Morbidity, (early) mortality, long-term survival (at least >2 years), quality of life, length of hospital stay, peri-operative and post-operative complications (p. 7,2008,p. 9, 2009)
Outcomes for endovascular interventions: Procedural outcomes and complications, long-term outcomes (at least 12 month) including clinical anatomic and hemodynamic outcomes (p. 20)<br>a. Efficacy: Long-term (>6 month) clinical outcomes: mortality, amputation, reintervention of treated vessel or lesion, clinical symptoms, quality of life, ulcer healing, ankle-brachial index, standardized walking time tests, improvement and maintenance of clinical status<br>b. Safety: Stent fracture, graft patency (surrogate), recurrence of primary symptoms, loss of pulse (p. 19ff)<br>- patients with claudication: QoL questionnaires, treadmill testing (p. 20)<br>- Patients with critical limb ischemia: complete wound healing, amputation-free survival (primary outcome), resolution of pain, limb salvage (p. 20)<br>- Peripheral stenting compared to other interventions: death, amputation, quality of life, surrogates: asymptomatic restenosis found with ultrasonography (p. 20ff)
no a-priori outcomes defined
a. Efficacy: Stenosis (RVOT-grade via echocardiography), insufficiency: regurgitation fraction, NYHA functional class (p. 9)<br>b. Safety: Reoperation rate, complications, mortality (p. 9)
Efficacy and safety (p. 1)
successful revascularisation, occurrence of restenosis, avoidance of major adverse cardiac events, including death, myocardial infarction and stroke, restenosis (measuring late lumen loss, presence of coronary stenosis greater than 50% = binary restenosis) (p. 6)
no a-priori outcomes defined
a. Efficacy: mortality,stroke, ischemic/hemorrhagic stroke, freedom from AF,hospitalization, quality of life, procedural complications, drug-related adverse events (p. 46)<br>b. Safety: peri-operative mortality and stroke, major and minor complications, Intracranial haemorrhage (ICH), non-ICH bleeding, drug-related adverse events (p. 70ff)
b. Efficacy: Control of hypertension (p. 2)
no a-priori outcomes defined
a. Efficacy: 30-day mortality rate, aneurysm-related mortality, all-cause mortality, health-related quality of life (HRQoL),<br>b. Safety: adverse effects and complications (aneurysm-related outcomes suchas rupture and events specific to endovascular aneurysm repair, e.g.frequency of endoleaks and device migration, major morbidity, cardiac events), reintervention rates including conversion from endovascular aneurysm repair to open procedure and secondary intervention (p. 10)
Mortality, rate of myocardial infarction, rate of revascularisation, rate of angina pectoris, major adverse cardiac or cerebral event (death, stroke, cardiac infection. reinterventions) (p. 25 fulltext)
successful revascularisation, occurrence of restenosis, avoidance of major adverse cardiac events, including death, myocardial infarction and stroke, restenosis (measuring late lumen loss, presence of coronary stenosis greater than 50% = binary restenosis) (p. 6)
no a-priori outcomes defined
Death, recurrent myocardinal infarction, target vessel revascularization, target lesion revascularization, stent thrombosis) (p.11)
Outcomes for endovascular interventions: Procedural outcomes and complications, long-term outcomes (at least 12 month) including clinical anatomic and hemodynamic outcomes (p. 20)<br>a. Efficacy: Long-term (>6 month) clinical outcomes: mortality, amputation, reintervention of treated vessel or lesion, clinical symptoms, quality of life, ulcer healing, ankle-brachial index, standardized walking time tests, improvement and maintenance of clinical status<br>b. Safety: Stent fracture, graft patency (surrogate), recurrence of primary symptoms, loss of pulse (p. 19ff)- patients with claudication: QoL questionnaires, treadmill testing (p. 20)<br>- Patients with critical limb ischemia: complete wound healing, amputation-free survival (primary outcome), resolution of pain, limb salvage (p. 20)<br>- Peripheral stenting compared to other interventions: death, amputation, quality of life, surrogates: asymptomatic restenosis found with ultrasonography (p. 20ff)
a. Efficacy: Revascularisation of an already treated lesion following the reappearance of clinical symptoms, restenosis (p. 4)<br>b. Safety: primary – death, thrombosis, secondary – myocardial infarction, major adverse cardiac events (death, myocardial infarction, stroke) (p.4)
no a-priori outcomes defined
Late lumen loss, revascularization rate, mortality, myocardial infarction, complications, adverse events (p.7)
a. Efficacy: Physical performance, quality of life, symptoms, mortality, severity of mitral valve regurgitation (MR) (p. 9, 2010), open surgical re-intervention (p. 11, 2012)<br>b. Safety: Complications during and after surgery, 30-day-mortality (p. 13, 2012)