SD)	133.57 ± 20.88
Diastolic blood pressure (mean ± SD)	83.36 ± 9.70
Haemoglobin (g/dL) (mean ± SD)	12.64 ± 2.45
Platelet count (mean ± SD)	205.85 ± 52.19
Baseline medical history, n (%)
Hypertension	217 (43.4)
Smoking current	203 (40.6)
Diabetes mellitus	70 (14)
Alcohol current	48 (9.6)
Dyslipidemia	17 (3.4)
Previous MI	274 (54.8)
History of CAD	24 (4.8)
Previous PCI	21 (4.2)
Previous Stroke	9 (1.8)
Baseline cardiac history, n (%)
Stable angina	299 (59.8)
Unstable angina	201 (40.2)
Angina class, n (%)
Class I	12 (2.4)
Class II	30 (6)
Class IIA	1 (0.2)
Class IIB	12 (2.4)
Class IIC	6 (1.2)
Class III	198 (39.6)
Class IIIA	15 (3)
Class IIIB	51 (10.2)
Class IIIC	37 (7.4)
Class IV	138 (27.6)
Disease vessel, n (%)
Single vessel	314 (62.8)
Double vessel	150 (30)
Triple vessel	27 (5.4)
Quadra vessel	9 (1.8)
LVEF (mean ± SD)	52.88 ± 15.46
Serum creatinine (mean ± SD)	1.47 ± 0.47

CABG: Coronary artery bypass graft; CAD: Coronary artery disease; LVEF: Left ventricular ejection fracture; MI: Myocardial infarction; PCI: Percutaneous coronary intervention.

Table 2 Procedural characteristics

Procedural characteristics (n = 500)
Lesion details
Total number of lesions treated with FlexyRap® (n)	730
Total number of stents deployed (n)	730
Total stent per lesion (n = 500 patients) (Total no. stent deployed (730)/Total lesion locations (729)	1.001
Total lesion per vessel (n = 500 patients); Total lesion locations (729)/(Sum of total No of diseased vessel (731)	0.997
Lesion locations (729) n (%)
D1	6 (0.82)
Distal LAD	17 (2.33)
Distal LCx	4 (0.54)
Distal RCA	16 (2.19)
LAD	279 (38.27)
LCx	98 (13.44)
LM	1 (0.13)
MID LAD	19 (2.6)
MID LCx	9 (1.23)
MID RCA	15 (2.05)
O Mid	7 (0.96)
OM	4 (0.54)
OM1	8 (1.09)
OM2	6 (0.82)
OM3	1 (0.13)
OMI	1 (0.13)
Osteoproximal LAD	2 (0.27)
Osteoproximal RCA	4 (0.54)
PDA	7 (0.96)
PLV	3 (0.41)
Proximal LAD	23 (3.15)
Proximal RCA	15 (2.05)
Proximal LCx	7 (0.96)
PTCA	8 (1.09)
Ramus intermedius	8 (1.09)
RCA	156 (21.40)
RCX	2 (0.27)
PLB	2 (0.27)
POM	1 (0.13)
Stent length (mean ± SD)	26.03 ± 10.86
Stent diameter (mean ± SD)	3.06 ± 0.41
Type of stenosis, n (%)
de novo	500 (100)
Thrombus load (n = 731), n (%)
None	519 (71)
Mild	90 (12.31)
Moderate	59 (8.07)
Severe	63 (8.62)
Lesion type [ACC/AHA classification] (n = 731), n (%)
Type A	20 (2.73)
Type B1	193 (26.40)
Type B2	302 (41.31)
Type C	216 (29.55)
Stent balloon inflation pressure (atm) (mean ± SD) (n = 500)	12.52 ± 1.75
TIMI FLOW n (%)
II	9 (1.8)
III	491 (98.2)
% of occlusion (mean ± SD) (n = 500)	88.60 ± 8.79
All values are presented in n (%) or mean ± SD

ACC/AHA: American college of cardiology/American heart association; LAD: Left anterior descending artery; LCx-: Left circumflex; LM: Left main; OM: Obtuse marginal artery; PDA: Patent ductus arteriosus; PLV: Posterior left ventricular artery; PTCA: Percutaneous transluminal coronary angioplasty; PLB: Posterolateral branch; POM: Medial preoptic nucleus; RCAL Right coronary arterial ligation; RCX: Right Circumflex artery; SD: Standard deviation; TIMI: Thrombolysis in myocardial infarction.

Table 3 Cardiac event rate, n (%)

Clinical event	12-mo (n = 500)	3-yr (n = 500)	5-yr (n = 500)
TLF	0 (0)	0 (0)	0 (0)
Cardiovascular Death	0 (0)	0 (0)	0 (0)
TV-MI	1 (0.2)	0 (0)	1 (0.2)
Clinically-driven TLR	0 (0)	0 (0)	0 (0)
Late ST	2 (0.4)	0 (0)	0 (0)
TVF	0 (0)	0 (0)	0 (0)
TVR	0 (0)	0 (0)	0 (0)
Very late ST	0 (0)	2 (0.4)	0 (0)
Total MACE	1 (0.2)	0 (0)	1 (0.2)

MACE: Major adverse cardiac event; TLF: Target lesion failure; TV-MI: Target vessel myocardial infarction; TLR: Target lesion revascularization; ST: Stent thrombosis; TVF: Target vessel failure; TVR: Target vessel revascularization.