The efficacy and safety of PRO-kinetic metal alloy stent in hospitalized patients with acute ST-elevation myocardial infarction (The PROMETHEUS Study).
BACKGROUND
We evaluated the clinical and angiographic outcomes of silicon carbide-coated cobalt chromium PROKinetic bare-metal stent in patients with acute ST-segment elevation myocardial infarction (STEMI) who underwent primary percutaneous coronary intervention (PCI).


METHODS
Patients with acute STEMI (2.75-5.00 mm vessels; lesion length ≤30 mm by visual estimation) were treated with PRO-Kinetic stents at 5 centers in Korea. The primary endpoint was the rate of major adverse cardiac events (MACE), defined as all-cause death, new myocardial infarction, and target lesion revascularization (TLR) at 6-month follow-up. Follow-up angiography was recommended after the completion of the 6-month clinical followup.


RESULTS
A total of 64 patients (56.6 ± 12.9 years old, 56 male) were enrolled in the study. Procedural success was achieved in 100% of the lesions. The mean stent size was 3.51 ± 0.67 mm and the mean stent length was 20.3 ± 4.4 mm. There was 1 case of in-hospital death due to cardiac tamponade. During the 6-month clinical follow-up, 4 patients (6.3%) received TLR. Therefore, the total rate of MACE was 7.8%. Angiographic follow-up data were available for 42 patients (65.6%) and the in-stent late lumen loss was 1.02 ± 0.62 mm and in-segment late lumen loss was 0.99 ± 0.64 mm. Binary restenosis occurred in 53% of reference vessel diameters (RVDs) ≤3.0 mm, 25% of RVDs between 3.0 and 3.5 mm, and 0% of RVDs >3.5 mm (P=.006).


CONCLUSIONS
The use of the PRO-Kinetic stent seems to be safe and feasible in primary PCI for acute STEMI, and shows favorable clinical and angiographic outcomes in large (>3.0 mm) coronary arteries, but not in small arteries.
Korea University Ansan Hospital, Ansan, Korea.
Sang-Yup
SY
Lim
Hyun-Woong
HW
Park
Woo-Young
WY
Chung
Song-Yee
SY
Kim
Ki-Seok
KS
Kim
Jang-Whan
JW
Bae
Tae-Jin
TJ
Youn
D000208:Acute Disease; D000328:Adult; D000368:Aged; D000497:Alloys; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation* / Q000379:methods; D017554:Carbon Compounds, Inorganic; D016009:Chi-Square Distribution; D002857:Chromium; D020099:Coated Materials, Biocompatible / Q000627:therapeutic use*; D003035:Cobalt; D017023:Coronary Angiography / Q000379:methods; D004562:Electrocardiography; D005260:Female; D005500:Follow-Up Studies; D017052:Hospital Mortality / Q000639:trends; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D007723:Korea; D008297:Male; D008670:Metals; D008875:Middle Aged; D009203:Myocardial Infarction / Q000175:diagnosis* / Q000401:mortality / Q000628:therapy*; D009204:Myocardial Revascularization / Q000295:instrumentation / Q000379:methods; D011446:Prospective Studies; D011474:Prosthesis Design; D012008:Recurrence; D018570:Risk Assessment; D012720:Severity of Illness Index; D017655:Silicon Compounds; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome
D000497:Alloys; D017554:Carbon Compounds, Inorganic; D020099:Coated Materials, Biocompatible; D008670:Metals; D017655:Silicon Compounds; D002857:Chromium; D003035:Cobalt; C022088:silicon carbide