This study sought to evaluate the short-term and 3-year outcomes of polytetrafluoroethylene-covered stent (PCS) for patients with coronary perforation. Implantation of a PCS has improved the immediate clinical outcomes of patients with coronary perforation. However, there are few reports regarding long-term outcomes. We evaluated a total of 57 patients who were treated with PCS for coronary perforation from April 2004 to March 2015 at a single high-volume center in Japan. Landmark analysis was performed at 30 days to determine short-term and long-term outcomes. Major adverse cardiac events (MACE) were defined as death, myocardial infarction, target vessel revascularization, and requirement for surgical repair. Of 285 patients who experienced coronary perforation, 57 patients (20%) were treated with PCS. The MACE rates were 28% at 30 days, 22% at 1 year, and 38% at 3 years. 30-day MACE was mainly driven by high rates of myocardial infarction (18%) and surgical repair (16%). The rates of target lesion revascularization were 8% and 12% at 1 and 3 years, respectively. Definite stent thrombosis was reported in 2 patients during the follow-up period. In conclusion, despite the relatively high incidence of MACE during early stage of follow-up, implantation of a PCS provides acceptable late clinical outcomes.
Coronary perforation is a rare complication of percutaneous coronary intervention (PCI) and ranges from 0.1% to 3.0%. When it does occur it presents a potentially critical complication associated with high mortality rates ranging from 7% to 44%, high rates of cardiac tamponade that reach approximately 40%, and may also require emergency surgical repair or coronary artery bypass grafting (CABG) in 37% to 63%. Treatment with a covered stent is an option when bleeding is difficult to stop using prolonged balloon inflation or when the patient is intolerant to this procedure. Currently, there are many different covered stents commercially available. Autologous vein-covered stents have the huge benefit of low thrombogenicity. However, a long time is required to harvest veins and manufacture the stent. In addition, the operator should have expertise in assembling the stent. In cases of uncontrollable coronary perforation, we predominantly use the polytetrafluoroethylene (PTFE)-covered stent (PCS), which is composed of a PTFE membrane sandwiched between 2 metallic stents. PCS have been associated with high restenosis and thrombosis rates ; however, they remain an essential device in managing coronary perforation. PCS use in diseased saphenous vein grafts has been shown to result in inferior outcomes compared with bare-metal stents and there also remain long-term safety and clinical outcome concerns in patients treated with PCS for coronary perforation in native coronary arteries. The aim of this study was to evaluate the efficacy of PCS for coronary perforation and to determine the long-term outcomes after PCS implantation.
Methods
We analyzed data that had been retrospectively collected at the New Tokyo Hospital in Japan from January 2004 to March 2015. Of 21,923 patients who underwent PCI, 285 patients (1.3%) experienced coronary perforation. We identified 57 patients treated with PTFE-covered JOSTENT GraftMaster or GRAFTMASTER stent (Abbott Vascular, Santa Clara, California) in native coronary arteries.
Two of the investigators retrospectively analyzed all angiograms and classified coronary perforation according to the Ellis classification. Cardiac tamponade was defined as the presence of a pericardial fluid collection by echocardiography in addition to clinical features of tamponade including hypotension. Patients who required pericardiocentesis were also included. Death was considered cardiac in origin unless obvious noncardiac causes were identified. Myocardial infarction (MI) was defined either as the development of new Q waves or as an increase of creatine kinase-MB level >5 times the upper reference limit. Periprocedural MI was classified as MI occurring within 48 hours of PCI. Target lesion revascularization (TLR) was defined as repeat PCI or CABG during follow-up period for the lesion in the previously stented segment or in the adjacent 5 mm. Target vessel revascularization (TVR) was defined as PCI or CABG of the target lesion or any segment of the epicardial coronary artery containing the target lesion. Major adverse cardiac events (MACE) included all-cause death, MI (including periprocedural MI), TVR, and surgical repair (including additional CABG). Stent thrombosis (ST) was defined according to the Academic Research Consortium definitions.
Clinical data were collected from hospital visits or telephone consultations. The antiplatelet regimens were low-dose aspirin 100 mg od, which was recommended to be taken indefinitely, and a thienopyridine (200 to 250 mg of ticlopidine bid or 75 mg of clopidogrel daily) for a minimum of 12 months after PCI. Prasugrel, ticagrelor, or glycoprotein IIb/IIIa inhibitors were not used in any patient. During PCI, activated clotting time was controlled by unfractionated heparin. The end points of the study were defined as MACE at short-term (30 days), and long-term (3 years) follow-ups. Furthermore, we evaluated the events rate of TLR, ST, and each component of MACE.
All continuous valuables were evaluated with the Kolmogorov–Smirnov test. Continuous variables are presented as the mean ± SD or the median ± interquartile range (25th to 75th percentile) for Gaussian and non-Gaussian distributed variables, respectively. Continuous variables between groups were compared between groups using an independent Student t test or Mann–Whitney U test for parametric and nonparametric variables, respectively. Categorical variables are presented as numeric values and percentages. Categorical data were compared using the chi-square or Fisher’s exact tests as appropriate. The event rates were generated using landmark analyses at 30 days to determine the short-term and late outcomes. All reported p values are 2-sided and values of p <0.05 were regarded as statistically significant. Analyses were performed using SPSS for Windows, version 20.0 (SPSS Inc., Chicago, Illinois).
Results
Fifty-seven patients treated with PCS for coronary perforation were included in the final analysis. The deployment of 72 PCS was attempted in 57 patients; however, 3 PCS could not be delivered to the target lesions resulting in a delivery success rate of 96%. Three PCS that could not be delivered: 2 could not be delivered to the desired site because of extreme vessel tortuosity and lesion calcification. In the other case, the covered stent was dislodged proximal to the perforation site. Multiple PCS implantation to definitively treat coronary perforation was required in 14 patients. The median follow-up period for patients treated with PCS was 2.52 (interquartile range 0.73 to 5.49) years.
The baseline demographic and clinical characteristics of patients are provided in Table 1 . Of note, the prevalence of chronic kidney disease was high (estimated glomerular filtration rate <60 ml/min/1.73 m 2 ; 53%, and patients under hemodialysis; 9%). Five patients (9%) presented with acute coronary syndrome, and 2 patients (4%) with poor ejection fraction (<35%). With regards to lesion and procedure characteristics ( Table 2 ), most of the patients with coronary perforation who required PCS implantation had American College of Cardiology/American Heart Association type B2/C lesions (91%), and 44% of perforations occurred in the context of chronic total occlusion lesions. Coronary perforations that required PCS implantation were mostly caused by stent injury (37%), followed by balloon injury (predilatation 18%, and postdilatation 19%). Ten lesions (17.5%) required PCS implantation for coronary wire perforation, in which hemostasis was not obtained after prolonged balloon inflation or coil or fat embolization. Twenty-five patients (44%) experienced Ellis grade II coronary perforations and 24 patients (42%) experienced Ellis grade III perforations ( Table 2 ). At the same procedure, drug-eluting stents were implanted to treat the perforated vessel in 36 patients (63%), and bare-metal stents in 14 patients (25%). Mean stent diameter and total stent length except for PCS was 3.02 ± 0.37 and 53.9 ± 28.8 mm, respectively.
| Variables | Patients (n=57) |
|---|---|
| Age (years) | 74.0 ± 8.9 |
| Male | 38 (67%) |
| Hypertension | 50 (88%) |
| Dyslipidemia | 44 (77%) |
| Diabetes mellitus | 19 (33%) |
| Insulin-dependent diabetes mellitus | 1 (2%) |
| Current smoking | 12 (21%) |
| Estimated glomerular filtration rate (ml/min/1.73 m 2 ) | 56.8 ± 24.5 |
| Chronic kidney disease (Estimated glomerular filtration rate <60 ml/min/1.73 m 2 ) | 30 (53%) |
| Hemodialysis | 5 (9%) |
| Previous myocardial infarction | 20 (35%) |
| Previous percutaneous coronary intervention | 32 (56%) |
| Previous coronary artery bypass grafting | 4 (7%) |
| Previous stroke | 4 (7%) |
| Acute coronary syndrome | 5 (9%) |
| Ejection fraction (%) | 57.0 ± 9.1 |
| Ejection fraction < 35% | 2 (4%) |
| Variables | n=57 |
|---|---|
| Lesion complexity (American College of Cardiology/American Heart Association classification) | |
| Type A | 3 (5%) |
| Type B1 | 2 (4%) |
| Type B2 | 8 (14%) |
| Type C | 44 (77%) |
| Chronic total occlusion | 25 (44%) |
| Coronary artery | |
| Left main coronary artery | 3 (5%) |
| Left anterior descending artery | 28 (49%) |
| Left circumflex artery | 8 (14%) |
| Right coronary artery | 18 (32%) |
| Device causing perforation | |
| Wire | 10 (18%) |
| Rotational atherectomy | 5 (9%) |
| Pre-dilation | 10 (18%) |
| Stent | 21 (37%) |
| Post-dilation | 11 (19%) |
| Perforation grade (Ellis grade) | |
| Type I | 7 (12%) |
| Type II | 25 (44%) |
| Type III | 24 (42%) |
| Cavity spilling | 1 (2%) |
| Procedure details and outcomes | |
| Delivery success | 69/72 (96%) |
| Hemostasis success | 50 (88%) |
| Number of polytetrafluoroethylene-covered stents implanted | 1.3 ± 0.5 |
| Polytetrafluoroethylene-covered stent diameter (mm) | 3.10 ± 0.26 |
| Polytetrafluoroethylene-covered stent length (mm) | 18.3 ± 7.5 |
| Post-dilation | 50 (88%) |
| Intravascular ultrasound or optical coherence tomography use | 9 (16%) |
| Cardiac tamponade | 16 (28%) |
| Intra-aortic balloon pump | 10 (18%) |
| Emergent surgical repair | 9 (16%) |
Of the 57 patients who received PCS, 50 patients (88%) had successful definitive treatment after PCS implantation for coronary perforation ( Table 2 ). Nine patients (16%) required subsequent surgical repair. This was performed in 7 patients because of continued coronary bleeding despite PCS implantation (n = 7), and in the remaining 2 patients despite a good angiographic result there were continuing doubts with regards to whether hemostasis was completely achieved. Surgical procedure was carried out as emergency procedures as soon as patients were optimally stabilized (e.g., after pericardiocentesis or placement of intraaortic balloon pump). Grafting of the perforated coronary artery was performed in 5 of 9 patients with adjunctive treatment at the surgeon’s discretion. The incidence of cardiac tamponade requiring pericardiocentesis was 28% (16 patients).
The cumulative MACE rate at 30 days was 28% (16 patients). Four patients died while in the hospital, representing 7% of patients treated with PCS. Of these, 2 patients died of disseminated vascular coagulation or multiple organ failure related to coronary perforation. One patient required surgical repair and died of postoperative pneumonia, and the remaining patients with acute coronary syndrome died from upper gastrointestinal bleeding during the perioperative period of gastrointestinal surgery.
Landmark analysis showed that the cumulative incidence of MACE was 16% at 6 months, 22% at 1 year, and 38% at 3 years ( Table 3 ). As provided in Table 3 and Figure 1 , most of the late events were affected by a high TVR rate (17% at 1 year and 26% at 3 years). In contrast, the cumulative incidence of TLR was much lower (8% at 1 year and 12% at 3 years) than that of TVR. Definite ST occurred in 2 patients who both continued dual-antiplatelet therapy (DAPT). One ST occurred at 5 months after PCS implantation and was treated by primary PCI. The other ST occurred at 13 months after PCS and resulted in cardiac death. The incidence of ST was 2% at 1 year and 5% at 3 years.
| Clinical event rates | |||||
|---|---|---|---|---|---|
| At 30-days | At 6-months | At 1-year | At 2-years | At 3-years | |
| Major adverse cardiac events | 16 (28%) | 8 (16%) | 11 (22%) | 15 (32%) | 17 (38%) |
| All-cause death | 4 (7%) | 3 (6%) | 3 (6%) | 5 (11%) | 7 (17%) |
| Cardiac death | 1 (2%) | 2 (4%) | 2 (4%) | 4 (9%) | 6 (15%) |
| Myocardial infarction | 10 (18%) | 1 (2%) | 1 (2%) | 2 (5%) | 2 (5%) |
| Target lesion revascularization | 1 (2%) | 4 (8%) | 4 (8%) | 4 (8%) | 5 (12%) |
| Target vessel revascularization | 1 (2%) | 5 (11%) | 8 (17%) | 10 (22%) | 11 (26%) |
| Surgical repair | 9 (16%) | 0 | 0 | 0 | 0 |
| Stent thrombosis (definite or probable) | 0 | 1 (2%) | 1 (2%) | 2 (5%) | 2 (5%) |
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