Ricardo Seabra-Gomes

Randomised comparison of implantation of heparin-coated stents with balloon angioplasty in selected patients with coronary artery disease (Benestent II)

BACKGROUND The multicentre, randomised Benestent-II study investigated a strategy of implantation of a heparin-coated Palmar-Schatz stent plus antiplatelet drugs compared with the use of balloon angioplasty in selected patients with stable or stabilised unstable angina, with one or more de-novo lesions, less than 18 mm long, in vessels of diameter 3 mm or more. METHODS 827 patients were randomly assigned stent implantation (414 patients) or standard balloon angioplasty (413 patients). The primary clinical endpoint was event-free survival at 6 months, including death, myocardial infarction, and the need for revascularisation. The secondary endpoints were the restenosis rate at 6 months and the cost-effectiveness at 12 months. There was also one-to-one subrandomisation to either clinical and angiographic follow-up or clinical follow-up alone. Analyses were by intention to treat. FINDINGS Four patients (one stent group, three angioplasty group) were excluded from analysis since no lesion was found. At 6 months, a primary clinical endpoint had occurred in 53 (12.8%) of 413 patients in the stent group and 79 (19.3%) of 410 in the angioplasty group (p=0.013). This significant difference in clinical outcome was maintained at 12 months. In the subgroup assigned angiographic follow-up, the mean minimum lumen diameter was greater in the stent group than in the balloon-angioplasty group, (1.89 [SD 0.65] vs 1.66 [0.57] mm, p=0.0002), which corresponds to restenosis rates (diameter stenosis > or =50%) of 16% and 31% (p=0.0008). In the group assigned clinical follow-up alone, event-free survival rate at 12 months was higher in the stent group than the balloon-angioplasty group (0.89 vs 0.79, p=0.004) at a cost of an additional 2085 Dutch guilders (US

A randomized comparison ofrepeat stenting with balloon angioplasty in patients with in-stent restenosis

1020) per patient. INTERPRETATION Over 12-month follow-up, a strategy of elective stenting with heparin-coated stents is more effective but also more costly than balloon angioplasty.

The role of cardiac registries in evidence-based medicine.

OBJECTIVES This randomized trial compared repeat stenting with balloon angioplasty (BA) in patients with in-stent restenosis (ISR). BACKGROUND Stent restenosis constitutes a therapeutic challenge. Repeat coronary interventions are currently used in this setting, but the recurrence risk remains high. METHODS We randomly assigned 450 patients with ISR to elective stent implantation (224 patients) or conventional BA (226 patients). Primary end point was recurrent restenosis rate at six months. Secondary end points included minimal lumen diameter (MLD), prespecified subgroup analyses, and a composite of major adverse events. RESULTS Procedural success was similar in both groups, but in-hospital complications were more frequent in the balloon group. After the procedure MLD was larger in the stent group (2.77 +/- 0.4 vs. 2.25 +/- 0.5 mm, p < 0.001). At follow-up, MLD was larger after stenting when the in-lesion site was considered (1.69 +/- 0.8 vs. 1.54 +/- 0.7 mm, p = 0.046). However, the binary restenosis rate (38% stent group, 39% balloon group) was similar with the two strategies. One-year event-free survival (follow-up 100%) was also similar in both groups (77% stent vs. 71% balloon, p = 0.19). Nevertheless, in the prespecified subgroup of patients with large vessels (> or =3 mm) the restenosis rate (27% vs. 49%, p = 0.007) and the event-free survival (84% vs. 62%, p = 0.002) were better after repeat stenting. CONCLUSIONS In patients with ISR, repeat coronary stenting provided better initial angiographic results but failed to improve restenosis rate and clinical outcome when compared with BA. However, in patients with large vessels coronary stenting improved the long-term clinical and angiographic outcome.

Laser angioplasty of restenosed coronary stents: Results of a multicenter surveillance trial

Cardiovascular disease remains the primary cause of mortality, and a major cause of disability in the developed world.1 This significant burden necessitates ongoing improvements in patient management, to minimize the impact of cardiovascular conditions on both patients and healthcare systems. These improvements in cardiovascular care are promoted by an evidence-based approach, shaped by comprehensive clinical guidelines. The scientific basis of recommendations is an important feature of clinical guidelines, and influences the degree to which they are followed in clinical practice.2 Recent studies have assigned the highest evidence grading to randomized controlled trials (RCTs) that are clinically important, and representative of the clinical population covered by the guideline recommendation.3 For example, this highest grading was assigned to a recommendation based on a meta-analysis of RCTs showing low-dose diuretics to be the most effective first-line treatment for cardiovascular event prevention in hypertensive patients. This study reviewed data from 42 RCTs which were, crucially, representative of the population that the recommendation was made for (i.e. hypertensive patients).3,4 The importance of the applicability of evidence to recommendations highlights the need to consider evidence from clinically relevant situations, not all of which have been assessed by RCTs. This evidence can originate from expert consensus, as well as non-randomized prospective studies. Although generally providing a lower evidence-level than RCTs,3,5 observational studies can make an important contribution to the evidence base when the study outcomes are clinically important, and the populations involved are representative. Indeed, information from several registries was considered in the recent American Heart Association Acute Coronary Care in the Elderly Scientific Statement.6 Non-randomized prospective registries document the treatment and outcomes for consecutive patients in clinical practice. Therefore, data are gained from a ‘real-world’ selection of patients, many of whom would be excluded from RCTs, …

Predictors of hospital mortality in the elderly undergoing percutaneous coronary intervention for acute coronary syndromes and stable angina

OBJECTIVES This study evaluated safety and efficacy of excimer laser angioplasty for treatment of restenosed or occluded coronary stents. BACKGROUND Balloon angioplasty of in-stent restenosis is limited by a high recurrence rate. Debulking by laser angioplasty is a novel concept to treat in-stent restenosis. METHODS A total of 440 patients with restenoses or occlusions in 527 stents were enrolled for treatment with concentric or eccentric laser catheters and adjunctive balloon angioplasty. RESULTS Laser angioplasty success (< or =50% diameter stenosis after laser treatment or successful passage with a 2.0-mm or 1.7-mm eccentric laser catheter) was achieved in 92% of patients. Adjunctive balloon angioplasty was performed in 99%. Procedural success (laser angioplasty success followed by < or =30% stenosis with or without balloon angioplasty) was 91%. There was neither a significant difference in success with respect to lesion length, nor were there differences between small and large vessels or native vessels and vein grafts. Success was higher and residual stenosis lower using large or eccentric catheters. Serious adverse events included death (1.6%, not directly laser catheter related), Q-wave myocardial infarction (0.5%), non-Q-wave infarction (2.7%), cardiac tamponade (0.5%) and stent damage (0.5%). Perforations after laser treatment occurred in 0.9% of patients and after balloon angioplasty in 0.2%. Dissections were visible in 4.8% of patients after laser treatment and in 9.3% after balloon angioplasty. Reinterventions during hospitalization were necessary in 0.9% of patients; bypass surgery was performed in 0.2%. CONCLUSIONS Excimer laser angioplasty with adjunctive balloon angioplasty is a safe and efficient technology to treat in-stent restenoses. These data justify a randomized comparison with balloon angioplasty.

Use and impact of intra-aortic balloon pump on mortality in patients with acute myocardial infarction complicated by cardiogenic shock: results of the Euro Heart Survey on PCI.

BACKGROUND The percentage of elderly treated with percutaneous coronary intervention (PCI) has been increasing year by year. Little is known about predictors of hospital mortality in elderly undergoing PCI for acute coronary syndromes (ACS) and stable angina. METHODS Between 2005 and 2008 a total of 47,407 consecutive patients undergoing PCI were prospectively enrolled into the PCI-Registry of the EHS Programme. For the present analysis patients were divided into four categories: ACS patients ≥ 75 (n=4,943) and < 75 years (n=19,446), and patients with stable angina ≥ 75 (n=3,393) and < 75 years (n=19,625). A multiple logistic regression analysis was conducted to detect independent predictors of mortality in patients ≥ 75 years undergoing PCI. In addition, differences in clinical characteristics, procedural details and in-hospital outcomes between the subgroups were evaluated. RESULTS Patients ≥ 75 years had more co-morbidities, and more severe coronary pathology. The use of guideline-recommended adjunctive therapy and procedural success was high in all groups. The incidence of in-hospital death was highest in ACS patients ≥ 75 years (5.2%) and < 75 years (1.7%), followed by patients with stable angina ≥ 75 (0.5%) and < 75 years (0.2%). Haemodynamic instability and acute ST-elevation myocardial infarction were the strongest determinants of hospital mortality among patients ≥ 75 years with ACS, whereas interventional complications were the most meaningful predictors of death in older patients undergoing elective PCI. CONCLUSIONS Patients ≥ 75 years undergoing PCI face a relatively low risk of hospital death. However, complication rates were significantly higher compared to younger patients, strongly influenced by clinical, angiographic and interventional variables.

EuroHeart score for the evaluation of in-hospital mortality in patients undergoing percutaneous coronary intervention

AIMS The intra-aortic balloon pump (IABP) is recommended by current guidelines as adjunct in patients with cardiogenic shock, despite the lack of larger clinical trials. We sought to investigate the use and impact on mortality of IABP in current practice of percutaneous coronary interventions in Europe. METHODS AND RESULTS Between May 2005 and April 2008 a total of 47,407 consecutive patients undergoing percutaneous coronary intervention (PCI) in 176 centres in 33 countries in Europe and the Mediterranean basin were enrolled into the registry. From these, 8,102 had ST-elevation myocardial infarction and 7,999 non-ST elevation myocardial infarction and cardiogenic shock was observed in 7.9% and 2.1%, respectively. Of the 653 patients with cardiogenic shock 25% were treated with an IABP. In-hospital mortality, with and without IABP, was 56.9% and 36.1%. In the multivariate analysis the use of IABP was not associated with an improved survival (odds ratio 1.47; 95% CI 0.97-2.21, p=0.07). CONCLUSIONS In current clinical practice in Europe, IABP is used only in one quarter of patients with cardiogenic shock treated with primary PCI. However, there was no hint of a beneficial effect of IABP on outcome. Therefore, a large randomised clinical trial is urgently needed to define the role of IABP in patients with PCI for shock.

A Model for Predicting Mortality in Acute ST-Segment Elevation Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention

AIMS The applicability of currently available risk prediction models for patients undergoing percutaneous coronary interventions (PCIs) is limited. We aimed to develop a model for the prediction of in-hospital mortality after PCI that is based on contemporary and representative data from a European perspective. METHODS AND RESULTS Our analyses are based on the Euro Heart Survey of PCIs, which contains information on 46 064 consecutive patients who underwent PCI for different indications in 176 participating European centres during 2005-08. Patients were randomly divided into a training (n = 23 032) and a validation (n = 23 032) set with similar characteristics. In these sets, 339 (1.5%) and 305 (1.3%) patients died during hospitalization, respectively. On the basis of the training set, a logistic model was constructed that related 16 independent patient or lesion characteristics with mortality, including PCI indication, advanced age, haemodynamic instability, multivessel disease, and proximal LAD disease. In both the training and validation data sets, the model had a good performance in terms of discrimination (C-index 0.91 and 0.90, respectively) and calibration (Hosmer-Lemeshow P-value 0.39 and 0.18, respectively). CONCLUSION In-hospital mortality in PCI patients was well predicted by a risk score that contains 16 factors. The score has strong applicability for European practices.

Carvedilol for Prevention of Restenosis After Directional Coronary Atherectomy Final Results of the European Carvedilol Atherectomy Restenosis (EUROCARE) Trial

Background—Accurate models to predict mortality are needed for risk stratification in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Methods and Results—We examined 5745 patients with STEMI undergoing primary PCI in the Assessment of Pexelizumab in Acute Myocardial Infarction Trial within 6 hours of symptom onset. A Cox proportional hazards model incorporating regression splines to accommodate nonlinearity in the log hazard ratio (HR) scale was used to determine baseline independent predictors of 90-day mortality. At 90 days, 271 (4.7%) of 5745 patients died. Independent correlates of 90-day mortality were (in descending order of statistical significance) age (HR, 2.03/10-y increments; 95% CI, 1.80 to 2.29), systolic blood pressure (HR, 0.86/10-mm Hg increments; 95% CI, 0.82 to 0.90), Killip class (class 3 or 4 versus 1 or 2) (HR, 4.24; 95% CI, 2.97 to 6.08), heart rate (>70 beats per minute) (HR, 1.45/10-beat increments; 95% CI, 1.31 to 1.59), creatinine (HR, 1.23/10-&mgr;mol/L increments >90 &mgr;mol/L; 95% CI, 1.13 to 1.34), sum of ST-segment deviations (HR, 1.25/10-mm increments; 95% CI, 1.11 to 1.40), and anterior STEMI location (HR, 1.47; 95% CI, 1.12 to 1.93) (c-index, 0.82). Internal validation with bootstrapping confirmed minimal overoptimism (c-index, 0.81). Conclusions—Our study provides a practical method to assess intermediate-term prognosis of patients with STEMI undergoing primary PCI, using baseline clinical and ECG variables. This model identifies key factors affecting prognosis and enables quantitative risk stratification that may be helpful in guiding clinical care and for risk adjustment for observational analyses.

Sirolimus‐eluting stents versus bare‐metal stents in patients with in‐stent restenosis: Results of a pooled analysis of two randomized studies

BACKGROUND In addition to its known properties as a competitive, nonselective beta and alpha-1 receptor blocker, carvedilol directly inhibits vascular myocyte migration and proliferation and exerts antioxidant effects that are considerably greater than those of vitamin E or probucol. This provides the basis for an evaluation of carvedilol for the prevention of coronary restenosis. METHODS AND RESULTS In a prospective, double-blind, randomized, placebo-controlled trial, 25 mg of carvedilol was given twice daily, starting 24 hours before scheduled directional coronary atherectomy and continuing for 5 months after a successful procedure. The primary end point was the minimal luminal diameter as determined during follow-up angiography 26+/-2 weeks after the procedure. Of 406 randomized patients, 377 underwent attempted atherectomy, and in 324 (88.9%), a </=50% diameter stenosis was achieved without the use of a stent. Evaluable follow-up angiography was available in 292 eligible patients (90%). No differences in minimal luminal diameter (1.99+/-0.73 mm versus 2.00+/-0.74 mm), angiographic restenosis rate (23.4% versus 23.9%), target lesion revascularization (16.2 versus 14.5), or event-free survival (79.2% versus 79.7%) between the placebo and carvedilol groups were observed at 7 months. CONCLUSIONS The maximum recommended daily dose of the antioxidant and beta-blocker carvedilol failed to reduce restenosis after successful atherectomy. These findings are in contrast to those of the Multivitamins and Probucol Trial, which raises doubts regarding the validity of the interpretation that restenosis reduction by probucol was via antioxidant effects. The relationship between antioxidant agents and restenosis remains to be elucidated.