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Biomedical subjects

Antonio Colombo

Publications and source records attributed to Antonio Colombo.

At least 109 records · Page 6Linked to original sources
PubMed2004

Clinical and angiographic outcome after sirolimus-eluting stent implantation in aorto-ostial lesions.

OBJECTIVES: This observational study evaluated the clinical and angiographic outcomes of patients with aorto-ostial coronary artery disease treated with sirolimus-eluting stents (SESs) or with bare metal stents (BMSs). BACKGROUND: The safety and effectiveness of SESs for the treatment of aorto-ostial lesions have not been demonstrated. METHODS: We identified 82 consecutive patients who underwent percutaneous coronary interventions in 82 aorto-ostial lesions using the SES (32 patients) or BMS (50 patients) and compared the two groups of patients. The incidence of major adverse cardiac events (MACE), including death or Q-wave myocardial infarction (MI), target lesion revascularization (TLR), and target vessel revascularization (TVR), were recorded in-hospital and at a 10-month follow-up. RESULTS: All stents were implanted successfully. There were no statistically significant differences regarding major in-hospital complications between the two groups. At 10-month follow-up, two (6.3%) patients in the SES group and 14 (28%) patients in the BMS group underwent TLR (p = 0.01); MACE were less frequent in the SES group compared to the BMS group (19% vs. 44%, p = 0.02). Angiographic follow-up showed lower binary restenosis rates (11% vs. 51%, p = 0.001) and smaller late loss (0.21 +/- 0.31 mm vs. 2.06 +/- 1.37 mm, p < 0.0001) in the SES group. CONCLUSIONS: The main finding of our study is that, compared to the BMS, implantation of the SES in aorto-ostial lesions appears safe and effective, with no increase in major in-hospital complications and a significant improvement in restenosis and late event rates at 10-month follow-up.

Aged↗
PubMed2004

N-Acetylcysteine versus fenoldopam mesylate to prevent contrast agent-associated nephrotoxicity.

OBJECTIVES: We performed a study to assess the efficacy of fenoldopam mesylate (a specific agonist of the dopamine-1 receptor) as compared with N-acetylcysteine (NAC) in preventing contrast agent-associated nephrotoxicity (CAN). BACKGROUND: Prophylactic administration of NAC, along with hydration, prevents CAN in patients with chronic renal insufficiency who are undergoing contrast media administration. Preliminary data support the hypothesis that fenoldopam might be as effective as NAC. METHODS: One hundred ninety-two consecutive patients with chronic renal insufficiency, referred to our institution for coronary and/or peripheral procedures, were assigned randomly to receive 0.45% saline intravenously and NAC (1,200 mg orally twice daily; NAC group; n = 97) or fenoldopam (0.10 microg/kg/min; fenoldopam group; n = 95) before and after a nonionic, iso-osmolality contrast dye administration. RESULTS: Baseline creatinine levels were similar in the two groups: NAC group = 1.72 mg/dl (interquartile range, 1.55 to 1.90 mg/dl) and fenoldopam group = 1.75 mg/dl (interquartile range, 1.62 to 2.01 mg/dl) (p = 0.17). An increase of at least 0.5 mg/dl of the creatinine concentration 48 h after the procedure occurred in 4 of 97 patients (4.1%) in the NAC group and in 13 of 95 patients (13.7%) in the fenoldopam group (p = 0.019; odds ratio 0.27; 95% confidence interval 0.08 to 0.85). The amount of contrast media administration was similar in the two groups (NAC group = 160 +/- 82 ml; fenoldopam group = 168 +/- 104 ml; p = 0.54). CONCLUSIONS: N-acetylcysteine seems to be more effective than fenoldopam in preventing CAN.

Acetylcysteine↗
PubMed2004

Effectiveness of sirolimus-eluting stent implantation for treatment of in-stent restenosis after brachytherapy failure.

The impact of the use of sirolimus-eluting stents (SESs) in the treatment of in-stent restenosis in previously irradiated sites has not been adequately evaluated. Fifteen consecutive patients who underwent percutaneous coronary interventions using SESs in lesion sites previously intervened with intracoronary radiation therapy were identified. All stents were implanted successfully, and there were no major in-hospital complications. At 30-day follow-up, there was 1 case of subacute thrombosis that led to target lesion revascularization (TLR). At 6 months, 2 patients underwent TLR because of recurrent angina with angiographic restenosis, and 1 patient underwent target vessel revascularization distally to the SES site; no other major adverse cardiac events occurred at long-term follow-up (mean 17 +/- 8 months).

Adult↗
PubMed2004

Creatine kinase-myocardial band isoenzyme elevation after percutaneous coronary interventions using sirolimus-eluting stents.

We evaluated predictors of increased periprocedural creatine kinase-MB isoenzyme levels after implantation of sirolimus-eluting stents with an intent to fully cover the diseased segment. The total stent length per patient (predisposing factor) and elective use of glycoprotein IIb/IIIa (protective factor) were independent predictors of increased creatine kinase-MB isoenzyme levels.

Angioplasty, Balloon, Coronary↗
PubMed2004

Intraprocedural stent thrombosis during implantation of sirolimus-eluting stents.

BACKGROUND: Intraprocedural stent thrombosis (IPST) is a rare event (<0.01% in our experience with bare metal stents), with the exception of specific settings such as acute myocardial infarction, thrombus-containing lesions, and dissections. We report the occurrence of this event during elective implantation of sirolimus-eluting stents. METHODS AND RESULTS: Between April 2002 and August 2003, 670 patients with 1362 lesions were treated with Cypher (Cordis, Johnson and Johnson Co) sirolimus-eluting stent implantation in San Raffaele Hospital and EMO Centro Cuore Columbus. Diabetes mellitus was present in 142 patients (21%), and 164 (24.5%) had unstable angina. Pretreatment with glycoprotein IIb/IIIa (GP IIb/IIIa) inhibitors was carried out in 235 patients (35%). Total stent length per vessel was 42.9+/-28.3 mm. IPST occurred in 5 patients (0.7%). None of the patients with IPST were pretreated with GP IIb/IIIa inhibitors. Using univariate exact logistic regression, only total stent length per vessel, in millimeters (exact OR, 1.03; 95% CI, 1.011 to 1.046; P=0.0028), was associated with the occurrence of IPST. CONCLUSIONS: Stent length was associated with the occurrence of IPST. Particular attention will need to be directed to this potential complication when long sirolimus-eluting stents are being used.

Adult↗
PubMed2004

Comparison of directional coronary atherectomy and stenting versus stenting alone for the treatment of de novo and restenotic coronary artery narrowing.

Late lumen loss after directional coronary atherectomy (DCA) is mainly determined by arterial remodeling. We hypothesized that stent implantation after optimal lesion debulking could be an effective approach to reduce restenosis. A total of 753 patients with de novo or restenotic coronary lesions were prospectively randomized to DCA plus stenting (n = 381) or stenting alone (n = 372). The patients were followed for 12 months. Procedural success was achieved in 91.5% versus 97.3% (p = 0.0007) of patients treated with DCA plus stent versus stent alone. Optimal atherectomy (<20% residual stenosis) was achieved in 26.5% of patients. The final minimal luminal diameter and the acute gain were similar in the 2 groups. There was no increase in 30-day major adverse cardiac events in the DCA plus stent group (3.9% vs 2.4%, p = 0.30). The primary end point, angiographic restenosis at 8 months, occurred in 26.7% of patients treated with DCA plus stents and in 22.1% of patients treated with stents alone (p = 0.237). Clinical follow-up to 1 year showed no difference in mortality (1.3% vs 0.8%, p = 0.725), acute myocardial infarction (4.2% vs 3.5%, p = 0.706), and target vessel failure (composite of death, Q-wave myocardial infarction, and target vessel revascularization) (23.9% vs 21.5%, p = 0.487) between patients with DCA plus stents and those with stents alone. This study failed to support the hypothesis that DCA before stenting lowers the angiographic restenosis rate compared with stents alone. At 12-month follow-up, there were no significant differences between the 2 groups in rates of death, reinfarction, or target vessel failure.

Adult↗
PubMed2004

Treatment of multivessel coronary artery disease with sirolimus-eluting stent implantation: immediate and mid-term results.

OBJECTIVES: This study evaluated clinical outcome after multivessel stenting with sirolimus-eluting stents (SES) in unselected lesions. BACKGROUND: Safety and effectiveness of multivessel SES implantation is currently unknown. METHODS: Major adverse cardiac events (MACE) (death, myocardial infarction [MI], and repeat revascularization) were analyzed at 30 days and at 6 months after multivessel SES implantation. RESULTS: In 155 consecutive patients, 573 SES were implanted in 3.3 +/- 1.3 lesions per patient. At 30 days, the cumulative MACE rate was 10.3%: 7.1% patients developed a non-Q-wave MI, 1.9% developed a Q-wave MI, 0.6% died for non-cardiac reasons, and 0.6% had a repeat revascularization. Clinical follow-up was obtained in all 112 eligible patients treated for 359 lesions at a mean time of 6.5 +/- 2.2 months. The cumulative MACE rate was 22.3%: 3 (2.7%) deaths (1 for cardiac reasons), 4 (3.6%) MIs, target lesion revascularization (TLR) in 16 (14.3%) patients with 24 (6.7%) lesions. Target vessel revascularization was required in 18 (16.1%) patients due to TLR of lesions treated with SES or to disease progression (1.8% of patients). Cox regression analysis revealed total stent length per patient as the most powerful independent predictor of MACE. Overall stent thrombosis occurred in three (1.9%) patients. CONCLUSIONS: Multivessel SES implantation can be safely performed on patients with complex coronary artery disease. The need for revascularization increases because of the cumulative effect of TLR on patients with multiple lesions.

Aged↗
PubMed2004

Cutting balloon versus conventional balloon angioplasty for the treatment of in-stent restenosis: results of the restenosis cutting balloon evaluation trial (RESCUT).

OBJECTIVES: The aim of this trial was to compare cutting balloon angioplasty (CBA) with conventional balloon angioplasty (i.e., percutaneous transluminal coronary angioplasty [PTCA]) for the treatment of patients with coronary in-stent restenosis (ISR). BACKGROUND: Retrospective studies suggest CBA might be superior to conventional PTCA in the treatment of ISR. METHODS: The Restenosis Cutting Balloon Evaluation Trial (RESCUT) is a multicenter, randomized, prospective European trial including 428 patients with all types of ISR (e.g., focal, multifocal, diffuse, proliferative). RESULTS: In both groups, the majority of ISR lesions were shorter than 20 mm. The length of restenotic stents was similar (CBA: 18.6 +/- 9.7 mm; PTCA: 18.3 +/- 8.7 mm). The number of balloons used to treat ISR was lower in the CBA group: only one balloon was used in 82.3% of CBA cases, compared with 75% of PTCA procedures (p = 0.03). Balloon slippage was less frequent in the CBA group (CBA 6.5%, PTCA 25%; p < 0.01). There was a trend toward a lower need for additional stenting in the CBA group (CBA 3.9%, PTCA 8.0%; p = 0.07). At seven-month angiographic follow-up, the binary restenosis rate was not different between the groups (CBA 29.8%, PTCA 31.4%; p = 0.82), with a similar pattern of recurrent restenosis. Clinical events at seven months were also similar. CONCLUSIONS: Cutting balloon angioplasty did not reduce recurrent ISR and major adverse cardiac events, as compared with conventional PTCA. However, CBA was associated with some procedural advantages, such as use of fewer balloons, less requirement for additional stenting, and a lower incidence of balloon slippage.

Angioplasty, Balloon↗
PubMed2004

Successful reduction of in-stent restenosis in long lesions using beta-radiation--subanalysis from the RENO registry.

PURPOSE: Long lesions remain a challenging task in interventional cardiology, with a high propensity of restenosis, especially within the stented segment. Although intracoronary gamma-radiation has been proved to reduce diffuse in-stent restenosis in long lesions, such an effect remains to be determined using beta-radiation. METHODS AND MATERIALS: Of 1098 consecutive patients at 46 European centers treated with localized beta-radiation ((90)Sr, Novoste Beta-Cath System), 139 patients (mean age 61.5 +/- 10.7 years, 84% male, 22% with diabetes mellitus) with lesions treated using a >40-mm source length underwent radiation using a single 60-mm source train (34%) or a stepping/pullback procedure with a 30-mm (12%) or 40-mm (87%) source length after conventional interventional procedures. The mean lesion length was 35.3 +/- 17.9 mm. RESULTS: Technical success was achieved in 96% of cases. Geographic miss was noted in 9 patients (6.5%). The reference (placebo) group was obtained from the Washington Hospital Center for In-Stent Restenosis Trial (WRIST) and the WRIST Trial for long lesions (LONG WRIST) studies by selecting the cases (94 patients) that required a dummy source length >/=13 seeds (or >51 mm in length). Statistically significant improvement was noted in late angiographic restenosis (34.7% vs. 76.5%, p <0.0001), target vessel revascularization (14.9% vs. 60.6), and major adverse cardiac events (i.e., death, myocardial infarction, or total vessel revascularization) (17.9% vs. 64.9%, p <0.0001) at 6 months in reference to the nonradiation group. CONCLUSION: This subanalysis from the Radiation in Europe with Novoste study confirms the safety and efficacy of beta-radiation combined with conventional interventional procedures in patients with diffuse, long, in-stent restenosis

Aged↗
PubMed2004

Contribution of stent underexpansion to recurrence after sirolimus-eluting stent implantation for in-stent restenosis.

BACKGROUND: We used intravascular ultrasound (IVUS) to evaluate recurrence after sirolimus-eluting stent (SES) implantation treatment of in-stent restenosis (ISR). METHODS AND RESULTS: Forty-eight ISR lesions (41 patients with objective evidence of ischemia) were treated with SES. Recurrent ISR was identified in 11 lesions (all focal); repeat revascularization was performed in 10. These were compared with 16 patients (19 lesions) without recurrence as documented by angiography. Nine of 11 recurrent lesions had a minimum stent area (MSA) <5.0 mm2 versus 5 of 19 nonrecurrent lesions (P=0.003); 7 of 11 recurrent lesions had an MSA <4.0 mm2 versus 4 of 19 nonrecurrent lesions (P=0.02); and 4 of 11 recurrent lesions had an MSA <3.0 mm2 versus 1 of 19 nonrecurrent lesions (P=0.03). A gap between SESs was identified in 3 of 11 recurrences versus 1 of 19 nonrecurrent lesions. CONCLUSIONS: Stent underexpansion is a significant cause of failure after SES implantation treatment of ISR.

Combined Modality Therapy↗
PubMed2004

Randomized study to evaluate sirolimus-eluting stents implanted at coronary bifurcation lesions.

BACKGROUND: A sirolimus-eluting stent (Cypher, Cordis Corp) has been reported to markedly decrease restenosis in selected lesions; higher-risk lesions, including coronary bifurcations, have not been studied. METHODS AND RESULTS: This prospective study evaluated the safety and efficacy of sirolimus-eluting stents for treatment of coronary bifurcation lesions. Patients were randomly assigned to either stenting of both branches (group A) or stenting of the main branch with provisional stenting of the side branch (SB) (group B). Eighty-five patients (86 lesions) were enrolled. There was 1 case of unsuccessful delivery of any device at the bifurcation site. Given the high crossover, more lesions were treated with 2 stents (n=63) than with stent/balloon (n=22). Clinical follow-up at 6 months was completed in all patients and angiographic follow-up in 53 patients in group A (85.5%) and 21 in group B (95.4%). One patient died suddenly 4.5 months after the procedure. There were 3 cases of stent thrombosis (3.5%). The total restenosis rate at 6 months was 25.7%, and it was not significantly different between the double-stenting (28.0%) and the provisional SB-stenting (18.7%) groups. Fourteen of the restenosis cases occurred at the ostium of the SB and were focal. Target lesion revascularization was performed in 7 cases; target vessel failure occurred in 15 cases (17.6%). CONCLUSIONS: These results are an improvement compared with historical controls using bare metal stents. Restenosis at the SB remains a problem. At this time, no statement can be made regarding the most appropriate technique to use when treating bifurcations with the Cypher stent.

Aged↗
PubMed2004

Comparison of diamond-like carbon-coated stents versus uncoated stainless steel stents in coronary artery disease.

Stainless steel (SS) and carbon-coated (CC) stents were randomly compared in 347 patients (520 lesions). No differences were observed in in-hospital major adverse cardiac events: 2.8% in the CC group and 4.5% in the SS group (p = 0.286). The 6-month follow-up showed similar rates of binary restenosis (31.8% in the CC group vs 35.9% in the SS group; p = 0.448) and of cumulative major adverse cardiac events (30.5% in the CC group vs 32.7% in the SS group; p = 0.675). In unselected patients and lesions, carbon coating does not provide significant improvements over SS stents with the same design.

Carbon↗
PubMed2004

Routine use of cerebral protection during carotid artery stenting: results of a multicenter registry of 753 patients.

PURPOSE: To evaluate the short-term outcome of patients who underwent carotid stenting with the routine use of cerebral protection devices. METHODS: In five centers, 808 successful stent procedures (of 815 attempted) were performed in 753 patients (557 [74%] men; mean [+/- SD] age, 70 +/- 8 years). Cerebral protection involved distal filter devices (n=640), occlusive distal balloons (n=144), or proximal balloon protection (n=24). RESULTS: The protection device was positioned successfully in 793 (98.2%) of the 808 attempted vessels. Neurologic complications occurred within 30 days after 46 procedures (5.6%), including seven major strokes, 17 minor strokes, and 22 transient ischemic attacks. There were four deaths (one following a major stroke). The 30-day incidence of stroke and death was 3.3% (27/815). The rate of stroke or death was 3.8% (8/213) for symptomatic lesions and 3.2% (19/602) for asymptomatic lesions (P=0.87), and 3.4% (25/729) in patients aged <80 years and 2% (2/86) in those aged > or =80 years (P=0.81). Protection device-related vascular complications, none of which led to neurologic symptoms, occurred after nine procedures (1.1%). CONCLUSION: In this uncontrolled study, routine cerebral protection during carotid artery stenting was technically feasible and clinically safe. The incidence of major neurologic complications in this study was lower than in previous reports of carotid artery stenting without cerebral protection.

Aged↗
PubMed2004

Vascular responses at proximal and distal edges of paclitaxel-eluting stents: serial intravascular ultrasound analysis from the TAXUS II trial.

BACKGROUND: On the basis of brachytherapy experience, edge stenosis has been raised as a potential limitation for drug-eluting stents. We used serial intravascular ultrasound (IVUS) to prospectively analyze vessel responses in adjacent reference segments after implantation of polymer-controlled paclitaxel-eluting stents. METHODS AND RESULTS: TAXUS II was a randomized, double-blind trial with 2 consecutive patient cohorts that compared slow-release (SR) and moderate-release (MR) paclitaxel-eluting stents with control bare metal stents (BMS). By protocol, all patients had postprocedure and 6-month follow-up IVUS. Quantitative IVUS analysis was performed by an independent core laboratory, blinded to treatment allocation, in 5-mm vessel segments immediately proximal and distal to the stent. Serial IVUS was available for 106 SR, 107 MR, and 214 BMS patients. For all 3 groups, a significant decrease in proximal-edge lumen area was observed at 6 months. The decrease was comparable (by ANOVA, P=0.194) for patients in the SR (-0.54+/-2.1 mm2) and MR (-0.88+/-1.9 mm2) groups compared with the BMS (-1.02+/-1.9 mm2) group. For the distal edge, a significant decrease in lumen area was only observed with BMS (-0.91+/-2.0 mm2, P<0.0001); this decrease was significantly attenuated with SR (0.08+/-2.0 mm2) and MR (-0.19+/-1.7 mm2) stents (P<0.0001 by ANOVA). Negative vessel remodeling was observed at the proximal (-0.48+/-2.2 mm2, P=0.011) but not the distal edges of BMS and at neither edge of SR or MR stents. CONCLUSIONS: The marked reduction in in-stent restenosis with SR or MR stents is not associated with increased edge stenosis at 6-month follow-up IVUS. In fact, compared with BMS, there is instead a significant reduction in late lumen loss at the distal edge with TAXUS stents.

Coronary Restenosis↗
PubMed2004

Incidence, predictors, in-hospital, and late outcomes of coronary artery perforations.

We sought to determine the incidence of coronary perforations, predisposing factors, and in-hospital and late outcome of patients with coronary perforations. Perforations occurred in 0.84% of treated lesions and more frequently in patients with complex lesions after atheroablative procedures and who underwent intravascular ultrasound guided lumen optimization. The incidence of adverse events, emergency coronary artery bypass grafting and death significantly decreased over time.

Causality↗
PubMed2004

Early experience with a novel plaque excision system for the treatment of complex coronary lesions.

The use of directional coronary atherectomy (DCA) in current practice has been limited. The SilverHawk System is a newly developed plaque excision device that aims to overcome the drawbacks of prior DCA platforms. The device was evaluated in a porcine coronary model and in a series of patients. Procedural variables along with outcomes were reviewed. Quantitative angiography (QCA) was performed and excised tissue fragments were weighed and examined histologically. In porcine cases, pretreatment MLD increased from 0.51 +/- 0.26 to 2.36 +/- 0.59 mm postdebulking and 19.9 +/- 7.6 mg of tissue was retrieved. In human cases, pretreatment MLD increased from 0.8 +/- 0.4 to 2.2 +/- 0.5 mm postdebulking and 15.2 +/- 7.8 mg of tissue was retrieved without complications. These data show that the SilverHawk System may offer significant utility in treating a wide variety of complex coronary lesions.

Adult↗
PubMed2004

Intracoronary brachytherapy, a promising treatment option for diabetic patients: Results from a European multicenter registry (RENO).

Despite advances in the interventional treatment of coronary disease, diabetics still have double the case fatality rate as nondiabetics. The purpose of this analysis from the Radiation in Europe With Novoste (RENO) registry was to assess the clinical and angiographic 6-month outcome of diabetic patients in comparison to nondiabetic patients after localized beta-radiation. A total of 1,098 patients (83.8% with in-stent restenosis) treated with the Novoste Beta-Cath system in Europe were enrolled in the RENO registry. Diabetes was, irrespective of the type of lesion treated, no significant risk factor for major adverse cardiac events or target vessel revascularization. Individuals with diabetes (n = 256) and without diabetes (n = 833) displayed no significant differences concerning clinical or angiographic endpoints. Vascular brachytherapy appears to be the first technique to even out the increased risk of diabetic patients undergoing percutaneous coronary interventions in the routine clinical setting. Thus, intracoronary brachytherapy represents a promising treatment option for diabetic patients.

Brachytherapy↗