The purpose of the SIROOP Registry is to retrospectively and prospectively collect baseline, clinical and procedural characteristics of patients who have undergone PCI and are treated with either currently available sirolimus or paclitaxel coated DCBs (see Table 1), irrespective of clinical presentation as well as to prospectively collect data about their clinical outcomes. Outcomes will be compared in different clinical subgroups. The impact of current DCBs in different clinical settings and coronary artery lesions on cardiovascular outcomes will be assessed.
Objectives in detail: * To evaluate procedural success, efficacy, performance and clinical outcomes among various patient cohorts, who undergo PCI using currently available DCBs: 1. Periprocedural outcomes/complications, which will be analyzed, include: final result (e.g. residual stenosis, TIMI flow), dissections, perforations, prevalence of thrombus (assessed by angiography and intravascular imaging) 2. Short and long-term clinical outcomes of interest comprise among others: new MI, unstable angina (UA), target lesion failure, target vessel revascularization, target lesion failure/ 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 DCB, either alone or in combination with other stent and coronary scaffold devices * To identify optimal strategies for lesion preparation in cases treated with DCB * To identify possible predictors for TLR after treatment with DCB * To describe early and late angiographic and OCT-findings among coronary artery disease (CAD) patients treated with DCB and/or various metallic stent and scaffold devices * To evaluate the impact of different antithrombotic regimens on patient's 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
2,000
PTCA with either a Sirolimus eluting balloon or Paclitaxel eluting balloon
Luzerner Heart Centre
Lucerne, Canton of Lucerne, Switzerland
RECRUITINGRate of target lesion failure (TLF) and target lesion revascularization (TLR)
Time frame: at 1 year
Rate of combination of major adverse cardiac and cerebrovascular events (MACCE) (including new MI, TLR or cardiovascular death)
Time frame: at 180 days, 1, 2 and 5 years
Rate of MACE
Time frame: at 180 days, 1, 2 and 5 years
Rate of new MI (NSTEMI / STEMI)
Time frame: at 180 days, 1, 2 and 5 years
Rate of TIA or stroke
Time frame: at 180 days, 1, 2 and 5 years
Rate of acute vessel closure
Time frame: at 180 days, 1, 2 and 5 years
Rate of stent thrombosis or ISR
Time frame: at 180 days, 1, 2 and 5 years
Rate of target vessel revascularization (TVR)
Time frame: at 180 days, 1, 2 and 5 years
Rate of target lesion revascularization (TLR)
Time frame: at 180 days, 1, 2 and 5 years
Rate of target lesion failure (TLF)
Time frame: at 180 days, 1, 2 and 5 years
Rate of ischemia driven TLR
Time frame: at 180 days, 1, 2 and 5 years
Rate of all-cause death
Time frame: at 180 days, 1, 2 and 5 years
Rate of cardiac death
Time frame: at 180 days, 1, 2 and 5 years
Rate of all myocardial infarction and TV-MI
Time frame: at 180 days, 1, 2 and 5 years
Rate of rehospitalization for recurrent angina
Time frame: at 180 days, 1, 2 and 5 years
Rate of hospitalization for HF
Time frame: at 180 days, 1, 2 and 5 years
Rate of rehospitalization for HF, resuscitated cardiac arrest or implantable cardioverter- defibrillator (ICD) implantation
Time frame: at 180 days, 1, 2 and 5 years
Rate of bleeding events (access site or non-access site related) according to the BARC classification
Time frame: at 180 days, 1, 2 and 5 years
Rate of vascular complications (according to VARC criteria)
Time frame: at 180 days, 1, 2 and 5 years
Rate of cardiogenic shock
Time frame: at 180 days, 1, 2 and 5 years
Rate of acute renal failure/ contrast-induced nephropathy (CIN)
Time frame: at 180 days, 1, 2 and 5 years
Rate of new ventricular arrhythmias
Time frame: at 180 days, 1, 2 and 5 years
Rate of major adverse limb events (MALE)
Time frame: at 180 days, 1, 2 and 5 years
Rate of new York Heart Association (NYHA) class
Time frame: at 180 days, 1, 2 and 5 years
Rate of angina according to Canadian Cardiovascular Society (CCS) Score
Time frame: at 180 days, 1, 2 and 5 years
Rate of procedural success (final diameter stenosis < 30% without flow-limiting dissections)
Time frame: at 180 days, 1, 2 and 5 years
Rate of periprocedural complications (e.g. coronary perforations, no-reflow)
Time frame: at 180 days, 1, 2 and 5 years
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