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To link to full-text access for this article, visit this link: http://dx.doi.org/10.1016/j.ahj.2006.06.010 Byline: Raban V. Jeger (a), Chi-Hong Tseng (b), Judith S. Hochman (a), Eric R. Bates (c) Abstract: Early revascularization (ERV) in patients with ST-elevation myocardial infarction (STEMI) and cardiogenic shock (CS) reduces mortality rates. Patients admitted to hospitals without revascularization capability have high mortality rates and are not often transferred for ERV. Author Affiliation: (a) Cardiovascular Clinical Research Center, New York University School of Medicine, New York, NY (b) Division of Biostatistics, New York University School of Medicine, New York, NY (c) Division of Cardiovascular Medicine, University of Michigan Medical Center, Ann Arbor, MI Article History: Received 10 March 2006; Accepted 21 June 2006

The study sought to evaluate the impact of diabetes mellitus on 3-year clinical outcome in patients undergoing drug-coated balloon (DCB) or drug-eluting stent (DES) treatment for de novo lesions. For treatment of de novo coronary small vessel disease, DCBs are noninferior to DES. In this prespecified analysis of a multicenter, randomized, noninferiority trial, including 758 patients with de novo lesions in coronary vessels <3 mm who were randomized 1:1 to DCB or DES and followed over 3 years for major adverse cardiac events (MACE) (cardiac death, nonfatal myocardial infarction [MI], and target vessel revascularization [TVR]), outcome was analyzed regarding the presence or absence of diabetes mellitus. In nondiabetic patients (n = 506), rates of MACE (DCB 13.0% vs DES 11.5%; hazard ratio [HR]: 1.24; 95% confidence interval [CI]: 0.73-2.09; P = 0.43), cardiac death (2.8% vs 2.9%; HR: 0.97; 95% CI: 0.32-2.92; P = 0.96), nonfatal MI (5.1% vs 4.8%; HR: 1.00; 95% CI: 0.44-2.28; P = 0.99), and TVR (8.8% vs 6.1%; HR: 1.64; 95% CI: 0.83-3.25; P = 0.16) were similar. In diabetic patients (n = 252), rates of MACE (19.3% vs 22.2%; HR: 0.82; 95% CI: 0.45-1.48; P = 0.51), cardiac death (8.8% vs 5.9%; HR: 2.01; 95% CI: 0.76-5.31; P = 0.16), and nonfatal MI (7.1% vs 9.8%; HR: 0.55; 95% CI: 0.21-1.49; P = 0.24) were similar in DCB and DES. TVR was significantly lower with DCBs vs DES (9.1% vs 15.0%; HR: 0.40; 95% CI: 0.17-0.94; P = 0.036; P = 0.011 for interaction). The rates of MACE are similar in DCBs and DES in de novo coronary lesions of diabetic and nondiabetic patients. In diabetic patients, need for TVR was significantly lower with DCB versus DES. (Basel Stent Kosten Effektivitäts Trial Drug Eluting Balloons vs Drug Eluting Stents in Small Vessel Interventions [BASKET-SMALL2]; NCT01574534) [Display omitted] [ABSTRACT FROM AUTHOR]

Although drug-eluting stents are still the default interventional treatment of coronary artery disease, drug-coated balloons (DCBs) represent a novel alternative therapeutic strategy in certain anatomic conditions. The effect of DCBs is based on the fast and homogenous transfer of antiproliferative drugs into the vessel wall during single balloon inflation by means of a lipophilic matrix without the use of permanent implants. Although their use is established for in-stent restenosis of both bare-metal and drug-eluting stents, recent randomized clinical data demonstrate a good efficacy and safety profile in de novo small-vessel disease and high bleeding risk. In addition, there are other emerging indications (e.g., bifurcation lesions, large-vessel disease, diabetes mellitus, acute coronary syndromes). Because the interaction among the different delivery balloon designs, doses, formulations, and release kinetics of the drugs used is important, there seems to be no "class effect" of DCBs. On the basis of the amount of recently published data, the International DCB Consensus Group provides this update of previous recommendations summarizing the historical background, technical considerations such as choice of device and implantation technique, possible indications, and future perspectives. • DES still have some limitations in certain clinical and anatomic conditions. • DCBs are a novel therapeutic strategy for coronary artery disease. • Besides ISR, new data show possible indications for native coronary artery disease. • Future research will focus on alternative drug coatings and other possible indications. [ABSTRACT FROM AUTHOR]

Objective: This study sought to evaluate the prognostic value of routine stress myocardial perfusion scintigraphy (MPS) 5 years after percutaneous coronary intervention (PCI). Background: Current appropriate use criteria define routine cardiac stress imaging <2 years after PCI as inappropriate and >2 years as uncertain in asymptomatic patients. Methods: All 339 of 683 BASKET (Basel Stent Kosteneffektivitäts Trial) 5-year survivors (55%) consenting to undergo protocol-mandated MPS and subsequent evaluation irrespective of symptoms were followed for major adverse cardiac events (MACE) (cardiac death, myocardial infarction [MI], or revascularization). For MPS, summed perfusion scores were calculated and perfusion defects were related to treated-vessel or remote myocardial areas. Results: Patients were 72 ± 10 years of age, 18% were female, and 90% were free of angina. MPS findings were abnormal in 205 of 339 patients (60%) with complete follow-up. During 3.7 ± 0.3 years, there were 7 cardiac deaths, 18 MIs, and 47 revascularizations, resulting in a MACE rate of 4.4% and a cardiac mortality rate of 0.6% per year. Patients with abnormal MPS findings had higher hazard ratios (HR) for MACE (HR: 1.95; 95% confidence interval [CI]: 1.06 to 3.59; p = 0.032), and cardiac death/MI (HR: 2.50; 95% CI: 0.93 to 6.69; p = 0.066) than patients with normal MPS finding. MACE rates were similar in patients with symptomatic and silent ischemia (p = 0.61) but higher than in patients with normal MPS findings (p < 0.05 for both comparisons). MACE rates were independently predicted by remote ischemia but not by treated-vessel ischemia or scar. Conclusions: Abnormal MPS findings 5 years after PCI are frequent irrespective of symptoms. The predictive power of abnormal MPS lies more in the detection of persistent or progressing coronary artery disease in remote vessel areas than in the diagnosis of late intervention-related problems in treated vessels. [Copyright &y& Elsevier]

Background: Drug-eluting stents (DESs) are associated with late stent thromboses, but the exact mechanism of action is unknown. Objective: The goal of this article was to assess the clinical interaction of glycoprotein IIb/IIIa inhibitors (GPIs) with different stent and vessel types in unselected patients undergoing percutaneous coronary intervention (PCI). Methods: This was a predefined retrospective analysis of the randomized controlled Basel Stent Kosten Effektivitats Trial (BASKET), which compared DES with bare-metal stents (BMSs) in patients undergoing PCI. Patients were compared for major adverse clinical events in relation to GPI use (abciximab and tirofiban) after 18 months. In a subgroup analysis prespecified in the study protocol, specific regard was given to angiographic groups at different risk levels for late events (high-risk vessels [ie, small vessels with a diameter <3.0 mm and saphenous vein grafts], and low-risk vessels [ie, large native vessels ≥3.0 mm]). Baseline differences between patients with or without GPI use were identified and incorporated into a multivariable Cox proportional hazards regression analysis if different at a <0.05 level. Results: A total of 826 patients (650 males, 176 females) were enrolled in BASKET; 301 (36%) received GPI therapy. Of these 301 patients, 255 (85%) received abciximab and 46 (15%) received tirofiban. After 18 months, the rate of cardiac death and nonfatal myocardial infarction was higher in patients with GPI use than in those without GPI use (35/301 [12%] vs 32/525 [6%]; P = 0.005). In patients undergoing PCI in anatomically low-risk vessels and receiving GPI therapy, there was a higher rate of cardiac death and nonfatal myocardial infarction at 18 months with a DES versus a BMS (22/151 [15%] vs 3/66 [5%]; P = 0.033). In patients undergoing PCI in anatomically low-risk vessels and without GPI therapy, there was no significant difference for cardiac death and nonfatal myocardial infarction (DES vs BMS, 11/207 [5%] vs 6/134 [4%]). In the multivariable analysis, GPI use (hazard ratio = 2.93; 95% CI, 1.53-5.63; P = 0.001) and age (hazard ratio = 1.034 per year increase; 95% CI, 1.008-1.062; P = 0.012) remained the only significant independent predictors of outcome. Interaction of stent type and GPI use was significant (P = 0.006). Conclusions: This retrospective analysis of the BASKET data found that GPIs and DESs used in patients with large native vessels may have an adverse interaction in terms of late stent thromboses. However, large prospective studies are needed to confirm these findings. [Copyright &y& Elsevier]

Abstract: Jeger RV, Rickenbacher P, Pfisterer ME, Hoffmann A. Outpatient rehabilitation in patients with coronary artery and peripheral arterial occlusive disease. Objective: To assess participation rates and outcome in outpatient cardiac rehabilitation (OCR) of patients with peripheral arterial occlusive disease (PAOD). Design: Prospective cohort study. Setting: Referral center, ambulatory care. Participants: All patients undergoing OCR at 2 university hospitals in Switzerland from March 1999 to August 2005. Intervention: OCR during 3 months. Main Outcome Measures: Primary endpoints were workload during bicycle stress test and quality of life (QOL), both at the end of OCR. Secondary endpoints were complications during OCR and termination of OCR. Results: Of 1508 patients, 99 (7%) had PAOD (27 with Fontaine stage I, 69 with stage II, 3 with stage III). Patients with PAOD were older, had more cardiovascular risk factors, and were more likely to have undergone cardiac bypass grafting than those without PAOD. PAOD patients at OCR entry achieved a lower exercise workload than non-PAOD patients (PAOD patients, 105±31W and 69%±17% of target vs non-PAOD patients, 125±38W and 79%±19%; P<.001) but both groups achieved similar gains in exercise capacity at the end of OCR (PAOD patients, 126±44W and 82%±25% vs non-PAOD patients, 153±48W and 98%±24%; P<.001). For both groups, QOL was similar at baseline and follow-up, and improved equally in most dimensions. OCR was discontinued more often in patients with PAOD than in those without (18% vs 10%, P=.018). Cardiac and noncardiac complication rates were similar. Conclusions: Patients with PAOD undergoing OCR have a similar benefit but higher dropout rates than other patients. Thus, PAOD patients should be encouraged to participate in OCR, possibly by creating specifically tailored concepts. [Copyright &y& Elsevier]

Little is known about the effect of revascularization in patients ≥75 years of age with symptomatic coronary artery disease (CAD) and diabetes mellitus (DM) for whom periprocedural risk and overall mortality are increased. Therefore, we examined the 301 patients of the Trial of Invasive versus Medical therapy in the Elderly with symptomatic CAD (TIME) with special regard to diabetic status. Patients were randomized to an invasive versus optimized medical strategy. The median follow-up was 4.1 years (range 0.1 to 6.9). Patients with DM (n = 69) had a greater incidence of hypertension (73% vs 58%, p = 0.03), ≥2 risk factors (93% vs 46%, p &#60;0.01), previous heart failure (22% vs 12%, p = 0.04), and previous myocardial infarction (59% vs 43%, p = 0.02), and a lower left ventricular ejection fraction (48% vs 54%, p = 0.02) than did patients without DM. Mortality was greater in patients with DM than in those without DM (41% vs 25%, p = 0.01; adjusted hazard ratio 1.86, p = 0.01). Revascularization improved the overall survival rate from 61% (no revascularization) to 79% (p &#60;0.01; adjusted hazard ratio 1.68, p = 0.03), an effect similarly observed in patients with and without DM. The event-free survival rate was 11% in nonrevascularized patients with DM compared with 40% in nonrevascularized patients without DM and 41% and 53% in revascularized patients with and without DM, respectively (p &#60;0.01). Angina severity and antianginal drug use were similar for patients with and without DM, but those with DM performed worse in daily activities and physical functioning. In conclusion, elderly diabetic patients with chronic angina have a worse outcome than those with DM but benefit similarly from revascularization regarding symptom relief and long-term outcome. However, physical functioning related to daily activities is reduced in those with DM and may need special attention. [Copyright &y& Elsevier]

Background The tradeoff between stent thrombosis (ST) and major bleeding (MB) of 12- versus 6-month dual antiplatelet therapy (DAPT) after coronary stent implantation has not been clearly defined. Methods Definite/probable ST and MB (TIMI major and Bleeding Academic Research Consortium (BARC) ≥3) were compared in 2 subsequent trials with similar inclusion criteria but different DAPT duration, that is, BASKET (6 months; n = 557) and BASKET-PROVE (12 months; n = 2,314), between months 0 to 6 (DAPT in both trials), 7 to 12 (DAPT in BASKET-PROVE only), and 13 to 24 (aspirin in both trials) using propensity score-adjusted, time-stratified Cox proportional hazard models. Results Overall, event rates were low with fewer ST but similar MB in prolonged DAPT. Analysis of the 3 periods showed a uniform pattern for ST (interaction DAPT/period; P = .145) but an inconsistent pattern for MB (interaction DAPT/period; P < .001 for TIMI major and P = .046 for BARC ≥3), with more MB occurring during months 7 to 12 with prolonged DAPT. Considering observed case fatality rates of 31% with ST and 11% with MB, the extrapolated prevention of 27 ST deaths and the excess of 5 MB deaths resulted in an expected benefit of 22 survivors/10,000 patients treated over 2 years with prolonged DAPT. Conclusion Despite overall low event rates, prolonged DAPT was associated with more MB during months 7 to 12 according to the interaction DAPT/period. Given the higher observed case fatality rates of ST versus MB, 12- versus 6-month DAPT was associated with an extrapolated reduction in mortality. Effective treatment periods and case fatality rates seem important in the analysis of different DAPT durations, specifically with regard to ongoing trials. [ABSTRACT FROM AUTHOR]

The long-term risk associated with different coronary artery disease (CAD) presentations in women undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES) is poorly characterized. We pooled patient-level data for women enrolled in 26 randomized clinical trials. Of 11,577 women included in the pooled database, 10,133 with known clinical presentation received a DES. Of them, 5,760 (57%) had stable angina pectoris (SAP), 3,594 (35%) had unstable angina pectoris (UAP) or non-ST-segment-elevation myocardial infarction (NSTEMI), and 779 (8%) had ST-segment-elevation myocardial infarction (STEMI) as clinical presentation. A stepwise increase in 3-year crude cumulative mortality was observed in the transition from SAP to STEMI (4.9% vs 6.1% vs 9.4%; p <0.01). Conversely, no differences in crude mortality rates were observed between 1 and 3 years across clinical presentations. After multivariable adjustment, STEMI was independently associated with greater risk of 3-year mortality (hazard ratio [HR] 3.45; 95% confidence interval [CI] 1.99 to 5.98; p <0.01), whereas no differences were observed between UAP or NSTEMI and SAP (HR 0.99; 95% CI 0.73 to 1.34; p = 0.94). In women with ACS, use of new-generation DES was associated with reduced risk of major adverse cardiac events (HR 0.58; 95% CI 0.34 to 0.98). The magnitude and direction of the effect with new-generation DES was uniform between women with or without ACS (pinteraction = 0.66). In conclusion, in women across the clinical spectrum of CAD, STEMI was associated with a greater risk of long-term mortality. Conversely, the adjusted risk of mortality between UAP or NSTEMI and SAP was similar. New-generation DESs provide improved long-term clinical outcomes irrespective of the clinical presentation in women. [ABSTRACT FROM AUTHOR]

Objectives: We sought to evaluate the incidence of silent ischemia versus symptomatic ischemia six months after percutaneous coronary intervention (PCI) and its impact on prognosis and to test the utility of myocardial perfusion single-photon emission computed tomography (SPECT), or MPS, for risk stratification in these patients.Background: Silent ischemia is frequent after PCI. However, little is known about silent ischemia and long-term outcome after PCI and stenting.Methods: In 356 consecutive patients with successful PCI and stenting and follow-up MPS after six months, long-term follow-up (4.1 +/- 0.3 years) was performed. The MPS images were interpreted by defining summed stress, rest, and difference scores (summed difference score [SDS] = extent of ischemia) and related to symptoms and outcome. Critical events included cardiac death, myocardial infarction, and target vessel revascularization.Results: Eighty-one patients (23%) had evidence of target vessel ischemia, which was silent in 62%. The only independent predictor of silent ischemia was SDS (odds ratio 0.64, p = 0.001). During follow-up, 67 critical events occurred. For patients with an SDS of 0, 1-4, and >4, the critical event rates were 17%, 29%, and 69%, respectively. Similarly, patients without ischemia, silent ischemia, and symptomatic ischemia had 17%, 32%, and 52% of critical events, respectively. Diabetes (relative risk 1.98, p = 0.03) and SDS (relative risk 1.2, p < 0.001) were independent predictors of critical events. The MPS image added incremental information for the prediction of critical events.Conclusions: Six months after PCI and stenting, 23% of patients had target vessel ischemia, which was silent in 62%. Silent ischemia predicted a worse outcome than did no ischemia and tended to have a better outcome than symptomatic ischemia. This was closely related to the extent of ischemia. The SDS added incremental value to pre-scan findings with respect to diagnosis and prognosis, indicating the utility of MPS for risk stratification after PCI and stenting. [ABSTRACT FROM AUTHOR]