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Could Paclitaxel-Eluting Stents Be Superior to Sirolimus-Eluting Stents for the Treatment of Saphenous Vein Graft Lesions?
READERS’ COMMENTS A Contemporary Meta-Analysis of Gender Differences in Mortality After Coronary Artery Bypass Grafting We read with great interest the report by Bukkapatnam et al,1 in which multivariate analysis indicated that women are at higher risk for operative mortality than men (adjusted odds ratio [OR] 1.61, 95% confidence interval [CI] 1.40 to 1.84) after coronary artery bypass grafting (CABG). In 2003, Nalysnyk et al2 suggested that female gender is associated with increased risk for death after CABG (pooled unadjusted OR 1.92, 95% CI 1.48 to 2.48) in their meta-analysis of 8 studies published through 2001. No further meta-analyses have been conducted to date. We report here a contemporary meta-analysis of gender differences in mortality after CABG, combining not unadjusted but adjusted ORs for death. To identify all contemporary studies providing adjusted ORs for perioperative death in women compared to men who underwent CABG, public-domain databases, including Medline and Embase, were searched from January 2000 to June 2010 using Web-based search engines (PubMed and Ovid), with exploding keywords including “sex;” “gender;” “women;” “female;” and “coronary artery bypass.” Studies considered for inclusion met the following criteria: the study population was patients who underwent onpump and off-pump CABG; and main outcomes included adjusted ORs (or; if unavailable; risk ratios or hazard ratios) for 30-day or in-hospital death using appropriate statistical methods (i.e.; multivariate logistic regression; Cox regression; and propensity score analysis) in women compared to men. We excluded studies reporting only unadjusted mortality or ORs for death. All analyses were conducted with RevMan version 5.0 (Nordic Cochrane Centre; Copenhagen; Denmark) and Comprehensive Meta-Analysis version 2 (Biostat; Englewood; New Jersey). Our search identified 27 studies providing 25 adjusted OR, 2 risk ratios, and 2 hazard ratios for death after CABG. Pooled analysis (representing 1,715,360 patients) demonstrated a statistically sig-
Figure 1. Forrest plot of ORs and 95% CIs for perioperative death in women compared to men who underwent CABG. ACVTA ⫽ Asian Cardiovascular & Thoracic Annals; AIM ⫽ Archives of Internal Medicine; AJC ⫽ The American Journal of Cardiology; AKD ⫽ Anadolu Kardiyoloji Dergisi; ATS ⫽ Annals of Thoracic Surgery; Circ ⫽ Circulation; CJC ⫽ Canadian Journal of Cardiology; DC ⫽ Diabetes Care; EJCTS ⫽ European Journal of Cardio-Thoracic Surgery; ICVTS ⫽ Interactive CardioVascular and Thoracic Surgery; IV ⫽ inverse variance; JACC ⫽ Journal of the American College of Cardiology; JACS ⫽ Journal of the American College of Surgeons; JCS ⫽ Journal of Cardiac Surgery; JGSM ⫽ Journal of Gender-Specific Medicine; JNMA ⫽ Journal of the National Medical Association; JTCVS ⫽ Journal of Thoracic and Cardiovascular Surgery; KP ⫽ Kardiologia Polska.
nificant increase in mortality in women compared to men in a random-effects model (pooled adjusted OR 1.38, 95% CI 1.29 to 1.49, p ⬍0.00001; Figure 1). There was significant between-study heterogeneity (p ⬍0.00001) and little difference in the pooled results of the fixed-effects model (pooled adjusted OR 1.42, 95% CI 1.39 to 1.45, p ⬍0.00001). The exclusion of any single study from the analysis did not substantively alter the overall results of our analysis. There was no evidence of significant publication bias (p ⫽ 0.59 by adjusted rank correlation test). The results of our analysis suggest that female gender is associated with increased risk for death after CABG, which was robust in sensitivity analyses and strengthens the results of the study by Bukkapatnam et al.1 As Hamlet said, “Frailty, thy name is woman.”
Am J Cardiol 2010;106:1367–1368 0002-9149/10/$ – see front matter Published by Elsevier Inc.
Hisato Takagi, MD Hideaki Manabe, MD Takuya Umemoto, MD, PhD Shizuoka, Japan 14 July 2010
1. Bukkapatnam RN, Yeo KK, Li Z, Amsterdam EA. Operative mortality in women and men undergoing coronary artery bypass grafting (from the California Coronary Artery Bypass Grafting Outcomes Reporting Program). Am J Cardiol 2010;105:339 –342. 2. Nalysnyk L, Fahrbach K, Reynolds MW, Zhao SZ, Ross S. Adverse events in coronary artery bypass graft (CABG) trials: a systematic review and analysis. Heart 2003;89:767–772. doi:10.1016/j.amjcard.2010.07.019
Could Paclitaxel-Eluting Stents Be Superior to Sirolimus-Eluting Stents for the Treatment of Saphenous Vein Graft Lesions? We read with great interest the important and timely study by Lee et al,1 who compared sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) for the treatment of saphenous vein graft lesions in the Southern California Registry. The investigators concluded that SES and PES had similar 1-year clinical outcomes. Although their interpretation of the study findings is correct, we would like to propose an alternative interpretation: that PES may provide superior results comwww.ajconline.org
1368
The American Journal of Cardiology (www.ajconline.org)
pared with SES in saphenous vein grafts, but this was not demonstrated in the investigators’ study because of small sample size. Indeed, the hazard ratio for target vessel revascularization was 2.54 (95% confidence interval 0.84 to 7.72, p ⫽ 0.09) in favor of PES. As Lee et al1 highlighted, there is a discrepancy in the results of the 2 prospective randomized trials of drug-eluting stents in saphenous vein grafts. The Reduction of Restenosis in Saphenous Vein Grafts With Cypher Sirolimus-Eluting Stent (RRISC) trial showed no benefit and increased risk with SES,2 whereas the Stenting of Saphenous Vein Grafts (SOS) trial showed benefit with PES and similar risk,3 even during long-term follow-up. Similarly favorable results with PES were seen in the Moderate Vein Graft Lesion Stenting With the Taxus Stent and Intravascular Ultrasound (VELETI) trial,4 and an analysis of the Taxus Peri-Approval Registry: A Multicenter Safety Surveillance (ARRIVE) program.5 Whether PES are truly superior to SES (and also the second-generation drug-eluting stents) remains to be proved. Emmanouil S. Brilakis, MD, PhD Subhash Banerjee, MD Dallas, Texas 31 July 2010
1. Lee MS, Hu PP, Aragon J, Shah AP, Oyama J, Dhoot J, Iqbal Z, Jones N, Penny W, Tobis J, Mahmud E, French W. Comparison of sirolimus-eluting stents with paclitaxel-eluting stents in saphenous vein graft intervention (from a Multicenter Southern California Registry). Am J Cardiol 2010;106:337–341.
2. Vermeersch P, Agostoni P, Verheye S, Van den Heuvel P, Convens C, Van den Branden F, Van Langenhove G. Increased late mortality after sirolimus-eluting stents versus bare-metal stents in diseased saphenous vein grafts: results from the randomized DELAYED RRISC trial. J Am Coll Cardiol 2007;50:261–267. 3. Brilakis ES, Lichtenwalter C, de Lemos JA, Roesle M, Obel O, Haagen D, Saeed B, Gadiparthi C, Bissett JK, Sachdeva R, Voudris VV, Karyofillis P, Kar B, Rossen J, Fasseas P, Berger P, Banerjee S. A randomized controlled trial of a paclitaxel-eluting stent versus a similar baremetal stent in saphenous vein graft lesions the SOS (Stenting of Saphenous Vein Grafts) trial. J Am Coll Cardiol 2009;53:919 –928. 4. Rodes-Cabau J, Bertrand OF, Larose E, Dery J-P, Rinfret S, Bagur R, Proulx G, Nguyen CM, Cote M, Landcop M-C, Boudreault J-R, Rouleau J, Roy L, Gleeton O, Barbeau G, Noel B, Courtis J, Dagenais GR, Despres J-P, DeLarochelliere R. Comparison of plaque sealing with paclitaxeleluting stents versus medical therapy for the treatment of moderate nonsignificant saphenous vein graft lesions. The Moderate Vein Graft Lesion Stenting With the Taxus Stent and Intravascular Ultrasound (VELETI) pilot trial. Circulation 2009;120:1978 –1986. 5. Brilakis ES, Lasala JM, Cox DA, Berger PB, Bowman TS, Starzyk RM, Dawkins KD. Outcomes after implantation of the TAXUS paclitaxel-eluting stent in saphenous vein graft lesions: results from the ARRIVE (TAXUS Peri-Approval Registry: A Multicenter Safety Surveillance) program. J Am Coll Cardiol Intv 2010;3:742–750. doi:10.1016/j.amjcard.2010.08.008
Do Advanced Practice Nurses or Physician Assistants Outperform Cardiologists? I read with interest the analysis from the Registry to Improve the Use of Evidence-Based Heart Failure Therapies in
the Outpatient Setting (IMPROVE-HF) program by Albert et al.1 The investigators suggested that having ⱖ2 advanced practice nurses (APN) or physician assistants (PAs) in cardiology practices was associated with greater use of implantable cardioverter-defibrillator therapy and delivery of heart failure education compared with practices with no APNs or PAs. The significant association of having ⱖ2 APNs or PAs with heart failure clinic, however, questions the generalizability of this finding. The investigators need to ensure that this finding is not heavily influenced by APNs or PAs practicing in heart failure clinics. The reader gets the impression that the findings apply to cardiology outpatient practices at large. To reach that conclusion, this association should be demonstrated in cardiology practices not associated with heart failure clinics; otherwise, the findings would more accurately reflect the performance of heart failure clinics. Jalal K. Ghali, MD Detroit, Michigan 28 July 2010
1. Albert NM, Fonarow GC, Yancy CW, Curtis, AB, Gattis Stough W, Gheorghiade M, Heywood JT, Mcbride M, Mehra MR, O’Connor CM, Reynolds D, Walsh MN. Outpatient cardiology practices with advanced practice nurses and physician assistants provide similar delivery of recommended therapies (findings from IMPROVE HF). Am J Cardiol 2010;105:1773–1779. doi:10.1016/j.amjcard.2010.08.007
Figure 1. Forrest plot of ORs and 95% CIs for perioperative death in women compared to men who underwent CABG. ACVTA ⫽ Asian Cardiovascular & Thoracic Annals; AIM ⫽ Archives of Internal Medicine; AJC ⫽ The American Journal of Cardiology; AKD ⫽ Anadolu Kardiyoloji Dergisi; ATS ⫽ Annals of Thoracic Surgery; Circ ⫽ Circulation; CJC ⫽ Canadian Journal of Cardiology; DC ⫽ Diabetes Care; EJCTS ⫽ European Journal of Cardio-Thoracic Surgery; ICVTS ⫽ Interactive CardioVascular and Thoracic Surgery; IV ⫽ inverse variance; JACC ⫽ Journal of the American College of Cardiology; JACS ⫽ Journal of the American College of Surgeons; JCS ⫽ Journal of Cardiac Surgery; JGSM ⫽ Journal of Gender-Specific Medicine; JNMA ⫽ Journal of the National Medical Association; JTCVS ⫽ Journal of Thoracic and Cardiovascular Surgery; KP ⫽ Kardiologia Polska.
nificant increase in mortality in women compared to men in a random-effects model (pooled adjusted OR 1.38, 95% CI 1.29 to 1.49, p ⬍0.00001; Figure 1). There was significant between-study heterogeneity (p ⬍0.00001) and little difference in the pooled results of the fixed-effects model (pooled adjusted OR 1.42, 95% CI 1.39 to 1.45, p ⬍0.00001). The exclusion of any single study from the analysis did not substantively alter the overall results of our analysis. There was no evidence of significant publication bias (p ⫽ 0.59 by adjusted rank correlation test). The results of our analysis suggest that female gender is associated with increased risk for death after CABG, which was robust in sensitivity analyses and strengthens the results of the study by Bukkapatnam et al.1 As Hamlet said, “Frailty, thy name is woman.”
Am J Cardiol 2010;106:1367–1368 0002-9149/10/$ – see front matter Published by Elsevier Inc.
Hisato Takagi, MD Hideaki Manabe, MD Takuya Umemoto, MD, PhD Shizuoka, Japan 14 July 2010
1. Bukkapatnam RN, Yeo KK, Li Z, Amsterdam EA. Operative mortality in women and men undergoing coronary artery bypass grafting (from the California Coronary Artery Bypass Grafting Outcomes Reporting Program). Am J Cardiol 2010;105:339 –342. 2. Nalysnyk L, Fahrbach K, Reynolds MW, Zhao SZ, Ross S. Adverse events in coronary artery bypass graft (CABG) trials: a systematic review and analysis. Heart 2003;89:767–772. doi:10.1016/j.amjcard.2010.07.019
Could Paclitaxel-Eluting Stents Be Superior to Sirolimus-Eluting Stents for the Treatment of Saphenous Vein Graft Lesions? We read with great interest the important and timely study by Lee et al,1 who compared sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) for the treatment of saphenous vein graft lesions in the Southern California Registry. The investigators concluded that SES and PES had similar 1-year clinical outcomes. Although their interpretation of the study findings is correct, we would like to propose an alternative interpretation: that PES may provide superior results comwww.ajconline.org
1368
The American Journal of Cardiology (www.ajconline.org)
pared with SES in saphenous vein grafts, but this was not demonstrated in the investigators’ study because of small sample size. Indeed, the hazard ratio for target vessel revascularization was 2.54 (95% confidence interval 0.84 to 7.72, p ⫽ 0.09) in favor of PES. As Lee et al1 highlighted, there is a discrepancy in the results of the 2 prospective randomized trials of drug-eluting stents in saphenous vein grafts. The Reduction of Restenosis in Saphenous Vein Grafts With Cypher Sirolimus-Eluting Stent (RRISC) trial showed no benefit and increased risk with SES,2 whereas the Stenting of Saphenous Vein Grafts (SOS) trial showed benefit with PES and similar risk,3 even during long-term follow-up. Similarly favorable results with PES were seen in the Moderate Vein Graft Lesion Stenting With the Taxus Stent and Intravascular Ultrasound (VELETI) trial,4 and an analysis of the Taxus Peri-Approval Registry: A Multicenter Safety Surveillance (ARRIVE) program.5 Whether PES are truly superior to SES (and also the second-generation drug-eluting stents) remains to be proved. Emmanouil S. Brilakis, MD, PhD Subhash Banerjee, MD Dallas, Texas 31 July 2010
1. Lee MS, Hu PP, Aragon J, Shah AP, Oyama J, Dhoot J, Iqbal Z, Jones N, Penny W, Tobis J, Mahmud E, French W. Comparison of sirolimus-eluting stents with paclitaxel-eluting stents in saphenous vein graft intervention (from a Multicenter Southern California Registry). Am J Cardiol 2010;106:337–341.
2. Vermeersch P, Agostoni P, Verheye S, Van den Heuvel P, Convens C, Van den Branden F, Van Langenhove G. Increased late mortality after sirolimus-eluting stents versus bare-metal stents in diseased saphenous vein grafts: results from the randomized DELAYED RRISC trial. J Am Coll Cardiol 2007;50:261–267. 3. Brilakis ES, Lichtenwalter C, de Lemos JA, Roesle M, Obel O, Haagen D, Saeed B, Gadiparthi C, Bissett JK, Sachdeva R, Voudris VV, Karyofillis P, Kar B, Rossen J, Fasseas P, Berger P, Banerjee S. A randomized controlled trial of a paclitaxel-eluting stent versus a similar baremetal stent in saphenous vein graft lesions the SOS (Stenting of Saphenous Vein Grafts) trial. J Am Coll Cardiol 2009;53:919 –928. 4. Rodes-Cabau J, Bertrand OF, Larose E, Dery J-P, Rinfret S, Bagur R, Proulx G, Nguyen CM, Cote M, Landcop M-C, Boudreault J-R, Rouleau J, Roy L, Gleeton O, Barbeau G, Noel B, Courtis J, Dagenais GR, Despres J-P, DeLarochelliere R. Comparison of plaque sealing with paclitaxeleluting stents versus medical therapy for the treatment of moderate nonsignificant saphenous vein graft lesions. The Moderate Vein Graft Lesion Stenting With the Taxus Stent and Intravascular Ultrasound (VELETI) pilot trial. Circulation 2009;120:1978 –1986. 5. Brilakis ES, Lasala JM, Cox DA, Berger PB, Bowman TS, Starzyk RM, Dawkins KD. Outcomes after implantation of the TAXUS paclitaxel-eluting stent in saphenous vein graft lesions: results from the ARRIVE (TAXUS Peri-Approval Registry: A Multicenter Safety Surveillance) program. J Am Coll Cardiol Intv 2010;3:742–750. doi:10.1016/j.amjcard.2010.08.008
Do Advanced Practice Nurses or Physician Assistants Outperform Cardiologists? I read with interest the analysis from the Registry to Improve the Use of Evidence-Based Heart Failure Therapies in
the Outpatient Setting (IMPROVE-HF) program by Albert et al.1 The investigators suggested that having ⱖ2 advanced practice nurses (APN) or physician assistants (PAs) in cardiology practices was associated with greater use of implantable cardioverter-defibrillator therapy and delivery of heart failure education compared with practices with no APNs or PAs. The significant association of having ⱖ2 APNs or PAs with heart failure clinic, however, questions the generalizability of this finding. The investigators need to ensure that this finding is not heavily influenced by APNs or PAs practicing in heart failure clinics. The reader gets the impression that the findings apply to cardiology outpatient practices at large. To reach that conclusion, this association should be demonstrated in cardiology practices not associated with heart failure clinics; otherwise, the findings would more accurately reflect the performance of heart failure clinics. Jalal K. Ghali, MD Detroit, Michigan 28 July 2010
1. Albert NM, Fonarow GC, Yancy CW, Curtis, AB, Gattis Stough W, Gheorghiade M, Heywood JT, Mcbride M, Mehra MR, O’Connor CM, Reynolds D, Walsh MN. Outpatient cardiology practices with advanced practice nurses and physician assistants provide similar delivery of recommended therapies (findings from IMPROVE HF). Am J Cardiol 2010;105:1773–1779. doi:10.1016/j.amjcard.2010.08.007