Seung Jea Tahk

Randomized Trial of Stents versus Bypass Surgery for Left Main Coronary Artery Disease

BACKGROUND Percutaneous coronary intervention (PCI) is increasingly used to treat unprotected left main coronary artery stenosis, although coronary-artery bypass grafting (CABG) has been considered to be the treatment of choice. METHODS We randomly assigned patients with unprotected left main coronary artery stenosis to undergo CABG (300 patients) or PCI with sirolimus-eluting stents (300 patients). Using a wide margin for noninferiority, we compared the groups with respect to the primary composite end point of major adverse cardiac or cerebrovascular events (death from any cause, myocardial infarction, stroke, or ischemia-driven target-vessel revascularization) at 1 year. Event rates at 2 years were also compared between the two groups. RESULTS The primary end point occurred in 26 patients assigned to PCI as compared with 20 patients assigned to CABG (cumulative event rate, 8.7% vs. 6.7%; absolute risk difference, 2.0 percentage points; 95% confidence interval [CI], -1.6 to 5.6; P=0.01 for noninferiority). By 2 years, the primary end point had occurred in 36 patients in the PCI group as compared with 24 in the CABG group (cumulative event rate, 12.2% vs. 8.1%; hazard ratio with PCI, 1.50; 95% CI, 0.90 to 2.52; P=0.12). The composite rate of death, myocardial infarction, or stroke at 2 years occurred in 13 and 14 patients in the two groups, respectively (cumulative event rate, 4.4% and 4.7%, respectively; hazard ratio, 0.92; 95% CI, 0.43 to 1.96; P=0.83). Ischemia-driven target-vessel revascularization occurred in 26 patients in the PCI group as compared with 12 patients in the CABG group (cumulative event rate, 9.0% vs. 4.2%; hazard ratio, 2.18; 95% CI, 1.10 to 4.32; P=0.02). CONCLUSIONS In this randomized trial involving patients with unprotected left main coronary artery stenosis, PCI with sirolimus-eluting stents was shown to be noninferior to CABG with respect to major adverse cardiac or cerebrovascular events. However, the noninferiority margin was wide, and the results cannot be considered clinically directive. (Funded by the Cardiovascular Research Foundation, Seoul, Korea, and others; PRECOMBAT ClinicalTrials.gov number, NCT00422968.).

Comparison of Zotarolimus-Eluting Stents With Sirolimus- and Paclitaxel-Eluting Stents for Coronary Revascularization The ZEST (Comparison of the Efficacy and Safety of Zotarolimus-Eluting Stent with Sirolimus-Eluting and PacliTaxel-Eluting Stent for Coronary Lesions) Randomized Trial

OBJECTIVES The aim of this study was to evaluate the relative efficacy and safety of zotarolimus-eluting stents (ZES) in comparison with the established and widely used sirolimus- (SES) and paclitaxel-eluting stents (PES) in routine clinical practice. BACKGROUND Whether ZES might provide similar clinical and angiographic outcomes in a broad spectrum of patients compared with SES or PES is undetermined. METHODS We performed a single-blind, multicenter, prospectively randomized trial to compare ZES with SES and PES in 2,645 patients undergoing percutaneous coronary intervention. The primary end point was a composite of major adverse cardiac events (MACE) (death, myocardial infarction, and ischemia-driven target vessel revascularization) at 12 months. A noninferiority comparison (ZES vs. SES) and a superiority comparison (ZES vs. PES) were performed for the primary end point. RESULTS Baseline clinical and angiographic characteristics were similar in the 3 groups. At 12 months, the ZES group showed noninferior rates of MACE compared with the SES group (10.2% vs. 8.3%, p for noninferiority = 0.01, p for superiority = 0.17) and significantly fewer MACE than the PES group (10.2% vs. 14.1%, p for superiority = 0.01). The incidence of death or myocardial infarction was similar among the groups (ZES vs. SES vs. PES, 5.8% vs. 6.9% vs. 7.6%, respectively, p = 0.31). The incidence of stent thrombosis was significantly lower in the SES group (ZES vs. SES vs. PES, 0.7% vs. 0% vs. 0.8%, respectively, p = 0.02). CONCLUSIONS In this large-scale, practical randomized trial, the use of ZES resulted in similar rates of MACE compared with SES and in fewer MACE compared with PES at 12 months. (Comparison of the Efficacy and the Safety of Zotarolimus-Eluting Stent Versus Sirolimus-Eluting Stent and PacliTaxel-Eluting Stent for Coronary Lesions; NCT00418067).

Randomized Trial of Stents Versus Bypass Surgery for Left Main Coronary Artery Disease 5-Year Outcomes of the PRECOMBAT Study

BACKGROUND In a previous randomized trial, we found that percutaneous coronary intervention (PCI) was not inferior to coronary artery bypass grafting (CABG) for the treatment of unprotected left main coronary artery stenosis at 1 year. OBJECTIVES This study sought to determine the 5-year outcomes of PCI compared with CABG for the treatment of unprotected left main coronary artery stenosis. METHODS We randomly assigned 600 patients with unprotected left main coronary artery stenosis to undergo PCI with a sirolimus-eluting stent (n = 300) or CABG (n = 300). The primary endpoint was a major adverse cardiac or cerebrovascular event (MACCE: a composite of death from any cause, myocardial infarction, stroke, or ischemia-driven target vessel revascularization) and compared on an intention-to-treat basis. RESULTS At 5 years, MACCE occurred in 52 patients in the PCI group and 42 patients in the CABG group (cumulative event rates of 17.5% and 14.3%, respectively; hazard ratio [HR]: 1.27; 95% confidence interval [CI]: 0.84 to 1.90; p = 0.26). The 2 groups did not differ significantly in terms of death from any cause, myocardial infarction, or stroke as well as their composite (8.4% and 9.6%; HR, 0.89; 95% CI, 0.52 to 1.52; p = 0.66). Ischemia-driven target vessel revascularization occurred more frequently in the PCI group than in the CABG group (11.4% and 5.5%, respectively; HR: 2.11; 95% CI: 1.16 to 3.84; p = 0.012). CONCLUSIONS During 5 years of follow-up, our study did not show significant difference regarding the rate of MACCE between patients who underwent PCI with a sirolimus-eluting stent and those who underwent CABG. However, considering the limited power of our study, our results should be interpreted with caution. (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease [PRECOMBAT]; NCT00422968).

Predictors and Outcomes of Side Branch Occlusion After Main Vessel Stenting in Coronary Bifurcation Lesions: Results From the COBIS II Registry (COronary BIfurcation Stenting)

OBJECTIVES This study sought to investigate the predictors and outcomes of side branch (SB) occlusion after main vessel (MV) stenting in coronary bifurcation lesions. BACKGROUND SB occlusion is a serious complication that occurs during percutaneous coronary intervention (PCI) for bifurcation lesions. METHODS Consecutive patients undergoing PCI using drug-eluting stents for bifurcation lesions with SB ≥2.3 mm were enrolled. We selected patients treated with the 1-stent technique or MV stenting first strategy. SB occlusion after MV stenting was defined as Thrombolysis in Myocardial Infarction flow grade <3. RESULTS SB occlusion occurred in 187 (8.4%) of 2,227 bifurcation lesions. In multivariate analysis, independent predictors of SB occlusion were pre-procedural percent diameter stenosis of the SB ≥50% (odds ratio [OR]: 2.34; 95% confidence interval [CI]: 1.59 to 3.43; p < 0.001) and the proximal MV ≥50% (OR: 2.34; 95% CI: 1.57 to 3.50; p < 0.001), SB lesion length (OR: 1.03; 95% CI: 1.003 to 1.06; p = 0.03), and acute coronary syndrome (OR: 1.53; 95% CI: 1.06 to 2.19; p = 0.02). Of 187 occluded SBs, flow was restored spontaneously in 26 (13.9%) and by SB intervention in 103 (55.1%) but not in 58 (31.0%). Jailed wire in the SB was associated with flow recovery (74.8% vs. 57.8%, p = 0.02). Cardiac death or myocardial infarction occurred more frequently in patients with SB occlusion than in those without SB occlusion (adjusted hazard ratio: 2.34; 95% CI: 1.15 to 4.77; p = 0.02). CONCLUSIONS Angiographic findings of SB, proximal MV stenosis, and clinical presentation are predictive of SB occlusion after MV stenting. Occlusion of sizable SB is associated with adverse clinical outcomes..

Impact of intravascular ultrasound guidance on long-term clinical outcomes in patients treated with drug-eluting stent for bifurcation lesions: Data from a Korean multicenter bifurcation registry

BACKGROUND although intravascular ultrasound (IVUS) has been widely used for complex lesions during coronary intervention, IVUS for stenting at bifurcation lesions has not been sufficiently assessed. The aim of this study was to investigate the impact of IVUS guidance on long-term clinical outcomes during drug-eluting stent (DES) implantation for bifurcation lesions. METHODS the Korean multicenter bifurcation registry listed 1,668 patients with non-left main de novo bifurcation lesions who underwent DES implantation between January 2004 and June 2006. Using propensity score matching with clinical and angiographic characteristics, 487 patients with IVUS guidance and 487 patients with angiography guidance were selected. The long-term clinical outcomes were compared between the 2 groups. RESULTS baseline clinical and angiographic characteristics were well matched and showed no significant differences between the 2 groups. Two-stent technique and final kissing ballooning angioplasty were more frequently performed in the IVUS-guided group. Maximal stent diameters at both the main vessel and the side branch were larger in the IVUS-guided group. Periprocedural creatine kinase-MB elevation (>3 times of upper normal limits) was frequently observed in the angiography-guided group. The incidence of death or myocardial infarction was significantly lower in the IVUS-guided group compared to the angiography-guided group (3.8% vs 7.8%, log rank test P = .03, hazard ratio 0.44, 95% CI 0.12-0.96, Cox model P = .04). CONCLUSIONS intravascular ultrasound guidance during DES implantation at bifurcation lesions may be helpful to improve long-term clinical outcomes by reducing the occurrence of death or myocardial infarction.

Intravascular Ultrasound Classification of Plaque Distribution in Left Main Coronary Artery Bifurcations Where Is the Plaque Really Located

Background—Angiographic classifications of the location and severity of disease in the main vessel and side branch of coronary artery bifurcations have been proposed and applied to distal left main coronary artery (LMCA) bifurcation. Methods and Results—We reviewed 140 angiograms of distal LMCA and ostial left anterior descending (LAD) and left circumflex (LCX) artery lesions with preintervention intravascular ultrasound (IVUS) of both the LAD and LCX arteries as well as the LMCA. Of 140 patients, 92.9% had at least 1 cross section with ≥40% IVUS plaque burden versus 57.2% of patients with an angiographic diameter stenosis ≥50%. Contrary to angiographic classifications, IVUS showed that bifurcation disease was rarely focal and that both sides of the flow divider were always disease-free. Continuous plaque from the LMCA into the proximal LAD artery was seen in 90%, from the LMCA into the LCX artery in 66.4%, and from the LMCA into both the LAD and LCX arteries in 62%. Plaque localized to either the LAD or LCX ostium and not involving the distal LMCA was seen in only 9.3% of LAD arteries and 17.1% of LCX arteries. Plaque distribution was not influenced by the LAD/LCX angiographic angle, lesion severity, LMCA length, or remodeling. We proposed an IVUS classification for bifurcation lesions illustrating longitudinal and circumferential spatial plaque distribution. Conclusions—Angiographic classification of LMCA bifurcation lesions is rarely accurate. IVUS shows that the carina is always spared and that the disease is diffuse rather than focal. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT00180466.

Intravascular Ultrasound Classification of Plaque Distribution in Left Main Coronary Artery Bifurcations

Background—Angiographic classifications of the location and severity of disease in the main vessel and side branch of coronary artery bifurcations have been proposed and applied to distal left main coronary artery (LMCA) bifurcation. Methods and Results—We reviewed 140 angiograms of distal LMCA and ostial left anterior descending (LAD) and left circumflex (LCX) artery lesions with preintervention intravascular ultrasound (IVUS) of both the LAD and LCX arteries as well as the LMCA. Of 140 patients, 92.9% had at least 1 cross section with ≥40% IVUS plaque burden versus 57.2% of patients with an angiographic diameter stenosis ≥50%. Contrary to angiographic classifications, IVUS showed that bifurcation disease was rarely focal and that both sides of the flow divider were always disease-free. Continuous plaque from the LMCA into the proximal LAD artery was seen in 90%, from the LMCA into the LCX artery in 66.4%, and from the LMCA into both the LAD and LCX arteries in 62%. Plaque localized to either the LAD or LCX ostium and not involving the distal LMCA was seen in only 9.3% of LAD arteries and 17.1% of LCX arteries. Plaque distribution was not influenced by the LAD/LCX angiographic angle, lesion severity, LMCA length, or remodeling. We proposed an IVUS classification for bifurcation lesions illustrating longitudinal and circumferential spatial plaque distribution. Conclusions—Angiographic classification of LMCA bifurcation lesions is rarely accurate. IVUS shows that the carina is always spared and that the disease is diffuse rather than focal. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT00180466.

Sirolimus- Versus Paclitaxel-Eluting Stents for the Treatment of Coronary Bifurcations: Results From the COBIS (Coronary Bifurcation Stenting) Registry

OBJECTIVES We aimed to compare the long-term clinical outcomes of patients treated with sirolimus-eluting stents (SES) or paclitaxel-eluting stents (PES) for coronary bifurcation lesions. BACKGROUND There are limited data regarding comparisons of SES and PES for the treatment of bifurcation lesions. METHODS Patients who received percutaneous coronary intervention for non-left main bifurcation lesions were enrolled from 16 centers in Korea between January 2004 and June 2006. We compared major adverse cardiac events (MACE [cardiac death, myocardial infarction, or target lesion revascularization]) between the SES and PES groups in patients overall and in 407 patient pairs generated by propensity-score matching. RESULTS We evaluated 1,033 patients with bifurcation lesions treated with SES and 562 patients treated with PES. The median follow-up duration was 22 months. Treatment with SES was associated with a lower incidence of MACE (hazard ratio [HR]: 0.53, 95% confidence interval [CI]: 0.32 to 0.89, p < 0.01) and target lesion revascularization (HR: 0.55, 95% CI: 0.31 to 0.97, p = 0.02), but not of cardiac death (HR: 2.77, 95% CI: 0.40 to 18.99, p = 0.62) and cardiac death or myocardial infarction (HR: 0.97, 95% CI: 0.38 to 2.49, p = 0.94). After propensity-score matching, patients with SES still had fewer MACE and target lesion revascularization incidences than did patients with PES (HR: 0.52, 95% CI: 0.30 to 0.91, p = 0.02, and HR: 0.48, 95% CI: 0.25 to 0.91, p = 0.02, respectively). There was no significant difference in the occurrences of stent thrombosis between the groups (0.7% vs. 0.7%, p = 0.94). CONCLUSIONS In patients with bifurcation lesions, the use of SES resulted in better long-term outcomes than did the use of PES, primarily by decreasing the rate of repeat revascularization. (Coronary Bifurcation Stenting Registry in South Korea [COBIS]; NCT00851526).

Low-molecular-weight heparin versus unfractionated heparin in acute ST-segment elevation myocardial infarction patients undergoing primary percutaneous coronary intervention with drug-eluting stents

BACKGROUND Whether low-molecular-weight heparin (LMWH) is superior to unfractionated heparin (UFH) in acute ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI) with drug-eluting stents (DESs) remains unclear. METHODS A total of 3,372 STEMI patients who underwent primary PCI with DESs received either LMWH (n = 1,531 patients, subcutaneous enoxaparin 1 mg/kg, bid for 3-5 days plus reduced dose of UFH [50 U/kg] during PCI) or UFH alone (n = 1,841 patients, intravenous bolus injection of 5,000 U, followed by 24,000 U/d infusion for at least 48 hours). The bleeding events and clinical outcomes during in-hospital and at 8 months were compared. RESULTS The incidences of major and minor bleeding events were similar between the 2 groups. Multivariable Cox regression analysis showed that LMWH group had lower incidences of cardiac death (adjusted odds ratio [OR] 0.55, 95% CI 0.39-0.77, P < .001), total death (adjusted OR 0.50, 95% CI 0.37-0.68, P < .001), and total major adverse cardiac events (adjusted OR 0.77, 95% CI 0.62-0.95, P = .017) at 8 months as compared with UFH group. Similar results were obtained across different subgroups including different DESs, age, and sex. CONCLUSIONS The LMWH enoxaparin combined with reduced dose of UFH (50 U/kg) administration as an adjunctive antithrombotic therapy in STEMI patients undergoing primary PCI with DESs seems to be safe and efficacious. However, randomized clinical trials are needed to confirm this conclusion.

Outcomes After Unrestricted Use of Everolimus-Eluting and Sirolimus-Eluting Stents in Routine Clinical Practice A Multicenter, Prospective Cohort Study

Background— It remains unclear whether there are differences in the safety and efficacy outcomes between everolimus-eluting stents (EES) and sirolimus-eluting stents (SES) in contemporary practice. Methods and Results— We prospectively enrolled 6166 consecutive patients who received EES (3081 patients) and SES (3085 patients) between April 2008 and June 2010, using data from the Interventional Cardiology Research In-Cooperation Society-Drug-Eluting Stents Registry. The primary end point was a composite of death, nonfatal myocardial infarction (MI), or target-vessel revascularization (TVR). At 2 years of follow-up, the 2 study groups did not differ significantly in crude risk of the primary end point (12.1% for EES versus 12.4% for SES; HR, 0.97; 95% CI, 0.84–1.12, P=0.66). After adjustment for differences in baseline risk factors, the adjusted risk for the primary end point remained similar for the 2 stent types (HR, 0.96; 95% CI, 0.82–1.12, P=0.60). There were also no differences between the stent groups in the adjusted risks of the individual component of death (HR, 0.93; 95% CI, 0.67–1.30, P=0.68), MI (HR, 0.97; 95% CI, 0.79–1.18, P=0.74), and TVR (HR, 1.10; 95% CI, 0.82–1.49, P=0.51). The adjusted risk of stent thrombosis also was similar (HR, 1.16; 95% CI, 0.47–2.84, P=0.75). Conclusions— In contemporary practice of percutaneous coronary intervention procedures, the unrestricted use of EES and SES showed similar rates of safety and efficacy outcomes with regard to death, MI, sent thrombosis, and TVR. Future longer-term follow-up is needed to better define the relative benefits of these drug-eluting stents. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT01070420.