EuroIntervention · 2022 · 58 citations · 26 references
MedicineCardiologySurgeryCardiothoracic SurgeryClinical CardiologyInterventional CardiologyAcute Coronary SyndromesCoronary Artery DiseaseIntracoronary ImagingIntravascular ImagingPercutaneous Coronary InterventionStent PlacementAdjuvant UseCalcified Coronary Lesion TreatmentIntracoronary Imaging GuidanceIntravascular Imaging GuidanceSafety Endpoint AnalysisSafety Endpoint AssessmentSeverely Calcified Coronary Lesions
<b>BACKGROUND: </b> Stent underexpansion increases the risk of cardiac adverse events. At present, there are limited options to treat refractory stent underexpansion. In this context, the intravascular lithotripsy (IVL) system might be a safe and effective strategy. AIMS: We aimed to evaluate the safety and efficacy of IVL in addressing resistant stent underexpansion due to heavy underlying calcification. <b>METHODS: </b> This was an international multicentre registry including patients receiving IVL therapy to treat stent underexpansion from December 2017 to August 2020. Angiographic and intracoronary imaging data were collected. The efficacy endpoint was device success (technical success with a final percentage diameter stenosis <50%). The safety endpoint was in-hospital major adverse cardiac events (MACE). <b>RESULTS: </b> Seventy patients were included, the mean age was 73±9.2 years and 76% were male. The median time from stent implantation to IVL therapy was 49 days (0-2,537). Adjuvant treatment with non-compliant balloon dilatations pre- and post-IVL was performed in 72.3% and 76.8% of patients, respectively, and additional stenting was performed in 22.4%. Device success was 92.3%. Minimum lumen diameter increased from 1.49±0.73 mm to 2.41±0.67 mm (p<0.001) and stent expansion increased by 124.93±138.19% (p=0.016). No IVL-related procedural complications or MACE were observed. The use of bailout IVL therapy directly after stenting and the presence of ostial underexpanded lesions negatively predicted lumen diameter gain. <b>CONCLUSIONS: </b> Coronary lithotripsy is safe and effective in increasing lumen and stent dimensions in underexpanded stents secondary to heavily calcified lesions.
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Clinical End Points in Coronary Stent Trials
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