Biomedical subjects
Marco Roffi
Publications and source records attributed to Marco Roffi.
Outcome of multivessel coronary intervention in the contemporary percutaneous revascularization era.
Clinical outcomes after multivessel versus single-vessel percutaneous coronary intervention (PCI) in the era of stents, glycoprotein IIb/IIIa inhibitors, and clopidogrel pretreatment have not been well studied. Thus, we compared outcomes from the Do Tirofiban and ReoPro Give Similar Efficacy Outcome Trial (TARGET) for patients who underwent multivessel versus single-vessel PCI and separately considered the effect of acute coronary syndromes on the results. Composite clinical outcomes (death, myocardial infarction, and target vessel revascularization) were evaluated at 30 days and 6 months and mortality at 1 year. Safety analysis included in-patient major and minor bleeding. Despite similar baseline characteristics, patients who underwent multivessel PCI (n = 775) had significantly higher 30-day and 6-month composite event rates than did those who were treated in a single coronary artery territory (n = 3,969). This association remained significant at 30 days (hazard ratio 1.57, 95% confidence interval 1.06 to 2.33, p = 0.025) after using propensity matching to minimize confounding factors. The higher event rate was primarily due to an increase in periprocedural myocardial infarction. However, there were no significant differences in propensity-matched ischemic outcomes at 6 months and 1 year or in bleeding. In addition, in a propensity-matched analysis that included 810 patients with acute coronary syndrome, multivessel stenting resulted in numerically more ischemic events than did single-vessel stenting, although this did not reach statistical significance (hazard ratio 1.32, 95% confidence interval 0.85 to 2.05, p = 0.221). In conclusion, multivessel PCI was more often associated with periprocedural myocardial infarction than single-vessel intervention, although this did not translate into higher 1-year mortality. A randomized trial comparing multivessel PCI with staged or surgical revascularization is warranted.
Failure to retrieve undeployed paclitaxel-eluting coronary stents.
Following the observation of difficulty in retrieving undeployed paclitaxel-eluting coronary stents (Taxus), we performed a retrospective analysis of 1,415 consecutive percutaneous coronary interventions and addressed the frequency of damaged or lost undeployed coronary stents. The incidence for Cypher, Taxus, and bare metal stents was 0%, 1.5%, and 0.3%, respectively (p = 0.0007). In the 11 cases involving Taxus stents, the treated vessel was invariably severely tortuous and/or calcified. The device was successfully retrieved despite being damaged and/or dislodged from the stent balloon in 5 cases; in 6 cases, stent embolization occurred. The clinical consequences were chronic claudication due to lower extremity device embolization in 1 patient and urgent surgical stent removal in 1 patient.
Intracoronary thrombus in a 26-year-old man.
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Sirolimus-eluting stenting of the external carotid artery for the treatment of ocular ischemia.
PURPOSE: To present a patient in whom severe external carotid artery (ECA) stenosis causing ocular ischemia was treated with a drug-eluting stent. CASE REPORT: A 55-year-old woman with severe, diffuse atherosclerosis presented with impaired left ocular perfusion and amaurosis fugax. Duplex ultrasonography and angiography documented bilateral occlusion at the origin of the internal carotid arteries, bilateral subtotal ECA stenoses, and subtotal distal left common carotid artery (CCA) restenosis following endarterectomy. Percutaneous revascularization of the left ECA and CCA stenoses was performed using a short coronary balloon-expandable sirolimus-eluting stent and a self-expanding nitinol stent, respectively. The procedure was uneventful, and the ocular symptoms resolved. At 6 months, the patient remained asymptomatic, with angiographically patent stents. CONCLUSION: Drug-eluting stenting may be a novel option to treat symptomatic ECA stenosis.
Sirolimus-eluting and paclitaxel-eluting stents for coronary revascularization.
BACKGROUND: Sirolimus-eluting stents and paclitaxel-eluting stents, as compared with bare-metal stents, reduce the risk of restenosis. It is unclear whether there are differences in safety and efficacy between the two types of drug-eluting stents. METHODS: We conducted a randomized, controlled, single-blind trial comparing sirolimus-eluting stents with paclitaxel-eluting stents in 1012 patients undergoing percutaneous coronary intervention. The primary end point was a composite of major adverse cardiac events (death from cardiac causes, myocardial infarction, and ischemia-driven revascularization of the target lesion) by nine months. Follow-up angiography was completed in 540 of 1012 patients (53.4 percent). RESULTS: The two groups had similar baseline clinical and angiographic characteristics. The rate of major adverse cardiac events at nine months was 6.2 percent in the sirolimus-stent group and 10.8 percent in the paclitaxel-stent group (hazard ratio, 0.56; 95 percent confidence interval, 0.36 to 0.86; P=0.009). The difference was driven by a lower rate of target-lesion revascularization in the sirolimus-stent group than in the paclitaxel-stent group (4.8 percent vs. 8.3 percent; hazard ratio, 0.56; 95 percent confidence interval, 0.34 to 0.93; P=0.03). Rates of death from cardiac causes were 0.6 percent in the sirolimus-stent group and 1.6 percent in the paclitaxel-stent group (P=0.15); the rates of myocardial infarction were 2.8 percent and 3.5 percent, respectively (P=0.49); and the rates of angiographic restenosis were 6.6 percent and 11.7 percent, respectively (P=0.02). CONCLUSIONS: As compared with paclitaxel-eluting stents, the use of sirolimus-eluting stents results in fewer major adverse cardiac events, primarily by decreasing the rates of clinical and angiographic restenosis.
Comparison of results of carotid stenting followed by open heart surgery versus combined carotid endarterectomy and open heart surgery (coronary bypass with or without another procedure).
We compared a novel strategy of carotid stenting (CS) followed by open heart surgery (OHS) to the combined carotid endarterectomy (CEA) and the OHS approach in patients requiring coronary and carotid revascularization. Between 1997 and 2002, CS as a prelude to OHS was performed in 56 patients, and 111 patients underwent combined CEA+OHS. Adverse events included stroke, myocardial infarction (MI), death, and their combinations. At baseline, the CS+OHS group had more unstable/severe angina (52% vs 27%, p = 0.002), severe left ventricular dysfunction (20% vs 9%, p = 0.05), symptomatic carotid disease (46% vs 23%, p = 0.002), and the need for repeat OHS (32% vs 9%, p = 0.0002). Severe contralateral carotid disease was more prevalent in the CEA+OHS group (28% vs 11%, p = 0.01). At 30 days, CS+OHS patients had a significantly lower incidence of stroke or MI (5% vs 19%, p = 0.02). A propensity score was created for each patient to account for baseline differences. In a final logistic regression model that included the propensity score, CS+OHS was associated with a trend toward reduced stroke or MI (odds ratio 0.26, 95% confidence interval 0.06 to 1.09, p = 0.06) and reduced death, stroke, or MI (odds ratio 0.40, 95% confidence interval 0.12 to 1.27, p = 0.12). In conclusion, despite a higher baseline risk profile, patients who underwent CS+OHS had significantly fewer adverse events than those undergoing CEA+OHS. CS may be a safer carotid revascularization option for this challenging patient population.
Randomized comparison of a titanium-nitride-oxide-coated stent with a stainless steel stent for coronary revascularization: the TiNOX trial.
BACKGROUND: Stent coating with titanium-nitride-oxide has been shown to reduce neointimal hyperplasia in the porcine restenosis model. We designed a prospective, randomized, clinical study to investigate the safety and efficacy of titanium-nitride-oxide-coated stents compared with stainless steel stents. METHODS AND RESULTS: Ninety-two patients with de novo lesions were randomly assigned to treatment with titanium-nitride-oxide-coated stents (n=45) or stainless steel stents of otherwise identical design (n=47; control). Baseline characteristics were similar in both groups. At 30 days, no stent thromboses or other adverse events had occurred in either group. Quantitative coronary angiography at 6 months revealed lower late loss (0.55+/-0.63 versus 0.90+/-0.76 mm, P=0.03) and percent diameter stenosis (26+/-17% versus 36+/-24%, P=0.04) in lesions treated with titanium-nitride oxide-coated than in control stents. Binary restenosis was reduced from 33% in the control group to 15% in the titanium-nitride oxide-coated stent group (P=0.07). Intravascular ultrasound studies at 6 months showed smaller neointimal volume in titanium-nitride-oxide-coated stents than in control stents (18+/-21 versus 48+/-28 mm3, P<0.0001). Major adverse cardiac events at 6 months were less frequent in titanium-nitride-oxide-coated stents than in control stent-treated patients (7% versus 27%, P=0.02), largely driven by a reduced need for target-lesion revascularization (7% versus 23%, P=0.07). CONCLUSIONS: Revascularization with titanium-nitride-oxide-coated stents is safe and effective in patients with de novo native coronary artery lesions. Titanium-nitride-oxide-coated stents reduce restenosis and major adverse cardiac events compared with stainless steel stents of otherwise identical design.
Comparison of the safety and efficacy of emboli prevention devices versus platelet glycoprotein IIb/IIIa inhibition during carotid stenting.
Distal embolization is the main potential risk of carotid stenting, and techniques to minimize this risk are evolving. Between July 1998 and March 2002, 305 consecutive patients who underwent elective or urgent percutaneous carotid intervention at The Cleveland Clinic were prospectively followed. During this period, the clinical practice of carotid stenting evolved from the routine use of glycoprotein IIb/IIIa inhibitors (GPIs) to routine emboli-prevention device (EPD) placement. A total of 199 patients received adjunctive GPIs (91% abciximab), and 106 patients underwent the procedure with an EPD (85% filter design, 15% occlusive balloon). At 30 days, the composite end point of neurologic death, nonfatal stroke, and major bleeding, including intracranial hemorrhage, was significantly lower among patients treated with EPDs compared with those treated with GPIs (0% vs 5.1%, p = 0.02). EPDs may provide an overall safer and more effective means of neuroprotection during carotid stenting than GPIs.
Inflammatory markers at the site of ruptured plaque in acute myocardial infarction: locally increased interleukin-6 and serum amyloid A but decreased C-reactive protein.
BACKGROUND: Acute myocardial infarction (AMI) is associated with inflammation. However, it remains unclear whether it originates from the ruptured plaque or represents a systemic process. METHODS AND RESULTS: In 42 patients with AMI, a balloon-based embolization protection device and aspiration catheter (PercuSurge) were used during acute coronary interventions. Samples from the site of the ruptured plaque were taken under distal balloon occlusion. Systemic samples were taken from the aorta. Sera, plaques, and thrombi were analyzed for inflammatory markers and lipoproteins. Systemic levels of C-reactive protein (CRP), interleukin-6 (IL-6), and serum amyloid A (SAA) in the aorta amounted to 3.0 mg/L, 5.0 ng/L, and 22.1 mg/L, respectively (interquartile ranges [IQRs], 1.1 to 7.4 mg/L, 5.0 to 6.5 ng/L, and 13.9 to 27.0 mg/L, respectively). In blood surrounding ruptured plaques, local levels of IL-6 (8.9 ng/L; IQR, 5.0 to 16.9 ng/L) and SAA (24.3 mg/L; IQR, 16.3 to 44.0 mg/L) were significantly higher, whereas CRP levels (2.5 mg/L; IQR, 0.9 to 7.7 mg/L) were decreased compared with the aorta (all P<0.0001). The coronary levels of IL-6 determined in vivo showed biological activity in vitro. Harvested thrombus contained CD68-positive monocytes expressing IL-6 and showed extracellularly and intracellularly positive staining for SAA, whereas CRP was found exclusively in the cytoplasm of phagocyting white blood cells. CONCLUSIONS: Coronary levels of IL-6 and SAA at the site of plaque rupture were increased relative to the systemic circulation, indicating local production of biologically active inflammatory mediators. In contrast, CRP was locally decreased, at least in part by uptake by the phagocyting cells, suggesting a systemic origin of the protein.
Platelet inhibition in percutaneous coronary interventions.
Mechanical disruption of atherosclerotic plaques at the time of percutaneous coronary intervention (PCI) is a potent stimulus for arterial thrombosis. Since platelets play a crucial role in the cascade of clot formation, platelet inhibition is an essential step for successful PCI. Aspirin remains the cornerstone of any antithrombotic regimen in the interventional setting. The addition of a thienopyridine is mandatory following stenting to prevent thrombosis of the device. Whenever possible, patients undergoing PCI should be pretreated with clopidogrel and the drug should be continued for up to 1 year. Glycoprotein IIb/IIIa antagonists should be administered in high-risk patients, such as those with acute coronary syndromes, diabetes, or complex coronary anatomy.
Severe stenosis of a bovine jugular vein graft in pulmonary position.
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Novel doppler assessment of intracoronary volumetric flow reserve: validation against PET in patients with or without flow-dependent vasodilation.
UNLABELLED: Volumetric blood flow (Q) determination requires simultaneous assessment of mean blood flow velocity and vessel cross-sectional area. At present, no method provides both values. Intracoronary Doppler-based assessment of coronary flow velocity reserve (CFVR) relies on average peak velocity (APV). Because this does not account for changes in velocity profile or vessel area usually occurring with flow-dependent vasodilation, results can be misleading. The aim of this clinical study was to validate against the current gold standard (measurement of myocardial perfusion reserve [MPR] by PET) a new, Doppler-based method for calculating coronary Q and coronary flow reserve (CFR). METHODS: Doppler-based intracoronary Q was measured with a proprietary guidewire device in a nonstenotic coronary artery at baseline and during adenosine-induced hyperemic flow (140 mug/kg/min intravenously during 7 min). Three gate positions were assessed, of which 2 were lying within the vessel and 1 was intersecting the vessel. The zeroth (M(0)) and the first (M(1)) Doppler moments of the intersecting gate were used to calculate mean blood flow velocity (M(1)/M(0)) and vessel area (M(0)), and M(0) of the 2 proximal gates was used to correct for scattering and attenuation. CFR was calculated as hyperemic/resting flow with Q and compared with APV-derived CFVR and with the corresponding segmental MPR obtained with (15)O-labeled water and PET. RESULTS: Q (CFR, 2.60 +/- 1.07) correlated well with PET (MPR, 2.58 +/- 1.11) (r = 0.832, P < 0.005; Bland-Altman limits, -1.42 to 1.09), whereas CFVR did not (r = 0.09, P = not statistically significant; Bland-Altman limits, -3.36 to 2.24). However, in vessels without dilation, there was no difference between CFR, CFVR, and MPR. CONCLUSION: This procedure for intracoronary Q measurement using the proprietary Doppler guidewire system, which accounts for both changes in flow profile and changes in vessel area, allows invasive, accurate assessment of CFR even in the presence of flow-dependent vasodilation.
ST-segment resolution 60 minutes after combination treatment of abciximab with reteplase or reteplase alone for acute myocardial infarction (30-day mortality results from the resolution of ST-segment after reperfusion therapy substudy).
The combination of abciximab with thrombolytic therapy when treating acute ST-elevation myocardial infarction has been hypothesized to enhance microvascular perfusion. Resolution of ST-segment elevation after thrombolytic therapy is believed to be a marker of myocardial reperfusion and to predict mortality rate. Among 16,588 patients enrolled in the Fifth Global Use of Strategies to Open Occluded Arteries in Acute Myocardial Infarction trial, 1,764 consecutive patients from selected centers had their study electrocardiograms evaluated by a core laboratory for ST-segment deviation resolution 60 minutes after treatment. Patients were categorized into 4 groups: complete resolution (>70%), partial resolution (<70% to 30%), no resolution (<30%), and worsening ST-segment deviation. Patients treated with reteplase or a combination of reteplase plus abciximab had similar rates of complete resolution (32% vs 34%), partial resolution (29% vs 27%), no resolution (15% vs 16%), and worsening ST-segment elevation (23 vs 23%; p = 0.59). The 30-day mortality rates in these 4 groups were 2.1%, 5.2%, 5.5%, and 8.1% (p <0.001). Even after accounting for baseline variables, incomplete ST-segment resolution (<70%) was associated with an increased risk of death within 30 days (adjusted hazard ratio 2.41, 95% confidence interval 1.25 to 4.63, p <0.008). Thus, ST-segment resolution at 60 minutes was no different in patients treated with full-dose reteplase from those treated with a combination of abciximab and reteplase. Patients with >70% ST-segment resolution within 60 minutes had markedly decreased mortality rates, irrespective of treatment.
Severe bilateral carotid stenosis: the impact of ipsilateral stenting on Doppler-defined contralateral stenosis.
OBJECTIVES: The study examined the effect of carotid stenting (CS) on contralateral carotid Doppler-defined degree of stenosis. BACKGROUND: Patients with carotid disease are frequently referred for carotid revascularization (carotid endarterectomy [CEA] or CS) based on the results of carotid duplex studies. Although a drop in flow velocities in the contralateral carotid has been described after CEA, the effect of ipsilateral stenting on contralateral velocities has not been defined. METHODS: A total of 104 consecutive patients underwent CS and were divided into two cohorts, those with unilateral stenosis, and those with bilateral stenosis. Doppler-defined pre-procedural peak systolic velocities (PSV) and end-diastolic velocities (EDV) in the contralateral carotid were compared with the post-procedural velocities. Post-procedural angiographic stenoses were compared with post-procedural duplex-defined stenoses. RESULTS: Among patients with bilateral stenosis, after ipsilateral stenting there was a drop in the contralateral PSV and EDV of 60.3 cm/s (p = 0.005) and 15.1 cm/s (p = 0.03), respectively. There was no change in the contralateral velocities in patients with unilateral stenosis. Among patients with > or =60% stenosis by duplex in the contralateral carotid, 20% dropped to a lower classification of contralateral stenosis after ipsilateral stenting. Furthermore, 71% of patients with significant contralateral stenosis by duplex pre-stenting did not have significant stenosis by angiography. CONCLUSIONS: Patients with bilateral carotid disease may have elevated Doppler flow velocities in the contralateral carotid resulting in an artifactually high grade of stenosis. After ipsilateral carotid revascularization, such patients should have a repeat Doppler of the contralateral carotid to assess the true grade of stenosis.
Feasibility of simultaneous bilateral carotid artery stenting.
Due to the progressive aging of the population, severe bilateral carotid stenosis has become a more frequent condition. On occasion, simultaneous revascularization may be appropriate. There is increased evidence that for these high-risk patients, a percutaneous revascularization may be the best approach. However, there are concerns that simultaneous bilateral carotid stenting may be associated with cerebral hyperperfusion, excessive bradycardia, and hypotension. We report a series of 10 consecutive patients who underwent simultaneous bilateral carotid stenting. All of these patients were not deemed to be surgical candidates due to high-risk comorbidities. All but one of the lesions were successfully stented. There were no procedural deaths, myocardial infarctions, or strokes. Thus, among carefully selected patients, simultaneous bilateral carotid artery stenting is a promising, technically feasible option.
Percutaneous coronary intervention in diabetic patients with non-ST-segment elevation acute coronary syndromes.
Key pathophysiologic mechanisms of diabetes-related coronary disease include inflammation and a prothrombotic state. In the setting of non-ST-segment elevation acute coronary syndromes diabetic patients are at high risk for subsequent cardiovascular events. At the same time, they derive greater benefit than non-diabetic counterparts from aggressive antithrombotic therapy, early coronary angiography, and stent-based percutaneous coronary intervention. The mainstays of antithrombotic therapy for diabetic patients undergoing percutaneous revascularization include aspirin, clopidogrel, platelet glycoprotein IIb/IIIa receptor antagonists, and heparin or low-molecular-weight heparin. Despite dramatic reduction in restenosis conferred by drug-eluting stents, diabetic patients remain at increased risk for repeat revascularization. More efforts are needed both in terms of local drug elution as well as systemic pharmacologic therapies to further contain the excessive neointimal proliferation that characterizes the diabetic response to vascular injury.
Early exercise after coronary stenting is safe.
OBJECTIVES: In this study, we sought to assess safety of symptom-limited exercise stress tests the day after coronary stenting. BACKGROUND: Isolated cases of coronary stent thrombosis have been linked to early exercise stress testing, thereby questioning the safety of unrestricted physical activity after the coronary procedure. METHODS: At a single center, 1,000 patients were randomized to a symptom-limited stress test the day after coronary stenting or no stress test. The antiplatelet regimen consisted of acetylsalicylic acid and postprocedural ticlopidine or clopidogrel. The primary end point of the study was the incidence of clinical stent thrombosis at 14 days. The secondary end point was the occurrence of access site complications. RESULTS: Clinical stent thrombosis occurred in five patients (1%) undergoing stress test and in five patients (1%) randomized to no stress test (p = 1.0). Access site complications were detected in 4% and 5.2% of cases, respectively (p = 0.37). CONCLUSIONS: Symptom-limited exercise stress testing the day after coronary stenting does not increase the risk of clinical stent thrombosis or access site complications. Further investigations on safety of early vigorous exercise after coronary stenting in a non-supervised setting are warranted.