José R. López-Mínguez

Drug-Eluting Stent Thrombosis Results From the Multicenter Spanish Registry ESTROFA (Estudio ESpañol sobre TROmbosis de stents FArmacoactivos)

OBJECTIVESnThis study sought to assess the incidence, predictors, and outcome of drug-eluting stent(DES) thrombosis in real-world clinical practice.nnnBACKGROUNDnThe DES thromboses in randomized trials could not be comparable to those observed in clinical practice, frequently including off-label indications.nnnMETHODSnWe designed a large-scale, nonindustry-linked multicentered registry, with 20 centers in Spain. The participant centers provided follow-up data for their patients treated with DES, reporting a detailed standardized form in the event of any angiography-documented DES-associated thrombosis occurring.nnnRESULTSnOf 23,500 patients treated with DES, definite stent thrombosis(ST) developed in 301: 24 acute, 125 subacute, and 152 late. Of the late, 62 occurred >1 year(very late ST). The cumulative incidence was 2% at 3 years. Antiplatelet treatment had been discontinued in 95 cases(31.6%). No differences in incidences were found among stent types. Independent predictors for subacute ST analyzed in a subgroup of 14,120 cases were diabetes, renal failure, acute coronary syndrome, ST-segment elevation myocardial infarction, stent length, and left anterior descending artery stenting, and for late ST were ST-segment elevation myocardial infarction, stenting in left anterior descending artery, and stent length. Mortality at 1-year follow-up was 16% and ST recurrence 4.6%. Older age, left ventricular ejection fraction <45%, nonrestoration of Thrombolysis In Myocardial Infarction flow grade 3, and additional stenting were independent predictors for mortality.nnnCONCLUSIONSnThe cumulative incidence of ST after DES implantation was 2% at 3 years. No differences were found among stent types. Patient profiles differed between early and late ST. Short-term prognosis is poor, especially when restoration of normal flow fails.

A randomized comparison ofrepeat stenting with balloon angioplasty in patients with in-stent restenosis

OBJECTIVESnThis randomized trial compared repeat stenting with balloon angioplasty (BA) in patients with in-stent restenosis (ISR).nnnBACKGROUNDnStent restenosis constitutes a therapeutic challenge. Repeat coronary interventions are currently used in this setting, but the recurrence risk remains high.nnnMETHODSnWe randomly assigned 450 patients with ISR to elective stent implantation (224 patients) or conventional BA (226 patients). Primary end point was recurrent restenosis rate at six months. Secondary end points included minimal lumen diameter (MLD), prespecified subgroup analyses, and a composite of major adverse events.nnnRESULTSnProcedural success was similar in both groups, but in-hospital complications were more frequent in the balloon group. After the procedure MLD was larger in the stent group (2.77 +/- 0.4 vs. 2.25 +/- 0.5 mm, p < 0.001). At follow-up, MLD was larger after stenting when the in-lesion site was considered (1.69 +/- 0.8 vs. 1.54 +/- 0.7 mm, p = 0.046). However, the binary restenosis rate (38% stent group, 39% balloon group) was similar with the two strategies. One-year event-free survival (follow-up 100%) was also similar in both groups (77% stent vs. 71% balloon, p = 0.19). Nevertheless, in the prespecified subgroup of patients with large vessels (> or =3 mm) the restenosis rate (27% vs. 49%, p = 0.007) and the event-free survival (84% vs. 62%, p = 0.002) were better after repeat stenting.nnnCONCLUSIONSnIn patients with ISR, repeat coronary stenting provided better initial angiographic results but failed to improve restenosis rate and clinical outcome when compared with BA. However, in patients with large vessels coronary stenting improved the long-term clinical and angiographic outcome.

Implantation of a drug-eluting stent with a different drug (switch strategy) in patients with drug-eluting stent restenosis. Results from a prospective multicenter study (RIBS III [Restenosis Intra-Stent: Balloon Angioplasty Versus Drug-Eluting Stent]).

OBJECTIVESnThis study sought to assess the effectiveness of a strategy of using drug-eluting stents (DES) with a different drug (switch) in patients with DES in-stent restenosis (ISR).nnnBACKGROUNDnTreatment of patients with DES ISR remains a challenge.nnnMETHODSnThe RIBS-III (Restenosis Intra-Stent: Balloon Angioplasty Versus Drug-Eluting Stent) study was a prospective, multicenter study that aimed to assess results of coronary interventions in patients with DES ISR. The use of a different DES was the recommended strategy. The main angiographic endpoint was minimal lumen diameter at 9-month follow-up. The main clinical outcome measure was a composite of cardiac death, myocardial infarction, and target lesion revascularization.nnnRESULTSnThis study included 363 consecutive patients with DES ISR from 12 Spanish sites. The different-DES strategy was used in 274 patients (75%) and alternative therapeutic modalities (no switch) in 89 patients (25%). Baseline characteristics were similar in the 2 groups, although lesion length was longer in the switch group. At late angiographic follow-up (77% of eligible patients, median: 278 days) minimal lumen diameter was larger (1.86 ± 0.7 mm vs. 1.40 ± 0.8 mm, p = 0.003) and recurrent restenosis rate lower (22% vs. 40%, p = 0.008) in the different-DES group. At the last clinical follow-up (99% of patients, median: 771 days), the combined clinical endpoint occurred less frequently (23% vs. 35%, p = 0.039) in the different-DES group. After adjustment using propensity score analyses, restenosis rate (relative risk: 0.41, 95% confidence interval [CI]: 0.21 to 0.80, p = 0.01), minimal lumen diameter (difference: 0.41 mm, 95% CI: 0.19 to 0.62, p = 0.001), and the event-free survival (hazard ratio: 0.56, 95% CI: 0.33 to 0.96, p = 0.038) remained significantly improved in the switch group.nnnCONCLUSIONSnIn patients with DES ISR, the implantation of a different DES provides superior late clinical and angiographic results than do alternative interventional modalities.

Long-Term Clinical Benefit of Sirolimus-Eluting Stents in Patients With In-Stent Restenosis: Results of the RIBS-II (Restenosis Intra-stent: Balloon angioplasty vs. elective sirolimus-eluting Stenting) Study

OBJECTIVESnWe sought to assess the long-term effectiveness and safety of sirolimus-eluting stents (SES) in patients with in-stent restenosis (ISR).nnnBACKGROUNDnTreatment of patients with ISR remains a challenge. The long-term outcome of patients with ISR treated with SES remains unknown.nnnMETHODSnThe RIBS-II (Restenosis Intra-stent: Balloon angioplasty vs. elective sirolimus-eluting Stenting) study was a randomized trial conducted in 150 patients with ISR (76 SES, 74 balloon angioplasty [BA]). The long-term (>1 year) clinical outcome and pre-specified subgroup analyses were pre-defined secondary study end points.nnnRESULTSnAt 1 year, the event-free survival (death, myocardial infarction, target vessel revascularization [TVR]) was better in the SES group (88% vs. 69%, p < 0.005). Additional long-term (>3 years) clinical follow-up was obtained in 97% of patients (median 3.3 years). After the first year, 3 patients died (1 SES, 2 BA), 5 suffered myocardial infarction (4 SES, 1 BA), and 7 required TVR (4 SES, 3 BA). At last follow-up, definitive/probable/possible stent thrombosis was similar in both groups (2/2/1 SES vs. 1/0/3 BA, p = NS). At 4 years, the event-free survival was 76% in the SES arm and 65% in the BA arm (p = 0.019). On multivariate analysis, SES implantation was an independent predictor of event-free survival. Subgroup analyses were consistent with the main outcome measure.nnnCONCLUSIONSnIn patients with ISR, SES implantation remains effective and safe at very long-term clinical follow-up.

Sirolimus‐eluting stents versus bare‐metal stents in patients with in‐stent restenosis: Results of a pooled analysis of two randomized studies

Treatment of patients with in‐stent restenosis (ISR) remains a challenge. We sought to compare results of sirolimus‐eluting stents (SES) with those of bare‐metal stents (BMS) in patients with ISR.