The Outcome of PCI for stent-ThrombosIs MultIcentre Study (OPTIMIST): rationale and design of a multicenter registry.
BACKGROUND
Stent thrombosis (ST) is a recognized complication limiting the clinical efficacy of percutaneous coronary interventions (PCI). Because of the increasing number of stent-based PCI, the absolute number of patients experiencing ST is expected to expand. Re-PCI is the commonly adopted treatment for patients with ST; however, the prognostic variables as well as the angiographic and clinical results have not been systematically assessed. Moreover, the possible benefit associated with the use of adjunctive devices (AD) with theoretical antiembolic property has not been systematically analyzed in this high-risk population.


METHODS
We present the design of a prospective and retrospective multicenter registry to assess the contemporary angiographic and clinical outcome of PCI in patients with ST. Moreover, we sought to assess if the use of thrombectomy or distal protection AD is associated with any improvement in the PCI's angiographic results. All patients with angiographically confirmed ST undergoing attempt of PCI in the enrolling centers during a fixed 2-year study period will enter the study. Clinical outcome during hospitalization, at 30 days and 6 months will be assessed. Percutaneous coronary intervention with or without AD will be performed according to physician's discretion. All PCI cine-film will undergo blind core laboratory analysis to assess a series of key angiographic data (TIMI flow, TIMI frame count, thrombus score, myocardial blush grade, distal embolization).


CONCLUSIONS
The OPTIMIST study is designed to provide a detailed description of the angiographic and clinical outcome achieved in the real world with contemporary PCI for ST. Moreover, it will provide observational data regarding the role of AD in this high-risk scenario.
Burzotta
Francesco
F
Institute of Cardiology, Catholic University of the Sacred Heart, Rome, Italy. f.burzotta@rm.unicatt.it
Romagnoli
Enrico
E
Manzoli
Alessandro
A
Pristipino
Christian
C
Belloni
Flavia
F
Sardella
Gennaro
G
Rigattieri
Stefano
S
Gioffrè
Gaetano
G
Mazzarotto
Pietro
P
Summaria
Francesco
F
Parma
Antonio
A
Danesi
Alessandro
A
Prati
Francesco
F
Trani
Carlo
C
D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation; D017023:Coronary Angiography; D003328:Coronary Thrombosis / Q000209:etiology / Q000628:therapy*; D005374:Filtration; D006801:Humans; D007558:Italy; D015337:Multicenter Studies as Topic; D011446:Prospective Studies; D012042:Registries; D012107:Research Design; D015607:Stents / Q000009:adverse effects*; D017131:Thrombectomy / Q000295:instrumentation; D016896:Treatment Outcome