Coronary artery disease management and cost implications with fractional flow reserve guided coronary intervention in Indian patients with stable ischemic coronary artery disease.

OBJECTIVES: To study the safety of stent avoidance, frequency of change in management decisions, and its cost implications while using a fractional flow reserve (FFR)-guided treatment strategy for intermediate-grade coronary artery stenosis. BACKGROUND: The impact of FFR in guiding management decisions and its cost implications has not been studied after imposition of a ceiling on stent prices by the Government of India. METHODS: In 400 patients with 477 intermediate-grade coronary lesions for whom coronary intervention was planned, functional assessment using FFR was done. Incidence of the primary composite endpoint (major adverse cardiac event [MACE], cardiac death, myocardial infarction, objective evidence of ischemia, and target vessel revascularization) in the stent avoided subset was compared with the stented group at follow-up. Micro-costing analysis was done using a computed model with current stent and FFR wire prices. RESULTS: The overall incidence of MACE was 4.9%, 0.9% in the stent-avoided subset and 6.9% in stented group (p = 0.04, comparing the latter two) at a median follow-up of 21 months (interquartile range 12-31 months). Serious adverse events occurred only in 1% of patients receiving adenosine. The average cost saving was Indian rupees (INR) 51,847 [United States Dollar (USD) 746] per patient, resulting in total savings of INR 15,813,379 (USD 227,530). Cost savings persisted but were lower by 36% (INR 18,613/USD 268 per patient) after the ceiling of stent prices. CONCLUSION: FFR-guided percutaneous coronary intervention (PCI) strategy is safe and cost-effective in countries where majority of patients self-finance their health care, resulting in stent and PCI avoidance in approximately one in three patients referred for coronary angioplasty.

Intravascular Brachytherapy for the Management of Repeated Multimetal-Layered Drug-Eluting Coronary Stent Restenosis.

BACKGROUND: Because of the widespread acceptance of percutaneous coronary intervention with drug-eluting stents as an effective treatment strategy for in-stent restenosis, it is common to encounter multimetal layer stent restenosis in the recent years. This study aimed to evaluate the clinical outcomes of such patients treated with intravascular brachytherapy (IVBT) in comparison with other percutaneous options. METHODS AND RESULTS: We enrolled patients who underwent percutaneous coronary intervention during the period between 2011 and 2015 for recurrent drug-eluting stents in-stent restenosis with at least 2 layers of stents at the lesion site. This analysis compared patients who underwent treatment with IVBT and those who did not (non-IVBT group). The primary end point measured was major adverse cardiac events defined as a composite of target lesion revascularization, myocardial infarction, and all-cause mortality at 12 months. Adjusted associations were measured using propensity score matching. A total of 328 percutaneous coronary intervention patients met the eligibility criteria, of which 197 patients received IVBT, and 131 patients underwent routine percutaneous intervention. The primary end point was significantly lower in patients undergoing IVBT (13.2% and 28.2%; P=0.01). A propensity score matching for risk factors of in-stent restenosis identified 182 patients. The advantages of IVBT with regard to 1-year major adverse cardiac events were confirmed in this matched cohort (13.2% and 30.8%; adjusted hazard ratio [95% CI]: 0.37 [0.18-0.73]; P<0.01). CONCLUSIONS: In this analysis, IVBT led to significantly lower major adverse cardiac events in patients with multilayered drug-eluting stents restenosis when compared with other percutaneous options at 1-year follow-up.