Eduardo Sousa

Randomised comparison of implantation of heparin-coated stents with balloon angioplasty in selected patients with coronary artery disease (Benestent II)

BACKGROUND The multicentre, randomised Benestent-II study investigated a strategy of implantation of a heparin-coated Palmar-Schatz stent plus antiplatelet drugs compared with the use of balloon angioplasty in selected patients with stable or stabilised unstable angina, with one or more de-novo lesions, less than 18 mm long, in vessels of diameter 3 mm or more. METHODS 827 patients were randomly assigned stent implantation (414 patients) or standard balloon angioplasty (413 patients). The primary clinical endpoint was event-free survival at 6 months, including death, myocardial infarction, and the need for revascularisation. The secondary endpoints were the restenosis rate at 6 months and the cost-effectiveness at 12 months. There was also one-to-one subrandomisation to either clinical and angiographic follow-up or clinical follow-up alone. Analyses were by intention to treat. FINDINGS Four patients (one stent group, three angioplasty group) were excluded from analysis since no lesion was found. At 6 months, a primary clinical endpoint had occurred in 53 (12.8%) of 413 patients in the stent group and 79 (19.3%) of 410 in the angioplasty group (p=0.013). This significant difference in clinical outcome was maintained at 12 months. In the subgroup assigned angiographic follow-up, the mean minimum lumen diameter was greater in the stent group than in the balloon-angioplasty group, (1.89 [SD 0.65] vs 1.66 [0.57] mm, p=0.0002), which corresponds to restenosis rates (diameter stenosis > or =50%) of 16% and 31% (p=0.0008). In the group assigned clinical follow-up alone, event-free survival rate at 12 months was higher in the stent group than the balloon-angioplasty group (0.89 vs 0.79, p=0.004) at a cost of an additional 2085 Dutch guilders (US

Feasibility of Transcatheter Aortic Valve Implantation Without Balloon Pre-Dilation: A Pilot Study

1020) per patient. INTERPRETATION Over 12-month follow-up, a strategy of elective stenting with heparin-coated stents is more effective but also more costly than balloon angioplasty.

Evaluation of coronary remodeling after Sirolimus-Eluting stent implantation by serial Three-Dimensional intravascular ultrasound

OBJECTIVES The purpose of this pilot study was to evaluate the feasibility and safety of transcatheter aortic valve implantation (TAVI) without balloon pre-dilation. BACKGROUND Balloon pre-dilation of the stenosed aortic valve is currently believed to be a necessary step for valve preparation before device placement in patients undergoing TAVI and, therefore, is considered an obligatory part of the procedure. However, clear evidence supporting this policy is lacking. In contrast, pre-dilation might be responsible in part for distal embolizations as well as atrioventricular conduction disturbances seen during TAVI procedures. METHODS A total of 60 consecutive patients (mean age 80.1 ± 6.4 years, 53% female, mean logistic EuroScore 23.3 ± 15.2%) undergoing TAVI using the self-expanding Medtronic CoreValve prosthesis (Medtronic, Minneapolis, Minnesota) have been prospectively enrolled at 13 international centers. RESULTS Pre-procedural mean transaortic valve gradient was 47.8 ± 15.5 mm Hg, mean effective orifice area was 0.67 ± 0.15 cm(2). Technical success rate was 96.7% (58 of 60) of patients. Post-dilation was performed in 16.7% (10 of 60) of patients. Post-procedural mean valve gradient was 4.4 ± 2.0 mm Hg. Circular and noncircular valve configuration was present in 41 and 19 cases (68.3% vs. 31.7%), respectively, with similar effective orifice areas (1.74 ± 0.10 cm(2) vs. 1.71 ± 0.22 cm(2), p = NS). In-hospital mortality, myocardial infarction, stroke, and major vascular complications occurred in 6.7% (4 of 60), 0%, 5%, and 10% of patients. There was no valve embolization. New permanent pacing was needed in 11.7% (7 of 60) of patients. CONCLUSIONS Transcatheter aortic valve implantation without balloon pre-dilation is feasible and safe, resulting in similar acute safety and efficacy as the current standard approach of TAVI with pre-dilation.

The NUGGET study: NIR ultra gold-gilded equivalency trial.

This study evaluates the response of the coronary vessel wall to implantation of the sirolimus-eluting stent (SES), Bx-VELOCITY, by using serial intravascular ultrasound. SESs have a major impact on the inhibition of in-stent neointimal hyperplasia. However, changes in the vessel wall and behind stent struts in animal models and humans have not been evaluated after SES implantation. Thirty-four patients who received a SES (n = 24) or a Bx-VELOCITY bare stent (BS) (n = 10) for single de novo coronary lesions and had serial motorized pullback 3-dimensional intravascular ultrasound were included. Stent, lumen, and vessel volumes were similar in the 2 groups at baseline. At follow-up, significantly larger lumen and lower neointimal hyperplasia volumes (0.7 vs 33 mm(3), p = 0.001) were seen in the SES group compared with the BS group. There was no significant difference between SES and BS in either the vessel volume (+2.4% vs +0.7%, p = NS) or the plaque behind stent volume change (+3.4% vs +2.5%, p = NS) from after the procedure to late follow-up. The stent edges also showed no significant difference between postprocedural and follow-up measurements, either in patients receiving SESs or BSs. No stented or edge segment required redilatation in the SES group, whereas 2 patients underwent repeat percutaneous coronary angioplasty in the BS group. In the SES group, 1 patient (4%) showed late acquired incomplete stent apposition. Thus, the SES is effective in inhibiting neointimal hyperplasia without affecting vessel volume and plaque behind the stent.

Intravascular-ultrasound-guided percutaneous transluminal coronary angioplasty/provisional stent implantation strategy: impact on long-term clinical follow-up

This study should clarify whether the gold‐coated NIROYAL stent is equivalent to the stainless steel NIR stent. Patients were randomized to either NIR stent (n = 298) or a NIROYAL stent (n = 305). The primary endpoint was the minimum lumen diameter of the target lesion at 6 months postprocedure. Secondary endpoints focused on clinical events. At 30 days, adverse events were similar in both groups. At 6 months, the minimal lumen diameter was 1.83/1.64 mm (P < 0.001; 95% CI = 0.08–0.30) and the angiographic restenosis rate was 20.6%/37.7% (P < 0.001; 95% CI = −24.7 to −9.3) for NIR/NIROYAL. The 6‐month MACE rates were NIR 7.4% and NIROYAL 10.5% (95% CI = −7.7 to 1.4). Compared to stainless steel stent, the NIROYAL stent demonstrated a smaller minimal lumen diameter, a higher late loss (i.e., higher neointimal hyperplasia in spite of a significantly better initial gain), with higher restenosis and similar MACE rates at 6 months. Catheter Cardiovasc Interv 2004;62:18–25.

DIRECT TRANSCATHETER AORTIC VALVE REPLACEMENT VERSUS IMPLANTATION WITH BALLOON PREDILATATION: INSIGHTS FROM THE BRAZILIAN TAVR REGISTRY

Two hundred and eighty-four consecutive patients with 438 native coronary artery stenoses were enrolled prospectively in a study of intravascular ultrasound (IVUS)-guided percutaneous transluminal coronary angioplasty (PTCA) with provisional stenting: (1) aggressive lesion-site media-to-media balloon-sizing; (2) IVUS-assessment of residual lumen dimensions to identify optimal PTCA results (minimum lumen area = 65% of the average of the proximal and distal reference lumen areas or = 6.0 mm 2 and no major dissection); and (3) liberal stent crossover. Overall, 206 stenoses in 134 patients (47%) were treated with PTCA alone. Reasons for crossover were flow-limiting or lumen-compromising dissections in 28% of patients and suboptimal IVUS minimum lumen area in 72% of patients. At one year, 8% of stenoses in the PTCA group and 16% in the stent crossover group required revascularization. In approximately half of the patients treated using an IVUS-guided aggressive PTCA strategy, stent implantation could be avoided without sacrificing an increase in acute complications or worse clinical outcome.

Sirolimus- vs Paclitaxel-Eluting Stents in De Novo Coronary Artery Lesions: The REALITY Trial: A Randomized Controlled Trial

Direct transcatheter aortic valve replacement (TAVR) is regarded as having potential advantages over TAVR with balloon aortic valve predilatation (BAVP) in reducing procedural complications. However, there is few data to support this approach. The objective of the study was to compare clinical