Dr. Francesco Burzotta,
Dr. Carlo Trani,
An early invasive strategy of coronary angiography and subsequent urgent percutaneous coronary intervention (PCI) has been shown to improve the clinical outcome of patients with ST-elevation acute myocardial infarction (STEMI). Despite the relevant advancements made in the field of the adjuvant medical therapy and the PCI technique, a sizeable proportion of STEMI patients does not receive adequate myocardial reperfusion (1). Embolization of thrombotic material is likely to play a key role in the pathogenesis of myocardial no-reflow (1) so that interventional techniques able to reduce thrombus burden by mechanically removing it from infarct related artery, i.e. “thrombectomy”, have been developed and tested. After a decade of (small) randomized trials providing conflicting results, the simpler thrombectomy technique (“manual thrombus-aspiration”) entered the clinical guidelines. This was mainly prompted by an overall positive impact on myocardial reperfusion and late clinical outcome observed in the largest available, “TAPAS”, trial (2 ) and in a patient-level, ATTEMPT, meta-analysis (3). Recently, the results of a large, multicentre, trial called “TASTE” have been published and bursted novel questions regarding the clinical impact of thrombectomy in STEMI patients (4). The TASTE investigators ideated a unique trial design which was intended to allow a large scale randomization of the majority of the STEMI patients undergoing primary PCI in Sweden (5). The study’s aim was to assess if thrombus-aspiration reduces 30-day mortality in STEMI patients and the observed results were negative: all-cause death occurred in 2.8% of patients randomized to thrombus-aspiration vs 3.0% in controls. Do the results of this 7,224-patients trial close the doors for thrombectomy in STEMI? Honestly, I have to call for heedful interpretations. The original study design of the TASTE trial has never been tested before and failed to solve the problem of selection bias in large clinical trials. This is clearly documented by 40% rate of STEMI patients excluded from randomization and by the 3.5-fold higher 30-day mortality rate observed in excluded patients (10.6%; vs 2.9% of randomized patients). The authors should be congratulated for such careful data reporting (since randomization rates and outcomes of excluded patients are often underreported) but these figures should taken in strong consideration. Indeed, despite all the efforts in the study design and conduction, the enrollment of such a “selected” study population composed of low-risk STEMI patients was unanticipated and created a drop in the statistical power of the study. With this concept in mind, can we say that thrombus-aspiration does not provide any advantage in the lower risk subgroup of STEMI patients randomized in the TASTE? Again, a word of caution is deserved. Thrombus-aspiration is expected to improve myocardial reflow and reflow may affect clinical outcome after the first month. This is suggested from previous thrombus-aspiration trials which documented no significant mortality benefit at 30-days but improved survival at later follow-ups (2,3).
Thus, longer follow-up clinical data from the TASTE trial will highly be waited before discarding the hypothesis of thrombus-aspiration benefit in low-risk STEMI patients. Finally, due to the multifactorial etiopathogenesis of no-reflow (1), the possible relevance of an interplay between thrombus-aspiration devices and adjunctive pharmacology (6) cannot be underestimated.
1. Niccoli G, Burzotta F, Galiuto L, Crea F. Coronary no-reflow in humans. J Am Coll Cardiol 2009; 54:281–292.2. Vlaar PJ, Svilaas T, van der Horst IC, Diercks GF, Fokkema ML, de Smet BJ, van den Heuvel AF, Anthonio RL, Jessurun GA, Tan ES, Suurmeijer AJ, Zijlstra F.Cardiac death and reinfarction after 1 year in the Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS): a 1-year follow-up study. Lancet 2008; 371:1915-20.3. Burzotta F, De Vita M, Gu YL, Isshiki T, Lefevre T, Kaltoft A, Dudek D, Sardella G, Orrego PS, Antoniucci D, De Luca L, Biondi-Zoccai GGL, Crea F, Zijlstra F. Clinical impact of thrombectomy in acute ST elevation myocardial infarction: an individual patient-data pooled analysis of 11 trials. Eur Heart J 2009; 30:2193–2203.4. Fröbert O, Lagerqvist B, Olivecrona GK, Omerovic E, Gudnason T, Maeng M, Aasa M, Angerås O, Calais F, Danielewicz M, Erlinge D, Hellsten L, Jensen U, Johansson AC, Kåregren A, Nilsson J, Robertson L, Sandhall L, Sjögren I, Ostlund O, Harnek J, James SK; TASTE Trial. Thrombus aspiration during ST-segment elevation myocardial infarction. N Engl J Med 2013 Oct 24;369:1587-97. 5. Fröbert O, Lagerqvist B, Gudnason T, Thuesen L, Svensson R, Olivecrona GK, James SK. Thrombus Aspiration in ST-Elevation myocardial infarction in Scandinavia (TASTE trial). A multicenter, prospective, randomized, controlled clinical registry trial based on the Swedish angiography and angioplasty registry (SCAAR) platform. Study design and rationale. Am Heart J 2010 Dec;160(6):1042-8.6. Niccoli G, Rigattieri S, De Vita MR, Valgimigli M, Corvo P, Fabbiocchi F, Romagnoli E, De Caterina AR, La Torre G, Lo Schiavo P, Tarantino F, Ferrari R, Tomai F, Olivares P, Cosentino N, D'Amario D, Leone AM, Porto I, Burzotta F, Trani C, Crea F. Open-label, randomized, placebo-controlled evaluation of intracoronary adenosine or nitroprusside after thrombus aspiration during primary percutaneous coronary intervention for the prevention of microvascular obstruction in acute myocardial infarction: the REOPEN-AMI study (Intracoronary Nitroprusside Versus Adenosine in Acute Myocardial Infarction). JACC Cardiovasc Interv. 2013 Jun;6(6):580-9.
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