The purpose of the OPTIMISER Registry is to prospectively and retrospectively collect baseline, clinical and procedural data in patients who present with AMI and are treated with PCI as well as prospectively collect the clinical outcome data. Outcomes will be compared in different clinical subgroups. The impact of PCI in AMI in general as well as cardiovascular outcomes after AMI will be assessed.
* To assess procedural success and clinical outcomes among persons with AMI, who undergo PCI and/ or CABG for AMI (STEMI or NSTEMI) 1. Periprocedural outcomes/ complications, which will be analyzed, represent: final result (e.g. TIMI flow), stent expansion, dissections, perforations, prevalence of thrombus (assessed by angiography and intravascular imaging) 2. Short and long-term clinical outcomes of interest including: new AMI, unstable angina (UA), stent-/scaffold thrombosis, target lesion failure, target vessel revascularization, ischemia driven revascularization, repeat hospitalization, new/worsening heart failure, cardiogenic shock, stroke, bleedings, cardiovascular death and all-cause death. * To describe procedural and clinical performance of various balloon, stent and scaffold devices implanted in patients presenting with AMI during the afore mentioned period * To study the impact of different devices and strategies used for lesion preparation and PCI optimization strategies among patients undergoing PCI * To describe early and late angiographic and OCT-findings among coronary artery disease in patients with AMI treated with various metallic stent and scaffold devices * To assess possible predictors for coronary stent implantation or device failure * To evaluate the impact of different antithrombotic regimens on patient clinical outcomes * To study procedural and clinical outcomes among CAD patients requiring hemodynamic support using mechanical devices. * To describe economic implications (cost-effectiveness) of various interventional treatments for CAD.
Study Type
OBSERVATIONAL
Enrollment
4,000
Luzerner Heart Centre
Lucerne, Switzerland
RECRUITINGRate of major adverse cardiac and cerebrovascular events (MACCE) (including new AMI, stroke or cardiovascular death) at 1 year
Time frame: at 1 year
Rate of major adverse cardiac and cerebrovascular events (MACCE)
Time frame: 1, 2, 5 and 10 years
Rate of new AMI
Time frame: 1, 2, 5 and 10 years
Rate of TIA or stroke
Time frame: 1, 2, 5 and 10 years
Rate of stent thrombosis
Time frame: 1, 2, 5 and 10 years
Rate of target vessel revascularization
Time frame: 1, 2, 5 and 10 years
Rate of target lesion failure
Time frame: 1, 2, 5 and 10 years
Rate of ischemia-driven revascularization
Time frame: 1, 2, 5 and 10 years
Rate of unstable angina
Time frame: 1, 2, 5 and 10 years
Rate of rehospitalization for recurrent angina
Time frame: 1, 2, 5 and 10 years
Rate of hospitalization for heart failure
Time frame: 1, 2, 5 and 10 years
Rate of rehospitalisation for heart failure, resuscitated cardiac arrest or implantable cardioverter-defibrillator (ICD) implantation at follow- up.
Time frame: 1, 2, 5 and 10 years
Rate of cardiovascular mortality
Time frame: 1, 2, 5 and 10 years
Rate of all-cause mortality
Time frame: 1, 2, 5 and 10 years
Rate of bleeding events (access site or non-access site related) according to the BARC classification.
Time frame: 1, 2, 5 and 10 years
Rate of vascular complications (according to VARC criteria)
Time frame: 1, 2, 5 and 10 years
Rate of new York Heart Association (NYHA) class
Time frame: 1, 2, 5 and 10 years
Rate of cardiogenic shock
Time frame: 1, 2, 5 and 10 years
Rate of acute renal failure
Time frame: 1, 2, 5 and 10 years
Rate of new atrial fibrillation
Time frame: 1, 2, 5 and 10 years
Rate of new ventricular arrhythmias
Time frame: 1, 2, 5 and 10 years
Rate of major adverse limb events (MALE)
Time frame: 1, 2, 5 and 10 years
Rate of periprocedural complications (e.g. coronary perforations, no- reflow)
Time frame: 1, 2, 5 and 10 years
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