Long-term health outcome and mortality evaluation after invasive coronary treatment using drug eluting stents with or without the IVUS guidance. Randomized control trial. HOME DES IVUS.
OBJECTIVE
To assess the role of the intravascular ultrasound (IVUS) during implantation of drug-eluting stents (DES) on long-term outcome in patients with complex coronary artery disease and high clinical risk profile with special attention to the development of late stent thrombosis (LST).


METHODS
Two hundred and ten patients were randomly assigned to receive DES either with (N = 105) or without (N = 105) the IVUS guidance. Dual antiplatelet treatment was administered for 6 months in all patients. At 18-month follow-up, the rates of major adverse cardiac events (MACEs) (death, myocardial infarction, and reintervention) were assessed in both groups with special attention to possible LST. Stent thrombosis was classified according to Academic Research Consortium (ARC).


RESULTS
At the 18-month follow-up, there was no significant difference between both groups regarding MACE (11% vs. 12%; P = NS). Stent thrombosis has occurred in four patients (3.8%) in the group with and in 6 patients (5.7%; P = NS) in the group without the IVUS guidance.


CONCLUSIONS
In our randomized trial we failed to demonstrate the superiority of the IVUS guidance during DES implantation over standard high-pressure postdilatation. However we confirmed worrisome results concerning DES thrombosis after discontinuation of dual antiplatelet-treatment with documented stent thrombosis related events in almost 5% of patients with 50% of mortality in this high-risk clinical scenario.
Jakabcin
Jozef
J
Department of Cardiology, Masaryk Hospital, Ustí nad Labem, Czech Republic 40113, Czech Republic.
Spacek
Radim
R
Bystron
Marian
M
Kvasnák
Martin
M
Jager
Jiri
J
Veselka
Josef
J
Kala
Petr
P
Cervinka
Pavel
P
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D016009:Chi-Square Distribution; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D004359:Drug Therapy, Combination; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000517:prevention & control; D010043:Outcome and Process Assessment, Health Care; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011446:Prospective Studies; D011474:Prosthesis Design; D018570:Risk Assessment; D013927:Thrombosis / Q000209:etiology / Q000517:prevention & control; D013997:Time Factors; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
D010975:Platelet Aggregation Inhibitors