Impact of stent diameter and length on in‐stent restenosis after DES vs BMS implantation in patients needing large coronary stents—A clinical and health‐economic evaluation

Abstract

SummaryAims: The British National Institute of Clinical Excellence (NICE) guidelines recommend to use drug-eluting stents (DES) instead of bare-metal stents (BMS) only in lesions >15 mm in length or in vessels <3 mm in diameter. We analyzed the impact of stent length and stent diameter on in-stent restenosis (ISR) in the BASKET-PROVE study population and evaluated the cost-effectiveness of DES compared to BMS. Methods/Results: The BASKET-PROVE trial compared DES vs BMS in large coronaryarteries (≥3 mm). We calculated incremental cost-effectiveness ratios (ICERs) and cost-effectiveness acceptability curves with regard to quality-adjusted life years (QALYs) gained and target lesion revascularizations (TLRs) avoided.A total of 2278 patients were included in the analysis. A total of 74 ISR in 63 patients were observed. In-stent restenosis was significantly more frequent in segments treated with a BMS compared to segments treated with a DES (5.4% vs 0.76%; P<.001).The benefit of a DES compared to a BMS regarding ISR was consistent among the subgroups of stent length >15 mm and ≤15 mm, respectively. With the use of DES in short lesions, there was only a minimal gain of 0.005 in QALYs. At a threshold of 10 000 CHF per TLR avoided, DES had a high probability of being cost-effective. Conclusion:In the BASKET-PROVE study population, the strongest predictor of ISR is the use of a BMS, even in patients in need of stents ≥3.0 mm and ≤15 mm lesion length and DES were cost-effective. This should prompt the NICE to reevaluate its recommendation to use DES instead of BMS only in vessels <3.0 mm and lesions >15 mm length. K E Y W O R D SBare-metal stents, Cost-effectiveness, Drug-eluting stents, In-stent restenosis 1

Impact of stent diameter on outcomes following percutaneous coronary intervention with second‐generation drug‐eluting stents: Results from a large single‐center registry

“…The efficacy of DES over BMS in reducing the rate of target lesion revascularization (TLR), rates of major adverse cardiac events (MACE), and target vessel revascularization (TVR) are now well established. This has been shown to be preserved in larger vessels as well . However, there are limited data examining the effect of stent diameter with second‐generation DES in routine clinical practice.…”

Assessment of vascular response to BiOSS LIM C® stents vs Orsiro® stents in the porcine coronary artery model

“…In the era of drug‐eluting stents (DES), results became very acceptable with most techniques, and many randomized clinical trials confirmed that the provisional T‐stenting should be the gold standard . Nevertheless, the optimal approach for true coronary bifurcations is still a subject of discussion, especially when the side branch is large, narrowed by a long plaque or not simply accessible . The role of dedicated devices in this setting remains unclear compared to the provisional approach as shown in the Tryton IDE study or POLBOS I and II trials …”

“…1 Nevertheless, the optimal approach for true coronary bifurcations is still a subject of discussion, especially when the side branch is large, narrowed by a long plaque or not simply accessible. 2 The role of dedicated devices in this setting remains unclear compared to the provisional approach as shown in the Tryton IDE study or POLBOS I and II trials. [3][4][5] As a mean to further improve performance of one of the dedicated bifurcation stents, Balton Company developed a new coronary version of BiOSS ® stent-BiOSS LIM C ® cobalt-chromium sirolimus-eluting stent with the biodegradable polymer.…”

Risk factors associated with intra‑stent restenosis after percutaneous coronary intervention

“…The advantages of DES over BMS in preventing ISR have been presented in the literature and are also confirmed in our study. Zbinden et al showed a significant higher risk of ISR in segments with a BMS compared to segments with a DES (5.4 vs. 0.76% after 2 years) in 2,278 patients ( 21 ). In addition, a systematic review concerning the treatment of coronary ISR confirmed a higher rate of ISR after BMS implantation (20-35%) vs. DES implantation (5-10%) ( 22 ).…”