Author + information
- Maciej Lesiak1,
- Magdalena Lanocha2,
- Aleksander Araszkiewicz1,
- Andrzej Siniawski3,
- Przemyslaw Mitkowski4,
- Marek Grygier5,
- Wlodzimierz Skorupski6,
- Malgorzata Pyda7,
- Marta Kaluzna-Oleksy8,
- Stanislaw Jankiewicz1,
- Michal Lesiak5,
- Sylwia Iwanczyk5,
- Magdalena Dudek1 and
- Stefan Grajek9
- 1Department of Cardiology, Poznan University of Medical Sciences, Poznan, Poland
- 2Poznań University of Medical Sciences, Poznan, Poland
- 3Ist Cardiology Clinic in Poznan, Poland, Poznan, Poland
- 4University Hospital of Lord's Transfiguration, Poznań, Poland
- 5Poznan University of Medical Sciences, Poznan, Poland
- 6University of Medical Sciences Poznan Poland, Poznan, Poland
- 7Poznan University of Medical Sciences, Poznan, Poland
- 81st Department of Cardiology Poznan University, Poznan, Poland
- 9Medical University, Poznan, Poland
The data concerning the use of bioresorbable vascular scaffolds(BVS) in coronary bifurcation lesions (CBL) are limited. Given the complexity of the procedure and the potential risk of side branch (SB) complications or occlusion after BVS implantation it is imperative to evaluate the efficacy and long-term safety of BVS in such lesions.
A prospective, nonrandomized clinical registry of patients with CBL treated with everolimus-eluting BVS. Consecutive patients, with stable coronary artery disease were enrolled between 2012-2015. Bifurcation lesions were classified according to European Bifurcation Club definition and Medina classification. The main clinical study end point was a device-oriented target lesion failure (TLF).
150 consecutive patients (male 78%, age 60,9 ± 9,4) were included. True bifurcation was in 57 patients (38%). 45 bifurcation (30%) involved into CTO lesions and 15 (10%) comprised the left main coronary artery. Mean syntax Score was 12,6±7,0. OCT-guided procedure were in 48(32%) cases. Baseline QCA assessment (Medis Suite XA):proximal and distal main vessel (MV) reference diameters were 3.32±0.31 mm and 2.71± 0.48 mm respectively, the MV stenosis was 68,4 ± 27.8%. The mean SB reference diameter was 2.36 ± 0.44 mm, SB diameter stenosis 41.6 ± 25,6%. A total of 201 BVS were implanted. Provisional T stenting was performed in 120 patients (80%), distal MV stenting in 7 (4,7%), systematic T stenting in 7 (10%), and T with minimal protrusion (TAP) in 3 patients (2%). SB ostial stenting was performed in additional 13 patients (8,7%). The procedural success was achieved in 100%. Control angiography and OCT were performed in 100 patients (66,6%) at a median time 18months (from 1 to 48 months) and 7 (4,7%) cases of restenosis were diagnosed (TLR=4,7%): 5x of SB occlusions and 2x restenosis after CTO recanalization. At the clinical follow up the rate of cardiac death was 2%(3 patients). The cumulative incidence of definite/probable scaffold thrombosis was 2% (3 patients).
Stenting of coronary bifurcation lesions with bioresorbable everolimus-eluting scaffolds is feasible with excellent acute performance and satisfactory early and long-term clinical outcomes.
CORONARY: Bioresorbable Vascular Scaffolds