DynamX Bioadaptor, a novel "uncaging" platform for coronary artery revascularization: final 36-month clinical results

BACKGROUND Compared with bare-metal stents, drug-eluting stents (DES) reduce major adverse cardiac events (MACE) in the first year after percutaneous coronary intervention (PCI) but still have an ongoing 2% to 3% annual event rate reaching 20% at 5 years and 40% to 50% at 10 years. The DynamX Novolimus-Eluting Coronary Bio adaptor System is a 71-mm, cobalt-chromium platform with a novel "uncaging" mechanism of circumferential rings that maintains the axial links between the rings following uncaging. Conventional metallic DES "cage" the coronary artery, inhibiting positive adaptive remodeling and vasomotion and causing geometric distortion. These factors likely contribute to the persistent annual MACE rate after PCI. The DynamX Bioadaptor combines the acute performance of contemporary DES and unique benefits of arterial "uncaging" beyond 6 months, allowing positive adaptive remodeling, restoring compli ance, and allowing treated vessels to return toward native vessel geometry. METHODS In this study the DynamX Bioadaptor was available in di ameters of 2.5 to 3.5 mm and lengths of 14 to 28 mm. This mechanistic clinical study enrolled 50 patients (mean age 66.3 8.8 years) at 5 centers in Belgium and Italy. Multiple endpoints including target lesion failure were assessed, with clinical follow-up through 3 years. Multimodality imaging endpoint analyses using quantitative coronary angiography, intravascular ultrasound, and optical coherence to mography were performed at baseline and at 9 or 12 months in separate subgroups. RESULTS Mean area changes for Bioadaptor, reference vessel and lumen as well as percentage neointimal volume and neointimal thickness observed at 9 and 12 months demonstrate Bioadaptor per formance and ability to preserve positive adaptive remodeling. Through 24 months, target lesion failure events were observed in 4.3% of patients, which is in line with contemporary DES clinical outcomes. Detailed imaging and final clinical data through 36 months will be presented. CONCLUSION The DynamX Bioadaptor demonstrated performance attributes of contemporary metallic DES with the unique capacity to restore positive adaptive remodeling through vessel "uncaging." Final clinical data through 36 months demonstrate longer term safety and efficacy.

Randomized comparison of primary stenting and provisional balloon angioplasty guided by flow velocity measurement

Background—Coronary stenting improves outcomes compared with balloon angioplasty, but it is costly and may haveother disadvantages. Limiting stent use to patients with a suboptimal result after angioplasty (provisional angioplasty) may be as effective and less expensive.Methods and Results—To analyze the cost-effectiveness of provisional angioplasty, patients scheduled for single-vessel angioplasty were first randomized to receive primary stenting (97 patients) or balloon angioplasty guided by Doppler flow velocity and angiography (523 patients). Patients in the latter group were further randomized after optimization to either additional stenting or termination of the procedure to further investigate what is “optimal.” An optimal result wasdefined as a flow reserve 2.5 and a diameter tenosis 36%. Bailout stenting was needed in 129 patients (25%) who were randomized to balloon angioplasty, and an optimal result was obtained in 184 of the 523 patients (35%). There was no significant difference in event-free survival at 1 year between primary stenting (86.6%) and provisional angioplasty (85.6%). Costs after 1 year were significantly higher for provisional angioplasty (EUR 6573 versus EUR 5885; (P50.014). Results after the second randomization showed that stenting was also more effective after optimal balloon angioplasty (1-year event free survival, 93.5% versus 84.1%; P50.066). Conclusions—After 1 year of follow-up, provisional angioplasty was more expensive and without clinical benefit. The beneficial value of stenting is not limited to patients with a suboptimal result after balloon angioplasty.