Gregor Fahrni1, Bruno Scheller2, Michael Coslovsky1, Nicole Gilgen1, Ahmed Farah3, Marc-Alexander Ohlow4, Norman Mangner5, Daniel Weilenmann6, Jochen Wöhrle7, Florim Cuculi8, Gregor Leibundgut9, Sven Möbius-Winkler10, Robert Zweiker11, Raphael Twerenbold1, Christoph Kaiser1, Raban Jeger12. 1. Department of Cardiology, University Hospital Basel, University of Basel, Petersgraben 4, 4031, Basel, Switzerland. 2. Clinical and Experimental Interventional Cardiology, University of Saarland, Homburg/Saar, Germany. 3. Knappschaftskrankenhaus, Klinikum Westfalen, Dortmund, Germany. 4. Central Clinic, Bad Berka, Germany. 5. Heart Center Dresden at the Technical University of Dresden, Dresden, Germany. 6. Kantonsspital St. Gallen, St. Gallen, Switzerland. 7. University Hospital Ulm, Ulm, Germany. 8. Kantonsspital Luzern, Luzern, Switzerland. 9. Kantonsspital Baselland, Liestal, Switzerland. 10. University Hospital Jena, Jena, Germany. 11. University Hospital Graz, Graz, Austria. 12. Department of Cardiology, University Hospital Basel, University of Basel, Petersgraben 4, 4031, Basel, Switzerland. raban.jeger@usb.ch.
Abstract
BACKGROUND: The randomized BASKET-SMALL 2 trial showed non-inferiority for treatment with drug-coated balloon (DCB) compared with drug-eluting stents (DES) in patients undergoingpercutaneous coronary intervention (PCI) for de novo lesions in small coronary arteries regarding clinical endpoints at 1 year. In this predefined substudy, we investigated the angiographic findings in patients undergoing a clinically indicated follow-up angiography during the study phase. METHODS:Eight-hundred and eighty-three patients underwentPCI with either DES or DCB in a culprit vessel < 3 mm in diameter for stable coronary artery disease or acute coronary syndrome. Event-driven re-angiographies and the corresponding images at baseline were analyzed for angiographic endpoints. RESULTS: One-hundred and eleven patients (117 lesions, 66 DES versus 51 DCB) presented for an unscheduled re-angiography at median 5.7 months after the index procedure. At baseline, mean reference vessel diameter was 2.05 mm and the residual in-segment stenosis after the index procedure was less in DES compared to DCB (23.7% vs 33.8%, p = 0.001). At follow-up angiography, diameter stenosis in the DES group (29.0%) was still somewhat smaller than after DCB angioplasty (35.8%) when adjusting for time since PCI (p = 0.047), whereas lumen loss (LL) did not differ between the two treatment arms (LL-DES 0.06 mm vs LL-DCB 0.10 mm, p = 0.20). Eight patients following DES implantation presented with a complete occlusion of the target lesion compared to no occlusion in the DCB group (p = 0.009). CONCLUSIONS: The clinically indicated follow-up angiography within 1 year showed no difference in LL. Complete thrombotic vessel occlusions were found only in the DES group. CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov ; number, NCT01574534.
RCT Entities:
BACKGROUND: The randomized BASKET-SMALL 2 trial showed non-inferiority for treatment with drug-coated balloon (DCB) compared with drug-eluting stents (DES) in patients undergoing percutaneous coronary intervention (PCI) for de novo lesions in small coronary arteries regarding clinical endpoints at 1 year. In this predefined substudy, we investigated the angiographic findings in patients undergoing a clinically indicated follow-up angiography during the study phase. METHODS: Eight-hundred and eighty-three patients underwent PCI with either DES or DCB in a culprit vessel < 3 mm in diameter for stable coronary artery disease or acute coronary syndrome. Event-driven re-angiographies and the corresponding images at baseline were analyzed for angiographic endpoints. RESULTS: One-hundred and eleven patients (117 lesions, 66 DES versus 51 DCB) presented for an unscheduled re-angiography at median 5.7 months after the index procedure. At baseline, mean reference vessel diameter was 2.05 mm and the residual in-segment stenosis after the index procedure was less in DES compared to DCB (23.7% vs 33.8%, p = 0.001). At follow-up angiography, diameter stenosis in the DES group (29.0%) was still somewhat smaller than after DCB angioplasty (35.8%) when adjusting for time since PCI (p = 0.047), whereas lumen loss (LL) did not differ between the two treatment arms (LL-DES 0.06 mm vs LL-DCB 0.10 mm, p = 0.20). Eight patients following DES implantation presented with a complete occlusion of the target lesion compared to no occlusion in the DCB group (p = 0.009). CONCLUSIONS: The clinically indicated follow-up angiography within 1 year showed no difference in LL. Complete thrombotic vessel occlusions were found only in the DES group. CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov ; number, NCT01574534.
Entities:
Keywords:
De novo; Drug-coated balloon; Drug-eluting balloon; Percutaneous coronary intervention; Quantitative coronary analysis; Small vessel disease
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