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BVS STEMI STRATEGY-IT: 1-Year Results Following a Pre-Specified Absorb Implantation Strategy in ST-Segment Elevation Myocardial Infarction

Authors:
*Alfonso Ielasi, Florinda Maiorana, Maurizio Tespili
Disclosure:

The authors have declared no conflicts of interest.

Citation
EMJ Int Cardiol. ;6[1]:42-44. Abstract Review No. AR1.

Each article is made available under the terms of the .

ST-segment elevation myocardial infarction (STEMI) can represent a suitable scenario for the use of bioresorbable vascular scaffold technologies because of the specific characteristics of STEMI patients (e.g., young age) and lesions (usually soft plaque with a necrotic core). Data from initial clinical experiences with a polymeric everolimus-eluting bioresorbable stent (BRS) (Absorb BVS®, Abbott Vascular, Chicago, Illinois, USA) in STEMI raised concerns among clinicians about the device safety because a noteworthy scaffold thrombosis (ScT) rate was reported at early, mid, and long-term (up to 3 years) follow-up after primary percutaneous coronary intervention (pPCI).1-3 Technical issues specifically related to the structural Absorb BRS features (e.g., thick polymeric struts and maximal post-expansion scaffold limits), as well as aspects related to the resorption process were advocated as probable causes for the BRS-related events reported. Nevertheless, prespecified technical suggestions of how to perform an optimal Absorb procedure in STEMI patients were lacking in each of the studies performed to date. Results from a multicentre, Italian, prospective evaluation of a standardised Absorb implantation strategy in 505 STEMI patients (17% of the overall population screened during the study period) suggested that the procedure was both feasible and associated with lower 30-day device-oriented composite endpoint (DOCE) and ScT rates compared to previous studies on the same topic.4,5 Although Absorb is no longer available on the market, further follow-up data are needed to understand the role of a specific BRS strategy (i.e., patient or lesion selection, implantation technique, and dual antiplatelet therapy regimen) in preventing BRS-related adverse events.

On this basis, the authors sought to assess the 1-year follow-up results following a prespecified Absorb implantation strategy in STEMI patients undergoing pPCI (Figure 1). According to the study protocol, direct Absorb implantation was feasible in 47 (9.3%) patients, while post-dilatation was performed in 468 (92.7%) cases, of whom 60.0% with an oversized (maximum diameter +0.5 mm compared to the Absorb nominal diameter implanted) non-compliant balloon. The hierarchical DOCE rate at 1-year follow-up was 1.2% (0.4% cardiac death, 0.4% target-vessel myocardial infarction, and 0.8% ischaemia-driven target lesion revascularisation) versus 0.6% at 30-day follow-up. Two episodes (0.4% of patients) of ScT (one probable subacute and one late definite) were reported. At 1-year follow-up, 99.2% of patients were on dual antiplatelet therapy (95% with ticagrelor or prasugrel). The limitations of this study include the observational nature, the lack of a direct comparison versus a current-generation drug-eluting stent, the short follow-up period, and the relatively selected STEMI cohort that precludes the generalisation of the outcomes reported in an all-comers STEMI population; however, the authors concluded that the prespecified Absorb implantation strategy in STEMI patients was associated with consistent low DOCE and ScT rates at 1-year follow-up. Longer term follow-up (3 and 5-year) is needed to assess the role of this strategy in preventing very late adverse events.6

Figure 1: The proposed management of a ST-segment elevation myocardial infarction patient undergoing primary percutaneous coronary intervention with Absorb implantation.
BVS: bioresorbable vascular scaffold; NC: non-compliant; QCA: quantitative coronary angiography; TIMI: thrombolysis in myocardial infarction.
Adapted from Ielasi et al.4

References
Brugaletta S et al. Absorb bioresorbable vascular scaffold versus everolimus-eluting metallic stent in ST-segment elevation myocardial infarction: 1-year results of a propensity score matching comparison: The BVS-EXAMINATION Study (bioresorbable vascular scaffold-a clinical evaluation of everolimus eluting coronary stents in the treatment of patients with ST-segment elevation myocardial infarction). JACC Cardiovasc Interv. 2015; 8(1 Pt B):189-97. Fam JM et al. Initial experience with everolimus-eluting bioresorbable vascular scaffolds for treatment of patients presenting with acute myocardial infarction: A propensity-matched comparison to metallic drug eluting stents 18-month follow-up of the BVS STEMI first study. EuroIntervention. 2016;12(1):30-7. Moscarella E et al. Clinical findings after bioresorbable vascular scaffold implantation in an unrestricted cohort of patients with ST-segment elevation myocardial infarction (from the RAI registry). Int J Cardiol. 2018;258:50-4. Ielasi A et al. A prospective evaluation of a standardized strategy for the use of a polymeric everolimus-eluting bioresorbable scaffold in ST-segment elevation myocardial infarction: Rationale and design of the BVS STEMI STRATEGY-IT study. Catheter Cardiovasc Interv. 2017;89(7):1129-38. Ielasi A et al. A prospective evaluation of a pre-specified absorb BVS implantation strategy in ST-segment elevation myocardial infarction: The BVS STEMI STRATEGY-IT study. JACC Cardiovasc Interv. 2017;10(18):1855-64. Azienda Ospedaliera Bolognini di Seriate Bergamo. Use of BVS in ST-segment Elevation Myocardial Infarction (STEMI): The BVS STEMI STRATEGY-IT Prospective Registry (STRATEGY-IT). NCT02601781. https://clinicaltrials.gov/ct2/show/NCT02601781.
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