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Antonio Colombo

Publications and source records attributed to Antonio Colombo.

At least 73 records · Page 4Linked to original sources
PubMed2005

Immediate and mid-term outcomes of sirolimus-eluting stent implantation for chronic total occlusions.

AIMS: To evaluate the outcomes of sirolimus-eluting stent (SES) implantation for the treatment of chronic total occlusion (CTO). METHODS AND RESULTS: We identified 122 patients who underwent revascularization in CTO lesions with SES from April 2002 to April 2004 (SES group). A control group was composed of 259 consecutive patients with CTO lesions treated with bare metal stents (BMS) in the 24 months immediately before the introduction of SES (BMS group). At 6-month follow-up, the cumulative rate of major adverse cardiac events (MACE) was 16.4% in the SES group and 35.1% in the BMS group (P<0.001). The incidence of restenosis was 9.2% in the SES group and 33.3% in the BMS group (P<0.001). The need for revascularization in the SES group was significantly lower, both target lesion revascularization (7.4 vs. 26.3%, P<0.001) and target vessel revascularization (9.0 vs. 29.0%, P<0.001). BMS implantation (HR: 2.97; 95% CI: 1.80-4.89; P<0.001), lesion length (>20 mm) (HR: 2.02; 95% CI: 1.37-2.99; P=0.0004), and baseline reference vessel diameter (>2.8 mm) (HR: 0.62; 95% CI: 0.42-0.92; P=0.02) were identified as predictors of MACE during 6-month follow-up. CONCLUSION: Compared with BMS, SES implantation in CTO lesions appears to be effective in reducing the incidence of restenosis and the need for revascularization at 6 months.

Case-Control Studies↗
PubMed2005

Treatment of saphenous vein graft lesions with drug-eluting stents: immediate and midterm outcome.

OBJECTIVES: The purpose of the present report was to evaluate clinical and angiographic outcomes of drug-eluting stent (DES) implantation in saphenous vein graft (SVG) lesions. BACKGROUND: The safety and efficacy of DES implantation for the treatment SVG lesions remains uncertain. METHODS: We evaluated in-hospital and six-month outcomes in 61 consecutive patients treated with DES in SVG lesions from March 2002 to March 2004 (DES group), as compared to 89 consecutive patients treated with bare-metal stents (BMS) in the 24 months immediately before the introduction of DES (BMS group). Major adverse cardiac events (MACE) including death, myocardial infarction, target lesion revascularization (TLR), and target vessel revascularization (TVR) were recorded in-hospital and at six-month follow-up. RESULTS: The rate of in-hospital MACE was similar between the two groups (6.6% vs. 5.6%, p = 1.0). Cumulative MACE at six months was 11.5% in the DES group and 28.1% in the BMS group (p = 0.02). The DES group had a significantly lower incidence of in-segment restenosis (10.0% vs. 26.7%, p = 0.03), TLR (3.3% vs. 19.8%, p = 0.003), and TVR (4.9% vs. 23.1%, p = 0.003). By Cox regression analysis, diabetes (hazard ratio [HR]: 3.03; 95% confidence interval [CI]: 1.33 to 6.90; p = 0.008), usage of BMS (HR: 2.53; 95% CI: 1.07 to 5.97; p = 0.03), and age of SVG (HR: 1.10; 95% CI: 1.02 to 1.19; p = 0.02) were identified as predictors of MACE at six-month follow-up. CONCLUSIONS: Compared to BMS implantation, DES implantation in SVG lesions appears safe with favorable and improved mid-term outcomes.

Aged↗
PubMed2005

In-hospital and nine-month outcome of treatment of coronary bifurcational lesions with sirolimus-eluting stent.

Between April 2002 and May 2004, 174 consecutive patients who underwent percutaneous coronary intervention of bifurcational lesions with sirolimus-eluting stents were identified. Two strategies were used: stenting only 1 branch (group 1S, n = 57) or stenting both branches (group 2S, n = 117). The incidence of major adverse cardiac events was evaluated in the hospital and at 9-month follow-up. There were no statistically significant differences between the 2 groups with regard to the incidence of target lesion revascularization (5.4% vs 8.9%, p = 0.76), target vessel revascularization (5.4% vs 11.1%, p = 0.51), and cumulative major adverse cardiac events (18.9% vs 23.3%, p = 0.76) at 9 months.

Aged↗
PubMed2005

Guidelines for percutaneous coronary interventions. The Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology.

In patients with stable CAD, PCI can be considered a valuable initial mode of revascularization in all patients with objective large ischaemia in the presence of almost every lesion subset, with only one exception: chronic total occlusions that cannot be crossed. In early studies, there was a small survival advantage with CABG surgery compared with PCI without stenting. The addition of stents and newer adjunctive medications improved the outcome for PCI. The decision to recommend PCI or CABG surgery will be guided by technical improvements in cardiology or surgery, local expertise, and patients' preference. However, until proved otherwise, PCI should be used only with reservation in diabetics with multi-vessel disease and in patients with unprotected left main stenosis. The use of drug-eluting stents might change this situation. Patients presenting with NSTE-ACS (UA or NSTEMI) have to be stratified first for their risk of acute thrombotic complications. A clear benefit from early angiography (<48 h) and, when needed, PCI or CABG surgery has been reported only in the high-risk groups. Deferral of intervention does not improve outcome. Routine stenting is recommended on the basis of the predictability of the result and its immediate safety. In patients with STEMI, primary PCI should be the treatment of choice in patients presenting in a hospital with PCI facility and an experienced team. Patients with contra-indications to thrombolysis should be immediately transferred for primary PCI, because this might be their only chance for quickly opening the coronary artery. In cardiogenic shock, emergency PCI for complete revascularization may be life-saving and should be considered at an early stage. Compared with thrombolysis, randomized trials that transferred the patients for primary PCI to a 'heart attack centre' observed a better clinical outcome, despite transport times leading to a significantly longer delay between randomization and start of the treatment. The superiority of primary PCI over thrombolysis seems to be especially clinically relevant for the time interval between 3 and 12 h after onset of chest pain or other symptoms on the basis of its superior preservation of myocardium. Furthermore, with increasing time to presentation, major-adverse-cardiac-event rates increase after thrombolysis, but appear to remain relatively stable after primary PCI. Within the first 3 h after onset of chest pain or other symptoms, both reperfusion strategies seem equally effective in reducing infarct size and mortality. Therefore, thrombolysis is still a viable alternative to primary PCI, if it can be delivered within 3 h after onset of chest pain or other symptoms. Primary PCI compared with thrombolysis significantly reduced stroke. Overall, we prefer primary PCI over thrombolysis in the first 3 h of chest pain to prevent stroke, and in patients presenting 3-12 h after the onset of chest pain, to salvage myocardium and also to prevent stroke. At the moment, there is no evidence to recommend facilitated PCI. Rescue PCI is recommended, if thrombolysis failed within 45-60 min after starting the administration. After successful thrombolysis, the use of routine coronary angiography within 24 h and PCI, if applicable, is recommended even in asymptomatic patients without demonstrable ischaemia to improve patients' outcome. If a PCI centre is not available within 24 h, patients who have received successful thrombolysis with evidence of spontaneous or inducible ischaemia before discharge should be referred to coronary angiography and revascularized accordingly--independent of 'maximal' medical therapy.

Angioplasty, Balloon, Coronary↗
PubMed2005

Maintenance of long-term clinical benefit with sirolimus-eluting coronary stents: three-year results of the RAVEL trial.

BACKGROUND: The use of sirolimus-eluting coronary stents has been associated with a nearly complete elimination of restenosis at 6 months and with a very low 1-year incidence of major adverse cardiac events (MACE). This analysis examined whether these beneficial effects persist over the longer term. METHODS AND RESULTS: This multicenter trial randomly assigned 238 patients to revascularization of single, de novo, native coronary artery lesions with sirolimus-eluting versus conventional bare-metal stents. Survival free from target lesion revascularization (TLR), target vessel failure (TVF), and MACE up to 3 years of follow-up was compared between the 2 treatment groups. Complete data sets were available in 94.2% of patients treated with sirolimus-eluting stents and in 94.1% of patients randomized to the control group. The cumulative 1-, 2-, and 3-year event-free survival rates were 99.2%, 96.5%, and 93.7% for TLR and 95.8%, 92.3%, and 87.9% for TVF, respectively, in the sirolimus-eluting stent group, versus 75.9%, 75.9%, and 75.0% for TLR and 71.2%, 69.4%, and 67.3% for TVF in the control group (P<0.001 for both comparisons at 3 years). Rates of MACE at 3 years were 15.8% in patients randomly assigned to sirolimus-eluting stents versus 33.1% in patients assigned to bare-metal stents (P=0.002). One patient treated with a sirolimus-eluting stent died of a cardiac cause between 12 and 36 months. CONCLUSIONS: Treatment of de novo coronary stenosis with sirolimus-eluting stents was associated with a sustained clinical benefit and very low rates of TLR and of other MACE up to 3 years after device implantation.

Coronary Restenosis↗
PubMed2005

Incomplete stent apposition after implantation of paclitaxel-eluting stents or bare metal stents: insights from the randomized TAXUS II trial.

BACKGROUND: The clinical impact of late incomplete stent apposition (ISA) for drug-eluting stents is unknown. We sought to prospectively investigate the incidence and extent of ISA after the procedure and at 6-month follow-up of paclitaxel-eluting stents in comparison with bare metal stents (BMS) and survey the clinical significance of ISA over a period of 12 months. METHODS AND RESULTS: TAXUS II was a randomized, double-blind study with 536 patients in 2 consecutive cohorts comparing slow-release (SR; 131 patients) and moderate-release (MR; 135 patients) paclitaxel-eluting stents with BMS (270 patients). This intravascular ultrasound (IVUS) substudy included patients who underwent serial IVUS examination after the procedure and at 6 months (BMS, 240 patients; SR, 113; MR, 116). The qualitative and quantitative analyses of ISA were performed by an independent, blinded core laboratory. More than half of the instances of ISA observed after the procedure resolved at 6 months in all groups. No difference in the incidence of late-acquired ISA was observed among the 3 groups (BMS, 5.4%; SR, 8.0%; MR, 9.5%; P=0.306), with a similar ISA volume (BMS, 11.4 mm3; SR, 21.7 mm3; MR, 8.5 mm3; P=0.18). Late-acquired ISA was the result of an increase of vessel area without change in plaque behind the stent. Predictive factors of late-acquired ISA were lesion length, unstable angina, and absence of diabetes. No stent thrombosis occurred in the patients diagnosed with ISA over a period of 12 months. CONCLUSIONS: The incidence and extent of late-acquired ISA are comparable in paclitaxel-eluting stents and BMS. ISA is a pure IVUS finding without clinical repercussions.

Aged↗
PubMed2005

Early and mid-term results of drug-eluting stent implantation in unprotected left main.

BACKGROUND: The safety and efficacy of percutaneous coronary intervention in unprotected left main (ULM) coronary arteries are still a matter of debate. METHODS AND RESULTS: All consecutive patients who had a sirolimus-eluting stent (Cypher, Cordis, Johnson and Johnson Co) or a paclitaxel-eluting stent (Taxus, Boston Scientific) electively implanted in de novo lesions on unprotected left main were analyzed. Patients treated with a drug-eluting stent (DES) were compared with the historical group of consecutive patients treated with bare metal stent (BMS). Eighty-five patients were treated with DES; 64 had BMS implantation. Patients treated with DES had lower ejection fractions (51.1+/-11% versus 57.4+/-13%, P=0.002) and were more often diabetics (21.2% versus 10.9%, P=0.12) with more frequent distal left main involvement (81.2% versus 57.8%, P=0.003). Furthermore, in the DES group, smaller vessels (3.33+/-0.6 versus 3.7+/-0.7 mm, respectively; P=0.0001) with more lesions (2.94+/-1.6 versus 2.25+/-1.3, P=0.004) and vessels (2.03+/-0.69 versus 1.8+/-0.72, P=0.05) were treated with longer stents (24.3+/-12 versus 15.8+/-8.6 mm, P=0.0001). Despite the higher-risk patients and lesion profiles in the DES group, the incidence of major cardiac events at a 6-month clinical follow-up was lower in the DES than in the BMS group (20.0% versus 35.9%, respectively; P=0.039). Moreover, cardiac deaths occurred in 3 DES patients (3.5%), as compared with 6 (9.3%) in the BMS group (P=0.17). CONCLUSIONS: In this early experience with DES in unprotected left main, this procedure appears safe with favorable and improved clinical results as compared with historical control subjects with a BMS. A randomized study comparing surgery appears justified at present.

Aged↗
PubMed2005

Is bare-metal stenting superior to balloon angioplasty for small vessel coronary artery disease? Evidence from a meta-analysis of randomized trials.

AIMS: To compare, by meta-analytical techniques, the clinical impact of bare-metal stenting vs. balloon angioplasty for the treatment of lesions in small coronary arteries. METHODS AND RESULTS: We included trials with random allocation and prospective comparison of angioplasty vs. stenting, reference vessel diameter<3 mm, and follow-up>or=6 months. Random effect odds ratios (OR) for death, myocardial infarction (MI), repeat revascularization (RR), and major adverse cardiac events (MACEs) were computed. In a pre-specified subgroup analysis, we compared stenting with optimal (post-procedural stenosis<20%) and suboptimal (>20%) angioplasty. Thirteen studies (4383 patients) were selected. No differences were found in terms of death and MI, while MACEs, mainly driven by RR, were significantly less common after stenting (17.6%) than after angioplasty (22.7%), OR 0.71 (0.57-0.90). Heterogeneity among trials was present. When considering only optimal angioplasty, MACE rates were homogeneously similar, 17.9 vs. 21.1%, OR 0.86 (0.66-1.11). If angioplasty were suboptimal, MACEs were significantly more common after angioplasty (24%) than after stenting (17.3%), OR 0.62 (0.44-0.88). CONCLUSION: Stenting is superior to balloon angioplasty for the treatment of small vessels, in particular after suboptimal angioplasty. However, MACE and RR rates remain high after stenting, and the advantage of stent over angioplasty is moderate. An optimal balloon angioplasty strategy (with provisional stenting) may achieve results not inferior to routine stenting.

Angioplasty, Balloon, Coronary↗
PubMed2005

Treatment of a coronary aneurysm involving bifurcation with the use of a custom-made polytetrafluoroethylene-covered bifurcation stent system.

We report a case with a large aneurysm of the proximal left anterior descending coronary artery involving the bifurcation with a diagonal branch. We used a custom-made bifurcation system with a polytetrafluoroethylene-covered stent for the main branch and a bare metal stent for the side branch with excellent clinical and angiographic result at 5-month follow-up.

Blood Vessel Prosthesis Implantation↗
PubMed2005

Preliminary experience with the Frontrunner coronary catheter: novel device dedicated to mechanical revascularization of chronic total occlusions.

The novel device Frontrunner coronary catheter (FCC), dedicated to recanalization of chronic total occlusions (CTOs), relies on blunt microdissections inside the plaque, allowing passage of guidewire through the lesion and adjunctive angioplasty. In order to evaluate efficacy and safety of recanalization using the FCC device, we included patients with de novo or restenotic CTOs in a native coronary artery with prior failure using a guidewire or considered unsuitable for guidewire attempt in which the FCC was attempted first. Between October 2000 and June 2003, 50 patients with 50 CTOs were included in the study. Thirty-two patients had prior failure with a mechanical wire. Device and angiographic success were obtained in 25 (50%) occlusions: 53% in lesions with prior guidewire failure and 44% when FCCs were attempted first (P = 0.8). During the first year of experience, angiographic success was 42% (5 occlusions) and in the third year 75% (12 occlusions; P = 0.12). Coronary perforation occurred in nine (18.0%) patients, leading to tamponade in two (4%) patients. Perforations occurred in 5 out of 12 attempted patients during the first year and in 4 out of 38 patients in the following period (41.7% vs. 10.5%; P = 0.04). Serious adverse events occurred in five (10%) patients within 30-day follow-up. Four non-Q-wave myocardial infarctions occurred in hospital (clinical success 42%) and one death 7 days after the index procedure. The use of FCC increases the success to open chronic total occlusions refractory to mechanical guidewires or that were considered unsuitable for an attempt with a guidewire. The risk of coronary perforation due to FCC use is relatively high and it can decrease with experience.

Aged↗
PubMed2005

Is overdilatation of 3.0 mm sirolimus-eluting stent associated with a higher restenosis rate?

We evaluated the safety and effectiveness of postdilating a 3.0 mm sirolimus-eluting stents (SESs; six cells) with a 3.5-4.0 mm balloon. We identified 254 consecutive patients who underwent percutaneous coronary interventions using SESs with a nominal diameter of 3.0 mm (six cells). Patients were divided into two groups based on whether they were subsequently postdilated with a 3.0 mm (group 1: 168 patients, 251 lesions) or a 3.5-4 mm balloon (group 2: 86 patients, 102 lesions). There were no significant differences regarding the incidence of in-hospital and long-term follow-up. Angiographic follow-up was available in 72% and 74% of groups 1 and 2, respectively. The two groups had no significant differences regarding late lumen loss (0.51 +/- 0.36 vs. 0.52 +/- 0.33; P = 0.3) and binary restenosis rates (10.7% vs. 8.8%; P = 0.1). Six-month clinical follow-up was available in all patients. At long-term follow-up (mean: 10.6 +/- 3.7 for group 1 and 11.3 +/- 3.9 months for group 2), there were no significant differences between the two groups regarding major adverse cardiac events (8.9% vs. 9.2%; P = 0.9). Implantation of a 3.0 mm SES with postdilation with a 3.5-4 mm balloon did not result in any significant difference in complications, in-hospital non-Q-wave myocardial infarction, binary restenosis, or target lesion revascularization. These data should lessen concern that overdilation may dilute the beneficial effects of SESs.

Catheterization↗
PubMed2005

Novel site-specific systemic delivery of Rapamycin with perfluorobutane gas microbubble carrier reduced neointimal formation in a porcine coronary restenosis model.

Earlier studies demonstrated that perfluorobutane gas microbubble carrier (PGMC) adheres to injured arteries and enhances the drug uptake specifically into the cells of the denuded vessel segment. The purpose of this study was to investigate the effect of PGMC-based systemic delivery of Rapamycin on expression of p27 in vascular tissue and restenosis in porcine coronary arteries after stent implantation. Eight pigs underwent coronary stent implantation (three stents per animal). Five pigs were treated with i.v. injection of PGMC with 2 mg of Rapamycin and three animals served as control. Four hours postprocedure, three pigs were sacrificed and stented segments were analyzed by high-performance liquid chromatography (HPLC) and Western blot. In chronic experiments, five pigs (15 stent sites) were sacrificed at 28 days following intervention and vessels were perfusion-fixed. HPLC of the treated arteries demonstrated high drug concentration in the vessel tissue, and Western blot analysis showed elevated expression of p27 at 4 hr postprocedure. Histomorphometry revealed significantly reduced (by 40%) neointimal formation in the PGMC/Rapamycin group compared with controls (1.84 +/- 0.84 vs. 4.77 +/- 1.71 mm2, respectively; P < 0.001). In the porcine coronary model, site-specific systemic delivery of Rapamycin utilizing PGMC resulted in overexpression of p27 and a significant reduction of neointimal formation within the stented segments.

Animals↗
PubMed2005

Results and follow-up after implantation of four or more sirolimus-eluting stents in the same patient.

The aim of this study was to assess the safety and effectiveness of > or =4 sirolimus-eluting stent (SES; Cypher, Cordis, Johnson and Johnson) implantation. The safety of implantation of > or =4 SESs in the same patient and setting has not been established. Furthermore, it has been hypothesized that sirolimus administration with the use of multiple stents may diminish the platelet inhibitory effects of clopidogrel and may trigger drug-drug interactions. We identified 96 consecutive patients (96 procedures) who underwent implantation of > or =4 SESs in 365 lesions (438 stents) during the same procedure. All patients received aspirin indefinitely and clopidogrel or ticlopidine for at least 1 year postprocedure; 57% and 47% of the patients were on calcium channel blocker and statin therapy, respectively. All stents were successfully deployed and glycoprotein IIb/IIIa inhibitors were used in 50% of the procedures. There were no in-hospital deaths, Q-wave myocardial infarction (MI), urgent bypass surgery, or repeat percutaneous coronary intervention; 18 patients (19%) suffered non-Q-wave MI (defined as CK-MB elevation >3 times the upper limit of normal). At 30-day follow-up, there was one (1%) subacute thrombosis resulting in target lesion revascularization. At mean follow-up time of 15.4 +/- 6.2 months, the frequency of target lesion revascularization, target vessel revascularization, and major adverse cardiac event rates were 12%, 16%, and 18%, respectively. No other notable clinical events that might have been attributed to the possible drug-drug interactions or discontinuation of concomitant antithrombotic, statin, or calcium channel blocker therapy were reported. Multiple (> or =4) SES implantation appears safe with no increase in major adverse cardiac events.

Aged↗
PubMed2005

Treating chronic total occlusions using subintimal tracking and reentry: the STAR technique.

Successful recanalization of coronary total occlusions (CTOs) remains an area where improvements are needed. We propose an approach similar to the one utilized in treating some peripheral artery occlusions and aimed to create a subintimal dissection with distal reentry. A 0.014' hydrophilic wire with a J-configuration is utilized for this purpose. We applied this technique to CTO of native coronaries in 31 patients where previous attempts failed in 21 of them (67%). The right coronary artery (RCA) was the index vessel in 87% of patients. Recanalization of the vessel and of most of distal branches was achieved in 21 patients; patency of at least one major distal branch was achieved in 9 patients. Drug-eluting stents (DESs) were implanted in 53% of patients. Three patients had intraprocedural vessel perforation without consequences. Five patients (16%) had in-hospital non-Q-wave myocardial infarction. No other adverse events occurred at a mean follow-up of 5.1 +/- 3.7 months except for one noncardiac death. Angiographic follow-up was performed in 21 (67%) patients and 53% of them developed restenosis. Reintervention on the target vessel was performed in 11 patients (52%). Complete success with the procedure was originally obtained in 8 of the 10 patients who did not develop restenosis and in 8 of them DESs were originally implanted. This technique appears a promising approach to recanalize difficult total occlusions, particularly the ones localize on the RCA, which has the most important side branches located distally.

Adult↗