Treatment of Stent Restenosis

Abstract

The journey taken for treatment of in-stent restenosis (ISR) began similarly to and then diverged markedly from the path traveled for de novo lesions. Similar to de novo lesions, balloon angioplasty initially demonstrated safety and moderate success rates for treatment of ISR (1). With more challenging lesions (i.e., diffuse ISR), though, balloon angioplasty proved to be far from adequate ( Fig. 1) (2,3). For both ISR and de novo lesions, a geometric model of treatment success was embraced (4): Optimization of final lumen diameter became the goal. Registry studies suggested a potential geometric benefit for debulking before angioplasty for both de novo and ISR lesions (5,6). Thus, interventional cardiologists embraced a variety of atherectomy techniques (7,8) to optimize final lumen diameter during ISR treatment. Although these options appeared to improve lumen diameters and recurrence rates in registry studies of ISR, they failed to establish superiority in the setting of multiple operators participating in randomized clinical trials (9 -11). See page 2152Stent restenosis therapy headed down its own road following pivotal brachytherapy trials that demonstrated benefit among patients with ISR but not with de novo lesions (12-15). Treatment of de novo lesions focused on optimization of final lumen diameter with stents. On the other hand, attempts to treat restenotic lesions with further implantation of bare metal stents did not show improved outcomes compared with balloon angioplasty (11). Thus, five years ago, treatment of de novo lesions (bare-metal stents to optimize lumen diameter) and restenotic lesions (brachytherapy to reduce late loss) followed divergent paths in interventional cardiology. DRUG-ELUTING STENTS (DES) FOR TREATMENT OF ISRBrachytherapy has practical limitations, efficacy concerns, and safety issues (12). Thus, the opportunity for both de novo and restenotic lesions to converge again with the simpler DES-based inhibition of late loss was embraced after approval of DES for de novo lesions (16). Rapid adoption of DES for such high-risk groups represented momentum and encouraging registry findings (17), but randomized superiority of DES to other therapies in enriched higher-risk populations had yet to be established. In this issue of the Journal, the Restenosis Intrastent: Balloon Angioplasty Versus Elective Sirolimus-Eluting Stent Implantation (RIBS-II) trial moves us beyond momentum by confirming superiority for sirolimus DES compared with balloon angioplasty for the treatment of patients with ISR ( Fig. 1) (18). Although the study sample is strikingly small (n ϭ 150) compared with the phase III clinical trials of DES (n Ͼ1,000), the enriched population of high-risk patients allows for meaningful comparisons of clinical end points.This study amplifies the findings of the randomized Intracoronary Stenting with Antithrombotic RegimenDrug-Eluting Stents for In-Stent Restenosis (ISAR-DESIRE) trial (19). In both studies, DES is associated with a greater than 50% reduction in recurrent restenosis comp...

Drug-Eluting Stents, Restenosis and Revascularization

“…The treatment of BMS-ISR with a DES is widely acceptable [86] but there is very little literature on management of DES-ISR [87]. Plaque modification methods such as directional and rotational atherectomy [88] are ineffective although they play a role as debulking devices.…”