A patient-level analysis drawn from three randomized, controlled trials finds no evidence that direct stenting improved myocardial reperfusion or clinical outcomes in ST-segment elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention.
Patients who underwent thrombus aspiration were more likely to receive direct stenting than conventional stenting, but there was no interaction between thrombus aspiration and outcomes, Karim D. Mahmoud, MD, reported in the European Heart Journal.
Direct stenting – stent implantation without balloon predilatation – has been widely adopted in an effort to improve PCI outcomes in STEMI patients, though no formal guidelines call for it. Small trials have suggested a benefit, but no large, definitive trials have been conducted.
Three previous trials have looked at thrombus aspiration in STEMI patients: TAPAS (the Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Myocardial Infarction Study) found that routine manual thrombus aspiration led to better myocardial reperfusion and lower 1-year cardiac mortality (N Engl J Med. 2008 Feb 7;358:557-67). Two larger trials – TASTE (Thrombus Aspiration in ST Elevation Myocardial Infarction in Scandinavia; N Engl J Med. 2013 Oct 24;369:1587-97) and TOTAL (Trial of Routine Aspiration Thrombectomy with PCI vs. PCI Alone in Patients with STEMI; N Engl J Med. 2015 Apr 9;372:1389-98) – both failed to show any benefit of routine thrombus aspiration. As a result, international guidelines recommended use of thrombus aspiration only in selected patients.
The TASTE and TOTAL trials suggested that thrombus aspiration may have led to higher rates of direct stenting, but those rates were lower in TAPAS. Some have suggested that a synergistic effect between thrombus aspiration and DS could explain the positive finding in TAPAS, compared with negative findings in TASTE and TOTAL, said Dr. Mahmoud of Erasmus Medical Center, Rotterdam, the Netherlands.
The researchers tested this idea by pooling patient-level data from the more than 17,000 participants in the three studies, 32% of whom underwent direct stenting. Patients who were randomized to undergo thrombus aspiration were nearly twice as likely to undergo direct stenting (41% vs. 22%, P less than .001). When the researchers 1:1 propensity matched direct stenting versus conventional stenting, 30-day cardiovascular death rates were similar between direct (1.7%) and conventional stenting (1.9%), and there was no interaction between direct stenting and thrombus aspiration. The latter result suggested that there is no synergistic effect. Similar results were found at 1-year follow-up, and with respect to 30-day stroke or transient ischemic attack.
One of the study authors received funding and or honoraria from Bayer, Medtronic, Vascular Solutions, Terumo, Boston Scientific, Abbott Vascular, AstraZeneca, and the Medicines Company.
SOURCE: Mahmoud KD et al. Eur Heart J. 2018;39:2472-9.