1-year Major Adverse Cardiac Events Rates Research Articles

Abstract 324: Real World Use of Bivalirudin in ST-Elevation Myocardial Infarction is Associated with Lower In-Hospital Complications, 1-Year Major Adverse Cardiac Events and Mortality

Background: Bivalirudin decreased bleeding and improved mortality in ST-elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention (PCI) in the HORIZON trial. Currently there is limited data regarding the benefits of bivalirudin in unselected STEMI patients in real-world clinical practice. Methods: We reviewed consecutive STEMI patients at a large regional STEMI referral center from June 2009 to December 2011. All patients received aspirin and P2Y12 inhibitors. In-hospital complications, length of stay (LOS), total variable costs, 1-year cardiovascular readmissions, major adverse cardiac events (MACE) and mortality were compared for: bivalirudin alone, heparin alone and either medication with IIb/IIIa inhibitors. Results: Among 759 STEMI PCI cases, 208 (27.4%) received bivalirudin, 216 (28.5%) heparin and 335 (44.1%) IIb/IIIa, including only 48 cases with bivalirudin. Bivalirudin alone had significantly lower in-hospital complications, bleeding events, mortality and 1-year MACE and mortality (p<0.05 for all) (Figure). There were no significant differences in LOS (median 2.6 vs. 2.8 vs. 2.9 days; p=0.065), total variable costs (median $9,303 vs. $9,242 vs. $9,860; p=0.15) or readmissions within 1 year. Conclusions: In an unselected population of STEMI patients, those treated with bivalirudin had lower in-hospital complications and lower 1-year MACE and mortality rates compared to patients receiving heparin or IIb/IIIa inhibitors. These results provide further support for bivalirudin use in STEMI patients.

Randomized Comparison of Clinical Outcomes Between Intravascular Ultrasound and Angiography-Guided Drug-Eluting Stent Implantation for Long Coronary Artery Stenoses

This study sought to assess the impact of intravascular ultrasound (IVUS) guidance on clinical outcomes following drug-eluting stent implantation when treating long lesions. The role of IVUS guidance when treating long lesions has been tested during bare-metal stent, but not during drug-eluting stent, implantation. A total of 543 patients treated with stents ≥ 28 mm in length were randomly assigned to IVUS guidance (n = 269) versus angiography guidance (n = 274). The primary endpoint was a composite of major adverse cardiac events (MACE), including cardiovascular death, myocardial infarction, target vessel revascularization, or stent thrombosis at 1 year following intervention. In the intention-to-treat analysis, total stent length was 32.4 mm in the IVUS-guided arm versus 32.3 mm in angiography-guided arm (p = 0.84). Adjunct post-dilation was more frequently performed in the IVUS-guided arm (54.6% vs. 44.5%, p = 0.03); post-intervention minimal lumen diameters were similar (2.55 vs. 2.55 mm, respectively, p = 0.50); and MACE occurred in 12 (4.5%) patients in IVUS-guided arm and in 20 (7.3%) patients in the angiography-guided arm (p = 0.16). However, among the 269 patients assigned to IVUS guidance, IVUS was not used in 13 patients (4.8%); conversely, in 274 patients assigned to angiography alone, 41 patients (15.0%) were treated with IVUS guidance. Therefore, in a per-protocol analysis according to actual IVUS usage, minimum lumen diameter was larger (2.58 vs. 2.51 mm, p = 0.04), and MACE rates were lower: 4.0% in the IVUS-guided arm versus 8.1% in the angiography-guided arm (p = 0.048). A strategy of routine IVUS for drug-eluting stent implantation in long lesions did not improve the 1-year MACE rates. The IVUS use per operator decision was associated with improved results. (A New Strategy Regarding Discontinuation of Dual Antiplatelet; NCT01145079).

Comparison of Double Kissing Crush Versus Culotte Stenting for Unprotected Distal Left Main Bifurcation Lesions

The study aimed to investigate the difference in major adverse cardiac event (MACE) at 1-year after double kissing (DK) crush versus Culotte stenting for unprotected left main coronary artery (UPLMCA) distal bifurcation lesions. DK crush and Culotte stenting were reported to be effective for treatment of coronary bifurcation lesions. However, their comparative performance in UPLMCA bifurcation lesions is not known. A total of 419 patients with UPLMCA bifurcation lesions were randomly assigned to DK (n = 210) or Culotte (n = 209) treatment. The primary endpoint was the occurrence of a MACE at 1 year, including cardiac death, myocardial infarction, and target vessel revascularization (TVR). In-stent restenosis (ISR) at 8 months was secondary endpoint, and stent thrombosis (ST) served as a safety endpoint. Patients were stratified by SYNTAX (Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) and NERS (New Risk Stratification) scores. Patients in the Culotte group had significant higher 1-year MACE rate (16.3%), mainly driven by increased TVR (11.0%), compared with the DK group (6.2% and 4.3%, respectively; all p < 0.05). ISR rate in side branch was 12.6% in the Culotte group and 6.8% in the DK group (p = 0.037). Definite ST rate was 1.0% in the Culotte group and 0% in the DK group (p = 0.248). Among patients with bifurcation angle ≥70°, NERS score ≥20, and SYNTAX score ≥23, the 1-year MACE rate in the DK group (3.8%, 9.2%, and 7.1%, respectively) was significantly different to those in the Culotte group(16.5%, 20.4%, and 18.9%, respectively; all p < 0.05). Culotte stenting for UPLMCA bifurcation lesions was associated with significantly increased MACEs, mainly due to the increased TVR. (Double Kissing [DK] Crush Versus Culotte Stenting for the Treatment of Unprotected Distal Left Main Bifurcation Lesions: DKCRUSH-III, a Multicenter Randomized Study Comparing Double-Stent Techniques; ChiCTR-TRC-00000151).

Outcomes of Patients With Prior Coronary Artery Bypass Grafting and Acute Coronary Syndromes: Analysis From the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) Trial

This study sought to assess the contemporary outcomes of patients with prior coronary artery bypass graft (CABG) who present with moderate and high-risk acute coronary syndromes (ACS) and are treated with an early invasive strategy and contemporary antithrombin regimens. The prognosis of patients with ACS and prior CABG in relation to triage strategy and contemporary antithrombotic regimens is unknown. In the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial, 2,475 of 13,764 patients (18.0%) with ACS managed with an early invasive strategy had previously undergone CABG. Their outcomes were examined according to treatment and randomized antithrombin regimen. Prior CABG was associated with older age, more frequent comorbidities, higher Thrombolysis In Myocardial Infarction risk score, and lower left ventricular ejection fraction. Patients with versus without prior CABG were less likely to undergo (repeat) CABG and were more likely to be managed medically. At 1 year, patients with versus without prior CABG had higher rates of major adverse cardiac events (MACE) (22.5% vs. 15.2%, p < 0.0001) due to greater mortality (5.4% vs. 3.9%, p < 0.0001), myocardial infarction (10.0% vs. 6.8%, p < 0.0001), and unplanned revascularization (13.1% vs. 8.2%, p < 0.0001). History of CABG was an independent predictor of MACE. The 1-year MACE rates were not significantly different after randomization to bivalirudin versus heparin plus a glycoprotein IIb/IIIa inhibitor (odds ratio: 1.24, 95% confidence interval: 0.90 to 1.70). Despite the progress in the treatment of coronary artery disease, patients with prior CABG and ACS have a poor prognosis, substantially worse than for those without prior CABG. Whereas bivalirudin monotherapy was an acceptable treatment for these patients, it did not improve their prognoses.

Abstract 4487: Clopidogrel Resistance in Patients Undergoing Percutaneous Coronary Intervention: One Year Outcome

Background: Clopidogrel therapy is critical in patients undergoing percutaneous coronary intervention (PCI). Data are lacking on long term outcomes of clopidogrel resistance (CR) and its definition. Methods: We identified 389 patients who underwent PCI during a 6 month period. Using the VerifyNow Point-of-care assay, P2Y12 platelet reaction units (PRU) and percent inhibition of platelet activation (IPA) were measured 16 –24 hours after the loading dose of clopidogrel (600mg for patients not on clopidogrel daily, and 300mg for patients on clopidogrel 75mg daily) but before the next day clopidogrel dose. CR was defined as PRU &gt;200, %IPA&lt;10% or IPA&lt;20%. Major adverse cardiac events (MACE) included death, myocardial infarction, coronary artery bypass graft surgery and unplanned repeat coronary revascularization. Results: Mean age of patients was 65±11 years, 24% females and 31% diabetics. PRU mean value is 173±93, IPA mean value=47.5±42, CR is found in PRU&gt;200 =36%(140), IPA&lt;10% =8%(31), IPA &lt;20% = 16.4%(64) patients. Presence of myocardial infarction, hypertension, hyperlipidemia, renal disease, smoking history, stable or unstable angina at admission were similar between the PRU groups and between IPA groups. Diabetes and older age were more prevalent in clopidogrel resistance patients. 1-year MACE rates are shown below. Conclusion: Clopidogrel resistance is an important predictor of long-term MACE in patients undergoing PCI, particularly when defined as Platelet Reaction Units &gt;200.

Elective implantation of sirolimus-eluting stents for bifurcated and non-bifurcated unprotected left main coronary artery lesions: clinical outcomes at one year

Recent studies of drug-eluting stents for unprotected left main coronary artery (LMCA) disease have been encouraging. We examined the performance of sirolimus-eluting stents (SES) for this indication. This retrospective study included 228 consecutive patients (mean age = 68 +/- 11 years, 80.6% men, 26.3% diabetics) who underwent implantation of SES for de novo LMCA stenoses. The mean additive and logistic EuroSCOREs were 5.2 +/- 3.9 and 8.2 +/- 13.2, respectively. The main objective of this study was to measure the rate of major adverse cardiac events (MACE), including death, myocardial infarction and target lesion revascularisation (TLR) at 12 months. Other objectives were to measure the rates of in-hospital MACE and 12-month TLR. Outcomes in 143 patients with (BIF+ group), versus 84 patients without (BIF-group) involvement of the bifurcation were compared. The pre-procedural percent diameter stenosis (%DS) was 60.1 +/- 11.2 in the BIF+ versus 54.7 +/- 12.2% in the BIF- group (p=0.008), and decreased to 18.0 +/- 9.7 and 13.9 +/- 11.3%, respectively (ns), after SES implant. The overall in-hospital MACE rate was 3.5%, and similar in both subgroups. The 1-year MACE rate was 14.5% overall, 16.8% in the BIF+ and 10.7% in the BIF- subgroup (ns). SES implants in high-risk patients with LMCA stenoses were associated with a low 1-year MACE rate. Stenting of the bifurcation was associated with significant increases in neither mortality nor 1-year MACE rate.

Impact of bifurcation lesions on clinical outcome and prognosis of primary angioplasty in acute myocardial infarction

The aim of this study was to determine the impact of bifurcation lesions on outcomes after primary percutaneous intervention (PCI) for acute myocardial infarction. We retrospectively reviewed a single-centre database of 646 patients admitted for primary angioplasty within 12 hours after AMI. We compared baseline characteristics and outcomes between bifurcation and non-bifurcation lesions. Bifurcation lesions were found in 23% of patients. They predominantly involved the left anterior descending artery. Provisional T-stenting was used in 89.3% of patients (with stenting of the main branch in 82% and of both branches in 7.3%), side-branch protection in 54.6%, and final kissing balloon inflation in 33%. The procedural success rate was 92% for the main branch of bifurcation lesions compared with 93% for non-bifurcation lesions (P=0.65). Major adverse cardiac event (MACE) rates were comparable in the two groups: in-hospital MACE was 13.3% in the bifurcation group versus 11.4% in the non-bifurcation group (P=0.72), and the 1-year total MACE rate was 22.6% in the bifurcation group versus 19.5% in the non-bifurcation group (P=0.56). Bifurcation lesions are common in patients with AMI. In a population with AMI, immediate and mid-term outcomes of primary PCI were similar in patients with and without bifurcation lesions.

Debulking of chronic coronary total occlusions with rotational or directional atherectomy before stenting: Final results of DOCTORS study

Objective To evaluate the safety and efficacy of pre-stent plaque debulking strategy for percutaneous coronary intervention for CTO. Background Drug-eluting stents (DES) reduce lesion recurrence after percutaneous coronary intervention for chronic total occlusion (CTO). However, massive plaque burden or calcified plaque sometime hinders optimal stenting. The aim of the study was to investigate the safety and the effectiveness of pre-stent plaque debulking in CTOs. The primary end-point was the angiographic restenosis rate at 6 months. Secondary end-points were the major adverse cardiac event (MACE) at 30 days and at 1 year. Method Between October 2000 and July 2003, 266 patients with CTOs were evaluated in 21 Japanese centers. After successful wire crossing, an operator judged the indications for a debulking strategy (177 patients for rotational and 89 for directional atherectomy). The subjects were then randomly assigned to a debulking (rotational: 90, directional: 48) or non-debulking (rotational: 87, directional: 41) group. Result Baseline clinical and lesion characteristics showed no differences between the groups. The debulking group tended to have the higher 30-day MACE rate than the non-debulking group (15.9% vs 8.5%, P = 0.07). Although binary 6 month restenosis rates did not reach statistical significance (debulking 23.8% vs non-debulking 34.6%; P = 0.072), the 1-year MACE rate was lower in the debulking group than in the non-debulking group (27.5% vs 39.8%; P = 0.033). Conclusion This study demonstrated that pre-stent plaque debulking of CTO was associated with a favorable mid-term outcome with lower target revascularization rate in the debulking group than in the non-debulking group.