Showing papers by "Rodolfo Staico published in 2009"

1-year results of the hydroxyapatite polymer-free sirolimus-eluting stent for the treatment of single de novo coronary lesions: the VESTASYNC I trial.

Abstract: Objectives We sought to assess the safety and efficacy of the novel VESTAsync-eluting stent (MIV Therapeutics, Atlanta, Georgia) combining a stainless steel platform with a nanothin-microporous hydroxyapatite surface coating impregnated with a polymer-free low-dose of sirolimus (55 μg). Background Durable polymers in first-generation drug-eluting stents (DES) have been linked to local inflammatory reaction leading to a positive vessel remodeling, late incomplete stent apposition, and in some cases, stent thrombosis. The removal of the polymer from the DES system could increase the safety profile of this novel technology. Methods A total of 15 patients with single de novo lesions in native coronary arteries with 3.0- to 3.5-mm diameter and ≤14-mm length were enrolled in this first-in-man study. Primary end point was in-stent late lumen loss (LL) at 4 and 9 months. Results Baseline characteristics included mean age of 63 years and 33% of diabetics. Reference vessel diameter and lesion length were 2.7 ± 0.3 mm and 10 ± 2.0 mm, respectively. Procedure success was obtained in all cases. Lifelong aspirin and 5-month clopidogrel treatment were prescribed to all patients. At 4 months, in-stent LL and percentage of neointimal hyperplasia were 0.3 ± 0.25 mm and 2.6 ± 2.2%, respectively, with a nonsignificant increase at 9 months (0.36 ± 0.23 mm and 4.0 ± 2.2%, respectively). Serial intravascular ultrasound did not show late incomplete stent apposition. There were no major adverse cardiac events within 1 year of follow-up. Conclusions The novel VESTAsync-eluting stent was effective in reducing LL and neointimal hyperplasia at 4 and 9 months, with no evidence of late catch-up by quantitative coronary angiography or intravascular ultrasound.

Angiographic and intravascular ultrasound findings following implantation of the Endeavor zotarolimus-eluting stents in patients from the real-world clinical practice.

Abstract: Aims: The aim of this study was to investigate the angiographic and intravascular ultrasound (IVUS) findings of the Endeavor™ zotarolimus-eluting stent (ZES) in patients from a “real-world” clinical practice. Methods and results: From January to March 2006, 100 patients undergoing routine or emergency percutaneous intervention were prospectively enrolled at one institution. Overall, 39% of the patients were diabetics and 80.8% of lesions were type B2/C. A total of 140 lesions were successfully treated with 174 ZES, and procedural success was 98%. Mean vessel diameter was 2.69 mm and mean lesion length was 16.0 mm; at 6-month angiographic follow-up (completed in 96%), in-stent late lumen loss was 0.66 mm, and in-segment restenosis was 8.2%. Angiographic restenosis was increased among diabetics (15.5 vs. 2.6%, p=0.009), and diabetes was the only significant predictor of angiographic restenosis (OR=15.27 [95%CI 2.45-95.04], p=0.003). By IVUS (performed in 88% at 6-month), % volume obstruction was 14.4±13.4%, and there was no late acquired incomplete stent apposition (ISA). At 1-year, overall MACE rate was 6%, including 5 TLRs (4% of patients), with no occurrence of stent thrombosis. Conclusions: In this prospective “real-world” experience, the ZES demonstrated favourable angiographic and IVUS results in complex patients, with overall in-stent late lumen loss of 0.66 mm, and absence of late acquired ISA. At 1-year, there were no safety concerns including absence of death and stent thrombosis.

Correlation between quantitative angiographic and intravascular ultrasound parameters in patients treated with sirolimus analogous-eluting stents

Abstract: Despite the undeniable contribution of intravascular ultrasound (IVUS) and quantitative coronary angiography (QCA) to assess drug-eluting stent (DES) effectiveness, the way these image modalities correlate to each other and to target-lesion revascularization (TLR) after PCI, is yet to be established Thus we sought to evaluate whether there is an acceptable correlation between QCA and IVUS after DES implantation We analyzed 204 pts treated with DES: Zotarolimus- (126), Sirolimus- (57), and Biolimus (31) with baseline and follow-up QCA and IVUS The correlation between QCA lumen loss (LL) and intimal hyperplasia (IH) volume obstruction by IVUS was assessed by multiple regression analysis Two QCA parameters (in-segment diameter stenosis and in-segment LL) and one IVUS variable (in-stent volume of IH) were evaluated as quantitative surrogates of 6 month TLR The receiver operating characteristic method with c-statistics was used to assess the ability of each surrogate endpoint to predict TLR QCA LL correlated positively with IVUS IH volume of obstruction (r = 069; CI95% 061–075: P < 00001), independent of DES type The 2 QCA parameters were superior to the IVUS parameter as surrogates for TLR Of note, QCA LL (c = 099) correlated best with TLR, even better than percent DS In the DES era there is a good correlation between QCA measured LL and IVUS IH volume and therefore can be used as a surrogate of DES efficacy