Use and outcomes of the PK Papyrus covered stent in France: SOS PK Papyrus Registry

Abstract

Objectives: To evaluate the rate of procedural success and long-term outcomes of the PK Papyrus (PKP) covered stent (CS).Background: CS are essential in the treatment of coronary artery perforation (CAP).They have also been used to treat coronary artery aneurysms. Limited evidence is available on clinical outcomes with the PKP.Methods: This was a multicenter, observational, retrospective, and prospective study. Consecutive patients undergoing intentional PKP implantation in 22 centers in France were included. The primary endpoint was the rate of procedural success. Secondary endpoints included rates of death, myocardial infarction (MI), target lesion revascularization (TLR), in-stent restenosis (ISR), and stent thrombosis (ST).Results: Data from 130 patients were analyzed (mean age 72.5 ± 10.5 years; 71% men). The main indication for PKP was CAP, in 84 patients (65%). Delivery success was achieved in 95% and procedural success in 91%. During the in-hospital stay, 15 patients died (12%) and 7 (5%) presented with ST. Data from 127 patients were available at 19.2 ± 12.8 month follow-up. Thirty-three patients died (26%), 15 (12%) had an MI and 21 (17%) presented with TLR. TLR was due to ISR in 12 patients (9%), 10 had definite ST (8%) and 1 patient for stent under-expansion. Conclusions:The principal indication for PKP was CAP. PKP had high rates of delivery and procedural success. At long-term follow-up, there was a high rate of TLR, mainly due to ISR and ST. These results are consistent with previously reported data in these clinical settings.

Clinical Outcomes of Self-Made Polyurethane-Covered Stent Implantation for the Treatment of Coronary Artery Perforations

“…Hernandez-Enriquez et al came to an encouraging conclusion that delivery time of PK Papyrus stent was shorter and brought about reduced frequency of pericardial effusion and cardiac arrest in comparison with the Graftmaster [ 20 ]. The largest registry study about PK Papyrus presented there was also a high rate of long-term TLR, mainly due to ISR and ST (9% and 10% at 12 months, respectively) [ 21 ]. What is more, second-generation single-layer pericardium-CS (Aneugraft Dx stent, ITGI Medical, Israel) was also a biocompatible and deliverable device to seal the extravasation.…”

“…This may reflect the combination of population with high burden of cardiovascular risk factors and complex lesions. Reported rates of in-hospital mortality for PTFE-CS in studies involving more patients ranged from 15% to 23% [ 20 , 26 ] and those of PU-CS were approximately 10% [ 19 , 21 ]. At 1-year follow-up, figures of all-cause mortality for PTFE-CS ranged from 26% to 41% [ 16 , 20 ], and those of PU-CS were approximately 26% [ 20 , 21 ].…”

“…Reported rates of in-hospital mortality for PTFE-CS in studies involving more patients ranged from 15% to 23% [ 20 , 26 ] and those of PU-CS were approximately 10% [ 19 , 21 ]. At 1-year follow-up, figures of all-cause mortality for PTFE-CS ranged from 26% to 41% [ 16 , 20 ], and those of PU-CS were approximately 26% [ 20 , 21 ]. According to Nagaraja and colleagues, the long-term mortality for patients receiving Graftmaster, PK Papyrus, and pericardial stents after CAP was 18.5%, 16.0%, and 26.1%, respectively [ 23 ].…”

Covered stents: Initially life‐saving but long‐term consequences persist

“…French registry reported outcomes from 130 patients treated with the Papyrus stent. 3 Sixty-five percentage of patients had coronary perforation as the indication for Papyrus, and 35% were for off label uses including aneurysms, pseudoaneurysm or other reasons. A six French sheath size was used in 85% of cases, delivery was successful in 95% with procedural success in 91%.…”

What have we learnt from the use of papyrus covered stent in France and Spain?

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We congratulate the authors for the publication of the largest series of patients treated with Papyrus covered stent to date. 1 Although the study provides important information on the clinical outcomes of Papyrus, there are some considerations that must be taken into account.

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