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Drug-Coated Balloon Angioplasty With Rescue Stenting Versus Intended Stenting for the Treatment of Patients With de Novo Coronary Artery Lesions - REC-CAGEFREE I
Contribution To Literature:
The REC-CAGEFREE I trial showed that PCI with paclitaxel-coated balloon did not meet criteria for noninferiority compared with traditional DES PCI among patients with de novo lesions, and in fact appeared to be inferior for multiple CV outcomes at 2 years.
Description:
The goal of the trial was to assess the safety and efficacy of a paclitaxel-coated balloon (DCB) compared to drug-eluting stent (DES) implantation among patients with coronary in-stent restenosis.
Study Design
Eligible patients in China were randomized in a 1:1 fashion to either DCB (n = 1,133) or DES (n = 1,139).
Patients in the DCB group received the Swide DCB (Shenqi Medical, Shanghai, China), which is a balloon that has been spray-coated via ultrasound with crystals smaller than 2 μm in average diameter containing a mixture of paclitaxel (dose 3 μg/mm²) and iopromide. For patients randomly assigned to the DES group, procedural techniques followed routine local clinical practice and established guidelines. Patients in the DES group received the Firebird 2 DES (MicroPort, Shanghai, China), which is a sirolimus-eluting DES with an L605 cobalt chromium alloy platform, 86 μm thick struts, and a durable polymer that elutes 80% of the sirolimus within 30 days. All participants received dual antiplatelet therapy with aspirin (100 mg once daily) and clopidogrel (75 mg once daily) or aspirin and ticagrelor (90 mg twice daily) for at least 1 month after percutaneous coronary intervention (PCI), with the decision on the full duration of therapy being at the discretion of the implanting physician. Patients were thereafter required to receive aspirin (100 mg once daily) or clopidogrel (75 mg once daily) monotherapy indefinitely.
- Total number of enrollees 2,272
- Median duration of follow-up: 734 days
- Median patient age: 62 years
- Percentage female: 31%
Inclusion criteria:
- Age ≥18 years
- PCI for acute or chronic coronary syndrome
- de novo, noncomplex target lesions, regardless of treated vessel diameter
Randomization was conducted after successful and satisfactory pre-dilatation of the target lesion, defined as pre-dilatation with no type D, E, or F dissection; no decreased blood flow (Thrombolysis in Myocardial Infarction [TIMI] flow of at least grade 3); no residual stenosis of 30% or more by visual assessment; and no serious complications requiring termination of the PCI.
Exclusion criteria:
- Cardiogenic shock
- In-stent restenosis requiring revascularization
Other salient features/characteristics:
- Prior PCI: 12%
- Ejection fraction ≤40% or prior heart failure: 5%
- Chronic kidney disease: 9%
- Indication for PCI: ST-segment elevation MI (STEMI): 16%, NSTEMI: 18%, chronic coronary disease: 45%
- Number of lesions: 1, length of DCB or DES use: 30 mm
- Imaging guidance for PCI: 11%
- Median SYNTAX score: 7
Principal Findings:
The primary outcome, device-oriented composite endpoint (composite of cardiovascular [CV] death, target vessel MI [TV-MI], and clinically and physiologically indicated target lesion revascularization) at 24 months, for DCB vs. DES, was: 6.4% vs. 3.4%, difference 3.04% (95% confidence interval 1.27 to 0.81, p for noninferiority = 0.65; p for superiority = 0.0008).
For small vessel disease (device diameter <3.0 mm), DCB and DES had comparable outcomes, but for larger vessels, DCB was inferior to DES (p for interaction = 0.02).
Secondary outcomes for DCB vs. DES:
- Patient-oriented composite endpoint (target vessel failure (defined as vessel-related CV death, TV-MI, and clinically and physiologically indicated target vessel revascularization): 11.9% vs. 7.9%, p = 0.0017
- All-cause mortality: 3.3% vs. 2.0%, p = 0.064 (CV death: 2.3% vs. 1.2%, p = 0.053)
- Any revascularization: 7.0% vs. 4.6%, p = 0.016 (clinically and physiology indicated: 3.3% vs. 1.6%, p = 0.0084)
- TV-MI: 1.9% vs. 1.6%, p = 0.61
- Definite or probable stent or vessel thrombosis: 0.4% vs. 0.3%, p = 0.69
- Bleeding Academic Research Consortium (BARC)-3 or BARC-5 bleeding: 1.4% vs. 2.4%, p = 0.096
Interpretation:
The results of this trial indicate that the Swide paclitaxel-coated balloon did not meet criteria for noninferiority for CV outcomes at 2 years compared with traditional DES use among patients with de novo lesions undergoing PCI, and in fact appeared to be inferior for multiple CV endpoints, particularly the need for repeat revascularization. Patients with small vessel disease were an exception to this finding, although this finding is hypothesis and needs to be confirmed in future studies. Interestingly, similar findings were noted in BASKET-SMALL 2. In that trial, the SeQuent Please DCB (same dose of paclitaxel) was noninferior at 1 year to DES use for patients with small vessel disease.
The Agent balloon was recently approved by the US FDA for use in the United States. It has a lower dose of paclitaxel (2 mcg/mm2) compared with the Swide balloon used in the current trial (3 mcg/mm2); the Swide balloon is available in China only.
References:
Gao C, He X, Ouyang F, et al., for the REC-CAGEFREE I Investigators. Drug-coated balloon angioplasty with rescue stenting versus intended stenting for the treatment of patients with de novo coronary artery lesions (REC-CAGEFREE I): an open-label, randomized, non-inferiority trial. Lancet 2024;Sep 2:[Epub ahead of print].
Presented by Dr. Chao Gao at the European Society of Cardiology Congress, London, UK, September 2, 2024.
Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Atherosclerotic Disease (CAD/PAD), Interventions and Coronary Artery Disease
Keywords: Angioplasty, Balloon, Coronary Artery Disease, Drug-Eluting Stents, Percutaneous Coronary Intervention, ESC Congress, ESC24
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