Combined Analysis of Two Parallel Randomized Trials of Sirolimus-Coated and Paclitaxel-Coated Balloons in Coronary In-Stent Restenosis Lesions
Authors: Scheller Bruno , Mangner Norman , Abdul Kader Muhamad Ali S.K. , Wan Ahmad Wan Azman , Jeger Raban , Wöhrle Jochen , Ong Tiong Kiam , Liew Houng Bang , Gori Tommaso , Mahfoud Felix , Nuruddin Amin Ariff , Woitek Felix , Abidin Imran Zainal , Schwenke Carsten , Schnorr Beatrix , Mohd Ali Rosli , Scheller Bruno , Rastoul Bianca , Hollinger Nicole , Scheller Bruno , Mahfoud Felix , Ewen Sebastian , Böhm Michael , Vukadinovic Davor , Kulenthiran Saaraken , Schwarz Viktoria , Clever Yvonne P. , Mangner Norman , Woitek Felix , Linke Axel , Höllriegel Robert , Winzer Ephraim , Jellinghaus Stefanie , Hommel Jennifer , Abdul Kader Muhamad Ali bin Sheikh , Wan Ahmad Wan Azman , Abidin Imran Zainal , Ismail Muhammad Dzafir , Mahmood Zuhdi Ahmad Syadi , Syed Mansor Syed Mukhtar , Jeger Raban , Kaiser Christoph , Fahrni Gregor , Gilgen Nicole , Harder-Allgöwer Andrea , Baumgartner Margarete , Wöhrle Jochen , Sinisa Markovic , Smirnova Olga , Kiam Ong Tiong , Yip Fong Alan Yean , Khiew Ning Zan , Said Asri Bin , Cham Yee Ling , Oon Yen Yee , Koh Keng Tat , Voon Chi Yen , Mohd Amin Nor Hanim bt , Johan Wilson anak , Liew Houng Bang , Fui Jien Mabelle Wong , Shu Theng Melanie Chong , Gori Tomasso , Nuruddin Amin Ariff , Omar Al Fazir , Azmi Shaiful , Kandasamy Balachandran , Mohamed Yusoff Ahmad Khairuddin , Selamat Salizah , Schwenke Carsten , Schnorr Beatrix , Kutschera Maren , Mohd Ali Rosli , Mathana Sundram Thavin Kumar 
Published: September 2022

Background:
Paclitaxel-coated balloons (PCBs) are a preferred treatment option for coronary in-stent restenosis. To date, data from randomized trials of alternative drug coatings are lacking. The aim of the randomized Malaysian and German-Swiss randomized trials was to investigate a novel sirolimus-coated balloon (SCB) compared with a PCB in in-stent restenosis.

Methods:
One hundred one patients with drug-eluting stent in-stent restenosis were enrolled in 2 identical randomized trials comparing the novel SCB (SeQuent SCB, 4 μg/mm²) with the clinically proven PCB (SeQuent Please, 3 μg/mm²). Primary end point was angiographic late lumen loss at 6 months. Secondary end points included procedural success, major adverse cardiac events, and individual clinical end points such as stent thrombosis, cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, and binary restenosis.

Results:
Quantitative coronary angiography revealed no differences in baseline parameters. After 6 months, in-segment late lumen loss was 0.25±0.57 mm in the PCB group versus 0.26±0.60 mm in the SCB group. Mean difference between SCB and PCB was 0.01 (95% CI, -0.23 to 0.24). Noninferiority at a predefined margin of 0.35 was shown. Clinical events up to 12 months did not differ between the groups.

Conclusions:
This first-in man comparison of a novel SCB with a crystalline coating showed similar angiographic and clinical outcomes in the treatment of coronary drug-eluting stent in-stent restenosis compared with PCB.

Registration:

URL:
https://www.clinicaltrials.gov
; Unique identifier: NCT02996318, NCT03242096.