Long-term outcome after sirolimus-eluting stents versus bare metal stents in patients with diabetes mellitus: a patient-level meta-analysis of randomized trials.

BACKGROUND: Although it is widely believed that patients with diabetes mellitus obtain the greatest benefit from drug-eluting stents, convincing evidence on long-term efficacy and safety of these stents is lacking. METHODS: We performed a meta-analysis of individual patient data from four randomized trials including 583 patients comparing sirolimus eluting with bare metal stents (median follow-up of 4.2 years). These were the only specific trials reporting on drug-eluting stents in diabetic patients. The primary endpoint was the incidence of major cardiac events. The secondary endpoints were all-cause mortality and myocardial infarction as a safety endpoint and target lesion re-intervention as an efficacy endpoint. Stent thrombosis was also evaluated. RESULTS: There was a significant reduction in the overall hazard of major cardiac events (hazard ratio [HR] 0.48, 95% confidence interval [CI] 0.36-0.63, P < 0.001) with sirolimus-eluting stents. This was mostly due to a significant reduction in the overall hazard of repeat revascularization (HR 0.27, 95% CI 0.18-0.41, P < 0.001) in favor of sirolimus-eluting stents. However, the overall hazard of death (HR 0.91, 95% CI 0.59-1.41, P = 0.68) as well as death or myocardial infarction (HR 0.77, 95% CI 0.54-1.09, P = 0.14) were not significantly different between the groups. No significant differences were observed regarding stent thrombosis (HR 0.50, 95% CI 0.15-1.69, P = 0.26). CONCLUSIONS: Sirolimus-eluting stents are highly effective in reducing the risk for major cardiac events and safe in diabetic patients with coronary artery disease.

Comparison of 2-year clinical outcomes with sirolimus and paclitaxel-eluting stents for patients with diabetes: results of the Registro Regionale AngiopLastiche Emilia-Romagna Registry.

BACKGROUND: Long-term outcomes of percutaneous coronary interventions (PCI) with sirolimus-eluting stents (SES) compared to paclitaxel-eluting-stents (PES) in unselected diabetics in routine practice is still debated. OBJECTIVE: This study compared the 2-year incidence of MACE (all-cause mortality, nonfatal myocardial infarction and target vessel revascularization) of SES and PES in a real-world setting of patients with diabetes. DESIGN: Observational, multicenter, nonrandomized study. SETTING: Prospective web-based registry (REAL Registry; study period, 2002-2005) comprising all 13 hospitals performing PCI. PATIENTS: Among the 945 eligible patients treated with either SES alone (n = 606) or PES alone (n = 339), 29% were insulin-requiring, 72% had multivessel coronary disease, 26% had prior myocardial infarction and 10% had poor left ventricular function. MEASUREMENTS: Unadjusted and propensity score-adjusted 2-year clinical outcome. RESULTS: After propensity score adjustment, 2-year MACE incidence in the SES and PES groups was equivalent (23.3% vs. 23.7%, HR 1.01, 95%CI 0.72-1.42, P = 0.96). Adjusted 2-year angiographic stent thrombosis occurred in 1.1% of the SES patients versus 2.6% of the PES patients (P = 0.15). In this large, real-world, diabetic population treated with DES, there was no difference in outcome between SES and PES. Further studies are needed to demonstrate the long-term safety of different types of DES in patients with diabetes.

Administration of eptifibatide during transfer for primary PCI in patients with STEMI: effect on Pre-PCI TIMI flow and its correlation with pain-to-therapy time.

BACKGROUND: Facilitation therapy in ST-elevation myocardial infarction (STEMI) is still controversial and no relationship between timing of treatment and efficacy has been reported to date. METHODS: In order to evaluate the effect of pre-catheterization laboratory (cath lab) administration of eptifibatide on pre-percutaneous coronary intervention (PCI) thrombolysis in myocardial infarction (TIMI) flow and its correlation with ischemia duration, we studied all 438 STEMI patients treated with primary PCI from January 2006 to December 2007: 310 patients were pretreated with eptifibatide (Group P), while 128 patients received either no glycoprotein IIb/IIIa inhibitors or were only given them in the cath lab (Group C). All ischemia times (chest pain onset, diagnostic electrocardiogram, eptifibatide administration, cath lab arrival, first balloon inflation) were recorded. Group P was divided into early (E:159 patients with symptoms duration or= 2 flow on multivariable analysis. Thirtyday mortality was 1.9% in Group P and 9.5% in Group C (p < 0.001). CONCLUSIONS: In our experience, very early (< 90 minutes) eptifibatide therapy prior to primary PCI achieves a higher rate of pre-PCI TIMI flow >or= 2 with respect to late administration.

Are drug-eluting stents superior to bare-metal stents in patients with unprotected non-bifurcational left main disease? Insights from a multicentre registry.

AIMS: To compare long-term clinical outcome following drug-eluting stents (DES) or bare-metal stents (BMS) implantation on lesions located at the ostium or the shaft of the left main in a large real-world population. The advent of DES decreased the risk of unprotected left main coronary artery (ULMCA) restenosis when compared with BMS, but it is unclear if this advantage continues when non-bifurcational lesions are considered. METHODS AND RESULTS: The GISE-SICI registry is a retrospective, observational multicentre registry promoted by the Italian Society of Invasive Cardiology in which 19 high-volume participating centres enrolled 1453 consecutive patients who underwent percutaneous coronary intervention on ULMCA between January 2002 and December 2006. From the registry, a total of 479 consecutive patients with ostial and shaft lesions who underwent DES (n = 334) or BMS (n = 145) implantation were analysed with extensive multivariable and propensity score adjustments. At 3-year follow-up, risk-adjusted survival rates were higher in patients treated with DES than in those treated with BMS. The adjusted hazard ratio (HR) for the risk of mortality after DES implantation relative to BMS implantation was 0.37 (95% CI: 0.15-0.96, P = 0.04). The adjusted HR for the risk of cardiac mortality was 0.31 (95% CI: 0.09-1.04, P = 0.06). The adjusted 3-year rates of target lesion revascularization (TLR) were not significantly lower in the DES group than in the BMS group (P = 0.60). CONCLUSION: In a large population of patients with lesions located at the ostium or the shaft of the left main in a real-world setting, DES were associated with favourable clinical outcomes when compared with BMS, although there was no evidence of a significant reduction in TLR with DES vs. BMS.

Percutaneous coronary interventions in octogenarians: Acute and 12 month results in a large single-centre experience.

OBJECTIVES: To review the results of PCI in patients aged >or=80 years. BACKGROUND: Octogenarians represent a growing proportion of patients treated with PCI; in this subset of high-risk patients, the role of complete revascularization is still controversial. METHODS: We examined in-hospital, 30 days, and 12-month events in 356 patients aged >or=80 years submitted to PCI from 2004 to 2006 and 754 patients aged <80 years treated in 2006. RESULTS: Octogenarians had a higher risk profile. A complete revascularization was obtained in 48% of them and in 65% of younger patients (P < 0.001); glycoprotein IIb/IIIa inhibitors (GPI) use was common in both groups (43 vs. 46.5%). In-hospital mortality was higher in octogenarians (3.9 vs. 1.3%, P = 0.01) as well as vascular complications (2.8 vs. 1%, P = 0.058). Mortality resulted 5.9 vs. 1.2% at 30 days (P < 0.001), and 16.3 vs. 3.9% at 12 months (P <0.001) in the two groups whereas repeat revascularization procedures did not differ (9.3 vs. 8.4%, respectively). In patients aged >or=80, there was no difference in 12 months total events (20 vs. 28%, P = 0.07) and repeat revascularizations (8 vs. 10%, P = 0.498) in completely or uncompletely revascularized subjects. At multivariate analysis age (P = 0.002), diabetes (P = 0.002), three vessel disease (P = 0.020) and procedural success (P = 0.002) were independent predictors of total events at 12 months. CONCLUSIONS: In our experience, frequent GPI use and multivessel PCI in 41% of >or=80 years-old patients resulted in good immediate and mid-term clinical outcomes, irrespective of the completeness of revascularization achieved.

Single or multivessel percutaneous coronary intervention in ST-elevation myocardial infarction patients.

OBJECTIVES: To evaluate clinical results of percutaneous coronary intervention (PCI) in ST-elevation myocardial infarction (STEMI) in patients with multivessel disease (MVD), in relation to single or multivessel (MV)-PCI and to patients with single vessel disease (SVD). METHODS: Patients treated with PCI in the setting of <24 hr STEMI in the years 2004-2007 were considered. RESULTS: Seven hundred forty-five primary PCI, 346 (46%) in patients with SVD and 399 (54%) in patients with MVD were performed. Among MVD patients, 156 (39%) had infarct related artery (IRA)-only treatment and 243 had MV-PCI: 147 (37%) in a single session, 48 (12%) within 24 hr, and 48 (12%) predischarge. Revascularization was complete in 46% of MVD patients. At a median follow-up of 597 days, mortality was 6.3% in SVD and 12% in MVD (P = 0.007), new revascularization 2.9% and 9%, respectively (P < 0.001). Thirty-day mortality was 2.4% in SVD and 6.7% in MVD (P = 0.006). After exclusion of patients with cardiogenic shock or pulmonary oedema, more frequent in the MV-PCI in single session group (P = 0.006), 30-day mortality was SVD 1.3%, IRA-only 6.3%, MV-PCI 2.8% (P = 0.023), without differences if in a single (3.3%) or in staged session (2.2%). By multivariate analysis, female sex, anterior STEMI, cardiogenic shock, MVD, and procedural failure were independent predictors of 30-day mortality. CONCLUSIONS: STEMI patients with MVD have a worse prognosis than those with SVD. MV-PCI in patients without hemodynamic compromise yields good short-term results, even if performed very early, with a 30-day mortality in between that of SVD patients and that of MVD patients with IRA-only treatment.

Comparison of effectiveness and safety of sirolimus-eluting stents versus bare-metal stents in patients with diabetes mellitus (from the Italian Multicenter Randomized DESSERT Study).

Few studies directly compared drug-eluting stents and bare-metal stents (BMSs) in diabetic patients. DESSERT was an Italian multicenter randomized trial to show the efficacy of sirolimus-eluting stents (SESs) compared with BMSs in de novo lesions of diabetic patients treated with insulin and/or oral antidiabetics for > or =3 months on top of glycoprotein IIb/IIIa inhibitors. The primary end point was in-stent late lumen loss, assessed using centralized quantitative coronary angiography at 8-month follow-up. Centrally adjudicated composite major adverse cardiac events (MACEs) and target-vessel failure (TVF; death, treated vessel-related acute myocardial infarction, and target-vessel revascularization) at 30 days and 9 and 12 months were secondary end points. Seventy-five patients were randomly assigned to an SES (109 lesions), and 75 (109 lesions), to a BMS. The 2 groups were well balanced for clinical, anatomic, and procedural characteristics. In-stent late lumen loss decreased from 0.96 +/- 0.61 mm for BMSs to 0.14 +/- 0.33 for SESs (p <0.001), and in-segment binary restenosis was 38.8% versus 3.6%, respectively (p <0.001). Twelve-month clinical events were significantly lower in the sirolimus group: MACEs 22.1% versus 40% (p = 0.023), target-lesion revascularization 5.9% versus 30% (p <0.001), and TVF 14.7% versus 34.3% (p = 0.008). At multivariate analysis, stent type was confirmed as an independent predictor of in-segment late loss (p <0.001), binary restenosis (p <0.001), 12-month TVF (p = 0.010), and 12-month MACEs (p = 0.037). In conclusion, the randomized DESSERT showed SESs to be safe and effective in decreasing both angiographic parameters of restenosis and incidence of MACEs compared with BMSs in diabetic patients with de novo 1- or 2-vessel coronary stenoses.

Long-term outcomes with drug-eluting stents versus bare metal stents in the treatment of saphenous vein graft disease (results from the REgistro Regionale AngiopLastiche Emilia-Romagna registry).

Percutaneous revascularization of saphenous vein grafts (SVGs) remains a challenging task. Drug-eluting stents (DESs) have been shown to decrease the incidence of restenosis in de novo native coronary artery lesions. However, their clinical value in SVGs remains to be established. We compared long-term clinical outcomes of percutaneous coronary intervention with DESs and bare metal stents (BMSs) for de novo lesions in SVGs. In a large prospective, multicenter registry, 360 patients underwent stenting of a de novo lesion in SVGs using BMSs (288 patients) or DESs (72 patients). Incidence of major adverse cardiac events (MACEs), including all-cause mortality, reinfarction, and target vessel revascularization, was recorded at a 12-month follow-up. Compared with the DES group, patients receiving BMSs were more likely to be men, to have chronic renal insufficiency or higher Charlson scores, but less likely to have undergone previous percutaneous coronary intervention. Incidence of MACEs at 12-month follow-up was similar in the 2 groups (17.8% in DES group vs 20.3% in BMS group, respectively, p = 0.460). Cox regression analysis identified age, chronic renal failure, cardiogenic shock at presentation, and ostial location of stenosis as independent predictors of long-term MACEs. In conclusion, our data suggest that rates of 12-month MACEs associated with the use of DESs and BMSs are similar in patients undergoing treatment of de novo lesions in SVGs.

Two-year clinical outcomes with drug-eluting stents for diabetic patients with de novo coronary lesions: results from a real-world multicenter registry.

BACKGROUND: The long-term effectiveness of drug-eluting stents (DES) in unselected diabetics in routine practice is currently unclear. METHODS AND RESULTS: To evaluate the long-term effectiveness of bare metal stents and DES in a real-world setting of diabetic patients, we analyzed 2-year follow-up data from all diabetic patients with de novo lesions enrolled in a prospective Web-based multicenter registry (Registro Regionale Angioplastiche dell'Emilia-Romagna; study period, 2002 to 2004) comprising all 13 hospitals performing percutaneous coronary interventions in the Emilia-Romagna region of Italy. Among the 1648 eligible patients treated with either bare metal stents alone (n=1089) or DES alone (n=559), 27% were insulin dependent and 83% had multivessel coronary disease. At 2 years, use of DES was associated with lower crude incidence of major adverse cardiac advents (all-cause mortality, nonfatal myocardial infarction, and target vessel revascularization) compared with bare metal stents (22.5% versus 28.1%; P=0.01). After propensity score adjustment, only target vessel revascularization appeared significantly lower in the DES group (11.6% versus 15.0%; hazard ratio, 0.66; 95% confidence interval, 0.46 to 0.96; P=0.041). Two-year angiographic stent thrombosis occurred in 1.5% DES patients and 0.7% of the bare-metal-stents patients (P=0.18). At Cox regression analysis, predictors of 2-year major adverse cardiac advents were left ventricular ejection fraction <35%, Charlson comorbidity index, insulin-dependent diabetes, and total lesion length. CONCLUSIONS: In this large, real-world, diabetic population, the use of DES was associated with a moderate reduction in the 2-year risk of target vessel revascularization, a benefit that was limited to non-insulin-dependent diabetic patients. Larger long-term studies are needed to clarify the long-term effectiveness and safety of such devices in diabetic patients.

Comparison of multiple drug-eluting stent percutaneous coronary intervention and surgical revascularization in patients with multivessel coronary artery disease: one-year clinical results and total treatment costs.

PURPOSE: Consecutive patients with multivessel coronary artery disease treated with multiple drug-eluting-stent (DES) percutaneous coronary intervention (PCI) (111 patients) or coronary artery bypass graft (CABG) (95 patients) on the basis of clinico-anatomical judgment were examined to investigate mediumterm clinical results and initial and total costs. METHODS: Clinical and procedural characteristics, duration of hospital stay, initial and total costs and 12-month follow-up events were considered in both groups. RESULTS: Previous revascularization procedures and acute coronary syndromes were more frequent in the PCI group, while triple-vessel and left main disease occurred more often in the CABG group. The mean number of treated vessels in multiple DES PCI was 2.7/patient, with 2.8 DES/patient. Complete revascularization was achieved in 70% of cases. Inhospital events were postprocedural non-Q-wave acute myocardial infarction in 5.4%, and 2 retroperitoneal hemorrhages. CABG was performed with a mean of 3.9 grafts/patient; 16 patients (17%) had early complications; mean hospital stay was significantly longer than for the PCI patients (23.5 +/- 10 vs. 5.3 +/- 3 days; p < 0.001). Twelve-month total mortality and acute myocardial infarction incidents were similar, while target vessel revascularization was significantly more frequent in the PCI group (12.6% PCI vs. 2.1% CABG; p < 0.001); cumulative major adverse cardiac events were not significantly different (15.3% PCI vs. 9.5% CABG; p = 0.271). Initial and final costs were lower for multivessel PCI with DES (20,050 +/- 2,702 for CABG vs. 10,214 +/- 4,184 for PCI; p < 0.001), but not completely covered by current DRG reimbursement. CONCLUSIONS: Multiple DES PCI showed good earlyand medium-term results with substantially lower costs than CABG.

One-year clinical results and total costs of drug-eluting stents implantation in multivessel coronary artery disease.

OBJECTIVES: One hundred and eleven consecutive patients with multivessel coronary artery disease treated with percutaneous coronary intervention with multiple drug-eluting stents were examined to investigate 1-year clinical results and initial and total costs. METHODS: Clinical and procedural characteristics, duration of hospital stay and 12-month follow-up events were considered. Real costs of multivessel percutaneous coronary intervention with multiple drug-eluting stents were calculated, including disposables, personnel, equipment depreciation and hospital stay, whereas medical resources consumption at 12 months were calculated as disease related group reimbursement tariffs. RESULTS: The patient population (69% males, mean age 65 +/- 10 years) presented mid to high-risk clinical and anatomical characteristics. The mean number of treated vessels was 2.36 per patient with 2.8 drug-eluting stents per patient. A complete revascularization was achieved in 70% of cases. In-hospital events were post-procedural non-Q myocardial infarction in 5.4% and two retroperitoneal haemorrhages. Post-procedural hospital stay was 2.5 +/- 2.3 days (mean total hospital stay = 5.3 +/- 3 days). At 12-month follow-up, total mortality and acute myocardial infarction incidence were 3.6% and 1.8%, respectively; only one patient (0.9%) presented subacute stent thrombosis at 3 months, which was treated by urgent re-percutaneous coronary intervention. Target vessel revascularization rate was 12.6% and the incidence of cumulative major adverse cardiac events was 15.3%. Initial hospital costs were 8992 euros +/- 2825 (5518 euros +/- 1098 for procedure and 3473 euros+/- 2347 for hospital stay); follow-up costs were 222 euros+/- 3087, leading to 12-month total costs of 10214 euros+/- 4184. CONCLUSIONS: Multivessel percutaneous coronary intervention with drug-eluting stents showed good early and medium-term results with acceptable total costs. Despite not completely being covered by actual disease related group reimbursement, the initial and final costs were substantially lower than that of disease related group reimbursement for coronary artery bypass graft.

Long-term safety and efficacy of drug-eluting stents: two-year results of the REAL (REgistro AngiopLastiche dell'Emilia Romagna) multicenter registry.

BACKGROUND: The long-term safety and efficacy of drug-eluting stents (DES) have been questioned recently. METHODS AND RESULTS: Between July 2002 and June 2005, 10,629 patients undergoing elective percutaneous coronary intervention with either DES (n=3064) or bare-metal stents (BMS, n=7565) were enrolled in a prospective registry comprising 13 hospitals. We assessed the cumulative incidence of major adverse cardiac events (death, acute myocardial infarction, and target-vessel revascularization) and angiographic stent thrombosis during 2-year follow-up. A propensity score analysis to adjust for different baseline clinical, angiographic, and procedural characteristics was performed. The 2-year unadjusted cumulative incidence of major adverse cardiac events was 17.8% in the DES group and 21.0% in the BMS group (P=0.003 by log-rank test). Angiographic stent thrombosis was 1.0% in the DES group and 0.6% in the BMS group (P=0.09). After adjustment, the 2-year cumulative incidence of death was 6.8% in the DES group and 7.4% in the BMS group (P=0.35), whereas the rates were 5.3% in DES and 5.8% in BMS for acute myocardial infarction (P=0.46), 9.1% in DES and 12.9% in BMS for target-vessel revascularization (P<0.00001), and 16.9% in DES and 21.8% in BMS for major adverse cardiac events (P<0.0001). Independent predictors of target-vessel revascularization in the DES group were diabetes mellitus (hazard ratio 1.36, 95% confidence interval 1.06 to 1.76), renal failure (hazard ratio 1.69, 95% confidence interval 1.06 to 2.69), and reference vessel diameter (hazard ratio 0.64, 95% confidence interval 0.45 to 0.93). CONCLUSIONS: In this large real-world population, the beneficial effect of DES in reducing the need for new revascularization compared with BMS extends to 2 years without evidence of a worse safety profile.

Percutaneous treatment of multivessel coronary disease in the drug eluting stent era: comparison of bare-metal stents, drug-eluting stents and a mixed approach in a large multicentre registry.

BACKGROUND: Restenosis and a high incidence of new revascularisations reduce the long-term efficacy of percutaneous coronary intervention (PCI) in patients with multivessel coronary artery disease. AIMS: To determine the modality of utilisation and the clinical efficacy of drug eluting stents (DES) in a real world multivessel PCI scenario. METHODS: From July 2002 to December 2004, 1726 consecutive patients enrolled in the REAL Registry (Registro REgionale AngiopLastiche Emilia-Romagna) underwent elective multivessel PCI with multiple stents in at least two different vessels; among them, 939 (54%) received only bare-metal stents (BMS group), 288 (17%) only DES (DES group) and 499 (29%) were treated with BMS and DES in different vessels (MIX group). The incidence of major adverse cardiac events (MACE= death, myocardial infarction and target vessel revascularisation) during follow-up was assessed. RESULTS: Patients in the BMS group were older, diabetes was more frequent in the DES and MIX groups, while more lesions and more often a three vessel treatment was performed in the MIX group. In the DES group, lesions were longer, in smaller vessels and more often in the left main compared with BMS and MIX groups. In the MIX group too, lesions treated with DES were at higher risk for restenosis than those treated with BMS. Procedural success was similar in the three groups (98.9%). Notwithstanding the different risk profile, 12-month follow up did not show differences in clinical end points among the three groups. Multivariate analysis indicated that age, a modified Charlson's comorbidity index and diabetes were independent predictors of death or AMI; total lesion length, use of only DES or MIX approach and treatment of left main were predictors of TVR, while left main treatment along with only DES use, modified Charlson's index and reference vessel diameter independently affected the incidence of MACE. Use of at least one DES reduced the risk of TVR by 37% and MACE by 29%, while DES in every lesion treated reduced TVR risk by 37% and MACE by 39%. CONCLUSIONS: In this large multicentre registry, DES were utilised in only half of the multivessel PCI procedures, mainly to treat high-risk patients and lesions. However, this selective use of DES was independently associated with a lower incidence of 1-year TVR and MACE. Whether increasing the rate of DES utilisation would further improve the clinical outcome remains to be investigated.

Effective intracoronary thrombectomy with the X-sizer catheter of the right coronary artery and left anterior descending artery in a patient with acute inferior and right ventricular infarction complicated by hypotension and diffuse intracoronary thrombosis.

Intracoronary thrombosis of non infarct-related arteries during an episode of acute myocardial infarction can be correlated with a general thrombogenic state and precipitated by prolonged hypotension. We report the case of a patient with acute inferior and right ventricular infarction with acute thrombotic obstruction of the proximal right coronary artery and associated sessile thrombus in the proximal left anterior descending artery, both successfully treated by thromboaspiration with the X-Sizer catheter (ev3, Inc., Plymouth, Minnesota, USA).

Percutaneous treatment of the left main coronary artery ostial obstruction following aortic valve replacement.

Iatrogenic left main coronary artery ostial stenosis is a rare and late life-threatening complication of aortic valve replacement. The exact causes of this critical condition, despite being still nowadays elusive, are possibly related to the insertion of perfusion catheters into the left coronary system for cardioplegia delivery. We describe the case of a 69-year-old man, with normal coronary arteries documented by preoperative coronary angiography before surgery, who developed 1 year after aortic valve replacement worsening effort angina. A second coronary angiography revealed a severe left main ostial stem stenosis, which was successfully treated by sirolimus-eluting stent deployment. This case demonstrates a new percutaneous approach of this poorly understood, yet potentially fatal complication following aortic valve replacement.

Occurrence of non-Q wave myocardial infarction following percutaneous coronary intervention in the stent era: systematic monitoring of the three markers of myocardial necrosis.

OBJECTIVES: To compare the elevation of the three markers total creatine kinase (CK), CK-MB mass, and troponin I (TnI) and their relationship with clinical and procedural characteristics following percutaneous coronary intervention (PCI). METHODS: We prospectively evaluated 385 patients consecutively undergoing successful PCI. The three markers were systematically measured before and at 6, 12, and 24 hours after PCI. Any increase above the upper normal limit (UNL) of any marker has been considered abnormal when basal values were normal, while a further increase was needed when basal values were altered. Patients with ongoing acute myocardial infarction were excluded from the analysis. RESULTS: TnI was above UNL in 183 patients (51%); in 138 (38.5%) it was the only marker altered. CK-MB mass was elevated in 12.8% patients, more than 3x UNL in 5.5% and more than 5x UNL in 2.8%. In over one half of these patients, CK-MB values peaked at 12 hours following PCI. Total CK was above UNL in 23 patients only (6.4%) and more than twice UNL in 5 (1.4%). Only 1 patient out of the 5 with CK-MB mass more than 10x UNL had total CK higher than twice UNL. In our population, post-PCI elevation of myocardial necrosis markers correlate with the occurrence of minor procedural complications (observed overall in 7.8% cases; TnI and/or CK-MB > 1xUNL 96% vs 47.5%, P < 0.001) and the presence of higher complexity clinical and/or procedural features, such as multivessel disease, multivessel or multilesion PCI, multiple stenting and use of glycoprotein IIb/IIIa inhibitors. CONCLUSIONS: The elevation of at least one biochemical marker of myocardial necrosis is frequent following successful PCI with routine stent implantation. CK-MB mass is the most practical marker, having optimal kinetic and peaking with the first 12-18 hours post-PCI. Definitive data on the prognostic role and the applicability for the diagnosis of myocardial infarction of minor elevation of CK-MB mass or isolated increase of TnI are lacking.

Comparison of effectiveness of sirolimus-eluting stents versus bare metal stents for percutaneous coronary intervention in patients at high risk for coronary restenosis or clinical adverse events.

We evaluated the clinical effect of selective use of sirolimus-eluting stents (SESs) in real-world, high-risk patients. A total of 4,237 consecutive patients who underwent percutaneous coronary intervention (SES, n = 872, bare metal stents [BMSs], n = 3,365) was enrolled in a prospective regional survey. A prespecified high-risk subset of patients was selected on the basis of clinical and angiographic characteristics. A propensity score analysis was performed to compare patients who received SESs with those who received BMSs. Patients in the SES group more often had diabetes and more frequently had previous myocardial infarction or coronary revascularization, type C lesions, and multivessel procedures. Patients who presented with acute myocardial infarction were treated more often with BMSs. At 9 months, the use of SESs was associated with fewer major adverse cardiac events (death, myocardial infarction, or target lesion revascularization; hazard ratio 0.56, 95% confidence interval 0.37 to 0.85) and target lesion revascularizations (hazard ratio 0.43, 95% confidence interval 0.20 to 0.91). This decrease was more evident in a prespecified high-risk subgroup of patients (major adverse cardiac events, 8.0% SES vs 15.6% BMS, hazard ratio 0.45, 95% confidence interval 0.29 to 0.72). We conclude that selective SES use in real-world patients who have high-risk clinical and angiographic characteristics is associated with significant decreases in major adverse cardiac events and repeat revascularizations compared with BMS use.

Starc II, a multicenter randomized placebo-controlled double-blind clinical trial of trapidil for 1-year clinical events and angiographic restenosis reduction after coronary angioplasty and stenting.

The objective of this study was to investigate the effect of trapidil 200 mg t.i.d. in preventing the occurrence of death, of myocardial infarction and the need for repeat revascularization at 12 months after balloon PTCA with or without stenting. Coronary restenosis after stenting is still a major drawback of percutaneous coronary interventions (PCI) for 30-40% of patients. Trapidil has been shown to prevent restenosis after PTCA. Eligible patients were randomized to placebo or oral trapidil 200 mg t.i.d. at least 48 hr before PCI and continuing 6 months after a successful balloon angioplasty or stent implantation. Aspirin was given to all patients, and ticlopidine 250 mg b.i.d. to those who received a stent for 4 weeks. In a randomized subgroup of 216 patients, quantitative coronary angiography was performed also at 6-month follow-up. Out of the 933 patients enrolled, primary endpoint incidence was 20.3% in trapidil and 18.0% in placebo (P = 0.37). When recurrence or deterioration of angina was added to the combined endpoint, incidence was 27.4% in trapidil and 23.0% in placebo (P = 0.12). Restenosis rate in patients with 6-month angiography was 25.0% in trapidil arm vs. 30.1% in placebo (P = 0.43). Stent restenosis rate was similar in patients randomized to trapidil or placebo (30.2% vs. 23.8%, respectively; P = 0.44), while in patients treated with balloon angioplasty, it was lower in trapidil (17.1%) than in placebo (40.0%; P = 0.03). Oral trapidil 200 mg t.i.d. for 6 months in addition to aspirin did not influence the occurrence of major cardiac events after coronary angioplasty with or without stenting. In a prespecified subgroup of 191 patients treated with balloon angioplasty only, trapidil reduced angiographic restenosis.

Cost of single-vessel and multivessel coronary drug-eluting stenting: comparison to the DRG funding level.

BACKGROUND: Large-scale utilization of drug-eluting stents (DES) presents significant economic limitations, related to the current high cost of the device and the absence of adequate reimbursement from the health care system. The aim of the study was to evaluate the cost of single-vessel and multivessel drug-eluting stenting and to compare it with the DRG funding level. METHODS: Between November 2003 and May 2004, we studied 100 consecutive patients who underwent a percutaneous coronary intervention (PCI) with DES, 50 single-vessel and 50 multivessel procedures, in order to evaluate the real procedure costs of DES. The cost fields calculated in the analysis included: costs for the materials and drugs used in each procedure, costs related to medical personnel and staff, costs for equipment depreciations, and costs for total hospitalization based on the length of stay in the coronary care unit and/or in the cardiology ward. RESULTS: With regard to the 50 patients with single-vessel disease, 63 lesions were treated with 58 DES. With regard to the 50 patients with multivessel disease, the average number of treated vessels was 2.3 and of lesions 2.8. An average of 2.7 DES per patient was implanted; glycoprotein Ilb/IIIa inhibitors were used in 70% of cases. The multivessel procedure necessitated an average of 1.62 guide catheters, 1.86 guides, 1.36 balloons, and 475 +/- 124 ml of contrast medium; the average endoscopy time was 16 +/- 8 min while the total procedural time was 106 +/- 37 min. The procedural success rate was 100% for both groups. The post-PCI hospital stay was 2.1 +/- 1.7 days for patients with single-vessel disease and 2.8 +/- 2.6 days for patients with multivessel disease; the total was 4.7 +/- 2.8 and 6 +/- 3.2 days respectively. The mean total cost of hospital stay for PCI and DES was 6390 +/- 2274 Euro for single-vessel PCI and 9828 +/- 3026 Euro for multivessel PCI, split as follows: materials 2915 +/- 963 Euro and 5294 +/- 1177 Euro, procedural costs 404 +/- 55 and 446 +/- 99 Euro, costs of hospital stay 3070 +/- 2024 Euro and 4089 +/- 2517 Euro respectively for single-vessel and multivessel PCI. CONCLUSIONS: The mean total cost of a single-vessel PCI with DES falls within the DRG 112 reimbursement level for coronary angioplasty of 7006 Euro, while that of multivessel PCI with multiple DES is about 40% above the same reimbursement level. Interestingly, the multivessel PCI cost with multiple DES does fall within the reimbursement amount related to DRG 107 for bypass surgery procedures (14,322 Euro).

[Impact of a regional project on patterns of care for acute myocardial infarction]. / Impatto di una iniziativa regionale sui percorsi assistenziali dei pazienti con infarto miocardico acuto.

BACKGROUND: On May 2003 the Emilia-Romagna Regional Commission for Cardiology and Cardiac Surgery launched a project aimed at improving health service ability to adopt interventions of well-known effectiveness for the treatment of patients with acute myocardial infarction. One of the main goals was to stimulate the clinical and organizational responsibilities operating at the local level, in order to improve the frequency of use of primary percutaneous coronary intervention. METHODS: In assessing the overall impact of this regional project, an interrupted time series regression analysis was conducted, relying on information drawn from the regional hospital discharge database. Overall, 18 957 patients admitted for acute myocardial infarction during the period January 2001-June 2004 were considered. RESULTS: One year after the inception of the regional project, the estimate of its effect documented a statistically significant increase in the frequency of use of percutaneous coronary angioplasty (5.8%, 95% confidence interval 4.6%-6.9%), paralleled by an increase (3.2%, 95% confidence interval 1.14%-5.0%) in the number of those directly admitted to centers with interventional cardiology facilities. No effect was observed as for the proportion of patients admitted to highly specialized departments. CONCLUSIONS: Despite the obvious limitations due both to source of information and study design, our findings document that the regional project had indeed some tangible impact, although variable across the different geographic areas of the region, on key aspects of the patterns of care of patients with acute myocardial infarction.