Acute stent thrombosis

Kindi, Fahad Al; Arafa, Salah; Arabi, Abdul Rahman

doi:10.4103/1995-705x.151094

Cited by 1 publication

(1 citation statement)

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“…The safety and efficacy primary endpoints were powered separately and the largest sample size from the two calculations was ultimately chosen as the final sample size for the study. From historical series, assuming a mixedprofile population, the following incidences were considered for each component of the composite safety endpoint, as a per patient analysis: (I) overall death 0.0-4.5% (17-23); (II) definite or probable stent thrombosis 0.0-3.3% (17,21,(24)(25)(26); (III) myocardial infarction 0.0-3.0% (20,25,27); (IV) vessel perforation (Ellis' grade III or IIIcavity spilling) or cardiac tamponade 0.4% (28,29); (V) unplanned invasive treatment 0.5% (20). Based on those figures, the goal rate of the safety composite primary endpoint was guessed at 5% with an upper value of 12% at maximum.…”

Section: Performance Goals and Statistical Considerationsmentioning

confidence: 99%

Safety and effectiveness of introducing a robotic-assisted percutaneous coronary intervention program in a tertiary center: a prospective study

Lemos¹,

Franken²,

Mariani³

et al. 2022

Cardiovasc Diagn Ther

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Background: Robotic-assisted percutaneous coronary intervention (PCI) is a novel technology that permits remote operation of interventional devices. However, little is known about the safety and effectiveness of introducing a robotic PCI program in a hospital already experienced in traditional coronary angioplasty.Methods: Prospective single-arm survey to assess the safety and effectiveness of robotic-assisted PCI in comparison to pre-defined performance goals. The study cohort comprised all consecutive cases treated with robotic PCI since its introduction. The safety primary endpoint was a composite of (I) overall death or (II) non-fatal adverse events related to target vessel complications (stent thrombosis, myocardial infarction, vessel perforation or cardiac tamponade, or repeat invasive treatment) during the index hospitalization. The efficacy primary endpoint was robotic-assisted procedural success, a composite of (I) successful dilatation of the target lesion and (II) successful robotic assistance, defined as absent non-planned manual conversion.Results: A total of 83 patients and 112 lesions were prospectively enrolled. The rate of angiographic success was 99.1%. From these, 97 lesions (86.6%) were treated with only robotic PCI or with hybrid according to the pre-interventional plan. The rates of efficacy and safety primary endpoints were 85.7% and 2.4% respectively (P<0.01 for non-inferior to the pre-defined performance threshold).Conclusions: Introduction of robotic-assisted PCI in a tertiary center was associated with safe and effective results, comparable to pre-defined goals of optimal performance.

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