OBJECTIVES:

Primary Percutaneous coronary intervention (PPCI) is the gold standard treatment for ST-elevated myocardial infarction (STEMI) patients. Despite improvements in interventional techniques, one year after discharge, mortality remains high (around 14%) and de novo heart failure develops in 20-30% patients.

Preliminary data suggest that pressure-controlled intermittent coronary sinus occlusion (PiCSO) might reduce infarct size in patients undergoing PPCI, leading to reductions of up to 34% in hospitalizations for heart failure and of 25% in associated mortality in the first year after procedure.

Aim of the study was to perform early cost-effectiveness modeling of PPCI+PiCSO compared to PPCI alone for the treatment of STEMI patients from the National Healthcare Service (NHS) perspective in Italy.

METHODS:

A Markov model with “post-MI”, “heart failure”, “recurrent-MI”, “stroke”, “recurrent stroke” and “death” health states was developed to estimate life years (LYs), quality-adjusted life years (QALYs) and costs associated with PPCI+PiCSO and PPCI alone. Transition probabilities, utility values and costs were derived from published literature. A discount rate of 3% was applied to costs and QALYs, and the model was constructed with 1-month Markov cycles. As in Italy the PiCSO technology is not covered by DRGs, one-way sensitivity analyses were performed on the cost of the medical device according to different willingness-to-pay (WTP) thresholds.

RESULTS:

Over a lifetime horizon, PPCI+PiCSO leads to 15.87 LYs and 12.16 QALYs versus 15.37 and 11.74 for PPCI alone, respectively. For a WTP threshold of 50,000€, PPCI+PiCSO would be cost-effective versus PPCI alone considering a cost for PiCSO <21,700€; assuming WTP thresholds of 30,000€ and 15,000€, PPCI+PiCSO would be cost-effective versus PPCI alone considering a cost for PiCSO <13,400€ and 7,100€, respectively.

CONCLUSIONS:

A cost lower than 21,700€ may be good value for money for a technology that may avoid cardiac events and improve patients’ life expectancy and quality of life.