TASTE-less endpoint of 30-day mortality (and some other issues with TASTE) in evaluating the effectiveness of thrombus aspiration in STEMI: not the “evidence” to change the current practice of routine consideration of manual thrombus extraction

One swallow does not a summer make but many swallows do: accumulating clinical evidence for nearly-eliminated peri-procedural and 30-day complications with mesh-covered stents transforms the carotid revascularisation field

“…This concern may be somewhat mitigated by enrolling only those patients who are high risk for CEA, since many patients at high risk for CEA can be safely treated with CAS. Randomised trials remove the treatment selection bias but, as demonstrated by several recent examples in cardiovascular medicine, they are greatly sensitive to patient selection bias [ 88 , 89 ]. Patient selection bias may lead paradoxically to removing from the study (“patients not subjected to randomisation”) those to whom the evaluated intervention is predominantly addressed [ 88 , 89 ].…”

“…Randomised trials remove the treatment selection bias but, as demonstrated by several recent examples in cardiovascular medicine, they are greatly sensitive to patient selection bias [ 88 , 89 ]. Patient selection bias may lead paradoxically to removing from the study (“patients not subjected to randomisation”) those to whom the evaluated intervention is predominantly addressed [ 88 , 89 ]. For instance, in the recent TASTE study one of the main reasons to exclude subjects with thrombus-containing coronary lesions from the cohort undergoing randomisation in a major clinical trial of coronary thrombus extraction in acute myocardial infarction [ 88 ] was thrombus burden requiring, in the operator’s judgment, thrombus aspiration/removal.…”

“…This was not indicated in the study inclusion/exclusion criteria but it was listed as one of the principal reasons why patients meeting the inclusion criteria did not undergo randomisation [ 88 ]. While this was no doubt right ethically, it was clearly wrong methodologically, resulting in low-risk subject enrolment and (unsurprisingly) an apparent “lack of benefit” of thrombus aspiration [ 89 ], particularly because the study was focused on a low-incidence endpoint of mortality [ 88 ]. While this provided zero evidence for the futility of routine consideration of thrombus aspiration in acute myocardial infarction, it led (surprisingly) to a “downgrade” in the role of this intervention in the guidelines from Class IIa (weight of evidence in favour of usefulness/efficacy – intervention should be considered) [ 90 ] to Class IIb (usefulness/efficacy is less well established – intervention may be considered) [ 91 ] because of the new “randomised study evidence”.…”

“…Because evidence from clinical studies should be applicable to routine clinical practice, the role of all-comer study protocols is increasingly understood in cardiovascular medicine [ 5 , 92 ] to minimise the proportion of trial-unrepresented patients [ 88 , 89 ] to whom the tested intervention is designed to apply. Routine access to tools that enable achievement of CAS 30-day complication rate ≤ 1% in truly all-comer populations comprised of a majority of symptomatic patients and including only increased-stroke-risk asymptomatic patients [ 5 ], transforms the carotid revascularisation field [ 10 , 93 ].…”

Myocardial regeneration strategy using Wharton’s jelly mesenchymal stem cells as an off-the-shelf ‘unlimited’ therapeutic agent: results from the Acute Myocardial Infarction First-in-Man Study

“…Several lines of evidence suggest that, in AMI, conventional pharmacological and mechanical therapies may have already reached the ceiling of efficacy (or are very close to such) in their capacity to limit myocardial injury and reduce the infarct size [ 25 ]. The concept of myocardial injury reversal (as the next step to follow maximized limitation as explored and implemented over the last three decades) by stimulating myocardial regeneration is gradually gaining evidence of feasibility in the experimental and clinical setting, and cellular therapies are a pillar of this concept [ 3 ].…”