DCB vs. DES for Treatment of In-Stent Restenosis
- TLR rates with DCB angioplasty are similar to repeat DES placement for BMS-ISR.
- While TLR rates are significantly higher with DCB angioplasty in DES-ISR, safety endpoints are numerically lower with DCB angioplasty in the same patient population.
- DCB angioplasty should be first-line treatment in BMS-ISR and more data are needed to define its role in DES-ISR.
What is the role of drug-coated balloon (DCB) angioplasty in the treatment of coronary in-stent restenosis (ISR)?
Patient-level data from 10 randomized trials comparing DCB angioplasty to repeat drug-eluting stent (DES) implantation in the treatment of coronary ISR (710 patients with BMS [bare-metal stent]-ISR and 1,248 with DES-ISR) were included in this analysis. The primary efficacy endpoint was target lesion revascularization (TLR) at 3 years. The primary safety endpoint was a composite of all-cause death, myocardial infarction (MI), or target lesion thrombosis at 3 years.
Overall risk of TLR was lower in BMS- vs. DES-ISR (9.7% vs. 17.0%; hazard ratio [HR], 0.56; 95% confidence interval [CI], 0.42-0.74), whereas safety was not significantly different between ISR types. In BMS-ISR, no significant difference between treatments was observed in terms of both efficacy (9.2% vs. 10.2%; HR, 0.83; 95% CI, 0.51-1.37) and safety (8.7% vs. 7.5%; HR, 1.13; 95% CI, 0.65-1.96). In DES-ISR, while the risk of TLR (efficacy) was significantly higher with DCB angioplasty (20.3% vs. 13.4%; HR, 1.58; 95% CI, 1.16-2.13), incidence of death, MI, and lesion thrombosis (safety) was numerically lower and barely missed statistical significance with DCB when compared to repeat DES placement (9.5% vs. 13.3%; HR, 0.69; 95% CI, 0.47-1.00).
At 3-year follow-up, DCB angioplasty and repeat stenting with DES had similar TLR in the treatment of BMS-ISR, whereas DCB angioplasty was associated with significantly higher TLR rates when compared with repeat DES implantation in the treatment DES-ISR. Overall DES performance was not affected by ISR type (BMS or DES), but DCB angioplasty performed better in BMS-ISR compared to DES-ISR in terms of TLR at 3 years.
There are fundamental mechanistic differences in BMS-ISR and DES-ISR. DES-ISR is often “a stent issue” and tends to be more focal, especially at the stent edge or in areas of stent fracture, whereas BMS-ISR is often “a lack of drug issue” and tends to be diffuse across the entire stented segment given there is no drug to inhibit intimal proliferation on the stent. DES placement is an established therapy for coronary ISR but these results, therefore, justify using DCB angioplasty over DES as first-line therapy for BMS-ISR. For DES-ISR, DCB angioplasty had higher TLR rates (met statistical significance) and lower death, MI, and lesion thrombosis rates (barely missing statistical significance). These conflicting yet very important findings warrant future investigation powered towards hard clinical endpoints.
Clinical Topics: Acute Coronary Syndromes, Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Aortic Surgery, Cardiac Surgery and SIHD, Interventions and ACS, Chronic Angina
Keywords: Acute Coronary Syndrome, Angioplasty, Balloon, Angioplasty, Balloon, Coronary, Coronary Restenosis, Drug-Eluting Stents, Myocardial Infarction, Myocardial Ischemia, Myocardial Revascularization, Percutaneous Coronary Intervention, Stents, Thrombosis
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