Author + information
- Received June 11, 2017
- Revision received July 10, 2017
- Accepted July 19, 2017
- Published online September 18, 2017.
- Alfonso Ielasi, MDa,∗ (, )
- Gianluca Campo, MD, PhDb,
- Claudio Rapetto, MDc,
- Attilio Varricchio, MD, PhDd,
- Bernardo Cortese, MDe,
- Salvatore Brugaletta, MD, PhDf,
- Salvatore Geraci, MDg,
- Paolo Vicinelli, MDh,
- Fortunato Scotto di Uccio, MDi,
- Gioel Gabrio Secco, MDj,
- Arnaldo Poli, MDk,
- Elisa Nicolini, MDl,
- Kohki Ishida, MDf,
- Azeem Latib, MDm,n and
- Maurizio Tespili, MDa
- aCardiology Division, ASST Bergamo Est, Bolognini Hospital Seriate, Seriate, Italy
- bCardiovascular Section, Medical Sciences Department, Azienda Ospedaliera Universitaria S. Anna, Ferrara, Italy
- cCardiology Division, Sanremo Hospital, Sanremo, Italy
- dCardiology Division, Santa Maria Della Pietà Hospital, Nola, Italy
- eCardiac Department, ASST Fatebenefratelli/Sacco, Fatebenefratelli Hospital, Milan, Italy
- fCardiology Department, Thorax Institute, IDIBAPS, University of Barcelona, Hospital Clinic, Barcelona, Spain
- gCardiology Division San Giovanni di Dio Hospital, Agrigento, Italy
- hCardiology Division, ASST Milanese Ovest, Fornaroli Hospital, Magenta, Italy
- iCardiology Division, Santa Maria Loreto Mare Hospital, Naples, Italy
- jCardiology Division, Santi Antonio, Biagio e Cesare Arrigo Hospital, Alessandria, Italy
- kCardiology Division, ASST Milanese Ovest, Legnano Hospital, Legnano, Italy
- lInterventional Cardiology Unit, Riuniti Hospital, Ancona, Italy
- mInterventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy
- nInterventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy
- ↵∗Address for correspondence:
Dr. Alfonso Ielasi, Cardiology Department, Azienda Socio Sanitaria Territoriale Bergamo Est, Bolognini Hospital Seriate, Via Paderno 21, 24068 Seriate (BG), Italy.
Objectives The aim of this study was to assess the feasibility and clinical results following a pre-specified bioresorbable scaffold (Absorb BVS) implantation strategy in patients with ST-segment elevation myocardial infarction (STEMI).
Background Concerns were raised about the safety of Absorb because a non-negligible rate of thrombosis was reported within 30 days and at midterm follow-up after primary percutaneous coronary intervention.
Methods This was a prospective, multicenter study of patients with STEMI (<75 years of age with symptom onset <12 h) undergoing primary percutaneous coronary intervention with Absorb following a dedicated implantation protocol. The primary endpoint was a device-oriented composite endpoint of cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization within 30 days.
Results During the study period, 505 patients with STEMI (16.9% of the overall STEMI population) were treated with the Absorb BVS. The mean age was 56.6 ± 9.4 years, and 487 patients (96.4%) were in Killip class I or II at admission. According to the study protocol, direct Absorb implantation was feasible in 47 patients (9.3%), whereas post-dilatation was performed in 468 cases (92.7%). Procedural success was attained in 94.8% of the cases. Dual antiplatelet therapy with ticagrelor or prasugrel was administered at discharge in 481 patients (95.1%). At 30-day follow-up, the hierarchical device-oriented composite endpoint rate was 0.6% (0.4% cardiac death, 0.2% target vessel myocardial infarction and ischemia-driven target lesion revascularization). One episode (0.2%) of probable scaffold thrombosis was reported.
Conclusions A pre-specified Absorb implantation strategy in real-world patients with STEMI undergoing primary percutaneous coronary intervention was feasible and associated with a low 30-day device-oriented composite endpoint rate. Mid- and long-term follow-up is strongly needed to eventually confirm these early results. (Use of BVS in ST-Segment Elevation Myocardial Infarction [STEMI]: The BVS STEMI STRATEGY-IT Prospective Registry [STRATEGY-IT]; NCT02601781)
This work was supported by a research grant from Abbott Vascular. The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received June 11, 2017.
- Revision received July 10, 2017.
- Accepted July 19, 2017.
- 2017 American College of Cardiology Foundation