Clinical Outcomes following Large Vessel Coronary Artery Perforation Treated with Covered Stent Implantation: Comparison between Polytetrafluoroethylene- and Polyurethane-Covered Stents (CRACK-II Registry)

Abstract

Data on the clinical outcomes comparing synthetic fluorocarbon polymer polytetrafluoroethylene- (PTFE, GraftMaster) and polyurethane- (Papyrus) covered stents (CSs) to seal coronary artery perforations (CAPs) are limited. We aimed to evaluate 30-day and 1-year clinical outcomes after PCI complicated by CAP and treated with CS. We assessed 106 consecutive patients with successful CAP sealing (122 CSs): GraftMaster (51 patients, 57 CSs) or Papyrus CS (55 patients, 65 CSs). The primary endpoint was the occurrence of major adverse cardiac events (MACE), defined as the composite of cardiac death, target lesion revascularisation (TLR), and myocardial infarction (MI). The mean age of subjects was 69 ± 9.6 years (53.8% males). No significant differences were identified between the GraftMaster and Papyrus groups at the 30-day follow-up for MACE, cardiac death, MI and stent thrombosis (ST), while significantly lower rate of TLR and TVR (p = 0.02) were confirmed in the Papyrus group. At one year, differences remained similar between stents for MACE, a trend towards a lower rate of TLR (p = 0.07), MI (p = 0.08), and ST (p = 0.08), and higher for cardiac death (p = 0.07) was observed in the Papyrus group. This real-life registry of CAP illustrated that the use of Papyrus CS is associated with lower rates of TLR and TVR at 30-day follow-up in comparison to the GraftMaster CSs and no significant differences between both assessed CS at one year of follow-up.

Mid-Term Outcomes of Novel Covered Stent with Biodegradable Membrane in Porcine Coronary Artery Perforation

“…The new generation single layer PTFE-coated covered stent had also been reported 18% long-term incidence of target lesion revascularization (TLR) and without any cases of stent thrombosis in only 42.6% (n = 61) available angiographic follow-up [ 18 ]. As for PK Papyrus covered stent, the late-term outcomes seemed to be inconsistent when compared to PTFE-coated covered stent [ 23 , 27 ]. TLR in long-term follow-up were reported in prior studies, with a 16% TLR and 8% definite stent thrombosis in the SOS PK Papyrus Registry (n = 127), a 3.8% TLR with no stent thrombosis in the Spain Papyrus Registry (n = 52) and a 9.3% TLR and 4.4% stent thrombosis in the Swedish SCAAR Registry (n = 265) [ 13 , 19 , 20 ].…”

“…The underlying pathogenesis of ISR in our new covered stent was inconsistent with other commercial covered stent. The construction of commercial covered stents with nondegradable membrane predisposed to increase inhomogeneous neointimal hyperplasia in the edge location and time course [ 23 , 27 ]. In the case reported by Araki et al .…”

A case report of left main perforation treated with BeGraft covered stent

“…The rate of major adverse events decreased with the latest generations of CSs, which are thinner and contain only one layer of metal (recent data show a target lesion revascularization rate of 5–18%, all cause death 8–20% at 1 year). 1–3 It is plausible that the larger final lumen in our LM case restored laminar flow and limited the risk of neoproliferation. Short CSs are important in bifurcations, especially in LM perforations.…”

Covered Stent Herniation into Coronary Aneurysm Sac—A Case-Inspired Review of Neurointerventional Realignment Techniques

“…Covered stent registries and retrospective studies reported high thrombosis rates in the short-and long-term observation, ranging from 4.4-8.9% in the 1-year period to 17.8% in the 10-year follow-up [8,11]. Some of them suggested that the risk may be higher for old polytetrafluoroethylene-covered stents than for newer polyurethane-covered prostheses (9.8% vs. 1.8%, respectively); however, these results may have also been affected by the usually prolonged dual antiplatelet therapy recommended with contemporary covered stents and more potent agents prescribed nowadays [12].…”