Sealing of Coronary Perforations with a Second Generation Stentgraft – Results from the Multicenter PASTPERF Registry

Background: Coronary artery perforation during percutaneous revascularization is associated with considerable morbidity and mortality. Covered stents provide a physical barrier to seal perforated arteries and prevent associated complications. The PK Papyrus is a second generation device with enhanced mechanical properties yet limited database.

Methods: Patients treated for coronary artery perforation with the PK Papyrus stent in 14 international centers were retrospectively identified. Procedural and follow up outcomes were ascertained. Procedural variables included device delivery, sealing of the perforation, complications related to the covered stent and antithrombotic management.

Results­: Among 95 patients with coronary perforation, Ellis grade III and III-cavity spilling perforations were characterized in 67.0% and 8.5% of events, respectively. The mean (± standard deviation) number of stents used per patient was 1.3±0.6. The PK Papyrus stent was successfully delivered to the site of perforation in 89 patients (93.7%); in 4 patients (4.2%) a perforated side branch was sealed. Complete sealing was reported in 85/93 patients (91.4%), partial sealing in 5/93 (5.4%). Pericardiocentesis was performed in 23/93 patients (24.7%), acute stent thrombosis occurred in one patient, 7 patients had emergency cardiac surgery and in-hospital death occurred in 11 (11.6%) patients. Median follow-up was 282 days. One stent thrombosis occurred after hospital discharge. Target lesion revascularization occurred in 5/82 patients (6.1%). Minor changes possible due to ongoing corelab analysis.

Conclusions: The registry demonstrates favorably high rates of successful delivery to and sealing of the perforation site with a second generation covered stent. Stent thrombosis and target lesion restenosis rates were low during follow-up.