Coronary Perforations and Use of Covered Stents: Safe and Effective Long-Term Strategy?

Coronary perforations remain one of the most serious complications of percutaneous coronary intervention (PCI), especially in cases of Ellis ruptures type III. In these extreme urgency situations, the implantation of covered stents has become one of the preferred strategies to immediately seal the injury. However, evidence on double-layer polyurethane (PTFE) covered stents has historically shown high rates of thrombosis, restenosis, and need for revascularization.

In this context, the RECOVER study aimed to evaluate the comparative 12-month safety and efficacy of “new-generation” covered stents: single-layer PTFE-covered models (BeGraft) versus polyurethane-covered models (PK Papyrus), in patients with coronary perforation during PCI. Both procedural performance (“strategy success”) and major clinical events were analyzed at one year, including mortality, acute myocardial infarction, treated vessel revascularization, and definite or probable stent thrombosis.

A retrospective, multicenter analysis with individual patient data was conducted. It included 170 consecutive cases treated in 20 European centers between 2013 and 2019. A total 208 stents were implanted (92 PTFE and 116 PU). Technical success, 12-month clinical outcomes, and thrombotic safety were analyzed.

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The study population was predominantly male, mean age 72, with high prevalence of hypertension, diabetes, and extensive coronary artery disease. Most treated lesions were located in native coronary arteries (93%), with high proportion of moderate or severe calcification (>80%). A particularly relevant finding was the marked difference in the proportion of chronic total occlusions: 51.3% in the PTFE group vs 8.5% in the PU group (p < 0.001). This suggests that operators tended to use BeGraft in more complex anatomies, possibly longer ones, which was also reflected in a significantly greater total stent length (43.9 vs. 24.4 mm; p < 0.001). Approximately 28% of patients presented cardiac tamponade, and about one-third required pericardiocentesis, with no significant differences between groups.

Both devices showed a high procedural success rate (strategy success 94.1%), with successful angiographic sealing in nearly 95% of cases. The need for bailout surgery was low (4.1%) and exclusively limited to the PU group. At 12 months, overall mortality was 11.8%, with no statistically significant differences between the groups (6.8% PTFE vs. 19% PU; p = 0.068), as was the case for cardiac mortality (6.8% vs. 8.1%). Spontaneous myocardial infarction incidence was very low with both strategies (<1.5%).

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Definite or probable stent thrombosis was infrequent and comparable between groups (2.4% overall), suggesting improvements in single-layer covered stents design have helped reduce this historically high risk. Rates of target-vessel revascularization (TVR) and target-lesion revascularization (TLR) were elevated in both groups (up to 28.4%), though there were no significant differences after statistical adjustment.

Conclusions

The RECOVER study shows that both BeGraft and PK Papyrus new-generation covered stents are effective and safe tools for the management of coronary perforations. Although ischemic events and the need for reintervention remain considerable, these results support their use in emergency scenarios.

Original Title: Comparative safety and efficacy of new-generation single-layer polytetrafluorethylene- versus polyurethane-covered stents in patients with coronary artery perforation for the RECOVER (REsults after percutaneous interventions with COVERed stents) Investigators. 

Reference: Voll F, Olivecronab G, Ferenc M, Hellig F, Schlundt C, Wöhrle J, Cassese S, Rottbauer W, Witkowski A, Xhepa E, Kuliczkowski W, Strauss L, Schrage B, Joner M, von Zur Mühlen C, Cook S, Miljak T, Eggebrecht H, Eeckhout E, Laugwitz KL, Monsegu J, Schunkert H, Westermann D, Kastrati A, Dumonteil N, Birkemeyer R, Kufner S. Comparative safety and efficacy of new-generation single-layer polytetrafluorethylene- versus polyurethane-covered stents in patients with coronary artery perforation for the RECOVER (REsults after percutaneous interventions with COVERed stents) Investigators. Cardiovasc Interv Ther. 2025 Apr;40(2):296-305. doi: 10.1007/s12928-025-01084-y. Epub 2025 Feb 7. PMID: 39918675; PMCID: PMC11910408.