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Carlo Di Mario

Publications and source records attributed to Carlo Di Mario.

At least 19 recordsLinked to original sources

Randomized evaluation of polytetrafluoroethylene-covered stent in saphenous vein grafts: the Randomized Evaluation of polytetrafluoroethylene COVERed stent in Saphenous vein grafts (RECOVERS) Trial.

BACKGROUND: Treatment of lesions located in saphenous vein grafts (SVGs) is associated with increased procedural risk and a high rate of restenosis. METHODS AND RESULTS: We conducted a randomized, multicenter trial to evaluate the usefulness of a polytetrafluoroethylene (PTFE)-covered stent compared with a bare stainless steel (SS) stent for prevention of restenosis and major adverse cardiac events (MACE) in patients undergoing SVG treatment. The primary end point was angiographic restenosis at 6 months. Secondary end points were 30-day and 6-month MACE rates, defined as the cumulative of death, myocardial infarction (MI), and target lesion revascularization. Between September 1999 and January 2002, 301 patients with SVG lesions were randomized to either the PTFE-covered JoStent coronary stent graft (PTFE group, n=156) or the SS JoFlex stent (control group, n=145). Angiographic and procedural success rates were similar between the 2 groups (97.4% versus 97.9% and 87.3% versus 93.8%, respectively). The incidence of 30-day MACE was higher in the PTFE group (10.9% versus 4.1%, P=0.047) and was mainly attributed to MI (10.3% versus 3.4%, P=0.037). The primary end point, the restenosis rate at 6-month follow-up, was similar between the 2 groups (24.2% versus 24.8%, P=0.237). Although the 6-month non-Q-wave MI rate was higher in the PTFE group (12.8% versus 4.1%, P=0.013), the cumulative MACE rate was not different (23.1% versus 15.9%, P=0.153). CONCLUSIONS: The study did not demonstrate a difference in restenosis rate and 6-month clinical outcome between the PTFE-covered stent and the SS stent for treatment of SVG lesions. However, a higher incidence of nonfatal myocardial infarctions was found in patients treated with the PTFE-covered stent.

Adult↗

Immediate results and one-year clinical outcome after percutaneous coronary interventions in chronic total occlusions: data from a multicenter, prospective, observational study (TOAST-GISE).

OBJECTIVES: We sought to investigate the success rate and the acute and 12-month clinical outcome of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) in the contemporary era. BACKGROUND: The technique of PCI involving CTO has improved over time. However, limited data on acute and follow-up results in patients treated with PCI on CTO in recent years are available. METHODS: Four hundred nineteen consecutive patients scheduled for PCI of CTO of > or =30 days of duration were enrolled in 29 centers; 390 CTOs were confirmed in 376 patients in an independent core laboratory. The end points were technical and procedural success, in-hospital and 12-month major adverse cardiac events (MACE) occurrence, and 12-month symptomatic status. RESULTS: Technical and procedural success was obtained in 77.2% and 73.3% of lesions, respectively. In-hospital major adverse cardiac events occurred in 5.1% of patients. Multivariate analysis identified CTO length >15 mm or not measurable, moderate to severe calcifications, duration > or =180 days, and multivessel disease as significant predictors of PCI failure. At 12 months, patients with a successful procedure experienced a lower incidence of cardiac deaths or myocardial infarction (1.05% vs. 7.23%, p = 0.005), a reduced need for coronary artery bypass surgery (2.45% vs. 15.7%, p < 0.0001), and were more frequently free of angina (88.7% vs. 75.0%, p = 0.008) compared with patients who had an unsuccessful procedure. CONCLUSIONS: Successful PCI was achieved in a high percentage of CTOs with a low incidence of complications. At one-year follow-up, patients with successful PCI of a CTO had a significantly better clinical outcome than those whose PCI was unsuccessful.

Angioplasty, Balloon, Coronary↗

Preliminary observations regarding angiographic pattern of restenosis after rapamycin-eluting stent implantation.

BACKGROUND: Restenosis after implantation of drug-eluting stents (DES) is a rare phenomenon, occurring more frequently peri-stent. METHODS AND RESULTS: We evaluated the pattern of restenosis occurring after implantation of DES in unselected lesions. From April 15 to December 6, 2002, we treated 368 patients with 735 lesions by using 841 rapamycin-eluting stents (Cypher, Cordis, a Johnson & Johnson Company). Mean baseline lesion length was 17.48+/-12.19 mm, and mean stent length was 27.59+/-14.02 mm. Follow-up ischemia-driven angiography was performed in 24 patients. Eleven patients had angiographic restenosis (> or =50% diameter stenosis) in 14 stented segments (stent and 5 mm proximal and distal to the stent). The pattern of restenosis in all 14 stented segments was focal, and in 6 of them it was multifocal, occurring inside the stents. Mean length of restenotic lesions was 5.62+/-1.90 mm, with a range from 2.54 to 8.44 mm. One multifocal restenosis involved also the distal stent margin. Intravascular ultrasound evaluation at follow-up, performed in 2 patients, showed significant lumen obstruction attributable to in-stent hyperplasia in both cases. Individual cases can be viewed in the Data Supplement. CONCLUSIONS: The pattern of restenotic lesions after rapamycin-eluting stent implantation was focal and mostly inside the stent.

Aged↗

A new dedicated stent and delivery system for the treatment of bifurcation lesions: preliminary experience.

We report the first clinical experience in eight patients with a new stent and delivery system specifically designed for the treatment of bifurcational lesions. The device (AST SLK-View system) consists of a premounted stent and a delivery system. The stent has a side aperture, which orients toward the ostium of the side branch. The system allows deployment of the stent while the access to both main and side branches is maintained by two wires. We evaluated this system in nine bifurcations. The location of bifurcations was left descending artery/diagonal branch in four lesions, left circumflex/obtuse marginal branch in three lesions, and postero-lateral branch/posterior descending artery in two lesions. Predilation was performed in six lesions of the main branches and in five lesions of the side branches. The stent was effectively delivered to all bifurcations except for one, in which the target lesion was located at a distal segment and the device could not be delivered. Following stent implantation in the main branch, two lesions at the side branches were treated by stent, while the other lesions were treated by balloon angioplasty without difficulty. Final kissing balloon was performed in four bifurcation lesions. No adverse event was observed during 1 month of clinical follow-up. Treatment of bifurcation lesions with this new dedicated device appears to be feasible. This new device may introduce a new approach for the treatment of coronary bifurcation lesions.

Aged↗

Elective versus provisional intra-aortic balloon pumping in high-risk percutaneous transluminal coronary angioplasty.

BACKGROUND: Elective intra-aortic balloon pump (IABP) support may reduce acute complications occurring during percutaneous coronary interventions (PCI) in patients with severe depression of the left ventricular ejection fraction (EF < or = 30%). METHODS: Since February 1998, 133 consecutive patients with EF < or =30% underwent elective PCI in our institution; 61 had elective preprocedural IABP support (group A) and 72 patients had conventional PCI (group B). Jeopardy score was calculated in each patient from the coronary angiograms to quantify the myocardium at risk. RESULTS: EF was similar in the 2 groups. Jeopardy score was higher in group A (8.0 +/- 2.8 vs 6.7 +/- 2.4, P =.008). The other principal clinical and angiographic characteristics were similar in the 2 groups. Severe hypotension and/or shock occurred in 11 patients, all in group B (P =.001). All required urgent IABP support, and 3 eventually died. Intraprocedural major adverse cardiac and cerebral events (eg, myocardial infarction, severe hypotension and/or shock, urgent bypass surgery, stroke, and death) were higher in group B (17% vs 0%, P =.001). By stepwise logistic regression analysis, elective IABP support (odds ration [OR] 0.11 [95% CI 0.21-0.60], P =.011), jeopardy score (OR 5.37 [95% CI 1.10-8.70], P =.040), and female sex (OR 2.72 [95% CI 1.85-3.10], P =.015), were the correlates of intraprocedural events. CONCLUSIONS: This study supports the potential usefulness of elective versus provisional IABP to prevent intraprocedural major adverse cardiac and cerebral events in high-risk PCI.

Aged↗

A randomized comparison of direct stenting versus stenting with predilatation in native coronary artery disease: results from the multicentric Crosscut study.

Stenting without predilatation has become possible due to the availability of a new generation of flexible, low-profile, securely crimped, balloon-expandable stents. This study compared the feasibility, efficacy and cost-effectiveness of direct stenting (DS) to the standard predilatation technique (PS) using the premounted Crossflex LC stent (Cordis Corporation, Miami Lakes, Florida). The study is a randomized prospective multicenter evaluation including 271 patients (140 patients in the DS group and 131 patients in the PS group) with 1 or 2 de novo or restenotic lesions located in native coronary arteries. Procedural success was 98.9% and 98.7% in the DS and PS groups, respectively (p = NS); crossover to PS was required in 22/166 lesions (13.2%) enrolled in the DS group because of inability to cross the target lesion without predilatation. Nonsignificant reductions in procedural time (-10.5%), fluoroscopy time (-4.7%) and amount of contrast (-3.8%) were observed in the DS group in comparison to the PS group. The number of balloons used (-76.6%) and the global cost of the procedure (-18.8%) were significantly lower in the DS group (p < 0.01 for both comparisons). After 6 months, no differences were observed in the restenosis rate between the two groups (22.0% for DS group versus 18.1% for PS group; p = NS) and in the incidence of major adverse clinical events (5.0% for DS group versus 3.0% for PS group; p = NS). Direct stenting is safe and feasible for the treatment of lesions in native coronary arteries and obtains a significant reduction in procedural cost, mainly due to the lower number of balloons used. Clinical and angiographic results at 6 months are comparable to those obtained after a conventional predilatation-stenting strategy.

Catheterization↗

Effects of selective alpha1- and alpha2-adrenergic blockade on coronary flow reserve after coronary stenting.

BACKGROUND: Coronary flow reserve (CFR) is not normalized shortly after coronary stenting. We hypothesized that alpha-adrenergic coronary vasoconstriction acts to limit CFR. METHODS AND RESULTS: We assessed flow velocity by Doppler wires and cross-sectional area by angiography in 46 patients undergoing coronary culprit lesion stenting (81+/-4% stenosis). Hyperemia was induced by adenosine (24 micro g IC or 140 micro g/kg per minute IV) before and after stenting. Finally, either the alpha(1)-antagonist urapidil (10 mg IC) or the alpha(2)-antagonist yohimbine (3 mg IC) was randomly combined with adenosine. In 8 subjects with angiographically normal coronary arteries, CFR was increased from 3.21+/-0.30 to 3.74+/-0.43 by yohimbine and to 4.58+/-0.65 by urapidil, respectively (P=0.0001). Patients were divided according to the cutoff of CFR > or =3.0 (n=18) or <2.5 (n=28). Revascularization per se did not change CFR. However, 15 minutes after stenting, CFR decreased to 2.05+/-0.55 from CFR 3.64+/-0.58, whereas in patients with CFR 2.39+/-0.51, it remained unchanged. Yohimbine improved CFR to 3.26+/-0.42 and to 3.41+/-0.58 in patients with >3.0 and <2.05+/-0.55 baseline CFR, respectively. Urapidil improved CFR to 3.52+/-0.30 and 3.98+/-1.07, respectively. CONCLUSIONS: Urapidil and yohimbine attenuated the CFR impairment occurring after revascularization by increasing both the epicardial vasodilator effect of adenosine and the blood flow velocity, thus suggesting that the adrenergic system plays an important role in limiting the capacity of the coronary circulation to dilate.

Adenosine↗

Mechanism of late in-stent restenosis after implantation of a paclitaxel derivate-eluting polymer stent system in humans.

BACKGROUND: We recently reported delayed angiographic restenosis in 15 patients who received 7-hexanoyltaxol (QP2)-eluting polymer stents (QuaDS) for the treatment of in-stent restenosis. This study presents the histological findings of atherectomy specimens from a subset of these patients receiving implants. METHODS AND RESULTS: Between October and December 2001, 5 patients treated with QuaDS-QP2 stents underwent directional coronary atherectomy at 11.2+/-1.0 months for recurrent in-stent restenosis. Restenotic lesion composition was assessed with special stains, immunohistochemistry with quantitative image analysis, and, in one specimen, transmission electron microscopy. Atherectomy specimens contained fibrin interspersed in a smooth muscle cell-rich neointima with proteoglycan matrix. In 2 of 5 specimens, large aggregates of macrophages and T-lymphocytes were noted. These areas of active inflammation demonstrated a relatively high proliferation index by Ki-67 antibody staining, whereas the proliferation index in smooth muscle cell-rich restenotic areas was low. CONCLUSION: Restenotic lesions from QuaDS-QP2-eluting stents at 12 months show persistent fibrin deposition with varying degrees of inflammation. These pathological changes, representing delayed healing, are usually observed up to only 3 months in human coronary arteries with stainless steel balloon-expandable stents. The nonreabsorbable polymer alone may have induced chronic inflammation.

Aged↗

7-hexanoyltaxol-eluting stent for prevention of neointimal growth: an intravascular ultrasound analysis from the Study to COmpare REstenosis rate between QueST and QuaDS-QP2 (SCORE).

BACKGROUND: Inhibition of neointimal tissue growth has been demonstrated in preliminary human feasibility studies with a stent-based polymer sleeve delivering 7-hexanoyltaxol. The Study to COmpare REstenosis rate between QueST and QuaDS-QP2 (SCORE) trial is a human, randomized, multicenter trial comparing 7-hexanoyltaxol (QP2)-eluting stents (qDES) with bare metal stents (BMS) in the treatment of de novo coronary lesions. The purpose of this substudy was to evaluate the acute expansion property and long-term neointimal responses of qDES compared with BMS as assessed by intravascular ultrasound (IVUS). METHODS AND RESULTS: A total of 122 (qDES 66, BMS 56) patients were enrolled into the IVUS substudy. All IVUS images (immediately after the procedure and at 6-month follow-up) were analyzed at an independent core laboratory in a blind manner. At baseline, qDES achieved stent expansion similar to BMS. At follow-up, qDES showed reduced neointimal growth by 70% at the tightest cross section and by 68% over the stented segment (P<0.0001 for both), resulting in a significantly larger lumen in qDES than in BMS. Unlike intracoronary brachytherapy, there was no evidence of negative edge effects, unhealed dissections, or late stent-vessel wall malapposition over the stented and adjacent references segments in either group. CONCLUSIONS: Detailed IVUS analysis revealed that qDES had comparable acute mechanical and superior long-term biological effects to BMS. Although the long-term benefits and limitations of this technology require further investigation, the reduction in neointimal thickenings demonstrated that local delivery of 7-hexanoyltaxol through polymer sleeves augments conventional mechanical treatment of atherosclerotic disease.

Blood Vessel Prosthesis Implantation↗

In-stent restenosis in small coronary arteries: impact of strut thickness.

UNLABELLED: OBJECTIVES; We sought to evaluate whether strut thickness may impact the restenosis rate after stent implantation in small coronary arteries. BACKGROUND: Small vessel size (<3.0 mm) is an independent risk factor for the occurrence of in-stent restenosis. It has been reported that vessel damage induced during stent deployment is an important factor in restenosis. METHODS: From our database, we selected all patients who had successful stenting in small native vessels, with angiographic follow-up available, between March 1996 and April 2001. The strut was defined as thin when <0.10 mm and thick when > or = 0.10 mm. According to these criteria, we identified two subgroups: a thin group and a thick group. RESULTS: A total of 821 (57%) of the 1,447 patients had angiographic follow-up available and were included in the analysis. The thin group included 400 patients with 505 lesions. The thick group included 421 patients with 436 lesions. The restenosis rate was 28.5% in the thin group and 36.6% in the thick group (p = 0.009; odds ratio [OR] 1.44, 95% confidence interval [CI] 1.09 to 1.90). The study group was classified into three subgroups according to the reference vessel diameter: < or = 2.50 mm, 2.51 to 2.75 mm and 2.76 to 2.99 mm. Strut thickness influenced the restenosis rate only in the subgroup with a reference vessel diameter between 2.76 and 2.99 mm, with rates of 23.5% in the thin group and 37% in the thick group (p = 0.006). By logistic regression analysis, predictors of restenosis were stent length (OR 1.03, 95% CI 1.01 to 1.04; p = 0.001), strut thickness (OR 1.68, 95% CI 1.23 to 2.29; p = 0.001) and diabetes mellitus (OR 2.10, 95% CI 1.21 to 3.68; p = 0.007). CONCLUSIONS: This study supports that strut thickness is an independent predictor of restenosis in coronary arteries with a reference diameter of 2.75 to 2.99 mm.

Aged↗

Results and long-term predictors of adverse clinical events after elective percutaneous interventions on unprotected left main coronary artery.

BACKGROUND: The safety and efficacy of percutaneous coronary intervention of de novo lesions in unprotected left main coronary arteries remains an unresolved issue. METHODS AND RESULTS: We analyzed 67 consecutive patients treated with the following devices: 39 with stents, 12 with rotational atherectomy plus stents, 13 with directional coronary atherectomy plus stents (a total of 64 patients were treated with stents), and 3 patients with directional coronary atherectomy only. The reference vessel size was 3.78+/-0.73 mm and lesion length was 6.6+/-3.0 mm. In-hospital complications were 2 coronary artery bypass grafts (CABGs) (3.0%), 2 Q-wave myocardial infarctions (MIs) (3.0%), and 3 non-Q-wave MIs (4.5%); there were no deaths. The estimated cardiac survival at 3 years was 91%. The cardiac mortality rate was higher in patients with Parsonnet score >15 versus < or =15 (21.4% versus 4.2%, P=0.02) at 3 years. The independent covariate of cardiac death was preserved left ventricular ejection fraction; for combined cardiac events (cardiac death, MI, repeat revascularization) it was large reference vessel size. Follow-up angiography at 5+/-2 months in 85% of eligible patients revealed 31.4% restenosis. Extending the follow-up to 31+/-23 months (19 patients with follow-up beyond 3 years) the cumulative event rates were 11 deaths (16.4%), 8 of them cardiac (11.9%), 2 (3.0%) MI, and 16 (23.9%) repeat revascularizations (CABG in 5 patients). CONCLUSIONS: Elective percutaneous coronary intervention of de novo lesions in left main coronary arteries is feasible, with low procedural risk. The long-term follow-up revealed a high rate of angiographic restenosis and repeat revascularization, with a relatively high incidence of cardiac death. Reference vessel size and left ventricular function are the most important predictors of favorable follow-up.

Adult↗

Outcome of nonobstructive residual dissections detected by intravascular ultrasound following percutaneous coronary intervention.

The purpose of this study was to assess the outcome of nonobstructive (or non-flow-limiting) residual dissection (RD) after percutaneous coronary intervention. Results of 124 consecutive native coronary lesions with angiographic nonobstructive RD in 97 patients (RD group) were compared with outcomes of 124 lesions without RD in 100 patients (non-RD group), whose characteristics were matched with those of the RD group. RD occurred after stent implantation (81 of 124 lesions, 65%) or balloon angioplasty (43 of 124 lesions, 35%). Angiographic types of RD were type A in 8 lesions (6%), B in 101 (82%), and C in 15 (12%). Stents were implanted in 65% of the lesions in each group. Clinical success (94% in RD group vs 95% in non-RD group, p = 0.77) and the in-hospital major adverse cardiac event rates were found to be similar in the 2 groups (6% vs 3%, respectively; p = 0.33). The late angiographic and clinical outcomes were also comparable. By intravascular ultrasound (IVUS) evaluation of the dissections in the RD group, area stenosis correlated with the incidence of in-hospital major adverse cardiac events (p = 0.023), whereas the final minimal lumen area correlated inversely with the occurrence of restenosis (p = 0.011). An area stenosis > or =58% was the best predictor for the incidence of in-hospital major adverse cardiac events (sensitivity 0.68, specificity 0.68). Most nonobstructive RDs are "favorable" and do not need stent implantation. IVUS evaluation identifies "unfavorable" nonobstructive (or non-flow-limiting) dissections that might be prone to acute occlusion. Nonobstructive dissections can be left untreated when final IVUS reveals an area stenosis of < 60% at the site of a dissection.

Aortic Dissection↗

Recombinant apolipoprotein A-I(Milano) infusion into rabbit carotid artery rapidly removes lipid from fatty streaks.

Apolipoprotein A-I(Milano) (AIM), a natural variant of human apolipoprotein A-I, confers to carriers a significant protection against vascular disease. In previous studies, administration of recombinant AIM-phospholipid (AIM-PL) complexes to hypercholesterolemic rabbits markedly inhibited neointimal formation after arterial injury; moreover, repeated injections of AIM-PL in apoE-deficient mice significantly reduced atherosclerosis progression. The objective of the present study was to determine if a single localized infusion of AIM-PL complexes administered directly to atheromatous lesions could promote plaque regression. Lipid-rich, atheromatous plaques were generated at both common carotid arteries of 25 rabbits by applying a perivascular electric injury, followed by 1.5% cholesterol diet for 90 days. Rabbits were infused with either saline, phospholipid vesicles, or 3 different AIM-PL doses (250, 500, or 1000 mg of protein) delivered through an intravascular ultrasound (IVUS) catheter positioned at the origin of the right carotid. The lesions at the left carotid artery were therefore exposed to the agents systemically. Infusion of AIM-PL at the 2 highest doses caused reduction of right carotid artery plaque area by the end a 90-minute infusion as assessed by IVUS analysis. Plaque area regression was confirmed by histology in carotid arteries receiving direct (500 and 1000 mg doses) and systemic (500 mg dose) delivery, 72 hours after the start of the treatment. Plaque lipid content was associated with significant and similar decreases in Oil Red O staining in both arteries. These results suggest AIM-PL complexes enhanced lipid removal from arteries is the mechanism responsible for the observed plaque changes.

Animals↗

First clinical experience with a paclitaxel derivate-eluting polymer stent system implantation for in-stent restenosis: immediate and long-term clinical and angiographic outcome.

BACKGROUND: It has been shown that antiproliferative drugs such as paclitaxel lower the amount of intimal hyperplasia after stent implantation. We report the first clinical experience of 7-hexanoyltaxol (QP2)-eluting polymer stent system (QuaDS) implantation for in-stent restenosis. METHODS AND RESULTS: Fifteen consecutive patients with elective indication to percutaneous coronary intervention for in-stent restenosis were treated with the QuaDS-QP2 stent implantation. The QuaDS-QP2 stent was successfully implanted in all but 2 target lesions. In one lesion, the restenotic segment could not be completely covered by the stent, and in another lesion, a bare metal stent was implanted distally to the QuaDS-QP2 stent. One patient suffered from postprocedural non-Q-wave myocardial infarction (NQWMI). No other adverse events were observed during hospital stay. Six- and 12-month angiographic and clinical follow-up was scheduled for all patients. At 6 months, 3 patients had target lesion revascularization (20%). Two patients had restenosis (13.3%); one experienced restenosis in a gap between 2 drug-eluting stents, and the other had stent occlusion leading to NQWMI. Minimal intimal hyperplasia was observed in all the segments covered by drug-eluting stents (late loss=0.47+/-1.01 mm with a loss index=0.17+/-0.39). At 12 months, 1 patient suffered from NQWMI, and 8 of 13 patients (61.5%) had angiographic restenosis (late loss=1.36+/-0.94 mm with a loss index=0.62+/-0.44). CONCLUSION: This first experience with QuaDS-QP2 stent implantation for in-stent restenosis revealed minimal intimal hyperplasia at the 6-month follow-up. However, the antiproliferative effect was not maintained at the 12-month follow-up, resulting in delayed occurrence of angiographic restenosis.

Bridged-Ring Compounds↗

Polytetrafluoroethylene-covered stent and coronary artery aneurysms.

Angiographically detected coronary aneurysms (i.e., coronary segment greater then 1.5 times the normal artery) have an incidence of 0.3%-4.9% among patients undergoing coronary angiography and have been reported after an intervention procedure with a frequency of 2%-10%. The indication for treatment and the best modality still need to be defined. Some authors reported the successful treatment of coronary aneurysms with the polytetrafluoroethylene (PTFE)-covered stent implantation, supporting the role of this strategy. In our institution, from September 1997 to December 1999 eight PTFE-covered stents were implanted to treat seven coronary aneurysms in seven patients. All aneurysms were successfully treated by the PTFE-covered stent. In one case, there was the necessity of an additional PTFE stent to cover the aneurysm completely. In no case did the loss of stent occur. No in-hospital MACE occurred. At 35 +/- 8 (21-44) months, six patients were symptom-free. Angiographic follow-up was performed in all patients at 10 +/- 6 months. Restenosis occurred in one patient (14%) who had repeat percutaneous coronary interventions. This preliminary experience suggests that PTFE-covered stent may be useful in the treatment of coronary artery aneurysms.

Adult↗