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Impact of Diabetes on Outcome With Drug-Coated Balloons Versus Drug-Eluting Stents: The BASKET-SMALL 2 Trial
Jochen Wöhrle1, Bruno Scheller2, Julia Seeger1
1Department of Cardiology and Intensive Care, Medical Campus Lake Constance, Friedrichshafen, Germany.
Insights
Drug-coated balloons (DCB) and drug-eluting stents (DES) show similar 3-year outcomes for de novo coronary lesions in diabetic and nondiabetic patients. However, diabetic patients experienced significantly lower target vessel revascularization rates with DCB versus DES.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Diabetes Mellitus Management
Background:
- Drug-coated balloons (DCB) are emerging as a viable alternative to drug-eluting stents (DES) for treating de novo coronary small vessel disease.
- Previous studies suggest comparable efficacy between DCB and DES, but long-term outcomes, particularly in diabetic populations, require further investigation.
Purpose of the Study:
- To evaluate the 3-year clinical outcomes of drug-coated balloon (DCB) versus drug-eluting stent (DES) treatment for de novo coronary lesions.
- To specifically assess the impact of diabetes mellitus on these outcomes, analyzing major adverse cardiac events (MACE) and target vessel revascularization (TVR).
Main Methods:
- A prespecified analysis of the multicenter, randomized BASKET-SMALL2 trial (NCT01574534) involving 758 patients with de novo coronary lesions (<3 mm).
- Patients were randomized 1:1 to receive either DCB or DES and followed for 3 years.
- Outcomes, including MACE (cardiac death, nonfatal myocardial infarction, TVR), were analyzed based on the presence or absence of diabetes mellitus.
Main Results:
- In nondiabetic patients (n=506), MACE rates were similar between DCB (13.0%) and DES (11.5%) (P=0.43).
- In diabetic patients (n=252), MACE rates were also similar (DCB 19.3% vs. DES 22.2%; P=0.51).
- Notably, diabetic patients treated with DCB showed a significantly lower rate of TVR (9.1%) compared to those treated with DES (15.0%) (P=0.036).
Conclusions:
- Both DCB and DES demonstrate similar 3-year efficacy in terms of MACE for de novo coronary lesions, irrespective of diabetes status.
- For diabetic patients undergoing treatment for de novo coronary lesions, DCB offers a significant advantage by reducing the need for target vessel revascularization compared to DES.
Objectives:
The study sought 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 treatment of de novo coronary small vessel disease, DCBs are noninferior to DES.
Methods:
In this prespecified analysis of a multicenter, randomized, noninferiority trial, including 758 patients with de novo lesions in coronary vessels <3 mm who were randomized 1:1 to DCB or DES and followed over 3 years for major adverse cardiac events (MACE) (cardiac death, nonfatal myocardial infarction [MI], and target vessel revascularization [TVR]), outcome was analyzed regarding the presence or absence of diabetes mellitus.
Results:
In nondiabetic patients (n = 506), rates of MACE (DCB 13.0% vs DES 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), nonfatal 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 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), and nonfatal MI (7.1% vs 9.8%; HR: 0.55; 95% CI: 0.21-1.49; P = 0.24) were similar in DCB and DES. TVR was significantly lower with DCBs vs DES (9.1% vs 15.0%; HR: 0.40; 95% CI: 0.17-0.94; P = 0.036; P = 0.011 for interaction).
Conclusions:
The rates of MACE are similar in DCBs and DES in de novo coronary lesions of diabetic and nondiabetic patients. In diabetic patients, need for TVR was significantly lower with DCB versus DES. (Basel Stent Kosten Effektivitäts Trial Drug Eluting Balloons vs Drug Eluting Stents in Small Vessel Interventions [BASKET-SMALL2]; NCT01574534).
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