What is the clinical evidence from this study?

Study design: Observational. Population: Iatrogenic, peri-PCI coronary artery perforation (CAP) (n=119). Intervention: Covered stent implantation. Primary outcome: Composite of major adverse cardiac events (MACE), defined as cardiac death, target lesion revascularization (TLR), and myocardial infarction (MI) at 1 year.

May 12, 2021PLoS ONE13 citationsOpen Access

Procedural and 1-year outcomes following large vessel coronary artery perforation treated by covered stents implantation: Multicentre CRACK registry

WWWojciech WańhaMedical University of Silesia RJRafał JanuszekInterventional Cardiology MKMichalina KołodziejczakGeneral / Preventive / Lipids

Key Result

Covered stent implantation for coronary artery perforation resulted in an 83.2% successful sealing rate, with a 1-year major adverse cardiac event rate of 26.2%.

Study Design

Type

Observational (n=119)

Multicenter

Yes

Structured PICO

Population

119 patients (mean age 68.9 years, 44.5% female) with iatrogenic peri-PCI coronary artery perforation treated with covered stent implantation, followed for up to 1 year.

Exposure

Covered stent implantation (e.g., PK Papyrus, Graftmaster, Direct-Stent, BeGraft, Aneugraft Dx) to seal coronary artery perforations.

Outcome

Composite of major adverse cardiac events (MACEs), defined as cardiac death, target lesion revascularization (TLR), and myocardial infarction (MI) assessed after 30 days and one year from the index procedure.composite

Covered stent implantation is an effective bailout strategy for coronary artery perforations, achieving 83.2% successful sealing, though patients remain at a relatively high risk for MACE and stent thrombosis at 1 year.

Limitations

No intravascular imaging data, so the mechanism of recorded stent thrombosis is unknown
Lack of quantitative findings such as reference vessel diameter or minimal lumen diameter

Abstract

BACKGROUND: Data regarding the clinical outcomes of covered stents (CSs) used to seal coronary artery perforations (CAPs) in the all-comer population are scarce. The aim of the CRACK Registry was to evaluate the procedural, 30-days and 1-year outcomes after CAP treated by CS implantation. METHODS: This multicenter all-comer registry included data of consecutive patients with CAP treated by CS implantation. The primary endpoint was the composite of major adverse cardiac events (MACEs), defined as cardiac death, target lesion revascularization (TLR), and myocardial infarction (MI). RESULTS: The registry included 119 patients (mean age: 68.9 ± 9.7 years, 55.5% men). Acute coronary syndrome, including: unstable angina 21 (17.6%), NSTEMI 26 (21.8%), and STEMI 26 (21.8%), was the presenting diagnosis in 61.3%, and chronic coronary syndromes in 38.7% of patients. The most common lesion type, according to ACC/AHA classification, was type C lesion in 47 (39.5%) of cases. A total of 52 patients (43.7%) had type 3 Ellis classification, 28 patients (23.5%) had type 2 followed by 39 patients (32.8%) with type 1 perforation. Complex PCI was performed in 73 (61.3%) of patients. Periprocedural death occurred in eight patients (6.7%), of which two patients had emergency cardiac surgery. Those patients were excluded from the one-year analysis. Successful sealing of the perforation was achieved in 99 (83.2%) patients. During the follow-up, 26 (26.2%) patients experienced MACE 7 (7.1%) cardiac deaths, 13 (13.1%) TLR, 11 (11.0%) MIs. Stent thrombosis (ST) occurred in 6 (6.1%) patients 4(4.0%) acute ST, 1(1.0%) subacute ST and 1(1.0%) late ST. CONCLUSIONS: The use of covered stents is an effective treatment of CAP. The procedural and 1-year outcomes of CAP treated by CS implantation showed that such patients should remain under follow-up due to relatively high risk of MACE.

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