Trends in Modifiable Risk Factors Amongst First Presentation ST Elevation Myocardial Infarction Patients in a Large Longitudinal Registry.

BACKGROUND: Recent studies suggest that the risk factor profile of patients presenting with ST elevation myocardial infarction (STEMI) is changing. AIM: The aim is to determine if there has been a shift of cardiovascular risk factors to cardiometabolic causes in the first presentation STEMI population. METHOD: We analysed data from a STEMI registry from a large tertiary referral percutaneous coronary intervention centre to determine the prevalence and trends of the modifiable risk factors of hypertension, diabetes, smoking and hypercholesterolaemia. PARTICIPANTS: Consecutive first presentation STEMI patients between January 2006 to December 2018. RESULTS: Among the 2,366 patients included (mean age 59, SD 12.66, 80% male) the common risk factors were hypertension (47%), hypercholesterolaemia (47%) current smoking (42%) and diabetes (27%). Over the 13 years, patients with diabetes (20% to 26%, OR 1.09 per year, CI 1.06-1.11, p<0.001) and patients with no modifiable risk factors increased (9% to 17%, OR 1.08, CI 1.04-1.11, p<0.001). Concurrently there was a fall in prevalence of hypercholesterolaemia, (47% to 37%, OR 0.94 per year, CI 0.92-0.96, p<0.001) and smoking (44% to 41%, OR 0.94, CI 0.92-0.96, p<0.001) but no significant change in rates of hypertension (53% to 49%, OR 0.99, CI 0.97-1.01, p=0.25). CONCLUSION: The risk factor profile of first presentation STEMI has changed over time with a reduction in smoking and a concurrent rise in patients with no traditional risk factors. This suggests the mechanism of STEMI may be changing and further investigation of potential causal factors is warranted for the prevention and management of cardiovascular disease.

Low Incidence of Ischemic Stroke Associated With Thrombus Aspiration in STEMI Patients Undergoing Primary PCI.

BACKGROUND: Thrombus aspiration (TA) during primary percutaneous coronary intervention (PPCI) for ST-segment elevation myocardial infarction (STEMI) was recommended to minimize distal embolization and to reduce thrombus burden prior to PPCI. Subsequent randomized trials showed no mortality benefit from TA and suggested an increased risk of stroke up to 180 days following TA, although it was not obvious that the procedure alone caused the strokes. METHODS AND RESULTS: This study retrospectively analyzed the periprocedural stroke rate in a series of STEMI patients treated with TA and PPCI at a single, large, tertiary hospital, where a rigorous uniform protocol of aspiration was used in all patients. Of 3734 patients, 1404 patients (38%; group 1) underwent TA as part of the PPCI procedure and 2330 patients (62%; group 2) did not undergo TA. There were no significant clinical differences between the 2 groups. In total, there were 20 strokes (0.54%), with 3 (0.2%) occurring in group 1, and 17 (0.7%) occurring in group 2 (P=.04). The majority of strokes occurred within 5 days of the procedure, and 3 (0.08%) were hemorrhagic. There were 22 intraprocedural deaths (0.6%), related to cardiogenic shock. There were no intraprocedural strokes. CONCLUSIONS: Very low stroke rates immediately post STEMI were seen in patients undergoing TA and PPCI in this real-world study. TA can be performed safely in STEMI patients undergoing PPCI with a short-term stroke risk equivalent to risk without TA. Further studies may be needed to explain the increased incidence of late stroke noted after TA and elucidate causative mechanisms.

Clinical and electrocardiographic correlates of normal coronary angiography in patients referred for primary percutaneous coronary intervention.

This study sought to determine the prevalence as well as clinical and electrocardiographic correlates of patients referred for primary percutaneous coronary intervention (PCI) who had angiographically normal coronary arteries. Data for 690 consecutive patients with ST-elevation myocardial infarction (STEMI) referred for primary PCI within a metropolitan area health service were reviewed. Characteristics of patients with angiographically normal coronary arteries (n = 87; 13%) were compared with patients with angiographically shown culprit lesions (control group; n = 594). Nine patients with significant coronary disease, but no identifiable culprit lesion, were excluded. Electrocardiograms (ECGs) from both groups were reviewed by 2 cardiologists blinded to angiographic findings. Patients in the normal coronaries group were younger and had fewer risk factors. On expert review of ECGs, 55% of patients in the normal coronaries group had ST-elevation criteria for STEMI (vs 93% in the control group; p <0.001), but the ECG was considered consistent with a diagnosis of STEMI by both observers in only 33% (vs 92% in the control group; p <0.001). Left branch bundle block independently correlated with normal coronary arteries on multivariate analysis (odds ratio for STEMI 0.016, 95% confidence interval 0.004 to 0.064, p <0.001). The discharge diagnosis in the normal coronaries group was predominantly pericarditis (n = 72; 83%). In conclusion, the prevalence of angiographically normal coronary arteries in patients referred for primary PCI was 13%. Electrocardiographic correlation suggested that this can be reduced by adherence to conventional electrocardiographic criteria for STEMI diagnosis and review of ECGs by experienced clinicians.

Short- and long-term clinical outcome after drug-eluting stent implantation for the percutaneous treatment of left main coronary artery disease: insights from the Rapamycin-Eluting and Taxus Stent Evaluated At Rotterdam Cardiology Hospital registries (RESEARCH and T-SEARCH).

BACKGROUND: The impact of drug-eluting stent (DES) implantation on the incidence of major adverse cardiovascular events in patients undergoing percutaneous intervention for left main (LM) coronary disease is largely unknown. METHODS AND RESULTS: From April 2001 to December 2003, 181 patients underwent percutaneous coronary intervention for LM stenosis at our institution. The first cohort consisted of 86 patients (19 protected LM) treated with bare metal stents (pre-DES group); the second cohort comprised 95 patients (15 protected LM) treated exclusively with DES. The 2 cohorts were well balanced for all baseline characteristics. At a median follow-up of 503 days (range, 331 to 873 days), the cumulative incidence of major adverse cardiovascular events was lower in the DES cohort than in patients in the pre-DES group (24% versus 45%, respectively; hazard ratio [HR], 0.52 [95% CI, 0.31 to 0.88]; P=0.01). Total mortality did not differ between cohorts; however, there were significantly lower rates of both myocardial infarction (4% versus 12%, respectively; HR, 0.22 [95% CI, 0.07 to 0.65]; P=0.006) and target vessel revascularization (6% versus 23%, respectively; HR, 0.26 [95% CI, 0.10 to 0.65]; P=0.004) in the DES group. On multivariate analysis, use of DES, Parsonnet classification, troponin elevation at entry, distal LM location, and reference vessel diameter were independent predictors of major adverse cardiovascular events. CONCLUSIONS: When percutaneous coronary intervention is undertaken at LM lesions, routine DES implantation, which reduces the cumulative incidence of myocardial infarction and the need for target vessel revascularization compared with bare metal stents, should currently be the preferred strategy.

Late angiographic stent thrombosis (LAST) events with drug-eluting stents.

OBJECTIVES: We sought to describe the incidence of late angiographic stent thrombosis (LAST) events in an unselected drug-eluting stent (DES) population. BACKGROUND: Concerns have been raised that LAST may be a potential limitation of DES. METHODS: We have previously reported the angiographic incidence of early stent thrombosis (1.0%) in this prospective cohort of 2,006 patients treated with either sirolimus-eluting stents (SES) (n = 1,017) or paclitaxel-eluting stents (PES) (n = 989). We continued long-term follow-up to determine the incidence of LAST events, defined as angiographically proven stent thrombosis associated with acute symptoms more than 30 days after DES implantation. All patients had at least 1 year of follow-up, mean duration 1.5 years. RESULTS: There were eight angiographically confirmed LAST events in seven patients: three with SES (at 2, 25, and 26 months) and five with PES (at 6, 7, 8, 11, and 14.5 months). Three cases were related to complete cessation of antiplatelet therapy, two cases occurred while patients were on aspirin therapy within one month of cessation of clopidogrel, and three cases occurred at a time when patients were apparently clinically stable on aspirin monotherapy. We observed no cases of LAST in patients who were on dual antiplatelet therapy. Two deaths occurred directly as a result of LAST. CONCLUSIONS: Angiographically proven late stent thrombosis occurs with an incidence of at least 0.35% (95% confidence limits 0.17% to 0.72%) in patients treated with DES. Importantly, it may also occur when patients are stable on antiplatelet monotherapy.

Endothelial progenitor cell capture by stents coated with antibody against CD34: the HEALING-FIM (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth-First In Man) Registry.

OBJECTIVES: This study was designed to evaluate whether rapid endothelialization of stainless steel stents with a functional endothelium prevents stent thrombosis and reduces the restenotic process. BACKGROUND: A "pro-healing" approach for prevention of post-stenting restenosis is theoretically favored over the use of cytotoxic or cytostatic local pharmacologic therapies. It is believed that the central role of the vascular endothelium is to maintain quiescence of the underlying media and adventitia. METHODS: Sixteen patients with de novo coronary artery disease were successfully treated with implantation of endothelial progenitor cell (EPC) capture stents. RESULTS: Complete procedural and angiographic success was achieved in all 16 patients. The nine-month composite major adverse cardiac and cerebrovascular events (MACCE) rate was 6.3% as a result of a symptom-driven target vessel revascularization in a single patient. There were no other MACCE despite only one month of clopidogrel treatment. At six-month follow-up, mean angiographic late luminal loss was 0.63 +/- 0.52 mm, and percent stent volume obstruction by intravascular ultrasound analysis was 27.2 +/- 20.9%. CONCLUSIONS: This first human clinical investigation of this technology demonstrates that the EPC capture coronary stent is safe and feasible for the treatment of de novo coronary artery disease. Further developments in this technology are warranted to evaluate the efficacy of this device for the treatment of coronary artery disease.

Thirty-day incidence and six-month clinical outcome of thrombotic stent occlusion after bare-metal, sirolimus, or paclitaxel stent implantation.

OBJECTIVES: We sought to determine the real-world incidence of angiographically confirmed and possible stent thrombosis (ST) in an unrestricted population during the first 30 days after bare-metal stent (BMS), sirolimus-eluting stent (SES), and paclitaxel-eluting stent (PES) implantation. BACKGROUND: Current data on ST in drug-eluting stents (DES) have come from randomized trials with strict entry criteria, which limits their generalizability to daily practice. METHODS: The study population comprised three sequential cohorts of 506 consecutive patients with BMS, 1,017 consecutive patients with SES, and 989 consecutive patients treated with PES. RESULTS: In the first 30 days after stent implantation, 6 BMS (1.2%, 95% confidence interval [CI] 0.5% to 2.6%; p = 0.9), 10 SES (1.0%, 95% CI 0.5% to 1.8%), and 10 PES (1.0%, 95% CI 0.6% to 1.9%) patients developed angiographically proven ST. Multiple potential risk factors were identified in most patients with ST. Bifurcation stenting in the setting of acute myocardial infarction was an independent risk factor for angiographic ST in the entire population (odds ratio [OR] 12.9, 95% CI 4.7 to 35.8, p < 0.001). In patients with DES who had angiographic ST, 30-day mortality was 15%, whereas another 60% suffered a nonfatal myocardial infarction; no further deaths occurred during six months of follow-up. Including possible cases, 7 BMS (1.4%, 95% CI 0.7% to 2.8%), 15 SES (1.5%, 95% CI 0.9% to 2.4%), and 16 PES (1.6%, 95% CI 1.0% to 2.6%) patients had ST. CONCLUSIONS: The unrestricted use of SES or PES is associated with ST rates in the range expected for BMS. Stent thrombosis was associated with a high morbidity and mortality. Bifurcation stenting, when performed in patients with acute myocardial infarction, was associated with an increased risk of ST.

Five-year outcomes after coronary stenting versus bypass surgery for the treatment of multivessel disease: the final analysis of the Arterial Revascularization Therapies Study (ARTS) randomized trial.

OBJECTIVES: The long-term (five-year) comparative results of treatment of multivessel coronary artery disease with stenting or coronary artery bypass grafting (CABG) is at present unknown. BACKGROUND: The Arterial Revascularization Therapies Study (ARTS) was designed to compare CABG and stenting in patients with multivessel disease. METHODS: A total of 1,205 patients with the potential for equivalent revascularization were randomly assigned to CABG (n = 605) or stent implantation (n = 600). The primary clinical end point was freedom from major adverse cardiac and cerebrovascular events (MACCE) at one year; MACCE at five-year follow-up constituted the final secondary end point. RESULTS: At five years, there were 48 and 46 deaths in the stent and CABG groups, respectively (8.0% vs. 7.6%; p = 0.83; relative risk [RR], 1.05; 95% confidence interval [CI], 0.71 to 1.55). Among 208 diabetic patients, mortality was 13.4% in the stent group and 8.3% in the CABG group (p = 0.27; RR, 1.61; 95% CI, 0.71 to 3.63). Overall freedom from death, stroke, or myocardial infarction was not significantly different between groups (18.2% in the stent group vs. 14.9% in the surgical group; p = 0.14; RR, 1.22; 95% CI, 0.95 to 1.58). The incidence of repeat revascularization was significantly higher in the stent group (30.3%) than in the CABG group (8.8%; p < 0.001; RR, 3.46; 95% CI, 2.61 to 4.60). The composite event-free survival rate was 58.3% in the stent group and 78.2% in the CABG group (p < 0.0001; RR, 1.91; 95% CI, 1.60 to 2.28). CONCLUSIONS: At five years there was no difference in mortality between stenting and surgery for multivessel disease. Furthermore, the incidence of stroke or myocardial infarction was not significantly different between the two groups. However, overall MACCE was higher in the stent group, driven by the increased need for repeat revascularization.

The unrestricted use of paclitaxel- versus sirolimus-eluting stents for coronary artery disease in an unselected population: one-year results of the Taxus-Stent Evaluated at Rotterdam Cardiology Hospital (T-SEARCH) registry.

OBJECTIVES: We investigated the efficacy of paclitaxel-eluting stents (PES) compared to sirolimus-eluting stents (SES) when used without restriction in unselected patients. BACKGROUND: Both SES and PES have been separately shown to be efficacious when compared to bare stents. In unselected patients, no direct comparison between the two devices has been performed. METHODS: Paclitaxel-eluting stents have been used as the stent of choice for all percutaneous coronary interventions in the prospective Taxus-Stent Evaluated At Rotterdam Cardiology Hospital (T-SEARCH) registry. A total of 576 consecutive patients with de novo coronary artery disease exclusively treated with PES were compared with 508 patients treated with SES from the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry. RESULTS: The PES patients were more frequently male, more frequently treated for acute myocardial infarction, had longer total stent lengths, and more frequently received glycoprotein IIb/IIIa inhibitors. At one year, the raw cumulative incidence of major adverse cardiac events was 13.9% in the PES group and 10.5% in the SES group (unadjusted hazard ratio [HR] 1.33, 95% confidence interval [CI] 0.95 to 1.88, p = 0.1). Correction for differences in the two groups resulted in an adjusted HR of 1.16 (95% CI 0.81 to 1.64, p = 0.4, using significant univariate variables) and an adjusted HR of 1.20 (95% CI 0.85 to 1.70, p = 0.3, using independent predictors). The one-year cumulative incidence of clinically driven target vessel revascularization was 5.4% versus 3.7%, respectively (HR 1.38, 95% CI 0.79 to 2.43, p = 0.3). CONCLUSIONS: The universal use of PES in an unrestricted setting is safe and is associated with a similar adjusted outcome compared to SES. The inferior trend in crude outcome seen in PES was due to its higher-risk population. A larger, randomized study enrolling an unselected population may assist in determining the relative superiority of either device.

Type D personality and diabetes predict the onset of depressive symptoms in patients after percutaneous coronary intervention.

BACKGROUND: Depression is common in cardiac patients and has been associated with adverse clinical outcome. However, little is known about predictors of the onset of depressive symptoms. We examined predictors of the onset of depressive symptoms at 12 months post-percutaneous coronary intervention (PCI) in patients treated in the drug-eluting stent era. METHODS: Unselected patients, free from depressive symptoms at 6 months with a depression score at 12 months treated with PCI with either drug-eluting or bare stent implantation as part of the RESEARCH registry qualified for inclusion in the current study. Patients completed the Hospital Anxiety and Depression Scale at 6 and 12 months and the Type D Personality Scale (DS14) at 6 months post-PCI. Six months was used as the baseline assessment. RESULTS: Of 542 patients, 41 (8%) had developed significant depressive symptoms at 12 months. The occurrence of a new cardiac event between 6 and 12 months post-index event did not influence the incidence of depressive symptoms at 12 months. Depressive patients were more likely to have a type D personality (34% vs 16%, P = .003) and diabetes (24% vs 11%, P = .01) than nondepressive patients. Type D personality (odds ratio 3.04, 95% CI 1.50-6.16) and diabetes (odds ratio 2.75, 95% CI 1.25-6.05) were independent predictors of the onset of depressive symptoms 12 months post-PCI in adjusted analyses. In patients with neither risk factors (type D or diabetes), the incidence of depression was 5.1% with the incidence more than doubling to 13.2% and 30% for each additional risk factor. CONCLUSIONS: Type D personality and diabetes comprise risk factors for the onset of depressive symptoms post-PCI. In clinical practice, patients with these risk factors should be identified and considered for psychosocial intervention targeting depression to enhance secondary prevention.

The SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery (SYNTAX) study: design, rationale, and run-in phase.

BACKGROUND: Changes in the treatment of coronary artery disease both surgically and percutaneously have rendered the major randomized trials historical. Furthermore, the restrictive criteria of previous trials excluded most patients treated in daily practice. Although coronary surgery is still considered the current, evidence-based, gold-standard treatment of left main (LM) and 3-vessel coronary disease, the added benefit of drug-eluting stents has further expanded the use of percutaneous coronary intervention (PCI) beyond less complex populations in daily practice. STUDY DESIGN: The 1500-patient, prospective, multicenter, multinational (European and North American), randomized SYNTAX study with nested registries will enroll "all-comers." Consecutive patients with de novo 3-vessel disease (3VD) and/or LM disease will be screened for eligibility by the Heart Team (composed of an interventionalist, a cardiac surgeon, and the study coordinator) at each site and then allocated to either (1) the randomized cohort, if comparable revascularization can be achieved by either PCI or coronary artery bypass surgery (CABG), or (2) to one of the nested registries for CABG-ineligible patients (PCI registry) or for PCI-ineligible patients (CABG registry). Randomized patients will be stratified based on LM disease and diabetes by site. The primary end point for the randomized comparison is noninferiority of major adverse cardiac and cerebral events between the 2 groups at 1 year. To adequately project the expected enrollment rate per site, a run-in phase was mandated for each site interested in participating in the trial. Both cardiothoracic and interventional cardiology departments within the same institution were asked to complete a questionnaire regarding their frequency of treatment of LM and 3VD over a retrospective 3-month period. IMPLICATIONS: By replacing most traditional inclusion and exclusion criteria with the real-world decision between the cardiothoracic surgeon and the interventionalist, this study will define the roles of CABG and PCI using drug-eluting stents in the contemporary management of LM and 3VD. Results of the run-in phase were used by the steering committee to determine eligibility and to project enrollment for each site.

Three-year clinical follow-up of the unrestricted use of sirolimus-eluting stents as part of the Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital (RESEARCH) registry.

Sirolimus-eluting stents (SESs) have been shown to decrease restenosis compared with bare metal stents (BMSs). Currently, there are limited data on the long-term efficacy of these devices in a real-world patient population. Furthermore, the potential of a late restenotic phenomenon has not yet been excluded. From April to October 2002, 508 consecutive patients with de novo lesions exclusively treated with SESs were enrolled and compared with 450 patients treated with BMSs in the preceding 6 months (control group). Patients in the SES group more frequently had multivessel disease and type C lesions, received more stents, and had more bifurcation stenting. After 3 years, the cumulative incidence of major adverse cardiac events (comprising death, myocardial infarction, and target vessel revascularization) was significantly lower in the SES group compared with the pre-SES group (18.9% vs 24.7%, hazards ratio 0.73, 95% confidence interval 0.56 to 0.96, p = 0.026). The 3-year risk of target lesion revascularization was 7.5% in the SES group versus 12.6% in the pre-SES group (hazards ratio 0.57, 95% confidence interval 0.38 to 0.87, p = 0.01). In conclusion, the unrestricted use of SESs is safe and superior to the use of BMSs. The beneficial effects, reported after 1 and 2 years in reducing major adverse cardiac events, persisted with no evidence of a clinical late restenotic "catch-up" phenomenon.

Risk factors for impaired health status differ in women and men treated with percutaneous coronary intervention in the drug-eluting stent era.

OBJECTIVES: In patients treated with percutaneous coronary intervention (PCI) in the drug-eluting stent era, we compared women's and men's health status 6 and 12 months post-PCI and investigated whether predictors of poor health status at 12 months are similar for women and men. METHODS: Consecutive patients (n=692; 28% women) treated with PCI completed the 36-item Short-Form Health Survey (SF-36) 6 and 12 months post-PCI. RESULTS: There was a significant improvement in health status over time (P<.001), but women experienced a significantly poorer health status compared with men (P<.001) at 6 and 12 months, adjusting for differences in baseline characteristics and health status at 6 months. Predictors of impaired health status were generally different for women and men. In women, the predominant predictors were previous coronary artery bypass graft (CABG) surgery, renal impairment, and older age; in contrast, in men, older age was associated with better functioning. In women, previous CABG was associated with a 4-15 fold increased risk of impaired health status. Health status at 6 months was a predictor of all SF-36 domains at 12 months in both women and men. CONCLUSIONS: Women reported poorer health status compared with men 6 and 12 months post-PCI, and predictors of impaired health status generally differed for women and men. Further studies examining risk factors for adverse outcomes for women and men separately, which will lead to better risk stratification in research and clinical practice, are warranted.

Anxiety enhances the detrimental effect of depressive symptoms on health status following percutaneous coronary intervention.

OBJECTIVE: We examined whether anxiety has incremental value to depressive symptoms in predicting health status in patients undergoing percutaneous coronary intervention (PCI) treated in the drug-eluting stent era. METHODS: A series of consecutive patients (n=692) undergoing PCI as part of the Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital registry completed the Hospital Anxiety and Depression Scale at 6 months and the Short-Form Health Survey (SF-36) at 6 and 12 months post-PCI. RESULTS: Of 692 patients, 471 (68.1%) had no symptoms of anxiety nor depression, 62 (9.0%) had anxiety only, 59 (8.5%) had depressive symptoms only, and 100 (14.5%) had co-occurring symptoms. There was an overall significant improvement in health status between 6 and 12 months post-PCI (P<.001); the interaction effect for time by psychological symptoms was also significant (P=.003). Generally, patients with co-occurring symptoms reported significantly poorer health status compared with the other three groups (Ps <.001). Patients with co-occurring symptomatology were also at greater risk of impaired health status on six of the eight subdomains of the SF-36 compared with the other three symptom groups, adjusting for baseline characteristics and health status at 6 months. CONCLUSION: Patients with co-occurring symptoms of anxiety and depression reported poorer health status compared with anxious or depressed-only patients and no-symptom patients, showing that anxiety has incremental value to depressive symptoms in identifying PCI patients at risk for impaired health status treated in the drug-eluting stent era.

Post-sirolimus-eluting stent restenosis treated with repeat percutaneous intervention: late angiographic and clinical outcomes.

BACKGROUND: We evaluated the clinical and angiographic outcomes of patients presenting with restenosis after sirolimus-eluting stent (SES) implantation treated with repeated percutaneous intervention. METHODS AND RESULTS: A total of 24 consecutive patients have undergone repeated percutaneous intervention to treat post-SES restenosis (27 lesions). The restenosis was located within the stent in 93% of lesions. From the 27 lesions, 1 (4%) was re-treated with a bare stent, 3 (11%) were treated with balloon dilatation, and the remaining 23 lesions (85%) were treated with repeated drug-eluting stent implantation (SES in 12 lesions [44%], paclitaxel-eluting stents in 11 lesions [41%]). The event-free survival rate was 70.8% after a median follow-up of 279 days from the post-SES treatment. The overall recurrent restenosis rate was 42.9%. The risk of recurrent restenosis was increased for patients with hypercholesterolemia, previous angioplasty, failed brachytherapy, post-SES restenosis needing early (<6 months) treatment, and post-SES restenosis treated with balloon dilatation. The recurrent restenosis rate of originally de novo lesions re-treated with drug-eluting stents was 18.2%. CONCLUSIONS: Even though de novo lesions treated with SES at baseline and re-treated with drug-eluting stents had reasonably better outcomes than other lesion types and strategies, our study shows that the treatment of post-SES restenosis is currently suboptimal and warrants further investigation.

Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy.

Although the safety profiles of coronary stents eluting sirolimus or paclitaxel do not seem to differ from those of bare metal stents in the short-to-medium term, concern has arisen about the potential for late stent thromboses related to delayed endothelialisation of the stent struts. We report four cases of angiographically-confirmed stent thrombosis that occurred late after elective implantation of polymer-based paxlitaxel-eluting (343 and 442 days) or sirolimus-eluting (335 and 375 days) stents, and resulted in myocardial infarction. All cases arose soon after antiplatelet therapy was interrupted. If confirmed in systematic long-term follow-up studies, our findings have potentially serious clinical implications.

Short- and long-term clinical benefit of sirolimus-eluting stents compared to conventional bare stents for patients with acute myocardial infarction.

OBJECTIVES: This study investigated the clinical outcomes of patients with ST-segment elevation myocardial infarction (MI) treated with sirolimus-eluting stents (SESs) or with conventional bare stents. BACKGROUND: The clinical impact of SES implantation for patients with ST-segment elevation MI is currently unknown. METHODS: Primary angioplasty was performed with SESs in 186 consecutive patients with acute MI who were compared with 183 patients treated with bare stents. The incidence of death, reinfarction, and repeat revascularization was assessed at 30 and 300 days. RESULTS: Postprocedure vessel patency, enzymatic release, and the incidence of short-term adverse events were similar in both the sirolimus and the bare stents (30-day rate of death, reinfarction, or repeat revascularization: 7.5% vs. 10.4%, respectively; p = 0.4). Stent thrombosis was not diagnosed in any patient in the sirolimus group and occurred in 1.6% of patients treated with bare stents (p = 0.1). At 300 days, treatment with SESs significantly reduced the incidence of combined adverse events (9.4% vs. 17%; hazard ratio [HR] 0.52 [95% confidence interval (CI) 0.30 to 0.92]; p = 0.02), mainly due to a marked reduction in the risk of repeat intervention (1.1% vs. 8.2%; HR 0.21 [95% CI 0.06 to 0.74]; p = 0.01). CONCLUSIONS: Compared to conventional bare stents, the SESs were not associated with an increased risk of stent thrombosis and were effective in reducing the incidence of adverse events at 300 days in unselected patients with ST-segment elevation acute MI referred for primary angioplasty.

"Full metal jacket" (stented length > or =64 mm) using drug-eluting stents for de novo coronary artery lesions.

BACKGROUND: Stented segment length was a predictive factor for restenosis in the bare metal stent era. The objective of the study was to evaluate the medium-term clinical outcome and the potential for adverse effects when very long segments (ie, > or =64 mm of stented length) are treated by drug-eluting stent (DES) implantation, an approach colloquially referred to as a "full metal jacket." METHODS: Since April 2002, we have used DES as the default stent for all percutaneous coronary interventions. From our prospective institutional database we identified 122 consecutive patients, with de novo coronary lesions, in whom a coronary artery was treated with at least 64 mm of overlapping DES: 81 patients were treated with sirolimus-eluting stents and 41 with paclitaxel-eluting stents. RESULTS: The mean number of stents per lesion was 3.3 +/- 1.1, and the median stented length was 79 mm (range 64-168 mm). Periprocedural Q-wave myocardial infarction (MI) occurred in 2 patients (1.6%) and subacute stent thrombosis in 1 patient (0.8%). During 1-year follow-up, 5 patients (4.1%), including 3 patients treated for acute MI with cardiogenic shock, died and 10 patients (8.2%) had nonfatal MI (creatine kinase-MB >3 times). The 1-year target vessel revascularization rate was 7.5% and the overall incidence of major adverse cardiac events was 18%. Outcomes in sirolimus-eluting stents and paclitaxel-eluting stents groups did not differ statistically. CONCLUSIONS: The use of DES for the treatment of diffuse lesions was associated with a low rate of repeat revascularization, irrespective of stent type. No safety concerns were raised at medium-term follow-up.

Immediate and one-year outcome of percutaneous intervention of saphenous vein graft disease with paclitaxel-eluting stents.

The aim of this study was to evaluate the outcome after paclitaxel-eluting stent implantation in 40 patients with 52 saphenous vein graft lesions. By Kaplan-Meier estimates, the probability of major adverse cardiac event-free survival for 1 year was 92.5%. A paclitaxel-eluting stent for saphenous vein graft disease appears to be feasible and safe, with a low rate of reintervention at 1 year, but late follow-up is needed to confirm these observations.