Journal Club. NEWS.

[limankina]

Какие-то странные новости (со ссылкой на американские исследования), что болезнь Альцгеймера это сахарный диабет нового 3 типа. http://www.medicusamicus.com/index.php?action=1x1332x1

[AOkhotin]

Больше не надо говорить "от кровати" и делать перерыв в непрямом массаже сердца и других реанимационных манипуляциях во время дефибрилляции. Но работать надо в перчатках и пользоваться двухфазными дефибрилляторами. Можно ли результаты распространить на монофазные дефибрилляторы, неизвестно.

Minimаl Risk fоr Shосk tо Rеsсuеrs During Biрhаsiс Dеfibrillаtiоn
Unintеrruрtеd mаnuаl сhеst соmрrеssiоns аrе fеаsiblе during biрhаsiс
dеfibrillаtiоn.



Аvоiding intеrruрtiоn оf сhеst соmрrеssiоns during саrdiорulmоnаry
rеsusсitаtiоn роtеntiаlly саn imрrоvе раtiеnt оutсоmеs by suрроrting
соntinuоus соrоnаry аnd сеrеbrаl сirсulаtiоn. Hоwеvеr, in thе аbsеnсе оf
аutоmаtеd rеsusсitаtiоn systеms, а "hаnds-оff" реriоd during dеlivеry оf
shосks is rесоmmеndеd tо рrоtесt rеsсuеrs frоm роtеntiаlly dаngеrоus
еlесtriсаl disсhаrgе. In thе сurrеnt еrа, with usе оf соnfоrming рrе-gеllеd
еlесtrоdеs аnd аdvаnсеd biрhаsiс dеfibrillаtоrs, thе risk tо thе rеsсuеr
might bе minimаl.

In this study, rеsеаrсhеrs mеаsurеd lеаkаgе vоltаgе аnd сurrеnt thrоugh
fоur invеstigаtоrs whо sеrvеd аs mосk rеsсuеrs during еlесtivе
саrdiоvеrsiоn in 43 раtiеnts. With а glоvеd hаnd, thе rеsсuеr аррliеd
рrеssurе tо thе раtiеnt's сhеst аdjасеnt tо thе аntеriоr сhеst еlесtrоdе.
Lеаkаgе vоltаgе аnd сurrеnt аnd реаk роtеntiаl diffеrеnсеs in thе rеsсuеr
wеrе mоnitоrеd during dеlivеry оf shосks. Nо shосks wеrе реrсерtiblе tо
rеsсuеrs (еvеn during dеlivеry оf 360 J). Thе сurrеnt mеаsurеd in thе
rеsсuеr's bоdy rаngеd frоm 19 tо 907 {miсrо}А. In mоst саsеs, thе lеаkаgе
сurrеnt mеаsurеd bеlоw rесоmmеndеd sаfеty stаndаrds. Thе аuthоrs соnсludе
thаt раusing СРR fоr dеlivеry оf shосks might nоt bе nесеssаry bесаusе thе
risk tо thе rеsсuеr is minimаl.

Соmmеnt: Thе сurrеnt rесоmmеndаtiоns rеgаrding саrdiас аrrеst strоngly
suрроrt minimizing аny intеrruрtiоn in сhеst соmрrеssiоn. Kеерing thе "рumр
рrimеd" hаs bееn shоwn tо imрrоvе сirсulаtiоn by mаintаining vаlvе
funсtiоn, аnd аny intеrruрtiоn оf соmрrеssiоns rеquirеs signifiсаnt timе tо
rееstаblish fоrwаrd flоw. Bаsеd оn thеsе findings, thеrе sееms tо bе nо
rеаsоn tо disсоntinuе сhеst соmрrеssiоns fоr biрhаsiс dеfibrillаtiоn during
СРR.

-- Ааrоn Е. Bаir, MD, MSс, FААЕM, FАСЕР

Рublishеd in Jоurnаl Wаtсh Еmеrgеnсy Mеdiсinе Mаy 30, 2008 Сitаtiоn(s):

Llоyd MS еt аl. Hаnds-оn dеfibrillаtiоn: Аn аnаlysis оf еlесtriсаl сurrеnt
flоw thrоugh rеsсuеrs in dirесt соntасt with раtiеnts during biрhаsiс
еxtеrnаl dеfibrillаtiоn. Сirсulаtiоn 2008 Mаy 13; 117:2510. (Subsсriрtiоn
mаy bе rеquirеd) (Frее)

[Igor Bulatov]

Бифазисные дефибрилляторы практически вытеснили с рынка однофазисные.Преимуществом бифазисных дефибрилляторов является более низкая энергетическая потребность (количество джоулей) позволяющая выдать электрический шок большей силы (количество ампер) за более короткий промежуток времени при относительно высоком напряжении тока (вольт).Большинство бифазисных дефибрилляторов вообще не рассчитаны,в отличие от монофазисных,на высокую энергию (>200J).Сила тока (в амперах) или то,что представляет собой наибольший фактор риска в отношении развития желудочковой фибрилляции у участника реанимации при случайном контакте с телом реанимируемого в момент дефибрилляции,значительно выше при бифазисной дефибриляции,чем при монофазисной.Если авторы статьи считают 360 J
бифазисной дефибрилляции безопасной при работе в перчатках,то монофазисная дефибрилляция,выдающая меньшую силу тока при 360 J будет также безопасной.Хотя продолжительность разряда при монофазисной дефибрилляции значительно длиннее,чем при бифазисной.
Энергия дефибриллятора (в джоулях)= напряжение(в вольтах)х сила тока (в амперах)х время разряда (мсек)

[rsp]

Суровая правда американской жизни

Women, Elderly, and Weekend Admissions Less Likely to Get Same-Day PCI (http://tctmd.com/show.aspx?id=68868)

Pathak EB, Strom JA. Disparities in use of same-day percutaneous coronary intervention for patients with ST-elevation myocardial infarction in Florida, 2001-2005. Am J Cardiol 2008;Epub ahead of print.

[Абугов]

Суровая правда американской жизни

Women, Elderly, and Weekend Admissions Less Likely to Get Same-Day PCI (http://tctmd.com/show.aspx?id=68868)

Pathak EB, Strom JA. Disparities in use of same-day percutaneous coronary intervention for patients with ST-elevation myocardial infarction in Florida, 2001-2005. Am J Cardiol 2008;Epub ahead of print.

Вот теперь и подумаешь, стоит ли быть одинокой, пожилой женщиной, черной, лесбиянкой и т.д.

[AOkhotin]

Вот теперь и подумаешь, стоит ли быть одинокой, пожилой женщиной, черной, лесбиянкой и т.д.

Ни в коем случае, Сергей Александрович. Неужели Вас посещали такие мысли?

[Абугов]

Вот теперь и подумаешь, стоит ли быть одинокой, пожилой женщиной, черной, лесбиянкой и т.д.

Ни в коем случае, Сергей Александрович. Неужели Вас посещали такие мысли?

Гы!

[Sergey Chevychelov]

Иртересная мысль пришла в голову после литры выпитой (с), а если электрошокеры, предназначенные для защиты от хулиганов, сделать в режиме дефибриллятора, как тогда повысится уровень спасенных жизней, или это уже применяют.

[Абугов]

Мальцеву надо поставить памятник. Выложил на РМСе ссылочку:
http://www.guideline.gov/
УУУУУУУУУУУУУУУУУУУУ! Класс!

[Igor Bulatov]

http://content.nejm.org/cgi/content/full/359/7/677

Effect of PCI on Quality of Life in Patients with Stable Coronary Disease

William S. Weintraub, M.D., John A. Spertus, M.D., M.P.H., Paul Kolm, Ph.D., David J. Maron, M.D., Zefeng Zhang, M.D., Ph.D., Claudine Jurkovitz, M.D., M.P.H., Wei Zhang, M.S., Pamela M. Hartigan, Ph.D., Cheryl Lewis, R.N., Emir Veledar, Ph.D., Jim Bowen, B.S., Sandra B. Dunbar, D.S.N., Christi Deaton, Ph.D., Stanley Kaufman, M.D., Robert A. O'Rourke, M.D., Ron Goeree, M.S., Paul G. Barnett, Ph.D., Koon K. Teo, M.D., William E. Boden, M.D., for the COURAGE Trial Research Group


ABSTRACT

Background It has not been clearly established whether percutaneous coronary intervention (PCI) can provide an incremental benefit in quality of life over that provided by optimal medical therapy among patients with chronic coronary artery disease.

Methods We randomly assigned 2287 patients with stable coronary disease to PCI plus optimal medical therapy or to optimal medical therapy alone. We assessed angina-specific health status (with the use of the Seattle Angina Questionnaire) and overall physical and mental function (with the use of the RAND 36-item health survey [RAND-36]).

Results At baseline, 22% of the patients were free of angina. At 3 months, 53% of the patients in the PCI group and 42% in the medical-therapy group were angina-free (P<0.001). Baseline mean (±SD) Seattle Angina Questionnaire scores (which range from 0 to 100, with higher scores indicating better health status) were 66±25 for physical limitations, 54±32 for angina stability, 69±26 for angina frequency, 87±16 for treatment satisfaction, and 51±25 for quality of life. By 3 months, these scores had increased in the PCI group, as compared with the medical-therapy group, to 76±24 versus 72±23 for physical limitation (P=0.004), 77±28 versus 73±27 for angina stability (P=0.002), 85±22 versus 80±23 for angina frequency (P<0.001), 92±12 versus 90±14 for treatment satisfaction (P<0.001), and 73±22 versus 68±23 for quality of life (P<0.001). In general, patients had an incremental benefit from PCI for 6 to 24 months; patients with more severe angina had a greater benefit from PCI. Similar incremental benefits from PCI were seen in some but not all RAND-36 domains. By 36 months, there was no significant difference in health status between the treatment groups.

Conclusions Among patients with stable angina, both those treated with PCI and those treated with optimal medical therapy alone had marked improvements in health status during follow-up. The PCI group had small, but significant, incremental benefits that disappeared by 36 months. (ClinicalTrials.gov number, NCT00007657 [ClinicalTrials.gov] .)




--------------------------------------------------------------------------------
Clinical trials involving patients with chronic coronary artery disease, in contrast to those involving patients with acute coronary syndromes, have not shown that percutaneous coronary intervention (PCI) prevents major cardiovascular events.1,2,3,4,5 The Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial compared a strategy of PCI plus optimal medical therapy with optimal medical therapy alone and showed no significant difference in the rate of the primary end point (death or myocardial infarction) during a median follow-up period of 4.6 years.6
Among patients with stable coronary artery disease, PCI is indicated for the relief of angina.2,3,7,8 Therefore, as part of the COURAGE trial, we used the Seattle Angina Questionnaire to assess the effect of therapy on the relief of angina. In addition, we used the RAND 36-item health survey (RAND-36) to evaluate the effect of therapy on broader health status.

Methods

Study Design

The methods used in the trial have been described previously.6,9,10 Between 1999 and 2004, we screened 35,539 patients with stable coronary artery disease at 50 centers in the United States and Canada. Approval for the study was obtained from each local institutional review board. Entry criteria included stenosis of more than 70% in at least one major epicardial coronary artery with objective evidence of myocardial ischemia or stenosis of at least 80% in at least one coronary artery and classic angina without provocative testing. After obtaining written informed consent, we randomly assigned 2287 of 3071 eligible patients to PCI plus optimal medical therapy or to optimal medical therapy alone.

All the patients received aspirin, and those who were undergoing PCI also received clopidogrel in accordance with treatment guidelines.8 Anti-ischemic therapy included long-acting metoprolol, amlodipine, and isosorbide mononitrate, alone or in combination, together with simvastatin and either lisinopril or losartan for secondary prevention. Patients were followed for a minimum of 30 months.

Sponsorship and oversight of the trial were provided by the Department of Veterans Affairs Cooperative Studies Program, with additional funding from the Canadian Institutes of Health Research. Supplemental support was received from several pharmaceutical companies, none of which had any role in the design, analysis, or interpretation of the quality-of-life study. An independent data and safety monitoring board monitored the trial for safety and efficacy. The study's executive committee had full access to the data and vouches for the accuracy and completeness of the analyses performed by the data-coordinating centers.

Measurement of Disease-Specific Health Status

Health status related to angina was assessed directly from patients at baseline; at 1, 3, 6, and 12 months; and at annual evaluations thereafter. Each assessment was performed with the use of the Seattle Angina Questionnaire, a 19-item questionnaire that quantifies physical limitations due to angina, any recent change in the severity of angina, the frequency of angina, satisfaction with treatment, and quality of life.11,12,13,14 Scores range from 0 to 100; higher scores indicate better health status.

We defined clinically significant changes in each of the Seattle Angina Questionnaire scales according to criteria developed by Wyrwich et al.15 (for details, see the Supplementary Appendix, available with the full text of this article at www.nejm.org). On the basis of this method, we defined clinical significance as a difference of 8 points or more on the physical-limitation scale, 25 or more on the angina-stability scale, 20 or more on the angina-frequency scale, 12 or more on the treatment-satisfaction scale, and 16 or more on the quality-of-life scale.15

Measurement of General Health Status

General health status was measured with the use of the RAND-36 health survey, which includes the following domains: physical functioning, role limitation due to physical problems, role limitation due to emotional problems, vitality, emotional well-being, social functioning, pain, and general health.16 Scores for each domain range from 0 to 100, with higher scores reflecting better health status. A clinically significant change was defined as a difference of 10 points or more for each domain. The RAND-36 health survey contains the same items as the Medical Outcomes Study 36-item Short Form General Health Survey (SF-36)17 but is scored differently.18

Statistical Analysis

All analyses were truncated at 36 months, because after that time, data were not available for an increasingly large proportion of patients owing to censoring, death, or failure to complete the health-status assessments. P values of less than 0.01 were considered to indicate statistical significance, with no formal correction for multiple comparisons. Of the multiple analyses performed, those that were specified before the initiation of trial enrollment are explicitly identified below.

The chi-square test was used to compare the proportions of patients in each treatment group who were angina-free as defined by the angina-frequency score on the Seattle Angina Questionnaire (with a score of 100 indicating that the patient was angina-free). Mean observed data for each of the domains of the Seattle Angina Questionnaire and the RAND-36 health survey were analyzed with the use of unpaired t-tests comparing the scores of patients in the PCI and medical-therapy groups at each visit (a prespecified end point). The chi-square test was used to assess the proportions of patients with clinically significant increases in scores from baseline (a post hoc analysis).

We performed prespecified longitudinal analyses with the use of linear mixed-effects models, assuming that any missing data were missing at random. Differences were assessed for interactions between treatment group and follow-up time. Quadratic and cubic terms of follow-up time were included in the models to account for nonlinear trends along with their interactions with treatment group. As an additional strategy, a multiple partial-imputation strategy was used to account for missing scores.19 Intermittent missing data (e.g., a missing observation at 6 months but a valid observation at 12 months) were assumed to be missing at random and were imputed with the use of multivariate imputation by chained equations. The resulting data sets contained only monotone missing patterns, defined as dropout at a particular follow-up time for any reason, including death. Five imputed data sets were generated for analysis, and the results of each were combined to estimate regression parameters. These data were then analyzed by means of a pattern-mixture model (prespecified).20 Further details of the approach to missing data are given in the Supplementary Appendix.

Additional prespecified sensitivity analyses were conducted by assigning zero to questionnaire scores from the time of death to 36 months of follow-up and by grouping patients according to the treatment initially received. Repeated-measures analysis of variance was used to analyze trends to 36 months for patients with complete data. Outcomes with respect to health status for prespecified subgroups according to age (<65 years vs. 65 years), sex, race or ethnic group (self-reported), previous or no previous myocardial infarction, previous or no previous coronary-artery bypass surgery, and presence or absence of diabetes were analyzed for interactions between time and treatment group. In additional post hoc subgroup analyses, patients were grouped into thirds for each domain, on the basis of the distribution of the particular domain, with scores adjusted for regression to the mean.21

Results

Baseline Characteristics and Primary End Point

Baseline clinical characteristics were similar in the group of 1149 patients randomly assigned to PCI plus optimal medical therapy and the group of 1138 patients assigned to optimal medical therapy alone (Tables 1S and 2S in the Supplementary Appendix). No significant difference was observed for the primary end point of death or myocardial infarction (19.0% with PCI, as compared with 18.5% with medical therapy; P=0.62) during a median follow-up interval of 4.6 years.6

Disease-Specific Health Status

At baseline, a minority of patients reported being angina-free (i.e., had an angina-frequency score of 100 on the Seattle Angina Questionnaire) (Figure 1). In both groups, the percentage of patients who became angina-free increased substantially by 1 month, with continuing improvement thereafter. During the follow-up period, the percentage of angina-free patients was significantly higher in the PCI group than in the medical-therapy group through 24 months but did not differ significantly between the two groups at 36 months.


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Figure 1. Freedom from Angina over Time as Assessed with the Angina-Frequency Scale of the Seattle Angina Questionnaire, According to Treatment Group.
OMT denotes optimal medical therapy, and PCI percutaneous coronary intervention.




Mean observed scores on the Seattle Angina Questionnaire are shown in Table 1 and Figure 2. Scores were similar in the two treatment groups at baseline and improved in both groups for all domains of the Seattle Angina Questionnaire by 1 to 3 months (P<0.001 for all comparisons); subsequent scores changed little. Scores were higher in the PCI group than in the medical-therapy group for 6 to 24 months, depending on the domain. By 36 months, the addition of PCI to optimal medical therapy no longer provided a significant advantage for any domain.

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Table 1. Scores on the Seattle Angina Questionnaire from Baseline to 36 Months.




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Figure 2. Mean Scores over Time in Five Domains of the Seattle Angina Questionnaire.
An asterisk indicates P<0.01 for the difference between treatment groups. OMT denotes optimal medical therapy, and PCI percutaneous coronary intervention.




Table 2 shows the proportion of patients who had a clinically significant improvement (as defined in the Methods section) within each domain. A greater proportion of the PCI group had clinically significant improvements in the scores for physical function, angina frequency, and quality of life for the first 6 months after randomization, but these differences were no longer significant by 12 months.

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Table 2. Patients with Clinically Significant Improvement from Baseline in Scores on the Seattle Angina Questionnaire.



Sensitivity and Subgroup Analyses

To determine whether crossovers from optimal medical therapy to revascularization (Fig. 1S in the Supplementary Appendix) explained the improvement in health status over time, we assessed the 895 patients assigned to medical therapy who did not cross over within the first 3 months, which was the time of greatest improvement. Among the patients in this subgroup, from baseline to 3 months, physical-limitation scores improved from 67±25 to 73±23, angina-frequency scores from 70±26 to 80±23 (Fig. 2S, Panel A, and Table 3S in the Supplementary Appendix), and quality-of-life scores from 52±25 to 68±23. These results were similar to those for the entire medical-therapy group.

Baseline values for all five Seattle Angina Questionnaire scores were lower for the 68 patients in the medical-therapy group who required coronary revascularization within 3 months after randomization than for those who did not. For example, the mean baseline score for angina frequency was 55±28 among those who crossed over within 3 months versus 69±26 among those who did not (P<0.001). By 3 months, angina-frequency scores had improved to 79±26 and 83±23, respectively (P=0.27). Similar patterns of baseline and 3-month scores were observed for the other domains.

Longitudinal analyses showed similar patterns, whether missing data were assumed to be missing at random (Fig. 2S, Panel B, and Table 4S in the Supplementary Appendix) or whether a pattern-mixture model was used (Fig. 2S, Panel C, and Table 5S in the Supplementary Appendix). As compared with observed mean scores, predicted mean scores from the longitudinal models showed similar but at times slightly less improvement in both groups from baseline to follow-up and slightly less difference between the groups. For example, baseline angina-frequency scores on the Seattle Angina Questionnaire were 71 for both treatment groups when either the missing-at-random or the pattern-mixture model was used. At 3 months, angina-frequency scores were 85 for the PCI group and 80 for the medical-therapy group with the missing-at-random model (P<0.001) and 84 and 80, respectively, with the pattern-mixture model (P<0.001), as compared with 85 and 80, respectively, for observed data (P<0.001).

When deaths were assigned a score of zero, the imputed mean scores were slightly lower than observed mean scores, with a greater effect over time as more deaths occurred (Fig. 3S, Panel D, and Table 6S in the Supplementary Appendix). However, there was no effect on the differences between groups. Analyses according to the treatment initially received also showed little effect on the differences between groups.

Complete data were available at 36 months for 328 patients in the PCI group and 303 patients in the medical-therapy group. Analysis of these data showed that, for both groups, mean scores tended to be higher by about 2 to 3 scale points than the means presented in Table 1, but the patterns of change and the differences between the groups were similar.

The three domains of physical limitation, angina frequency, and quality of life are of particular importance in the analysis of the Seattle Angina Questionnaire because they most closely reflect the effect of angina on current health status and the change in health status over time. We examined these three domains for evidence of interactions between treatment group and baseline domain score according to thirds. For angina frequency, there was a greater improvement in the mean score from baseline to 3 months and a greater benefit from PCI in the lowest third (reflecting the most severe angina) than in the middle or highest third (P=0.008 for the interaction) (Table 3). The largest clinical improvement was in the lowest third, with no improvement in the highest third (P<0.001 for the interaction). The magnitude of improvement in the lowest and middle thirds was reduced by about one half after adjustment for regression to the mean (Table 7S in the Supplementary Appendix). The results for physical limitation and quality of life were similar (P<0.001 for the interactions in both domains) (Tables 8S to 11S in the Supplementary Appendix). There was an intermittent advantage of PCI with respect to the percentage of patients with clinically significant improvement in the lowest and middle thirds for up to 2 years, depending on the domain. No other subgroup interactions were consistently significant (see the Supplementary Appendix).

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Table 3. Angina-Frequency Scores According to Thirds of Baseline Score.



General Health Status

There were no significant differences at baseline between the groups for any RAND-36 domain (Figure 3, and Table 13S in the Supplementary Appendix). There was improvement in all domains in both groups between randomization and follow-up at 1 to 3 months (P<0.001 for all comparisons). There was also an incremental advantage of PCI over medical therapy at 3 months for the scores in five domains: physical functioning (69±27 vs. 65±26, P<0.001), role limitation–physical (60±42 vs. 52±43, P<0.001), vitality (56±23 vs. 53±23, P=0.008), pain (72±25 vs. 68±26, P=0.006), and general health (61±21 vs. 58±21, P<0.001). The benefit across domains was less consistent than that seen in the results for the Seattle Angina Questionnaire, with an advantage of PCI that was noted in most but not all domains and that had a shorter duration. At 6 months, the PCI group was more likely than the medical-therapy group to have a clinically significant improvement (as defined in the Methods section) in physical functioning (50% vs. 43%) and role limitation–physical (48% vs. 43%), but no advantage was observed at 12 months (Table 14S in the Supplementary Appendix). There were no significant subgroup interactions in the RAND-36 results (Table 15S in the Supplementary Appendix).


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Figure 3. Mean Scores over Time in Eight Domains of Health Status as Assessed with the RAND-36 Health Survey.
An asterisk indicates P<0.01 for the difference between treatment groups. OMT denotes optimal medical therapy, and PCI percutaneous coronary intervention.




Discussion

The primary results of the COURAGE trial showed that in patients with stable coronary disease and inducible ischemia who were treated with optimal medical therapy, the addition of PCI did not significantly reduce the risk of death or myocardial infarction.6 However, therapeutic procedures are performed not only to prevent events but also to improve health status. On the basis of the Seattle Angina Questionnaire analyses, patients had an incremental benefit from PCI for the first 12 to 24 months in the key domains of physical limitations, frequency of angina, and quality of life. The Seattle Angina Questionnaire data are supported by those from the RAND-36 survey, a general health questionnaire, which showed a less consistent benefit from PCI. These patient-reported outcomes are also consistent with the assessment of angina according to the Canadian Cardiovascular Society classification, as noted in the previous report on the COURAGE trial,6 as well as in earlier reports.7,22,23

Although the differences in health status between the two treatment groups were significant, they were substantially smaller than the within-group differences noted for both groups. Somewhat unexpectedly, there was significant and rapid improvement in Seattle Angina Questionnaire scores among the patients in the medical-therapy group, including those who did not cross over to revascularization treatment. This finding with respect to the benefit of optimal medical therapy alone shows that PCI is not always essential for the relief of symptoms in patients with stable angina.

Throughout the follow-up period, the mean differences between the treatment groups in the scores on all Seattle Angina Questionnaire scales were small (less than five points). However, the likelihood of a clinically significant improvement from baseline was greater in the PCI group for some domains during the first 6 months (though not thereafter). On the basis of these data, 17 patients would need to be treated with PCI plus optimal medical therapy as compared with optimal medical therapy alone for 1 to have a significantly greater amount of angina relief, 11 would need to be treated for 1 to have a significant benefit in physical function, and 12.5 would need to be treated for 1 to have a significant improvement in quality of life.

The benefit of therapy was influenced by the baseline frequency of angina, which was used to divide the patient population into thirds. In general, the data indicate that patients in the lowest third typically had multiple episodes of angina per week; those in the middle third had angina about once a week; and those in the highest third had angina only rarely. Among these subgroups, the patients in the lowest third had the greatest improvement over time and the greatest advantage with PCI, those in the middle third had less improvement and less advantage with PCI, and those in the highest third had no improvement and no advantage with PCI. In the small group of patients who required revascularization early in the trial, markedly low Seattle Angina Questionnaire scores were observed at baseline, and rapid, dramatic improvements were observed after revascularization, confirming that some patients have an especially marked benefit from PCI.

The most important limitation of this study is the amount of missing data. Data on quality of life are difficult to obtain and cannot be collected retrospectively. Although potential bias from missing data cannot be definitively ruled out, several analyses that were performed to account for missing data did not identify meaningful bias.

An additional potential concern is that patients were not unaware of treatment. Therefore, there may have been a placebo effect of PCI. However, the consistency and persistence of the incremental benefit from PCI with respect to angina make it less likely that a placebo effect could fully explain the observed differences, and it would not explain the substantial improvement in the medical-therapy group. Although we did not adjust for multiple testing in our analyses (except to set a P value of <0.01 as indicating statistical significance in order to be consistent with the report on the clinical results of the COURAGE trial), the consistency of the findings with multiple significant P values makes it unlikely that the results are due to chance.

As with any trial, there may be concerns about the generalizability of the findings. In particular, we enrolled a minority of women and nonwhites, and the effect of PCI plus optimal medical therapy on health-related quality of life in these important subgroups remains uncertain. In addition, the trial was designed and conducted such that high standards of treatment were established (and met), and free access was provided to many medications. Whether the substantial benefits of optimal medical therapy observed in this trial can be replicated outside the context of a clinical trial remains to be determined.

The benefit of PCI as currently practiced may be greater than that observed in this trial. Drug-eluting stents were used in only 31 patients in this study, because they became available only toward the end of the study. Although drug-eluting stents have not been shown to decrease the rate of death or of myocardial infarction, they do decrease the incidence of restenosis, and as a result, the likelihood of recurrent angina after PCI with drug-eluting stents is less than that after PCI with bare-metal stents. However, restenosis develops in only a minority of patients who receive bare-metal stents, and angina develops in only some of those patients (11% of the patients in our trial who were treated with PCI underwent a repeat procedure within 12 months). We did not quantify potential transient decrements in health-related quality of life associated with restenosis or other nonfatal events.

In conclusion, the COURAGE trial showed that patients with chronic coronary disease may expect relief from angina whether they are treated with PCI plus optimal medical therapy or with optimal medical therapy alone. However, an initial strategy of PCI added to optimal medical therapy relieved angina and improved self-assessed health status to a greater extent than an initial strategy of optimal medical therapy alone for approximately 24 months. A greater benefit from PCI was observed in those patients with more severe and more frequent angina.




Dr. Weintraub reports receiving consulting fees from Sanofi-Aventis, GlaxoSmithKline, Indigo Pharmaceuticals, and CV Therapeutics and grant support from Sanofi-Aventis, AstraZeneca, Otsuka, and Bristol-Myers Squibb; Dr. Spertus, receiving consulting fees from Amgen and United Healthcare and grant support from Amgen, Roche Diagnostics, Atherotech, Bristol-Myers Squibb, Sanofi-Aventis, and Eli Lilly and holding a patent on the Seattle Angina Questionnaire; Dr. Jurkovitz, receiving grant support from Bristol-Myers Squibb, CV Therapeutics, Otsuka, Sanofi-Aventis, and AstraZeneca; Dr. Deaton, receiving grant support from Eli Lilly; and Dr. Boden, receiving consulting fees from Pfizer, Merck, PDL BioPharma, Bristol-Myers Squibb, Abbott, and CV Therapeutics and lecture fees from Sanofi-Aventis, Kos Pharmaceuticals, and Novartis. No other potential conflict of interest relevant to this article was reported.

* Members of the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial are listed in the Supplementary Appendix, available with the full text of this article at www.nejm.org.

[Igor Bulatov]

Study: Bypass better than stents in long term


MUNICH, Germany (AP) — For heart patients with clogged arteries, the choice between bypass surgery or an angioplasty may come down to one question: How many procedures would you like to have?

In research presented Monday at the European Society of Cardiology meeting in Munich, experts concluded that while bypass surgery and angioplasty offer comparable results, patients who have angioplasties are twice as likely to require another procedure within a year.

"If you don't want to have another heart operation for at least a decade, you should pick the surgery," said Dr. Heinz Drexel, professor of medicine at the University of Innsbruck in Austria and spokesman for the European Society of Cardiology. Drexel was not connected to the research.

"But that means you have to have your chest cracked open," he said.

When arteries become blocked, doctors have two main options. Traditionally they have done a bypass surgery, which reroutes blood vessels to detour around blockages.

But in recent years, angioplasties have become increasingly popular. An angioplasty is a non-surgical procedure where a balloon is pushed into a blood vessel to flatten the blockage, leaving a stent to prop the artery open.

In the study results announced Monday, European doctors compared the effectiveness of open-heart surgery versus angioplasty in a trial of more than 3,000 patients in Europe and the United States. They excluded patients who had acute heart attacks and included those who had single and multiple vessel blockages.

About a third of the patients had medical conditions that required surgery. The remaining patients were randomly assigned to receive either surgery or an angioplasty. Patients who got an angioplasty needed an average of nearly five stents.

The study was paid for by Boston Scientific, makers of the drug-coated stent used in the trial.

After one year, researchers found that patients who had surgery had a lower death rate. Among surgery patients, the death rate was 3.5 percent; in angioplasty patients, it was 4.3 percent.

In patients who had an angioplasty, nearly 14 percent needed another procedure after a year, compared with about 6 percent of surgery patients.

But patients who had surgery had about a 2 percent stroke risk versus nearly zero risk for patients who had an angioplasty. Doctors said that any surgery had an inherent stroke risk, compared with an angioplasty.

In January, a study published in the New England Journal of Medicine found that bypass surgery was still the best option for heart patients with more than one clogged artery.

"Surgery still comes out as the winner in a head-to-head trial," said Dr. Douglas Weaver, president of the American College of Cardiology, who was unconnected to the research.

"This comes down to a conversation with patients and making sure they know that with an angioplasty, there will be a higher rate of revascularization," he said, referring to the need for repeat procedures.

Patients typically need at least a month to fully recover from an open-heart surgery, a five-hour long operation under general anesthesia.

Angioplasty patients, however, are often up and walking around after three days.

"You invest more in terms of recuperation with surgery," said Dr. Tim Gardner, president of the American Heart Association. "But the advantage is durability."

When drug-coated stents were first introduced in 2003, they became the fastest-selling medical device in recent history. Doctors thought that the tiny tubes, which leak drugs to prevent tissue regrowth, would make angioplasty a much better alternative to surgery for patients.

But in 2006, studies began to emerge showing that patients with the drug-coated stents were more likely to develop potentially fatal blood clots months and even years after they were implanted.

Stent sales plummeted and doctors have become more wary of their use, saving them only for certain patients with no other options.

Doctors cautioned that more data is still needed about the pros and cons of bypass surgery versus angioplasties, and that patients needed to be tracked for at least five years.

"This only tells us what happens after one year," Drexel said. "We need to wait for at least five years to get a good answer about which therapy is really better."

[plexus]

"This only tells us what happens after one year," Drexel said. "We need to wait for at least five years to get a good answer about which therapy is really better."

Будем ждать.

[AOkhotin]

Исследование PRoFESS:
У больных после ишемического инсульта телмисартан оказался не лучше плацебо, при условии, что больные получают гипотензивную терапию.

Yusuf S et al. for the PRoFESS Study Group. Telmisartan to prevent
recurrent stroke and cardiovascular events. N Engl J Med 2008 Aug 27;
[e-pub ahead of print]. (http://dx.doi.org/10.1056/NEJMoa0804593)

[MGilarov]

Study: Bypass better than stents in long term

В этом исследовании больше удивляет не высокая чатота повторных процедур в группе PCI, а высоченная ранняя смертность - больше 2% в этой же группе. Я на эту сессию не ходил, но так понял, что хирургические центры отбирались более придирчиво.

[AOkhotin]

Принимайте аспирин, плавикс и курите не менее полпачки сигарет в течение полугода после ангиопластики?

Курение более полпачки сигарет в день значительно усиливает антиагрегантное действие клопидогреля.

Smоking Еnhаncеs Рlаtеlеt Inhibitiоn by Clорidоgrеl
Rеsults оf аn оbsеrvаtiоnаl study substаntiаtе а роssiblе cоntributоr tо
thе vаriаtiоn in раtiеnt rеsроnsе tо clорidоgrеl.


High rеsiduаl рlаtеlеt аctivity hаs bееn аssоciаtеd with аdvеrsе ischеmic
еvеnts аftеr реrcutаnеоus cоrоnаry intеrvеntiоn, аnd vаriаbility in
рlаtеlеt inhibitiоn by clорidоgrеl mаy cоntributе tо such еvеnts. Nоting
thаt cigаrеttе smоking cаn inducе а hераtic еnzymе thаt cоnvеrts
clорidоgrеl tо its аctivе mеtаbоlitе, invеstigаtоrs ехаminеd thе еffеct оf
smоking оn рlаtеlеt rеsроnsе tо clорidоgrеl аftеr еlеctivе cоrоnаry
stеnting in 104 currеnt smоkеrs аnd 155 nоnsmоkеrs. Рlаtеlеt аggrеgаtiоn
wаs аssеssеd by cоnvеntiоnаl light-trаnsmissiоn аggrеgоmеtry 18 tо 24 hоurs
аftеr РCI in раtiеnts whо did nоt rеcеivе а glycорrоtеin (GР) IIb/IIIа
inhibitоr аnd [>=]5 dаys аftеr РCI in thоsе whо did.

Аggrеgаtiоn inducеd by аdеnоsinе diрhоsрhаtе (АDР; 20 {micrо}mоl/L) wаs
lоwеr in smоkеrs (43%) thаn in nоnsmоkеrs (52%, Р=0.008). АDР-stimulаtеd GР
IIb/IIIа-rеcерtоr ехрrеssiоn wаs аlsо lоwеr in smоkеrs (7 mеаn fluоrеscеncе
intеnsity) thаn in nоnsmоkеrs (19 mеаn fluоrеscеncе intеnsity; Р=0.0007).
Thе еffеcts wеrе mоrе mаrkеd in раtiеnts whо smоkеd [>=]1/2 раck реr dаy
thаn in thоsе whо smоkеd <1/2 раck реr dаy. In а multivаriаblе аnаlysis,
currеnt smоking wаs thе оnly significаnt рrеdictоr оf lоw рlаtеlеt
аggrеgаtiоn (оdds rаtiо, 2.63).

Cоmmеnt: Thеsе findings аrе cоnsistеnt with thе knоwn mеchаnism оf
clорidоgrеl аctivаtiоn аnd dеmоnstrаtе еnhаncеd рlаtеlеt inhibitiоn by
clорidоgrеl аftеr РCI in currеnt smоkеrs. Thеy mаy ехрlаin sоmе оf thе
vаriаbility thаt hаs bееn оbsеrvеd in рlаtеlеt functiоn аnd sоmе clinicаl
study rеsults thаt wеrе unехреctеdly bеttеr in smоkеrs thаn in nоnsmоkеrs.
Hоwеvеr, whеthеr thеsе diffеrеncеs in рlаtеlеt inhibitiоn реrsist in
smоking аnd nоnsmоking раtiеnts оn chrоnic clорidоgrеl thеrарy аftеr РCI
rеmаins tо bе dеmоnstrаtеd.

-- Hоwаrd C. Hеrrmаnn, MD

Рublishеd in Jоurnаl Wаtch Cаrdiоlоgy Sерtеmbеr 10, 2008 Citаtiоn(s):

Blidеn KР еt аl. Thе аssоciаtiоn оf cigаrеttе smоking with еnhаncеd
рlаtеlеt inhibitiоn by clорidоgrеl. J Аm Cоll Cаrdiоl 2008 Аug 12; 52:531.
(Subscriрtiоn mаy bе rеquirеd) (Frее)