Paclitaxel-eluting balloon versus everolimus-eluting stent for treatment of drug-eluting stent restenosis.

Drug-eluting stent (DES) implantation is a very effective treatment of bare-metal stent-in-stent restenosis (BMS-ISR). Therapeutic options for drug-eluting stent-in-stent restenosis (DES-ISR) are less well defined, as there are only few data on safety and effectiveness of interventional modalities. This study compared the 1-year clinical outcome after the use of drug-eluting balloon (DEB) to second-generation everolimus-eluting stent (EES) for treatment of DES-ISR. This observational study included 86 patients with 86 DES-ISR. Forty patients were treated by repeat percutaneous coronary intervention (PCI) using an EES. Forty-six patients were treated by repeat PCI using a DEB. Follow-up periods were 22 ± 11 and 25 ± 19 months, respectively. The primary endpoint of the study was survival free of major adverse cardiac events (MACEs) at 1 year. Secondary endpoints were needed for target lesion revascularization (TLR), definite stent thrombosis (ST) at 1 year, and MACE rate during total follow-up period. Baseline clinical and angiographic parameters were comparable between the two groups. EES were associated with a higher MACE rate at 1 year compared to DEB (27.5 vs. 8.6%, respectively; P = 0.046). TLR rates for EES and DEB were 22.5% versus 4.3%, respectively, P = 0.029, while rates of definite ST at 1 year follow-up were comparable (2.5% vs. 0%, respectively; P = 0.945). There were no differences in myocardial infarction rates between the two groups (5% vs. 2%, respectively; P = 0.595) and in mortality. Considering the complete follow-up periods, DEB were associated with significantly less MACE compared to EES (log-rank test, P = 0.045). Furthermore, comparison of TLR rates showed a strong trend in favor of DEB compared to EES (P = 0.074). Treatment of DES-ISR using a DEB is associated with favorable rates of MACE and TLR at 1-year follow-up compared to the implantation of an EES.

Almalla M ，Schröder J ，Pross V ，Marx N ，Hoffmann R ... -  《-》

Effectiveness of everolimus-eluting stents in the treatment of drug-eluting stent versus bare-metal stent restenosis.

Almalla M ，Pross V ，Marx N ，Hoffmann R ... -  《-》

Two-year outcomes after first- or second-generation drug-eluting or bare-metal stent implantation in all-comer patients undergoing percutaneous coronary intervention: a pre-specified analysis from the PRODIGY study (PROlonging Dual Antiplatelet Treatment

This study sought to assess device-specific outcomes after implantation of bare-metal stents (BMS), zotarolimus-eluting Endeavor Sprint stents (ZES-S), paclitaxel-eluting stents (PES), or everolimus-eluting stents (EES) (Medtronic Cardiovascular, Santa Rosa, California) in all-comer patients undergoing percutaneous coronary intervention. Few studies have directly compared second-generation drug-eluting stents with each other or with BMS. We randomized 2,013 patients to BMS, ZES-S, PES, or EES implantation. At 30 days, each stent group received up to 6 or 24 months of clopidogrel therapy. The key efficacy endpoint was the 2-year major adverse cardiac event (MACE) including any death, myocardial infarction, or target vessel revascularization, whereas the cumulative rate of definite or probable stent thrombosis (ST) was the key safety endpoint. Clinical follow-up at 2 years was complete for 99.7% of patients. The MACE rate was lowest in EES (19.2%; 95% confidence interval [CI]: 16.0 to 22.8), highest in BMS (32.1%; 95% CI: 28.1 to 36.3), and intermediate in PES (26.2%; 95% CI: 22.5 to 30.2) and ZES-S (27.8%; 95% CI: 24.1 to 31.9) groups (chi-square test = 18.9, p = 0.00029). The 2-year incidence of ST in the EES group (1%; 95% CI: 0.4 to 2.2) was similar to that in the ZES-S group (1.4%; 95% CI: 0.7 to 2.8), whereas it was lower compared with the PES (4.6%, 95% CI: 3.1 to 6.8) and BMS (3.6%; 95% CI: 2.4 to 5.6) groups (chi-square = 16.9; p = 0.0001). Our study shows that cumulative MACE rate, encompassing both safety and efficacy endpoints, was lowest for EES, highest for BMS, and intermediate for PES and ZES-S groups. EES outperformed BMS also with respect to the safety endpoints with regard to definite or probable and definite, probable, or possible ST. (PROlonging Dual antiplatelet treatment after Grading stent-induced Intimal hyperplasia studY [PRODIGY]; NCT00611286).

Valgimigli M ，Tebaldi M ，Borghesi M ，Vranckx P ，Campo G ，Tumscitz C ，Cangiano E ，Minarelli M ，Scalone A ，Cavazza C ，Marchesini J ，Parrinello G ，PRODIGY Investigators ... -  《-》

5-year results of a randomized comparison of XIENCE V everolimus-eluting and TAXUS paclitaxel-eluting stents: final results from the SPIRIT III trial (clinical evaluation of the XIENCE V everolimus eluting coronary stent system in the treatment of patient

This study sought to evaluate the long-term safety and efficacy of everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) in patients with obstructive coronary artery disease. The use of EES compared to PES has been shown to result in improved clinical outcomes in patients undergoing PCI. However, there have been concerns regarding the durability of these benefits over longer-term follow-up. SPIRIT III was a prospective, multicenter trial in which 1,002 patients were randomized 2:1 to EES versus PES. Endpoints included ischemia-driven target vessel failure (TVF) (death, myocardial infarction (MI), or ischemia-driven target vessel revascularization [TVR]), the pre-specified primary endpoint), target lesion failure (TLF) (cardiac death, target-vessel MI, or ischemia-driven target lesion revascularization [TLR]), major adverse cardiac events (MACE) (cardiac death, MI, or ischemia-driven TLR), their individual components and stent thrombosis. Five-year follow-up was available in 91.9% of patients. Treatment with EES versus PES resulted in lower 5-year Kaplan-Meier rates of TVF (19.3% vs. 24.5%, p = 0.05), TLF (12.7% vs. 19.0%, p = 0.008), and MACE (13.2% vs. 20.7%, p = 0.007). EES also resulted in reduced rates of all-cause death (5.9% vs. 10.1%, p = 0.02), with nonsignificantly different rates of MI, stent thrombosis, and TLR, and no evidence of late catch-up of TLR over time. At 5 years after treatment, EES compared to PES resulted in durable benefits in composite safety and efficacy measures as well as all-cause mortality. Additionally, the absolute difference in TLR between devices remained stable over time without deterioration of effect during late follow-up.

Gada H ，Kirtane AJ ，Newman W ，Sanz M ，Hermiller JB ，Mahaffey KW ，Cutlip DE ，Sudhir K ，Hou L ，Koo K ，Stone GW ... -  《-》

Clinical outcomes of the Resolute zotarolimus-eluting stent in patients with in-stent restenosis: 2-year results from a pooled analysis.

This study sought to assess the clinical safety and effectiveness of the Resolute zotarolimus-eluting stent (R-ZES) in patients with in-stent restenosis (ISR) from 2 large trials. ISR treatment is associated with higher rates of subsequent cardiac events compared with treatment of de novo lesions. Although drug-eluting stents (DES) are an option, second-generation DES are largely untested in the treatment of ISR. A total of 3,489 patients were pooled from the RAC (RESOLUTE All Comers) trial and the RESOLUTE International (RINT) registry. Two-year clinical endpoints included clinically driven target lesion revascularization (TLR), target lesion failure (TLF), cardiac death (CD), target vessel myocardial infarction (TVMI), combined CD or TVMI (CD/TVMI), and Academic Research Consortium definite and probable stent thrombosis (ST). Overall, 281 patients (8.1%) received an R-ZES for ISR. Two-year TLR and TLF rates were significantly higher in ISR patients than in non-ISR patients (TLR: 12.7% vs. 4.3%, p = 0.003; TLF: 17.4% vs. 9.4%, p = 0.007); however, the CD/TVMI rate was not (6.9% vs. 6.1%, p = 0.711). Seven ISR patients had ST. Two-year outcomes by ISR stent type were similar: bare-metal stent (BMS)-ISR TLR was 12.5% and TLF was 17.2%; DES-ISR TLR was 13.0% and TLF was 18.8%. CD/TVMI was 7.3% and 7.2% for BMS-ISR and DES-ISR, respectively. Using R-ZES to treat ISR appears equally safe in BMS-ISR and DES-ISR, with CD/TVMI rates comparable to 2-year outcomes in other clinical trials. Although revascularization rates are still higher in ISR lesions, the R-ZES offers an effective alternative for treatment of BMS-ISR and DES-ISR. (Randomized, Two-Arm, Non-inferiority Study Comparing Endeavor-Resolute Stent With Abbot Xience-V Stent [RESOLUTE-AC]; NCT00617084; and RESOLUTE International Registry: Evaluation of the Resolute Zotarolimus-Eluting Stent System in a 'Real-World' Patient Population [RINT]; NCT00752128).

Richardt G ，Leschke M ，Abdel-Wahab M ，Toelg R ，El-Mawardy M ，Serruys PW ，Silber S ，Windecker S ，Belardi JA ，Neumann FJ ，Widimsky P ，RESOLUTE All Comers ，RESOLUTE International Investigators ... -  《-》