Impact of diabetes on outcome with drug-coated balloons versus drug-eluting stents: the BASKET-SMALL 2 trial

Abstract

Objectives To evaluate the impact of diabetes mellitus on 3 year clinical outcome in patients undergoing drug-coated balloon (DCB) or drug-eluting stent (DES) treatment for de-novo lesions. Background For the treatment of de-novo coronary small vessel disease DCB are non-inferior to DES regarding clinical outcome up to 3 years. Methods In this prespecified analysis of a multicenter, randomized, non-inferiority trial, including 758 patients with de-novo lesions in coronary vessels <3mm who were randomized 1:1 to DCB (n=382) or DES (n=376) and followed over 3 years for major adverse cardiac events (MACE: cardiac death, non-fatal myocardial infarction [MI], and target-vessel revascularization [TVR]), outcome was analyzed regarding the presence or absence of diabetes mellitus. Results In non-diabetic patients (n=506) rates of MACE (13.0% vs. 11.5%, hazard ratio [HR] 1.24, 95% confidence interval [CI] 0.73–2.09, p=0.43), cardiac death (2.8% vs. 2.9%, HR 0.97, 95% CI 0.32–2.92, p=0.96), non-fatal MI (5.1% vs. 4.8%, HR 1.00, 95% CI 0.44–2.28, p=0.99), and TVR (8.8% vs. 6.1%, HR 1.64, 95% CI 0.83–3.25, p=0.16) were similar in DCB and DES. In diabetic patients (n=252) rates of MACE (19.3% vs. 22.2%, HR 0.82, 95% CI 0.45–1.48, p=0.51), cardiac death (8.8% vs. 5.9%, HR 2.01, 95% CI 0.76–5.31, p=0.16), non-fatal MI (7.1% vs. 9.8%, HR 0.55, 95% CI 0.21–1.49, p=0.24) were similar in DCB and DES, whereas TVR was significantly lower with DCB compared to DES (9.1% vs. 15.0%, HR 0.40, 95% CI 0.17–0.94, p=0.036). In addition, need for TVR was highest in diabetic patients treated with DES (Picture 1). Conclusions The rates of MACE are similar in DCB and DES in de-novo coronary lesions of diabetic and non-diabetic patients. In diabetic patients the need for TVR was significantly lower with DCB compared to DES. FUNDunding Acknowledgement Type of funding sources: Foundation. Main funding source(s): Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung, Basel Cardiovascular Research Foundation, and B Braun Medical AG. Picture 1

The comparative short-term efficacy and safety of drug-coated balloon vs. drug-eluting stent for treating small-vessel coronary artery lesions in diabetic patients

“…We accessed and screened the full texts of 21 studies, and 15 studies were excluded due to three reasons, including unrelated to the topic ( n = 11), conference abstract without sufficient data ( n = 3), and duplicate publication ( n = 1). Finally, as shown in Figure 1 , we included 6 studies ( 26 – 29 , 44 , 45 ) in this study for meta-analysis.…”

“…All studies were randomized controlled trials (RCTs) and were published between 2017 and 2021. Three studies were conducted in China ( 27 – 29 ), two studies in Italy ( 26 , 44 ), and one study in Germany ( 45 ). Three studies ( 26 , 44 , 45 ) were conducted in multiple centers; however, other three studies ( 27 – 29 ) were conducted in a single center.…”

“…Three studies were conducted in China ( 27 – 29 ), two studies in Italy ( 26 , 44 ), and one study in Germany ( 45 ). Three studies ( 26 , 44 , 45 ) were conducted in multiple centers; however, other three studies ( 27 – 29 ) were conducted in a single center. The sample size of individual study ranged from 70 to 252, with an accumulated number of 847.…”

“…The sample size of individual study ranged from 70 to 252, with an accumulated number of 847. Among the 6 included studies, five studies ( 26 , 27 , 29 , 44 , 45 ) reported MACE outcome, all studies ( 26 – 29 , 44 , 45 ) reported technique success, two studies ( 26 , 27 ) reported binary restenosis, four studies ( 26 – 29 ) reported MLD and LLL, and three studies ( 26 , 27 , 29 ) reported NLG. We can access the remaining basic information of all studies in Table 1 .…”

“…The sample size of individual study ranged from 70 to 252, with an accumulated number of 847. Among the 6 included studies, five studies (26,27,29,44,45)…”