Author + information
- Richard J. Jabbour, MD,
- Akihito Tanaka, MD,
- Piera Capranzano, MD,
- Bernardo Cortese, MD,
- Maciej Lesiak, MD, PhD,
- Luca Testa, MD, PhD,
- Pamela Gatto, MD,
- José Suarez de Lezo, MD, PhD,
- Alessio Mattesini, MD,
- Salvatore Geraci, MD,
- Alfonso Ielasi, MD,
- Roberto Diletti, MD, PhD,
- Davide Capodanno, MD, PhD,
- Dario Buccheri, MD,
- Sylwia Iwanczyk, MD,
- Francesco Bedogni, MD,
- Didier Tchetche, MD,
- Carlo Di Mario, MD, PhD,
- Giuseppe Caramanno, MD,
- Nicolas M. Van Mieghem, MD, PhD,
- Corrado Tamburino, MD, PhD,
- Antonio Colombo, MD and
- Azeem Latib, MD∗ ()
- ↵∗Interventional Cardiology Unit, San Raffaele Scientific Institute, Via Olgettina 60, 20132 Milan, Italy
Drug-eluting stents (DES) are valid treatment options for left main (LM) disease (1), but the presence of a permanent metallic foreign body provides the continued risk of late adverse events. Bioresorbable vascular scaffolds (BVS) may be an attractive alternative because of their complete resorption properties. To date, several outcomes have been reported; however, data regarding LM treatment with BVS are lacking (2,3). Therefore, we performed a multicenter retrospective evaluation of the mid-term outcomes of BVS implantation for LM disease.
Data were examined from 60 patients (of a total of 2,765 LM percutaneous coronary interventions [PCI]), from an international registry involving 12 centers, who underwent BVS (Absorb, Abbott Vascular, Santa Clara, California) implantation between June 2012 and December 2015. All patients provided informed consent for the procedure and subsequent data collection and analysis.
The decision to implant BVS and PCI strategy was dependent on individual operators. PCI with BVS was only performed in patients with reference diameters <4.0 mm and <0.5 mm difference between the proximal and distal reference diameters. PCI was avoided in patients with a concomitant right coronary artery chronic total occlusion or severe calcification of the LM shaft/bifurcation.
The primary endpoint was target lesion failure defined as a composite of cardiac death, target vessel myocardial infarction, and ischemia driven target lesion revascularization (TLR). Cumulative event rates were analyzed using Kaplan-Meier methods.
The mean age of patients was 55.1 ± 8.8 years and 28.3% (n = 17) had diabetes. The mean SYNTAX score of patients was 20.6 ± 9.9. Seventy percent of patients (n = 42) underwent PCI for stable indications, with the remaining 30% (n = 18) for acute coronary syndromes. Most target lesions were LM bifurcations (n = 46; 76.7%), of which 41.3% (n = 19) were true bifurcations. The remaining 14 (23.3%) cases did not involve the LM bifurcation, and received isolated LM shaft stenting. Of the 46 LM bifurcations lesions, a provisional approach was undertaken in 37 cases and elective 2-stenting in 9 cases. The rate of pre-dilatation and post-dilatation was 93.3% (n = 56) and 96.7% (n = 58), respectively. Post-dilatation of the main branch was performed at high pressures (mean, 18.9 ± 4.1 atm). Intravascular imaging was used in most cases (80%; n = 48).
There were no incidences of periprocedural stroke or death. During BVS deployment, 1 patient (provisional LM–left anterior descending strategy) experienced temporary hemodynamic instability. The median follow-up time was 593 days (interquartile range: 230 to 817 days). The primary endpoint of target lesion failure occurred in 14.9% (n = 7) and 25.0% (n = 10) of patients at 1 and 2 years, respectively (Figure 1). This was primarily caused by ischemia-driven TLR because the overall TLR rate was 13.4% (n = 6) and 23.6% (n = 9) at 1 and 2 years. The cardiac death rate was 1.8% (n = 1) at 2 years and there were no target vessel myocardial infarction or definite/probable ST segment events at 2 years.
The median time to ischemia-driven TLR was 343 days (interquartile range: 216 to 716 days). Associated findings determined by follow-up intravascular imaging from 9 cases included late recoil (n = 3), intrascaffold tissue growth (n = 4), underexpansion (n = 2), discontinuity (n = 2), and malapposition (n = 1).
Several concerns and restrictions exist regarding BVS deployment for LM disease. They include: 1) restricted BVS expansion capability; 2) lower radial strength when compared with DES; 3) increased delivery profile; 4) prolonged inflation times; and 5) left circumflex side branch jailing (4).
Some limitations may be overcome by careful case selection and optimal implantation strategies. More specifically, the operator must ensure that LM diameter must not exceed 4.0 mm with <0.5 mm difference between the proximal and distal reference diameters. Optimal implantation strategies include pre- and post-dilatation to high pressures, and intravascular imaging guidance. Regarding prolonged inflation times, temporary hemodynamic instability occurred in only 1 case without any other periprocedural complications. Finally, side branch strut dilatation is of concern when a large left circumflex artery is the side branch, because of the risk of side branch strut fracture and main branch scaffold distortion with ballooning. Mini-kissing balloon inflations or sequential inflations may minimize risk.
In conclusion, the use of BVS in highly selected patients with LM disease was technically possible; however, the TLR rate was high when compared with trials involving DES. By contrast, there were no definite/probable ST segment or target vessel myocardial infarction events at midterm follow-up. Notably, the number of patients and events in our cohort was small with no control group, so firm conclusions cannot be made. Therefore, the use of BVS in LM disease should remain exploratory and DES remains the preferred platform.
Please note: Dr. Capodanno has received minor consultancies from Abbott Vascular. Dr. Cortese has received lecture fees and consultancies from Abbott Vascular. Dr. Lesiak has received modest individual payments for being on the advisory board and speaker honoraria from Abbott Vascular and AstraZeneca. Dr. Mattesini has received speaker fees from Abbott Vascular. Professor Di Mario has received a research grant to his institution from Abbott Vascular for the EXCEL trial and the British BVS Registry. Dr. Van Mieghem has received advisory fees from Abbott Vascular. Dr. Tamburino has received speaker honoraria from Abbott and Medtronic. Dr. Latib serves on the advisory board for Medtronic; and has received speaking honoraria from Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- 2017 American College of Cardiology Foundation
- Tanaka A.,
- Latib A.,
- Kawamoto H.,
- et al.
- Everaert B.,
- Capranzano P.,
- Tamburino C.,
- et al.