Real-world outcomes of endovascular treatment in a non-selected population with peripheral artery disease - prospective study with 2-year follow-up.

Background: The study aimed to evaluate the outcomes of percutaneous transluminal angioplasty (PTA) in lower-extremity peripheral artery disease (PAD) patients. Patients and methods: A multi-centre, observational study was performed with 32 German and Austrian centres contributing data to the PTA registry. Data of 1,781 patients with lower-leg and pelvic PAD who were suitable for endovascular PTA treatment were contributed from participating centres. Data from 1,533 patients are reported here (1,055 male and 478 female). This study did not have exclusion criteria. Quality of life (QOL) questionnaire (EQ-5D) scores, Rutherford classification, mortality, patency rate and details of major adverse cardiovascular events were collected at 6-, 12-, 18-, and 24-month follow ups. Results: PTA with/without stenting achieved 90.3 %, 86.5 %, 82.7 %, and 71.9 % technical success (recanalisation achieving ≥ 70 % patency, no evidence of embolisation, recoiling or dissection) in iliac, femoral, popliteal, and below-the-knee arteries, respectively. Procedural/postprocedural complications occurred in 142 (9.3 %, 1 death) and 74 (4.8 %) patients. QOL, mobility, self-care, activity, and pain/discomfort scores improved (p < 0.01), anxiety/depression was insignificantly improved. During follow-up, 409 (26.7 %) patients were hospitalised for PAD, 281 (18.3 %) required reintervention, and 145 (9.5 %) died or needed amputation (n = 49; 3.2 %). Multivariate analysis demonstrated poorer outcomes in patients with comorbidities. Conclusions: PTA with/without stenting is effective, safe, and widely applicable, with few complications. It improves QOL, but not anxiety/depression.

Predictors of early scaffold thrombosis: results from the multicenter prospective German-Austrian ABSORB RegIstRy.

BACKGROUND: In randomized clinical trials, the risk of thrombotic events with the absorb bioresorbable vascular scaffold (BVS) was significantly higher than with metallic drug-eluting stents. We evaluated predictors of scaffold thrombosis in the large-scale, multicenter German-Austrian ABSORB RegIstRy. METHODS AND RESULTS: 3178 patients with treatment of 4252 lesions using 5020 scaffolds were included. Follow-up rate at 6 months was 97.4%. Forty-five (1.42%) patients experienced definite/probable scaffold thrombosis during follow-up. Multiple regression analysis showed implantation of absorb BVS in bifurcation lesions [odds ratio (OR): 4.43; 95% confidence interval (CI): 1.69-11.59; P=0.0024] or treatment in the years 2013/2014 (OR: 1.88; 95% CI: 1.02-3.47; P=0.04) to be significant predictors of scaffold thrombosis. Excluding bifurcation lesions, the incidence of definite/probable scaffold thrombosis decreased from 1.8% (95% CI: 1.17-2.64%) in 2013/2014 to 0.89% (95% CI: 0.5-1.46%) in 2015/2016. In the latter period, absorb BVS were implanted more often in younger patients with less complex de novo lesions, and debulking devices and postdilatation were used more frequently. Between the two treatment periods, there was a significant reduction in myocardial infarction (2.73-1.24%, P<0.01; OR: 0.45; 95% CI: 0.26-0.77), definite/probable scaffold thrombosis (1.79-0.88%, P<0.05; OR: 0.49; 95% CI: 0.26-0.93), and target lesion failure and revascularization during follow-up. CONCLUSION: Improved procedural technique and more strict patient selection may explain a significant decrease in the absorb BVS thrombosis rates during the recruitment period of the large-scale German-Austrian ABSORB RegIstRy. In addition, treatment of bifurcation lesions was identified as an independent predictor of definite/probable scaffold thrombosis.

Coronary magnetic resonance imaging after routine implantation of bioresorbable vascular scaffolds allows non-invasive evaluation of vascular patency.

BACKGROUND: Evaluation of recurrent angina after percutaneous coronary interventions is challenging. Since bioresorbable vascular scaffolds (BVS) cause no artefacts in magnetic resonance imaging (MRI) due to their polylactate-based backbone, evaluation of vascular patency by MRI might allow for non-invasive assessment and triage of patients with suspected BVS failure. METHODS: Patients with polylactate-based ABSORB-BVS in proximal coronary segments were examined with 3 Tesla MRI directly (baseline) and one year after implantation. For assessment of coronary patency, a high-resolution 3D spoiled gradient echo pulse sequence with fat-saturation, T2-preparation (TE: 40 ms), respiratory and end-diastolic cardiac gating, and a spatial resolution of (1.08 mm)3 was positioned parallel to the course of the vessel for bright blood imaging. In addition, a 3D navigator-gated T2-weighted variable flip angle turbo spin echo (TSE) sequence with dual-inversion recovery black-blood preparation and elliptical k-space coverage was applied with a voxel size of (1.14 mm)3. For quantitative evaluation lumen diameters of the scaffolded areas were measured in reformatted bright and black blood MR angiography data. RESULTS: 11 patients with implantation of 16 BVS in the proximal coronary segments were included, of which none suffered from major adverse cardiac events during the one year follow up. Vascular patency in all segments implanted with BVS could be reliably assessed by MRI at baseline and after one year, whereas segments with metal stents could not be evaluated due to artefacts. Luminal diameter within the BVS remained constant during the one year period. One patient with atypical angina after BVS implantation was noninvasively evaluated showing a patent vessel, also confirmed by coronary angiography. CONCLUSIONS: Coronary MRI allows contrast-agent free and non-invasive assessment of vascular patency after ABSORB-BVS implantation. This approach might be supportive in the triage and improvement of diagnostic workflows in patients with postinterventional angina and scaffold implantation. TRIAL REGISTRATION: German Register of Clinical Studies DRKS00007456.

Evaluation of the short- and long-term safety and therapy outcomes of the everolimus-eluting bioresorbable vascular scaffold system in patients with coronary artery stenosis: Rationale and design of the German-Austrian ABSORB RegIstRy (GABI-R).

BACKGROUND: Third-generation drug-eluting metal stents are the gold standard for treatment of coronary artery disease. The permanent metallic caging of the vessel, however, can result in limited vasomotion, chronic inflammation, and late expansive remodeling, conditions that can lead to late and very late stent thrombosis. The development of bioresorbable scaffolds (BRSs) promises advantages over metal stents due to complete biodegradation within 2-4years. Theoretically, since vessel scaffolding is temporary and no permanent implant remains in the vessel, BRSs, as opposed to metal stents, once degraded would no longer be potential triggers for stent-related adverse events or side effects. METHODS/DESIGN: The short- and long-term outcome after implantation of an everolimus-eluting, poly-L-lactic acid-based bioresorbable scaffold system (ABSORB, Abbott Vascular, Santa Clara, CA, USA) in the world-wide greatest all-comers cohort will be evaluated in the prospective, non-interventional, multicenter German-Austrian ABSORB RegIstRy (GABI-R). GABI-R will include over 5000 patients from about 100 study sites in Austria and Germany. Safety endpoints such as cardiac death, myocardial infarction, and clinically driven percutaneous or surgical target lesion and vessel revascularization will be evaluated during hospitalization and in the follow-up period (minimum of 5years). CONCLUSION: Although two randomized controlled trials and several registries have documented safety and efficacy as well as non-inferiority of this everolimus-eluting ABSORB device compared with drug-eluting metal stents, the current knowledge regarding clinical application, treatment success, and long-term safety of using this BRS in daily routine is limited. Thus, the goal of GABI-R is to address this lack of information.

Long-term follow-up after coronary stenting with the sirolimus-eluting stent in clinical practice: results from the prospective multi-center German Cypher Stent Registry.

AIMS: To obtain long-term follow-up data of the sirolimus-eluting coronary stent (SES) and to determine factors associated with clinical events and target vessel revascularization (TVR). METHODS AND RESULTS: Between 2002 and 2005, 5,946 patients were treated with at least one SES. A follow-up after a median of 4.1 years was obtained in 5,247 patients (88.2 %). During the follow-up, death occurred in 9.2 % of patients, nonfatal myocardial infarction in 5.9 %, nonfatal stroke in 2.2 % and MACCE (death/myocardial infarction/stroke) in 16.3 %. Any TVR was performed in 20.3 %. Independent predictors of MACCE were: older age (p < 0.0001), renal insufficiency (p < 0.0001), prior myocardial infarction (p < 0.0001), diabetes mellitus (p < 0.0001), cardiogenic shock (p = 0.0002), three-vessel disease (p = 0.0012), reduced left ventricular function (p = 0.0048), target vessel = bypass graft (p = 0.0122), indication for treatment = ACS (p = 0.0181) and PCI before implantation (p = 0.0308). Independent predictors of TVR were target vessel = coronary bypass (<0.0001), two- or three-vessel disease (p < 0.0001), ostial lesions (p < 0.0001), total length of SES implanted (p = 0.0012) and older age being a protective factor (p = 0.0187). CONCLUSIONS: Long-term follow-up of the SES in clinical practice showed clinical event rates that were comparable to randomized trials with a MACCE rate of 16.3 % and TVR rate of 20.3 %.

Five-year results of the Multicenter Randomized Controlled Open-Label Study of the CYPHER Sirolimus-Eluting Stent in the Treatment of Diabetic Patients with De Novo Native Coronary Artery Lesions (SCORPIUS) study: a German multicenter investigation on the effectiveness of sirolimus-eluting stents in diabetic patients.

BACKGROUND: Because a delayed arterial healing response after drug-eluting stent implantation has raised concerns about safety in diabetic patients, long-term effects of treatment with sirolimus-eluting stent (SES), as compared with bare-metal stent (BMS), have to be established. The aim of the 5-year follow-up of the randomized, controlled, open-label multicenter SCORPIUS study was to assess long-term safety and efficacy of the CYPHER (Cordis, Johnson & Johnson, Bridgewater, NJ) SES in percutaneous coronary intervention of diabetic patients. METHODS: A total of 190 patients with type 2 diabetes mellitus were randomized to receive either a SES (n = 95) or a BMS (n = 95). Dual-antiplatelet therapy (aspirin plus clopidogrel) was prescribed for at least 6 months. Clinical follow-up data were scheduled at 1, 8, and 12 months and 5 years. RESULTS: Treatment with SES resulted in a 16% decrease in the rate of major adverse cardiac events (36% vs 52%; hazard ratio 0.6, 95% CI 0.4-0.9; P = .02). This reduction in major adverse cardiac events with SES at 5 years was mostly attributable to a lower number of repeat target lesion revascularization (13% vs 29%; hazard ratio 0.4, 95% CI 0.2-0.7; P = .003). No differences between groups were observed for safety end points (all-cause mortality 21% vs 21%, cardiac death 15% vs 13%, repeat myocardial infarction 8% vs 9%, and stent thrombosis 5% vs 6%) at 5 years. CONCLUSIONS: The 5-year follow-up of the SCORPIUS trial demonstrates the long-term antirestenotic efficacy of SES in diabetic patients with significantly reduced target lesion revascularization and comparable rates of mortality, myocardial infarction, and stent thrombosis compared with BMS.

Coronary stenting with the sirolimus-eluting stent in patients with restenosis after intracoronary brachytherapy: results from the prospective multicentre German Cypher Stent Registry.

BACKGROUND: Treatment of restenosis following intracoronary brachytherapy (ICB) is still a challenging problem. Implantation of sirolimus-eluting stents (SES) in this setting may be an option to be evaluated. METHODS AND RESULTS: We analysed the prospective multicentre SES registry, the German Cypher Stent Registry. 7,445 patients treated with an SES during percutaneous coronary intervention (PCI) were registered. Out of these patients, 61 (0.8%) were treated for restenosis after ICB: 56 patients with completed follow-up could be evaluated. Median age was 65 years, with 80% male patients. 48% of patients had a prior myocardial infarction and 25% had already coronary bypass surgery (CABG). Type B2 lesion was present in 40% and type C lesion in 22.4%. Event rates from SES implantation until 6.6 months follow-up were death 0%, myocardial infarction 3.6%, stroke 2.1%. Target vessel revascularization rate (TVR) was 16.4%, and major adverse cardiovascular or cerebral events (MACCE) or TVR occurred in 17.9% of patients. This TVR rate was higher compared with that of other patients treated with an SES: 8.4% (P = 0.04). During 65 months follow-up MACCE or TVR occurred in 44.6% of patients. CONCLUSIONS: The treatment of lesions after ICB occurred in 0.8% out of all patients treated with an SES. Clinical event rates during early follow-up were low. However, the TVR rate was 16.4%, which was significantly higher when compared with other SES-treated patients (8.4%, P = 0.04). The treatment of restenosis after ICB with SES seems to be safe and reasonably effective; however, there might be a late catch-up phenomenon.

Sirolimus-eluting stent treatment at high-volume centers confers lower mortality at 6-month follow-up: results from the prospective multicenter German Cypher Registry.

BACKGROUND: Studies continue to identify percutaneous coronary intervention procedural volume both at the institutional level and at the operator level as being strongly correlated with outcome. High-volume centers have been defined as those that perform >400 percutaneous coronary intervention procedures per year. The relationship between drug-eluting stent procedural volume and outcome is unknown. We investigated this relationship in the German Cypher Registry. METHODS AND RESULTS: The present analysis included 8201 patients treated with sirolimus-eluting stents between April 2002 and September 2005 in 51 centers. Centers that recruited >400 sirolimus-eluting stent patients in this time period were considered high-volume centers; those with 150 to 400 patients were considered intermediate-volume centers; and those with <150 patients were designated as low-volume centers. The primary end point was all death, myocardial infarction, and target-vessel revascularization at 6 months. This end point occurred in 11.3%, 12.1%, and 9.0% of patients in the low-, intermediate-, and high-volume center groups, respectively (P=0.0001). There was no difference between groups in the rate of target-vessel revascularization (P=0.2) or cerebrovascular accidents (P=0.5). The difference in death/myocardial infarction remained significant after adjustment for baseline factors (odds ratio 1.85, 95% confidence interval 1.31 to 2.59, P<0.001 for low-volume centers; odds ratio 1.69, 95% confidence interval 1.29 to 2.21, P<0.001 for intermediate-volume centers). Patient and lesion selection, procedural features, and postprocedural medications differed significantly between groups. CONCLUSIONS: The volume of sirolimus-eluting stent procedures performed on an institutional level was inversely related to death and myocardial infarction but not to target-vessel revascularization at 6-month follow-up. Safety issues are better considered in high-volume centers. These findings have important public health policy implications.

Prognostic value of the modified American College of Cardiology/American Heart Association lesion morphology classification for clinical outcome after sirolimus-eluting stent placement (results of the prospective multicenter German Cypher Registry).

The modified American College of Cardiology/American Heart Association (ACC/AHA) lesion morphology classification scheme has prognostic impact for early and late outcomes when bare-metal stents are used. Its value after drug-eluting stent placement is unknown. The predictive value of this lesion morphology classification system in patients treated using sirolimus-eluting stents included in the German Cypher Registry was prospectively examined. The study population included 6,755 patients treated for 7,960 lesions using sirolimus-eluting stents. Lesions were classified as type A, B1, B2, or C. Lesion type A or B1 was considered simple (35.1%), and type B2 or C, complex (64.9%). The combined end point of all deaths, myocardial infarction, or target vessel revascularization was seen in 2.6% versus 2.4% in the complex and simple groups, respectively (p = 0.62) at initial hospital discharge, with a trend for higher rates of myocardial infarction in the complex group. At the 6-month clinical follow-up and after adjusting for other independent factors, the composite of cumulative death, myocardial infarction, and target vessel revascularization was nonsignificantly different between groups (11.4% vs 11.2% in the complex and simple groups, respectively; odds ratio 1.08, 95% confidence interval 0.8 to 1.46). This was also true for target vessel revascularization alone (8.3% of the complex group, 9.0% of the simple group; odds ratio 0.87, 95% confidence interval 0.72 to 1.05). In conclusion, the modified ACC/AHA lesion morphology classification system has some value in determining early complications after sirolimus-eluting stent implantation. Clinical follow-up results at 6 months were generally favorable and cannot be adequately differentiated on the basis of this lesion morphology classification scheme.

Treatment of in-stent restenosis with sirolimus-eluting-stents: results from the prospective German Cypher stent registry.

AIMS: Drug-eluting stents have been reported to effectively reduce in-stent restenosis (ISR). However, the effectiveness and safety have yet been investigated only in small trials or case series. The aim of this prospective large scale registry was to show that treatment of ISR with sirolimus eluting stents (SES) is safe, effective and feasible in daily routine. METHODS AND RESULTS: The German Cypher registry prospectively enrolled 6,555 patients undergoing implantation with SES for various indications, including 1,533 patients treated for ISR. Follow-up data (median 6.6 months) of this cohort was available for 1,531 patients (99.8%). Of these patients 75.8% were male. Of these patients 36.5% (n = 552) presented with acute coronary syndromes. In total, 1,932 SES were used with successful implantation in 98.9%. MI during hospitalization was observed in 0.7% (n = 11) while in-hospital mortality was only 0.1% (n = 2). MACE-rate at follow-up was 13.8% (n = 211) including a mortality of 1.3% (n = 20) and MI in 1.9% (n = 29). Total revascularization procedures including CABG (1.7%) were necessary in 12.3% (n = 186). Target vessel revascularization (TVR) rate was 9.3% (n = 139) and thus similar to patients with de novo lesions (8.1%, P = 0.69). Ten patients (0.65%) suffered from subacute stent thrombosis Vs. 0.24% observed in patients with de novo lesions (P = 0.03). CONCLUSION: This large registry confirms that treatment of ISR with sirolimus-eluting-stents is effective and save with good clinical results at index procedure and follow-up. TVR was not different from de novo lesions.

Sirolimus-eluting stents in the treatment of chronic total coronary occlusions: results from the prospective multi-center German Cypher Stent Registry.

OBJECTIVES: We assessed the effectiveness and safety of the sirolimus-eluting stent (SES) in the treatment of chronic total coronary occlusions. BACKGROUND: Chronic total occlusions (CTO) of coronary vessels have an unacceptable high restenosis rate of approximately 50% after stenting. Few data exist about the performance of drug eluting stents (DES) in the treatment of CTO. METHODS: All coronary interventions using the Cypher stent performed at 122 centers engaged in the German Cypher registry between April 2002 and December 2004 were analyzed; a total of 5,344 patients; 374 with and 4,970 without CTO were compared. RESULTS: There was no significant difference between both groups regarding demographics, coronary status and left ventricular function. Patients in the CTO group had a higher level of angina symptoms, the coronary lesions were more complex and the stents used were smaller and longer than in the No-CTO group. The In-hospital outcome was similar in both groups, with importantly no difference regarding mortality and complications. Stenting was as successful in the CTO as in the No-CTO group; during a follow-up of 6.6 months we found no significant difference regarding the rate of mortality, complications, and revascularization between both groups. CONCLUSIONS: Implantation of the Cypher stent reduces the restenosis rate and seems to be a safe and effective tool for the treatment of chronic total coronary occlusions.

Sirolimus eluting stent (Cypher) in patients with diabetes mellitus: results from the German Cypher Stent Registry.

BACKGROUND: Patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention (PCI) are at increased risk for adverse outcomes. The use of sirolimus eluting stents (SES) has been shown to improve outcomes in diabetic patients. Since results from randomized trials were derived from selected patients scientific scrutiny under real world conditions is necessary. METHODS AND RESULTS: 1,948 patients with DM and 4,707 patients without DM were included in the German Cypher Registry, a post-marketing survey of use of SES in Germany. In >99% of entry cases a structured clinical follow-up was completed. By angiographic criteria severity of coronary artery disease was higher in diabetic patients compared to non-diabetics. However, procedural success and in-hospital complication rates were comparable between DM- and non-DM-patients. 6 months MACE rate in the DM group was significantly higher than in the non-DM group (16.4% vs. 13.0%) but lower than expected from historical data with the use of bare metal stents (BMS). CONCLUSION: The results with SES in diabetics are encouraging but DM remains a risk factor for poor outcome of PCI. No statement is justified whether the treatment of diabetics with SES is at least as safe as bypass surgery. This intriguing question has to be answered in a direct randomized head-to-head comparison with state of the art surgery.

One-year results of the SCORPIUS study: a German multicenter investigation on the effectiveness of sirolimus-eluting stents in diabetic patients.

OBJECTIVES: This study sought to analyze the effectiveness of drug-eluting stents in a high-risk group of diabetic patients. Previously, this had been analyzed only in substudies of larger trials or in clinical investigations enrolling a small number of patients. BACKGROUND: Drug-eluting stents are highly effective in reducing the rate of in-stent restenosis. METHODS: Two hundred patients with diabetes and de novo coronary artery lesions were enrolled in 16 centers: 98 were randomly assigned to sirolimus-eluting stents (SES) and 102 received bare-metal stents (BMS). The primary end point was in-segment late luminal loss. Major adverse cardiac events (MACE) rate was analyzed at 30 days and 8 and 12 months. RESULTS: The extent of in-segment late luminal loss in the SES group was 0.18 mm compared with 0.74 mm in the BMS group. In-segment restenosis was identified on follow-up angiography in 8.8% of the patients in SES and in 42.1% in BMS (p < 0.0001). Target lesion revascularization was performed in 5.3% of the patients in SES and in 21.1% of the patients in BMS (p = 0.002). The SES was effective in the treatment group with oral diabetic medication as well as in the insulin-dependent treatment group (3.6% SES vs. 38.8% BMS). There was no subacute stent thrombosis in the SES group up to 1 year. The MACE rate was not significantly different at 30 days. At 12 months, MACE rate was 14.7% in SES versus 35.8% in BMS. CONCLUSIONS: The SES is safe and highly effective in patients with diabetes mellitus and coronary artery disease and associated with a significant decrease in the extent of late luminal loss.

Implantation of sirolimus-eluting stents in saphenous vein grafts is associated with high clinical follow-up event rates compared with treatment of native vessels.

AIMS: The clinical effectiveness of sirolimus-eluting stents (SES) for treatment of patients with saphenous vein graft disease is not well defined. This analysis sought to evaluate the clinical follow-up after treatment of stenotic saphenous vein grafts using SES in a large patient registry. Patients treated with SES for saphenous vein graft disease were compared with patients receiving SES in native vessel disease. METHOD: This is a subanalysis from the prospective multicenter German Cypher Stent Registry. Only patients with completed 6 months clinical follow-up were included. The analysis comprises 344 patients with 353 lesions in saphenous vein grafts treated with 400 SES (Cypher, Cordis Inc., Cordis Corp., Warren, New Jersey, USA) and 6411 patients with 7607 native coronary artery lesions treated with 8725 SES. RESULTS: Mean SES length per lesion was 22.6+/-11.7 mm and mean stent diameter 3.0+/-0.3 mm in saphenous vein graft lesions. Target vessel revascularization rate was 18.1% and major adverse cardiovascular events (MACE) rate was 23.8% at 6-month follow-up after SES implantation for saphenous vein graft lesions. Even after adjustment for different baseline characteristics, target vessel failure and MACE rate were significantly higher after SES implantation for saphenous vein graft lesions than for native coronary vessel stenosis [odds ratio: 2.10 (95% confidence interval: 1.40-3.13), P<0.001] and [odds ratio: 2.15 (95% confidence interval: 1.49-3.09), P<0.001], respectively. CONCLUSION: Treatment of saphenous vein graft disease is associated with high target vessel revascularization and MACE rates also with the use of SES if applied to unselected patients. Target vessel revascularization and MACE rates remain significantly higher after SES for saphenous vein graft lesions than after SES in native vessel disease.

Outcome in the elderly undergoing percutaneous coronary intervention with sirolimus-eluting stents: results from the prospective multicenter German Cypher Stent Registry.

BACKGROUND: Patients older than 75 years undergoing percutaneous coronary interventions are at increased risk for major adverse cardiac events strongly influenced by comorbidities. In various randomized trials, sirolimus-eluting stent (SES) implantation has been shown to decrease the incidence of in-stent restenosis and to reduce repeat revascularization regardless of patient age. METHODS: The present study evaluates the outcome after SES implantation in 954 patients older than 75 years compared with 5801 patients younger than 75 years enrolled in the German Cypher Registry in a routine clinical setting. RESULTS: The elderly were at higher risk regarding renal failure, diabetes, hypertension, impaired left ventricular function, and 3-vessel disease. The SES implantation resulted in an impressive relief of angina. As expected, in-hospital and 6-month mortality rates were higher in the elderly. However, there was no difference with respect to the rate of major adverse cardiac events (death, myocardial infarction, ischemia-driven target vessel revascularization) at 6-month follow-up. CONCLUSIONS: Nonfatal complications such as myocardial infarction or repeat target vessel revascularization did not increase with age, even taking patients older than 80 years into account.

Sirolimus-eluting stent treatment for unprotected versus protected left main coronary artery disease in widespread clinical routine: 6-month and 3-year clinical follow-up results from the prospective multicentre German Cypher Registry.

BACKGROUND: Percutaneous coronary intervention (PCI) of left main coronary artery (LMCA) disease in the bare stent era was limited by high restenosis rates which eventually resulted in sudden death in unprotected cases. Clinical and angiographic restenosis has been substantially reduced by drug-eluting stents, reviving therefore this indication for PCI despite the absence of direct comparative studies with coronary artery bypass graft surgery. OBJECTIVE: To assess the acute, mid- and long-term outcomes of patients treated with sirolimus-eluting stents for unprotected LMCA stenoses and to compare them with those treated for protected LMCA disease in the same time period from the German Cypher Registry. SETTING AND PATIENTS: The German Cypher Registry included 6755 patients. Eighty-two patients treated for unprotected LMCA disease were compared with 118 patients treated for protected LMCA stenoses. All patients were treated by sirolimus-eluting stents. The primary end point was death, myocardial infarction (MI) and target vessel revascularisation at 6 months' follow-up. Survival free of MI at the long term was considered as the safety end point. RESULTS: One-third of the patients in both groups were treated for the distal left main bifurcation. Angiographic success was 98.5% for both groups. The cumulative combined incidence of all-cause death, non-fatal MI and target vessel revascularisation at 6 months was 14.1% in the unprotected LMCA group and 13.1% in the protected group (hazard ratio = 0.81 (95% CI 0.37 to 1.74), p = 0.8). At long-term, death/MI were reported among 20.2% (95% CI 13.5% to 29.6%) of the protected group versus 11.8% (95% CI 6.3% to 21.4%) of the unprotected group (p = 0.2). CONCLUSION: Sirolimus-eluting stent treatment of unprotected and protected LMCA stenoses is technically feasible in widespread routine clinical use. Acceptable long-term clinical results can be achieved, with no particular safety concerns about treatment of unprotected LMCA disease.

The Sirolimus-eluting coronary stent in daily routine practice in Germany: trends in indications over the years. Results from the prospective multi-centre German Cypher Stent Registry.

BACKGROUND: Drugeluting coronary stents (DES) are increasingly used during percutaneous coronary interventions (PCI). Due to limited budgets in Germany, no special reimbursement has been given for their use and therefore they were mainly used in selected patients. METHODS: In order to determine the change in indications in patients treated with a Sirolimus-eluting stent (SES) in daily clinical practice between 2002 and 2005, we analysed data from a prospective multi-centre DES registry, the German Cypher Stent Registry. RESULTS: From April 2002 until September 2005, 11 507 patients at 132 hospitals, who received at least one SES during their PCI, were included. Between 2002 and 2005, the median age of patients increased from 63 years to 66 years (p for trend <0.0001), whereas the prevalence of prior coronary bypass surgery (p<0.0001) and prior PCI (p<0.001) significantly decreased. Initial presentation of patients was stable over time, with a small increase of patients treated for non-ST elevation myocardial infarction (p=0.05). We found a significant increase in the treatment of complex stenoses (p<0.0001) as well as an increase in the proportion of chronic total occlusions (p<0.01). There was a steady increase in the proportion of patients treated for de novo lesions (p<0.0001), which was accompanied by a relative decrease in the proportion of patients treated for in-stent restenosis (p<0.0001). Concerning interventional characteristics a significant increase in the length of SES implanted per lesion, the numbers of SES implanted per lesion as well as an increase of the proportion of patients treated for more than one stenosis during one intervention could be observed (all p<0.0001). There was a significant decrease in the use of glycoprotein II b/IIIa antagonists during the PCI (2002: 26.5 to 14.2% in 2005, p<0.0001). MACE rates until hospital discharge did not change significantly over time. CONCLUSIONS: Between 2002 and 2005 there were two trends in the use of SES: a) a significant increase in the use of SES for de novo lesions and b) a significant trend to use SES for longer lesions, smaller arteries, more complex lesions and more SES per lesion. In summary these findings indicate that still SES are mainly used in patients with lesions that are at high risk for restenosis.