Key result
BVS plus GDMT increases minimum lumen area by ~3.9 mm² versus GDMT alone in vulnerable plaques.
Why the study?
Does treatment with a bioresorbable vascular scaffold plus GDMT improve minimum lumen area in patients with non-flow-limiting vulnerable plaques compared to GDMT alone?
RCT (n=182)
randomized
Yes
Does treatment with a bioresorbable vascular scaffold plus GDMT improve minimum lumen area in patients with non-flow-limiting vulnerable plaques compared to GDMT alone?
PCI of angiographically mild but vulnerable plaques with large plaque burden using a bioresorbable scaffold significantly increased minimum lumen area without excess safety events compared to medical therapy alone.
BACKGROUND Acute coronary syndromes most commonly arise from thrombosis of lipid-rich coronary atheromas that have large plaque burden despite angiographically appearing mild. OBJECTIVES We sought to examine the outcomes of percutaneous coronary intervention (PCI) of non-flow-limiting vulnerable plaques. METHODS Three-vessel imaging was performed with a combination intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS) catheter after successful PCI of all flow-limiting coronary lesions in 898 patients presenting with myocardial infarction (MI). Patients with an angiographically non-obstructive stenosis not intended for PCI but with IVUS plaque burden ≥65% were randomized to treatment of the lesion with a bioresorbable vascular scaffold (BVS) plus guideline-directed medical therapy (GDMT) vs. GDMT alone. The primary powered effectiveness endpoint was the IVUS-derived minimum lumen area (MLA) at protocol-driven 25-month follow-up. The primary (non-powered) safety endpoint was randomized target lesion failure (TLF; cardiac death, target vessel-related MI or clinically-driven target lesion revascularization) at 24 months. The secondary (non-powered) clinical effectiveness endpoint was randomized lesion-related major adverse cardiac events (MACE; cardiac death, MI, unstable angina, or progressive angina) at latest follow-up. RESULTS A total of 182 patients were randomized (93 BVS, 89 GDMT alone) at 15 centers. The median angiographic diameter stenosis of the randomized lesions was 41.6%; by NIRS-IVUS median plaque burden was 73.7%, median MLA was 2.9 mm2, and median maximum lipid plaque content was 33.4%. Angiographic follow-up at 25 months was completed in 167 patients (91.8%), and median clinical follow-up was 4.1 years. The follow-up MLA in BVS-treated lesions was 6.9±2.6 mm2 compared with 3.0±1.0 mm2 in GDMT alone-treated lesions (least square means difference 3.9 mm2, 95% CI 3.3-4.5, P<0.0001). TLF at 24 months occurred in similar rates of BVS-treated and GDMT alone-treated patients (4.3% vs. 4.5%; P=0.96). Randomized lesion-related MACE occurred in 4.3% BVS-treated patients vs. 10.7% GDMT alone-treated patients (OR 0.38, 95% CI 0.11-1.28, P=0.12). CONCLUSIONS PCI of angiographically mild lesions with large plaque burden was safe, substantially enlarged the follow-up MLA and was associated with favorable long-term clinical outcomes, warranting the performance of an adequately powered randomized trial.
No takes yet. Share an insight, caveat, or question.
Stone et al. (2020) conducted an RCT in Myocardial infarction with vulnerable coronary atherosclerotic plaque (n=182). Bioresorbable vascular scaffold (BVS) plus guideline-directed medical therapy (GDMT) vs. GDMT alone was evaluated on IVUS-derived minimum lumen area (MLA) at 25-month follow-up (MD 3.9, 95% CI 3.3-4.5, p=<0.0001). Treatment of vulnerable plaques with a bioresorbable vascular scaffold plus GDMT significantly increased the minimum lumen area at 25 months compared to GDMT alone (MD 3.9 mm2; P<0.0001).
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: